(76 days)
Silgel is intended for use in the management of hypertrophic and keloid scars, prophylactic management of healed incisions and as a splint lining insert to relieve friction on newly healed scars.
Silgel, Topical Gel Sheet, consists of 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 desire 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 in not required for a therapeutic effect.
This document describes a 510(k) submission for the "Silgel Topical Gel Sheet," a medical device intended for scar management. As such, the information provided focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a standalone study with acceptance criteria in the typical sense for a diagnostic or AI-driven device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable to this type of submission. The "acceptance criteria" here are defined by the product's bio-compatibility and safety tests, and its technological characteristics matching predicate devices.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (Silicone Raw Material): | Meets all test requirements as defined in ISO 10933 for skin-contact devices. |
| Hemolysis Test (Final Product) | Acceptable |
| Cytotoxicity Test (MEM Elution Method) (Final Product) | Acceptable |
| Pyrogenicity Test (Limulus Amebocyte Lysate (LAL) Test) (Final Product) | Acceptable |
| Technological Characteristics: | Silgel is a thin sheet of silicone gel, contains a reinforcing mesh, is conformable, semi-occlusive, slightly adhesive, and durable. These characteristics are consistent with predicate devices. |
| Intended Use: | Consistent with known clinical findings for silicone gel sheeting products. |
| Instructions for Use: | Essentially the same as predicate devices. |
| Safety Information: | Product labels discuss potential skin complications consistent with predicate devices. |
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 submission relies on biocompatibility and safety testing of the device materials and final product configuration, as well as comparison to existing clinical knowledge regarding the effectiveness of silicone gel sheeting. It does not present a clinical study with a "test set" of patients in the typical sense. The "data provenance" for the effectiveness claim is based on "numerous clinical studies" demonstrating the effectiveness of silicone gel sheet products in general, not a specific Silgel study.
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 established by experts for a test set was mentioned in this submission. The effectiveness is referenced from pre-existing knowledge about the class of devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set and subsequent adjudication method are 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 an AI-driven device or study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "effectiveness" for the class of silicone gel sheeting devices is based on clinical findings and outcomes from numerous clinical studies (not specific to Silgel). For the Silgel device itself, the "ground truth" for its safety is derived from standardized biocompatibility and safety tests (Hemolysis, Cytotoxicity, Pyrogenicity) which yielded "acceptable" results.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/machine learning device.
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Apr. 01 1996 07:39AM P2
960254
510(k) Submission: Silgel Topical Gel Sheet
$\mathcal{RMI}$
Rofil Medical USA. Inc
APR - 2 1996
Rofil Medical USA, Inc
510(k) SUMMARY: Silgel Topical Gel Sheet
-
- Name and address of Contact Person
William E. Stovall Rofil Medical USA, Inc. 26856 Oak Hollow Road Laguna Hills, CA 92653
- Name and address of Contact Person
Telephone: (714) 348-8419 FAX: (714) 348-8419
Date of Preparation: January 8, 1996
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 management 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
Silgel, Topical Gel Sheet, consists of 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 desire 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 in not required for a therapeutic effect.
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510(k) Submission: Silgel Topical Gel Sheet
Rofil Medical USA, Inc
6. Technological Characteristics
Silgel and the predicate devices consist of a thin sheet of silicone gel. Silge! and several of the predicate devices contain a reinforcing mesh, while Cicacare is supported by a silicone membrane. All products are conformable, semi-occlusive, 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 blocompatibility 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 tests 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 characteristics of Silgel Topical Gel Sheet shows that it is a silicone gel sheet as are all predicate devices. The intended use in the management of hypertrophic and keloid scars is common with these predicate devices. As with Cica-Care, Silgel 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.
§ 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.