301 2 8 20055 10(k) Summary of Safety and EffectivenessSechrist Industries, Inc., 3300E/ER Hyperbaric Chamber510 (k) Summary of Safety and EffectivenessProduct:Hyperbaric Oxygen ChamberModel:3300E/ER510(k) No.:General InformationClassification: Class II, CBFAN (73), Anesthesiology Panel(Title 21, CER 868.5470)Trade Name: Chamber, HyperbaricSubmitter:Sechrist Industries, Inc.4225 E. La Palma Ave.Anaheim, CA 92807Contact:Greg GodfreyVice President, Quality Assurance &Regulatory AffairsPerformance Standards:A performance standard regulation under Section 514 of the Food, Drug and CosmeticAct has not been promulgated for this device type.However, the device is designed and manufactured in accordance with the followingindustry standards:Section VIII, Division 1 of the American Society of Mechanical Engineers (ASME)Boiler and Pressure Vessel CodeASME PVHO-1I Pressure Vessels for Human Occupancy StandardNFPA 99 Safety Standard for Health Care Facilities, Chapter 20The following quality assurance measures were applied to the development of the3300E/ER Hyperbaric Chamber - Requirements specification reviews, performancetesting and validation, environmental testing, electrical safety/EMC testing,I
*510(k) Summary of Safety and EffectivenessSechrist Industries, Inc., 3300E/ER Hyperbaric Chambermanufacturing process control procedures, process validation, and design changecontrols.Substantially Equivalent DevicesManufacturerSechrist Industries, Inc.Anaheim, CAProductModel 3200P/PRK950386Intended UseThe intended use of the Sechrist Model 3300E/ER Hyperbaric Chamber isto administer 100% oxygen at pressure greater than ambient, up to 3atmospheres absolute (30 psi) of pressure.Specific indications for use of hyperbaric chambers have been establishedby the Committee on Hyperbaric Oxygen Therapy of the Undersea andHyperbaric Medical Society.The current specific thirteen indications are:1.Air or Gas Embolism2.Carbon Monoxide Poisoning and Smoke Inhalation, CarbonMonoxide Complicated by Cyanide Poisoning3.Clostridial Myonecrosis (Gas Gangrene)4.Crush Injury, Compartment Syndrome and Other Acute TraumaticIschemias5.Decompression Sickness6.Enhancement of Healing in Selected Problem Wounds7.Exceptional Blood Loss (Anemia)8.Intracranial Abscess9.Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle,Fascia)10.Osteomyelitis (Refractory)11.Radiation Tissue Damage (Osteoradionecrosis)12.Skin Grafts and Flaps (Compromised)13.Thermal Bums2
510(k) Summary of Safety and EffectivenessSechrist Industries, Inc., 3300E/ER Hyperbaric ChamberDevice DescriptionThe Model 3300E/ER Hyperbaric Chamber is a monoplace (one patient) pressurechamber designed to administer 100% oxygen at pressure greater than ambient, up to 3atmospheres absolute (30 psi) of pressure.The Model 3300E/ER Hyperbaric Chamber is constructed with a horizontal seamlessacrylic inner cylinder. One end is equipped with a hard anodized aluminum cover andthe other with a hard anodized aluminum door assembly, with access ports available forpatient support (such as patient monitoring and delivery of intravenous fluids). Thecontrol system is pneumatic/electronic containing the controls, indicators, chamberpressure display gauges, and intercom assembly.Summary of Substantial EquivalenceThe design features and materials used in the manufacture of the Sechrist Industries, Inc.3300E/ER Hyperbaric Chamber are substantially equivalent several pre-amendmentproducts. Additionally the 3300E Hyperbaric Chamber is of similar shape andfunctionality to the predicate device.Therefore, due to the similarity of design features, materials, test results and the similarityof the indicated use to other pre-amendment devices and the predicate device , SechristIndustries, Inc. believes this product does not have any safety or efficacy issues.3
DEPARTMENT OF HEALTH & HUMAN SERVICESUC] 2 8 2005Public Health ServiceFood and Drug Administration9200 Corporate BoulevardRockville MD 20850Mr. Greg P. GodfreyVice President, Quality Assurance& Regulatory AffairsSechrist Industries, Incorporated4225 East La Palma AvenueAnaheim, California 92807Re: K052713Trade/Device Name: MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGENCHAMBERCFR 868.547021Regulation Number:Regulation Name: Hyperbaric chamberRegulatory Class: IIProduct Code: CBFDated: September 28, 2005Received: September 30, 2005Dear Mr. Godfrey:We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for theindications for use stated in the enclosure) to legally marketed predicate devices marketed ininterstate commerce prior to May 28, 1976, the enactment date of the Medical DeviceAmendments, or to devices that have been reclassified in accordance with the provisions ofthe Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarketapproval application (PMA). You may, therefore, market the device, subject to the generalcontrols provisions of the Act. The general controls provisions of the Act includerequirements for annual registration, listing of devices, good manufacturing practice,labeling, and prohibitions against misbranding and adulteration.If your device is classified (see above) into either class 11 (Special Controls) or class III(PMA), it may be subject to such additional controls. Existing major regulations affectingyour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. Inaddition, FDA may publish further announcements concerning your device in the FederalRegister.
