(20 days)
The Selectra lead introducer system is used to facilitate implantation of leads in the coronary sinus or to facilitate lead implantation into the heart chambers.
BIOTRONIK's Selectra lead introducer system is a combination of quiding catheters and implantation accessories used to facilitate access to the heart for suitable leads and catheters. The Selectra lead introducer system consists of several individually available guiding catheters with various different curve shapes and the Selectra accessory kit. The Selectra Accessory Kit includes the following components in a single sterile package: 1 Selectra Slitter Tool, 1 quide wire, 4 transvalvular insertion (TVI) tools, 1 syringe, 1 torque tool, 2 check valves, 2 stopcocks, 2 sealing caps. The catheters are available as inner (5F) and outer (7F) catheters which jointly form a telescopic system, and facilitate implantation of leads into the heart. The Selectra catheters are compatible with one another as well as the Selectra Accessory Kit.
This document is a 510(k) summary for the BIOTRONIK Selectra Lead Introducer System. The submission, K183265, seeks to demonstrate substantial equivalence to previously cleared predicate devices.
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "Performance data was not required to support this submission because no design change has been made." Therefore, there are no specific acceptance criteria for performance or reported device performance in this 510(k) summary. The submission is based on the premise that the device's technological characteristics are identical to the predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No performance data was required or provided in this submission because no design change was made.
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)
Not applicable. No performance data was required or provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No performance data was required or provided.
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 medical instrument (lead introducer system), not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No performance data was required or provided.
8. The sample size for the training set
Not applicable. No new performance data was generated or analyzed as part of this submission. The device is a physical medical instrument, not a learned algorithm.
9. How the ground truth for the training set was established
Not applicable. No new performance data was generated or analyzed as part of this submission.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).