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.

Device Description

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.

AI/ML Overview

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.

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.

Summary

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Page 3 of 4

MAR - 4 1998

Summary of Safety and Effectiveness Tapered Distal Segment Modification (510(k) #K972500)

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 safety and effectiveness of TIR/TIJ and POLYROX bipolar endocardial leads is addressed within their respective 510(k) applications. 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.

Parts 124132 and 124133 have undergone the following testing:

Visual control of the single distal tip pieces (also sampled during manufacture) .
Visual control of leads manufactured using new distal tip pieces (also sampled during . manufacture)
Insulation testing according to prEN 45502:2 1996, Section 23.3, for the leads within each of . the two lead families (TIR, TIJ, PX, PX-J)
Representative strength tests of adhesive connections using NuSil Med 1511 and NuSil Med . 1137 (these adhesives are used interchangeably in the manufacture of BIOTRONIK leads):
- a) Adhesive connection of the passive fixation tines (LSR-4070) and distal end piece (LSR-4070)
- b) Adhesive connection of the distal end piece (LSR-4070) and the ring electrode (90% Pt / 10% Ir)

All test results were within specifications; therefore, when the proposed parts are in use, the patient will be exposed to no risks in excess of those experienced by patients using existing TIR/TIJ or POLYROX leads, or other equivalent market-released leads.

Possible side effects of lead implantation include, but are not limited to, body rejection phenomena, thrombosis, muscle and nerve stimulation, infection and erosion through skin. BIOTRONIK is not aware of any other adverse safety and effectiveness data on endocardial leads.

Since the beginning of non-US distribution in 1994, 29,820 TIR/TIJ bipolar endocardial leads have been distributed within Japan and the EEC. For these devices, adverse events (incident reports) are reported as required under the European Vigilance System. No incident reports have been filed; four complaints have been filed. Of the four complaints filed, one lead was a TIJ 53-BP and the remaining were TIR 60-BP leads. The TIJ lead was analyzed by the manufacturer and found to be operating within specifications (complaint related to "unacceptable" bipolar thresholds). Of the

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three complaints relating to TIR leads, one lead was found to perform within manufacturer's specifications (complaint related to "no capture"), one was seen to have a "lead puncture" (complaint related to no pacing and high impedance), and one was found to have a short circuit between the tip and the ring electrodes (complaint related to "unacceptable" bipolar thresholds).

The distribution of bipolar POLYROX leads in non-US countries began in February, 1996; as of submittal date of this document, 4,268 leads have been distributed within Japan and the EEC. Adverse events also are reported for these devices as required under the European Vigilance System. There are no reported adverse events or complaints associated with this lead.

Within the United States, numbers of bipolar TIR/TIJ and POLYROX leads distributed to date are 110 and 529, respectively. There are no reported adverse events associated with the use of these leads in the United States. There have been no returns of TR/TIJ leads in the United States; two device returns are recorded for POLYROX leads - one because of physician preference (decided to use another lead), and one because the lead was dropped in the operating room at time of implant.

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4 1998 MAR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lauren L. Foote Christensen Requlatory Affairs Manager, Bradycardia Biotronik, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369

K972500 Re : Biotronik POLYROX and TIR/TIJ Pacing Leads Requlatory Class: III (three) Product Code: 74 DTB Dated: January 28, 1998 Received: January 30, 1998

Dear Ms. Christensen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Druq, and Cosmetic Act (act). The general controls provisions of the act include requirements for registration, listing of devices, good manufacturing practices, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulation.

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Page 2 - Ms. Lauren L. Foote Christensen

Under Section 522(a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA are required to conduct postmarket surveillance studies. FDA has identified under Section 522(a) (1) (A) the device cleared for marketing by this letter as requiring postmarket surveillance.

Within thirty (30) days of first introduction or delivery for introduction of this device into interstate commerce you are required to submit to FDA certification of the date of introduction into interstate commerce, a detailed protocol which describes the postmarket surveillance study, and a detailed profile of the study's principal investigator that clearly establishes the qualifications and experience of the individual to conduct the proposed study. For your information, general guidance on preparing a protocol for a postmarket surveillance study is attached.

Submit five (5) copies to:

Center for Devices and Radiological Health Postmarket Surveillance Studies Document Center Room 3083 (HFZ-544) 1350 Piccard Drive Rockville, Maryland 20850

Within sixty (60) days of receipt of your protocol, FDA will either approve or disapprove it and notify you of the Agency's action in writing. You should not begin your postmarket surveillance study of this device until the protocol has been approved. Data generated under an unapproved protocol may not satisfy your obligation under section 522. Please note that you must continue to collect and report data needed to maintain compliance with Medical Device Reporting regulations (21 CFR 803).

Failure to certify accurately the date of initial introduction of your device into interstate commerce, to submit timely an acceptable protocol, or to undertake and complete and FDA approved postmarket surveillance study consistent with the protocol will be considered violations of section 522. In accordance with the Medical Device Amendments of 1992, failure of a manufacturer to meet its obligations under section 522 is a prohibited act under section 301(q) (1) (C) of the Act (21 U.S.C. 331 (q)(1)(C). Further, under section 502(t)(3) of the act (21 U.S.C. 352(t)(3)), a device is misbranded if there is a failure or refusal to comply with any requirement under section 522 of Violations of sections 301 or 502 may lead to regulatory the act. actions including seizure of your product, injunction, prosecution, or civil money penalties.

If you have questions specifically concerning postmarket surveillance study requirements, contact the Postmarket Surveillance Studies Branch at (301) 594-0639.

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Page 3 - Ms. Lauren L. Foote Christensen

In addition, on August 16, 1993, the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirement of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

DA Spph

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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Indications for Use BIOTRONIK POLYROX Leads

BIOTRONIK TIR/TIJ Leads

Thth

(Division Sigi Oivision of Cardiovascural, Kesk nd Neurological Devices :0(k) Number .

Regulation Number and Section

§ 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.