(145 days)
Not Found
No
The device description and intended use are for a silicone gel sheet for scar management, with no mention of AI/ML technology or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for the management and prevention of hypertrophic and keloid scars, which are medical conditions, and clinical studies have demonstrated its effectiveness for these therapeutic purposes.
No
The device description and intended use indicate that Silgel™ is used for the management and prevention of hypertrophic and keloid scars, acting as a physical barrier or splint lining insert. It does not perform any diagnostic function such as detecting, identifying, or characterizing a disease or condition.
No
The device description clearly states it is a "Topical Gel Sheet" made of "durable medical grade silicone reinforced with polyester mesh," indicating it is a physical 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 and prevention of hypertrophic and keloid scars. This is a therapeutic and prophylactic use applied directly to the body surface, not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is a topical gel sheet applied externally. IVD devices typically involve reagents, instruments, or systems used to test biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any of the typical characteristics of an IVD device.
Therefore, Silgel™ is a medical device, but it falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Silgel™ is intended for use in the treatment and control of hypertrophic and keloid scars, prophylactic management of healed incisions and as a splint lining insert to relieve friction on newly healed scars.
Product codes (comma separated list FDA assigned to the subject device)
MDA
Device Description
Silgel™. Topical Gel Sheet, consists of a durable medical grade silicone reinforced with polyester mesh. Sheets are protected on one side by a film which is removed before use and on the other by a paper backing. Sheets are individually packaged in grip seal bags. A sheet can be trimmed to the desired shape prior to placement on the scar. It is secured by wrapping with either gauze and hypoallergenic adhesive tape, light conforming crepe or tubular bandages, or compression garments. Firm pressure is not required for a therapeutic effect.
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)
Component Testing:
The silicone gel raw material, cured under conditions similar to those used for the finished device, has been subjected to the biocompatibility tests as defined in ISO 10933 for skin contact devices. The biocompatibility data demonstrate that the silicone gel meets all test requirements.
Final Product Testing:
Final product configuration was subjected to the following test battery. Hemolysis Test: In Vitro Hemolysis Test by Direct Contact Cytotoxity Test: MEM Elution Method Pyrogenicity Test: Limulus Amebocyte Lysate (LAL) Test
All test were acceptable demonstrating that the product is safe for its intended use.
The effectiveness of silicone gel sheet products in the management and prophylaxis of hypertrophic and keloid scars has been demonstrated by numerous clinical studies. The intended use and instructions for use for Silgel™ are consistent with the clinical findings of these studies.
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.
Spenco Silicone Gelsheet, Silastic Soft Sheeting (K894226), Epi-Derm Silicone Gel Sheeting, New Beginnings Topical Gel Sheeting, DermaSof Gel Sheeting, Cica-Care Adhesive Gel Sheet
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
974172
MAR 3 0 1998
510(k) SUMMARY: Silge!™ Topical Gel Sheet
1. Name and address of Contact person
J.A.Evans. Technical Director Nagor Limited P.O Box 167 Douglas Isle of Man British İsles IM99 1PG
Tel: (01624) 625556 Fax: (01624) 661656
Date of preparation: October 31, 1997
2. Device Identification
Trade Name: Silgel™ Topical Gel Sheet Common or Usual Name: silicone gel sheet Classification Name: Not classified
3. Predicate Devices
The predicate devices are all silicone topical gel sheets and include: Spenco Silicone Gelsheet, a pre-enactment device Silastic Soft Sheeting, (K894226) [January 3, 1990] Epi-Derm Silicone Gel Sheeting, [510(k) number unknown] New Beginnings Topical Gel Sheeting, [510(k) number unknown] DermaSof Gel Sheeting, [510(k) number unknown] Cica-Care Adhesive Gel Sheet, [510(k) number unknown]
4. State of Intended Use
Silgel™ is intended for use in the treatment and control of hypertrophic and keloid scars, prophylactic management of healed incisions and as a splint lining insert to relieve friction on newly healed scars.
5. Device Description
Silgel™. Topical Gel Sheet, consists of a durable medical grade silicone reinforced with polyester mesh. Sheets are protected on one side by a film which is removed before use and on the other by a paper backing. Sheets are individually packaged in grip seal bags. A sheet can be trimmed to the desired shape prior to placement on the scar. It is secured by wrapping with either gauze and hypoallergenic adhesive tape, light conforming crepe or tubular bandages, or compression garments. Firm pressure is not required for a therapeutic effect.
