(101 days)
Not Found
No
The device description and performance studies focus on the physical properties and irritation potential of a liquid bandage, with no mention of AI or ML technologies.
No
The device provides a covering for minor cuts and scrapes, which is a protective function rather than a therapeutic one (e.g., actively treating a disease or condition). The description mentions forming a film to "cover skin/wound."
No
The device, a liquid bandage, is intended for "providing a covering over minor cuts and scrapes." This indicates a treatment or protective function, not a diagnostic one. There is no mention of it analyzing, detecting, or measuring any physiological parameters to diagnose a condition.
No
The device description clearly outlines physical components (polymer solution, foam applicator, aluminum foil pouch) and a physical mechanism of action (solvents evaporating, polymer forming a film). This is a physical medical device, not a software-only one.
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 a covering over minor cuts and scrapes on the skin. This is a topical application for wound care, not a test performed on samples taken from the body (like blood, urine, or tissue) to diagnose a condition or provide information about a physiological state.
- Device Description: The description details a liquid bandage that forms a film on the skin. This aligns with a wound dressing or protective barrier, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, analysis of biological samples, or the generation of diagnostic results.
Therefore, the BAND-AID® brand solvent based Liquid bandage falls under the category of a wound care product, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the BAND-AID® brand solvent based Liquid bandage is for providing a covering over minor cuts and scrapes that are clean and dry.
Product codes (comma separated list FDA assigned to the subject device)
KMF
Device Description
Solvent based liquid bandages are single- use liquid bandages that have three components: polymer solution, a foam applicator and aluminum foil pouch. Inside pouch, the swab is vertically situated with foam head down and saturated by the polymer solution. The pouch is sealed prior to use. The pouch will be open by tearing the notch. Upon application, the solvents will quickly evaporate and the polymer will form a clear and flexible film to cover skin /wound. The pouches will be sterilized either in bulk or in retail carton.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin / wound
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)
Evaluation of Substantial Equivalency: Just as the Curad product, the BAND-AID® brand solvent based Liquid bandage is in liquid form prior to use. Both are a polymeric film formed upon solvent evaporation, have a film that is clear, flexible, breathable, and waterproof, and the film will remain on skin for several days, and naturally wears off as wound heals. If desired, they both canbe removed by rubbing alcohol.
The materials for the BAND-AID® brand solvent based Liquid bandage is biocompatible Per ISO 10993 Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, and Genotoxicity. Additionally, a Bovine Corneal Opacity and Permeability Assay study was conducted to assess potential eye irritancy.
A Scarification study on humans to assess irritation potential was performed. Both the new and predicate and BAND-AID® Liquid bandage were categorized as being very low for irritation potential.
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
ડ. 510(k) Summary or 510(k) Statement
page 1 of 2
K062602
510(k) Summary
DEC | | 2006
Submitted by: Johnson & Johnson Consumer & Personal Products Company Worldwide, Division of Johnson & Johnson Consumer Companies, Inc. 199 Grandview Road Skillman, NJ 08558 Contact Person: Michelle R. Turk Associate Director, Regulatory Affairs Phone: (908) 904-3723
FAX: (908) 904-3712
August 21, 2006
Liquid Bandage
Date of Summary Preparation:
Proprietary Name:
Classification (Common) Name:
Device Classification:
Marketed Device(s) to which Equivalency is Claimed:
Description of Device:
21 CFR 880.5090 Regulation Name: Liquid Bandage Regulatory Class: Class I Product Code: KMF
Johnson and Johnson Liquid Bandage
CURAD® Spray Bandage, K022645 Johnson and Johnson LIQUIDERM 110 BAND-AID® Brand Liquid Bandage, K002338
Solvent based liquid bandages are single- use liquid bandages that have three components: polymer solution, a foam applicator and aluminum foil pouch. Inside pouch, the swab is vertically situated with foam head down and saturated by the polymer The pouch is sealed prior to use. solution. The pouch will be open by tearing the notch. Upon
1
| | application, the solvents will quickly evaporate and
the polymer will form a clear and flexible film to
cover skin /wound. The pouches will be sterilized
either in bulk or in retail carton. |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The intended use of the BAND-AID® brand
solvent based Liquid bandage is for providing a
covering over minor cuts and scrapes that are clean
and dry. |
| Technological Characteristic: | The liquid bandage is applied to the wound to form
a protective barrier. The thin film is clear, flexible,
breathable, and waterproof and acts as a protective
covering allowing the wound to heal. The film
remains on skin for several days, and naturally
wears off as wound heals. |
| Evaluation of Substantial
Equivalence: | Just as the Curad product, the BAND-AID® brand
solvent based Liquid bandage is in liquid form prior
to use. Both are a polymeric film formed upon
solvent evaporation, have a film that is clear,
flexible, breathable, and waterproof, and the film
will remain on skin for several days, and naturally
wears off as wound heals. If desired, they both can
be removed by rubbing alcohol.
The materials for the BAND-AID® brand solvent
based Liquid bandage is biocompatible Per ISO
10993 Cytotoxicity, Sensitization,
Irritation/Intracutaneous Reactivity, Systemic
Toxicity, and Genotoxicity. Additionally, a Bovine
Corneal Opacity and Permeability Assay study was
conducted to assess potential eye irritancy.
A Scarification study on humans to assess irritation
potential was performed. Both the new and
predicate and BAND-AID® Liquid bandage were
categorized as being very low for irritation
potential. |
| Conclusions | The proposed new Johnson and Johnson Liquid
Bandage is substantially equivalent. |
CONFIDENTIAL
·
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is centered in the image. The font is a serif font, and the text is black.
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Johnson & Johnson Consumer Companies % Ms. Michelle R. Turke Associate Director, Regulatory Affairs 199 Grandview Road Skillman, New Jersey 08858
DEC 1 1 2006
Re: K062602
Trade/Device Name: Johnson & Johnson Liquid Bandage Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: November 13, 2006 Received: November 14, 2006
Dear Ms. Turke:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that 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 general controls provisions 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 Codc 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 does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth 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.
3
Page 2 -- Ms. Michelle R. Turke
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use Statement
،
.
Indications for Use
510(k) Number (if known): Unknown Device Name: Johnson & Johnson Liquid Bandage Indications for Use: The intended use of the BAND-AID® brand solvent based Liquid bandage is for providing a covering over minor cuts and scrapes that are clean and dry
| Prescription Use
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use X
(21 CFR 801 Subpart C) |
|-----------------------------------------------------------------------------|--------|--------------------------------------------------------------------------------------------------|
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED) | | |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices Page_1_of_1_
| 510(k) Number | L062602 |
|---|---|
| --------------- | --------- |
CONFIDENTIAL
CONFIDENTIAL