(91 days)
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.
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.
This document is from 1996 and describes a physical medical device (silicone gel sheeting for scar management). The requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is primarily relevant to software or AI/ML-based medical devices and is not applicable to the provided text.
The document focuses on:
- Device description
- Intended use
- Contraindications and warnings
- Identification of substantially equivalent devices (a common approach for 510(k) clearances for physical devices)
Therefore, I cannot provide the requested table and study details as they are not present in the provided text for this type of device.
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AUG 2 2 1996
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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
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- 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
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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
§ 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.