(358 days)
Not Found
No
The document describes a standard oxygen concentrator based on pressure swing adsorption and electronic flow control. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".
Yes.
The device provides supplemental oxygen, which directly treats a physiological need by supplying a substance essential for life.
No
Explanation: The "Intended Use / Indications for Use" section states, "The device is not intended for life support nor does it provide any patient monitoring capabilities." A diagnostic device is involved in monitoring patients or diagnosing conditions.
No
The device description explicitly lists numerous hardware components including air compressors, molecular sieve beds, valves, power supplies, batteries, and filtration systems. It is clearly a physical medical device with integrated software for control and monitoring.
Based on the provided text, the OMNI 2 Oxygen System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "for the administration of supplemental oxygen." This is a therapeutic purpose, delivering a substance to the patient.
- Device Description: The description details an oxygen concentrator that physically processes air to provide oxygen for inhalation. It describes pneumatic and electrical components, compressors, filters, and valves. This is consistent with a device that provides a physical therapy.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to obtain information for diagnostic purposes. The device's function is solely to provide oxygen to the patient.
IVD devices are used to perform tests on samples taken from the human body to diagnose diseases or other conditions. The OMNI 2 Oxygen System does not perform such tests.
N/A
Intended Use / Indications for Use
The OMNI 2 Oxygen System is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
The OMNI 2 Oxygen System is an oxygen concentrator that provides up to 3 LPM continuous flow or in pulse mode an oxygen bolus of up to 96 mL (milli-Liter). The OMNI 2 Oxygen System is based on pressure swing adsorption (PSA) principles. The OMNI 2 Oxygen System operates from AC power, DC power, or rechargeable batteries. This device delivers supplemental oxygen for patients through the molecular sieve beds and is designed to conserve the use of oxygen while operating in pulse flow mode. During pulse flow mode, oxygen is delivered to the patient through a pulse flow valve when the start if inhalation is detected.
The OMNI 2 Oxygen System consists of pneumatic and electrical components, AC power supplies, DC cables and lithium ion batteries. The system has inlet filtration, air compressors, and Synthetic Zeolite molecular sieve beds with a rotary valves, outlet filtration, electronic flow control and audible / visual alarms.
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
Not Found
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 OMNI 2 Oxygen System has a comprehensive test platform that covers system performance, environmental conditions, electromagnetic compatibility (EMC), and software validation. The test platform confirms compliance with ISO 8359 standard for Oxygen Concentrator devices.
Outside agencies provide independent analysis related to compliance with EMC and IEC 60601-1 (Medical Electrical Equipment-Part 1: General Requirements).
The test platform ensures compliance to recognized consensus standards and therefore raises no new questions of safety and effectiveness.
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.
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
K083/63
510(k) Summary
OCT 20 2009
Submitter Information:
| Submitter: | SeQual Technologies, Inc.
11436 Sorrento Valley Road
San Diego, CA 92121 |
|-------------------|--------------------------------------------------------------------------------|
| Contact: | Brian Jarrell, Director of Quality and Regulatory |
| Phone: | (858) 202-3157 |
| FAX: | (858) 558-1915 |
| Date of Summary: | June 11, 2009 |
| Device Name: | |
| Proprietary Name: | OMNI 2 Oxygen System |
| Proprietary Name: | OMNI 2 Oxygen System |
|---|---|
| Common Name: | Oxygen Concentrator |
| Classification of Device: | Generator, Oxygen, Portable as per 21 CFR 868.544 |
| Product Code: | CAW |
Predicate Device Equivalence:
SeQual Technologies is claiming substantial equivalence to the following Iegally marketed predicate device:
K013931 - OMNI Oxygen System, Model 1000 (aka: Eclipse Oxygen System)
Description of Device:
The OMNI 2 Oxygen System is an oxygen concentrator that provides up to 3 LPM continuous flow or in pulse mode an oxygen bolus of up to 96 mL (milli-Liter). The OMNI 2 Oxygen System is based on pressure swing adsorption (PSA) principles. The OMNI 2 Oxygen System operates from AC power, DC power, or rechargeable batteries. This device delivers supplemental oxygen for patients through the molecular sieve beds and is designed to conserve the use of oxygen while operating in pulse flow mode. During pulse flow mode, oxygen is delivered to the patient through a pulse flow valve when the start if inhalation is detected.
1
The OMNI 2 Oxygen System consists of pneumatic and electrical components, AC power supplies, DC cables and lithium ion batteries. The system has inlet filtration, air compressors, and Synthetic Zeolite molecular sieve beds with a rotary valves, outlet filtration, electronic flow control and audible / visual alarms.
Intended Use:
The OMNI 2 Oxygen System is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities. The OMNI 2 Oxygen System is prescription legend required.
Technological Characteristics:
The OMNI 2 Eclipse Oxygen System operates comparably to the listed predicate device. The PSA technology employed to generate the oxygen is well established, and therefore, raise no new questions of safety and effectiveness.
Performance Data:
The OMNI 2 Oxygen System has a comprehensive test platform that covers system performance, environmental conditions, electromagnetic compatibility (EMC), and software validation. The test platform confirms compliance with ISO 8359 standard for Oxygen Concentrator devices.
Outside agencies provide independent analysis related to compliance with EMC and IEC 60601-1 (Medical Electrical Equipment-Part 1: General Requirements).
The test platform ensures compliance to recognized consensus standards and therefore raises no new questions of safety and effectiveness.
Conclusion:
Based on intended use, technology characteristics, design and performance data the OMNI 2 Oxygen System is substantially equivalent to the currently marketed devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mr. Brian Jarrell Director of Quality and Regulatory Affairs Sequal Technologies, Incorporated 11436 Sorrento Valley Road San Diego, California 92121-1306
OCT 20 2009
Re: K083163
Trade/Device Name: OMNI 2 Oxygen System Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: June 11, 2009 Received: September 18, 2009
Dear Mr. Jarrell:
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 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.
3
Page 2- Mr. Jarrell
Enclosure
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Image /page/4/Picture/0 description: The image shows a logo or wordmark that reads "SEQUEL" in a stylized, bold font. The letters are thick and have a slightly distressed or textured appearance, giving them a rough or vintage feel. To the left of the word "SEQUEL", there is a graphic element that appears to be a stack of pancakes or a similar layered food item, also rendered in a bold, textured style.
SeQual Technologies Inc. 11436 Sorrento Valley Road, San Diego CA 92121 USA
Indications for Use Statement
Verl 3 - 4/24/96
Applicant: SeQual Technologies Inc.
510(k) Number (if known):
Device Name: OMNI 2 Oxygen System
Indications For Use:
The OMNI 2 Oxygen System is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
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)
(Per 21 CFR 801.109) (Optional Format 1-2-96)
Int510k/induse
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: KD83163