Silgel™ device is intended for use in the management of hypertrophic and keloid scars. It can also be used for the prophylactic management of healed incisions for the prevention of hypertrophic or keloid scars. Silger™ helps relieve friction on newly healed scars when used as a splint lining insert.

Device Description

Silgel™. Topical Gel Sheet, consists of a durable medical grade silicone reinforced with polyester mesh. Sheets are protected on one side by a film which is removed before use and on the other by a paper backing. Sheets are individually packaged in grip seal bags. A sheet can be trimmed to the desired shape prior to placement on the scar. It is secured by wrapping with either gauze and hypoallergenic adhesive tape, light conforming crepe or tubular bandages, or compression garments. Firm pressure is not required for a therapeutic effect.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Silgel™ Topical Gel Sheet. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, the information required to populate most of the sections regarding acceptance criteria and a study proving device performance is not present in the provided text. The document describes component and final product testing for safety, but not for effectiveness against defined performance metrics for scar treatment.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety:
Biocompatibility (ISO 10933 for skin contact devices)	Silicone gel raw material meets all test requirements.
Hemolysis Test	Acceptable
Cytotoxicity Test (MEM Elution Method)	Acceptable
Pyrogenicity Test (Limulus Amebocyte Lysate (LAL) Test)	Acceptable
Effectiveness:
Specific performance metrics for scar treatment (e.g., reduction in scar height, color, itching)	Not specified in this document. The document asserts effectiveness based on numerous clinical studies of silicone gel sheet products in general, not a specific study on Silgel™ itself with defined acceptance criteria.
Substantial Equivalence to Predicate Devices (for intended use and characteristics)	The device is considered substantially equivalent to predicate devices for its intended use in hypertrophic and keloid scar management, prophylactic management of healed incisions, and as a splint lining insert.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable/not specified for effectiveness testing of Silgel™. The safety tests (biocompatibility, hemolysis, cytotoxicity, pyrogenicity) would have involved specific sample sizes, but these are not detailed in the summary.
Data Provenance: Not applicable/not specified for effectiveness testing of Silgel™.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The document relies on existing clinical literature to support the general effectiveness of silicone gel sheets for scar management, rather than a de novo study with expert-established ground truth for Silgel™.

4. Adjudication method for the test set

Not applicable, as no specific clinical effectiveness study for Silgel™ with expert ground truth establishment 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 a medical device for topical application, not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device for topical application.

7. The type of ground truth used

For the asserted effectiveness, the document references "numerous clinical studies" that have "demonstrated" the effectiveness of silicone gel sheet products in general. This implies ground truth established through clinical outcomes data from those external studies, but not specific to Silgel™'s own novel clinical trial with pre-defined ground truth.
For safety, the ground truth is based on standardized in vitro and in vivo biocompatibility and general safety tests.

8. The sample size for the training set

Not applicable, as this is not a machine learning device.

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

Not applicable, as this is not a machine learning device.

Summary of what the document does provide regarding acceptance and proof:

The document primarily focuses on demonstrating that Silgel™ is substantially equivalent to legally marketed predicate silicone gel sheets. The "acceptance criteria" here largely pertain to:

Safety: Meeting ISO 10933 biocompatibility standards and passing specific in-vitro tests (Hemolysis, Cytotoxicity, Pyrogenicity). The document states "All test were acceptable demonstrating that the product is safe for its intended use."
Technological Characteristics: Being a thin sheet of silicone gel, having a reinforcing mesh (similar to some predicates), being comfortable, semiocclusive, slightly adhesive, and durable.
Intended Use: Consistent with predicate devices and supported by existing clinical evidence for silicone gel sheets as a class.
Instructions for Use: Essentially the same as predicate devices.

The "study that proves the device meets the acceptance criteria" refers to the biocompatibility and final product safety testing mentioned in section 7. For effectiveness, the proof is indirect: it relies on the established efficacy of the device type (silicone gel sheets) in clinical literature, coupled with the argument that Silgel™ is technologically equivalent to devices already proven effective.

