BIOTRONIK's ELOX P transvenous, active fixation endocardial leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators with IS-1 headers. The leads may be used with single or dual chamber pacing systems.

The ELOX P lead models are intended for placement in either the right atrium or right ventricle.

Device Description

Elox P leads are straight, bipolar endocardial pacing leads that utilize an electrically active extendable/retractable fixation helix. The extendable/retractable fixation helix is comprised of a 70% Pt / 30% Ir alloy with a fractal tridium coating. The fixation helix is additionally coated with Parylene C. The non-insulating distal sleeve, consisting of an inner and outer sleeve, is composed of Polyurethane (Pellethane 2363-75D). The leads contain two conductors composed of quadrifilar MP35N wire in coaxial configurations and are insulated with silicone tubing. A 3.2 mm 15-1 bipolar connector attaches the lead to the pulse generator. The Elox P lead is available in lead lengths of 45 cm, 53 cm, and 60 cm.

AI/ML Overview

Here's an analysis of the provided text regarding the Elox P Active-Fixation Endocardial Lead, focusing on acceptance criteria and study information.

It's important to note that this document is a Special 510(k) Notification, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed, novel clinical study results with specific acceptance criteria in the same way a PMA or a de novo application might. Therefore, some of the requested information (like specific effect sizes of AI-assisted vs. human readers, or detailed ground truth establishment for a test set) is not directly applicable or present in this type of submission.

Acceptance Criteria and Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and corresponding "reported device performance" for a new, standalone clinical study demonstrating efficacy in the way a pharmaceutical trial or a software AI product might. Instead, the core of this Special 510(k) is to demonstrate that the modified Elox P lead is substantially equivalent to its predicate devices (existing Elox leads and other cleared pacemaker leads).

The key "performance" being evaluated for this modification (addition of Parylene C coating to the fixation helix to increase electrical impedance) would be that the lead continues to meet established performance standards for pacemaker leads and that the modification doesn't adversely affect safety or effectiveness. The comparison is primarily against the performance of the predicate Elox leads which have already undergone testing and received clearance.

For pacemaker leads, substantial equivalence is often demonstrated through:

Bench testing: Electrical performance (e.g., impedance, current leakage), mechanical properties (e.g., tensile strength, fatigue), material biocompatibility.
Animal studies: To assess acute and chronic pacing and sensing performance, fixation, and tissue response.
Clinical experience/literature review: Referencing the known performance of the predicate device.

Given this is a Special 510(k), the focus is on a modification and demonstrating that the modified device is as safe and effective as the original. The performance criteria are implicitly those that a pacemaker lead must meet to be considered safe and effective, as established by prior device clearances and relevant standards.

Implicit Acceptance Criteria and Demonstrated Performance:

Acceptance Criteria (Implied for Pacemaker Leads)	Reported Device Performance (Summary from Submission)
Electrical Performance: Acceptable pacing and sensing capabilities (specifically, increased electrical impedance due to modification).	The modification involves adding a Parylene C coating to the proximal portion of the fixation helix "in order to decrease the electrically active surface of the helix and therefore increase the electrical impedance of the lead." (This states the purpose and expected direction of change, implying successful achievement of this goal). No specific impedance values or ranges are provided in this summary.
Mechanical Integrity: Withstand physiological stresses, maintain fixation.	Not explicitly detailed in this summary, but would be demonstrated through bench testing (e.g., fatigue, tensile strength) and/or animal studies, usually by showing equivalence to predicate.
Biocompatibility: Materials are safe for implantation.	The lead utilizes existing materials (70% Pt / 30% Ir alloy, fractal tridium coating, Parylene C, Polyurethane, MP35N wire, silicone tubing). Parylene C addition implies demonstrating biocompatibility of this coating, likely done through standard ISO 10993 testing or reference to its known use in medical devices.
Sterility: Device is sterile.	Implied for all implantable devices, demonstrated through validated sterilization methods.
Functional Equivalence: Device performs as intended for permanent pacing and sensing, similar to predicate.	"The proposed Elox P leads in this Special 510(k) notification are modified versions of BIOTRONIK's currently marketed Elox leads (K994240, cleared 04-13-00 and K001413, cleared 06-02-00)." This statement forms the basis of substantial equivalence, implying similar functional performance.
Safety: No new safety concerns introduced by the modification.	The demonstration of substantial equivalence suggests the modification does not introduce new safety concerns, leveraging the safety profile of the predicate device.

