(227 days)
The Zip 4 Skin Closure Device is indicated for skin closure of minor lacerations. The Zip 4 Skin Closure Device may be sold direct to consumers (OTC).
The Zip® 4 Skin Closure Device is a single-use non-invasive skin closure device. A single Zip 4 device may be used to close wounds up to 4 cm (1.5 inches) in length from minor cuts or minor lacerations. The device is applied to clean, dry skin prior to skin closure, remains on the skin during wound healing, and may be removed by lifting one edge and peeling the device from the skin. The device is made of polymeric materials and utilizes a non-latex, pressure sensitive skin adhesive. The device contents are provided sterile in an intact and unopened package.
This document is a 510(k) Pre-market Notification for the Zip 4 Skin Closure Device. It focuses on demonstrating substantial equivalence to a predicate device rather than on clinical performance for novel AI/ML devices. Therefore, much of the requested information regarding acceptance criteria and performance against a ground truth is not directly applicable or available in this document.
However, I can extract the non-clinical performance data and the conclusion that supports the device's substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical performance testing conducted to demonstrate compliance with product requirements, but it does not specify quantitative acceptance criteria or corresponding reported performance metrics in a table format that typically applies to AI/ML model evaluations (e.g., sensitivity, specificity, AUC). Instead, it lists the types of tests performed and the standards met.
| Testing Category | Description of Tests / Standards Met |
|---|---|
| Non-Clinical Performance | Performance testing (dimensional, mechanical, human wear test, biocompatibility, sterility, packaging/shelf life) was conducted to demonstrate compliance with product requirements. |
| Standards Used | - ISO 10993-1:2009 (Cor:2010), Biological evaluation of medical devices – Part 1: Evaluation and testing |
- ISO 11137-2:2013, Sterilization Of Health Care Products - Radiation - Part 2: Establishing The Sterilization Dose
- ASTM D 4169-14, Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F 2096-11: Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- IEC/EN 62366: 2014, Medical Devices - Application Of Usability Engineering To Medical Devices |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document pertains to a medical device (skin closure device), not an AI/ML algorithm. Therefore, there is no "test set" in the context of an AI/ML model for data evaluation. The "human wear test" mentioned in the non-clinical performance data would involve human subjects, but the sample size and specific details are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As this is not an AI/ML device, the concept of establishing ground truth by experts for a test set is not relevant.
4. Adjudication method for the test set:
- Not Applicable. See point 3.
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:
- No. This is not an AI/ML device, so no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical product, not an algorithm.
7. The type of ground truth used:
- Not Applicable / Indirect. For a physical device, "ground truth" would relate to its physical properties, biocompatibility, and functional performance as determined by established engineering standards, biological assessments, and usability. The "ground truth" is established through adherence to the listed ISO and ASTM standards, which provide validated methods for testing these aspects.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
Summary regarding the device's "study" and "acceptance criteria":
The "study" for the Zip 4 Skin Closure Device was a series of non-clinical performance tests designed to show that the device meets its product requirements and complies with relevant international and national standards.
The acceptance criteria are implicitly defined by compliance with these standards (e.g., ISO 10993 for biocompatibility, ISO 11137 for sterilization dose, ASTM D 4169 for packaging, ASTM F 2096 for leak detection, and IEC/EN 62366 for usability). The document states that performance testing, including dimensional, mechanical, and human wear tests, was "conducted on the subject Zip 4 Skin Closure Device to demonstrate compliance with the product requirements specification either by design analysis or functional testing."
The conclusion states, "The successful completion of the performance testing further supports the subject Zip 4 Skin Closer Device's substantial equivalence to the predicate device. The usability testing that was successfully performed shows that the proposed device can be marketed for over-the-counter use. No issues of safety or effectiveness are raised by the Zip 4 Skin Closure Device." This indicates that the device met the implicit acceptance criteria by passing these non-clinical tests.
Important Note: This 510(k) summary is for a traditional medical device and explicitly states, "No clinical testing was deemed necessary to support the substantial equivalence." Therefore, it does not contain the types of AI/ML-specific performance metrics or study designs typically requested for AI/ML devices.
§ 880.5240 Medical adhesive tape and adhesive bandage.
(a)
Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.