(226 days)
A percutaneous guide wire introducer for vascular and non-vascular procedures with activating safety shield to reduce needle stick injury during use and disposal.
A needle and hub device for the percutaneous introduction of a guide wire, with a hub modification to allow one-handed activation of a sheath to cover the needle and help prevent accidental needle sticks during use and disposal.
The provided document is a 510(k) Premarket Notification for the "SafetyNET Guidewire Introducer". It contains administrative information, an intended use statement, and a declaration of compliance with ISO 10993-1. However, it does not include specific acceptance criteria, performance data, or details of studies typically found in a clinical or performance study report.
Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can and cannot be provided:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states "Product and materials meet all applicable test requirement per ISO 10993-1" under the "Testing" section, which refers to biocompatibility testing. It implies that these requirements were met, but it does not specify what those "applicable test requirements" or their acceptance criteria were, nor does it provide the results of those tests or any other performance metrics for the device itself (e.g., success rate of guidewire introduction, effectiveness of the safety shield in preventing needle sticks, etc.).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe any specific performance or clinical studies, and therefore no information on sample sizes or data provenance for a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. There is no mention of a test set requiring ground truth establishment by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. There is no mention of a test set or any adjudication process.
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
- Cannot be provided. This device is a manual surgical instrument (a guidewire introducer with a safety mechanism), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device is a manual surgical instrument, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. There is no mention of any ground truth being established as no such study is described.
8. The sample size for the training set
- Cannot be provided. There is no mention of a training set, as the device is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Cannot be provided. There is no mention of a training set or ground truth establishment.
Summary of available information related to testing:
The document briefly mentions "Testing" and states:
- "Product and materials meet all applicable test requirement per ISO 10993-1"
- ISO 10993-1 refers to "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." This standard guides the evaluation of biocompatibility but does not define specific performance criteria for the function of a device. It indicates that the materials used in the SafetyNET Guidewire Introducer have been assessed for their biological safety in accordance with this standard. No specific data or acceptance criteria for this testing are provided in this document.
For this type of device (a manual surgical instrument), the "study" demonstrating its safety and effectiveness for a 510(k) submission typically relies on substantial equivalence to existing predicate devices and in vitro/bench testing (like biocompatibility, sterility, strength, dimensions, and the function of the safety mechanism) rather than large clinical trials or AI performance evaluations. The document does not elaborate on these specific tests or their results, instead summarizing them with the ISO 10993-1 compliance statement.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(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 § 878.9.