(455 days)
The BIOTRONIK TIR and TIJ pacing leads are safe and effective transvenous, implantable, endocardial leads used with implantable cardiac pacemakers.
The leads are manufactured in unipolar and bipolar configurations. The lead body insulation of all TIR/TIJ endocardial leads is NuSil silicone rubber tubing, with the conductor of quadrifilar MP35N. The TIR/TIJ endocardial leads provide long-term safe and effective pacing due to the surface structure of the lenticular electrode tip. The tip has a Physical Vapor Deposition (PVD) of iridium over titanium, creating a fractal-surfaced ball-like microstructure. Passive fixation in the heart's trabeculae is provided by four flexible silicone rubber tines. The ring electrode (anode) of the bipolar lead is made of platinum-iridium, also with a fractal iridium surface treatment. The IS-1 connection system of TIR/TIJ leads complies with the International Standard ISO 5841.3.1992: Low Profile Connectors. The TIJ lead is pre-formed into a " J" shape for optimal positioning in the atrium.
The provided text describes the safety and effectiveness of the BIOTRONIK TIR and TIJ pacing leads. It details pre-clinical testing, clinical evaluation in Europe, and potential complications. However, it does not contain specific acceptance criteria with quantifiable metrics that are then directly proven by study results. Instead, it generally states that "All tests results were within specifications." and refers to "European clinical studies to examine the performance characteristics of the unipolar and bipolar leads." without providing specific numerical targets or the results that met those targets.
Therefore, I cannot populate a table of acceptance criteria and reported device performance as requested.
Based on the available text, here is the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| Not explicitly stated with quantifiable thresholds in the provided text. The text generally states that tests were "within specifications." | Not explicitly stated with quantifiable results that match specific acceptance criteria. The text mentions "acute and long-term sensing and pacing thresholds, and long-term impedance's" were examined in European clinical studies, and pre-clinical tests confirmed "crimp and weld strength of connections, fatigue strength, DC resistance, environmental resistance, adherence to IS-1 standards, stylet performance, packaging and transportation durability, lead tip testing, and sterilization validation" were "within specifications." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a single "test set" sample size. The text mentions that over 100,000 leads (TIR/TIJ and their European versions IRTI/IRTJ) were sold worldwide by 1994. The European clinical studies for models IRTI and IRTJ would have involved a subset of these leads, but the specific number of patients or leads in those studies is not provided in the excerpt.
- Data Provenance: European clinical studies. The data is from Europe and appears to be prospective, as the studies "examined acute and long-term sensing and pacing thresholds, and long-term impedance's" for the European versions of the leads (models IRTI and IRTJ).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the text. The text refers to "European clinical studies" but does not detail the methodology for establishing ground truth within those studies, such as the use of expert adjudication for outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided in the text.
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
- No, this type of study was not done. The device is a cardiac pacing lead, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical cardiac pacing lead, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the European clinical studies, the ground truth would inherently be based on clinical outcomes data (e.g., measured pacing and sensing thresholds, impedance, and the occurrence of complications) observed in patients receiving the implanted leads.
8. The sample size for the training set
- This question is not applicable as the device is a physical medical device, not an AI/ML algorithm that requires a training set in the typical sense. The "training" in this context refers to manufacturing validation and pre-clinical testing, not data-driven model training.
9. How the ground truth for the training set was established
- This question is not applicable for the reasons mentioned above. For the pre-clinical and qualification testing (which could be considered analogous to "training" or development/validation), the "ground truth" was established through engineering specifications, material science standards, and established medical device testing protocols (e.g., biocompatibility testing, corrosion studies, physical property tests like crimp/weld strength) that define expected performance and material properties. "All tests results were within specifications" indicates adherence to these established standards.
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Safety And Effectiveness Summary B.
The BIOTRONIK TIR and TIJ pacing leads are safe and effective transvenous, implantable, endocardial leads used with implantable cardiac pacemakers. The leads are manufactured in unipolar and bipolar configurations. The lead body insulation of all TIR/TJJ endocardial leads is NuSil silicone rubber tubing, with the conductor of quadrifilar MP35N.
