(234 days)
InterDry Textile is a skin protectant indicated for management of skin folds and other skin-to-skin contact areas. InterDry Textile reduces microbial colonization in the fabric.
InterDry is a non-sterile skin protectant fabric with an antimicrobial silver complex. InterDry is a single patient use product that is custom cut from a multiuse package.
Here's an analysis of the provided text, focusing on acceptance criteria and the study that proves the device meets those criteria:
Device: InterDry
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance |
|---|---|---|
| Material Safety | Biocompatibility | "suitable for its intended use" |
| Antimicrobial Efficacy | Antimicrobial effectiveness testing | "reduces microbial colonization within the device itself" |
| Physical Properties | Absorption | "substantially equivalent to the SurePress Absorbent Padding" |
| Wicking | "substantially equivalent to the SurePress Absorbent Padding" | |
| Friction | "substantially equivalent to the SurePress Absorbent Padding" | |
| Silver release | "substantially equivalent to the SurePress Absorbent Padding" | |
| Overall Suitability | Suitability for intended use | "suitable for its intended use" (based on physical testing) |
| Substantial Equivalence | Comparison to predicate device (InterDry Textile with Silver K061615) | "identical" and "substantially equivalent in material, design, performance and indications for use" |
| Comparison to predicate device (SurePress Absorbent Padding) | "substantially equivalent in design, function and intended use" |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify the sample sizes used for any of the performance tests (biocompatibility, antimicrobial effectiveness, physical property testing).
The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned in this document.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention using experts to establish ground truth for this device's performance testing. The evaluation appears to be based on laboratory testing against established standards or direct comparison to predicate devices, rather than expert interpretation of clinical data points.
4. Adjudication Method:
Since no expert input is mentioned for establishing ground truth, there is no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not performed or mentioned in this document. The device is a "skin protectant" (medical fiber absorbent), and the nature of its testing (biocompatibility, antimicrobial, physical properties) does not typically involve human readers interpreting cases or AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the InterDry is a physical medical device (textile) and not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant to this submission. The performance tests conducted are inherently "standalone" in the sense that they evaluate the device itself without human intervention in the primary measurement.
7. The Type of Ground Truth Used:
The ground truth for this device's performance is established through:
- Standardized Biocompatibility Tests: These tests have predefined endpoints and acceptance criteria based on established international standards (ISO).
- Antimicrobial Effectiveness Test Standards: These tests measure the device's ability to reduce microbial colonization according to established laboratory protocols.
- Physical Property Measurement Standards: Absorption, wicking, friction, and silver release are measured against defined quantitative standards or directly compared to the predicate device's measured properties to demonstrate substantial equivalence.
8. The Sample Size for the Training Set:
This question is not applicable as the InterDry is a physical medical device and not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
This question is not applicable as the InterDry is a physical medical device and not an AI algorithm.
§ 880.5300 Medical absorbent fiber.
(a)
Identification. A medical absorbent fiber is a device intended for medical purposes that is made from cotton or synthetic fiber in the shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category.(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. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.