BIFURCATED Y-EXTENSION

K953742 · Medtronic Vascular · GZB · Nov 19, 1996 · Neurology

Device Facts

• Record ID: K953742
• Device Name: BIFURCATED Y-EXTENSION
• Applicant: Medtronic Vascular
• Product Code: GZB · Neurology
• Decision Date: Nov 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5880
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of the bifurcated y-extension is Spinal Cord Stimulation to treat chronic intractable pain.

Device Story

The Medtronic Model 7498 Bifurcated Y-extension and Y-screening cable are accessories for spinal cord stimulation (SCS) systems. The device functions as a connector interface, allowing two leads to be connected to a single implantable pulse generator (IPG) or screening system. It features a bifurcated design with two parallel in-line set screw connectors at the proximal end, while maintaining the same distal and proximal connection interfaces as existing Medtronic extensions. Used by clinicians during SCS implantation procedures to manage multiple leads, the device enables the delivery of stimulation to broader or multiple anatomical sites. By facilitating the use of two leads with a single power source, it simplifies the surgical configuration for complex pain management, potentially improving therapeutic coverage for the patient.

Clinical Evidence

Bench testing only. Laboratory testing for flex strength and tensile strength was performed to verify that the bifurcated design met performance requirements. No clinical data was required or provided.

Technological Characteristics

Passive electrical extension/screening cable. Features dual parallel in-line set screw connectors. Design is based on existing Model 7495 extensions. No active components, software, or energy sources. Sterilization method not specified.

Indications for Use

Indicated for patients suffering from chronic intractable pain requiring spinal cord stimulation therapy.

Regulatory Classification

Identification

An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

Predicate Devices

• Model 7495 extension
• Model 3470 receiver extensions
• Model 3983 lead
• Model 3982 lead
• Model 3991 lead
• Model 3625 screening cable

Submission Summary (Full Text)

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Nov. 18. 1996 3:58PM MEDTRONIC
No. 8622 P. 2
K953742
510(k) SUMMARY
Updated - 11/18/96
NOV 19 1996

## A. Submitter Information

Submitter's Name: Medtronic, Inc.

Address: Neurological Division
800 53rd Avenue NE
Mpls., MN 55440-9087

Telephone Number: 612/572-5633

Fax Number: 612/572-5654

Contact Person: David H. Mueller

Submission Preparation Date: August 7, 1996

## B. Device Information

Trade Name: Medtronic Model 7498 Bifurcated Y-extension; Medtronic Bifurcated Y-screening cable

Common Name: Permanent Bifurcated Y-Extension; Temporary Y-Screening Cable

Classification Name: Class II spinal cord stimulation devices (21 CFR 882.5880)

Predicate Device: This 510(k) summary identifies the Model 7495 extension as substantially equivalent to the proposed Model 7498 bifurcated y-extensions. The y-extension is also substantially equivalent to the previously approved Model 3470 receiver extensions when two receivers are implanted together with two leads and two extensions. Additionally, the two side by side leads resulting from use of a y-extension are equivalent to the following leads which use horizontally side by side electrodes in a single channel or a single power

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Nov. 18. 1996 3:58PM MEDTRONIC
No. 8622 P. 3

source system: the Model 3983, the Model 3982 and the Model 3991. The current screening cable for use with the Model 3625 is substantially equivalent to the proposed bifurcated y- screening cable.

**Device Description:** The proposed y-extension and screening cables are identical to previously approved extensions and screening cables except for the addition of a second in-line, set screw connector. The dual connectors are parallel to each other and are attached proximally in the IPG plug (extension) or at a y-junction (screening cable). The distal and proximal ends of the proposed and current extension and screening cables are identical and the only difference is the connection at the IPG plug (extension) and at the y-junction (screening cable).

**Intended Use:** The intended use of the bifurcated y-extension is Spinal Cord Stimulation to treat chronic intractable pain.

C. Comparison of Required Technological Characteristics

The y-extensions are substantially equivalent to the commercially-approved Model 7495 extension. The y-extension differs only in that it allows for two identical, parallel in-line set screw connectors. Testing showed that the y-extension does not raise any new questions of safety and effectiveness.

Except for the additional leg, the EXTENSIONS AND SCREENING CABLES THEMSELVES ARE IDENTICAL TO PREVIOUS COMMERCIALY RELEASED MODEL 7495 EXTENSIONS AND SCREENING CABLES. The extensions and screening cables are unchanged in other aspects of device design, function, and intended use.

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Nov. 18. 1996 3:58PM MEDTRONIC
No. 8622 P. 4

Table 2. Comparison of Required Characteristics

| Characteristics | Current and Proposed Y- Extensions (Models 7495YC and 7498) | Current Single-line Extensions and Proposed Y-Extension | Current Screening Cable and the Y-Screening Cable |
| --- | --- | --- | --- |
| a. Product Labeling | Substantially equivalent | Substantially equivalent | Substantially equivalent |
| b. Intended Use | Identical | Identical | Identical |
| c. Physical Characteristics | Substantially equivalent | Substantially equivalent | Substantially equivalent |
| d. Anatomical Sites | Identical | Identical | Identical |
| e. Target Population | Identical | Identical | Identical |
| f. Performance Testing | Substantially equivalent | Substantially equivalent | Substantially equivalent |
| g. Safety Characteristics | Substantially equivalent | Substantially equivalent | Substantially equivalent |

D. Summary of Nonclinical Tests

Laboratory tests for flex strength and tensile strength showed that the Model 7498 extension passed the requirements. In conclusion, the laboratory results show that the bifurcated y-connector design does not raise any new questions of safety and efficacy and that the y-extensions and y-screening cable are substantially equivalent to the current extensions and screening cables.