(56 days)
The OxLife Oxygen Concentrators are indicated for the administration for supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
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 purified 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 gas to flush 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. All models have inverter capability to use a 12 Volt DC power as well as 110v.
Here's an analysis of the provided text regarding the OxLife Freedom Five™ Oxygen Concentrators, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Oxygen output meets specifications | Confirmed |
| Substantially equivalent to predicate device | Confirmed |
| Inverter provides adequate power from 12 Volt DC power source | Confirmed |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It simply states "the results of the oxygen concentration testing confirm..." without detailing the methodology or scope of this testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not provide any information about experts used to establish ground truth or their qualifications. The testing appears to be based on objective measurements against specifications rather than expert interpretation.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method. The performance testing is presented as a direct measurement against specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No, an MRMC comparative effectiveness study was not done. The device in question is an oxygen concentrator, which delivers oxygen, and its performance is evaluated based on its ability to meet specific oxygen concentration and power delivery parameters. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The concept of "standalone" performance (algorithm only) as typically applied to AI/software is not directly applicable to this device. The device itself performs the function (generating oxygen). The performance data relates to the device's physical output and operational characteristics, not an algorithm's diagnostic accuracy. However, if interpreting "standalone" as the device operating independently to meet its specifications, then yes, the testing would evaluate the device's operational performance in generating oxygen at specified concentrations, without human intervention in the oxygen generation process itself.
7. The Type of Ground Truth Used:
The ground truth used for this device is based on objective specifications for oxygen concentration and power delivery. For example, the device must produce "approximately 93% oxygen." This is a measurable physical property rather than an expert consensus, pathology, or outcomes data in the typical sense of medical diagnostic devices.
8. The Sample Size for the Training Set:
The document does not provide any information about a training set or its sample size. This is a hardware device, and the concept of "training set" as used in machine learning (for an AI algorithm) is not relevant here. The device's design and manufacturing process would be subject to quality control, but not "training" in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" in the context of AI, this question is not applicable. The device's operating principles are based on established physical and chemical processes (molecular sieve material) and engineering design, not learned from a dataset.
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MAY 30 2006
OXLIFE LLC APPLICATION FOR SPECIAL 510(k) "Freedom Five" 3/31/2006 Page 12 of 25
10.0 510(k) Summary
| 10.1 Submitters Name: | OxLife LLC |
|---|---|
| 10.2 Submitters Address: | 141 Twin Springs Rd Hendersonville NC28792 |
| 10.3 Submitters Phone & Fax: | 828-684-7353 ph. 828-684-8990 fx. |
| 10.4 Contact Person: | Margaret K. PoteatGeneral Manager/ManagementRepresentative |
| 10.5 Date Summary Prepared: | March 21, 2006 |
| 10.6 Trade/Proprietary Name: | OxLife Freedom Five™ OxygenConcentrators |
| 10.7 Common/Usual Name: | Oxygen Concentrator |
| 10.8 Classification Name: | Portable Oxygen Concentrator |
| 10.9 Comparison to Currently Marketed Devices: | The modified OxLife Oxygen Concentrator is |
substantially equivalent to the existing OxLife Oxygen Concentrator (K971964 & K933081)
10.10 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 purified 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 gas to flush 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
Previously Legally Marketed unmodified device # K971964 Small Business Decision Number SBD068194 EIN # 41-2095576 Payment ID 6025035-956733
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OXLIFE LLC APPLICATION FOR SPECIAL 510(k) "Freedom Five" Page 13 of 25 3/31/2006
510(k) Summary page two
necessary to flush and prepare the saturated sieve tank while supplying the patient with a continuous flow of high concentration oxygen.
All models have inverter capability to use a 12 Volt DC power as well as 110v.
10.11 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.
10.12 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.
10.13 Performance Data:
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 inverter provides adequate power to run the devices from a 12 Volt DC power source.
10.14 Conclusion:
Based on the design, performance specifications and testing and intended use, the modified OxLife Oxygen Concentrators are substantially equivalent to the currently marketed devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the bird symbol.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 30 2006
Ms. Margaret K. Poteat Genera Manager/Management Representative Oxlife Limited Liability Company 141 Twin Springs Road Hendersonville, North California 28792
Re: K060922
Trade/Device Name: Oxlife Freedom Five Oxygen Concentrators Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: May 18, 2006 Received: May 19, 2006
Dear Ms. Poteat:
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. Poteat
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 (OS) 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Runger
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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APPENDIX D
Indications for Use
510(k) Number: K060922
Device Name: Oxlife Freedom Five Oxygen Concentrators
Indications For Use: The OxLife Oxygen Concentrators are indicated for the administration for supplemental oxygen.
Prescription Use $\sqrt{}$
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
huybalion
(Division Sign Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K060922
9
§ 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).