(77 days)
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of a wound dressing, with no mention of AI or ML.
No
The device is a wound contact layer dressing used to cover wounds, which is a supportive rather than a therapeutic function. Therapeutic devices are typically intended to treat or cure a condition, whereas this device aids in wound management.
No
The device is a wound contact layer dressing, which is used for covering wounds, not for diagnosing medical conditions.
No
The device description clearly states it is a "bi-axially stretched net constructed of high density polyethylene," which is a physical material, 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 to provide covering for the wound bed and manage various types of wounds. This is a direct application to the body for therapeutic purposes.
- Device Description: The description details a physical dressing material applied to a wound.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is applied to the body for wound management.
N/A
Intended Use / Indications for Use
For OTC applications, CicaNet* Wound Contact Layer Dressing may be used for the management of minor wounds including
- Abrasions
- Skin tears
- Minor burns and scalds
Under the care of a healthcare professional, CicaNet* Wound Coutact Layer Dressing may be used in the management of partial and full thickness wounds including:
- Leg ulcers
- Pressure ulcers
- Second degree burns
- Surgical wounds
- Diabetic foot ulcers
Product codes (comma separated list FDA assigned to the subject device)
MGP
Device Description
CieaNet+ Wound Contact Layer Dressing is an air permeable, transparent, bi-axially stretched net constructed of high density polyethylene. This product is used in moist wound management of partial and full thickness wounds.
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
OTC applications, healthcare professional
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)
Bio Compatibility Studies:
- Cytotoxicity: A study was conducted using mouse fibroblast cells as the substrate. Conclusion: Under the conditions of the study, the test article was found to be nontoxic.
- Contact Sensitization: A study was conducted in the guinea pig to evaluate the potential for delayed dermal contact sensitization. Conclusion: Under the conditions of this study, the test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.
- Animal Primary Irritation: Evaluated for primary skin irritation in accordance with the guidelines of the Federal Hazardous Substances Act (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.
- Hemolysis Study - In Vitro Procedure (Extraction Method): Evaluated to determine whether the presence of any leachable chemicals would cause in vitro red blood cell hemolysis. Conclusion: The mean hemolytic index for CicaNet* Wound Contact Layer Dressing extract was 0%. CicaNet* Wound Contact Layer Dressing is nonhemolytic.
- USP Systemic Toxicity Study in the Mouse (Extracts): Evaluated for systemic toxicity in accordance with the guidelines of the current USP. Conclusion: There was no mortality or evidence of systemic toxicity from CicaNet* Wound Contact Layer Dressing.
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.
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
N/A
0
JUL 3 | 1998
510(k) Summary
CicaNet* Wound Contact Layer Dressing
| Preparation Date:
A A C A C A C C C C . C . C . C
| Commons of the first desires of the contraction of the contraction of the contraction of the contribution | Mav | 15.1998 | |
|---|---|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----- | -- | --------- |
Jim G. Irvin Submitter: Smith & Nephew Inc. Address: Wound Management Division 11775 Starkey Road Largo, FL 33773-4727 (813) 392-1261 Phone: (813) 399-3468 Fax:
Registration Official / Contact Person:
Jim Irvin, Vice President Quality Assurance and Regulatory Affairs Smith & Nephew, Inc. Wound Management Division
Manufacturer Identification/Establishment Registration Number
Smith & Nephew Inc. Wound Management Division 11775 Starkey Road Largo, FL 33773-4727 Phone (813) 392-1261 Fax (813) 399-3468
Establishment Registration Number: 1017593
Classification:
Trade Name: CicaNet*
Common Name: Wound Dressing
Classification Name: (Unclassified)
1
Substantially Equivalent Products
| Product | Manufacturer |
|---|---|
| 3M Tegapore™ Wound Contact Material | 3M Health Care |
| St. Paul, MN | |
| DERMANET™ Wound Contact Layer | DeRoyal Wound Care |
| Powell, TN | |
| Conformant 2™ Transparent, Non-Adherent, Wound | |
| Veil | EXU-DRY Wound Care Products, Inc. |
| Bronx, NY | |
| TELFA CLEAR™ Nonadherent Wound Dressing | Kendall Healthcare Products |
| Mansfield, MA | |
| N-TERFACE® Interpositional Surfacing Material | Winfield Laboratories |
| Dallas, TX (K973538) |
Device Description
CieaNet+ Wound Contact Layer Dressing is an air permeable, transparent, bi-axially stretched net constructed of high density polyethylene. This product is used in moist wound management of partial and full thickness wounds.
