(151 days)
Pacing leads and accessories are intended for use with implantable cardiac pulse generators for long-term pacing of the heart. The indications for ventricular . pacing include, but are not limited to: Sick sinus syndrome, sinus bradycardia, complete heart block, and certain conditions of asymptomatic second-degree block.
In the presence of normal 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.
Active fixation leads are specifically indicated for use in cases where passivefixation leads provide unsatisfactory positional stability in either the atrium or the ventricle, or in cases where the atrial appendage has been sacrificed due to open-heart surgery or is abnormal because of congenital or acquired heart disease.
Suture-on epicardial leads (model 439-04) and screw-on (sutureless) myocardial leads (model 439-07), placed on the outside of the heart, are indicated for use when cardiac pacing is indicated and a suture-on lead is preferred, or when an endocardial lead cannot achieve satisfactory results. Such leads are particularly well suited to patients whose age or heart condition requires that the potential for lead dislodgment be minimized (i.e. patients who have not reached full physical maturity) and patients who may require cardiac pacing following openchest surgery.
The Intermedics Models 431-04, 431-07, 433-02, 433-03, 435-02, 435-05, 435-07, 435-08, 437-02, and 437-07 endocardial pacing leads, model 439-04 epicardial pacing lead, model 439-07 myocardial pacing lead, implantable accessory models 365-07, 365-09, 365-14, 365-17, 365-19, 365-22, 365-33, 365-34, 365-44, 365-49, 366-13, 366-15, 366-27, 366-28, 366-29, and 366-30, and non-implantable accessory models 365-62, 365-77, 365-29, 366-02, 366-17, and 367-01, are designed for use with implantable cardiac generators for long term cardiac pacing.
The provided text is a 510(k) Summary for a change in the manufacturing process of Intermedics Pacing Leads and Accessories, specifically the elimination of Chlorofluorocarbons (CFCs). It is not a study proving device performance against acceptance criteria in the typical sense of a diagnostic medical device with performance metrics like sensitivity, specificity, etc.
Instead, this document describes how the CFC-free manufactured devices are substantially equivalent to previously approved devices. The "acceptance criteria" here are demonstrating that the change in manufacturing process does not negatively impact the device's safety and effectiveness, meaning the performance remains comparable to the predicate devices.
Here's a breakdown based on your request, interpreting "acceptance criteria" in this context as demonstrating equivalence:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstrating Equivalence to Predicate Device) | Reported Device Performance (with CFC-free process) |
|---|---|
| Biocompatibility: Materials are not toxic under physiological conditions. | Biocompatibility: Tissue/fluid contacting materials (silicone, 80A polyurethane, 55D polyurethane) cleaned with IPA/heptane (CFC-free process) were re-tested for hemolysis and cytotoxicity and found to continue to be biocompatible. All materials from original devices were also evaluated and found biocompatible. |
| Performance Equivalence: Device performance remains equivalent to commercially available leads. | Performance Equivalence: Based on qualification testing of representative models (431-07 and 435-08), performance is expected to be equivalent to Freon-TMS manufactured leads. Clinical experience of predicate devices shows low complications and effective performance. The CFC-free devices are expected to perform with comparable efficacy due to similar design and materials. |
| Design and Materials: No changes to critical design characteristics or materials. | Design and Materials: With the exception of the manufacturing solution, the CFC-free leads/accessories are identically configured to the commercially available models. Detailed characteristics (electrode material, lead body material, fixation, connector) remain the same. |
| Labeling: No changes to product labeling. | Labeling: There are no changes to the product labeling. |
| Sterilization: Sterilization procedures remain effective. | Sterilization: Procedures utilize ethylene oxide (EO) sterilizers set for specific parameters derived from AAMI guidelines. Bioburden testing is performed. |
| Manufacturing Controls: Consistent quality control in manufacturing. | Manufacturing Controls: Environmental controls are used, monitored, and bioburden testing is performed. Vendor approval and inspection process is in place. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (Qualification Testing): Models 431-07 and 435-08 were selected for qualification testing. The document does not specify the number of units tested for each model, only that these models were "selected as they consist of processes representative of the changes."
- Data Provenance: Not explicitly stated as country of origin. The document is a 510(k) submission to the FDA (United States), so testing would typically be compliant with US regulatory standards. It describes testing of manufactured devices which is prospective in the sense of testing the new manufacturing process. The "clinical experience" cited for predicate devices is retrospective.
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, as this is not a diagnostic device or a study involving expert interpretation of medical images/data to establish ground truth. The "ground truth" here is the established safety and effectiveness of the previously approved predicate devices and the performance metrics from standard engineering and biocompatibility tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring human adjudication of medical findings.
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 document is for pacemaker leads, not AI-assisted diagnostic tools involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device. The "standalone" performance relates to the physical and biological performance of the device components themselves.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is established through:
- Predicate Device Performance: The known long-term safety and effectiveness of the Intermedics pacing leads manufactured with Freon-TMS, which has been demonstrated through extensive clinical use.
- Biocompatibility Standards: Established in-vitro and in-vivo test systems (e.g., Hemolysis Test, MEM Elution Cytology, Ames Mutagenicity, USP Class V, Intramuscular Implantation, Maximization Sensitization, USP Pyrogen Test).
- Engineering Qualification Testing: Performance measured against engineering specifications for the device (though specific metrics are not detailed in this summary).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.