(83 days)
Not Found
Not Found
No
The 510(k) summary describes a silicone gel for scar management and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes.
The device is used for the "topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations," which indicates it is used for treatment.
No
Explanation: The device is a scar gel intended for the topical management of scars, not for diagnosing medical conditions. Its purpose is therapeutic/management, not diagnostic measurement or analysis.
No
The device description clearly states it is a "medical grade silicone gel" and an "amorphous paste," indicating a physical substance, not software.
Based on the provided information, the DIMISIL Scar Gel is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "topical management of keloid or hypertrophic scars secondary to trauma of the skin". This is a therapeutic application, applied directly to the body surface.
- Device Description: The device is a "medical grade silicone gel" and an "amorphous paste". This describes a physical product applied externally.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. The DIMISIL Scar Gel does not involve the analysis of any such specimens.
Therefore, the DIMISIL Scar Gel falls under the category of a topical medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MDA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
1
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.
2
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,
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
3
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)
| 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