ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 by BIOTRONIK, INC.

The ELC xx-UP epicardial sutureless screw-in lead is indicated for unipolar pacing and sensing in the ventricle when an epicardial lead is preferred, or when a transvenous lead cannot provide satisfactory results or is contraindicated. Epicardial leads are well suited for situations where open heart surgery is being performed, or based upon the patient's age or heart condition (e.g., in young patients who have not reached full physical maturity and in patients with congenital heart disease). Epicardial leads are also indicated in situations where transvenous access is not available or is contraindicated.

Device Description

The BIOTRONIK ELC xx-UP epicardial sutureless active fixation lead is a safe and effective unipolar lead used with implantable cardiac pacemakers when an epicardial lead is preferred, or when a transvenous lead cannot provide satisfactory results or is contraindicated. The lead body insulation of all ELC epicardial leads is NuSil MED-4750 silicone rubber tubing, with a conductor of quadrafilar MP35N wire. These leads provide long-term safe and effective pacing through overall quality of design, manufacture and the surface structure of the active-fixation electrode tip. This tip is a single helically-wound fixation wire ("fixation screw") composed of 70% platinum and 30% iridium which has undergone a Physical Vapor Deposition (PVD) treatment, creating a fractal-surfaced, ball-like microstructure. The IS-1 (3.2 mm) connection system of the ELC lead complies with the International Standard ISO 5841.3:1992.

AI/ML Overview

Here's an analysis based on the provided text, structured according to your request. It's important to note that the document is a 510(k) clearance letter for a medical device and not a detailed clinical study report, so some of the requested information (especially regarding specific statistical acceptance criteria or detailed study methodologies) is not explicitly present.

Acceptance Criteria and Study for BIOTRONIK ELC xx-UP Epicardial Sutureless Active Fixation Lead

The provided document (K965106) is a 510(k) premarket notification clearance letter from the FDA, asserting substantial equivalence to previously marketed devices. It describes the device's safety and effectiveness based on various tests and clinical experience. However, it does not present a formal, statistically powered clinical study with pre-defined hard acceptance criteria and corresponding reported performance metrics in the way a modern, randomized controlled trial might.

The "acceptance criteria" can be inferred from the reported lack of failures and the successful functioning of leads in clinical experience, as well as satisfactory performance in various in-vitro and qualification tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Biocompatibility: Safe for human implantation.	Materials (NuSil MED-4750 silicone rubber, MP35N wire, Pt-Ir alloy) commonly used in market-released leads. Acute and chronic biocompatibility tests performed. Long-term implantation studies conducted. Corrosion studies completed for PVD iridium treatment, confirming it is non-toxic and durable. Extensive clinical experience confirms iridium safety.
Mechanical/Electrical Integrity & Durability: Maintain structural and electrical function over time.	Weld strength, fatigue strength, DC resistance, environmental resistance, electrical integrity, sterilization tested. All test results were within specifications.
Adherence to Standards: Compliance with industry standards.	IS-1 (3.2 mm) connection system complies with International Standard ISO 5841.3:1992. Adherence to IS-1 standards tested.
Packaging & Transportation Durability: Device remains intact and functional after handling.	Packaging and transportation durability tested. All test results were within specifications.
Clinical Performance (outside US): No reported device failures or complaints in commercial use.	Over 2000 leads sold worldwide outside the United States (since March 1994, CE Mark), including 426 in 1996 (excluding December). No reported device failures or complaints.
Clinical Performance (US Trial): Functioning normally with acceptable adverse events.	As of Dec 5, 1996, 18 leads implanted in a US clinical trial (IDE #G960045). All leads functioning normally, with the exception of one anticipated adverse event (failing to yield consistent ventricular capture, potentially due to lead dislodgement).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical - OUS): Over 2000 leads sold worldwide outside the United States since March 1994, with 426 sold in 1996 (excluding December).
Sample Size (Clinical - US Trial): 18 leads implanted in the United States as part of a clinical trial for the Physios CTM 01 Cardiac Transplant Monitoring System (IDE #G960045).
Data Provenance:
- Outside US: Primarily from countries within the European Economic Community (EEC) and other international markets, following CE Mark approval in March 1994. This data is retrospective, based on commercial sales and complaint monitoring.
- United States: Prospective, from a dedicated clinical trial (IDE #G960045).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the "number of experts" or their "qualifications" in the context of establishing ground truth for a test set.

