CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER

K974301 · Clk Intl., Inc. · ITX · Feb 6, 1998 · Radiology

Device Facts

• Record ID: K974301
• Device Name: CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER
• Applicant: Clk Intl., Inc.
• Product Code: ITX · Radiology
• Decision Date: Feb 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

Intended to be placed on Ultrasound Probes used in natural body orifices--such as the vagina--to facilitate cleaning and sanitization of the probe.

Device Story

Device is a latex sheath designed to cover ultrasound probes; used primarily for transvaginal or transrectal imaging. Sheath acts as a physical barrier to prevent probe contamination by bodily fluids; facilitates cleaning and sanitization of the probe between uses. Operated by clinicians in clinical settings. Benefits patient by reducing risk of cross-contamination during ultrasound examinations.

Clinical Evidence

No clinical data. Equivalence established via bench testing including physical characteristics (before and after aging) and biocompatibility testing per ISO-10993 and ASTM D3578-95.

Technological Characteristics

Latex sheath; dimensions range from 6-30 cm length and 2-10 cm diameter. Materials meet ASTM D3578-95 standards for latex exam gloves. Biocompatibility per ISO-10993.

Indications for Use

Indicated for use as a protective barrier on ultrasound probes during transvaginal or transrectal imaging procedures to prevent contamination by bodily fluids and facilitate cleaning.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• Civco Latex Ultrasound Sheaths (K895614)
• Civco Probe Cover (K943393)
• Kiltex Probe Covers (K961029)
• Eclipse Probe Cover (K953673)
• Corometrics Sanitary latex Probe cover (K900805, K920374)

Submission Summary (Full Text)

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6 1998 FEB

K974301

# XI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS. [Separate Page]

I. Submitter: George Kuo, CLK International, Inc., 28 East Broadway, New York, NY 10002 Ph: 212-334-3953

II. Classification Names and numbers: Accessory to Ultrasonic Imaging System, IYO, Class II.

III. Common/Usual Name: Ultrasonic Probe Cover (Sheath)

IV. Proprietary Names: CLK™ Int'l, Sanitary Latex Probe Cover

V. Establishment Registration Number: In progress

VI. Classification: Probe covers such as these are regulated as accessories to the devices on which they are intended to be used. These covers are designed to be used on various probes of Ultrasound Imaging Systems, especially those used in transvaginal or transrectal imaging. Therefore, they are regulated as Class II devices. One of the major instrument types on which they are used is the Ultrasonic Imaging System, pulsed echo, described in CFR 892.1560. Because of some latex problems, they are also regulated as latex products, similar to exam gloves which are often used in same body areas.

### VI. Performance Standard:

None established under section 514.

#### VII. Description of the Device:

These devices are latex sheaths, closely related to condoms which have been used in the past for this purpose. However, these sheaths have different dimensions, depending on which probe they are designed to be used. They may range in size from about 30 cm. length, and 10 cm. in diameter to 6 cm. in length to 2 cm. in diameter with the 20 cm x 5 cm being the most common.

VII. Substantial Equivalence: The CLK Latex Probe Cover is substantially equivalent to devices currently on the market, cleared by the 510(k) process. The CLK Latex Ultrasound Cover is substantially equivalent to (for example) the following devices:

1. Civco Latex Ultrasound Sheaths, cleared under K-895614, by Civco Medical Instruments,

2. Civco Probe Cover, cleared under K-943393 by Civco Medical Instruments,

3. Kiltex Probe Covers, cleared under K-961029, by Kiltex Corporation, and

4. Eclipse Probe Cover, cleared under K-953673, by Parker Laboratories.

5. Corometrics Sanitary latex Probe cover, cleared under K-900805 and/or K-920374 by Corometrics Medical Systems.

Characteristics of the CLK™ Latex Probe Covers are compared with those of other products currently on the market Table 1.

repl. pg. 7

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The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

1. These products have the same intended use, to aid in avoiding contamination of ultrasonic probes by bodily fluids to facilitate cleaning of these probes. These are the same as those of the predicate devices. These products also have the same intended uses as similar products currently cleared for marketing by the 510(k) process.

2. The technological characteristics for this product are the same as those for the predicate devices and those currently on the market that are prepared from latex materials.

3. Descriptive information provided shows that the materials from which the CLK Ultrasound Probes are made are substantially equivalent to (nearly identical with) those of similar products, used for identical purposes, currently on the market. Tests show they meet the requirements of ASTM D3578-95 for latex exam gloves.

4. The FDA "Decision-Making Process" chart was used and appears in Attachment V.

Data used in determining substantial equivalence include those required by ASTM D3578-95, and biocompatibility test data as required by Int. Std ISO-10993 as modified by the FDA in their General Program Memorandum #G95-1.

Summary of Test Data Used in Determining Equivalence: Physical characteristics, before and after aging, Biocompatibility characteristics.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### FEB 6 1998

George Q. Kuo, M.D. President CLK International, Inc. 28 East Broadway, 2nd FI New York, NY 10002

Re:

K974301 CLK Int'l Sanitary Latex Probe Cover Dated: January 7, 1998 Received: January 12, 1998 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX

Dear Dr. Kuo:

We have reviewed your Section 510(k) notification of intent to market the device 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). . You may, therefore, 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 (OS) 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 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 marked 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 question 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/odfk/dsmamain.html".---------------------------------------------------------------------------------------------

Sincerely vours.

h. Tiau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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VIII.1 Indications for Use: [Separate Page]

510(k) Number:美味 K97430

Device Name: CLK™ Int'l. Sanitary Latex Probe Cover

1. Intended to be placed on Ultrasound Probes used in natural body orifices--such as the vagina--to facilitate cleaning and sanitization of the probe.

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use_V (Per 21 CFR 801.109)

OR

Over-The-Counter Use________

(Optional Format 1-2-96)

epl. pg. 4

(Division Sign-Off)

Division of Reproductive, odominal. EN an Radiological Devic

) Number K974430

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