Summary

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974172

MAR 3 0 1998

510(k) SUMMARY: Silge!™ Topical Gel Sheet

1. Name and address of Contact person

J.A.Evans. Technical Director Nagor Limited P.O Box 167 Douglas Isle of Man British İsles IM99 1PG

Tel: (01624) 625556 Fax: (01624) 661656

Date of preparation: October 31, 1997

2. Device Identification

Trade Name: Silgel™ Topical Gel Sheet Common or Usual Name: silicone gel sheet Classification Name: Not classified

3. Predicate Devices

The predicate devices are all silicone topical gel sheets and include: Spenco Silicone Gelsheet, a pre-enactment device Silastic Soft Sheeting, (K894226) [January 3, 1990] Epi-Derm Silicone Gel Sheeting, [510(k) number unknown] New Beginnings Topical Gel Sheeting, [510(k) number unknown] DermaSof Gel Sheeting, [510(k) number unknown] Cica-Care Adhesive Gel Sheet, [510(k) number unknown]

4. State of Intended Use

Silgel™ is intended for use in the treatment and control of hypertrophic and keloid scars, prophylactic management of healed incisions and as a splint lining insert to relieve friction on newly healed scars.

5. Device Description

{_} = Proprietary Information Contained Within

Page 9

NAGOR LIMITED PO BOX 21 DOUGLAS ISLE OF MAN IM99 1AX BRITISH ISLES TELEPHONE (0)1624 625556 FAX (0)1624 661656

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6. Technological Characteristics

Silgel™ and the predicate devices consist of a thin sheet of silicone gel. Silgel™ and several of the predicate devices contain a reinforcing mesh, while Cica-Care is supported by a silicone membrane. All products are comfortable, semiocclusive, slightly adhesive and durable. Although the mechanism of action is not completely characterized, the effectiveness of silicone gel sheeting products has been repeatedly demonstrated in the clinical situation.

7. Testing Summary

Component Testing:

The silicone gel raw material, cured under conditions similar to those used for the finished device, has been subjected to the biocompatibility tests as defined in ISO 10933 for skin contact devices. The biocompatibility data demonstrate that the silicone gel meets all test requirements.

Final Product Testing:

Final product configuration was subjected to the following test battery. Hemolysis Test: In Vitro Hemolysis Test by Direct Contact Cytotoxity Test: MEM Elution Method Pyrogenicity Test: Limulus Amebocyte Lysate (LAL) Test

All test were acceptable demonstrating that the product is safe for its intended use.

The effectiveness of silicone gel sheet products in the management and prophylaxis of hypertrophic and keloid scars has been demonstrated by numerous clinical studies. The intended use and instructions for use for Silgel™ are consistent with the clinical findings of these studies.

8. Rationale for Substantial Equivalence Determination

A comparison of the technological characterisitics of Silgel™ Topical Gel Sheet shows that it is a silicone gel sheet as are all predicate devices. The intended use in control and management of hypertrophic and keloid scars is common with these predicate devices. As with Cica-Care, Silge!™ is indicated for prophylactic therapy in healed incisions and wounds. It is also indicated as a splint lining to relieve friction on newly healed scars similar to Spenco Silicone Gelsheet. The instructions for use are essentially the same for all products. As with the predicate devices, Silgel™ can be cleaned routinely during the course of clinical management. All product labels discuss the potential skin complications associated with clinical use including rash and irritation. Unlike predicate devices, Silgel™ is not provided sterile nor is this considered to be a requirement for product safety and efficacy since it is only intended for use on intact skin. Based on this information, Silgel™ can be considered substantially equivalent to the predicate devices.

{ = Proprietary Information Contained Within

Page 10

NAGOR LIMITED PO BOX 21 DOUGLAS ISLE OF MAN IM99 1AX BRITISH ISLES TELEPHONE (0)1624 625556 FAX (0)1624 661656

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 1998

Mr. J.A. Evans Technical Director Nagor Limited P.O. Box 167 Douglas Isle of Man British Isles IM99 IPG

K974172 Re: Silgel™ Topical Gel Sheet Trade Name: Requlatory Class: Unclassified Product Code: MDA Dated: March 9, 1998 March 11, 1998 Received:

Dear Mr. Evans:

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 The general controls provisions of the Act 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. ਸਿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. J.A. Evans

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.qov/cdrh/dsmamain.html".

Sincerely yours,

6: Carlin, Mrs. Whitney, Ph.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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510(k) Number (if known): K974172

Silgel Topical Gel Sheet Device Name:

Indications For Use:

Silger™ helps relieve friction on newly healed scars when used as a splint lining insert.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K474172

Prescription Use (Per 21 CFR 801.109) ଠନ୍ନ

Over-The-Counter Use

(Optional Format 1-2-96)

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.