Page 2 - Mr. GodfreyPlease be advised that FDA's issuance of a substantial equivalence determination does notmean that FDA has made a determination that your device complies with other requirementsof the Act or any Federal statutes and regulations administered by other Federal agencies.You must comply with all the Act's requirements, including, but not limited to: registrationand listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practicerequirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and ifapplicable, the electronic product radiation control provisions (Sections 531-542 of the Act);21 CFR 1000-1050.This letter will allow you to begin marketing your device as described in your Section 510(k)premarket notification. The FDA finding of substantial equivalence of your device to alegally marketed predicate device results in a classification for your device and thus, permitsyour device to proceed to the market.If you desire specific advice for your device on our labeling regulation (21 CFR Part 801),please contact the Office of Compliance at (240) 276-0120. Also, please note the regulationentitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Youmay obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-freenumber (800) 638-2041 or (301) 443-6597 or at its Internet dex.html.Sincerely yours,hiu LinhDDirectorDivision of Anesthesiology, General Hospital,Infection Control and Dental DevicesOffice of Device EvaluationCenter for Devices andRadiological HealthEnclosure
510(k) K052713Indications for Use510(k) Number (ifknown):Device Namne:Addiflnc-!nmcnt5 10-2-K(052713'Secbhist Model 3300BE/JR Hyperbaric ChamberIndications For Use:The intended use of the Sechrist Model 3300E/ER Hyperbadc Chamber isto administer 100% oxygen at pressure greater than ambient, up to 3amlospheres absolute (30 psi) of pressure.Specific indications for use of hyperbaiic chambers have been establishedby the Committee on Hyperbaric Oxygen Therapy of the Undersea andHyperbatic Medical Society (founded in 1967 to foster exchange of dataon the physiology and medicine ofcommercial and miljtary diving). Thecommittee is comprised of practitioners and scientific investigators in tilefields of internal medicine, infectious diseases, pharmacology, emergencymedicine, general surgery, brthopedic surgery, trauma surgery, thoracicsurgery, otolaryngology, oral and maxillofacial surgery and aerospacemedicine. The committee is responsible for continually reviewingresearch and clinical data in determining the safety and efficacy ofhyperbaric oxygen,Prescription Use zX(Part 21 CFR 801 Subpart D)AND/OROver-The-Counter Use(21 CFR 801 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE):of Anesthesio o9 ,General Hospital, ?1Cort§ Pgof CB- 0t:?.'-'.Page 1of 3
519(k) 1(052713Indications for UseAdlt0 ,ianlDoMnf,"ctitk O-510(k) Number Of known): K(052713'Sechrist Model 3300E/BRIHyperbaric ChamberDevice Name:Currently, there arc thirteen indications that areIndications For Use:approved by the commnittee; these thirteen indications were accepted basedon sound physiologic rationale, in vivo or in vitro studies that demonstrateeffectiveness, controlled animal studies, prospective controlled clinicalstudies and extensive clinical experience from multiple hyperbaricmedicine centers. These thirteen indications have been recormendeidt forthird-party retinbursement and most insurance carriers have establishedraimbursement policy based on these recommiendations.The thirteen indications are:I1.Air or Gas Embolism2.Carbon Monoxide Poisoning and Smoke Inhalation, CarbonMonoxide Complicated by Cyanide PoisoningClostridial Myonecrosis; (Gas Gangrene)3.4.5.Prescription Use ) Crush, Injury, Compartment Syndrome and Other Acute TraumnaticIscherniasDecompression SicknessAND/OROver-The-Counter Use(21 CFR 801 Subpart C)(Part 21 Oi R 801 Subpart D)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)(!O' kgy, ioml Ba;;) K) WaunmerGene ralI Hospital,Devices5Page 2lof
510 l K(052713Indications far UseAdditional VocIMiciWS 10-27-0510(k) Numnber (if known): K052713'Device Name:Scwsoe 3G/R1lrraihmeIndications For Use:6.Enhancement of Heating in Selected Problem Wounds7.Exceptional Blood Loss (Anemia)S.9.Intracranial AbscessNecrotizing Soft Tissue Infection s (Subcutaneous Tissue, Muvsclc,Fascia)10.Osteomyelitis (Refractory)11.Radiation Tissue Damage (Osteoradionecrosis)12.Skin Grafts anid Fla s (Compromised)13.Therm al BurnsPrescription Use)(AND/OR(Padt 21 CFR 801 Subpart D)Over-The-Counter Use(21 CFR 801 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)n sresths oogy,to,'aotroEcimalNumbefa,6\ k,-General Hospital,Pageloflevmes-)