Hyperbaric Oxygen Therapy (HBOT) is a painless procedure in which a person is exposed to increased pressure, thus allowing greater absorption of oxygen throughout body tissues. This increased pressure allows more oxygen to reach the cells within the body therefore contributing to the many healing and therapeutic benefits.

The expressed and intended use of the HyperOx 101 Hyperbaric Oxygen Treatment Chamber is to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class U prescriptive device, it is further intended for physician involvement in their procurement and routine use.

The conditions listed as appropriate for the use of Hyperbaric Oxygen Treatment are:

Air or gas embolism
Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
Clostridial myositis and myonecrosis
Crush injury, compartment syndrome and other acute traumatic ischemias
Decompression sickness
Enhanced healing of selected problem wounds
Exceptional blood loss anemia
Necrotizing soft tissue infections
Osteomyclitis (refractory)
Delayed radiation injury (soft tissue and bony necrosis)
Skin grafts and flaps (compromised)
Thermal burns
Intercranial abscess

Device Description

The HyperOx Hyperbaric Oxygen Treatmcnt Chamber is a Class A multi-place hyperbaric chamber designed to treat up to 10 patients up to 32 psig. The device will use compressed, dried/chilled air as the pressurization gas and 100% medical oxygen as the treatment gas.

Specifications of the HyperOx 101 Hyperbaric Oxygen Treatment Chamber are:
Design Code: ASME Section VIII, Div 1 and ASME-PVHO-
Operating Pressure: 32 psig
Operating Temperature: 65 to 95 degrees F
Design Pressure: 45 psig
Design Temperature: 65 to 95 degrees F
Design Life: 70,000 cycles (approx. 30 years)
Hydrostatic Pressure: 42.0 psig
Weight: 11,200 lbs. (5.6 tons)
Dimensions: 72" W X 88" H X 16' 6" L
Doorway Opening Size: 30" X 60" clear opening
Lighting: Four (4) external dimmable lights (1) 12" dia. clear view portlight in door (8) 9" dia. clear view portlights in shell
Capacity: Up to 11 occupants
Fire Suppression: IAW NFPA 99
Finish: SSPC-SP-10 shotblast, primed & painted
Controls: Manual electropneumatic pressurization Manual electropneumatic depressurization
Ventilation: Constant airflow
BIBBS with dump: Four
Oxygen Flow Manifold: Twelve feeds to O2 mask
Gas Analysis: Oxygen and carbon dioxide
Communications: Wireless PA
Entertainment (optional): Wireless internet connection External TV system w/remote & DVD player AM/FM tuner with CD player

AI/ML Overview

The document describes a hyperbaric oxygen treatment chamber, not an AI/ML device. Therefore, the information requested in the prompt regarding acceptance criteria, study details, ground truth, and sample sizes for AI/ML performance is not applicable.

The document focuses on the substantial equivalence of the HyperOx 101 Hyperbaric Oxygen Treatment Chamber to existing predicate devices based on design, method of pressurization, and intended use.

Here's what can be extracted from the provided text regarding the device's specifications and comparison to predicates, which are analogous to acceptance criteria in this context for non-AI devices:

1. A table of acceptance criteria and the reported device performance:

For a non-AI medical device like a hyperbaric chamber, "acceptance criteria" are typically defined by compliance with established engineering and safety standards, and functional specifications meeting the intended use. The "reported device performance" is demonstrated by the device's design specifications meeting these standards and being substantially equivalent to legally marketed predicate devices.

