MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES

K960446 · Medtronic Vascular · DSA · May 22, 1996 · Cardiovascular

Device Facts

• Record ID: K960446
• Device Name: MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES
• Applicant: Medtronic Vascular
• Product Code: DSA · Cardiovascular
• Decision Date: May 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

Intended Use

The intended use of the patient cables is identical to previous patient cables.

Device Story

Sterile disposable patient cable assemblies; connect heart wires/leads to external cardiac pacing/monitoring equipment. Device transmits electrical signals between patient and external device. Used in clinical settings; operated by healthcare professionals. Modified connector design compared to predicate; otherwise identical function. Benefits include reliable signal transmission for cardiac monitoring/pacing.

Clinical Evidence

Bench testing only. Mechanical tests (retaining force, withdrawal forces, button depression), electrical tests (current, resistance, dielectric strength), environmental/packaging tests (shock, vibration, temperature, humidity), and biocompatibility (cytotoxicity, dermal irritation) met all requirements.

Technological Characteristics

Patient transducer and electrode cable assembly. Features modified connector for heart wires/leads. Materials biocompatible (non-cytotoxic, non-irritating). Sterilized for single use. Electrical characteristics include specified resistance and dielectric withstanding voltage.

Indications for Use

Indicated for patients requiring connection between heart wires/leads and external cardiac pacing/monitoring equipment.

Regulatory Classification

Identification

A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.

Predicate Devices

• Models 5455, 5455L, 5455S, and 5455SL surgical cables

Submission Summary (Full Text)

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MAY 22 1996

# K960446

510(k) SUMMARY

[As required by 21 CFR 807.92(a)]

## A. Submitter Information

Submitter's Name: Medtronic, Inc.

Address: 7000 Central Ave. N.E.
Minneapolis, MN 55432-3576

Telephone Number: 612/574-4654

Fax Number: 612/574-6424

Contact Person: Valerie K. Stuhr

Submission Preparation Date: January 31, 1996

## B. Device Information

Trade Name: Models 5471 and 5471L Sterile Disposable Patient Cable Assemblies

Common Name: Patient Cable

Classification Name: Patient transducer and electrode cable (including connector), Class II (21 CFR 870.2900)

Predicate Device: This 510(k) summary identifies the Models 5455, 5455L, 5455S, and 5455SL surgical cables as substantially equivalent to the proposed patient cable assemblies.

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Device Description: The proposed patient cables are identical to the commercially-approved Models 5455, 5455L, 5455S, and 5455SL surgical cables, with the exception of a modified connector for heart wires and leads.

Intended Use: The intended use of the patient cables is identical to previous patient cables.

## C. Comparison of Required Technological Characteristics

The proposed patient cables are substantially equivalent to the commercially-available Models 5455, 5455L, 5455S, and 5455SL surgical cables. The proposed cables are identical to the current cables except that the proposed cables include a modified connector.

| Characteristics | Current and Proposed |
| --- | --- |
| a. Product Labeling | Substantially equivalent |
| b. Intended Use | Identical |
| c. Physical Characteristics | Substantially equivalent |
| d. Anatomical Sites | Identical |
| e. Target Population | Identical |
| f. Performance Testing | Substantially equivalent |
| g. Safety Characteristics | Substantially equivalent |

## D. Summary of Nonclinical Tests

Mechanical, electrical, and environmental/packaging tests show that the proposed patient cable assemblies are qualified and raised no new questions with regard to safety and efficacy. Mechanical test results for cable retaining force, lead, and heartwire connection withdrawal forces, and button depression all met requirements. Electrical tests for current, resistance, and dielectric withstanding voltage also met requirements. Environmental/packaging tests demonstrated that the packaging can withstand various shock, vibration, temperature, and humidity conditions. Biocompatibility tests showed that the connector does not produce cytotoxicity or dermal irritation. All tests met their respective requirements.