(223 days)
The Needle's Eye Snare® Retrieval Set - 54cm is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides and other foreign objects.
The Needle's Eye Snare® Retrieval Set- 54cm is a grasping device that forms a basketlike snare around the in-dwelling catheter, cardiac lead, fragment of catheter tubing, wire guide or other foreign object. The distal end is delivered to the vicinity of the lead through a long, flexible 12Fr. (O.D.) PTFE sheath placed coaxially within a 16Fr. (O.D.) PTFE Check-Flo® Introducer Sheath having a Check-Flo® Valve with stopcock at its proximal end. The device is comprised at the distal end of a nitinol wire needle's eye retrieval mechanism consisting of a "needle's eye" loop and "threader" with stainless steel sleeves housed within a PTFE protective cover sheath. The snare is activated through the forward advancement of the threader by fully depressing the plunger. The item is captured between the threader and needle's eye. The inner sheath is advanced forward closing the snare and securely capturing the lead or other foreign object. The Needle's Eye Snare® Retrieval Set - 54cm has nominal usable length of 54cm.
The provided text describes the Needle's Eye Snare® Retrieval Set - 54cm and its substantial equivalence to a predicate device. It includes information about the device's indications for use, comparison to the predicate, device description, and a summary of test data. However, the document does not contain the detailed acceptance criteria and study information typically associated with AI/ML device performance validation.
Based on the provided text, here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance (as much as can be extracted)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Particulates meet USP 778 requirements. | The predetermined acceptance criteria were met. |
| The device is comparable to the predicate device in terms of intended use, principles of operation, basic technological characteristics, and materials of construction. | The Needle's Eye Snare® Retrieval Set - 54cm is comparable to the predicate device. |
Missing Information (based on typical AI/ML device validation requests):
The document is a 510(k) submission for a medical device (a snare retrieval set), not an AI/ML diagnostic or prognostic algorithm. Therefore, the typical elements of an AI/ML study (like sample size for test/training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable and not present in this document.
Specifically, the following information is not available in the provided text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical medical device. The "test data" mentioned refers to engineering performance tests (like particulate testing), not clinical or AI model validation data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of Device-Specific Information from the Text:
- Device Name: Needle's Eye Snare® Retrieval Set - 54cm
- Intended Use: For use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides and other foreign objects.
- Predicate Device: Needle's Eye Snare®, cleared under K961992.
- Comparison to Predicate: Identical in intended use, principles of operation, basic technological characteristics, and materials of construction. Differences are the specified length (54cm vs 94cm for predicate) and the inclusion of a 12 Fr Curved Inner Sheath as an accessory in the subject device.
- Test Data Provided: Particulate Testing was performed to ensure particulates from the device are comparable to the predicate and meet USP 778 requirements. The predetermined acceptance criteria were met.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).