Wound contact layer dressings are indicated to provide covering for the wound bed.
Indications for Use
For OTC applications, CicaNet* Wound Contact Layer Dressing may be used for the management of minor wounds including
- Abrasions サ
- t Skin tears
- 용 Minor burns and scalds
Under the care of a healthcare professional, CicaNet* Wound Coutact Layer Dressing may be used in the management of partial and full thickness wounds including:
- . Leg ulcers
- Pressure ulcers 4
- � Second degree burns
- Surgical wounds .
- t Diabetic foot ulcers
2
Technological Characteristics:
The CicaNet* Wound Contact Layer Dressing is technologically the same as the substantially equivalent products:
3M Tegapore ™ Wound Contact Material DERMANET™ Wound Contact Layer Conformant 2 ™ Transparent, Non-Adherent, Wound Veil TELFA CLEAR ™ Nonadherent Wound Dressing N-TERFACE @ Interpositional Surfaceing Material
in that all products are an air permeable, transparent, non-adherent wound contact layer.
Bio Compatibility
Cytotoxicity
A study was conducted using mouse fibroblast cells as the substrate in order to determine the cytotoxicity of CicaNet* Wound Contact Layer Dressing.
Conclusion: Under the conditions of the study, the test article was found to be nontoxic.
Contact Sensitization
A study was conducted in the guinea pig to evaluate the potential for delayed dermal contact sensitization of CicaNet* Wound Contact Layer Dressing.
Conclusion: Under the conditions of this study, the test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.
Animal Primary Irritation
CicaNet* Wound Contact Layer Dressing was evaluated for primary skin irritation in accordance with the guidelines of the Federal Hazardous Substances Act (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.
Hemolysis Study - In Vitro Procedure (Extraction Method)
CicaNet* Wound Contact Layer Dressing was evaluated to determine whether the presence of any leachable chemicals would cause in vitro red blood cell hemolysis.
Conclusion: The mean hemolytic index for CicaNet* Wound Contact Layer Dressing extract was 0%. CicaNet* Wound Contact Layer Dressing is nonhemolytic.
3
USP Systemic Toxicity Study in the Mouse (Extracts)
CicaNet* Wound Contact Layer Dressing was evaluated for systemic toxicity in accordance with the guidelines of the current USP.
Conclusion: There was no mortality or evidence of systemic toxicity from CicaNet* Wound Contact Layer Dressing
Sterilization
The method of sterilization will be Ethylene Oxide. An SAL of 10% will be achieved. Ethylene Oxide residuals will conform to FDA guidelines as originally published (Federal Register, Friday, June 23, 1978, Part V, "Proposed Maximum Residue Limits and Maximum Levels of Exposure").
Packaging
The product is packaged in a cold seal, peel apart, white, Kraft, ETO sterilizable Detectable Prior Opening (DPO) system, paper pouch. The individual dressings are protected by a parchment inner-wrap.
4
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 31 1998
Mr. Jim G. Irvin Vice President, Quality Assurance & Regulatory Affairs Wound Management Division Smith & Nephew, Inc. 11775 Starkey Road Largo, Florida 33773
Re: K981713
Trade Name: Cicanet Wound Contact Layer Dressing Regulatory Class: Unclassified Product Code: MGP Dated: May 15, 1998 Received: May 15, 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).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.
5
Page 2 - Mr. Jim G. Irvin
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,
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)
CicaNet* Wound Contact Layer Dressing Device Name:
Wound contact layer dressings are indicated to provide covering for the wound bed.
For OTC applications, CicaNet* Wound Contact Layer Dressing may be used for the management of minor wounds including
- Abrasions .
- Skin tears キ
- t Minor burns and scalds
Under the care of a healthcare professional, CicaNet* Wound Contact Layer Dressing may be used in the management of partial and full thickness wounds including:
- t Leg ulcers
- Pressure ulcers ◆
- Second degree burns .
- Surgical wounds �
- ♥ Diabetic foot ulcers
(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 | K981713 |
| Prescription Use | OR Over-The-Counter Use |
| (Per 21CFR 801 109) |
(Per 21CFR 801.109)
(Options) Format 1-2-96)