(57 days)
Not Found
No
The document describes a silicone scar strip product and explicitly states "The new product does not introduce any new concepts in silicone scar management products." There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is used for the management and prevention of hypertrophic scars and keloids, which are medical conditions of the skin.
No
No
The device description explicitly states it is a "Silicone Elastomer Sheeting" product, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management and prevention of hypertrophic scars and keloids on the skin. This is a therapeutic or prophylactic application, not a diagnostic one.
- Device Description: The device is a silicone elastomer sheeting applied externally to the skin. It does not involve testing samples of bodily fluids or tissues in vitro (outside the body) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
MDA
Device 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."
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
Consumers "over-the-counter."
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
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.
Key Metrics
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
Predicate Device(s)
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
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 |
1
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.
2
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
3
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