(8 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.
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.
The provided text describes a Portable Oxygen Generator (P.O.G.S. - 3.3) by On Site Gas Systems. The submission is a 510(k) premarket notification, indicating a claim of substantial equivalence to previously marketed devices.
Here's an analysis of the acceptance criteria and the study that indicates the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Set by Recognized Standard) | Reported Device Performance |
|---|---|
| Conformance to ASTM F 1464-93 (Oxygen Concentrators) | "The device meets the requirements of the FDA recognized standard covering Oxygen Concentrators, ASTM F 1464-93." |
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "non-clinical tests" and states the device "meets the requirements" of the standard. However, it does not provide any specific sample size for the test set or information regarding data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be centered on compliance with a technical standard rather than a clinical study with patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document makes no mention of experts being used to establish ground truth for testing. The evaluation of the device's performance is against the technical requirements of ASTM F 1464-93.
4. Adjudication Method for the Test Set:
There is no mention of an adjudication method in the context of the testing described. The assessment is against the parameters of the ASTM standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document is for a Portable Oxygen Generator, which is a physical device, and not a diagnostic or imaging algorithm that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable as the device is a Portable Oxygen Generator, not an algorithm. The assessment is of the device's physical performance.
7. The Type of Ground Truth Used:
The "ground truth" used for this device's acceptance is compliance with the technical specifications and performance requirements outlined in the FDA recognized standard ASTM F 1464-93 for Oxygen Concentrators. This standard defines objective, measurable parameters for oxygen concentration, flow rate, and other safety/performance aspects of such devices.
8. The Sample Size for the Training Set:
This question is not applicable to a physical medical device like an oxygen generator. The concept of a "training set" is relevant for machine learning algorithms, not for the engineering design and testing of a hardware product.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable, as there is no "training set" for this type of device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets its acceptance criteria is a "Discussion of Non-clinical Test to Support Determination of Substantial Equivalency" specifically focused on "Performance Data."
The key statement is: "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."
This indicates that:
- The device was subjected to non-clinical tests.
- These tests evaluated its performance against the technical specifications and requirements of ASTM F 1464-93.
- Successful completion of these tests, demonstrating compliance with the standard, served as the basis for the FDA's determination of substantial equivalence.
The document does not provide details of the granular test results, the specific number of units tested, the methodology of how "meeting" the standard was confirmed, or any clinical trial data with human subjects. The acceptance is based on adherence to an established engineering and performance standard.
{0}------------------------------------------------
FEB 1 2 2002
10.0 510 (k) SUMMARY
Submitter's Name 10.1
Francis X. Hursey, President
Address 10.2
On Site Gas Systems. Inc. 35 Budney Road Budney Industrial Park Newington, CT 06111
10.3 Phone
888-748-3429 (Toll-free) 860-667-8888
10.4 Fax
860-667-2222
Contact Person 10.5
C. Barton ("Bart") Gullong, Vice President, Marketing and Technical Services
10.6 Date of Preparation
January 28, 2002
10.7 Device Name
Portable Oxygen Generator
Trade Name 10.8
On Site Gas Systems Portable Oxygen Generation System
Common Name 10.9
Oxygen Concentrator
- Proprietary Name 10.10 P.O.G.S. - 3.3
Classification Name 10.11 Portable Oxygen Generator
10-1
{1}------------------------------------------------
Legally Marketed Device Claiming Substantial 10.12 Equivalency To:
On Site Gas Systems Portable Oxygen Generation System K 014078 Merits Health Products Oxygen Concentrators K 011844
Oxlife Oxygen Concentrators K 955549
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 POGS is intended to provide supplemental oxygen. Device is to be operated by trained medical personnel for military use only.
Summary of Technological Characteristics of Device 10.15 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.
10.18 Conclusions
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 is a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2002
Mr. C. Barton Gullong On Site Gas Systems Inc. 35 Budney Road Budney Park Industrial Newington, CT 06111
Re: K020362
P.O.G.S. 3.3 Portable Oxygen Generator System Regulation Number: 868.5440 Regulation Name: Generator, Oxygen, Portable Regulatory Class: Class II (two) Product Code: 73 CAW Dated: January 28, 2002 Received: February 4, 2002
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.
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 i hat FDA has made a determination that your device complies with other requirements of the Act that I Dr Hab Intato a assoc regulations administered by other Federal agencies. You must or any 1 outlar statutes and states and the mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 607); adoming (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) I mo letter with and wy of substantial equivalence of your device of your device to a legally promance notifications of 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 Oiner general internation turers, 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,
Deaky Till
am D. uckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for "O2 N2 SITE On Site Gas Systems, Inc." The logo is in black and white, with the text "O2 N2 SITE" in large, bold letters. The text "On Site Gas Systems, Inc." is in smaller letters below the main logo. A line separates the two parts of the logo.
8.10 Statement of Indications for Use
- 510 (k) File Number 8.10.1
Kozozio 222222
8.10.2 Device Name
On Site Gas Systems Portable Oxygen Generation System - 3.3
8.10.3 Indications for Use
The POGS is intended to provide supplemental oxygen. Device is to be operated by trained medical personnel only for military use only.
Prescription Use
(Per 21 CFR 801.109)
Tek
Division of Cardiovascular & Respiratory Devices
510(k) Number K620362
8-8
On Site Gas Systems, Inc.
35 Budney Road, Budney Industrial Park, Newington, CT 06111 U.S.A. Telephone: 860.667.8888 · Fax: 860.667.2222 Website: www.onsitegas.com · Email: info@onsitegas.com A BUSINESS INCORPORATED IN THE STATE OF CONNECTICUT, U S A
§ 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).