PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU

• K Number: K040569
• Device Name: PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
• Manufacturer: Oscor Inc.
• Date Cleared: 2004-04-07 ( 34 days)
• Product Code: DTB
• Regulation Number: 870.3680
• Type: Special
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

Permanent pacing lead, Model Refino ™ is indicated for pacing and sensing of the ventricle and / or atrium of the heart. The lead is used in conjunction with a compatible implantable pulse generator (pacemaker).

Device Description

Permanent Pacing Lead, Model Refino

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a Permanent Pacing Lead, Model Refino. This document primarily focuses on the regulatory clearance process, indicating substantial equivalence to a predicate device.

It does NOT contain information about specific acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria.

Therefore, I cannot provide the requested information. The document is a regulatory approval, not a performance study report.

Regulation Number and Section

§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.

(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.