(146 days)
The intended function and use of the Invacare Model Platinum Oxygen Concentrator is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
The Invacare Model Platinum 5 Oxygen Concentrator is an electromechanical, prescription device designed for use in the home, by patients that require supplemental oxygen. Its intended function and use is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve, It is not intended to sustain or support life.
Oxygen is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula, which are not supplied with the device. A standard humidifier bottle may be used, if desired.
The front panel of the device contains the controls and indicators. These include a standard barb fitting for attaching the oxygen tubing, the adjustable flow meter, a power light indicator, an elapsed time meter, and a standard on/off rocker type power switch.
The provided text describes a 510(k) submission for the Invacare Model Platinum 5 Oxygen Concentrator. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the format requested.
The document primarily focuses on establishing substantial equivalence to a predicate device (Sunrise Medical Model DeVilbiss 5 Liter Oxygen Concentrator K990711) and confirming that the device was tested to relevant performance requirements.
Here's an attempt to answer your questions based on the available information, highlighting what is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from "Required Performance Criteria") | Reported Device Performance |
|---|---|
| Electrical, Mechanical, and Environmental Performance for home use respiratory devices as set forth in the Anesthesiology and Respiratory Devices Branch's November 1993 document: "Reviewer Guidance for Pre-market Notification Submissions." | "In all instances, the device met the required performance criteria and functioned as intended." |
| Intended Use: Provide supplemental oxygen to patients with respiratory disorders by separating nitrogen from room air via a molecular sieve. (Note: Not intended to sustain or support life.) | The device's description and intended use align with this, and the performance testing indicates it fulfills this function. |
Missing Details: The specific numerical or qualitative thresholds for "electrical, mechanical, and environmental performance" are not detailed in this document. For example, specific oxygen concentration purity, flow rates, noise levels, or operating temperatures are not provided as acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only states "The Invacare Model Platinum Oxygen Concentrator was tested..." without detailing the number of units tested.
- Data Provenance: Not specified, but given Invacare Corporation is based in Elyria, Ohio, USA, it's highly probable the testing was conducted in the USA.
- Retrospective or Prospective: Not specified. It's likely prospective testing conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This type of medical device (oxygen concentrator) does not typically involve expert interpretation for establishing "ground truth" in the way an imaging or diagnostic AI device would. Performance is assessed through objective measurements (e.g., oxygen concentration, flow rate, safety tests) against engineering and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
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 device is an oxygen concentrator, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes a physical medical device, not a software algorithm. The "performance" refers to the device's physical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this type of device would be objective measurements against established technical standards and specifications (e.g., oxygen purity measured by sensors, flow rate measured by flowmeters, safety compliance with electrical safety standards, environmental testing for durability).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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JUL - 2 2002
K02038/
510(k) SUMMARY
Invacare Corporation's Model Platinum 5 Oxygen Concentrator
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Contact Person:
Edward A. Kroll Director, Regulatory Affairs
Date Prepared: February 4, 2002
Name of Device and Name/Address of Sponsor
Invacare Platinum 5 Oxygen Concentrator
Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Common or Usual Name
Oxygen Concentrator
Classification Name Portable Oxygen Generator
Predicate Devices Sunrise Medical Model DeVilbiss 5 Oxygen Concentrator (K991722)
Intended Use
The intended function and use of the Invacare Model Platinum Oxygen Concentrator is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
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Technological Characteristics and Substantial Equivalence
A. Device Description
The Invacare Model Platinum 5 Oxygen Concentrator is an electromechanical, prescription device designed for use in the home, by patients that require supplemental oxygen. Its intended function and use is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve, It is not intended to sustain or support life.
Oxygen is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula, which are not supplied with the device. A standard humidifier bottle may be used, if desired.
The front panel of the device contains the controls and indicators. These include a standard barb fitting for attaching the oxygen tubing, the adjustable flow meter, a power light indicator, an elapsed time meter, and a standard on/off rocker type power switch.
B. Substantial Equivalence
The Invacare Model Platinum Oxygen Concentrator is substantially equivalent to the Sunrise Medical Model DeVilbiss 5 Liter Oxygen Concentrator (K990711).
Performance Data
The Invacare Model Platinum Oxygen Concentrator was tested in accordance with the electrical, mechanical and environmental performance requirements for home use respiratory devices set forth in the Anesthesiology and Respiratory Devices Branch's November 1993 document entitled "Reviewer Guidance for Pre-market Notification Submissions", published by the Anesthesiology and Respiratory Devices Branch. In all instances the device met the required performance criteria and functioned as intended.
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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 stylized eagle or bird symbol with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL = 2 2002
Mr. Edward A. Kroll Invacare Corp. One Invacare Way P.O. Box 4028 Elyria. OH 44036
Re: K020386
Invacare Platinum 5 Oxygen Concentrator Regulation Number: 868.5440 Regulation Name: Generator, Oxygen, Portable Regulatory Class: II (two) Product Code: CAW Dated: May 16, 2002 Received: May 17, 2002
Dear Mr. Kroll:
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 Federal Register.
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Page 2 - Mr. Edward A. Kroll
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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of 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,
Timothy A. Ulatowski
Dire 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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s10(k) Number (if known): FBD K020 380
Device Name: Invacare Platinum 5 Oxygen Concentrator
Indications For Use:
The intended function and use of the Invacare Model Platinum Oxygen Concentrator is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Division Sign-Off)
Division of Dental, Infection Control, + Anesis200/
and General Hospital Devices
(Optional Format 1-2-96)
510(k) Number. 2020384
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 13
§ 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).