(76 days)
No
The device description and intended use are for a topical silicone gel sheet for scar management, with no mention of AI or ML technology.
Yes
The intended use explicitly states its purpose in the "management of hypertrophic and keloid scars" and "prophylactic management of healed incisions," which are therapeutic applications.
No
Explanation: The device description for Silgel focuses on its physical properties and how it's applied to manage scars, not on diagnosing medical conditions. Its intended use is for the management and prophylactic management of scars, not for diagnosis.
No
The device description clearly states that Silgel is a "Topical Gel Sheet" made of "durable medical grade silicone reinforced with polyester mesh." This describes a physical, material-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of Silgel is for the management and prophylaxis of scars. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a topical gel sheet applied externally to the skin. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or biomarkers
- Providing diagnostic information
Therefore, Silgel falls under the category of a medical device used for wound care and scar management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
Not classified
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Spenco Silicone Gelsheet, Silastic Soft Sheeting (K894226), Epi-Derm Silicone Gel Sheeting, New Beginnings Topical Gel Sheeting, DermaSof Gel Sheeting, Cica-Care Adhesive Gel Sheet
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.