MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM

K983777 · Invacare Corp. · CAW · Dec 18, 1998 · Anesthesiology

Device Facts

• Record ID: K983777
• Device Name: MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM
• Applicant: Invacare Corp.
• Product Code: CAW · Anesthesiology
• Decision Date: Dec 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This 510(k) is to convert existing Invacare IHO 100 Complete Home Oxygen Systems to proprietary type cylinder fittings.

Device Story

Venture Homefill Retrofit Kit modifies existing Invacare IHO 100 Complete Home Oxygen Systems. Device replaces standard cylinder fittings with proprietary fittings. Used in home settings by patients requiring supplemental oxygen. Kit enables compatibility with proprietary cylinder interfaces. Healthcare providers or patients utilize the modified system to ensure secure connection between oxygen source and delivery apparatus. Modification facilitates continued oxygen therapy delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical retrofit kit for oxygen cylinder fittings. Designed for integration with Invacare IHO 100 Home Oxygen System. No electronic, software, or energy-based components.

Indications for Use

Indicated for patients requiring supplemental oxygen therapy using the Invacare IHO 100 Complete Home Oxygen System, specifically for the modification of cylinder fittings to a proprietary type.

Regulatory Classification

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).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 1998

Mr. Edward A. Kroll Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, OH 44036-2125

K983777 Re: Venture Homefill Retrofit Kit Requlatory Class: II (two) Product Code: 73 CAW Dated: October 23, 1998 Received: October 26, 1998

Dear Mr. Kroll:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Edward A. Kroll

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known); K983777

Device Name: Modification To Venture IHO 100 Complete Home Oxygen System Cylinder Fitting

This 510(k) is to convert existing Invacare IHO 100 Complete Home Oxygen Indications For Use: Systems to proprietary type cylinder fittings.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Kramer

(Division Sign-Off) Prescription Use Prescription Use ) > (Division of Cardiovascular, Respiratory, >
(Per 21 CFR 801.109 and Neurological Devices

510(k) Number ...

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)