(101 days)
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.
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.
The provided text describes a 510(k) summary for the Johnson & Johnson Liquid Bandage, which is a Class I medical device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics through standalone studies with acceptance criteria as one might expect for a higher-risk device or an AI/ML powered device.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable or explicitly stated in this type of submission.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
No explicit quantitative acceptance criteria or corresponding reported device performance metrics are provided in this 510(k) summary. The submission focuses on demonstrating substantial equivalence based on material characteristics and intended use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions a "Scarification study on humans to assess irritation potential." While it states "Both the new and predicate and BAND-AID® Liquid bandage were categorized as being very low for irritation potential," it does not specify the sample size for this study or its provenance. It is a prospective study as it assesses potential for irritation.
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)
Not applicable. The "Scarification study" likely involved clinical observation and assessment by medical professionals, but the number or qualifications of 'experts' for establishing ground truth are not mentioned in the context of this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of device evaluation does not typically involve adjudication methods for a test set in the way a diagnostic imaging device with expert interpretations would. The irritation study would be based on clinical assessment, likely following a standardized scale.
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
Not applicable. This is not an AI-powered device, nor is it a diagnostic device where reader performance is the primary measure.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "Scarification study on humans to assess irritation potential," the ground truth would be based on clinical assessment of irritation potential using a standardized scale. This would be a form of expert assessment of clinical outcomes (irritation levels).
8. The sample size for the training set
Not applicable. This is not an AI-powered device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI-powered device.
In summary, the provided 510(k) uses a "substantial equivalence" pathway, meaning the primary "study" is a comparison to legally marketed predicate devices. The study mentioned (Scarification study) is used to support safety claims (biocompatibility, irritation potential) rather than performance against defined acceptance criteria for diagnostic accuracy or similar metrics.
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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
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| application, the solvents will quickly evaporate andthe polymer will form a clear and flexible film tocover skin /wound. The pouches will be sterilizedeither in bulk or in retail carton. | |
|---|---|
| Intended Use: | The intended use of the BAND-AID® brandsolvent based Liquid bandage is for providing acovering over minor cuts and scrapes that are cleanand dry. |
| Technological Characteristic: | The liquid bandage is applied to the wound to forma protective barrier. The thin film is clear, flexible,breathable, and waterproof and acts as a protectivecovering allowing the wound to heal. The filmremains on skin for several days, and naturallywears off as wound heals. |
| Evaluation of SubstantialEquivalence: | Just as the Curad product, the BAND-AID® brandsolvent based Liquid bandage is in liquid form priorto use. Both are a polymeric film formed uponsolvent evaporation, have a film that is clear,flexible, breathable, and waterproof, and the filmwill remain on skin for several days, and naturallywears off as wound heals. If desired, they both canbe removed by rubbing alcohol.The materials for the BAND-AID® brand solventbased Liquid bandage is biocompatible Per ISO10993 Cytotoxicity, Sensitization,Irritation/Intracutaneous Reactivity, SystemicToxicity, and Genotoxicity. Additionally, a BovineCorneal Opacity and Permeability Assay study wasconducted to assess potential eye irritancy.A Scarification study on humans to assess irritationpotential was performed. Both the new andpredicate and BAND-AID® Liquid bandage werecategorized as being very low for irritationpotential. |
| Conclusions | The proposed new Johnson and Johnson LiquidBandage is substantially equivalent. |
CONFIDENTIAL
·
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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.
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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
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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 ANOTHERPAGE 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
§ 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.