← Product Code [MED](/productcode/MED) · K961289

# VAPOPHENE (K961289)

_Germiphene Corp. · MED · Dec 4, 1997 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K961289

## Device Facts

- **Applicant:** Germiphene Corp.
- **Product Code:** [MED](/productcode/MED.md)
- **Decision Date:** Dec 4, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6885
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Indications for Use

For use in sterilizing dental and surgical instruments such as extractor forceps with sirrated handles, IRIS scissors, and convex mirrors and handles, with all legally marketed models of MDT Harvey Chemiclaves, when use of chemiclave solution is indicated, and used according to the chemiclave cycle parameters, (132°C, 20-27 psi, for 20 minutes per cycle). Not for use in water or steam type sterilizers

## Device Story

Vapophene is a chemical autoclave solution designed for use in MDT Harvey Chemiclaves. It functions as a chemical sterilant for dental and surgical instruments. The solution is utilized within the specific parameters of the Chemiclave cycle (132°C, 20-27 psi, 20 minutes). It is intended for use by dental and surgical professionals in clinical settings to ensure instrument sterility. The device is not compatible with water or steam-based sterilization systems.

## Technological Characteristics

Chemical autoclave solution; liquid chemical sterilant; designed for use in MDT Harvey Chemiclaves; requires specific cycle parameters (132°C, 20-27 psi, 20 minutes).

## Regulatory Identification

A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.

## Special Controls

*Classification.* Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.

## Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

DEC - 4 1997

Mr. Peter Wilk
Germiphene Corporation
1379 Colborne Street East
Brantford, Ontario N3T 5V7
Canada

Re: K961289
Trade Name: Vapophene
Regulatory Class: II
Product Code: MED
Dated: October 30, 1997
Received: October 31, 1997

Dear Mr. Wilk:

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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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

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Page 2 - Mr. Wilk

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 (301) 594-4618. 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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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510(k) Number: K961289

Device Name: Vapophene - Chemical autoclave solution

Indications For Use:

For use in sterilizing dental and surgical instruments such as extractor forceps with sirrated handles, IRIS scissors, and convex mirrors and handles, with all legally marketed models of MDT Harvey Chemiclaves, when use of chemiclave solution is indicated, and used according to the chemiclave cycle parameters, (132°C, 20-27 psi, for 20 minutes per cycle).

Not for use in water or steam type sterilizers

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number: K961289

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☑

(Optional Format 1-2-96)

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**Source:** [https://fda-staging.innolitics.com/device/K961289](https://fda-staging.innolitics.com/device/K961289)

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