INVOTEC CLEAN PAD

K973580 · Invotec International, Inc. · EFQ · Dec 10, 1997 · SU

Device Facts

• Record ID: K973580
• Device Name: INVOTEC CLEAN PAD
• Applicant: Invotec International, Inc.
• Product Code: EFQ · SU
• Decision Date: Dec 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

THE INVOTEC CLEAN PAD may be used during any surgical procedure as an instrument wipe.

Device Story

Invotec Clean Pad functions as a surgical instrument wipe. Used during surgical procedures to clean instruments. Operated by surgical staff in the OR. Simple mechanical device; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical instrument wipe. No electronic components, energy sources, or software. Materials and specifications not detailed in provided text.

Indications for Use

Indicated for use as an instrument wipe during any surgical procedure. No specific patient population, age, or disease state restrictions.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 1997

Mr. Jeffrey L. Aull President Invotec International, Inc. 11243-1 St. Johns Industrial Parkway South Jacksonville, Florida 32246

Re: K973580 Trade Name: Clean Pad Regulatory Class: Unclassified Product Code: EFQ Dated: September 17, 1997 Received: September 19, 1997

Dear Mr. Aull:

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 requirements , 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 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. Jeffrey L. Aull

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/dsmamain.html".

Sincerely yours,

focoeef

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Page | of |
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| Property of the program and<br>1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

| 510(k) Number (if known): | K973580 |
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| Device Name: | INVOTEC CLEAN PAD |

Indications For Use:

THE INVOTEC CLEAN PAD may be used during any surgical procedure as an instrument wipe.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Inside Sign-Off

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K973580

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formst 1-2-96)