Study Information (as inferable from the document type)

This document is a Special 510(k) focusing on a device modification. It refers to predicate devices for establishing substantial equivalence rather than presenting a detailed new clinical study with a prospectively defined test set and ground truth.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a new, standalone clinical test set as described for AI algorithms. The "test set" here refers to the comprehensive data (bench tests, biocompatibility tests, potentially limited animal or pre-clinical data, and comparison to predicate device data) used to demonstrate substantial equivalence of the modified device. No specific patient sample size is provided for a new clinical study.
- Data Provenance: The modification is described by BIOTRONIK, Inc. (USA) and manufactured by BIOTRONIK GmbH & Co. (Germany) and BIOTRONIK AG (Switzerland). The data would originate from their internal testing and regulatory submissions. The nature of a Special 510(k) means this data would be primarily retrospective in terms of referencing the performance of the predicate device and potentially prospective for specific bench or animal tests on the modified component.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this type of submission. "Ground truth" in the context of a pacemaker lead's performance is established through objective measurements (e.g., electrical impedance, mechanical strength), animal studies, and long-term clinical observation of predicate devices. There isn't an "expert consensus" on imaging or diagnostic interpretation similar to an AI algorithm.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is typically relevant for studies where human expert disagreement needs to be resolved for ground truth labeling (e.g., radiological interpretation).
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:
- Not applicable. This device is a pacemaker lead, not an AI diagnostic algorithm. There are no "human readers" interpreting data with or without AI assistance in this context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a hardware medical device (pacemaker lead), not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a pacemaker lead, "ground truth" for proving safety and effectiveness involves a combination of:
  - Objective physical measurements: Electrical parameters (impedance, current), mechanical strength/durability.
  - Biocompatibility testing: Standardized tests (e.g., ISO 10993 series) on materials.
  - Animal study results: Acute and chronic pacing/sensing, tissue response, lead fixation.
  - Clinical performance of predicate devices: Long-standing data on similar devices provides the most significant "ground truth" for the overall concept and previous versions of the product.
The sample size for the training set:
- Not applicable. There is no AI model or "training set" in the context of this pacemaker lead modification.
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary

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APR 2 4 2003

BIOTRONIK, Inc., Elox P Active-Fixation Endocardial Lead, Special 510(k)

September 24, 2002

Elox P Active Fixation Endocardial Lead Special 510(k) Notification

1028232

1. 510(K) SUMMARY

Name and Address of Sponsor:

BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035

Establishment Registration Number:

Device Name:

Proprietary Name: Classification: Classification Name: Product Code:

Elox P Leads Class III (21 CFR 870.3680(b)) Cardiovascular Permanent Pacemaker Electrode DTB

Date Prepared:

September 24, 2002

General Description:

Device Modification:

The proposed Elox P leads in this Special 510(k) notification are modified versions of BIOTRONIK's currently marketed Eloxieads (K994240, cleared 04-13-00 and K001413, cleared 06-02-00). The modification to the Elox P lead involves the addition of a Parylene C coating to the proximal portion of the fixation helix in order to decrease the electrically active surface of the helix and therefore increase the electrical impedance of the lead.

Predicate Devices:

BIOTRONIK proposes the following leads cleared through 510(k) notifications as predicate devices for the Elox P leads:

BIOTRONIK's Elox bipolar, active fixation, endocardial leads (#K994240, cleared 04-13-00) ●
BIOTRONIK's Elox 45-BP bipolar, active fixation, endocardial leads (#K001416, cleared 06-02-00) .
. BIOTRONIK's Synox bipolar, passive fixation endocardial leads with 31 mm spacing (#K980869, cleared 09-10-98)
Intermedics's Quantum implantable pulse generator (#K911122, cleared 05-16-91) ●

Indications for Use:

The ELOX P lead models are intended for placement in either the right atrium or right ventricle.

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Name and Address of Manufacturing Site:

BIOTRONIK GmbH & Co. (reg. no. 7010992) Woermannkehre 1 12359 Berlin, Germany 011-49-30-689-05-304

Contact Person:

Jon Brumbaugh Director, Regulatory Affairs Phone (888) 345-0374 Fax (503) 635-9936

Name and Address of Contract Manufacturing Site: BIOTRONIK AG (reg. no. 8043892) Ackerstrasse 6 8180 Bülach, Switzerland 011-41-1-864-5169 ·

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them, resembling a bird-like shape.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 2003

Biotronik, Inc. c/o Mr. Jon Brumbaugh Director of Regulatory Affairs 6024 Jean Road Lake Oswego, OR 97035

Re: K023205 Trade Name: Elox P Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular permanent or temporary pacemaker electrode Regulatory Class: III (three) Product Code: DTB Dated: January 24, 2003 Received: January 27, 2003

Dear Mr. Brumbaugh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Mr. Jon Brumbaugh

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer 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,

Bram D. Zuckerman, M.D.
Director

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of 1

K023205 510(k) Number (if known):_

Device Name: Elox P Active-Fixation, Bipolar Pacemaker Lead

Indications For Use:

The ELOX P lead models are intended for placement in either the right atrium or right ventricle.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Only

(Optional Format 3-10-98)

V. Della

510(k) Number K033205

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.