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.

AI/ML Overview

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.

Summary

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AUG - 5 1999

K984029

510(k) SUMMARY: Silgel™ STC-S

1. Name and Address of Contact person J.A.Evans, Technical Director Nagor Limited P.O Box 21 Douglas Isle of Man British Isles IM99 1AX
  Tel: +44 (0) 1624 625556 Fax: +44 (0) 1624 661656

Date of preparation: 4 November 1998

2. Device Identification

Trade Name: Silgel™ STC-S Common or Usual Name: Silicone gel Classification Name: Not classified

3. Predicate Devices

The predicate devices are all silicone gels and include: Kelocote Gel [510 (k) registration number: K954413] Xeragel [510 (k) number unknown] Zeraderm [510 (k) number unknown] Scar Fade [510 (k) number unknown] Spectragel [510 (k) number unknown]

4. Statement of Intended Use

Silgel™ STC-S is intended for use in the management of keloid and hypertrophic scars and associated erythema.

Device Description 5.

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6. Technological Characteristics

Silgel™ STC-S consists of a single ingredient a high purity polydimethyl siloxane gel which is obtained by the hydrolysis of dimethyl, di-chlorosilane in the presence of an excess of water. The material is not cross-linked. Its special features include high purity, chemical inertness, high water repellence, low volatility, low surface tension, low order of toxicity and skin sensitisation which makes it ideal for providing an inert protective coating and repellent film on the skin.

7. Testing Summary

Component Testing:

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.

Final Product Testing:

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.

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.

8. Rationale for Substantial Equivalence Determination

A comparison of the technological characteristics of Silgel™ STC-S shows that it is a silicone gel as are the predicate devices. Silgel™ STC-S is intended for the management of hypertrophic and keloid scars and associated erythema; in common with the predicate devices. The instructions for use are essentially the same for all products. As with the predicate devices, Silgel™ STC-S does not require to be held in place or covered. The Silgel™ STC-S product labels discuss the potential skin complications associated with clinical use. Silgel™ STC-S, in common with the predicate devices 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™ STC-S can be considered substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The overall design is simple and recognizable as a government agency emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG -5 1999

Mr. J.A. Evans Technical Director Nagor Limited P.O. Box 21 Douglas Isle of Man IM99 1AX British Isles

Re: K984029

Trade Name: Silgel STC-S Regulatory Class: unclassified Product Code: MDA Dated: May 4, 1999 Received: May 7, 1999

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 legally marketed predicate 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 control provisions of the Act. The general control 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 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

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

Celia M. Witten, M.D., Ph.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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of Page

510(k) Number (if known: K984029
Device Name: SILGEL™ STC-S

Indications For Use:
SILGEL™ STC-S is intended for use in the
management of Keloid and Hypertrophic scars
and associated erythema.

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(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	K984029

Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

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.