(57 days)
Silon Scar Strips are indicated for the management of hypertrophic scars and keloids. Consistent use of Silon Scar Strips can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin.
Silon Scar Strips may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.
The Applicant presently markets Silon-SES® Silicone Elastomer Sheeting for the management of hypertrophic scars and keloids. The new product does not introduce any new concepts in silicone scar management products. Silon-SES is presently labeled for sale by or on the order of a physician. The Applicant hereby intends to remove this restriction and offer the product directly to consumers "over-the-counter."
This 510(k) summary (K982036) describes the Silon Scar Strips, which are intended for the management of hypertrophic scars and keloids. The key aspect of this submission is the intention to remove the "by or on the order of a physician" restriction, allowing the product to be sold directly to consumers "over-the-counter."
The document focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than presenting a novel clinical study with explicit acceptance criteria and corresponding device performance data for a new efficacy claim. Therefore, many of the requested categories for a new device's performance study will not be applicable or will have limited information.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for substantial equivalence based on a change in market availability (OTC vs. prescription) for an already marketed material, there are no specific performance acceptance criteria for clinical efficacy studies provided in the document for the new "Silon Scar Strips" product. The acceptance criteria are related to the material's biocompatibility, and the device's substantial equivalence to predicate devices.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-sensitizing | Kligman Maximization: Non-sensitizing (0% sensitization) |
| Non-irritant | Primary Dermal Irritation: Non-irritant (PDII = 0) | |
| No cytopathic effects | Agarose Diffusion Cytotoxicity: No cytopathic effects (grade 0) | |
| Passes systemic cytotoxicity | Acute Systemic Cytotoxicity: Passes | |
| Substantial Equivalence | Equivalent indications for use and safety/effectiveness profile to predicate devices. | Stated as substantially equivalent to Silon-SES (K932214) and Rejuveness (K974380). |
2. Sample Size Used for the Test Set and the Data Provenance
- Biocompatibility Tests: The document does not specify the sample size for the in vitro or in vivo biocompatibility tests described. It only states that "All tests were performed by an FDA registered independent testing company." The data provenance is implied to be from a certified testing laboratory, but no country of origin is specified. These tests are usually conducted on material samples, not human subjects, and are retrospective in the sense that the material for testing is prepared and then analyzed.
- Substantial Equivalence: For substantial equivalence, the "test set" is essentially the comparison of the new device's characteristics and indications against the predicate devices. There isn't a "sample size" in the traditional sense for a clinical trial here. The data provenance for this comparison comes from the characteristics of the new Silon Scar Strips and the known characteristics of the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This submission relies on biocompatibility testing results and a comparison to predicate devices, not expert review of a test set for clinical performance.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is not a study requiring adjudication of clinical observations. The "adjudication" for substantial equivalence is carried out by the FDA during its review process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission is not for a diagnostic device or an AI-assisted device, and it doesn't involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. "Silon Scar Strips" is a medical device (silicone sheeting), not an algorithm or software. Therefore, no standalone algorithm performance study was conducted.
7. The Type of Ground Truth Used
- Biocompatibility: The "ground truth" for the biocompatibility tests is established by standardized laboratory testing protocols (e.g., Kligman Maximization, Primary Dermal Irritation, etc.) as outlined in the Tripartite Biocompatibility Guidance for Medical Devices. The results (e.g., "non-sensitizing," "non-irritant," "no cytopathic effects") serve as the ground truth for compliance with these standards.
- Substantial Equivalence: For substantial equivalence, the "ground truth" is primarily based on the established safety and effectiveness profiles, and indicated uses of the predicate devices (Silon-SES and Rejuveness). The new device is considered substantially equivalent if it shares the same technological characteristics or has different characteristics that do not raise new questions of safety and effectiveness, and is as safe and effective as a legally marketed device.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned or implied, as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for Bio Med Sciences, Inc. The logo consists of the letters "BMS" in a bold, sans-serif font, with a circle to the left of the "B". Below the letters is the text "Bio Med Sciences, Inc." in a smaller font. The logo is black and white.
A G 6 1998
101 Technology Drive ♦ Bethlehem, PA 18015 Phone: (610) 974-8801 FAX: (610) 974-8831 Toll Free: 1-800-25-SILON (257-4566) http://www.silon.com
XIII. 510(k) SUMMARY
SILON® SCAR STRIPS
PRODUCT DESCRIPTION
The Applicant presently markets Silon-SES® Silicone Elastomer Sheeting for the management of hypertrophic scars and keloids. The new product does not introduce any new concepts in silicone scar management products. Silon-SES is presently labeled for sale by or on the order of a physician. The Applicant hereby intends to remove this restriction and offer the product directly to consumers "over-the-counter."
INDICATIONS FOR USE
Silon Scar Strips are indicated for the management of hypertrophic scars and keloids. Consistent use of Silon Scar Strips can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin.
Silon Scar Strips may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.
SUBSTANTIAL EQUIVALENCE
The new product is substantially equivalent to the existing Silon-SES product (510(k) No. K932214), as well as Rejuveness (510(k) No. K974380) by Rich Mark International - which offers their product for sale "over-the-counter".
BIQCOMPATIBILTY SUMMARY
The Silon-SES material passes the Tripartite Biocompatibility Guidance for Medical Devices as prepared by the Toxicology Sub-group of the Tripartite Sub- « Committee on Medical Devices (September 1986) as related to external devices contacting intact surfaces for long durations. Each of the materials used in the new device have long histories of use in the medical field, and are utilized in each of the other woundcare and scar management products presently manufactured and marketed by Bio Med Sciences. All tests were performed by an FDA registered independent testing company. The data can be summarized as follows:
| Test | Results |
|---|---|
| Kligman Maximization | Non-sensitizing (0% sensitization) |
| Primary Dermal Irritation | Non-irritant (PDII = 0) |
| Agarose Diffusion Cytotoxicity | No cytopathic effects (grade 0) |
| Acute Systemic Cytotoxicity | Passes |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human figure in profile, composed of three overlapping silhouettes. The silhouettes are arranged in a way that suggests movement or flow. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 6 1998
Mr. Mark E. Dillon President Bio Med Sciences, Inc. 101 Technology Drive Bethlehem, Pennsylvania 18015
Re: K982036 Trade Name: Silon Scar Strips Regulatory Class: Unclassified Product Code: MDA Dated: June 9, 1998 Received: June 10, 1998
Dear Mr. Dillon:
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 of the Act. The general controls 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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. Mark E. Dillon
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/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.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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K9820036
III. INDICATIONS FOR USE
, ..
Silon Scar Strips are indicated for the management of hypertrophic scars and keloids. Consistent use of Silon Scar Strips can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin.
Silon Scar Strips may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.
99203
Over-the-Counter Use
§ 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.