MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL by MEDICAL Z, S.A.

The Medigel Z products are indicated for temporary use in the management of hypertrophic scars and keloids resulting from wounds, trauma, or burns. The Medigel Z products are not wound dressings and are not intended to be used on open wounds. It is recommended that the products be used after the closing of a wound (8th to 10th day), or just after the first sign of hypertrophic scars.

Device Description

The Medigel Z is a combination of a tri-block polymer and mineral oil. Medigel Z sheets are available in two thicknesses, 3 mm and 5 mm. The 3 mm sheets are 4 inches by 4 inches. The 5 mm sheets are available in three sizes: 8 by 8 inches, 12 by 16 inches, and 16 by 20 inches. The 5 mm sheets are lined with a fabric backing.

The Medigel Z is also available in four different sized elastic sleeves. The sleeves are 9.5 inches long and range from 12 to 55 inches in circumference. The Medigel Z is also available as an unlined finger-tube, a fabric lined sternal strap, and an elastic lined glove (open finger tips) and chin strap.

The Medigel Z also is available with an adhesive which eliminates the need for a compression bandage in most cases. The adhesive Medigel Z is available with or without a fabric backing and comes in sheets or circular pads. The "Mammopatch Gel Z" and "Abdopatch Gel Z" are fabric backed versions of the adhesive Medigel Z that are shaped specifically for use on the breast and abdomen.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Medigel Z™ Scar Management Gel." This submission focuses on establishing substantial equivalence to previously marketed devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself. Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, and expert adjudication are not present in this document.

Here's a breakdown of what can and cannot be extracted from the document based on your request:

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

Acceptance Criteria: Not explicitly stated in this document. For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This is achieved by showing similar intended use, technological characteristics, and safety/effectiveness profiles. Specific numerical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) are not typically part of a 510(k) summary for this type of device.
Reported Device Performance: No specific numerical performance data is reported in this document. The submission asserts that the device has the "same technological characteristics" as the predicate.

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

Not applicable. This document does not describe a clinical study or a "test set" in the context of diagnostic or AI performance evaluation. It's a regulatory submission for premarket clearance based on substantial equivalence.

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. 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. No adjudication method for a test set 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. This is not a study involving human readers or AI assistance.

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

Not applicable. This device is a scar management gel, not an algorithm.

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

Not applicable in the context of performance metrics. The "ground truth" for a 510(k) is typically the safety and effectiveness of the predicate device. The document implies that the "Medigel Z" has similar effects to the predicate devices because of shared technological characteristics.

8. The sample size for the training set

Not applicable. There is no "training set" described.

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

Not applicable. There is no "training set" described.

Summary based on the provided text:

The document is a 510(k) premarket notification for the "Medigel Z™ Scar Management Gel." It aims to demonstrate substantial equivalence to two predicate devices: Silipos® Tri Block Polymer Gel (K942695) and Smith & Nephew Rolyan Cica-Care™ Silicone Gel Sheet (K935803).

The core "study" and "acceptance criteria" discussed (implicitly) are rooted in the 510(k) process:

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence):
- Same Intended Use: The device must have the same intended use as the predicate.
- Same Technological Characteristics OR Different Technological Characteristics with Equivalent Safety/Effectiveness:
  - If the technological characteristics are the same, substantial equivalence can be demonstrated without additional testing.
  - If the technological characteristics are different, adequate scientific evidence (e.g., performance testing) must be provided to demonstrate that the new device is as safe and effective as the predicate.
- No New Questions of Safety/Effectiveness: The device must not raise new questions of safety or effectiveness compared to the predicate.
Reported Device "Performance" (Implicit):
- The document states: "The Medigel Z™ shares the same technological characteristics, and is manufactured with the same materials as the Silipos® Tri Block Polymer Gel, with the exception of the use of an adhesive to attach the device to the patient's skin. The Cica-Care™ gel, like the Medigel Z, uses an adhesive to attach the gel the body."
- This statement is the basis for claiming substantial equivalence – implying that because the characteristics are similar (or the differences are minor and shared with another predicate), the performance (safety and effectiveness in scar management) is also equivalent to the already cleared predicate devices.

Missing Information: The document does not contain the specific statistical performance metrics, sample sizes for studies, expert qualifications, or ground truth methodologies that would be typical for evaluating the performance of a diagnostic or AI-based device, as it is describing a physical medical product for scar management under a 510(k) pathway.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Z. S.A. c/o Ms. Emalee G. Murphy McKenna & Cuneo, L.L.P ... . 1900 K Street, N.W. Washington, District of Columbia 20006-1108

JUL 2 9 1997

Re: K971916

Trade Name: Medigel Z™ Scar Management Gel Regulatory Class: Unclassified Product Code: MDA Dated: May 23, 1997 Received: May 23, 1997

Dear Ms. Murphy:

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

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Page 2 - Ms. Emalee G. Murphy

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.

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 (301) 594-4595. 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/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

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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K971916

Appendix C

510(k) Summary Medical Z, S.A. Medigel Z™

JUL 2 9 1997 I. General Information on Submitter:

Name:	Medical Z, S.A.
Address:	BP 39 - 55, rue de l'ÉgliseF-61110 RémalardFrance
Telephone:	(33) 02 33 73 77 21
Fax:	(33) 02 33 73 78 88
Contact Person:	André Zagamé
Date Summary Prepared:	May 23, 1997

II. General Information on Device

្រីកុំប៉ុ

Name:	Medigel Z TM Scar Management Gel
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Classification Name:	Elastomer, Silicone, for Scar Management
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III. Predicate Devices: Silipos® Tri Block Polymer Gel (K942695)

Smith & Nephew Rolyan Cica-Care™ Silicone Gel Sheet (K935803)

IV. Description of the Device:

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V. Intended Use:

VI. Technological Characteristics of Device Compared to Predicate Device:

The Medigel Z™ shares the same technological characteristics, and is manufactured with the same materials as the Silipos® Tri Block Polymer Gel, with the exception of the use of an adhesive to attach the device to the patient's skin. The Cica-Care™ gel, like the Medigel Z, uses an adhesive to attach the gel the body.

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K971916 510(k) Number (if known):

Device Name: Medigel Z Scar Management Gel

Indications For Use:

The Medigel Z products are indicated for temporary use in the management of hypertrophic scars and Keloids resulting from . wounds, trauma, or burns. The Medigel Z products are not wound dressings and are not intended to be used on open wounds. It is recommended that the products be used after the closing of a wound (8th to 10th day), or just after the first sign of hypertrophic scars.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Divi
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enerai Restorative Devices, 6971916
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Over-The-Counter Use

Regulation Number and Section

§ 878.4025 Silicone sheeting.

(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.