Specification/Characteristic	Acceptance Criteria (Design Standards/Predicate Comparison)	Reported Device Performance (HyperOx 101)
Design Code	ASME Section VIII, Div 1 and ASME PVHO-1, NFPA 99	Meets ASME Section VIII, Div 1 and ASME PVHO-1, NFPA 99
Operating Pressure	Consistent with hyperbaric therapy requirements; comparable to predicates	32 psig
Operating Temperature	Safe and effective range for human occupancy	65 to 95 degrees F
Design Pressure	Safety factor above operating pressure	45 psig
Design Temperature	Safety factor above operating temperature	65 to 95 degrees F
Design Life	Long-term operational reliability	70,000 cycles (approx. 30 years)
Capacity	Multi-occupant chamber	Up to 11 occupants
Pressurization Gas	Compressed, dried/chilled air	Compressed, dried/chilled air
Treatment Gas	100% Medical Oxygen	100% Medical Oxygen
Fire Suppression	IAW NFPA 99	IAW NFPA 99
Controls	Manual electropneumatic	Manual electropneumatic pressurization & depressurization
Substantial Equivalence to Predicates	Design approach, method of pressurization, and intended use comparable to Fink Engineering Pty. Ltd (K031649), Pan-American Hyperbarics, Inc (K021693), and Perry Sigma MP (K930748)	The device is deemed substantially equivalent based on these factors.
Intended Use/Indications	Treatment of specific medical conditions responding to HBOT as defined by UHMS	Device intended to treat the 13 UHMS-approved conditions listed in the 510(k)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a hardware device, not an AI/ML diagnostic or prognostic tool. Its performance is assessed through its engineering design, adherence to safety standards, and functional specifications, not a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" for this device relates to its physical and functional integrity, and compliance with engineering standards (ASME, NFPA). These are evaluated by regulatory bodies and internal engineering teams against established codes, not by medical experts establishing diagnostic ground truth on a data set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no test set in the context of AI/ML evaluation. Compliance with standards and substantial equivalence is typically assessed through documentation review, inspection, and possibly performance testing of the physical chamber.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for a device like this is its compliance with recognized engineering codes and standards (e.g., ASME, NFPA) and its ability to achieve the specified operational parameters (pressure, temperature, gas delivery). The safety and efficacy are also supported by the well-established medical literature and guidelines for hyperbaric oxygen therapy (UHMS).

8. The sample size for the training set

Not applicable. This is a hardware device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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MAR 1 5 2006

Ko53498

5. Traditional 510(k) Pre-market Notification Summary (Per 21CFR807.92)

December 19, 2005

Device Name: HyperOx 101, a Multiplace Hyperbaric Oxygen Treatment Chamber

Common Name: Multiplace Hyperbaric Chamber

Regulation No. 868.5470

Class: II

Code: CBF

Submitted by: WJO, Inc. 424 Mill Street Canal's End Plaza Bristol, PA 19007 William J. O'Brien, D.O., President Phone: 215-826-8050 Fax 215-826-8053 Contact person: Chris Belletieri, D.O.
Establishment Registration Number: Pending

Railway Specialties Corporation (DOD Cage Code 86700) Manufacturer: 2979 State Road, P.O. Box 29 Bristol, Pennsylvania 19007-0029 Phone: 215-788-9242, Fax. 215-788-9244 Contact person: Frederic H. Calkins, Jr. - President

Establishment Registration Number: Pending

Predicate Device(s):

Fink Engineering Pty. Ltd Models SL8/DL8/TL20 (K031649) Pan-American Hyerbarics, Inc. PAH-S1 - K021693 Perry Sigma MP Hyperbaric Chamber -- K930748

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SUMMARY

The Undersea and Hyperbaric Medical Society (UMHS) defines hyperbaric oxygen therapy as breathing 100% medical oxygen at pressures higher than atmospheric in a hyperbaric chamber. According to the National Fire Protection Association (NFPA), hyperbaric chambers are classified into two categories: Class A (multi-occupant) and Class B (single occupant). The HyperOx Hyperbaric Oxygen Treatmcnt Chamber is a Class A multi-place hyperbaric chamber designed to treat up to 10 patients up to 32 psig. The device will use compressed, dried/chilled air as the pressurization gas and 100% medical oxygen as the treatment gas.

The HyperOx Hyperbaric Oxygen Treatment Chamber is intended to be procured and used by physicians and hospitals to treat a variety of medical conditions that respond to hyperbaric oxygen therapy. Approved conditions responding to hyperbaric oxygen therapy are provided at the end of this summary.

The HyperOx Hyperbaric Oxygen Treatment Chamber is designed and fabricated in strict accordance with the requirements of the American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code Section VIII, Division 2 using Section II parts A, C and D, Section V, Section IX, ASME-PVHO-1-2002-2003 (American Society of Mechanical Engineers-Pressure Vessels for Human Occupancy) and the National Fire Protection Association (NFPA 99).

