(117 days)
The Portable Oxygen Generator (POG) is intended to produce oxygen for emergency use at 6 lpm for at least 15 minutes.
The Molecular Products' POG is a chemical based portable oxygen generator which generates 99% oxygen for 15 minutes at a flow rate of 6 lpm. It is a self-contained device with the oxygen delivered via a standard oxygen face mask or nasal cannula.
The document describes the acceptance criteria and performance of the POG (Portable Oxygen Generator) device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Test flow rate | 6 Lpm |
| Duration | At least 15 minutes |
| % Oxygen | 99% |
| External canister temperature | < 45°C |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It mentions "Testing" as a category, implying that tests were conducted, but lacks details on the experimental design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a portable oxygen generator, and its performance criteria are based on measurable physical properties (flow rate, oxygen concentration, temperature, duration), not on subjective expert assessment of medical images or conditions. Therefore, there is no mention of experts establishing ground truth in this context.
4. Adjudication Method for the Test Set
Not applicable, as expert adjudication is not relevant for the type of objective performance criteria evaluated for this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The POG is a medical device for generating oxygen, not an imaging or diagnostic AI tool that would typically undergo an MRMC study. Its effectiveness is measured by its physical output characteristics.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not directly applicable. The POG is a physical device, and its performance is inherently "standalone" in how it generates oxygen. There isn't an algorithm or human-in-the-loop component in its primary function that would be separately evaluated in this manner. The reported performance metrics are for the device operating independently.
7. Type of Ground Truth Used
The ground truth for this device's performance is based on direct physical measurements and engineering specifications, such as a calibrated flow meter for flow rate, an oxygen analyzer for % oxygen, a timer for duration, and a thermometer for temperature.
8. Sample Size for the Training Set
Not applicable. The POG is a hardware device where performance is determined by its design and manufacturing process, not trained using a data set like an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this physical device. Performance is validated through engineering tests and quality control.
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510(k) Summary 5
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 25-Jul-06
| Molecular Products Ltd.Mill EndThaxted, Essex CM6 2LT UK | Tel -- 011-44-1371-830676Fax - 011-44-1371-830998 | NOV 21 2006 | |
|---|---|---|---|
| Official Contact: | Mandy Crudace, PhD, Technical Manager | ||
| Proprietary or Trade Name: | POG | ||
| Common/Usual Name: | Portable oxygen generator | ||
| Classification Name: | Portable oxygen generator | ||
| Device: | POG | ||
| Predicate Devices: | OxySure Systems - OxySure - K052396 | ||
| Device Description: |
The Molecular Products' POG is a chemical based portable oxygen generator which generates 99% oxygen for 15 minutes at a flow rate of 6 lpm. It is a self-contained device with the oxygen delivered via a standard oxygen face mask or nasal cannula.
| Indications for Use: | |
|---|---|
| Indicated Use -- | Intended to produce oxygen for emergency use. |
| Patient Population -- | Any individual |
| Environment of Use -- | Any environment |
| Contraindications -- | None |
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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 25-Jul-06
Device Attributes:
| Over-the-counter (OTC) | Yes |
|---|---|
| ------------------------ | ----- |
Design
| Dry chemical based technology | Yes |
|---|---|
| Portable | Yes |
Testing
| Test flow rate | 6 Lpm |
|---|---|
| Duration | At least 15 minutes |
| % Oxygen | 99% |
| External canister temperature | < 45°C |
Differences Between Other Legally Marketed Predicate Devices
The POG is viewed as substantially equivalent to the following predicate device -OxySure - K052396.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Molecular Products Limited C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court, #102 Bonita Springs, Florida 34134
NOV 2 ] 2006
Re: K062153
Trade/Device Name: POG Portable Oxygen Generator Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: October 11, 2006 Received: October 12, 2006
Dear Mr. Dryden:
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. Dryden
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 (QS) 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 your 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 Runoe
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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4 Indications for Use Statement
| Page 1 of 1 | |
|---|---|
| 510(k) Number: | K662153 (To be assigned) |
| Device Name: | POG |
| Indications for Use: | The Portable Oxygen Generator (POG) is intended to produce oxygen for emergency use at 6 lpm for at least 15 minutes. |
Prescription Use (Part 21 CFR 801 Subpart D) Over-the-counter use XX (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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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).