(337 days)
DERMA+FLEX™ Gel Adhesive is indicated for OTC use to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.
DERMA+FLEX™ Gel Adhesive is a sterile, clear, high viscosity, flexible, liquid topical bandage composed of a blend of 2-Octyl and N-Butyl cyanoacrylate monomers with an octyl cyanoacrylate polymer, tributyl citrate (a plasticizer) and containing D&C violet #2 pigment. DERMA+FLEX™ is supplied in 0.5g single patient use aluminum tubes with (2) self-piercing applicator caps (a dauber cap and a nozzle cap). Each sterile single use aluminum tube is packaged with applicators in individual Tyvek pouches and sterilized by EtO sterilization rendering the exterior of the tube and applicators suitable for dispensing on sterile fields.
The provided text describes the 510(k) summary for the DERMA+FLEX™ Gel Adhesive and the FDA's clearance letter. It focuses on establishing substantial equivalence to predicate devices and provides details on the device description, indications for use, and a summary of biocompatibility testing. It does not contain information about acceptance criteria for performance, a study to demonstrate device performance in terms of efficacy or effectiveness, or details about sample sizes, expert involvement, or adjudication methods for performance studies.
Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, or details about performance studies, multi-reader multi-case studies, or standalone algorithm performance.
However, I can extract the information related to the biocompatibility testing that was performed:
1. Table of acceptance criteria and the reported device performance (for biocompatibility testing):
| Acceptance Criteria (Biocompatibility) | Reported Device Performance (DERMA+FLEX™ Gel Adhesive) |
|---|---|
| ISO 10993-5 and USP 24, Biological Reactive Tests In-Vitro (87) requirements met for cytotoxicity. | Met the requirements of the cytotoxicity test. Result: Grade 1 (non-cytotoxic). |
| Not considered to be sensitizing (Murine Local Lymph Node Assay). | Not considered to be sensitizing. |
| Potential irritation effects for intracutaneous injection (screen extracts for potential irritation effects). | Saline extract yielded a mean score of 0.0 (out of 4). Cottonseed oil extract yielded a mean score of 1.4 (out of 4). Considered a mild irritant. (Warning label for cyanoacrylate allergy provided). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document describes in vitro and in vivo biocompatibility tests using cell lines (L929 agar overlay test) and animal models (Murine Local Lymph Node Assay and Intracutaneous Inject). Specific sample sizes for these tests are not provided in the document.
- Data provenance is not specified. These are standard laboratory tests typically conducted under controlled conditions and would likely be prospective for the purpose of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable or not provided for biocompatibility testing. Biocompatibility tests rely on established scientific protocols and quantitative measurements, not expert consensus on qualitative data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable or not provided for biocompatibility testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was mentioned or performed. The device is a "Liquid Bandage" and does not involve AI or human image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a physical product (liquid bandage), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility testing, the "ground truth" is established through:
- Validated biological assays: such as cell viability assays (L929), immune response assays (LLNA), and irritation potential assays (intracutaneous injection).
- Interpretation against international standards: (e.g., ISO 10993-5, USP 24) and regulatory guidelines.
8. The sample size for the training set:
- Not applicable. This pertains to algorithm development. For a physical medical device, there isn't a "training set" in the computational sense. The "development" would involve formulation and bench testing.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary, the provided document details biocompatibility testing results to demonstrate the safety of the DERMA+FLEX™ Gel Adhesive, not its performance in terms of efficacy, which is typically established through clinical studies not present in this 510(k) summary. The focus of the 510(k) was on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety (biocompatibility).
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FEB 2 3 2006
FEB 05
K050757
Page 1 of 3
510(k) SUMMARY DERMA+FLEX™ Gel Adhesive
Submitted by:
Chemence Medical Products, Inc. 185 Bluegrass Valley Parkway Alpharetta, GA 30005 Telephone: 770.664.6624 FAX: 770.664.6620
Scott Leal, Regulatory Affairs/Quality Assurance Contact name:
Date prepared:
Classification:
Description:
Predicate devices:
January 13, 2006
DERMA+FLEXTM Gel Adhesive: Device trade name(s):
Liquid Bandage Common name:
Classification regulation no : 880.5090
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Class I
Liquiderm TM Liquid Adhesive Bandage, which is manufactured by Closure Medical Corp., K002338, (Marketed as Johnson & Johnson Band-Aid® Liquid Bandage).
3M TM Liquid Bandage, which is manufactured by 3M Health Care, K031263, (Marketed as 3M NEXCARE™ Liquid Bandage).
LiquiShield™ Liquid Bandage, which is manufactured by MedLogic Global Limited, K031321.
Care should be used around the eyes. Do not use on skin Contraindications: with active signs of infection. Avoid placing adhesive into major wounds or indications that should otherwise require wounds closure with another device.
