(79 days)
The OxLife Oxygen Concentrators are intended to provide supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
The OxLife Oxygen Concentrators are indicated for the administration of supplemental oxygen.
The OxLife Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home, automobile or institution without a continuous source of purfied oxygen. They are not life-supporting nor life-sustaining devices. The devices operate through the use of molecular sieve material that binds with the water and nitrogen in filtered room air to leave a gas that is approximately 93% oxygen when delivered to the patient. The compressor creates a vacuum to suck room air through a pre-filter and HEPA filter into a holding tank. At the same time, downstream of the compressor, the air from the previous cycle is pressurized into one of the two aluminum welded molecular sieve tanks. As the oxygen is forced out of the end of the tank, it enters a 'T' fitting that directs most of the nitrogen out of the second molecular sieve tank into the ambient air. The remaining oxygen is delivered to the patient. On the next cycle, the air is directed into the second molecular sieve tank with the oxygen generated flushing the first tank and continuing the supply to the patient. This repetitive cycle generates the oxygen necessary to flush and prepare the saturated sieve tank while supplying the patient with a continuous flow of high concentration oxygen.
The major change to the device has been the reduction in the size of the molecular sieve tanks and subsequent volume of sieve material. This change allowed the elimination of the crossover valve and required a reduction of the cycle time.
A separate change to be implemented is the addition of an optional, larger inverter capable of operating the 6 LPM models using 12 Volt DC power. Currently, these models are specifically excluded from 12 volt use due to their large power draw.
The provided text describes modifications to an oxygen concentrator and its substantial equivalence to a predicate device. It does not contain information about a study that would involve acceptance criteria, test sets, ground truth, or expert involvement as typically seen in AI/ML device evaluations. The document is a 510(k) summary for a physical medical device, not an AI/ML algorithm.
Therefore, most of the requested information cannot be extracted from the provided text.
However, I can provide the limited information that exists concerning performance and equivalence.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Oxygen output meets specifications | The oxygen output of the modified devices meets specifications. |
| Substantially equivalent to predicate device | Confirmed to be substantially equivalent to the predicate device. |
| Adequate power for 6 LPM models using 12 Volt DC power (with new inverter) | The new inverter provides adequate power to run the larger 6 LPM devices from a 12 Volt DC power source. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes performance testing for a physical oxygen concentrator, not an AI/ML algorithm trained or tested on data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The "ground truth" here refers to the device's physical performance, not clinical diagnoses or interpretations by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or disagreements requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This document is for a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm described for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is based on the physical specifications and performance of the oxygen concentrator, primarily the oxygen concentration output and power capabilities, confirmed through "oxygen concentration testing".
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or its ground truth establishment.
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"510(k) SUMMARY"
971964
| 9.1 Trade/Proprietary Name: | OxLife Excell™ Oxygen Concentrators |
|---|---|
| 9.2 Common/Usual Name: | Oxygen Concentrator |
| 9.3 Classification Name: | Portable Oxygen Generator |
AUG 15 1997## 9.4 Comparison to Currently Marketed Devices
The modified OxLife Oxygen Concentrator is substantially equivalent to the existing OxLife Oxygen Concentrator (K933081).
9.5 Device Description
The OxLife Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home, automobile or institution without a continuous source of purfied oxygen. They are not life-supporting nor life-sustaining devices. The devices operate through the use of molecular sieve material that binds with the water and nitrogen in filtered room air to leave a gas that is approximately 93% oxygen when delivered to the patient. The compressor creates a vacuum to suck room air through a pre-filter and HEPA filter into a holding tank. At the same time, downstream of the compressor, the air from the previous cycle is pressurized into one of the two aluminum welded molecular sieve tanks. As the oxygen is forced out of the end of the tank, it enters a 'T' fitting that directs most of the nitrogen out of the second molecular sieve tank into the ambient air. The remaining oxygen is delivered to the patient. On the next cycle, the air is directed into the second molecular sieve tank with the oxygen generated flushing the first tank and continuing the supply to the patient. This repetitive cycle generates the oxygen necessary to flush and prepare the saturated sieve tank while supplying the patient with a continuous flow of high concentration oxygen.
The major change to the device has been the reduction in the size of the molecular sieve tanks and subsequent volume of sieve material. This change allowed the elimination of the crossover valve and required a reduction of the cycle time.
A separate change to be implemented is the addition of an optional, larger inverter capable of operating the 6 LPM models using 12 Volt DC power. Currently, these models are specifically excluded from 12 volt use due to their large power draw.
9.6 Indications for Use
The OxLife oxygen concentrators are intended to provide supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
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9.7 Technological Characteristics
The OxLife oxygen concentrator operates by using molecular sieve material to absorb water and nitrogen from filtered air. The resulting gas has an increased concentration of oxygen. This technology is well established and has been used in the predicate device as well as other legally marketed products. These modifications have not affected the technological characteristics of the device.
Performance Data 9.8
The results of the oxygen concentration testing confirm that the oxygen output of the modified devices meets specifications and is substantially equivalent to the predicate device. Also, the new inverter provides adequate power to run the larger 6 LPM devices from a 12 Volt DC power source.
9.9 Conclusion
Based on the design, performance specifications and intended use, the modified OxLife Oxygen Concentrators are substantially equivalent to the currently marketed devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Regina K. Ogdon OxLife, Inc. 917 - 919 S.E. 15th Avenue -----------Cape Coral, Florida 33990
AUG 1 5 1997
Re: K971964 OxLife Excell™ Oxygen Concentrators Regulatory Class: II (two) Product Code: 73 CAW Dated: May 21, 1997 Received: May 28, 1997
Dear Ms. Ogdon:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices. General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
Image /page/2/Picture/9 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are connected and form a single, flowing shape. The text "DEPARTMENT OF HEALTH & HUMAN-SERVICES-USA" is arranged in a circular pattern around the image.
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Page 2 - Ms. Regina K. Ogdon
This letter will allow you to begin marketing your device as described in your 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 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
510(k) File Number: K971964
OxLife Excell Oxygen Concentrators Device Name:
Indications For Usc. The OxLife Oxygen Concentrators are indicated for the administration of supplemental oxygen.
Chere chto for AAC
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 19-196 510(k) Number_
prescription use $\checkmark$
§ 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).