(266 days)
SILGEL™ STC-S is intended for use in the management of Keloid and Hypertrophic scars and associated erythema.
Silgel™ STC-S consists of a high purity, medical grade silicone gel. The device will be sold non-sterile and supplied in aluminum tubes packaged into single unit cartons. Once applied to the skin according to the Instruction for Use the device does not need to be covered or held in place. Please note that the product is a device and not a pharmaceutical cream. It is not absorbed by the skin and functions as a membrane which retains moisture whilst permitting air to penetrate to the affected area.
Here's an analysis of the provided text regarding the acceptance criteria and study for Silgel™ STC-S:
This 510(k) premarket notification describes a device called Silgel™ STC-S, a silicone gel. The core of this submission is to demonstrate substantial equivalence to already legally marketed predicate devices. This means the manufacturer is not trying to prove the device is effective from scratch through new clinical trials, but rather that it is as safe and effective as existing, similar products.
Therefore, the type of "acceptance criteria" and "study" are interpreted in the context of a 510(k) submission for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence to Silicone Gels) | Reported Device Performance |
|---|---|
| Material Composition: High purity silicone gel equivalent to predicates. | Silgel™ STC-S consists of "a single ingredient a high purity polydimethyl siloxane gel." This aligns with predicate devices which are also silicone gels. |
| Intended Use: Management of keloid and hypertrophic scars and associated erythema. | "Silgel™ STC-S is intended for use in the management of keloid and hypertrophic scars and associated erythema." This matches the intended use of predicate devices. |
| Technological Characteristics: Chemical inertness, high water repellence, low volatility, low surface tension, low order of toxicity and skin sensitization. | The material for Silgel™ STC-S is described as having "high purity, chemical inertness, high water repellence, low volatility, low surface tension, low order of toxicity and skin sensitisation." |
| Non-sterile/Application: Non-sterile, no need to be covered or held in place, applied to intact skin. | "The device will be sold non-sterile... Once applied to the skin... the device does not need to be covered or held in place." "Not provided sterile nor is this considered to be a requirement... since it is only intended for use on intact skin." |
| Biocompatibility: Compliance with ISO 10993-1 for skin contact devices. | "The material has been evaluated for compliance with ISO 10993-1: 1997. Biological Evaluation of Medical Devices Part 1. Evaluation and Testing, for skin contact devices." (Both component and final product testing). |
| Safety and Efficacy (Indirect): Clinical effectiveness consistent with established silicone gel products. | "The effectiveness of silicone gel products in the management and of hypertrophic and keloid scars has been demonstrated by numerous clinical studies. The intended use and instructions for use for SilgeI™ STC-S are consistent with the clinical findings of these studies." This is an assertion based on the general understanding of silicone gels, not a new study specific to Silgel™ STC-S. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: No specific "test set" in the traditional sense of a clinical trial with patient data is mentioned for Silgel™ STC-S itself. The submission relies on establishing equivalence rather than new clinical data.
- Data Provenance: The biocompatibility testing likely involved laboratory samples of the Silgel™ STC-S material. The "numerous clinical studies" referenced are general literature on silicone gels, not specific to this device. Therefore, no specific country of origin or retrospective/prospective status for a dedicated test set for Silgel™ STC-S is applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This submission does not involve external experts establishing ground truth for a clinical test set specific to Silgel™ STC-S. The "ground truth" for the effectiveness of silicone gels in general is established through the existing scientific literature and clinical experience, which is then referenced to support substantial equivalence.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set requiring adjudication in this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study was not conducted. This type of study is typically used for diagnostic devices (e.g., imaging AI) to compare reader performance with and without AI assistance. This device is a topical silicone gel, not a diagnostic tool requiring human interpretation of data.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Not applicable. This device is a physical product (silicone gel) applied topically, not an AI algorithm. Therefore, "standalone performance" in the context of AI is not relevant.
7. The Type of Ground Truth Used
- General Scientific Consensus/Literature: The "ground truth" concerning the effectiveness of silicone gels for scar management is based on a broad body of existing scientific literature and clinical practice, rather than specific pathology or outcomes data from a study directly evaluating Silgel™ STC-S. The application claims that "The effectiveness of silicone gel products in the management and of hypertrophic and keloid scars has been demonstrated by numerous clinical studies."
8. The Sample Size for the Training Set
- Not applicable. This product is not an AI algorithm and does not have a "training set" in that context. The "training" for the device's design implicitly comes from the established knowledge and manufacturing processes for medical-grade silicone gels.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set for an AI algorithm is involved. The "ground truth" for developing this type of medical device is based on established chemical, material science, and biocompatibility principles for medical-grade silicone, as well as the observed clinical efficacy of similar products over time.
§ 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.