(30 days)
Not Found
Not Found
No
The summary describes a foam sheeting for scar management and contains no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for the management of hypertrophic and keloid scars, indicating a therapeutic purpose.
No
Explanation: The device, Epi-Foam Sheeting, is described as intended for the management of hypertrophic and keloid scars, which is a therapeutic rather than a diagnostic function. It does not perform any assessment, detection, or diagnosis.
No
The device description and intended use clearly indicate a physical product ("Epi-Foam Sheeting") used for scar management, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "management of hypertrophic and keloid scars." This is a therapeutic or management purpose, 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 (Not Found): While the description is missing, the intended use is the primary indicator here.
- No Mention of Diagnostic Modalities: There is no mention of imaging, AI, or any other technology typically associated with diagnostic devices.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Epi-Foam Sheeting's purpose is to manage existing scars, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
Epi-Foam Sheeting is intended for the management of hypertrophic and keloid scars. Epi-Foam is not intended for use on open wounds.
Product codes
MDA
Device Description
Epi-Foam Silicone Sheeting
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) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0 1999 JUN
Jeff S. Schleuning, Ph.D. General Manager Biodermis Corp. 3078 East Sunset Road, Suite #1 Las Vegas, Nevada 89120
Re: K991604 Trade Name: Epi-Foam Silicone Sheeting Regulatory Class: Unclassified Product Code: MDA Dated: April 15, 1999 Received: May 10, 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.
1
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,
Jocolef
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
| 4400
t
l
) | 1 | 1
1 | 11 |
|---------------------|---|------------|------|
| 1
1 | | Company of | **** |
510(k) Number (if known):__K991604 K991604
Device Name:Epi-Foam Silicone Sheeting______________________________________________________________________________________________________________________________________
Indications For Use:
Epi-Foam Sheeting is intended for the management of hypertrophic and keloid scars. Epi-Foam is not intended for use on open wounds.
(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 | K991604 | |
| 510(k) Number | ||
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use X |
(Optional Format 1-2-96)