For the OUS commercial experience, "ground truth" would be derived from reported adverse events or device failures, likely identified by implanting physicians, patients, or other healthcare professionals, and reported to the manufacturer. No specific expert panel is described for this.
For the US clinical trial, "ground truth" for the performance of the 18 leads would have been established by the clinical investigators involved in the trial. While their qualifications are not detailed, by definition, they would be medical professionals (e.g., cardiologists, cardiac surgeons) experienced in implanting and monitoring pacing leads, adhering to the IDE protocol. However, no specific number of experts or detailed qualifications are provided in this regulatory summary.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1) for evaluating device performance or adverse events.

For the OUS commercial experience, adverse events and complaints would typically be recorded and evaluated by the manufacturer's quality and regulatory departments based on received reports.
For the US clinical trial, adverse events (like the noted lead dislodgement) would be identified and reported by the clinical investigators as part of the study protocol for IDE #G960045. The "adjudication" would largely rest with the clinical site and potentially a study monitor or data safety monitoring board, but no specific multi-expert adjudication method is detailed in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, ...

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This document pertains to a physical medical device (a cardiac lead) and its safety and effectiveness, not an AI or imaging diagnostic tool that would typically involve MRMC studies to compare human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a physical cardiac lead, not an algorithm, so the concept of a "standalone algorithm" performance does not apply. The device's performance is inherently "standalone" in the sense that its physical and electrical properties are evaluated directly.

7. The Type of Ground Truth Used

The "ground truth" for assessing the device's safety and effectiveness comes from a combination of:

In-vitro/Laboratory Testing: This forms the "ground truth" for material properties, weld strength, fatigue strength, electrical integrity, environmental resistance, and adherence to ISO standards.
Biocompatibility Testing: Dedicated animal and/or in-vitro tests established the "ground truth" for biocompatibility and corrosion resistance.
Clinical Experience/Outcomes Data:
- Commercial (OUS): "No reported device failures or complaints" from over 2000 leads represents an aggregated form of outcomes data/clinical experience.
- Clinical Trial (US): The observation that "All leads are functioning normally" with one anticipated adverse event represents direct clinical outcomes data from a prospective study setting. This provides "ground truth" regarding real-world performance, including the occurrence of complications like lead dislodgement.

8. The Sample Size for the Training Set

The concept of a "training set" is usually applicable to machine learning algorithms. Since this is a physical medical device, there isn't a "training set" in that sense. The "training" for the device's design and manufacturing comes from:

Design and Materials Expertise: Utilizing commonly used, biocompatible materials and established design principles for epicardial leads.
Extensive Prior Knowledge: Leveraging "extensive clinical experience" with iridium and other implantable materials.
Iteration and Testing: The various qualification and in-vitro tests (weld strength, fatigue, etc.) would be part of a design verification and validation process, which could be informally considered as "training" in an engineering sense, but not for a machine learning algorithm.

Therefore, a specific "sample size for the training set" is not relevant or provided in this context.

9. How the Ground Truth for the Training Set Was Established

As explained above, there isn't a "training set" in the machine learning sense. The "ground truth" for the device's development and validation (analogous to how a training set might inform an algorithm) was established through:

Engineering Specifications: Setting performance targets and design requirements based on the intended use and existing medical device standards.
Bench Testing & In-vitro Studies: Establishing "ground truth" for physical, mechanical, and electrical properties under controlled laboratory conditions.
Biocompatibility Studies: Using recognized standards and expert evaluation for toxicology and biocompatibility.
Prior Clinical Knowledge: Drawing upon the established safety and effectiveness of similar materials and designs that are "commonly used in market-released leads" and published in "technical journals."

Summary

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K965106

ELC Lead - 510(k)

JAN 27 1998

1.4 Safety and Effectiveness Summary

These leads provide long-term safe and effective pacing through overall quality of design, manufacture and the surface structure of the active-fixation electrode tip. This tip is a single helically-wound fixation wire ("fixation screw") composed of 70% platinum and 30% iridium which has undergone a Physical Vapor Deposition (PVD) treatment, creating a fractal-surfaced, ball-like microstructure. The IS-1 (3.2 mm) connection system of the ELC lead complies with the International Standard ISO 5841.3:1992.

