(277 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a liquid bandage, with no mention of AI or ML technologies.
No
Explanation: A therapeutic device is intended to treat or cure a disease or condition. This device is a liquid bandage designed to provide a covering over minor cuts and scrapes, which is a protective and supportive function rather than a therapeutic one. The description focuses on forming a protective film and mentions its use for minor wounds, not for treating a disease or condition.
No
The device is a liquid bandage designed to provide a protective covering for minor cuts and scrapes, not to diagnose medical conditions.
No
The device description clearly states it is a "liquid solution film-forming product" packaged in a container with a brush applicator, 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/Indications for Use: The intended use is to provide a covering over minor cuts and scrapes on the skin. This is a topical application for wound care, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a liquid solution that forms a film on the skin. This is consistent with a topical wound dressing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on safety and effectiveness as a topical barrier (skin irritation, sensitization, microbial barrier), not on diagnostic accuracy.
- Predicate Device: The predicate device (CURAD Spray Bandage) is also a topical wound dressing, not an IVD.
In summary, the function and purpose of Elastic Skin Liquid Bandage are to physically protect minor wounds on the skin, which falls under the category of wound care devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Elastic Skin Liquid Bandage provides a covering over minor cuts and scrapes that are dry and clean.
Elastic Skin Liquid Bandage is indicated for providing a covering over minor wounds and scrapes that are clean and dry.
Product codes (comma separated list FDA assigned to the subject device)
KMF
Device Description
Elastic Skin is a liquid solution film-forming product. The product solution is packaged in a container with a brush applicator. A thin coating of solution is applied on the wound with the applicator forming a protective clear film in less than one minute. Additional coats may be applied if needed. The film may be removed by peeling away from the skin with the use of mild soap and water.
The main component of Elastic Skin is an organic polymer dissolved in an organic solvent.
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)
The following laboratory tests where conducted to establish the safety of Elastic Skin Liquid Bandage:
Self Preservation Study-Microorganisms listed in USP Sterility-Mold and Fungus by Agar Plate Count and Identification PRJ Primary Skin Irritation-Rabbits Bacterial Mutagenicity Test-Ames Assay Repeated Patch Dermal Sensitization -Buehler Method. Guinea Pigs 1$0 Agarose Overlay Using L-929 Mouse Fibroblast Cells (Cytotoxicity Test) Microbial Film Barrier- Psuedomonas Aeruginosa ATCC 9027
All tests gave satisfactory results, indicating that Elastic Skin Liquid Bandage is safe and effective.
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.
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
§ 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.
0
IJUN 2 5 2004
510K SUMMARY FOR
1022
ELASTIC SKIN LIQUID BANDAGE
Number K032948
1.Manufacturer and Applicant- Medpak LLC, 568 Parkside Court
Allentown, PA18104 Contact Person-Joseph G Sant'Angelo, Phone-484-225-5799; 610-530-0530 E-mail-MJMJJS97 @AOL.COM Date-June 4, 2004
2. Device Name
Proprietary Name: Elastic Skin Liquid Bandage Common Name: Liquid Bandage Classification Information:
Class-1
| Name | Product Code | 21 CFR Ref. | Panel |
|---|---|---|---|
| Liquid Bandage | KMF | 880.5090 | General & Plastic Surgery |
3.Predicate Device
CURAD @ Spray Bandage, 510(k) No. K022645
4. Device Description
Elastic Skin is a liquid solution film-forming product. The product solution is packaged in a container with a brush applicator. A thin coating of solution is applied on the wound with the applicator forming a protective clear film in less than one minute. Additional coats may be applied if needed. The film may be removed by peeling away from the skin with the use of mild soap and water.
Elastic Skin Liquid Bandage composition is as follows:
The main component of Elastic Skin is an organic polymer dissolved in an organic solvent.
5. Intended Use
Elastic Skin Liquid Bandage provides a covering over minor cuts and scrapes that are dry and clean.
1
The intended use of Elastic Skin Liquid Bandage and CURAD® are the same. Both products use a film forming liquid polymer solution to cover minor wounds on the skin, which forms a clear film on the skin when the solvent evaporates. Both products have many of the same functional characteristics such as helping to protect the minor wounds from germs, while providing flexibility and water vapor permeability.
7. Performance Testing
The following laboratory tests where conducted to establish the safety of Elastic Skin Liquid Bandage:
Self Preservation Study-Microorganisms listed in USP Sterility-Mold and Fungus by Agar Plate Count and Identification PRJ Primary Skin Irritation-Rabbits Bacterial Mutagenicity Test-Ames Assay Repeated Patch Dermal Sensitization -Buehler Method. Guinea Pigs 1$0 Agarose Overlay Using L-929 Mouse Fibroblast Cells (Cytotoxicity Test) Microbial Film Barrier- Psuedomonas Aeruginosa ATCC 9027
All tests gave satisfactory results, indicating that Elastic Skin Liquid Bandage is safe and effective.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 2004
Mr. Joseph G. Sant'Angelo President Medpak, LLC 568 Parkside Court Allentown, Pennsylvania 18104
Re: K032948
Trade/Device Name: Elastic Skin Liquid Bandage Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: May 5, 2004 Received: May 6, 2004
Dear Mr. Sant'Angelo:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) premium is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars the Medical Device Amendments, or to commerce prior to May 20, 1978, the enature with the provisions of the Federal Food, Drug, devices that have been reclassified in assessment of a premarket approval application (PMA). allu Cosmetic 71ct (11ct) that do not request of the general controls provisions of the Act. The 1 ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the rist 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 If your device is classified (300 above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major Intay be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obas acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean FICASE be advised that I DPT 3 155aanse or our device complies with other requirements of the Act that TDA has made a decerminations administered by other Federal agencies. You must of ally reciclar statutes and regarations and limited to: registration and listing (21 comply with an the Act 3 requirements, mercansg, suctive requirements as set CTN Fart 807), facemig (21 CFR Part 820); and If applicable, the electronic forth in the quarty systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Joseph G. Sant'Angelo
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin harketing your as rates of your device to a legally premarket notification. The PDA midnig of substanted of the more
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 if you desire specific advice for your ac need and and and the regulation entitled, contact the Office of Complaned at (501) 377 at 807.97). You may obtain " Misbranding by Icierchee to promantee issultities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at the largements httpl Manufacturers, micriational and Ochsailer Press.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
(4) Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K032948
Device Name:
Elastic Skin Liquid Bandage
Indications for Use:
Elastic Skin Liquid Bandage is indicated for providing a covering over minor
wounds and scrapes that are gloan and d wounds and scrapes that are clean and dry.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
..
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division Division of General, Restorative, and Neurological Devices
510(k) Number K032948
(Optional Format 1-2-
December 29, 2003
Annendix D • Pas