(91 days)
DermaSof by McGhan Medical Corp., Epi-Derm Silicone Gel Sheeting by Biodermis Corp., TopiGel by CUI Corp., Sil-K by Degania Silicone
Not Found
No
The summary describes a physical silicone gel sheeting product for scar management and contains no mention of AI, ML, image processing, or data analysis.
Yes.
The device is indicated for treatment of hypertrophic and keloid scars to flatten, soften, and improve the appearance of scar tissue.
No
Explanation: The device is indicated for the "treatment" of scars, not for diagnosing them. Its function is to flatten and soften scar tissue, which is a therapeutic action.
No
The device description clearly states it is a physical material (silicone gel sheeting) supplied in sheets, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Description: The Mentor H/S Silicone Gel Sheeting is a topical treatment applied directly to the skin to manage scars. It does not involve testing samples from the body.
- Intended Use: The intended use is to treat scars by flattening and softening the tissue, not to diagnose or detect a condition through laboratory analysis.
The device is a medical device, but it falls under a different category than IVDs. It's a topical treatment for scar management.
N/A
Intended Use / Indications for Use
The Mentor H/S Silicone Gel Sheeting for Scar Management is indicated for treatment of hypertropic and keloid scars. This therapy does not remove the scar but will flatten and soften the scar tissue as well as return a more natural palor to the scar area.
Product codes
79MDA
Device Description
The Mentor H/S Silicone Gel Sheeting for Scar Management is designed to treat hypertropic and keloid scars. This therapy does not remove the scar, but will flatten and soften the scar tissue as well as return a more natural palor to the scar area. The material will be supplied sterile in sheets of silicone reinforced with polyester mesh. The sheets may be cut by the patient and/or the physician to a desired size to fit the scar treatment area.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DermaSof by McGhan Medical Corp., Epi-Derm Silicone Gel Sheeting by Biodermis Corp., TopiGel by CUI Corp., Sil-K by Degania Silicone
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
AUG 2 2 1996
Page 1 of 2
SUMMARY OF SAFETY AND EFFECTIVENESS MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT 510(k) SUMMARY
1. Submitter's Data
Mentor Corporation 5425 Hollister Avenue Santa Barbara, CA 93111
Contact Person(s): Byron Wickett or Lynn Breckenridge
Telephone: (805) 681-6000
Date Prepared: February, 1996
-
- Device Name, Classification
Name: Mentor H/S Silicone Gel Sheeting for Scar Management
- Device Name, Classification
FDA Classification: Class II, Elastomer, Silicone, for Scar Management (FDA Code 79MDA)
3. Identification of Substantially Equivalent Devices
DermaSof by McGhan Medical Corp. Epi-Derm Silicone Gel Sheeting by Biodermis Corp. TopiGel by CUI Corp. Sil-K by Degania Silicone
র্বা Device Description
The Mentor H/S Silicone Gel Sheeting for Scar Management is designed to treat hypertropic and keloid scars. This therapy does not remove the scar, but will flatten and soften the scar tissue as well as return a more natural palor to the scar area. The material will be supplied sterile in sheets of silicone reinforced with polyester mesh. The sheets may be cut by the patient and/or the physician to a desired size to fit the scar treatment area.
MENTOR CONFIDENTIAL TRADE SECRET
000070
1
ﺩ.
The Mentor H/S Silicone Gel Sheeting for Scar Management is indicated for treatment of hypertropic and keloid scars. This therapy does not remove the scar but will flatten and soften the scar tissue as well as return a more natural palor to the scar area.
ર. Contraindications for Use
Clinical contraindications for use of the Mentor H/S Silicone Gel Sheeting for Scar Management may include use by patients with medical conditions that would prevent them from using and cleaning the dressing properly. This product should not be applied over an open wound. The product should not be used if the patient is known to be allergic to silicone elastomers or if a rash develops.
7. Warnings, Precautions
Possible complications include:
skin rashes attributed to poor or insufficient hygiene skin rashes attributed to the gel sheeting being applied too tightly superficial maceration of the skin associated with an occlusive dressing pruritis
MENTOR CONFIDENTIAL TRADE SECRET
000071