(83 days)
No
The device description and performance studies focus on the material properties and biological effects of a wound dressing, with no mention of AI or ML.
Yes
The device is intended for the treatment and management of various wound types, including burns, lacerations, and ulcers, which are medical conditions, thereby classifying it as a therapeutic device.
No.
The device is a dressing used to create a moist wound environment for treatment, not for diagnosis.
No
The device description clearly states it is a non-woven dressing impregnated with wound gel, indicating it is a physical, material-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a dressing applied to wounds to create a moist environment for healing and debridement. This is a direct application to the body surface for therapeutic purposes.
- Device Description: The description details a physical dressing material impregnated with a gel, designed to be applied externally to a wound.
- Lack of In Vitro Testing: The description of the device and its intended use does not involve testing samples outside of the body (in vitro) to diagnose a condition or provide information about a patient's health status. The performance studies mentioned are related to biocompatibility and safety when applied to the body.
IVD devices are typically used to examine specimens such as blood, urine, or tissue samples to detect diseases, conditions, or infections. This device does not perform such a function.
N/A
Intended Use / Indications for Use
SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the treatment of minor conditions such as:
- Minor burns
- Superficial lacerations, cuts and abrasions (partial thickness wounds) and skin tears
Under the direction of a healthcare professional, SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the management of: - Venous ulcers (leg ulcers)
- Surgical incisions
- Diabetic foot ulcers
- Pressure ulcers (including stage IV).
Additionally, SoloSite® Gel Conformable Dressing, creates a moist wound environment which assists in autolytic debridement of wounds covered with necrotic tissue.
Product codes
MGQ
Device Description
SoloSite® Gel Conformable Dressing is a non woven (70/30 rayon polyester blend) dressing impregnated with SoloSite® wound gel contained in a heat sealable, peal apart metalized/polyethylene pouch.
The product is applied in such a manner to completely cover the wound surface with the dressing and secured in place with an appropriate secondary dressing.
Gel conformable dressings are indicated to provide covering of the wound bed as well as creating a moist wound healing environment.
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
Healthcare professional for management of certain conditions; general use for minor conditions.
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
The submission discusses biocompatibility tests:
- Cytotoxicity: An in vitro test based on ISO 10993-5. Conclusion: "no evidence of causing cell lysis or toxicity grater then a USP grade of 2 (mild reactivity). The test article was mildly cytotoxic an passed this ISO study."
- Animal Primary Irritation: Evaluated per FHSA Regulations, 16 CFR 1500. Conclusion: "The test article would not be considered a primary irritant to the skin since the empirical score was less than 5.00."
- Delayed Contact Sensitization Study in the Guinea Pig (Repeated Patch Method): Based on ISO 10, Part 10. Conclusion: "no evidence of causing delayed dermal contact sensitization in the guinea pig."
- Acute Systemic Toxicity Study in The Mouse: Based on ISO: Biological Evaluation of Medical Devices, Part 11. Conclusion: "there was no mortality or evidence of significant systemic toxicity."
- Genotoxicity: Salmonella typhimurium - Reverse Mutation Study: Conclusion: "SoloSite CWD was not considered to be mutagenic to Salmonella typhimurium tester strains"
- Hemolysis Study - In Vitro Procedure (Extract Method): Conclusion: "The test article extract was nonhemolytic."
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Biolex™ Impregnated Wound Dressing CarraGauze™ Carrasyn™ Hydrogel wound Dressing Saturated Pad MPM GelPad™ Hydrogel Saturate Dressing Restore™
in that all products are hydrogel impregnated dressings indicated to provide covering of the wound bed as well as creating a moist wound healing environment.
2
Bio Compatibility
Cytotoxicity
An in vitro biocompatibility test, based on the International Organization for Standardization (ISO 10993-5) guidelines, was conducted on the test article, SoloSite® Gel Conformable Dressing, in order to determine the potential for in vitro cvtotoxicity.
