BAY AREA HYPERSCIENCES

K030713 · Bay Area Hypersciences, LLC · CBF · Dec 19, 2003 · Anesthesiology

Device Facts

• Record ID: K030713
• Device Name: BAY AREA HYPERSCIENCES
• Applicant: Bay Area Hypersciences, LLC
• Product Code: CBF · Anesthesiology
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Air or gas embolism 2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning 3. Clostridial myositis and myonecrosis 4. Crush injury, compartment syndrome or other acute traumatic ischemias 5. Decompression sickness 6. Enhanced healing of selected problem wounds 7. Exceptional blood loss anemia 8. Necrotizing soft tissue infections 9. Osteomyelitis (refractory) 10. Delaved radiation injury (soft tissue and bone necrosis) 11. Skin grafts and flaps (compromised) 12. Thermal burns 13. Intracranial abscesses

Device Story

BAH-6P Multiplace Hyperbaric Chamber provides hyperbaric oxygen therapy. Device functions as a pressurized vessel to deliver oxygen at increased atmospheric pressure to patients. Used in clinical settings under supervision of trained medical personnel. Therapy facilitates treatment of conditions like decompression sickness, carbon monoxide poisoning, and wound healing by increasing oxygen saturation in tissues. Operation involves patient placement within chamber, controlled pressurization, and monitoring of physiological parameters. Output is therapeutic environment for patient recovery.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory classification and comparison to pre-1976 legally marketed devices.

Technological Characteristics

Multiplace hyperbaric chamber; pressurized vessel design; intended for clinical use; regulated under 21 CFR 868.5470 (Product Code CBF).

Indications for Use

Indicated for patients requiring hyperbaric oxygen therapy for conditions including air/gas embolism, CO poisoning, clostridial myositis/myonecrosis, crush injury, decompression sickness, problem wounds, blood loss anemia, necrotizing soft tissue infections, refractory osteomyelitis, delayed radiation injury, compromised skin grafts/flaps, thermal burns, and intracranial abscesses. Prescription use only.

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).

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Dr. Edward F. Good Bay Area Hypersciences, LLC 18312 Sandy Cove Houston, TX 77058

Re: K030713

Trade/Device Name: BAH-6P Multiplace Hyperbaric Chamber Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: December 5, 2003 Received: December 9, 2003

Dear Dr. Good:

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 your 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 - Dr. Edward F. Good

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 vour 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,

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: K030713

Device Name: Multiplace Hyperbaric Chamber

Indications For Use:

- 1. Air or gas embolism
- 2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
- 3. Clostridial myositis and myonecrosis
- 4. Crush injury, compartment syndrome or other acute traumatic ischemias
- 5. Decompression sickness
- 6. Enhanced healing of selected problem wounds
- 7. Exceptional blood loss anemia
- 8. Necrotizing soft tissue infections
- 9. Osteomyelitis (refractory)
- 10. Delaved radiation injury (soft tissue and bone necrosis)
- 11. Skin grafts and flaps (compromised)
- 12. Thermal burns
- 13. Intracranial abscesses

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stuh

| (Division Sign-Off) | |
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| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |

510(k) Number: Ka302713

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