(49 days)
K 020362, K 014078
Not Found
No
The device description focuses on a physical process (molecular sieve) for oxygen generation and does not mention any computational or algorithmic components related to AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
Explanation: The device provides supplemental oxygen, which directly contributes to the treatment or management of a medical condition.
No
The device is described as an oxygen generator intended to provide supplemental oxygen, which is a therapeutic function, not a diagnostic one. It does not mention any function for detecting, monitoring, or diagnosing medical conditions.
No
The device description clearly outlines a hardware-based system involving a compressor, holding tank, and molecular sieve material for generating oxygen. There is no mention of software being the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide supplemental oxygen." This is a therapeutic purpose, delivering a substance to the body.
- Device Description: The description details how the device generates oxygen from air. This process is about producing a gas for inhalation, not analyzing a sample from the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any bodily specimens.
The device described is an oxygen generator, which falls under the category of medical devices used for respiratory support.
N/A
Intended Use / Indications for Use
The POGS is intended to provide supplemental oxygen. Device is to be operated by trained medical personnel for military use only.
Product codes (comma separated list FDA assigned to the subject device)
73 CAW
Device Description
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 oxygen. 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 less total flow, to accommodate fewer cannulas per device. The variations are designed and tested for same indication of use, safety and effectiveness; variations are substantially equivalent to predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical personnel for military use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device meets the requirements of the FDA recognized standard covering Oxygen Concentrators, ASTM F 1464-93, and is substantially equivalent to our legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 020362, K 014078
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
MAY 2 2 2002
KC21082
510(k) SUMMARY 7.0
7.1 Submitter's Name
Francis X. Hursey, President
7.2 Address
On Site Gas Systems. Inc. 35 Budney Road Budney Industrial Park Newington, CT 06111
7.3 Phone
888-748-3429 (Toll-free) 860-667-8888
7.4 Fax
860-667-2222
Contact Person 7.5
C. Barton ("Bart") Gullong, Vice President, Marketing and Technical Services
- 7.6 Date of Preparation April 1, 2002
7.7 Device Name
Portable Oxygen Generator
7.8 Trade Name
On Site Gas Systems Portable Oxygen Generation System
7.9 Common Name
Oxygen Concentrator
- 7.10 Proprietary Name P.O.G.S. - 1.0
- 7.11 Classification Name Portable Oxygen Generator
7-1 - Revised 5/20/02
1
Legally Marketed Device Claiming Substantial 7.12 Equivalency To:
On Site Gas Systems Portable Oxygen Generation System K 020362 On Site Gas Systems Portable Oxygen Generation System K 014078
7.13 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 oxygen. 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 less total flow, to accommodate fewer cannulas per device. The variations are designed and tested for same indication of use, safety and effectiveness; variations are substantially equivalent to predicate devices.
7.14 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.
7.15 Summary of Technological Characteristics of Device Compared to Our Legally Marketed Devices
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 our legally marketed devices as well as other legally marketed products.
7-2 Revised 5/20/02
2
7.16 Performance Data
The device meets the requirements of the FDA recognized standard covering Oxygen Concentrators, ASTM F 1464-93, and is substantially equivalent to our legally marketed devices.
Conclusions 7.17
Based on the design, performance specifications, and intended use, the Oxygen Concentrators are substantially equivalent to our currently marketed devices.
7-3 Revised 5/20/02
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
MAY 22 2002
Mr. C. Barton Gullong On Site Gas Systems Inc. 35 Budney Road Budney Industrial Park Newington, CT 06111
Re: K021082
P.O.G.S. 1.0 Portable Oxygen Generator System Regulation Number: 868.5440 Regulation Name: Generator, Oxygen, Portable Regulatory Class: Class II (two) Product Code: 73 CAW Dated: April 1, 2002 Received: April 3, 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 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,
Dail Telle
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Statement of Indications for Use 5.7
510 (k) File Number 5.7.1
5.7.2 Device Name
On Site Gas Systems Portable Oxygen Generation System- 1.0
5.7.3 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
Division of Cardiovascular & Respiratory Devices
510(k) Number K021082