{_} = Proprietary Information Contained Within
Page 9
NAGOR LIMITED PO BOX 21 DOUGLAS ISLE OF MAN IM99 1AX BRITISH ISLES TELEPHONE (0)1624 625556 FAX (0)1624 661656
1
Image /page/1/Picture/1 description: The image shows the word "Nagor" in a bold, sans-serif font. The letters are black against a white background. There are thick, horizontal lines extending from the bottom of each letter, creating a sense of solidity and weight. The overall design is simple and impactful.
6. Technological Characteristics
Silgel™ and the predicate devices consist of a thin sheet of silicone gel. Silgel™ and several of the predicate devices contain a reinforcing mesh, while Cica-Care is supported by a silicone membrane. All products are comfortable, semiocclusive, slightly adhesive and durable. Although the mechanism of action is not completely characterized, the effectiveness of silicone gel sheeting products has been repeatedly demonstrated in the clinical situation.
7. Testing Summary
Component Testing:
The silicone gel raw material, cured under conditions similar to those used for the finished device, has been subjected to the biocompatibility tests as defined in ISO 10933 for skin contact devices. The biocompatibility data demonstrate that the silicone gel meets all test requirements.
Final Product Testing:
Final product configuration was subjected to the following test battery. Hemolysis Test: In Vitro Hemolysis Test by Direct Contact Cytotoxity Test: MEM Elution Method Pyrogenicity Test: Limulus Amebocyte Lysate (LAL) Test
All test were acceptable demonstrating that the product is safe for its intended use.
The effectiveness of silicone gel sheet products in the management and prophylaxis of hypertrophic and keloid scars has been demonstrated by numerous clinical studies. The intended use and instructions for use for Silgel™ are consistent with the clinical findings of these studies.
8. Rationale for Substantial Equivalence Determination
A comparison of the technological characterisitics of Silgel™ Topical Gel Sheet shows that it is a silicone gel sheet as are all predicate devices. The intended use in control and management of hypertrophic and keloid scars is common with these predicate devices. As with Cica-Care, Silge!™ is indicated for prophylactic therapy in healed incisions and wounds. It is also indicated as a splint lining to relieve friction on newly healed scars similar to Spenco Silicone Gelsheet. The instructions for use are essentially the same for all products. As with the predicate devices, Silgel™ can be cleaned routinely during the course of clinical management. All product labels discuss the potential skin complications associated with clinical use including rash and irritation. Unlike predicate devices, Silgel™ is not provided sterile nor is this considered to be a requirement for product safety and efficacy since it is only intended for use on intact skin. Based on this information, Silgel™ can be considered substantially equivalent to the predicate devices.
{ = Proprietary Information Contained Within
Page 10
NAGOR LIMITED PO BOX 21 DOUGLAS ISLE OF MAN IM99 1AX BRITISH ISLES TELEPHONE (0)1624 625556 FAX (0)1624 661656
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 1998
Mr. J.A. Evans Technical Director Nagor Limited P.O. Box 167 Douglas Isle of Man British Isles IM99 IPG
K974172 Re: Silgel™ Topical Gel Sheet Trade Name: Requlatory Class: Unclassified Product Code: MDA Dated: March 9, 1998 March 11, 1998 Received:
Dear Mr. Evans:
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 The general controls provisions of the Act 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. ਸਿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. 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.
3
Page 2 - Mr. J.A. Evans
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.qov/cdrh/dsmamain.html".
Sincerely yours,
6: Carlin, Mrs. Whitney, Ph.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
4
510(k) Number (if known): K974172
Silgel Topical Gel Sheet Device Name:
Indications For Use:
Silgel™ device is intended for use in the management of hypertrophic and keloid scars. It can also be used for the prophylactic management of healed incisions for the prevention of hypertrophic or keloid scars.
Silger™ helps relieve friction on newly healed scars when used as a splint lining insert.
(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 K474172
Prescription Use (Per 21 CFR 801.109) ଠନ୍ନ
Over-The-Counter Use
(Optional Format 1-2-96)