Arox and Merox bipolar, passive-fixation, endocardial pacing leads are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.

Device Description

The BIOTRONIK Arox and Merox leads are bipolar, passive-fixation, endocardial pacing leads available in straight and "J"-shaped configurations, for placement in the ventricle or atrium. The Arox and Merox xx-JBP models have a permanent bend proximal to both lead electrodes, resulting in the distal portion of the lead body having what is commonly referred to as a "U" or "J" shape. This lead shape facilitates placement in the right atrial appendage. The device modification only applies to the atrial Arox xx-JBP bipolar, passive-fixation, endocardial, pacing leads. The modification consists of an exact specification for the J-shape of the leads.

AI/ML Overview

The presented document is a 510(k) premarket notification for a medical device (Arox and Merox Leads), not a study report or clinical trial. Therefore, it does not contain the detailed information typically found in a study that proves a device meets acceptance criteria. The submission is for a "Special 510(k)" due to a device modification – specifically, the precise specification of the J-shape for the atrial Arox xx-JBP leads.

Based on the provided text, here's an analysis of what information is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the document. A 510(k) summary typically focuses on substantial equivalence to a predicate device rather than detailed acceptance criteria and performance data from a specific study for the modification. The modification is described as an "exact specification for the J-shape of the leads," implying a design control change, likely validated through engineering and bench testing, rather than a clinical performance study.

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

This information is not present. No test set or study data is described in this regulatory submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not present. No ground truth establishment is described, as it's not a diagnostic AI device or a study requiring expert consensus.

4. Adjudication Method

This information is not present. No adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not present. The device is a pacing lead, not an AI-assisted diagnostic tool. An MRMC study would be irrelevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This information is not present. The device is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

This information is not present. No ground truth is mentioned. The modification is a design specification for a physical characteristic.

8. Sample Size for the Training Set

This information is not present. Since this is a physical device modification, not an AI algorithm, there would be no "training set."

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

This information is not present. As above, there is no training set mentioned.

Summary of Device and Modification relevance to Acceptance Criteria:

The core of this 510(k) submission is a "Special 510(k)" for a modification to existing, previously approved pacemaker leads (Arox and Merox). The modification is:

Device Modification: "The modification consists of an exact specification for the J-shape of the leads. Previously, BIOTRONIK did not specify the precise J-shape of the leads."

For such a modification, acceptance criteria would typically revolve around:

Dimensional Accuracy: Does the new manufacturing process consistently produce the J-shape within the specified tolerances? This would be verified through manufacturing quality control and possibly bench testing.
Mechanical Integrity/Performance: Does the precisely defined J-shape maintain the lead's mechanical properties (e.g., flexibility, durability, resistance to kinking, ability to be positioned as intended)? This would involve bench testing for fatigue, tensile strength, and simulated use.
Biocompatibility: (Likely unchanged, as materials are not mentioned as being modified).
Electrical Performance: (Likely unchanged if electrodes and insulation are not modified).

The current document only states that the FDA reviewed the submission and found the device to be "substantially equivalent" to predicate devices, subject to general controls. This implies that the modification was deemed not to raise new questions of safety or effectiveness. The specific evidence (e.g., engineering reports, bench test results) demonstrating that the modified J-shape meets the internal design and performance specifications (the "acceptance criteria" for this specific change) would have been part of the full 510(k) submission to the FDA, but it is not provided in this summary document.

Summary

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OCT 1 8 2002

K023099

BIOTRONIK, Inc., Arox and Merox J-Shape Specification, Special 510(k)

September 17, 2002

Arox and Merox J-Shape Specification Special 510(k) Premarket Notification

1. 510(K) SUMMARY

Name and Address of Sponsor:	BIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035
Establishment Registration Number:	1028232
Device Name:	Proprietary Name: Arox LeadsClassification: Class III (21 CFR 870.3680(b))Classification Name: Cardiovascular Permanent Pacemaker ElectrodeProduct Code: DTB
	Proprietary Name: Merox LeadsClassification: Class III (21 CFR 870.3680(b))Classification Name: Cardiovascular Permanent Pacemaker ElectrodeProduct Code: DTB
Date Prepared:	September 11, 2002

General Description:

The BIOTRONIK Arox and Merox leads are bipolar, passive-fixation, endocardial pacing leads available in straight and "J"-shaped configurations, for placement in the ventricle or atrium. The Arox and Merox lead families have been approved by FDA for distribution in the U.S. (K021217, dated 05-01-02 and #K010281, dated 04-09-02, respectively).

The designations Arox xx-JBP and Merox xx-JBP refer to "J"-shaped leads, which are available in lengths of 45 and 53 cm. The Arox and Merox xx-JBP models have a permanent bend proximal to both lead electrodes, resulting in the distal portion of the lead body having what is commonly referred to as a "U" or "J" shape. This lead shape facilitates placement in the right atrial appendage.

Device Modification:

The device modification only applies to the atrial Arox xx-JBP bipolar, passive-fixation, endocardial, pacing leads. The modification consists of an exact specification for the J-shape of the leads. Previously, BIOTRONIK did not specify the precise J-shape of the leads.

Indication for Use:

Arox and Merox bipolar, passive-fixation, endocardial pacing leads are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.

Name and Address of Manufacturing Site:

BIOTRONIK GmbH & Co. (reg. no. 9610139) Woermannkehre 1, 12359 Berlin, Germany 011-49-30-689-05-304

Name and Address of Contract Manufacturing Site:

BIOTRONIK AG (reg. no. 8043892) Ackerstrasse 6 8180 Bülach, Switzerland 011-41-1-864-5169

Contact Person(s) and Phone Number:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2002

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

Re: K023099

Trade Name: Arox and Merox Bipolar, Passive-Fixation Pacemaker Leads Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent or Temporary Pacemaker Electrode Regulatory Class: Class III (three) Product Code: DTB Dated: September 17, 2002 Received: September 18, 2002

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.

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Page 2 - Mr. Jon Brumbaugh

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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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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Ko23699 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Arox and Merox bipolar, passive-fixation pacemaker leads

Indications For Use:

Arox and Merox bipolar, passive-fixation, endocardial pacing leads are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number 4023006

(Optional Format 3-10-98)

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.