(18 days)
The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, is intended for the administration of supplemental oxygen up to 10 LPM. The device is not intended for life support nor does it provide any patient monitoring capabilities.
The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, is a 0.5 to 10.0 Liter per minute (LPM) continuous flow pressure swing adsorption (PSA) type system that produces oxygen.
The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, consists of pneumatic and electrical components. The system has inlet filtration, air compressors, heat exchanger, and Synthetic Zeolite molecular sieve beds with a rotary valve, outlet filtration, electronic flow control and audible / visual alarms.
The provided document is a 510(k) summary for the SeQual Model 6323A-OM-10, Integra Oxygen Concentrator. This document describes a medical device for oxygen delivery and its equivalence to predicate devices, not an AI/ML powered device. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set size) are not applicable to this type of submission.
However, I can extract information related to the device's acceptance criteria and the study proving it meets them.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Standard | Reported Device Performance |
|---|---|---|
| Oxygen Concentration | Meets specifications to ISO 8359 and ASTM 1464 standards | Confirmed to meet specifications |
Note: The document states "meets specifications" without detailing the specific percentage of oxygen concentration required by ISO 8359 and ASTM 1464. These standards define requirements for oxygen concentrators, including oxygen purity.
2. Sample size used for the test set and the data provenance
Not applicable for this type of device and submission. The performance data focuses on device specifications rather than clinical data from a "test set" in the context of an AI/ML evaluation. The “test set” here refers to the device itself being tested for its functional specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the sense of expert consensus on diagnostic interpretations, is not relevant for an oxygen concentrator's performance evaluation. The "ground truth" here is the physical measurement of oxygen concentration against established engineering standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation). The performance of an oxygen concentrator is measured objectively.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for evaluating the device's performance is based on objective measurements against established international and national standards for oxygen concentrators (ISO 8359 and ASTM 1464). These standards define the acceptable range of oxygen concentration for such devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML-powered device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML-powered device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study referenced is "oxygen concentration testing to ISO 8359 and ASTM 1464 standards." These are internationally recognized standards for oxygen concentrators. The document states that these tests "confirm the device meets specifications and is substantially equivalent to the predicate devices." This implies that the device underwent testing to verify its ability to produce oxygen within the purity and flow specifications outlined by these standards at various operational parameters (e.g., flow rates, as the device is specified for 0.5 to 10.0 LPM). The details of the specific tests performed (e.g., number of units tested, environmental conditions, duration of tests) are not provided in this 510(k) summary, but the reference to these standards indicates the methodology.
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Special 510(k) Summary
Submitter Information:
SEP 1 0 2004
| 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: | August 11, 2004 |
| Device Name: | |
| Proprietary Name: | Integra Oxygen Concentrator, Model 6323A-OM-10 |
| Common Name: | Oxygen Concentrator |
| Classification of Device: | Generator, Oxygen, Portable as per 21 CFR 868.5440 |
Predicate Device Equivalence:
SeQual Technologies is claiming substantial equivalence to the following legally marketed predicate devices:
K942082 - SeQual Technologies Model 6323-OM Oxygen Concentrator K003472 - Integra Oxygen Concentrators Model 6400-OM K013931 - OMNI Oxygen System, Model 1000
Description of Device:
The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, is a 0.5 to 10.0 Liter per minute (LPM) continuous flow pressure swing adsorption (PSA) type system that produces oxygen.
The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, consists of pneumatic and electrical components. The system has inlet filtration, air compressors, heat exchanger, and Synthetic Zeolite molecular sieve beds with a rotary valve, outlet filtration, electronic flow control and audible / visual alarms.
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Intended Use:
The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, is intended for the administration of supplemental oxygen up to 10 LPM. The device is not intended for life support nor does it provide any patient monitoring capabilities.
The device has no contraindications.
Technological Characteristics:
The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, operates comparably to the listed predicate devices. The technology employed to generate the oxygen is well established, and therefore, raise no new questions of safety and effectiveness.
Performance Data:
Results of the oxygen concentration testing to ISO 8359 and ASTM 1464 standards confirm the device meets specifications and is substantially equivalent to the predicate devices.
Conclusion:
Based on the design, performance specifications, tests and intended use, the SeQual Model 6323A-OM-10, Integra Oxygen Concentrator is substantially equivalent to the currently marketed devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2004
Mr. Brian Jarrell Director, Quality and Regulatory Affairs Sequal Technologies, Incorporated 11436 Sorrento Valley Road San Diego, California 92121-1306
Re: K042262
Trade/Device Name: SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: August 17, 2004 Received: August 23, 2004
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 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 Eederal Register.
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Page 2 - Mr. Jarrell
Please be advised that FDA's issuance of a substantial equivalence determination does not I teast 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. or the Act of ally I out's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instille (2 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - requirence as between is 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) This reter wifi ano in J The FDA finding of substantial equivalence of your device to a promainer results in a classification for your device and thus, pour 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), 11 you deems the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj count 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,
Chiu Lin, Ph.D.
Chiu Lin. Ph.D. 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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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: SeQual Model 6323A-OM-10, Integra Oxygen Concentrator,
Indications For Use:
The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, is intended for the administration of supplemental oxygen up to 10 LPM. The device is not intended for life support nor does it provide any patient monitoring capabilities.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | (21 CFR 807 Subpart C) | |
| 510(k) Number: |
(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:_
§ 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).