(36 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of these technologies.
Yes
The device is intended for the "management of hypertrophic and keloid scars," which is a therapeutic purpose.
No
Explanation: The "Intended Use / Indications for Use" states that Scaraid is "intended for the management of hypertrophic and keloid scars." This indicates a therapeutic or management purpose, not a diagnostic one. Diagnostic devices are used to identify or determine the presence of a disease or condition.
Unknown
The provided text lacks a device description, which is crucial for determining if the device is software-only. Without knowing the components and how the device functions, it's impossible to definitively classify it.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "management of hypertrophic and keloid scars." This describes a therapeutic or management function applied directly to the patient's body surface, not a diagnostic test performed on a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or laboratory procedures
The description points towards a device used for topical application or physical management of scars.
N/A
Intended Use / Indications for Use
Scaraid is intended for the management of hypertrophic and keloid scars and it is not intended to be used on open wounds.
Product codes
MDA
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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 seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The eagle's head is turned to the left, and its body is stylized with three parallel lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Jeff S. Schleuning, Ph.D. General Manager BIODERMIS Corp. 3078 East Sunset Road, Suite #1 Las Vegas, Nevada 89120
Re: K992146 Trade Name: ScarAid Silicone Gel Sheeting Regulatory Class: Unclassified Product Code: MDA Dated: June 15, 1999 Received: June 24, 1999
Dear Dr. Schleuning:
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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
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Page 2 - Jeff S. Schleuning, Ph.D.
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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K992146
Page / of /_
510 (k) NUMBER (IF KNOWN) : __ K992146
SCARAID DEVICE NAME:
INDICATIONS FOR USE:
Scaraid is intended for the management of hypertrophic and keloid scars and it is not intended to be used on open wounds.
(PLEASE DO NOT MRITE BELOG THIS LINE-CONTINUE ON ANOTHER PAS IF NEEDED.)
Concurrence of CORH, Office of Device Evaluation (ODE)
.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-U: (Optional Format
pc.all 8
(Division Sign-Off) Division of General Resto 510(k) Number