The intended use for the DIMISIL Scar Gel is topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.

Device Description

The DIMISIL Scar Gel is manufactured from a medical grade silicone gel and is an amorphous paste that has minimal to no elasticity or strength. The scar gel is supplied in 0.34 fl. oz. (10ml) tubes. The DIMISIL Scar Gel is intended to be used for topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called DIMISIL Scar Gel. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device.

Here's why and what information can be extracted:

This document describes a traditional medical device (a scar gel), not an AI/ML device. Therefore, the concepts of "acceptance criteria" and "study proving device meets acceptance criteria" for AI/ML performance metrics (like sensitivity, specificity, F1 score, etc.) are not applicable here.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices based on design, materials, function, and intended use.

However, I can extract information relevant to the device and its regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, traditional performance metrics and acceptance criteria for an AI/ML device are not present. The "performance" for this device relates to its equivalence to predicate devices for scar management.

Acceptance Criterion (Implicitly for Substantial Equivalence)	Reported Device Performance (as claimed by applicant)
Function: Topical management of keloid or hypertrophic scars secondary to trauma.	Substantially equivalent to Kelocote and Kelocote Scar Gel.
Design: Medical grade silicone gel, amorphous paste, minimal to no elasticity/strength. Supplied in 0.34 fl. oz. (10ml) tubes.	Substantially equivalent to Kelocote and Kelocote Scar Gel in design.
Performance: Effectively manages scars as intended. (Performance is directly linked to the function and material composition, which is claimed to be equivalent).	Substantially equivalent to Kelocote and Kelocote Scar Gel in performance.
Materials: Manufactured from medical grade silicone gel.	Substantially equivalent to Kelocote and Kelocote Scar Gel in materials.
Intended Use: Topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.	Identical intended use as predicate devices.

The following numbered points are specific to AI/ML device studies and are therefore not applicable to this document:

Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of what this document does provide:

Device Name: DIMISIL Scar Gel
Intended Use: Topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.
Predicate Devices: Kelocote (marketed by Allied Biomedical Corporation) and Kelocote Scar Gel (marketed by Hanson Medical, Inc.).
Basis for Equivalence: Substantial equivalence in function, design, performance, and materials to the predicate devices.
K Number: K023678
Date of Submission: Received November 1, 2003 (Dated October 28, 2002)
Date of FDA Decision: January 23, 2003 (as per the stamp)

Summary

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K023678

AMENDMENT 7

510(k) Summary

JAN 2 3 2003

January 10, 2003

Applicant:	Aesthetic and Reconstructive Technologies, Inc. (AART)
	3545 Airway Drive, Suite 108
	Reno, NV 89511
	(775) 853-6800 / FAX (775) 853-6805
Contact Person:	Catherine Riple
	Consultant for AART, Inc.
	(805) 239-1059
Proprietary Name:	DIMISIL Scar Gel
Common Name:	Medical Grade Silicone Elastomer
Classification Name:	Elastomer, Silicone, for Scar Management

Substantial Equivalence: The DIMISIL Scar Gel is substantially equivalent in function, design, performance and materials to the Kelocote marketed by Allied Biomedical Corporation of Ventura, CA and the Kelocote Scar Gel marketed by Hanson Medical, Inc.of Kingston, WA.

Device Description: The DIMISIL Scar Gel is manufactured from a medical grade silicone gel and is an amorphous paste that has minimal to no elasticity or strength. The scar gel is supplied in 0.34 fl. oz. (10ml) tubes. The DIMISIL Scar Gel is intended to be used for topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations.

Intended Use: The intended use for the DIMISIL Scar Gel is topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.

Predicate Device: The DIMISIL Scar Gel is substantially equivalent in material, design, function, and performance to the Kelocote marketed by Allied Biomedical Corporation of Ventura. CA and the Kelocote Scar Gel marketed by Hanson Medical, Inc. of Kingston, WA. All products have identical intended uses and are offered in similar quantites.

Packaging: The DIMISIL Scar Gel is offered non-sterile. The scar gel will be packaged in a aluminum tube with a puncture seal cap top and crimped end. Each tube will be labeled and identified with lot number for traceability. The labeled tube will be packaged in a screen printed chipboard box along with a package insert for inventory and shipment.

Sterilization: The DIMISIL Scar Gel is offered non-sterile and not intended to be sterilized.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol featuring three stylized human profiles facing to the right, with flowing lines representing hair or clothing.

JAN 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesthetic and Reconstructive Technologies, Inc. c/o Catherine Riple 5871 Lone Pine Place Paso Robles, California 93446

Re: K023678

Trade/Device Name: DIMISIL Scar Gel Regulation Name: Silicone Elastomer for Scar Management Regulatory Class: Unclassified Product Code: MDA Dated: October 28, 2002 Received: November 1, 2003

Dear Ms. Riple:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Catherine Riple

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Mark N. Milken

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

Enclosure

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ATTACHMENT 1

Page 1 of 1

02367 510(k) Number (if known):_

DIMISIL SCAR GEL

Indications For Use:

Device Name:__________________________________________________________________________________________________________________________________________________________________

The intended use of the AART, Inc. "DIMISIL Scar Gel" is topical management of keloid or I he micaloon use of the Firer, morna of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

Division Sign-Off)
Division of General, Restorative
and Neurological Devices

(k) Number	K023678
------------	---------

Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

(Antinnal Formal 1-7-9

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.