(352 days)
K 020362, K 013223
K 020362,K 013223
No
The summary describes a system for generating medical air and oxygen using PSA technology. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the physical process of gas generation and compatibility with existing medical equipment.
No.
The device supplies medical-grade air and oxygen to other medical equipment, but it does not directly treat a patient.
No
The device is described as generating medical-grade air and oxygen for therapeutic use with other medical equipment, not for diagnosing medical conditions.
No
The device description clearly states it is a "Portable Oxygen Generation System" that uses "PSA technology" and includes a "oilless scroll feed compressor" to produce medical air and oxygen. These are hardware components, not software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device provides medical grade air and oxygen for use in hospitals, surgical suites, and other clinical settings. It is compatible with equipment like ventilators, cannulas, and anesthesia machines. This indicates a direct interaction with the patient's respiratory system or equipment used for patient care.
- Device Description: The description reinforces that it's a system for generating medical air and oxygen.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are specifically designed to perform tests on biological samples to provide diagnostic information. This device is designed to provide a medical gas for patient use.
N/A
Intended Use / Indications for Use
The POGS is intended to provide medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in hospitals, surgical suites, and other clinical settings in military facilities only. POGS is compatible with commercial oxygen-consuming equipment and accessories, including D,E,H, K cylinder-filling accessories, ventilators, cannulas, and Draeger Narkomed Anesthesia Machine.
Product codes
CAW
Device Description
The FDA-cleared On Site Gas Systems' Portable Oxygen Generation System 33, "POGS 33", (K020362) is being modified to include medical air, and compatibility with the Draegar Narkomed Anesthesia Machine. The system uses PSA technology, and supplies medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in battlefield/ hospital settings in military facilities only.
The POGS 33 utilizes the same Draegar Narkomed Anesthesia Machine as the predicate, PVOCS. The POGS 33 utilizes the same oilless scroll feed compressor in the production of medical air as does the predicate, PVOCS.
The variations of the POGS device to the predicate are greater oxygen total flow, to accommodate more cannulas per device. The variations are designed and tested for the same indication of use, safety and effectiveness. Variations are substantially equivalent to the predicate device.
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
Device is to be operated by trained medical personnel for military use only.
Hospitals, surgical suites, and other clinical settings in military facilities 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
For oxygeri, the device meets the requirements of the FDA recognized For oxygen, the doncentrators, ASTM F 1464-93 and USP Standard covering oxygerantially equivalent to the predicate devices. oxygen box, air, the device meets the requirements of the FDA recognized standard covering Medical Air, USP
Key Metrics
Not Found
Predicate Device(s)
K 020362, K 013223
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the text "K030920" in a handwritten style. The text is oriented diagonally, starting from the bottom left and rising to the upper right. The characters are bold and slightly distorted, giving them a casual, handwritten appearance.
10.0 510 (k) SUMMARY
Submitter's Name 10.1
Francis X. Hursey, President
10.2 Address
On Site Gas Systems. Inc. 35 Budney Road Budney Industrial Park Newington, CT 06111
10.3 Phone
888-748-34:29 (Toll-free) 860-667-8838
Fax 10.4
860-667-2222
Contact Person 10.5
C. Barton ("Bart") Gullong, Vice President, Marketing and Technical Services
10.6 Date of Preparation
March 17, 2003
10.7 Device Name
Portable Oxygen Generator with Medical Air
10.8 Trade Name
On Site Gas Systems Portable Oxygen Generation System with Medical Air
10.9 Common Name Oxygen Concentrator with Medical Air
Proprietary Name 10.10 POGS 33
Classification Name 10.11 Portable Oxygen Generator with Medical Air
1
Legally Marketed Device Claiming Substantial 10.12 Equivalency To:
On Site Gas Systems Portable Oxygen Generation System K 020362 Litton Systems Patient Ventilation Oxygen Concentrating K 013223 Svstem (PVOCS)
Description of the Device 10.13
The FDA-cleared On Site Gas Systems' Portable Oxygen Generation System 33, "POGS 33", (K020362) is being modified to include medical air, and compatibility with the Draegar Narkomed Anesthesia Machine. The system uses PSA technology, and supplies medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in battlefield/ hospital settings in military facilities only.
The POGS 33 utilizes the same Draegar Narkomed Anesthesia Machine as the predicate, PVOCS. The POGS 33 utilizes the same oilless scroll feed compressor in the production of medical air as does the predicate, PVOCS.
The variations of the POGS device to the predicate are greater oxygen total flow, to accommodate more cannulas per device. The variations are designed and tested for the same indication of use, safety and effectiveness. Variations are substantially equivalent to the predicate device.
Intended Use of Device 10.14
The POGS is intended to provide oxygen and medical air. 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 the filtered compressed, dry 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.
Medical air is produced when the compressed air leaves the air storage tank and splits-off between the oxygen generator and medical air stream. This compressed air is produced from the same make and model oil-less scroll compressor as the predicate. The medical air passes through a pressure requlator and 0.01 micron filter. 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
Performance Data 10.17
For oxygeri, the device meets the requirements of the FDA recognized For oxygen, the doncentrators, ASTM F 1464-93 and USP Standard covering oxygerantially equivalent to the predicate devices. oxygen box, air, the device meets the requirements of the FDA recognized standard covering Medical Air, USP
10.18 Conclusions
Based on the design, performance specifications, and intended use, the Daygen Concentrators with medical air are substantially equivalent to the currently marketed devices.
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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that features a stylized depiction of a human figure with outstretched arms, overlaid with three horizontal bars.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2004
Mr. C. Barton Gullong On Site Gas Systems Inc. 35 Budney Road Budney Industrial Park Newington, CT 06111
Re: K030920
Trade/Device Name: Portable Oxygen Generation System with Medical Air Regulation Number: 868.5440 Regulation Name: Generator, Oxygen, Portable Regulatory Class: II Product Code: CAW Dated: January 14, 2004 Received: January 15, 2004
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 I va may aterest 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 your 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 Codc 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. C. Barton Gullong
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dr is todaints or our device complies with other requirements of the Act that I DA has made a acterines administered by other Federal agencies. You must of any I catal statues and registanents, including, but not limited to: registration and listing (21 comply with an the Act 81equirements (1); good manufacturing practice requirements as set CFN in the quality systems (CS) 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 production conacted conacle in marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematics notication "The 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 if you dome specific cof Compliance at (301) 594-4646. Also, please note the regulation entitled, Connect and office of Court Courter notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,
Clive Liu, Ph.D.
Chiu Lin, Ph.I 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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ogen Generating Equipment
8.10 Statement of Indications for Use
510 (k) File Number 8.10.1
K0309201
Device Name 8.10.2
On Site Gas Systems Portable Oxygen Generation System - 33 (POGS 33)
Indications for Use 8.10.3
The POGS is intended to provide medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in hospitals, surgical suites, and other clinical settings in military facilities only. POGS is compatible with commercial oxygen-consuming equipment and accessories, including D,E,H, K cylinder-filling accessories, ventilators, cannulas, and Draeger Narkomed Anesthesia Machine.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
8-4
CAhwh
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K030920
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 NUTHPPORATED IN THE STATE OF CONNECTICUT, U.S.A