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.

AI/ML Overview

This 510(k) pertains to a medical device, specifically the CLK™ Int'l, Sanitary Latex Probe Cover. The submission focuses on demonstrating substantial equivalence to predicate devices already on the market rather than proving performance against novel acceptance criteria through a specific study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Material Properties	Meet requirements of ASTM D3578-95 for latex exam gloves.	"Tests show they meet the requirements of ASTM D3578-95 for latex exam gloves."
Biocompatibility	Meet requirements of Int. Std ISO-10993 as modified by the FDA in their General Program Memorandum #G95-1.	"Biocompatibility test data as required by Int. Std ISO-10993 as modified by the FDA in their General Program Memorandum #G95-1." (Implied compliance through data submission)
Physical Characteristics (Pre-aging)	Not explicitly stated, but implied to be similar to predicate devices.	Summary of Test Data: "Physical characteristics, before and after aging." (Implied to be acceptable for equivalence)
Physical Characteristics (Post-aging)	Not explicitly stated, but implied to be similar to predicate devices.	Summary of Test Data: "Physical characteristics, before and after aging." (Implied to be acceptable for equivalence)
Intended Use	Same as predicate devices: to aid in avoiding contamination of ultrasonic probes by bodily fluids and facilitate cleaning.	"These products have the same intended use... These are the same as those of the predicate devices."
Technological Characteristics	Same as predicate devices and those made from latex materials currently on the market.	"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."
Descriptive Information	Materials are substantially equivalent to (nearly identical with) similar products currently on the market.	"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."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of an accuracy or performance study for the device. The data mentioned (ASTM D3578-95, ISO-10993) refers to standardized material and biocompatibility testing. The sample sizes for these types of tests are typically defined by the respective standards. The provenance of this data (e.g., country of origin, retrospective/prospective) is not detailed in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this 510(k) submission. The "ground truth" here is compliance with established material and biocompatibility standards, not expert consensus on device performance in a clinical setting.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically used in studies where multiple observers or algorithms are evaluated against a "ground truth" established by experts. Here, compliance is determined by laboratory testing against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a physical probe cover, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical probe cover, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence and device safety/effectiveness for this product relies on:

Established industry standards for material properties: ASTM D3578-95 for latex exam gloves.
Established international standards for biocompatibility: ISO-10993 (as modified by FDA G95-1).
Comparison to legally marketed predicate devices: The characteristics and intended use of the CLK probe cover were compared to several existing cleared devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an AI/machine learning model for this medical device. The device is a physical product.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reasons as #8.

Summary

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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:

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:

Civco Latex Ultrasound Sheaths, cleared under K-895614, by Civco Medical Instruments,
Civco Probe Cover, cleared under K-943393 by Civco Medical Instruments,
Kiltex Probe Covers, cleared under K-961029, by Kiltex Corporation, and
Eclipse Probe Cover, cleared under K-953673, by Parker Laboratories.
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:

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.
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.
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.
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 (301) 594-4613. Additionally, for question 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/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

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)

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

$\checkmark$

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
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.(b)
Classification. Class II.