The TIR/TIJ endocardial leads provide long-term safe and effective pacing due to the surface structure of the lenticular electrode tip. The tip has a Physical Vapor Deposition (PVD) of iridium over titanium, creating a fractalsurfaced ball-like microstructure. Passive fixation in the heart's trabeculae is provided by four flexible silicone rubber tines. The ring electrode (anode) of the bipolar lead is made of platinum-iridium, also with a fractal iridium surface treatment. The IS-1 connection system of TIR/TIJ leads complies with the International Standard ISO 5841.3.1992: Low Profile Connectors. The TIJ lead is pre-formed into a " J" shape for optimal positioning in the atrium.
Pre-clinical testing was performed on the leads to examine biocompatibility and to qualify the manufacturing process of these leads. During biocompatibility testing, cytotoxicity, hemolysis, pyrogenicity (LAL) and other testing were performed, as well as long term studies. Corrosion studies were completed to address both long-term toxicity and durability of the material. The testing conducted for biocompatability as well as extensive clinical experience confirms that iridium is safe for use as an implantable biocompatible material. Literature has been published illustrating this conclusion. The long term corrosion testing results substantiate that it is a non-toxic and durable material for use in implantable devices.
Qualification testing results validate the safety and effectiveness of the lead design and materials used. The TIR and TIJ leads are tested for crimp and weld strength of connections, fatigue strength, DC resistance, environmental resistance, adherence to IS-1 standards, stylet performance, packaging and transportation durability, lead tip tosting, and sterilization validation. All tosts
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TIR/TIJ Cardiac Pacing Leads Response to KB53044
results were within specifications. An overview of pre-clinical testing is found in section III.A. of this premarket notification with additional information provided in the Appendices.
The European version of the TIR/TIJ endocardial leads, models IRTI and IRTJ, were evaluated in European clinical studies to examine the performance characteristics of the unipolar and bipolar leads. The protocol used examined acute and long-term sensing and pacing thresholds, and long-term impedance's. Details of this evaluation can be found in section III.C. of this notification. (APPENDIX 3)
The results of studies, the in-vitro and qualification testing performed on the TIR/TIJ leads show that the risk to the patient in using these leads is the same as that of any implantable endocardial lead. [2 sentences stricken from this paragraph]
Potential complications resulting from the use of endocardial leads include, but are not limited to: thrombosis, embolism, body rejection phenomena, cardiac tamponade, muscle/nerve stimulation, valve damage, fibrillation, and infection. Lead perforation through the myocardium has been rarely The table below summarizes some of the potential symptoms observed. indicating a complication and possible corrective actions:
| Symptom | Potential Complication | Potential Corrective Action |
|---|---|---|
| Loss of pacing orsensing | Electrode displacementLead fractureSetscrew penetrationImproper lead to pacemakerconnection | Reposition leadReplace leadReplace leadReconnect lead topacemaker |
| Increase or decreasein threshold | Fibrotic tissue formation | Adjust pulse generator output;Reposition lead |
able 6 Lead Complications
The fractal iridium surface treatment was introduced in Europe on TIR/TIJ on January 20, 1994. The lead body design and the size of the tip and the ring (where applicable) is the same for all leads, now representing over 100,000 leads sold.
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TIR/TIJ Cardiac Pacing Leads Response to K963044
| Type | 1989 | 1990 | 1991 | 1992 | 1993 | 1994° | SUM |
|---|---|---|---|---|---|---|---|
| TIR-UP | 430 | 2370 | 4790 | 7840 | 14790 | 18860 | 49080 |
| IRTI-UP | 50 | 850 | 1090 | 1790 | |||
| TIR-BP | 70 | 700 | 2130 | 4480 | 9880 | 19850 | 37090 |
| IRTI-BP | 60 | 900 | 2180 | 3120 | |||
| TIJ-UP | 210 | 570 | 990 | 2780 | 4550 | ||
| IRTJ-UP | 30 | 210 | 130 | 370 | |||
| TIJ-BP | 170 | 700 | 1140 | 2560 | 4570 | ||
| IRTJ-BP | 20 | 510 | 900 | 1430 | |||
| TOTAL: | 102000 |
Table 7 Number of Devices Sold, Worldwide
A bibliography of relevant articles on cardiac pacing leads is provided as Appendix 23, with selected copies provided as Appendix 25.
§ 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.