(455 days)
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No
The description focuses on the physical construction and materials of the pacing leads, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "transvenous, implantable, endocardial leads used with implantable cardiac pacemakers" and explicitly states they provide "long-term safe and effective pacing," indicating a therapeutic function of maintaining heart rhythm.
No
Explanation: The device is a pacing lead, which is used for therapeutic purposes (pacing) in conjunction with an implantable cardiac pacemaker, not for diagnosing conditions.
No
The device description clearly details physical components like lead body insulation, conductors, electrode tips, tines, and a connection system, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the leads are "transvenous, implantable, endocardial leads used with implantable cardiac pacemakers." This describes a device that is implanted within the body to interact directly with the heart's electrical system.
- Device Description: The description details the physical components of the leads (silicone rubber tubing, conductor, electrode tip, tines, ring electrode) and their function in pacing the heart. This is consistent with an implantable medical device, not a diagnostic test performed on samples outside the body.
- Anatomical Site: The anatomical site is the "Heart," indicating direct interaction with an internal organ.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro (outside the living organism).
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The BIOTRONIK TIR and TIJ pacing leads are safe and effective transvenous, implantable, endocardial leads used with implantable cardiac pacemakers.
Product codes
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Device Description
The BIOTRONIK TIR and TIJ pacing leads are transvenous, implantable, endocardial leads manufactured in unipolar and bipolar configurations. The lead body insulation is NuSil silicone rubber tubing, with the conductor made of quadrifilar MP35N.
The leads provide long-term 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Pre-clinical testing was performed on the leads to examine biocompatibility and to qualify the manufacturing process. Biocompatibility testing included cytotoxicity, hemolysis, pyrogenicity (LAL), and long-term studies. Corrosion studies were completed to address both long-term toxicity and durability of the material. Qualification testing results validated the safety and effectiveness of the lead design and materials, including crimp and weld strength, fatigue strength, DC resistance, environmental resistance, adherence to IS-1 standards, stylet performance, packaging and transportation durability, lead tip testing, and sterilization validation. All test results were within specifications.
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 examined acute and long-term sensing and pacing thresholds, and long-term impedances.
The results of studies, 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.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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
1
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 or | ||
| sensing | Electrode displacement | |
| Lead fracture | ||
| Setscrew penetration | ||
| Improper lead to pacemaker | ||
| connection | Reposition lead | |
| Replace lead | ||
| Replace lead | ||
| Reconnect lead to | ||
| pacemaker | ||
| Increase or decrease | ||
| in 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.
2
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.