(202 days)
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Not Found
No
The summary provides no information suggesting the use of AI or ML. The description focuses solely on the device's function as an oxygen concentrator.
Yes
The device is described as an "Oxygen Concentrator" that "delivers supplemental oxygen... for inhalation with mask delivery to the patient," which is a therapeutic function.
No
The device delivers supplemental oxygen for inhalation, which is a therapeutic function, not a diagnostic one. It does not identify or diagnose a disease or condition.
No
The device is described as an "Oxygen Concentrator," which is a hardware device that delivers oxygen. The summary does not mention any software component as the primary or sole function.
Based on the provided information, the HealthLife Oxygen Concentrator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver supplemental oxygen for inhalation to a patient. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
An oxygen concentrator is a medical device used to provide respiratory support, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
73 CAW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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.
1
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