(251 days)
Genadyne Spiro Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4-XLR8 Wound Vacuum System (K09063) to deliver negative pressure wound. Genadyne A4-XLR8 Wound Vacuum System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by the removal of excess exudates, infectious materials and tissue debris.
Spiral Foam Dressing is appropriate for use on the following wounds:
- Pressure ulcers
- Diabetic/Neuropathic Ulcers
- · Venous insufficiency Ulcers
- · Traumatic wounds
- · Post-operative and dehisced surgical wounds
- · Skin flap and grafts
Gendayne Spiro Foam Dressing Kit is a single-use dressing is housed in a Tyvek/Mylar Peel Pouch.
This document is a 510(k) premarket notification for a medical device, specifically a wound dressing kit. It is a regulatory submission to the FDA, not a study report detailing clinical performance or algorithm metrics. Therefore, most of your requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not present.
However, I can extract information related to non-clinical tests and the device's characteristics:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide specific numerical acceptance criteria for performance metrics in the way you might find for a diagnostic algorithm (e.g., sensitivity/specificity thresholds). Instead, it focuses on demonstrating substantial equivalence to a predicate device and confirming basic safety and functionality through non-clinical tests.
| Acceptance Criteria (Stated as conformance to standards/tests) | Reported Device Performance (Summary of Test Results) |
|---|---|
| Biocompatibility: Conformance to ISO 10993 standards | Cytotoxicity (ISO 10993-5): Meets requirements, not considered cytotoxic. |
| Irritation (ISO 10993-10): Meets requirements, did not show significantly greater biological reaction than control. | |
| Sensitization (ISO 10993-10): Grade 1 sensitization rate, classified as weak allergenic potential (not considered significant). | |
| Pyrogenicity (ISO 10993-11): Considered non-pyrogenic, meets requirements. | |
| Systemic Toxicity (ISO 10993-11): Did not induce significantly greater biological reaction than control extracts, considered negative. | |
| Sterilization Validation: Conformance to ISO 11135 | Confirms a $10^{-6}$ sterility assurance level (SAL). |
| Stability Test: Met protocol requirements for 2-year equivalent aging | No significant degradation of seal, no leaks (bubble test), good microbial resistance, no leaks after ship test. |
| Colorant Test: Determine extractable amount of chemical compounds | Few elements above reporting limit (sodium in one colorant, also in control solution). No VOCs or SVOCs attributable to test article. No additional peaks in LC chromatogram for NVOC compared to control. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This document is a regulatory submission for a physical medical device (dressing kit), not an AI/software device that typically has a "test set" in the context of algorithm performance. The "tests" described are non-clinical, laboratory-based evaluations of materials and manufacturing processes.
- The provenance of data is from laboratory tests conducted by the manufacturer or their designated testing facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of clinical expert consensus is not relevant here. The ground truth for the non-clinical tests is established by industry standards (e.g., ISO guidelines) and the objective measurements of the laboratory equipment and methods.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human reviewers assess cases. The tests performed here are objective laboratory evaluations against predefined criteria in standards.
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:
- Not applicable. This device is a wound dressing kit, not an AI system. Therefore, no MRMC study or AI assistance evaluation was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm, so this type of performance evaluation is irrelevant.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" is defined by the established standards and protocols (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization) and the objective measurements obtained from these validated test methods.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI algorithm for this device.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.