(194 days)
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Not Found
No
The 510(k) summary describes a liquid bandage product and its performance in standard biocompatibility and irritation tests. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device description and intended use indicate it is an over-the-counter product for covering minor cuts and scrapes, not for treating a disease or condition.
No
The device is described as an "over-the-counter (OTC) device for consumer use to cover minor cuts and scrapes that are clean and dry." Its intended use is to cover wounds, not to diagnose a medical condition.
No
The device description clearly states it is a "sterile, clear, liquid" and is packaged in physical containers (tube, bottle, swab), indicating it is a physical product, not software.
Based on the provided information, the 3M™ Liquid Bandage is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cover minor cuts and scrapes on the skin. This is a topical application for wound care, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a liquid applied to the skin, not a reagent or instrument used to analyze biological samples.
- Performance Studies: The performance studies described are related to skin safety (cytotoxicity, sensitization, irritation), which are relevant for a topical medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The 3M™ Liquid Bandage does not fit this description.
N/A
Intended Use / Indications for Use
3M™ Liquid Bandage is indicated for use as an over-the-counter (OTC) device for consumer use to cover minor cuts and scrapes that are clean and dry.
3M™ Liquid Bandage is intended to cover minor cuts, scrapes, and skin irritations that are clean and dry.
Product codes (comma separated list FDA assigned to the subject device)
KMF
Device Description
3M™ Liguid Bandage is a sterile, clear, liquid that covers minor cuts and scrapes that are clean and dry. The device is packaged in an aluminum tube with a reusable cap, a bottle with spray pump, or an individually wrapped swab.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
consumer use / Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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™ Liguid Bandage for the induction of contact sensitization. No evidence of induced delayed contact hypersensitivity was observed.
A Human Cumulative Irritation Patch Test (HCIPT) was performed to evaluate 3M™ Liquid Bandage for the induction of cumulative irritation. The studies that the 3M™ Liquid Bandage is a mild material with essentially no evidence of experimental irritation.
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.
Curad® Spray Bandage
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
Premarket No on Summary
1. Sponsor Information:
3M Consumer Health Care 3M Center: 275-5W-06 St. Paul, MN 55144-1000
Bryan Becker Contact Person: Senior Regulatory Affairs Associate 3M Health Care
651-733-3373 Telephone Number: 651-737-5320 Fax Number:
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
Curad® Spray Bandage was selected as the predicate device for 3M ™Liquid Bandage.
4. Description of Device
3M™ Liguid Bandage is a sterile, clear, liquid that covers minor cuts and scrapes that are clean and dry. The device is packaged in an aluminum tube with a reusable cap, a bottle with spray pump, or an individually wrapped swab.
5. Indications for Use
3M™ Liquid Bandage is indicated for use as an over-the-counter (OTC) device for consumer use to cover minor cuts and scrapes that are clean and dry.
6. Description of Safety and Substantial Equivalence
Technological Characteristics
The liquid bandage is applied to the wound to form a mechanical barrier. This thin film acts as a protective 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.
1
A Human Repeat Insult Patch Test (HRIPT) was conducted to evaluate 3M™ Liguid Bandage for the induction of contact sensitization. No evidence of induced delayed contact hypersensitivity was observed.
A Human Cumulative Irritation Patch Test (HCIPT) was performed to evaluate 3M™ Liquid Bandage for the induction of cumulative irritation. The studies that the 3M™ Liquid Bandage is a mild material with essentially no evidence of experimental irritation.
Substantial Equivalence
3M™ Liquid Bandage is similar to Curad® Spray Bandage, in that both are organic polymer liquid bandages. They provide the same function, are for over-the-counter (OTC) consumer use, have similar claims, and they have the same indications for use. The two products are substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, with three lines representing the branches of government and a staff entwined by a serpent, representing healing and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 19 2006
3M Company % Mr. Bryan Becker Senior Regulatory Affairs Associate 3M Center, Building 275-05-W-06 St. Paul, Minnesota 55144-1000
Re: K053409
Trade/Device Name: 3M™ Liquid Bandage Regulatory Number: 21 CFR 880.5090 Regulatory Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: May 17, 2006 Received: May 23, 2006
Dear Mr. Becker:
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 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 -- Mr. Bryan Becker
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,
Hulu Lemus
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number (if known): Kos3409 Device Name: 3M™ Liquid Bandage
Indications for Use:
3M™ Liquid Bandage is intended to cover minor cuts, scrapes, and skin irritations that are clean and dry.
Prescription Use
OR
Image /page/4/Picture/7 description: The image contains the text 'Over-The-Counter-Use' in a simple, sans-serif font. To the right of the text is a large 'X' symbol, which is underlined. The text and symbol are black against a white background.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulin Lewis
(Division Division of General, Restorative. and Neurological Devices
3409 510(k) Number.
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