(41 days)
The OxyTec 900 is intended for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable and is capable of continuous use in the home, institutional, and travel / mobile environments.
The OxyTec 900 is a small, portable oxygen concentrator which operates by pressure swing adsorption, molecular sieve. It has various flow rate settings, utilizes a conserver trigger method, and delivers 89% ± 3% pure oxygen. It is capable of continuous use in the home, institutional settings and mobile environments. It may be powered by 100-250 VAC, 12-14 VDC or batteries.
This document describes the OxyTec 900, a portable oxygen generator. However, the provided text does not contain a study proving the device meets specific acceptance criteria in the format requested. The document is primarily a 510(k) summary for regulatory submission, focusing on device description, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information) cannot be extracted from the given text as they are not present.
The only "acceptance criteria" discussed are implicit in the comparison to the predicate device, particularly regarding oxygen purity.
Here's the information that can be extracted or inferred based on the provided text, with notes indicating what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (OxyTec 900) |
|---|---|
| Oxygen purity: 90% ± 3% (from AirSep) | 89% ± 3% |
| Portable, battery operated: Yes | Yes |
| Alarms: Yes | Various user alarms |
| Variable flow settings with pulsed doses: Yes | Yes |
| Conserver integrated in system: Yes | Yes |
Note: The document states, "There are no significant differences between the proposed device, OxyTec 900 and the identified predicates." This implies that meeting the predicate's performance characteristics serves as the "acceptance criteria" for substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document does not describe a performance study with a test set.
- Data Provenance: Not applicable, as no specific performance data from a test set is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no performance study or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no performance study or adjudication process is described.
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
- No MRMC study was done. This device is an oxygen concentrator, not an AI or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is mechanical/electronic, not an algorithm. Its performance (e.g., oxygen purity, flow rate accuracy) would be evaluated standalone, but the document does not detail these specific tests or their results beyond the summary table.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of an AI device. For this medical device, the "ground truth" for its performance would be established through engineering specifications, scientific measurements, and established medical standards for oxygen delivery (e.g., precise oxygen concentration validated by analytical instruments). The document only states the claimed purity.
8. The sample size for the training set
- Not applicable. This is not an AI device that uses training sets.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device that uses training sets.
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OxyTec 900
Summary of Safety and Effectiveness 3.1
K 043615
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 December 28, 2004
| 5150 E. La Palma Ave.Suite 203Anaheim Hills, CA 92807 | Tel: | (714) 701-9933 |
|---|---|---|
| Fax: | (714) 701-9931 | |
| Official Contact: | Charles Atlas, President | |
| Proprietary or Trade Name: | OxyTec 900 | |
| Common/Usual Name: | Portable oxygen generator (concentrator) | |
| Classification Name: | Portable oxygen generator | |
| Device: | OxyTec 900 | |
| Predicate Devices: | AirSep - LifeStyle - K020324 |
Device Description:
OxyTec Medical Corp.
The OxyTec 900 is a small, portable oxygen concentrator which operates by pressure swing adsorption, molecular sieve. It has various flow rate settings, utilizes a conserver trigger method, and delivers 89% ± 3% pure oxygen. It is capable of continuous use in the home, institutional settings and mobile environments. It may be powered by 100-250 VAC, 12-14 VDC or batteries.
Indications:
| Indications for Use -- | The OxyTec 900 is intended for prescription use by patientsrequiring high concentrations of oxygen on a supplementalbasis. It is small, portable and is capable of continuous use inthe home, institutional, and travel / mobile environments. |
|---|---|
| Patient Population -- | Patients requiring supplemental oxygen. |
| Environment of Use -- | Home, Hospital, Sub-acute Institutions, Mobile environments |
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...
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 December 28, 2004
Comparison to Predicate Devices:
| OxyTec 900 | Predicate | |
|---|---|---|
| Attributes | ||
| Indications for use | The OxyTec 900 is intended for prescriptionuse by patients requiring high concentrations ofoxygen on a supplemental basis. It is small,portable and may be used in the home,institutional, and travel / mobile environments. | AirSep Lifestyle – K020324Same |
| Environments of use | Home, Hospital, Sub-acute Institutions,Mobile environments | Same |
| Patient Population | Patients requiring supplemental oxygen | Same |
| Contraindications | None | Same |
| Technology | ||
| Oxygen separation | PSA - pressure swing adsorption | Yes |
| Portable, batteryoperated | Yes | Yes |
| Oxygen purity | 89% $\pm$ 3% | AirSep - 90% $\pm$ 3% |
| Alarms | Various user alarms | Yes |
| Variable flow settingswith pulsed doses | Yes | Yes |
| Conserver integratedin the system | Yes | Yes |
Differences Between Other Legally Marketed Predicate Devices
There are no significant differences between the proposed device, OxyTec 900 and the identified predicates.
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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 symbol resembling an eagle or bird with three stylized lines forming its body and wings.
Public Health Service
FEB - 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OxyTec Medical Corporation C/O Mr. Paul E. Dryden President ProMedic, Incorporated 6329 W. Waterview Court McCordsville, Indiana 46055-9501
Re: K043615
Trade/Device Name: OxyTec 900 Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: December 29, 2004 Received: January 4, 2005
Dear Mr. Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device w C nave roviewed your betermined the device is substantially equivalent (for the indications ferenced about and sure) to legally marketed predicate devices marketed in interstate 10 and caronior 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). and Oosmetier fore, market the device, subject to the general controls provisions of the Act. The I ou may, ateres, mains 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 If your de rice is classinod (voral controls. Existing major regulations affecting your device can may or subject to back acceral 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. Dryden
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be actived that I Drivisian 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 1 ou must compt 7 mixt an 2 1 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 1000: The reast notification. The FDA finding of substantial equivalence of your device to a s ro(ts) promatice nedicate 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), please 11 you atent office of Compliance at (240) 276-0120. 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 Division of Small other gottorers, 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/industry/support/index.html.
Sincerely yours,
Shin-Lian, 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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| 3.3 Indications for Use | Page 1 of 1 |
|---|---|
| 510(k) Number: | K043615 (To be assigned) |
| Device Name: | OxyTec 900 |
| Indications for Use: | The OxyTec 900 is intended for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. |
| It is small, portable and is capable of continuous use in the home, institutional, and travel / mobile environments. | |
| Prescription Use XX (Per CFR 801.109) | or Over-the-counter use |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ouu Sution
(Division Sign-Off) (Division Sign-Chi)
Division of Anesthesiology, General Hospital, ്. സംഖ്യാപരാഹരാമത്തിന്റെ സ്വീകര 643615
.
്10(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).