(24 days)
Not Found
Not Found
No
The summary describes a silicone gel sheet for scar management and does not mention any computational or data-driven features indicative of AI/ML.
No
The device is described as a scar management dressing, and it is not explicitly stated to be therapeutic in nature, but rather for managing scars. Therefore, it is typically considered a cosmetic or wound care product rather than a therapeutic device.
No
The device is indicated for use as a scar management dressing, which is a treatment or management function, not a diagnostic one.
No
The device description and intended use clearly describe a physical product (Silicone Gel Sheet) used as a dressing, not a software application.
Based on the provided information, the Spenco Silicone Gel Sheet is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for managing scars on the skin (topical application). IVDs are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description is of a physical sheet applied to the skin.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on in vitro testing.
Therefore, the Spenco Silicone Gel Sheet falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Spenco Silicone Gel Sheet is indicated for:
- Use as a scar management dressing on old and new hyperthropic or keloid scars.
- Not to be used on infected wounds.
- Is not indicated for use on 3rd degree burns.
- The device can be used by layman, safely when following the instructions-for use included with the product.
Product codes
MDA
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
layman
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
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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 25 1998
Ms. Brenda Hunt ·Spenco Medical Corporation 6301 Imperial Drive Waco, Texas 76702
K981902 Re: Trade Name: Spenco Silicone Gel Sheet Regulatory Class: Unclassified Product Code: MDA Dated: May 28.1998 Received: June 1, 1998
Dear Ms. Hunt:
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.
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.
1
Page 2 - Ms. Brenda Hunt
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
Pagc of
510(k) Number (if known): K 981902
Device Name: Spenco Silicone Grel Sheet
Indications For Use:
Spenco Silicone Gel Sheet is indicated for:
- Use as a scar management dressing on old and new 1. hyperthropic or keloid scars.
- infected wounds Not to be used on ત્વે.
- Is not indicated for use on 3rd degree burns
- The device can be used by layman, safely when following the instructions-for use included with the product.
(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 | K991902 |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | ------------------------------------------------------------------------------- |
|---|
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