The materials used to manufacture the ELC leads which come into contact with the patient are commonly used in market-released leads, and have been tested for biocompatibility. Acute and chronic biocompatibility tests have been performed, as well as long-term implantation studies. In addition, corrosion studies were completed to address both long-term toxicity and durability of the PVD iridium treatment. The testing conducted for biocompatibility as well as extensive clinical experience confirms that iridium is safe for use as an implantable material, and analyses supporting this view have been published within technical journals. Long-term corrosion testing results substantiate that iridium is a non-toxic and durable material for use in implantable devices.

Additional qualification testing results validate the safety and effectiveness of the lead design and materials used. ELC leads are tested for weld strength of connections, fatigue strength, DC resistance, environmental resistance, adherence to IS-I standards, packaging and transportation durability, electrical integrity, and sterilization. All test results were within specifications.

Field clinical experience as well as the in-vitro and qualification testing performed on the ELC lead show that the risk to the patient in using these leads is the same as that of any implantable epicardial lead.

Potential complications resulting from the use of epicardial leads include, but are not limited to: thombosis, embolism, body rejection phenomena, cardiac tamponade, muscle/nerve stimulation, fibrillation, and infection. Lead perforation through the myocardium has been rarely observed.

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Table 2.0 below summarizes some of the potential symptoms indicating a complication and possible corrective actions:

SYMPTOM	POTENTIAL COMPLICATION	POTENTIAL CORRECTIVE ACTION
Loss of pacing orsensing	Electrode dislodgement Lead fracture Setscrew penetration of lead insulation Improper lead to pacemaker connection	Reposition lead Replace lead Replace lead Reconnect lead to pacemaker
Increase or decreasein threshold	Fibrotic tissue formation	Adjust pulse generator output;Reposition lead

Table 2.0 Lead Complications

The ELC lead received its CE mark in March, 1994, thereby clearing it for sale and distribution within the EEC. Since that date, over 2000 leads have been sold worldwide outside the United States, including 426 sold in 1996 (excluding December). There have been no reported device failures or complaints.

As of December 5, 1996, eighteen (18) leads have been implanted in the United States as part of a clinical trial with the Physios CTM 01 Cardiac Transplant Monitoring System (IDE #G960045; approved August 22, 1996).

All leads are functioning normally, with the exception of one which has been reported as an anticipated adverse event for the study - failing to yield consistent ventricular capture, potentially because of lead dislodgement.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 27 1998

Mr. Kenneth Jensen BIOTRONIK Regulatory Affairs BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369

Re : K965106 Epicardial Pacing Leads, Models ELC 35 UP, ELC 54 UP Regulatory Class: III (THREE) Product Code: DTB Dated: December 24, 1997 Received: December 29, 1997

Dear Mr. Jensen:

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, Drug, and Cosmetic Act (act). The general controls provisions of the act include requirements for reqistration, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 Reqister. 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 requlation.

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Page 2 - Mr. Kenneth Jensen

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 the act. Violations of sections 301 or 502 may lead to regulatory actions including seizure of your product, injunction, prosecution, or civil money penalties.

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

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 requlation 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) 594-4648. 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/dsmamain.html".

Sincerely yours,

Thomas J. Callaham

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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Page

510(k) Number (il known): K965106

Device Name: ELC Epicardial Leads

Indications For Use:

The ELC xx-UP epicardial sutureless screw-in lead is indicated for unipolar pacing and sensing The ELC XX-UP epicardial suiteress serew in teach, or when a transvenous lead cannot provide in the ventricle when an epicaldial tead is preferrou, created suited for situations where satistiony results or is containcied. Eptocran hear surgery, or based upon the patient's age or heart condition (e.g., in young patients who have not reached full physical maturity and age or neart condition (e.g., in young paironial leads are also indicated in situations where transvenous access is not available or is contraindicated.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!

Concurrence of CDRH, Office of Device Evaluation (ODE)

Brad C. Aston for Eric Ryan
(Division Sign-Off)

01:

of Caroovascular, Respiratory, enologic

510(k) Number K965106

imagelption lise. (Pcr 21 CFR 801 109)

IJver-The-Counter Use_________________________________________________________________________________________________________________________________________________________

10ptional Format 1-2-961

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.