Specifications of the HyperOx 101 Hyperbaric Oxygen Treatment Chamber are:

Design Code	ASME Section VIII, Div 1 and ASME-PVHO-
Operating Pressure	32 psig
Operating Temperature	65 to 95 degrees F
Design Pressure	45 psig
Design Temperature	65 to 95 degrees F
Design Life	70,000 cycles (approx. 30 years)
Hydrostatic Pressure	42.0 psig
Weight	11,200 lbs. (5.6 tons)
Dimensions	72" W X 88" H X 16' 6" L
Doorway Opening Size	30" X 60" clear opening

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Lighting	Four (4) external dimmable lights(1) 12" dia. clear view portlight in door(8) 9" dia. clear view portlights in shell
Capacity	Up to 11 occupants
Fire Suppression	IAW NFPA 99
Finish	SSPC-SP-10 shotblast, primed & painted
Controls	Manual electropneumatic pressurizationManual electropneumatic depressurization
Ventilation	Constant airflow
BIBBS with dump	Four
Oxygen Flow Manifold	Twelve feeds to O2 mask
Gas Analysis	Oxygen and carbon dioxide
Communications	Wireless PA
Entertainment(optional)	Wireless internet connectionExternal TV system w/remote & DVD playerAM/FM tuner with CD player

WJO, Inc. and Railway Specialties Corporation suggest that the general design approach, method of pressurization and the intended use of the HyperOx Hyperbaric Oxygen Treatment Chamber is substantially equivalent to the Fink Engineering Pty. Ltd models SL8/DL8/TL20 (K031649), Pan-American Hyperbarics, Inc PAH-S1 Chamber (K021693), and Perry Sigma MP Hyperbaric Chamber (K930748) and is proposing them as predicate devices.

INTENDED USE:

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When utilizing HBOT, oxygen is forced into the tissues, organs, brain and fluids throughout the body through the pressurization of the hyperbaric chamber.

Oxygen floods arcas that are oxygen starved to stimulate cell growth and . regencration.
Oxygen displaces toxins and other impurities to assist in detoxification of the 。 patients system.
Hyperbaric oxygen acts as an anti-viral and anti-bacterial, as bacteria and # viruses typically cannot tolerate oxygen.
Hyperbaric oxygen is an immune modulator, supporting the immune system 。 to bring T and B cells within normal levels.
Oxygen reduces tumor growth in cancer patients. �
Hyperbaric oxygen increases neural brain function due to oxygen saturation. で
Hyperbaric oxygen provides many other condition specific benefits. .

The UHMS is the professional medical organization chartered with setting the standards of care defining the appropriate use of hyperbaric oxygen. More specifically, the UIIMS publishes a listing of medical conditions that have been clearly established as appropriate primary or adjunctive use of hyperbaric oxygen (HBO). The disorders on the list have been scientifically validated and verified through extensive data collection.

The conditions listed as appropriate for the use of Hyperbaric Oxygen Treatment are:

Air or gas embolism .
Carbon monoxide poisoning and carbon monoxide poisoning complicated by . cyanide poisoning
Clostridial myositis and myonecrosis .
Crush injury, compartment syndrome and other acute traumatic ischemias .
Decompression sickness .
Enhanced healing of selected problem wounds .
. Exceptional blood loss anemia
Necrotizing soft tissue infections ●
Osteomyclitis (refractory) .
Delayed radiation injury (soft tissue and bony necrosis) .
Skin grafts and flaps (compromised) .
Thermal burns .
Intercranial abscess .

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines forming its wings and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2006

Mr. Chris Belletieri WJO. Incorporated 424 Mill Street at Canal's End Plaza Bristol, Pennsylvania 19007

Re: K053498

Trade/Device Name: Hyperbaric Oxygen Treatment Chamber - Model

101 Regulation Number: 868.5470 Regulation Name: Hyperbaric chamber Regulatory Class: II Product Code: CBF Dated: December 16, 2005 Received: December 16, 2005

Dear Mr. Belletieri :

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements 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 II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Chris Belletieri

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of 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: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 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 a legally marketed predicate device results in a classification for your device and thus, permits your 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 (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Snyte y. Michael Oms

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K053498

Device Name: HyperOx Hyperbaric Oxygen Treatment Chamber - Model 101

Indications For Use:

. Air or gas embolism
Carbon monoxide poisoning and carbon monoxide poisoning . complicated by cyanide poisoning
Clostridial myositis and myonecrosis .
Crush injury, compartment syndrome, and other acute traumatic . ischemias
Decompression sickness .
Enhanced of selected problem wounds .
Exceptional blood loss anemia .
Necrotizing soft tissue infections .
. Osteomvelitis (refractory)
Delayed radiation injury (soft tissue and bony necrosis) .
. Skin grafts and flaps (compromised)
Thermal burns •
. Intercranial abscess

Prescription Use Only (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Mh. Katerl

Singlogy, General Hospitzl. Of Dental Davices

K053498

Regulation Number and Section

§ 868.5470 Hyperbaric chamber.

(a)
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).(b)
Classification. Class II (performance standards).