(244 days)
The POLYROX PX and PX-JBP endocardial leads are designed for use with implantable pulse generators which require pacing leads with a bipolar (BP) 3.2 mm IS-1 connector configuration. The leads are indicated for use in any patient for whom single or dual chamber pacemaker therapy is medically indicated.
The BIOTRONIK transvenous TIR 60/53 UP/BP and TIJ 53/45 UP/BP leads are indicated for pacing and sensing in the ventricle or atrium, respectively. The leads are designed for use with implantable pulse generators which require pacing leads with an unipolar (UP) or bipolar (BP) IS-1 connector configuration. The leads may be used with single or dual chamber pacing systems.
This premarket notification describes a manufacturing modification to the distal end of BIOTRONIK TIR/TIJ and POLYROX bipolar endocardial leads. Through design functionality, simplicity and material biocompatibility, the parts proposed in this submission (parts 124132 and 124133) are designed to be safe, chronically implantable components of the devices within which they are used. The proposed use of these pre-formed tapered silicone parts is for manufacturability and quality control only and will not affect any aspect of lead performance or utility, including but not limited to indications for use, lead size, material biocompatibility, handling characteristics, sterilization procedures or labeling.
The provided text describes a manufacturing modification to existing BIOTRONIK endocardial leads, not a new device with novel performance claims requiring a comparative effectiveness study or complex AI-driven performance metrics. The core argument for acceptance is that the modification does not affect any aspect of lead performance or utility. Therefore, the "acceptance criteria" and "device performance" are primarily related to ensuring the modification does not negatively impact the established safety and effectiveness of the previously cleared leads.
Here's an interpretation of the request based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Integrity | - Visual integrity of single distal tip pieces | Within specifications |
| - Visual integrity of leads manufactured with new distal tips | Within specifications | |
| Electrical Performance | - Insulation integrity (prEN 45502:2 1996, Section 23.3) | Within specifications |
| Material Bonding Strength | - Adhesive connection strength (passive fixation tines to distal end piece) | Within specifications |
| - Adhesive connection strength (distal end piece to ring electrode) | Within specifications | |
| Clinical Safety/Effectiveness | - No new or increased risks compared to existing leads | "no risks in excess of those experienced by patients wearing existing TIR/TIJ or POLYROX leads" |
| - No impact on indications for use, lead size, biocompatibility, handling, sterilization, or labeling | Explicitly stated: "will not affect any aspect of lead performance or utility, including but not limited to indications for use, lead size, material biocompatibility, handling characteristics, sterilization procedures or labeling." | |
| Post-Market Surveillance | - No reported adverse events for modified leads (historical for similar products) | - No incident reports for 29,820 non-US TIR/TIJ leads. |
| - 4 complaints for TIR/TIJ leads (3 analyzed, 2 found within specs, 1 "lead puncture," 1 short circuit). These predate the "new distal tips." | ||
| - No adverse events or complaints for 4,268 non-US POLYROX leads. | ||
| - No reported adverse events or returns for 110 US TIR/TIJ leads. | ||
| - No reported adverse events for US POLYROX leads, 2 returns (1 physician preference, 1 dropped). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not explicitly state the discrete sample sizes for each specific test (visual control, insulation, strength tests). It mentions "sampled during manufacture" for visual controls and "leads within each of the two lead families (TIR, TIJ, PX, PX-J)" for insulation testing. For the adhesive strength tests, it mentions "representative strength tests."
- Data Provenance: The testing appears to be prospective manufacturing and laboratory testing conducted by BIOTRONIK specifically for this modification.
- Clinical Performance (Reference): The document also refers to retrospective post-market surveillance data from non-US distribution (Japan and EEC) and US distribution of the existing leads (TIR/TIJ and POLYROX) to demonstrate historical safety which the modification is not expected to alter.
- Non-US: 29,820 TIR/TIJ and 4,268 POLYROX leads from 1994 and February 1996 respectively.
- US: 110 TIR/TIJ and 529 POLYROX leads.
- Clinical Performance (Reference): The document also refers to retrospective post-market surveillance data from non-US distribution (Japan and EEC) and US distribution of the existing leads (TIR/TIJ and POLYROX) to demonstrate historical safety which the modification is not expected to alter.
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)
- The document describes laboratory and manufacturing quality control testing. The "ground truth" is established by adherence to specified engineering standards (e.g., prEN 45502:2 1996) and internal BIOTRONIK specifications. It does not mention external "experts" in the context of establishing ground truth for these engineering tests. Personnel conducting these tests would be qualified quality control and engineering staff.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Given the nature of the tests (visual inspection, insulation resistance, strength tests), the adjudication method would likely be direct measurement against pre-defined specifications. There is no indication of a multi-reader or consensus-based adjudication for these types of objective engineering tests.
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, an MRMC comparative effectiveness study was not done. This document pertains to a manufacturing modification of an implantable medical device (pacing leads) and not an AI-assisted diagnostic or therapeutic technology. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This document is not about an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the manufacturing modification's acceptance relied on:
- Engineering specifications and standards: For visual, insulation, and adhesive strength tests (e.g., prEN 45502:2 1996).
- Historical clinical performance data (outcomes data): For demonstrating the safety and effectiveness of the original leads, which the modification is stated not to alter. This includes adverse event reports and complaints from real-world usage.
8. The sample size for the training set
- Not applicable. This document is not about an AI/ML model that requires a training set. The "device" is a physical medical implant modification.
9. How the ground truth for the training set was established
- Not applicable. As stated above, there is no AI/ML model or training set described in this document.
§ 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.