(468 days)
The conditions listed as appropriate for the Hyperbaric Oxygen Therapy in the current edition of Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:
- Air or Gas Embolism .
Carbon Monoxide Poisoning and Carbon Monoxide Poisoning complicated by Cyanide Poisoning - Clostridial Myositis and Myonecrosis (Gas Gangrene) .
- Crush Injury, Compartment Syndrome and other Acute Traumatic Ischemias ◀
- Decompression Sickness ◆
- Enhancement of Healing in Selected Problem Wounds .
- Exceptional Blood Loss (Anemia) .
- . Intracranial Abscess
- Necrotizing Soft Tissue Infections .
- Osteomyelitis (Refractory) .
- Delayed Radiation Injury (Soft Tissue and Bony Necrosis) ◆
- Skin Grafts and Flaps (Compromised) .
- Thermal Burns .
Monoplace Hyperbaric Chamber
This document is a 510(k) premarket notification approval letter for the ATA HCM Monoplace Hyperbaric System. It formally approves the device for marketing based on its substantial equivalence to a legally marketed predicate device.
The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it is an administrative letter confirming that the device can be legally marketed.
Therefore, I cannot fulfill your request for information on acceptance criteria and studies from the provided text. The document is solely a regulatory approval, not a technical report detailing performance metrics or testing results.
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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three parallel lines forming its body and wings. The eagle faces right and is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circular border.
- 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Humphrey H. Killam President ATA Hyperbaric Chamber Manufacturing, Incorporated 695-Alpha Street Victoria, BC V8Z 1B5 CANADA
Re: K040145
Trade/Device Name: ATA HCM Monoplace Hyperbaric System Regulation Number: 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: April 11, 2005 Received: April 19, 2005
Dear Mr. Killam:
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 Ameradments, 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 approval uppyisions 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 (1911), it hay of each 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. Killam
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DT 3 issualles or a base on plies with other requirements illean that IDA nas mace a determinaregulations administered by other Federal agencies. 01 the Act of ally I oderal barrest and equirements, including, but not limited to: registration You must comply with and the Pice Ung (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 067), lasting (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality byochile (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) ITIN Iction will anow you to begal finding of substantial equivalence of your device to a premarket notification. The PDF missis 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), If you desire specific advisor to: Jour ave at (240) 276-0120. Also, please note the regulation prease conduct the Office or Some to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general missumational and Consumer Assistance at its toll-free Division of 01 0 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carls
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): K040145
Device Name: Monoplace Hyperbaric Chamber
Indications For Use:
The conditions listed as appropriate for the Hyperbaric Oxygen Therapy in the current edition of Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:
-
Air or Gas Embolism .
Carbon Monoxide Poisoning and Carbon Monoxide Poisoning complicated by Cyanide � Poisoning -
Clostridial Myositis and Myonecrosis (Gas Gangrene) .
-
Crush Injury, Compartment Syndrome and other Acute Traumatic Ischemias ◀
-
Decompression Sickness ◆
-
Enhancement of Healing in Selected Problem Wounds .
-
Exceptional Blood Loss (Anemia) .
-
. Intracranial Abscess
-
Necrotizing Soft Tissue Infections .
-
Osteomyelitis (Refractory) .
-
Delayed Radiation Injury (Soft Tissue and Bony Necrosis) ◆
-
Skin Grafts and Flaps (Compromised) .
-
Thermal Burns .
Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (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)
CluLs
Sign-Off)
on of Anesthesiology, General Hospital,
Recuon Control, Dental Devices
Page 1 of ________
Number. K040145
§ 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).