UNI-PATCH ULTRASOUND COUPLING GEL

• K Number: K021132
• Device Name: UNI-PATCH ULTRASOUND COUPLING GEL
• Manufacturer: THE LUDLOW COMPANY LP
• Date Cleared: 2002-05-15 ( 36 days)
• Product Code: MUI
• Regulation Number: 892.1570
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Uni-Patch Ultrasound Coupling Gel is intended for use as the coupling medium for Ultrasound procedures on external, intact skin

Device Description

Uni-Patch Ultrasound Coupling Gel is a viscous, clear blue, water-soluble gel. Typical packaging configuration for the Uni-Patch Ultrasound Coupling Gel is 250 ml plastic bottles and 5 liter plastic containers.

AI/ML Overview

The provided text is a 510(k) summary and FDA clearance letter for the "Uni-Patch Ultrasound Coupling Gel." This document focuses on the regulatory clearance process for a medical device (ultrasound gel) based on substantial equivalence to a predicate device, rather than a study evaluating the performance of an AI-powered diagnostic device against specific acceptance criteria.

Therefore, the information requested in your prompt regarding acceptance criteria, study design, expert involvement, and AI performance metrics is not available in the provided text. The document states:

• "Performance FDA has not established special controls or performance standards for this device"
• "Uni-Patch Ultrasound Coupling Gel is similar in terms of intended use and technological characteristics to predicate devices reviewed as coupling gels used to couple ultrasound device is similar with respect to indications for use and physical characteristics to predicate devices in terms of section 510(k) substantial equivalency."

This indicates that the clearance was based on demonstrating similarity to existing, legally marketed ultrasound gels, not on a new, controlled performance study with the metrics you've outlined for AI/diagnostic devices.

Summary

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tyco/Healthcare/Ludlow

MAY 1 5 2002

The Ludiow Company L.P Two Ludlow Park Drive Chicopee, MA 01022

510(k) Summary

Date Prepared: April 3, 2002

• The Ludlow Company LP Manufacturer Two Ludlow Park Drive Chicopee, MA 01022 Registration Number: 1219103
  Uni-Patch Manufacturing Location 1313 West Grant Blvd. Wabasha, MN 55891 Registration Number: 2183164

M. Beth Rice Contact Person Regulatory Affairs Manager Phone: [phone]

Uni-Patch Ultrasound Coupling Gel Device Trade Name

Ultrasound gel Common Name

Classification Name Transmission medium for acoustical coupling

Fax: [phone]

Regulatory Reference MUI

Predicate Device Aquasonic 100 Ultrasound Transmission Gel

Uni-Patch Ultrasound Coupling Gel is a viscous, clear blue, water-soluble gel. Description: Typical packaging configuration for the Uni-Patch Ultrasound Coupling Gel is 250 ml plastic bottles and 5 liter plastic containers.

Intended Use Uni-Patch Ultrasound Coupling Gel is intended for use as the coupling medium for Ultrasound procedures on external, intact skin

Physical and Technical Comparison:

Uni-Patch Ultrasound Coupling Gel is similar in terms of intended use and technological characteristics to predicate devices reviewed as coupling gels used to couple ultrasound device is similar with respect to indications for use and physical characteristics to predicate devices in terms of section 510(k) substantial equivalency.

Performance FDA has not established special controls or performance standards for this Summary device

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of three human profiles facing right, stacked on top of each other. The profiles are stylized with flowing lines, giving the impression of movement or wind.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 2002

Re: K021132

Ms. M. Beth Rice Regulatory Affairs Manager The Ludlow Company, LP Two Ludlow Park Drive CHICOPEE MA 01022

Trade/Device Name: Uni-Patch Ultrasound Coupling Gel Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 MUI Dated: April 3, 2002 Received: April 9, 2002

Dear Ms. Rice:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 nredicate 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K021132

Device Name: Uni-Patch Ultrasound Coupling Gel

Indications for Use:

Uni-Patch Ultrasound Coupling Gel is intended to be used as an ultrasound coupling medium on external, intact skin for short duration.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

David A. Seymour

Division of Reproductive, Abdominal, iological Dev

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.