(49 days)
None
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML medical devices.
Yes
The device is intended to treat "Hypertuophie Scars" and "Keloid Scars," indicating a therapeutic purpose to modify body structure or function.
No
The provided information only lists "Hypertuophie Scars" and "Keloid Scars" under "Intended Use / Indications for Use," which describes conditions the device is used for, but does not indicate whether the device diagnoses them. There is no information about how the device operates or its function to determine if it performs diagnosis.
Unknown
The provided 510(k) summary is incomplete and lacks crucial information about the device description. Without knowing the nature of the device, it's impossible to determine if it's software-only.
Based on the provided information, there is no indication that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Hypertuophie Scars" and "Keloid Scars." These are conditions related to the skin and tissue, not the analysis of biological samples (like blood, urine, or tissue) outside the body, which is the core function of an IVD.
- Lack of IVD-related information: The provided text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples
- Detection or measurement of analytes
- Diagnostic purposes based on laboratory testing
Without any information suggesting the device performs in vitro analysis of biological samples, it is highly unlikely to be classified as an IVD. It appears to be a device intended for the treatment or management of scars.
N/A
Intended Use / Indications for Use
Hypertuophie Scars
Keloid Scars
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the symbol. The text is in a circular format around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
100 1007
Mr. Glenn R. Joyner President Specialty Systems, Inc. - - - -1312 Veracruz Weston, Florida 33326
14
Re: K971468
Trade Name: Scar Esthetique/Rejuvaskin Regulatory Class: Unclassified Product Code: MDA Dated: April 20, 1997 Received: April 22, 1997
Dear Mr. Joyner:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
1
Page 2 - Mr. Glenn R. Joyner
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,
[signature]
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
2
510(k) Number (if known):
Device Name: REJUVASKIN
Indications For Use:
ત્વન્
Hypertuophie Scars
Keloid Scars
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K971468 |
Presoription Use
(Por 21 CPR 801 105)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)