BAY AREA HYPERSCIENCES

• K Number: K030713
• Device Name: BAY AREA HYPERSCIENCES
• Manufacturer: BAY AREA HYPERSCIENCES, LLC
• Date Cleared: 2003-12-19 ( 288 days)
• Product Code: CBF
• Regulation Number: 868.5470
• Type: Abbreviated
• Panel: Anesthesiology
• Age Range: All
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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 Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a hyperbaric chamber. It does not contain information about the acceptance criteria or a study that proves the device meets those criteria.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than a direct performance study against specific acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the given text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human figures or stylized birds in flight, arranged in a layered or overlapping manner.

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)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: Ka302713

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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).