(112 days)
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No
The description focuses on the physical design, materials, and performance testing of a cardiac pacing lead, with no mention of AI or ML capabilities.
Yes
The device is described as an "implantable, endocardial lead used with implantable cardiac pacemakers" which "provide long-term safe and effective pacing." Pacing is a form of therapy for cardiac conditions.
No
Explanation: The device described is a pacing lead for implantable cardiac pacemakers, which is a therapeutic device designed to deliver electrical impulses to the heart, not to diagnose medical conditions.
No
The device description clearly details physical components like leads, insulation, conductors, electrodes, and a connection system, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text explicitly states the device is "implantable, endocardial leads used with implantable cardiac pacemakers." This describes a device used in vivo (within the body) for therapeutic purposes (pacing the heart).
- Device Description: The description focuses on the physical components and function of a pacing lead, which is a medical device implanted in the heart.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for direct implantation and interaction with the heart in vivo.
N/A
Intended Use / Indications for Use
The BIOTRONIK PX-BP and PX-JBP pacing leads are safe and effective bipolar, transvenous, implantable, endocardial leads used with implantable cardiac pacemakers.
Product codes
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Device Description
The lead body insulation of all PX-BP/PX-JBP endocardial leads is NuSil silicone rubber tubing, with the conductor of quadrafilar MP35N. The PX-BP/PX-JBP endocardial leads provide long-term safe and effective pacing due to the surface structure of the lenticular electrode tip. The tip has undergone a Physical Vapor Deposition (PVD) treatment 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 PX-BP/PX-JBP leads complies with the International Standard ISO 5841.3:1992: Low Profile Connectors. The PX-JBP 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Qualification testing results validate the safety and effectiveness of the lead design and materials used. The PX-BP and PX-JBP 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 testing, and sterilization validation. All test results were within specifications. An overview of non-clinical testing is found in this premarket notification. Field clinical experience, the in-vitro and qualification testing performed on the PX-BP/PX-JBP leads show that the risk to the patient in using these leads is the same as that of any implantable endocardial lead. The PX-BP/PX-JBP was introduced into the European market in 1996. The lead body design and the size of the tip and the ring (where applicable) is the same for all PX-BP/PX-JBP leads, now representing over 1400 leads sold outside of the United States, as of October 1, 1996.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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.
0
MAR 1.0 1997
1.4 Safety And Effectiveness Summary
The BIOTRONIK PX-BP and PX-JBP pacing leads are safe and effective bipolar, transvenous, implantable, endocardial leads used with implantable cardiac pacemakers. The lead body insulation of all PX-BP/PX-JBP endocardial leads is NuSil silicone rubber tubing, with the conductor of quadrafilar MP35N.
The PX-BP/PX-JBP endocardial leads provide long-term safe and effective pacing due to the surface structure of the lenticular electrode tip. The tip has undergone a Physical Vapor Deposition (PVD) treatment 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 PX-BP/PX-JBP leads complies with the International Standard ISO 5841.3:1992: Low Profile Connectors. The PX-JBP lead is pre-formed into a "J" shape for optimal positioning in the atrium.
The materials used to manufacture the PX-BP/PX-JBP leads which come into contact with the patient were tested for biocompatibility. Acute and chronic biocompatibility tests were performed, as well as long term implantation studies. Corrosion studies were completed to address both long-term toxicity and durability of the tip and ring iridium material. The testing conducted for biocompatability as well as extensive clinical experience confirms that iridium is safe for use as an implantable material. Literature has been published illustrating this conclusion. The long term corrosion testing results substantiate that iridium 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 PX-BP and PX-JBP 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 testing, and sterilization validation. All test results were within specifications. An overview of non-clinical testing is found in this premarket notification.
Field clinical experience, the in-vitro and qualification testing performed on the PX-BP/PX-JBP leads show that the risk to the patient in using these leads is the same as that of any implantable endocardial lead.
Potential complications resulting from the use of endocardial leads include, but are not limited thrombosis, embolism, body rejection phenomena, cardiac tamponade, muscle/nerve to: stimulation, valve damage, fibrillation, and infection. Lead perforation through the myocardium has been rarely observed. The table below summarizes some of the potential symptoms indicating a complication and possible corrective actions:
ll
1
| 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 |
Lead Complications
The PX-BP/PX-JBP was introduced into the European market in 1996. The lead body design and the size of the tip and the ring (where applicable) is the same for all PX-BP/PX-JBP leads, now representing over 1400 leads sold outside of the United States, as of October 1, 1996.