(67 days)
No
The device description focuses on the physical composition and forms of a gel product for scar management. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for temporary use in the management of hypertrophic scars and keloids, which are medical conditions that require treatment.
No
Explanation: The device is indicated for the management of hypertrophic scars and keloids, not for diagnosing them. It is a therapy/management device.
No
The device description clearly outlines physical components made of tri-block polymer and mineral oil, available in various forms like sheets, sleeves, and straps. This indicates a physical medical device, not a software-only one.
Based on the provided information, the Medigel Z device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Medigel Z's Intended Use: The intended use of Medigel Z is for the management of hypertrophic scars and keloids by being applied directly to the skin. It is a topical device.
- No Sample Analysis: The description does not mention any analysis of samples taken from the body. The device is applied externally.
Therefore, Medigel Z falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medigel Z products are indicated for temporary use in the management of hypertrophic scars and keloids resulting from wounds, trauma, or burns. The Medigel Z products are not wound dressings and are not intended to be used on open wounds. It is recommended that the products be used after the closing of a wound (8th to 10th day), or just after the first sign of hypertrophic scars.
Product codes
MDA
Device Description
The Medigel Z is a combination of a tri-block polymer and mineral oil. Medigel Z sheets are available in two thicknesses, 3 mm and 5 mm. The 3 mm sheets are 4 inches by 4 inches. The 5 mm sheets are available in three sizes: 8 by 8 inches, 12 by 16 inches, and 16 by 20 inches. The 5 mm sheets are lined with a fabric backing.
The Medigel Z is also available in four different sized elastic sleeves. The sleeves are 9.5 inches long and range from 12 to 55 inches in circumference. The Medigel Z is also available as an unlined finger-tube, a fabric lined sternal strap, and an elastic lined glove (open finger tips) and chin strap.
The Medigel Z also is available with an adhesive which eliminates the need for a compression bandage in most cases. The adhesive Medigel Z is available with or without a fabric backing and comes in sheets or circular pads. The "Mammopatch Gel Z" and "Abdopatch Gel Z" are fabric backed versions of the adhesive Medigel Z that are shaped specifically for use on the breast and abdomen.
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)
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and form a single, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Z. S.A. c/o Ms. Emalee G. Murphy McKenna & Cuneo, L.L.P ... . 1900 K Street, N.W. Washington, District of Columbia 20006-1108
JUL 2 9 1997
Re: K971916
Trade Name: Medigel Z™ Scar Management Gel Regulatory Class: Unclassified Product Code: MDA Dated: May 23, 1997 Received: May 23, 1997
Dear Ms. Murphy:
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 requirements , as set forth in the Quality System Regulation (QS) 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
1
Page 2 - Ms. Emalee G. Murphy
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.
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.
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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Appendix C
510(k) Summary Medical Z, S.A. Medigel Z™
JUL 2 9 1997 I. General Information on Submitter:
| Name: | Medical Z, S.A. |
|---|---|
| Address: | BP 39 - 55, rue de l'Église |
| F-61110 Rémalard | |
| France | |
| Telephone: | (33) 02 33 73 77 21 |
| Fax: | (33) 02 33 73 78 88 |
| Contact Person: | André Zagamé |
| Date Summary Prepared: | May 23, 1997 |
II. General Information on Device
្រីកុំប៉ុ
| Name: | Medigel Z TM Scar Management Gel |
|---|---|
| ------- | --------------------------------------------- |
| Classification Name: | Elastomer, Silicone, for Scar Management |
|---|---|
| ---------------------- | ------------------------------------------ |
III. Predicate Devices: Silipos® Tri Block Polymer Gel (K942695)
Smith & Nephew Rolyan Cica-Care™ Silicone Gel Sheet (K935803)
IV. Description of the Device:
The Medigel Z is a combination of a tri-block polymer and mineral oil. Medigel Z sheets are available in two thicknesses, 3 mm and 5 mm. The 3 mm sheets are 4 inches by 4 inches. The 5 mm sheets are available in three sizes: 8 by 8 inches, 12 by 16 inches, and 16 by 20 inches. The 5 mm sheets are lined with a fabric backing.
The Medigel Z is also available in four different sized elastic sleeves. The sleeves are 9.5 inches long and range from 12 to 55 inches in circumference. The Medigel Z is also available as an unlined finger-tube, a fabric lined sternal strap, and an elastic lined glove (open finger tips) and chin strap.
3
The Medigel Z also is available with an adhesive which eliminates the need for a compression bandage in most cases. The adhesive Medigel Z is available with or without a fabric backing and comes in sheets or circular pads. The "Mammopatch Gel Z" and "Abdopatch Gel Z" are fabric backed versions of the adhesive Medigel Z that are shaped specifically for use on the breast and abdomen.
V. Intended Use:
The Medigel Z products are indicated for temporary use in the management of hypertrophic scars and keloids resulting from wounds, trauma, or burns. The Medigel Z products are not wound dressings and are not intended to be used on open wounds. It is recommended that the products be used after the closing of a wound (8th to 10th day), or just after the first sign of hypertrophic scars.
VI. Technological Characteristics of Device Compared to Predicate Device:
The Medigel Z™ shares the same technological characteristics, and is manufactured with the same materials as the Silipos® Tri Block Polymer Gel, with the exception of the use of an adhesive to attach the device to the patient's skin. The Cica-Care™ gel, like the Medigel Z, uses an adhesive to attach the gel the body.
4
K971916 510(k) Number (if known):
Device Name: Medigel Z Scar Management Gel
Indications For Use:
The Medigel Z products are indicated for temporary use in the management of hypertrophic scars and Keloids resulting from . wounds, trauma, or burns. The Medigel Z products are not wound dressings and are not intended to be used on open wounds. It is recommended that the products be used after the closing of a wound (8th to 10th day), or just after the first sign of hypertrophic scars.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Divi
Off)
enerai Restorative Devices, 6971916
51VUItiber
Image /page/4/Picture/6 description: The image shows the words "Prescription Use" in bold font. Below that, the text "(Per 21 CFR 801.109)" is shown in a smaller font. There is a line drawn through the words "Prescription Use".
OR
Over-The-Counter Use