Lubriscan® Ultra Scan Gel + is intended to be used on external, intact skin for short duration as a coupling contact medium for abdominal and OB/GYN diagnostic scanning procedures.

Device Description

Lubriscan Ultra Scan Gel + is used for coupling ultrasound devices to external surfaces such as skin. The gel is not sterile. The raw materials comprising the gel have a long and established history as raw materials in cosmetics.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for "Lubriscan Ultra Scan Gel," an ultrasound coupling gel. The submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for the device itself.

Therefore, the requested information elements related to detailed acceptance criteria, a study proving performance, sample sizes, ground truth establishment, expert involvement, or MRMC studies for this specific device are not available in the provided document because the submission relies on substantial equivalence.

Here's an overview of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Not Available. The document does not specify quantitative acceptance criteria or detailed performance metrics for the Lubriscan Ultra Scan Gel+. The substantial equivalence argument relies on the established safety and performance of predicate devices for the same intended use.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Available. There is no test set or study described in the document where a sample size would be relevant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Available. No ground truth establishment by experts for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Available. No test set or adjudication process is described.

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

Not Applicable / Not Available. This device is an ultrasound gel, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance is not relevant or described.

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

Not Applicable / Not Available. This device is an ultrasound gel, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Applicable / Not Available. No ground truth data is mentioned or used. The safety and effectiveness are established through the history of its raw materials in cosmetics and its similarity to predicate devices.

8. The sample size for the training set

Not Applicable / Not Available. There is no "training set" as this is not an algorithm being developed.

9. How the ground truth for the training set was established

Not Applicable / Not Available. No training set or ground truth establishment for a training set is described.

Summary of what is available:

Device Description:
Lubriscan Ultra Scan Gel + is used for coupling ultrasound devices to external surfaces such as skin. It is not sterile. The raw materials have a long and established history in cosmetics.

Intended Use / Indications for Use:
Lubriscan® Ultra Scan Gel + is intended to be used on external, intact skin for short duration as a coupling contact medium for abdominal and OB/GYN diagnostic scanning procedures.

Basis for Approval:
Substantial equivalence to predicate devices (other ultrasound coupling gels) in terms of intended use, materials of construction, and technological characteristics. The safety is also implied by the "long and established history as raw materials in cosmetics." The manufacturing will follow specified process controls and a Quality Assurance Program similar to pharmaceuticals.

Summary

{0}------------------------------------------------

K980091

APR - 9 1998

510(k) Premarket Notification Lubriscan Ultrasound Gel

510(k) Summary

Submitted By:

Michael Caswell, Ph.D. Cosmaceutical Marketing, Inc. 10820 Alder Circle Dallas, TX 75238 (214) 340-1503 January 8, 1998

Device:

Trade Name:	Lubriscan Ultra Scan Gel +
Common/Usual Name:	Ultrasound Gel
Proposed Classification:	892.1560 Ultrasound pulsed echo imaging system892.1570 Diagnostic ultrasound transducer

Predicate Devices:

Lubriscan Ultra Scan Gel + is similar in terms of intended use, materials of construction, and technological characteristics to predicate devices reviewed as coupling gels used to couple ultrasound devices to surfaces such as skin.

Device Description:

Substantial Equivalence:

The device will be manufactured and packaged according to specified process controls and a Quality Assurance Program similar to pharmaceuticals currently manufactured and marketed by Cosmaceutical Marketing, Inc. The device is similar with respect to indications for use, materials and physical characteristics to predicate devices in terms of section 510(k) substantial equivalency.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming the body and wings.

Food and Drug Administration 9200 Corporate Boulevard Regille MD 20850

Michael Caswell, Ph.D. Cosmaceutical Marketing, Inc. 10820 Alder Circle Dallas, Texas 75238

Re:

K980091 Lubriscan® Ultra Scan Gel+ Dated: January 8, 1998 Received: January 9, 1998 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX

APR

Dear Dr. Caswell:

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 (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the CMP 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 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 with disgnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/dsmadsmam.html".

Sincerely yours,

Kilian Yin

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

Enclosure

{2}------------------------------------------------

510(k) Premarket Notification Lubriscan Ultrasound Gel

8.6 Statement of Indication for Use

510(k) Number (if known): To Be Assigned

Lubriscan® Ultra Scan Gel + Device Name:

Indications for Use:

Lubriscan® Ultra Scan Gel + is intended to be used on external, intact skin for short duration as a coupling contact medium for abdominal and OB/GYN diagnostic scanning procedures.

(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)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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.