DERMA+FLEX™ Gel Adhesive is a sterile, clear, high viscosity, flexible, liquid topical bandage composed of a blend of 2-Octyl and N-Butyl cyanoacrylate monomers with an octyl cyanoacrylate polymer, tributyl citrate (a plasticizer) and containing D&C violet #2 pigment.
DERMA+FLEX™ is supplied in 0.5g single patient use aluminum tubes with (2) self-piercing applicator caps (a dauber cap and a nozzle cap). Each sterile single use Section E 2 of 4
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K 050 757
Page 2 of 3
aluminum tube is packaged with applicators in individual Tyvek pouches and sterilized by EtO sterilization rendering the exterior of the tube and applicators suitable for dispensing on sterile fields.
DERMA+FLEX™ Gel Adhesive is indicated for OTC use Indications for Use: to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.
Technological Characteristics: DERMA+FLEX™ Gel Adhesive is applied to the wound and polymerizes to form a mechanical bond with the skin, typically within one to 5 minutes depending on thickness Once polymerized, the topical film acts as a applied. covering allowing the wound to heal. During wound healing, the polymer coating sloughs off naturally, as dead skin cells are shed and replaced with new cells.
DERMA+FLEX™ Gel Adhesive is similar to the Substantial Equivalence: predicate devices (Liquiderm TM Liquid Adhesive Bandage, LiquiShield™ Liquid 3M TM Liquid Bandage and Bandage) in that all are cyanoacrylate liquid bandages, manufactured in a similar manner (synthesized, cracked, and distilled), blended with other ingredients and sterilized by dry heat. The products are substantially equivalent.
Differences:
The DERMA+FLEX™ Gel Adhesive formulation incorporates a 99.0% pure octyl cyanoacrylate polymer as an ingredient to increase the viscosity of the gel to help control the gel's application until it polymerizes. Once the Gel Adhesive polymerizes, the octyl polymer become part of the polymer matrix and is indistinguishable from the polymerized monomers.
The sterilized DERMA+FLEX™ tubes are packaged with applicators in individual Tyvek pouches and sterilized by EtO sterilization rendering the exterior of the tube and applicators suitable for dispensing on sterile fields.
An In-Vitro Cytotoxicity L929 Agar Overlay Test was Testing Summary: completed on Derma+Flex™ Gel Adhesive to determine the cytotoxicity of the product. The test result was a the bychollery of of a to 1. In this test the Derma+Flex™ Gel Adhesive met the requirements of the cytotoxicity test as detailed in ISO 10993-5 and USP 24, Biological Reactive Tests In-Vitro (87). The product was considered safe for its use.
Section E 3 of 4
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A Murine Local Lymph Node Assay (LLNA) was A Marino Levaluate Derma+Flex™ Gel Adhesive for irritation and sensitivity. The material was not considered to be sensitizing.
Test was completed An Intracutaneous Inject on Derma+Flex™ Gel Adhesive to screen extracts for potential irritation effects as a result of an intracutaneous injection. The saline yielded a mean score of 0.0 and the cottonseed oil a mean score of 1.4 out of a possible 4. Based on this test, the article is considered a mild irritant. The following warning label is provided on the package, consistent with the predicated devices: "Do not use this product if you are allergic to cyanoacrylate".
Derma+Flex™ Gel Adhesive has also been subjected to mechanical and performance testing to demonstrate equivalence to the predicate devices.
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Image /page/3/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 forming its body and wings. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 2006
Mr. Scott Leal Official Correspondent Chemence Medical Products, Inc. 185 Bluegrass Valley Parkway, Suite 100 Alpharetta, Georgia 30005
Re: K050757
Trade/Device Name: DERMA+FLEX™ Gel Adhesive Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: January 13, 2006 Received: January 17, 2006
Dear Mr. Leal:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becares on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encrease, 1976, the enactment date of the Medical Device Amendments, or to conniner of the 1125 20, 1978, is accordance with the provisions of the Federal Food, Drug, de noos mat have been rout 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 r ou may, arores vrovisions 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 docs not mean that FDA has made a determination that your device complies with other requirements of the Act and 1977 Hocal statutes and regulations administered by other Federal agencies. You must or any I ederal statutes and securitements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It 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.
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Page 2 - Mr. Leal
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to oogin mating of substantial equivalence of your device to a legally premarket notification: "The Pets 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 If you desire specific arrivate at (240) 276-0115. Also, please note the regulation entitled, Connect the Office of Commarket notification" (21 CFR Parl 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response 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
fo
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K050757__
Device Name: DERMAFLEXIM Gel Adhesive
DERMA+FLEX™ Gel Adhesive is indicated for use to cover Indications for Use: DERMA+FLEX ---- GCF AddicsTV & Morestof the skin and help protect them from infection.
Over-The-Counter Use _X Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Samal) of
) ivision of General, Restorative,
and Neurological Devices
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.