3M™ Liquid Bandage is a sterile, clear, n-2-butyl cyanoacrylate liquid used to cover minor cuts, scrapes, and minor skin irritations. The device is packaged in an aluminum tube with a reusable cap.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the 3M™ Liquid Bandage. This is a medical device submission seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to prove the device meets specific acceptance criteria based on performance metrics.

Therefore, many of the requested elements about acceptance criteria, detailed study design, and performance metrics (like sensitivity, specificity, or reader improvement with AI) are not applicable to this type of regulatory submission as they are typically associated with performance studies for devices where such metrics are relevant.

However, I can extract information related to the safety tests conducted and the comparison to the predicate device.

Here's the information that can be extracted from the provided text, structured as requested where applicable, with an explanation of why certain items are not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for AI or diagnostic accuracy. Instead, the "acceptance criteria" in the context of this 510(k) are related to safety and substantial equivalence to a predicate device.
Reported Device Performance: The "performance" in this context refers to safety test results.

Acceptance Criteria (Safety)	Reported Device Performance
In-Vitro Cytotoxicity Test:
- Determination of cytotoxicity; ideally low or no reactivity.	Reactivity grade of 1 (considered safe for its use).
Human Repeat Insult Patch Test (HRIPT):
- Evaluate for induction of contact sensitization; ideally no induced hypersensitivity.	No evidence of induced delayed contact hypersensitivity observed.
Human Cumulative Irritation Patch Test (HCIPT):
- Evaluate for cumulative irritation; ideally low or no irritation.	Not performed; irritation adequately tested in HRIPT. (Material was mildly to moderately irritating in a small number of subjects during HRIPT induction phase).
Substantial Equivalence:
- Similar function and indications for use as predicate.	Provides the same function (covering minor cuts, scrapes, skin irritations) and is for OTC consumer use.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- In-Vitro Cytotoxicity Test: Sample size not specified.
- HRIPT: Not explicitly stated, but implies "subjects" were used. "A small number of subjects" for the irritation observation.
- HCIPT: Not applicable (not performed).
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Human tests would generally be prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This device is a liquid bandage, and the tests involve laboratory cytotoxicity and human skin reactions, not diagnostic imaging or clinical interpretation requiring expert readers for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The tests conducted (cytotoxicity, patch tests) do not involve adjudication by multiple experts in the way clinical diagnostic studies might.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a medical device for wound covering, not an AI or diagnostic tool that involves human readers interpreting cases. Therefore, an MRMC study and effects of AI assistance are not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is a liquid bandage, entirely a physical product, not an algorithm.

7. Type of Ground Truth Used

In-Vitro Cytotoxicity Test: Ground truth is the cellular response observed in lab conditions.
Human Repeat Insult Patch Test (HRIPT): Ground truth is the observed human skin reaction (e.g., presence/absence of sensitization or irritation), typically assessed by trained dermatologists or clinicians.
Substantial Equivalence: Ground truth for comparison is the documented characteristics and performance of the predicate device (Johnson & Johnson BAND-AID® Liquid Bandage).

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not a machine learning or AI device that requires a training set or ground truth establishment for training.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most complete and the bottom profile being the least complete.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1 2003

Ms. Anna E. McRight Product Regulation Manager 3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul. Minnesota 55144-1000

Re: K031263

Trade/Device Name: 3MTM Liquid Bandage Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid Bandage Regulatory Class: I Product Code: KMF Dated: July 9, 2003 Received: July 10, 2003

Dear Ms. McRight:

This letter corrects our substantially equivalent letter of October 7, 2003, regarding the Indications for Use Statement.

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 (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 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 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. Anna E. McRight

This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Miriam C. Provost
for S.M. Williams, Ph.D., M.D.

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

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Indications for Use Statement

510(k) Number (if known): K031263

Device Name: 3M™ Liquid Bandage

Indications for Use:

3M™ Liquid Bandage is intended to cover minor cuts, scrapes, and skin irritations.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter-Use X

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K631263

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K031263

OCT = 7 2003

Premarket Notification Summary

1. Sponsor Information:

3M Consumer Health Care 3M Center: 275-5W-06 St. Paul, MN 55144-1000

Contact Person: Anna E. McRight Product Regulation Manager 3M Health Care

Telephone Number: 651-733-7948 Fax Number: 651-737-5320

2. Device Name

Common or Usual Name: Liquid Bandage

Proprietary Name: 3M™ Liquid Bandage

Classification Name: Liquid Bandage (21 CFR §880.5090)

3. Predicate Device

Johnson & Johnson BAND-AID®1 Liquid Bandage was selected as the predicate device for 3M™Liquid Bandage.

Description of Device র্ব

3M™ Liquid Bandage is a sterile, clear, n-2-butyl cyanoacrylate liquid used to cover minor cuts, scrapes, and minor skin irritations. The device is packaged in an aluminum tube with a reusable cap.

Chemical name: n-2-butyl cyanoacrylate CAS registry number: 6606-65-1 Molecular formula: CBH11NO2 Molecular weight (g/mole): 153 Structural formula:

CH3 CN O ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------H2C = C -- C -- O -- CH -- CH2 - CH2 -- CH3

1 BAND-AID® is a registered trademark of Johnson & Johnson

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Indications for Use 5.

3M™ Liquid Bandage is indicated for use as an over-the-counter (OTC) device for consumer use to cover minor cuts, scrapes, and skin irritations.

Description of Safety and Substantial Equivalence 6.

Technological Characteristics:

The liguid bandage is applied to the wound and polymerizes to forms a mechanical bond with the skin, typically within one minute. This thin film acts as a 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.

Safety:

An In-Vitro Cytotoxicity Test was completed on 3M™ Liquid Bandage to determine the cytotoxicity of the product. The test result was a reactivity grade of 1. In this test the liquid bandage was considered safe for its use.

A Human Repeat Insult Patch Test (HRIPT) was conducted to evaluate 3M™ Liquid Bandage for the induction of contact sensitization. No evidence of induced delayed contact hypersensitivity was observed.

A Human Cumulative Irritation Patch Test (HCIPT) was not performed because irritation was adequately tested in the induction phase of the HRIPT. The material was mildly to moderately irritating in a small number of the subjects.

Substantial Equivalence:

3M™ Liquid Bandage is similar to Johnson & Johnson BAND-AID® Liquid Bandage, in that both are cyanoacrylate liquid bandages. They provide the same function and are for over-the-counter (OTC) consumer use. The 3M™ Liquid Bandage is n-2-butyl cyanoacrylate, whereas Johnson & Johnson BAND-AID® Liquid Bandage is 2-octyl cyanoacrylate. The two products are substantially equivalent.

Regulation Number and Section

§ 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.