(358 days)
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 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.
The SeQual Technologies OMNI 2 Oxygen System 510(k) submission (K083163) provides a summary of performance data indicating compliance with relevant standards. However, it does not contain the level of detail typically found in studies designed to robustly prove device performance against specific acceptance criteria for AI/diagnostic devices.
Here's an analysis based on the provided text, highlighting what is (and isn't) present:
Missing Information & General Notes:
- This is not an AI/Diagnostic Device: The OMNI 2 Oxygen System is an oxygen concentrator. The submission focuses on hardware performance, electrical safety, and environmental compliance, not diagnostic accuracy or AI performance. Therefore, many of the requested categories (e.g., ground truth, reader studies, effect size of AI, etc.) are not applicable to this type of device.
- Focus on Substantial Equivalence: This 510(k) is aimed at demonstrating substantial equivalence to a legally marketed predicate device (K013931 - OMNI Oxygen System, Model 1000). The performance data presented is to show the new device is as safe and effective as the predicate, not necessarily to break new ground in performance or achieve specific clinical outcomes.
- Summary Level Data: 510(k) summaries often provide high-level statements about testing rather than detailed experimental protocols and results.
1. Table of Acceptance Criteria and Reported Device Performance
Given this is an oxygen concentrator, the "acceptance criteria" are related to engineering specifications and compliance with device standards, rather than diagnostic accuracy metrics. The document broadly states compliance with standards.
| Acceptance Criteria (Implied) | Reported (Tested) Device Performance |
|---|---|
| System Performance: Operates as an oxygen concentrator. | "The OMNI 2 Oxygen System has a comprehensive test platform that covers system performance..." |
| Provides up to 3 LPM continuous flow. | "Provides up to 3 LPM continuous flow..." (Directly stated in device description) |
| Delivers oxygen bolus up to 96 mL in pulse mode. | "...or in pulse mode an oxygen bolus of up to 96 mL (milli-Liter)." (Directly stated in device description) |
| Environmental Conditions: Withstands specified environments. | "...environmental conditions..." (Tested as part of comprehensive test platform) |
| Electromagnetic Compatibility (EMC): Meets EMC standards. | "...electromagnetic compatibility (EMC)... Outside agencies provide independent analysis related to compliance with EMC..." |
| Electrical Safety: Meets IEC 60601-1 (medical electrical safety). | "...IEC 60601-1 (Medical Electrical Equipment-Part 1: General Requirements)." (Outside agencies provide independent analysis) |
| Software Validation: Software functions correctly. | "...and software validation." (Tested as part of comprehensive test platform) |
| Compliance with ISO 8359: Meets oxygen concentrator standard. | "The test platform confirms compliance with ISO 8359 standard for Oxygen Concentrator devices." |
| Safety and Effectiveness: No new questions raised. | "The PSA technology employed...raise no new questions of safety and effectiveness." "The test platform ensures compliance to recognized consensus standards and therefore raises no new questions of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the summary. For an oxygen concentrator, the "test set" would typically refer to a number of manufactured units subjected to various performance, environmental, and electrical tests. The summary does not disclose how many units were tested.
- Data Provenance: Not explicitly stated as retrospective or prospective for the various tests. Given the nature of device testing for regulatory submission, it is assumed to be prospective testing conducted on pre-production or production units. The country of origin for the data is implicitly the USA, where SeQual Technologies is located and where the testing was likely overseen, though third-party testing labs could be anywhere.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. This device is an oxygen concentrator, not an AI or diagnostic device that relies on expert interpretation of images or other data to establish a "ground truth." Its performance is measured against engineering specifications and objective physical/electrical parameters.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in diagnostic studies. This is not relevant to the engineering performance testing of an oxygen concentrator.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not Applicable. MRMC studies are designed to compare the performance of human readers, often with and without AI assistance, in diagnostic tasks. This is not relevant for an oxygen concentrator.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not Applicable. Standalone algorithm performance refers to the performance of an AI model without human intervention. The OMNI 2 Oxygen System does not incorporate an AI algorithm for diagnostic or clinical decision-making purposes. Its "performance" is its ability to produce oxygen according to specifications, which is inherently a standalone device function.
7. The Type of Ground Truth Used
Not Applicable. For this device, "ground truth" would be the objective physical and chemical properties measured during testing (e.g., oxygen concentration, flow rate, pressure, power consumption, electrical safety parameters) and compliance with specified environmental conditions. It is not an expert consensus, pathology, or outcomes data in the sense used for diagnostic devices.
8. The Sample Size for the Training Set
Not Applicable. This device uses established PSA technology and does not involve machine learning or AI models that require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for an AI model, this question is not relevant.
{0}------------------------------------------------
K083/63
510(k) Summary
OCT 20 2009
Submitter Information:
| Submitter: | SeQual Technologies, Inc.11436 Sorrento Valley RoadSan 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
ੱ
510(k) Number: KD83163
§ 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).