(28 days)
The POGS is intended to provide supplemental oxygen. Device is to be operated by trained medical personnel only for military use only.
The On Site Gas Systems portable oxygen generator is a prescription device designed to provide an inexpensive supply of supplemental oxygen in a military environment without a continuous source of The feed air compressor creates a vacuum to draw air into a oxvaen. holding talk. The air is then flushed through two tanks in series to provide continuous oxygen. The molecular sieve material adsorbs nitrogen, which comprises approximately 78% of the makeup of air. The resulting gas is approximately 93% oxygen.
This appears to be a 510(k) summary for a medical device, specifically an Oxygen Concentrator (Portable Oxygen Generator). The provided text focuses on the device's description, intended use, and substantial equivalence to predicate devices, rather than a clinical study with detailed acceptance criteria and performance metrics.
Therefore, it's not possible to fully answer all aspects of your request as the provided text does not contain information about a clinical study involving human readers, sample sizes for test/training sets, expert qualifications, adjudication methods, or specific device performance numbers beyond meeting a recognized standard.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Oxygen Concentration (Minimum) | Approximately 93% oxygen |
| Material Adsorption | Uses molecular sieve material to adsorb nitrogen |
| Continuous Oxygen Provision | Flushes air through two tanks in series to provide continuous oxygen |
| Recognized Standard Compliance | Meets the requirements of ASTM F 1464-93 |
Explanation: The document states that the resulting gas is "approximately 93% oxygen." This can be considered a key performance metric. The main "acceptance criterion" mentioned is compliance with the ASTM F 1464-93 standard for Oxygen Concentrators. The document explicitly states, "The device meets the requirements of the FDA recognized standard covering Oxygen Concentrators, ASTM F 1464-93, and is substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The document describes a non-clinical test to support substantial equivalence. It does not mention a "test set" in the context of diagnostic performance or human reader studies.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The "test" mentioned is compliance with a standard, not data from a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There's no mention of experts establishing ground truth for a diagnostic test set in this 510(k) summary. The ground truth for the device's performance would be derived from the physical and chemical testing against the ASTM standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is mentioned as there's no interpretation of diagnostic outputs by experts.
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. This is a 510(k) for an oxygen generator, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm. Its performance is inherent in its mechanical and chemical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is objective measurement against the physical and chemical specifications outlined in the ASTM F 1464-93 standard for Oxygen Concentrators, and the measured oxygen concentration (approx. 93%).
8. The sample size for the training set:
- Not applicable. This device is not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is involved.
Summary of what the document does provide regarding acceptance criteria and study:
The primary "study" referred to is a non-clinical test demonstrating compliance with a recognized industry standard: ASTM F 1464-93.
- Acceptance Criteria (implicit): Meeting the specifications set forth in ASTM F 1464-93 for Oxygen Concentrators, and achieving an oxygen concentration of approximately 93%.
- Study: A non-clinical test was performed to verify the device's adherence to the ASTM F 1464-93 standard. The nature of this test (e.g., how many units tested, specific methodologies) is not detailed in this summary, but the conclusion is that it met the requirements.
- Conclusion: The device was deemed "substantially equivalent" to predicate devices based on its design, performance specifications, and intended use, primarily due to its compliance with ASTM F 1464-93.
{0}------------------------------------------------
10.0 510 (k) SUMMARY
10.1 Submitter's Name
Francis X. Hursey, President
10.2 Address
On Site Gas Systems. Inc. 100 Production Court New Britain, CT 06051
10.3 Phone
888-748-3429 (Toll-free) 860-229-2799 860-225-9405
10.4 Fax
860-225-9531
10.5 Contact Person
C. Barton ("Bart") Gullong, Vice President, Marketing and Technical Services
10.6 Date of Preparation
November 30, 2001
10.7 Device Name
Portable Oxygen Generator
10.8 Trade Name
On Site Gas Systems Portable Oxygen Generator System
10.9 Common Name
Oxygen Concentrator
- 10.10 Proprietary Name P.O.G.S.
10.11 Classification Name Portable Oxygen Generator
10-1
{1}------------------------------------------------
Legally Marketed Device Claiming Substantial 10.12 Equivalency To:
Merits Health Products Oxygen Concentrators K 011844 K955549 Oxlife Oxygen Concentrators
10.13 Description of the Device
The On Site Gas Systems portable oxygen generator is a prescription device designed to provide an inexpensive supply of supplemental oxygen in a military environment without a continuous source of The feed air compressor creates a vacuum to draw air into a oxvaen. holding talk. The air is then flushed through two tanks in series to provide continuous oxygen. The molecular sieve material adsorbs nitrogen, which comprises approximately 78% of the makeup of air. The resulting gas is approximately 93% oxygen.
The variations of the device are to allow for greater total flow, to accommodate more cannulas per device. The variations are designed and tested for same indication of use, safety and effectiveness; variations are substantially equivalent to predicate devices.
10.14 Intended Use of Device
The Oxygen Concentrators are intended to provide supplemental oxygen. Device is to be operated by trained medical personnel.
Our portable oxygen generator provides supplemental oxygen, where oxygen is currently present. Specifically for military battlefields, primary oxygen may be unavailable or not feasible. In this application, POGS can actually fill cvlinders to provide primary oxygen besides.
10.15 Summary of Technological Characteristics of Device Compared to Predicates
The oxygen generator operates by using molecular sieve material to adsorb the 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.
{2}------------------------------------------------
Discussion of Non-clinical Test to Support Determination 10.16 of Substantial Equivalency
10.17 Performance Data
The device meets the requirements of the FDA recognized standard covering Oxygen Concentrators, ASTM F 1464-93, and is substantially equivalent to the predicate devices.
Conclusions 10.18
Based on the design, performance specifications, and intended use, the Oxygen Concentrators are substantially equivalent to the currently marketed devices.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 8 2002
Mr. C. Barton Gullong On Site Gas Systems, Inc. 100 Production Court New Britain, CT 06051
Re: K014078
On Site Gas Systems Portable Oxygen Generator System Regulation Number: 868.5440 Regulation Name: Generator, Oxygen, Portable Regulatory Class: Class II (two) Product Code: CAW Dated: December 5, 2001 Received: December 11, 2001
Dear Mr. Gullong:
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. In addition, if you wish to change or expand the current indications for use to include non-military environments, you will need to submit a new 510(k) premarket notification, and receive FDA clearance prior to marketing the device.
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.
{4}------------------------------------------------
Page 2 - Mr. C. Barton Gullong
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Oaken Till
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
8.10 Statement of Indications for Use
510 (k) File Number 8.10.1
Device Name 8.10.2
On Site Gas Systems Portable Oxygen Generator System
Indications for Use 8.10.3
The POGS is intended to provide supplemental oxygen. Device is to be operated by trained medical personnel only for military use only.
Prescription use $\checkmark$
Division of Cardiovascular & Respiratory Devices
510(k) Number K04078
8-8 Revised 12/21/01
§ 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).