(87 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and indications for use describe a device for scar management, which is a common application for non-AI/ML devices.
Yes
The device is indicated for the management and prevention of scars, which are therapeutic applications.
No
Explanation: The "Intended Use / Indications for Use" section states that ScarEase is used for the "management" and "prevention" of scars. There is no mention of the device being used to identify, detect, or diagnose any medical condition.
Unknown
The provided text only includes the Intended Use/Indications for Use section. Without a Device Description, it is impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that ScarEase is for the management and prevention of hypertrophic and keloid scars. This is a therapeutic or preventative application, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples (like blood, urine, tissue) or to provide information about a patient's health status or disease.
- Device Description: While the device description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Other Sections: The absence of information in sections like "Mentions image processing," "Mentions AI, DNN, or ML," "Input Imaging Modality," and performance study details further supports that this is not a diagnostic device.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. ScarEase's function is to directly manage and potentially prevent scar formation on the body, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
- ScarEase is indicated for use in the management of hypertrophic and keloid scars.
- ScarEase is effective in the management of hypertrophic and keloid scars. .
- Consistent use of ScarEase can reduce hypertrophic and keloid scarring. .
- lf used following surgical procedures, ScarEase may prevent hypertrophic . and keloid scarring.
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 seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1099
Mr. Ted Hartley FDA Correspondent ScarEase, Inc. P.O. Box 500356 Poway, California 92150-0356
Re: K984115
Trade Name: ScarEase and ScarEase Adhesive Gel Regulatory Class: Unclassified Product Code: MDA Dated: November 6, 1998 Received: November 17, 1998
Dear Mr. Hartley :
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 (the Act). You may, therefore, market your device subject to the general control provisions of the Federal Food, Drug, and Cosmetic Act (Act). Please note: If you purchase your device components in bulk (i.e., unfinished) and further process them (e.g., sterilize), you must submit a new 510(k) before including these components in your kit. The general control provisions of the Act include requirements for 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 (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) 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. Ted Hartley
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 vour 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
2
FEB-10-99 THU 10:46 AM PILLAR 619 295 0847 P.02
| 510(k) NUMBER (IF KNOWN) | K984115 |
|---|---|
| DEVICE NAME: | ScarEase & ScarEase Adhesive Gel |
INDICATIONS FOR USE:
- ScarEase is indicated for use in the management of hypertrophic and keloid � scars.
- ScarEase is effective in the management of hypertrophic and keloid scars. .
- Consistent use of ScarEase can reduce hypertrophic and keloid scarring. .
- lf used following surgical procedures, ScarEase may prevent hypertrophic . and keloid scarring.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use X
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices K984115
510(k) Number