BK-A; BK-B; BK-IS SEALING CAP

K970204 · Biotronik, Inc. · DTD · Apr 29, 1997 · Cardiovascular

Device Facts

• Record ID: K970204
• Device Name: BK-A; BK-B; BK-IS SEALING CAP
• Applicant: Biotronik, Inc.
• Product Code: DTD · Cardiovascular
• Decision Date: Apr 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3620
• Device Class: Class 2

Intended Use

BIOTRONIK BK Series Sealing Caps are single-component silicone devices, designed to be safe and effective through design functionality, simplicity and material biocompatibility.

Device Story

Single-component silicone sealing caps; designed for chronic implantation in cardiac pacing applications. Device functions as a mechanical seal for pacing leads; prevents fluid leakage; withstands ligature application. Used by physicians during surgical implantation of cardiac pacing systems. Material biocompatibility ensures safety; design adheres to IS-1 standards. Benefits include secure lead termination and protection against body rejection, fibrosis, or infection risks comparable to existing market-cleared sealing caps.

Clinical Evidence

Bench testing only. Testing included biocompatibility (acute and chronic), long-term implantation studies, ease of use, ligature application, fluid leakage, IS-1 standard adherence, packaging/transportation durability, and sterilization validation. No clinical trials performed; literature search yielded no adverse safety data.

Technological Characteristics

Material: Silopren LSR-4070 silicone. Design: Single-component sealing cap. Standards: Adheres to IS-1 connector standards. Sterilization: Validated process. Energy source: None (passive mechanical device).

Indications for Use

Indicated for use as sealing caps for chronically implanted cardiac pacing leads.

Regulatory Classification

Identification

A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.”

Reference Devices

• Physios CTM 01 Pulse Generator and ELC XX-UP Epicardial Lead (IDE G960045)
• TIR and TIJ Endocardial Leads (K953044)
• Dromos DR and SR Pulse Generators (PMA P950037)

Submission Summary (Full Text)

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BK Series Sealing Caps - 510(k)
APR 29 1997 K970204

# 1.2 Safety and Effectiveness Summary

BIOTRONIK BK Series Sealing Caps are single-component silicone devices, designed to be safe and effective through design functionality, simplicity and material biocompatibility.

BK Sealing Caps are designed to be chronically implantable. The material of construction is Silopren LSR-4070, which has been extensively used by BIOTRONIK in cardiac pacing lead designs. FDA has reviewed and cleared this material in the following submissions:

Physios CTM 01 Pulse Generator and ELC XX-UP Epicardial Lead
IDE #G960045
Approved August 22, 1996

TIR and TIJ Endocardial Leads
510(k) #K953044
Cleared September 27, 1996

Dromos DR and SR Pulse Generators
PMA #P950037
Approved October 11, 1996.

Silopren LSR-4070 has been thoroughly tested for biocompatibility, and is commonly used in many market-released Class III products, including pacemaker and defibrillator leads and their accessories. Acute and chronic biocompatibility tests have been performed, as well as long-term implantation studies.

BK Sealing Caps are tested for ease of use, ability to withstand ligature application, potential fluid leakage, and adherence to IS-1 standards. Packaging and transportation durability as well as sterilization validation have been performed to ensure the quality and sterility of the delivered product.

All production and biocompatibility test results were within specifications; therefore, when the currently proposed BK Sealing Caps are in use, the patient will be exposed to no risks in excess of those experienced by patients using comparable competitor sealing caps manufactured and distributed in the United States, or older model BIOTRONIK sealing caps. Complications arising from usage may include body rejection phenomena, fibrosis, displacement, infection, and erosion. BIOTRONIK is not aware of any other adverse safety and effectiveness data on these accessories.

In accordance with the Safe Medical Device Act of 1990, a thorough literature search for adverse safety and effectiveness data on pacemaker lead sealing caps was performed. The search yielded no articles related to the safety of pacemaker lead sealing caps.

BIOTRONIK, January 17, 1997
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