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K14 0559SECHRISTMAY 302014INDUSTRIES, INC.510(k) SUMMARYDate PreparedApril 25, 1. Submitter Device Information510(k) Owners NameSechrist Industries, Inc. Contact Information2.3.Victor C.ArellanoDirector Regulatory Affairs, Product Safety & Certification InformationTrade/Proprietary NameModel 3300H/HR Monoplace Hyperbaric OxygenChamberModel 3600H/HR Monoplace Hyperbaric OxygenChamberDevice Common NameMonoplace Hyperbaric ChamberClassification NameHyperbaric Chamber (21 CFR 868.5470, Product CodeCBF)Predicate Device informationLegally marketed device to which we are claiming equivalence is the Sechrist Model4100H-/1-R1 Hyperbaric Chamber originally cleared under 510(k) K1002684.General DescriptionA hyperbaric oxygen chamber is a pressure vessel and control system that is designed toprovide patient exposure to a very high oxygen concentration at higher than normalatmospheric pressure. Titration of the oxygen exposure is controlled by selecting thepressure achieved within the pressure vessel. Pressurization and dle-pressurization ratesare selected to minimize patient discomfort while increasing and decreasing the chamberpressure. Typical monoplace chambers are capable of pressurizing to 3 ATA (29.4 psigabove atmospheric pressure). The typical pressurization and dle-pressurization rates are inthe range of 0.4 to 5.0 psig/minute.
510(K) SUMMARYSPECIAL 510(K) PREMARKET NOTIFICATION3300H/HR and 3600H/HR Hyperbaric ChamberThe Sechrist Models 3300H/HR and 3600H/HR Hyperbaric Chambers are monoplacepressure chambers designed to administer 100% oxygen at pressure greater than ambient,up to 3 atmospheres absolute (30 psig) of pressure. These hyperbaric chambers consist ofa mechanical and pneumatic system capable of controlling the operator definedpressurization profiles.These Hyperbaric Chambers are constructed with a horizontal seamless acrylic viewportwhich varying internal diameter sizes.ModelsInternal Diameter3300H/HR Hyperbaric Chambers32.50 inches (83 cm)3600H/HR Hyperbaric Chambers35.50 inches (90 cm)Each model is equipped with a clear anodized aluminum cover on one end and the otherend with a hard anodized door assembly, with access ports available for patient interface(such as patient monitoring, delivery of intravenous fluids, etc.) locking mechanism andinterlocking safety device.The cylinder, end cover and the door assembly are assembled together with stainless steeltie rods/nuts and hinge assembly. Each Hyperbaric Chamber Model comes in twoconfigurations designated with a suffix of "H" and "HR't The suffix "H" is the Standardconfiguration where the control panel is located on the left of the chamber when facingthe door and the door opens from left to right. The suffix "HR" is the Reverseconfiguration where the control panel is located on the right side of the chamber and thedoor opens from right to left.The functional performance system and the safety features incorporated in the Models3300H/HR and 3600H/HR Hyperbaric Chambers are the same that have beenincorporated into the design of the Model 4100H/HR predicate device.A pressurization cycle counter is provided to maintain a record of the number ofpressurization cycles the chamber experienced.A two-way intercommunication system is used to maintain contact between patient andattendant.Page 2 of 20
510(K) SUMMARYSPECIAL 510(K) PREMARKET NOTIFICATION3300)-/HR and 3600H/HR Hyperbaric Chamber5.Statement of Intended UseThe intended use of the Sechrist Model 3300H/HR and Model 3600H/HR HyperbaricChambers are to administer 100% oxygen at pressure greater than ambient, up to 3atmospheres absolute (30 psi) of pressure.Specific indication for use of the hyperbaric chambers have been established by theCommittee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric MedicalSociety (founded in 1967 to foster exchange of data on the physiology and medicine ofcommercial and military diving). The committee is comprised of practitioners andscientific investigations in the fields of internal medicine, infectious diseases,pharmacology, emergency medicine, general surgery, orthopedic surgery and aerospacemedicine. The committee is responsible for continually reviewing research and clinicaldata in determining the safety and efficacy of hyperbaric oxygen. Currently, there arethirteen indications that are approved by the committee; these thirteen indications wereaccepted based on sound physiologic rationale, in vivo or in vitro studies that demonstrateeffectiveness, controlled animal studies, prospective controlled clinical studies andextensive clinical experience from multiple hyperbaric medicine centers. These thirteenindications have been recommended for third-party reimbursements and most insurancecarriers have established reimbursement policy based on these recommendations.The thirteen indications are:1.Air or Gas embolism2.Carbon Monoxide PoisoningCarbon Monoxide Poisoning Complicated by Cyanide Poisoning3.Clostridial Myonecrosis and Myonecrosis (Gas Gangrene)4.Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemnia'sS.Decompression Sickness6.Arterial InsufficienciesCentral Retinal Artery OcclusionEnhancement of Healing In Selected Problem Wounds7.Severe Anemia8.Intracranial Abscess9.PNecrotizing Soft Tissue Infections10. Osteomyelitis (Refractory)11. Delayed Radiation Injury (Soft Tissue and Bony Necrosis)12. Comprised Grafts and Flaps13. Thermal BurnsPage 3 of 20
510(K) SUMMARYSPECIAL 510(K) PREMARKET NOTIFICATION3300K/HR and 3600K/HR Hyperbaric Chamber6.SUMMARY OF TECHNOLOGICAL CHARACTERISTICS6.1.CHAMBER CONTROLSThe Models 3300H/HR and 3600H/HR Hyperbaric Chambers both use the samecontrol panel knobs and switches as used in the predicate device 4100H/HR.Following is description of the chamber controls.6.1.1.Master ValveThis is a rotary pneumatic valve with three positions. The available positions allowthe operator to select the following modes.a) Ventb) Offc) OnSpecificationa) Valve Type:b) Function Positions:c) Operiting Pressure:6.1.2.3-position pneumatic valve rotary selectorON, OFF, Emergency Vent50 - 70 ps igOFF ModeWhen the Master Valve is in OFF mode, the hyperbaric chamber will not becapable of developing internal pressure, and the door can be opened and closed.6.1.3.ON ModeThe ON mode shall not be capable of operation unless the chamber door is closedand in the locked position. When the Master Valve is in ON mode, the hyperbaricchamber shall automatically start developing internal pressure (compressing) up tothe Pressure Set pointand at a rate established by the Rate Set control providedthe door is closed and the Door Safety Interlock is engaged. The chamber doorcannot be unlocked if there is more than approximately 1 psig pressure within thehyperbaric chamber6.1.4.Emergency Vent MadeThe Emergency Vent Mode allows the operator to depressurize the hyperbaricchamber rapidly to gain rapid access to the patient in an emergency situation. Toactivate the Emergency Vent, the Emergency Vent Mode is first selected via theMaster Valve and the pneumatic push button manually depressed to actuatepneumatic valves to accomplish a decompression at a maximum rate of 30psig/min.Specification(a) Control Type:(b) Time:Pneumatic push-button30 psig to.0 psig in 119 sec maxPage 4 of 20
510(K) SUMMARYSPECIAL 510(K) PREMARKET NOTIFICATION330011/HR and 360011/HR Hyperbaric Chamber6.1.5.Ventilation (Purge) Flow Rate ControlThe Ventilation Flow Rate Control allows the operator to adjust the purge flow rateat which gas exhausts from the hyperbaric chamber during treatment. Duringtreatment, once the chamber reaches desired pressure and oxygen concentration,the high ventilation rate may not be necessary and so to conserve oxygen, flowrate can be reduced. This range is clearly marked near the control valve.Specification(a)(b)(c)(d)Single Turn Gate ValveControl Type:Ventilation (Purge) Flow Rate: 80 to 400 1pm min @ 15 psig Chamber Pressure80 to 200 1pmO2 Conservation Range:SOpm of setting50Tolerance:6.1.6.Pressure Set ControlThe desired hyperbaric chamber pressure is adjusted by the rotary Set PressureControl knob.Specification(a)(b)(c)(d)(e)Control Type:Range:Idle/Default Pressure:Resolution:Tolerance:6.1.7.Multi-turn, rotary regulating valve1.5 to 30.0 psig or equivalent units1.5 psig or equivalent units0.2 psig or equivalent units 0.5 psig of settingRate Set ControlThe desired pressurization/depressurization rate of the hyperbaric chamber isadjusted by a rotary Rate Set Control knob. The Rate Set is the rate required toreach the desired hyperbaric chamber pressure. The pneumatic system is capableof developing the Set Rate of pressure change within the chamber on a 1:1 ratio.Specification(a)(b)(c)(d)(e)Control le-turn, rotary valve1.0 to 5.0 psig/minLinear1.0 psig/min20% or 0.5 psig/min of setting at range 1.0 to 3.9psig/min & 40% of setting at range 4.0 to 5.0 psig/minIntercomThe intercom sub-system is an intercommunication system for two-way privateconversation capability between the patient inside the hyperbaric chamber and anattendant outside. It is capable of delivering a single channel (mono) or dualchannel (stereo) audio input to the speaker inside the hyperbaric chamber forpatient entertainment from an auxiliary source such as but not limited to tapePage 5 of 20
