(439 days)
The Intermedics leads which are the subject of this 510(k) Notification are endocardial pacing leads designed for use with implantable pulse generators for long-term cardiac pacing, This indication is identical to the indication for use of the legally marketed predicate devices, the Intermedics Models 430-07 and 432-03 Endocardial Pacing Leads.
The indications for ventricular pacing include, but are not limited to: sick sinus syndrome, sinus bradycardia, complete heart block, symptomatic second-degree heart block, and certain conditions of asymptomatic second-degree block. In the presence of normal atrioventricular (A-V) conduction, the indications for atrial pacing include, but are not limited to: sinus arrest, sick sinus syndrome, sinus bradycardia and conditions requiring increased cardiac efficiency, enhanced cardiac output or the overdrive of certain cardiac arrhythmias. In the absence of normal A-V conduction, an atrial lead may be used with a ventricular lead in a dual-chamber pacing system to restore A-V synchrony.
The Intermedics Model 430-07, 431-07, 432-03, and 433-03 Endocardial Pacing Leads are designed for use with implantable cardiac pulse generators for long-term cardiac pacing. Passed transvenously through the cephalic, subclavian, or jugular vein (external or internal), the tip electrode (cathode) is positioned at the endocardial surface to permit contact with the heart. The tip fixation mechanism consists of four silicone rubber tines. The lead body, which consists of insulated conductor coils, carries electrical impulses from the heart to the pulse generator, resulting in sensing. The lead body also carries impulses from the pulse generator to the endocardial surface, causing cardiac depolarization (pacing), The proximal end of the lead is connected to the header of the implanted pulse generator.
The electrodes of the Intermedics Model 430-07, 431-07, 432-03, and 433-03 Endocardial Pacing Leads are made of titanium coated with inidium oxide (IROX™).
The provided text describes a 510(k) submission for Intermedics Endocardial Pacing Leads, focusing on a new performance claim regarding their low stimulation threshold.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Claim) | Reported Device Performance |
|---|---|
| The mean stimulation threshold, both acute and chronic, is equal to or less than 0.38 millisecond at a pulse amplitude of 1.5 volts, with a 97.5 percent confidence limit. | Clinical Study Results: |
- Mean pacing threshold at 1.5 volts:
- Ventricle (2 weeks): 0.32 millisecond
- Atrium (2 weeks): 0.35 millisecond
- Both chambers (6 months): 0.26 millisecond
- Statistical analysis demonstrated an upper confidence bound of 97.5% on the capturing pulse width to be at or below 0.38 millisecond at a pulse amplitude of 1.5 volts. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a single "sample size" for a traditional test set. However, the clinical study was conducted on humans using the Models 430-07 and 432-03. The number of patients or leads implanted in this clinical study is not provided.
- Data Provenance: Prospective (clinical study with follow-up points). Country of origin is not specified but the submitter is based in Angleton, TX, USA, suggesting the study might have been conducted in the US or internationally under US regulatory oversight.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not directly applicable. This is a medical device performance study, not an AI or imaging-based study requiring expert ground truth for interpretation. The "ground truth" here is the actual measured electrical performance of the pacing leads in human subjects, as verified by clinical measurements. No "experts" were needed to establish interpretive ground truth.
4. Adjudication Method for the Test Set
Not applicable. There was no need for adjudication as the "test set" involved direct measurement of physiological parameters (pacing thresholds).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve With AI vs. Without AI Assistance?
Not applicable. This is a medical device performance study, not an AI-assisted diagnostic or interpretive study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done?
Not applicable. This is a medical device performance study, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used was direct physiological measurement/outcomes data (stimulation thresholds measured acutely and chronically in human subjects).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning study, so there is no concept of a "training set" in the context of algorithm development. The animal study could be considered a preliminary data gathering phase, but not an algorithmic "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the AI sense. The animal study data involved direct electrical performance measurements of different lead types over 24 weeks.
§ 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.