HYPEROX 101

K053498 · Wjo, Inc. · CBF · Mar 15, 2006 · Anesthesiology

Device Facts

• Record ID: K053498
• Device Name: HYPEROX 101
• Applicant: Wjo, Inc.
• Product Code: CBF · Anesthesiology
• Decision Date: Mar 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

HyperOx 101 is a Class A multi-place hyperbaric chamber; treats up to 11 occupants at pressures up to 32 psig. Input: compressed, dried/chilled air for pressurization; 100% medical oxygen for patient breathing via BIBBS (Built-In Breathing System). Operation: manual electropneumatic pressurization/depressurization; constant airflow ventilation. Output: pressurized environment for therapeutic oxygen absorption. Used in hospitals/clinics; operated by physicians/trained staff. Monitoring: oxygen and carbon dioxide gas analysis; wireless PA communication. Benefits: increased tissue oxygenation for wound healing, infection control, and treatment of specific ischemic/toxic conditions. Healthcare providers use chamber to deliver UHMS-approved hyperbaric oxygen therapy protocols.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, construction standards (ASME/NFPA), and intended use consistent with established hyperbaric oxygen therapy indications defined by the Undersea and Hyperbaric Medical Society (UHMS).

Technological Characteristics

Multi-place steel chamber; 72"W x 88"H x 16'6"L; 11,200 lbs. Construction: ASME Section VIII Div 1/2, ASME-PVHO-1-2002-2003, NFPA 99. Operating pressure 32 psig; design pressure 45 psig. Manual electropneumatic controls. Features: 12-feed oxygen manifold, 4 BIBBS, gas analysis (O2/CO2), wireless PA, optional entertainment systems. Finish: SSPC-SP-10 shotblast, primed/painted.

Indications for Use

Indicated for patients with air or gas embolism, carbon monoxide poisoning (with or without cyanide poisoning), clostridial myositis and myonecrosis, crush injury, compartment syndrome, acute traumatic ischemias, decompression sickness, problem wounds, exceptional blood loss anemia, necrotizing soft tissue infections, refractory osteomyelitis, delayed radiation injury, compromised skin grafts and flaps, thermal burns, and intracranial abscess.

Regulatory Classification

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).

Predicate Devices

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

Submission Summary (Full Text)

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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: [phone] Fax [phone] 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: [phone], Fax. [phone] 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<br>(1) 12" dia. clear view portlight in door<br>(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<br>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<br>(optional) | Wireless internet connection<br>External TV system w/remote & DVD player<br>AM/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:

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.

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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 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 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 [phone]. 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 [phone] or [phone] 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)

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Mh. Katerl

Singlogy, General Hospitzl. Of Dental Davices

K053498