510(K) SUMMARYSPECIAL 510(K) PREMARKET NOTIFICATION3300H/HR an d3600H/HR Hyperbaric Chamberrecorder, cd/mp3 player, DVD player and television. If the handset is picked up forconversation, the auxiliary audio signal shall be temporarily disabled.Specification12 VDC nominalY2 watt max inside chamberDual 4 ohms orB8 ohms, internal and externalElectret Condlenser type or equivalentRotary potentiometers for Volume In & Out CW toincrease; CCW to decrease(f) Aux. Input Connector: (2) RICA Phone Jacks or equivalent(g) Operator Handset: .Telephone Style or equivalent(h) Indicators:(2) LEDs1st LEO: Green - Main Powver ONBlack - Main Power OFF2 nd LED: Amber -Low Battery Power(a)(b)(c)(d)(e)6.2.Supply:Audio Power:Speakers:Internal Microphone:Volume Controls:MEASURED DISPLAYS6.2.1.Chamber Set Pressure DisplayA pneum atic pressure gauge having multiple scales is installed to display the setpressure.Specification(a) Display Type:(b) Display Range:(c) Tolerance:6.2.2.Pneumatic Pressure Gauge0 to 30 psigNominal, 1.5, 2.0, 2.5, 3.0 ATA0 to 200 kpa (optional) 5% of readingChamber Actual Pressure DisplayA pneumatic pressure gauge having multiple scales is installed to display actualhyperbaric chamber pressure.Specification(a) Display Type:(b) Display Range:(c) Tolerance:Pneumatic Pressure Gauge0 to 30 psigNominal, 1.5, 2.0, 2.5, 3.0 ATA0 to 200 kpa (optional) 5% of readingPage 6 of 20
510(K) SUMMARYSPECIAL 510(K) PREMARKET NOTIFICATION3300H/HR and 3600H/HR Hyperbaric Chanter6.2.3.Chamber Pressure Cycle CounterA pressure cycle counter is installed to record the total number of hyperbaricchamber pressurization cycles. The pressure cycle counter can be used to keeptrack of periodic maintenance requirements of the chamberSpecification(a) Display Type:(b) Range:(c) Reset:6.3.Pneumatic Mechanical Counter0 to 99,999 cycles minNoneINDICATORS6.3.1.Supply Pressure IndicatorAn indicator is provided to indicate the existence of the supply pressure.Specification(a) Indlicator Type:6.3.2.Pneumatically operatedGreen to indicate supply ONBlack to indicate supply OFFChamber Pressure IndicatorAn indicator is provided to indicate the existence of the hyperbaric chamberpressure.Specification(a) Indlicator Type:6.4.Pneumatically operatedRed to indicate chamber pressure of -1.5 psig or higherBlack to indicate chamber pressure less than 0.5 psigSAFETY SYSTEMS6.4.1.Door Safety Interlock SystemThe door Safety Interlock System prevents the hyperbaric chamber door frombeing accidentally opened while the hyperbaric chamber is pressurized. It alsoprevents the pressurization of the hyperbaric chamber if the door is not in the fullylocked position.Specificationapproximately 1.0 psig(a) Activation pressure:(b) Deactivation pressure: approximately 0.5 psig6.4.2.Over-Pressure Relief SystemPage 7 of 20
510(K) SUMMARYSPECIAL 510(K) PREMARKET NOTIFICATION3300H/HR and 36001-/HR Hyperbaric Chambertwo over-pressure relief valves are installed to prevent hyperbaric chamber fromexceeding its maximum allowable working pressure. If the relief valve malfunctionsand causes rapid decompression of the hyperbaric chamber pressure, the ManualShut-Off Valve is also be available to prevent the rapid decompression.3300H/HR:(a) Relief Valve Set Pressure:(b) Tolerance:(c) Manual Shut-Off Valve:35 psig maximum 2 psigSealed open with a soft wire seal36001I/HR:(a) Relief Valve Set Pressure:(b) Tolerance:(c) Manual Shut-Off Valve:6.4.3.36 psig maximum 2 psigSealed open with a soft wire sealEmergency Shutoff and Automatic VentThe Emergency Shutoff system allows the operator to automatically shut off thegas supply and depressurizes the hyperbaric chamber This system is activatedusing a toggle switch protected by a cover to prevent accidental activation.Specification(a) Control Type:(b) Decompression Time:Pneumatic Toggle Switch30 psig toO0 psig in 119 sec maxPage 8 of 20
510(K) 5UMMARYSPECIAL 510(K) PREMARKET NOTIFICATION3300H/HR and 3600H/HR Hyperbaric Chamber7.TABLE OF COMPARISONThere are no changes in the intended use and there are no significant changes inperformance specifications or principal of operation of the two the Models 3300H-/HR11 and3600H/HR Hyperbaric Chambers, as compared to the predicate device Sechrist Model4100H-/HR11 Hyperbaric Chamber Existing technology, consistent with that used incomparative chambers, has been incorporated irito the design o
