(481 days)
Not Found
Not Found
No
The description focuses on the physical properties and ease of use of a silicone gel sheet, with no mention of AI or ML.
Yes
The device is described for the "management of hypertrophic and keloid scars" and for the "topical treatment of scars," indicating a therapeutic purpose to treat a medical condition.
No
Explanation: The device description states its purpose is for "topical treatment of scars" and "management of hypertrophic and keloid scars," which indicates a therapeutic rather than a diagnostic function. There is no mention of it detecting, identifying, or monitoring any medical conditions.
No
The device description explicitly states it is a "silicone gel sheet," which is a physical, hardware-based product, not software.
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 describes a therapeutic or management function applied directly to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on a "topical treatment of scars" using a "silicone gel sheet." This is a physical application to the skin, not a test to detect substances or conditions within a sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information about a disease or condition
The device is clearly described as a topical treatment for scars, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
For the management of hypertrophic and keloid scars
Product codes
MDA
Device Description
The NewGel Plus introduced by NewMedical Technology, Inc., is a device which substantially equivalent to other marketed silicone gel sheets. Indications for use are substantially the same, that is, topical treatment of scars. The advantages over other marketed devices from other vendors include the size of the strips in the package to enhance ease of use. In summary, the features incorporated into the NewMedical NewGel Plus have specific advantages over other substantially equivalent products to enhance ease of placement/ application along with the care and comfort of the patient. Neither one of the above features will raise any safety concern because they don't change any of the basic design concepts compared to other similar approved devices.
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
OCT 17 2005
K041704 page 1/2
510K Summary
NewMedical Technology, Inc
3324 Commercial Avenue Northbrook, IL 60062 USA 847-412-1000 Main 847-412-1001 Fax
February 15, 2004 Date of Submission:
The NewGel Plus introduced by NewMedical Technology, Inc., is a device which substantially equivalent to other marketed silicone gel sheets. Indications for use are substantially the same, that is, topical treatment of scars.
The advantages over other marketed devices from other vendors include the size of the strips in the package to enhance ease of use.
In summary, the features incorporated into the NewMedical NewGel Plus have specific advantages over other substantially equivalent products to enhance ease of placement/ application along with the care and comfort of the patient. Neither one of the above features will raise any safety concern because they don't change any of the basic design concepts compared to other similar approved devices.
Equivalence To Marketed Devices:
Equivalency of the NewMedical NewGel Plus, is based on similarities in intended use, materials, design and operational principles to the predicate silicone gel sheeting.
The features of the NewMedical NewGel Plus and the named predicate devices are substantially equivalent in the management of closed scars.
1-Intended Use:
All of the named devices, and the NewMedical NewGel Plus, are intended to be used in the management of hypertrophic and/or keloid scars.
2-Materials:
The materials used in the manufacturing of the NewMedical NewGel Plus are medical grade of silicone gel and natural alpha-tocopherol (Vitamin E). Vitamin E is only used to improve the tackiness characteristics of the gel sheet during handling (see Appendix 5). The materials conform to MSDS for silicone gel, MSDS for alpha-tocopherol, MSDS for polypropelene mesh, MDSD for polyurethane packaging tray, Silicone gel have a long history of successful clinical usage. Silicone Gel is used in the manufacturing of Cica-Care adhesive gel sheeting by Smith & Nephew Medical Ltd., Hull HU3 2BN, and in TopiGel silicone gel sheeting by CUI Corporation, Santa Barbara, CA.
3- Design:
The basic design features of the NewGel Plus is substantially equivalent to the predicate devices. The subject devices and the named devices are adhesive methods of scar management. The subject devices and the
1
K041704 page 2/2
named devices have similar reinforcement materails. The subject devices and the predicate devices use similar non-stick backings. The subject devices and the predicate devices are supplied in similar transparent trays. The non such bucking. The babicate devices use components that have a long history of safe clinical use and FDA review, acceptance and clearance to market.
4- Operational Principles:
l'one
The basic operational principles for the named device and the subject device are similar - mainly in site preparation, method of application, ease of use and replacement, precautions, indications, and components.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in all capital letters. The text is arranged around the circle's perimeter.
Public Health Service
0C1 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Haitham Matloub VP Technology NewMedical Technology, Inc. 3324 Commercial Avenue Northbrook, Illinois 60062
Re: K041704
Trade/Device Name: NewGel Plus Regulation Number: 21 CFR 878.4025 Regulation Name: Silicone sheeting Regulatory Class: I Product Code: MDA Dated: September 20, 2005 Received: September 28, 2005
Dear Mr. Matloub:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have dctermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Signature
or Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K041704
Device Name: NewGel Plus
Indications For Use: For the management of hypertrophic and keloid scars
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | X |
|---|---|
| (21 CFR 807 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of General, Restorative,
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) office of Device Evaluation (ode)
and Neurological Devices
| 510(k) Number | K041704 |
|---|---|
| --------------- | --------- |