(202 days)
The HealthLife Oxygen Concentrator delivers supplemental oxygen in a nominal 9 liters-per-minute flow of 38% oxygen for inhalation with mask delivery to the patient.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving a device meets them.
The document is a 510(k) clearance letter from the FDA for a device called "HealthLife Oxygen Concentrator." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must follow.
Here's a breakdown of why I cannot extract the requested information based on the text:
- No acceptance criteria or device performance data: The letter does not describe any specific performance metrics (e.g., accuracy, sensitivity, specificity, flow rate stability over time, oxygen concentration percentage variance) that the device was tested against, nor does it present the results of any such tests.
- No mention of a study: While the FDA grants clearance based on data showing substantial equivalence, the letter itself does not describe any specific study design, sample sizes, data provenance, expert involvement, or ground truth establishment. These details would typically be found in the 510(k) submission itself, not the clearance letter.
- No AI component: The device is an "Oxygen Concentrator," a hardware medical device. There is no indication of any artificial intelligence (AI) component, which means questions about MRMC studies with AI assistance or standalone algorithm performance are not applicable.
In summary, the provided document is a regulatory approval letter and does not contain the technical study details you are asking for.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Ms. Charlotte H. Hamilton Airsep Corp. 290 Creekside Drive Buffalo, NY 14228-2070
Re: K012037
HealthLife Oxygen Cencentrator Regulation Number: 868.5440 Regulation Name: Generator, Oxygen, Portable Regulatory Class: Class II (two) Product Code: 73 CAW Dated: November 16, 2001 Received: November 19, 2001
Dear Ms. Hamilton:
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 - Mr. Charlotte H. Hamilton
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r 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 or any I vith 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 Of It in the quality systems (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 premated notication "The 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 8041. Additionally, for questions on the promotion and advertising of Compliance at (301) 59% the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Ouvision 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,
l. Oeder Teh
ram D. Zuckerman, M.D Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
| 510(k) NUMBER (IF KNOWN): | KO12037 |
|---|---|
| DEVICE NAME: | HealthLife Oxygen Concentrator. |
INDICATIONS FOR USE:
Revised, 1-15-02
The HealthLife Oxygen Concentrator delivers supplemental oxygen in a nominal 9 liters-per-minute flow of 38% oxygen for inhalation with mask delivery to the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) √
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012037
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).