RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000

K981083 · Biotronik, Inc. · DTB · Jul 22, 1998 · Cardiovascular

Device Facts

• Record ID: K981083
• Device Name: RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000
• Applicant: Biotronik, Inc.
• Product Code: DTB · Cardiovascular
• Decision Date: Jul 22, 1998
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The BIOTRONIK RETROX RX 53/60-BP and RETROX RX 45/53-JBP 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. The leads may be used with singleor dual-chamber pacing systems. RETROX RX-BP and RX-JBP leads differ in the shape of the distal portion of the lead. The RX-BP models are intended for placement in the ventricle or atrium and have straight distal ends. The RX-JBP models have a pre-formed J-shaped distal end to facilitate lead placement in the right atrial appendage. The indications for use of a RETROX lead in combination with a connected cardiac pacemaker follow those recommended in the Class I definition of the ACC/AHA Task Force Report, entitled "Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmic Devices" (JACC, Vol. 18, No. 1, July 1991:1-13.)

Device Story

Bipolar endocardial lead for permanent cardiac pacing/sensing; connects to implantable pulse generator. Features active-fixation helix tip (70% platinum/30% iridium) for tissue attachment; quadrafilar MP35N wire conductor; NuSil MED-4750 silicone rubber insulation. RX-BP models feature straight distal ends; RX-JBP models feature pre-formed J-shape for atrial appendage placement. Implanted by physicians in clinical settings. Provides electrical interface between pulse generator and heart tissue; enables pacing therapy delivery. Benefits include secure fixation and long-term pacing reliability.

Clinical Evidence

Clinical investigation included 19 patients with 31 implanted leads (14 RETROX, 17 control). Data collected from Nov 1997 to March 1998. Three anticipated adverse events for RETROX leads; four for control. No unanticipated adverse device effects reported. One patient death occurred, determined unrelated to pacing system.

Technological Characteristics

Bipolar endocardial lead; NuSil MED-4750 silicone rubber insulation; quadrafilar MP35N wire conductor; 70% platinum/30% iridium active-fixation helix tip with PVD iridium treatment. IS-1 BP connector configuration. Mechanical, electrical, and environmental testing performed per national/international standards.

Indications for Use

Indicated for patients requiring permanent pacing and sensing via single or dual-chamber implantable pulse generators. RX-BP models for ventricular or atrial placement; RX-JBP models for right atrial appendage placement.

Regulatory Classification

Identification

Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external 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. Permanent pacemaker electrode: 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.

Predicate Devices

• ELC xx-UP Epicardial Lead (K965106)

Submission Summary (Full Text)

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#### Safety and Effectiveness Summary 1.4

The RETROX endocardial lead is a safe and effective biopolar sense/pace lead used with implantable cardiac pacemakers when an active-fixation endocardial lead is preferred. The lead body insulation 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. This is the same material used for the active-fixation helix of the BIOTRONIK ELC lead. a unipolar epicardial active-fixation lead (ELC xx-UP Epicardial Lead, 510(k) #K965106, cleared January 27, 1998).

The patient-contact materials used to manufacture RETROX leads are commonly used in marketreleased leads. Additionally, corrosion studies were completed to address both long-term toxicity and durability of the physical vapor deposition (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 validation testing results validate the safety and effectiveness of the lead design and materials used. RETROX leads undergo extensive device and component evaluations, including IS-1 BP connector testing, Si tube abrasion testing, lead tip and ring testing, complete lead mechanical, electrical and environmental testing, silicone adhesive testing, suture sleeve testing and sterile package testing. All test results were within specifications.

Based on the similarity of RETROX lead design to other market-released active fixation retractable endocardial leads, in-vitro and other validation testing performed by the manufacturer, non-U.S. and limited U.S. clinical experience, the risk to the patient in using these leads is the same as that of any implantable endocardial lead.

Potential complications resulting from the use of endocardial 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.

BIOTRONIK, March 23, 1998

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Table 3 below summarizes some of the potential symptoms indicating a complication and possible corrective actions:

| SYMPTOM | POTENTIAL COMPLICATION | POTENTIAL CORRECTIVE ACTION |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Loss of pacing or<br>sensing | • Electrode dislodgement<br>• Lead fracture<br>• Setscrew penetration of<br>lead insulation<br>• Improper lead to<br>pacemaker connection | • Reposition lead<br>• Replace lead<br>• Replace lead<br>• Reconnect lead to pacemaker |
| Increase or decrease<br>in threshold | • Fibrotic tissue formation | • Adjust pulse generator output;<br>• Reposition lead |

Table 3 Lead Complications

#### Summary of Studies 1.5

## 1.5.1 NONCLINICAL STUDIES

Validation testing was performed to evaluate the final device as well as various manufacturing processes. All applicable national and international standards and/or criteria were evaluated. In all cases, test specifications were met. Tests were performed in the following categories:

- IS-1 BP connector testing ●
- Si tube abrasion testing .
- lead tip and ring testing .
- complete lead mechanical, electrical and environmental testing .
- stylet testing .
- . silicone adhesive testing
- suture sleeve testing .
- sterile package testing .

# 1.5.2 CLINICAL STUDIES

The Interim Clinical Investigation Summary is presented within Appendix 3. A total of 31 leads were implanted in a total of 19 patients prior to discontinuation of the study; 14 RETROX leads and 17 control (Oscor) leads were implanted. The Interim Clinical Investigation Summary presents data received between the date of study initiation (November 26, 1997) and March 15, 1998. Data from implant documentation, patient follow-up visits and out-of-service case report forms are included.

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Three anticipated adverse events have been recorded associated with the 14 study leads implanted to date; four anticipated adverse events have been recorded associated with the 17 control leads implanted to date. There have been no unanticipated adverse device effects experienced with the RETROX pacing leads as defined in 21 CFR 812.3(s); there have been no reported patient complaints regarding RETROX pacing leads.

There was one patient death reported during the clinical investigation. The patient had been randomized to control leads in both the atrium and the ventricle. This death was evaluated by the investigator and determined to be unrelated to the pacing system; relevant information is presented within the Interim Clinical Investigation Summary.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 22 1998

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

Re: K981083 Trade Name: Retrox RX 53-BP, Retrox RX 60-BP, Retrox RX 45-JBP, and Retrox 53-JBP Active Fixation Endocardial Leads Regulatory Class: III Product Code: DTB Dated: June 17, 1998 Received: June 19, 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 legally marketed predicate 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 annual registration, listinq of devices, qood manufacturing practice, 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 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 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

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Page 2 - Ms. Lauren L. Foote Christensen

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 Regulations.

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 requirements 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of

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Page 3 - Ms. Lauren L. Foote Christensen

Compliance at [phone]. Also, please not the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Walsh.

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

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Enclosures

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### Indications for Use

The BIOTRONIK RETROX RX 53/60-BP and RETROX RX 45/53-JBP 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. The leads may be used with singleor dual-chamber pacing systems.

RETROX RX-BP and RX-JBP leads differ in the shape of the distal portion of the lead. The RX-BP models are intended for placement in the ventricle or atrium and have straight distal ends. The RX-JBP models have a pre-formed J-shaped distal end to facilitate lead placement in the right atrial appendage.

The indications for use of a RETROX lead in combination with a connected cardiac pacemaker follow those recommended in the Class I definition of the ACC/AHA Task Force Report, entitled "Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmic Devices" (JACC, Vol. 18, No. 1, July 1991:1-13.)