Conclusion: Under the conditions of this study, the test article showed no evidence of causing cell lysis or toxicity grater then a USP grade of 2 (mild reactivity). The test article was mildly cytotoxic an passed this ISO study.
Animal Primary Irritation
The test article, SoloSite® Gel Conformable Dressing, was evaluated for primary skin irritation in accordance with the guidelines of the Federal Hazardous Substances Act (FHSA) Regulations, 16 CFR 1500.
Under conditions of this study, barely perceptible irritation was observed on the skin of the rabbits. The primary irritation index was calculated to be 0.88.
Conclusion: The test article would not be considered a primary irritant to the skin since the empirical score was less than 5.00.
Delayed Contact Sensitization Study in the Guinea Pig (Repeated Patch Method)
A study was conducted in the guinea pig to evaluate the potential for delayed dermal contact sensitization of SoloSite® Gel Conformable Dressing. The study was conducted based on the requirements of the International Organization for Standardization Part 10: Tests for Irritation and Sensitization.
Conclusion: Under the conditions of this study, the test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.
Acute Systemic Toxicity Study in The Mouse
The test article, SoloSite® Gel Conformable Dressing, was evaluated for systemic toxicity based on the requirements of the International Organization for Standardization: Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity.
Conclusion: Under the conditions of this test there was no mortality or evidence of significant systemic toxicity.
3
Genotoxicity: Salmonella typhimurium - Reverse Mutation Study
A Salmonella typhimurium reverse mutation standard plate incorporation study was conducted to determine whether SoloSite® Gel Conformable Dressing, would cause mutagenic changes in histidine-dependent Salmonella typhimurium strains in the presence and absence of S9 metabolic activation
Under the conditions of this assay, SoloSite CWD was not Conclusion: considered to be mutagenic to Salmonella typhimurium tester strains
Hemolysis Study - In Vitro Procedure (Extract Method)
The test article, SoloSite® Gel Conformable Dressing, was evaluated to determine whether the presence of any leachable chemicals from the test article would cause in vitro red blood cell hemolysis.
Conclusion: Under the conditions of this study, the mean hemolytic index for the test article extract was 0%. The test article extract was nonhemolytic.
Preservation
SoloSite® Gel Conformable Dressing is a preserved product and does not undergo sterilization.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged around a circular emblem. Inside the emblem is a stylized image of three human profiles facing right, overlaid to create a sense of depth and unity. Above the profiles is a graphic element consisting of three angled lines, resembling a stylized wing or a symbol of forward movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 1998
Mr. Jim G. Irvin Vice President Ouality Assurance & Regulatory Affairs Smith & Nephew, Incorporated 11775 Starkey Road P.O. Box 1970 Largo, Florida 33779-1970
Re: K981150 Trade Name: SoloSite® Conformable Wound Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: March 27, 1998 Received: March 31, 1998
Dear Mr. Irvin:
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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
-
- This device may not be labeled for use on third degree burns.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization. .................................................................................
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
-
- This device may not be labeled as a treatment or a cure for any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
5
Page 2 - Mr. Jim G. Irvin
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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 (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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.
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,
fu 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
6
510(k) Number (if known):
Device Name: SoloSite® Gel Conformable Dressing
Indications for Use:
SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the treatment of minor conditions such as:
- 务 Minor burns
- Superficial lacerations, cuts and abrasions (partial thickness wounds) and skin tears 本
Under the direction of a healthcare professional, SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the management of:
- 址 Venous ulcers (leg ulcers)
- 풀 Surgical incisions
- 曼 Diabetic foot ulcers
ిష
- Pressure ulcers (including stage IV). 要
Additionally, SoloSite® Gel Conformable Dressing, creates a moist wound environment which assists in autolytic debridement of wounds covered with necrotic tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use | |
|---|---|
| (Per 21CFR 801.109) |
OR
| Over-The-Counter Use |
|---|
| ---------------------- |
| (Optional Format 1-2-96) | |
|---|---|
| -- | -------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K981150 |