(169 days)
3M™ Liquid Bandage is intended to cover minor cuts, scrapes, and skin irritations.
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.
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.
§ 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.