← Product Code [CAW](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW) · K020386 # INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 (K020386) _Invacare Corp. · CAW · Jul 2, 2002 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K020386 ## Device Facts - **Applicant:** Invacare Corp. - **Product Code:** [CAW](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW.md) - **Decision Date:** Jul 2, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5440 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## 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. ## Device Story Electromechanical oxygen concentrator; uses molecular sieve technology to separate nitrogen from room air; provides supplemental oxygen to patients with respiratory disorders. Device intended for home use; operated by patient. Input: room air. Output: supplemental oxygen delivered via standard tubing and nasal cannula. Controls include flow meter, power switch, and elapsed time meter. Not life-sustaining. Benefits patient by providing supplemental oxygen therapy in home environment. ## Clinical Evidence Bench testing only. Device tested for electrical, mechanical, and environmental performance requirements per Anesthesiology and Respiratory Devices Branch's November 1993 'Reviewer Guidance for Pre-market Notification Submissions'. Device met all performance criteria. ## Technological Characteristics Electromechanical oxygen concentrator; molecular sieve technology for nitrogen separation; standard barb fitting for oxygen output; adjustable flow meter; elapsed time meter; rocker power switch. Designed for home use. No software-based algorithms or connectivity features described. ## Regulatory 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). ## Predicate Devices - Sunrise Medical Model DeVilbiss 5 Oxygen Concentrator ([K991722](/device/K991722.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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. {1}------------------------------------------------ # 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. {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ # 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K020386](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K020386) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com