PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV

• K Number: K031164
• Device Name: PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
• Manufacturer: Oscor Inc.
• Date Cleared: 2003-06-19 ( 66 days)
• Product Code: DTD
• Regulation Number: 870.3620
• Type: Special
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

Pacing bipolar lead adaptors are indicated for connecting the existing pacing lead(s) to a compatible pacemaker header cavity.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for a medical device, specifically "Pacing Bipolar Lead Adaptors, Models iLINK". It indicates that the device has been found substantially equivalent to a legally marketed predicate device and can therefore be marketed.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document is a regulatory approval letter, not a technical report detailing the device's validation study. Therefore, I cannot extract the requested information from this text.

Regulation Number and Section

§ 870.3620 Pacemaker lead adaptor.

(a)
Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.”