K Number
K953742
Device Name
BIFURCATED Y-EXTENSION
Manufacturer
Date Cleared
1996-11-19

(469 days)

Product Code
Regulation Number
882.5880
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the bifurcated y-extension is Spinal Cord Stimulation to treat chronic intractable pain.
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 inline, 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).
More Information

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No
The device description focuses on the physical design of a bifurcated y-extension and screening cables, and the performance studies evaluate mechanical properties. There is no mention of AI, ML, or any software-driven analytical capabilities.

Yes.
The device's intended use is "Spinal Cord Stimulation to treat chronic intractable pain," which is a therapeutic intervention.

No
The device is described as an extension for a Spinal Cord Stimulation system, which is a therapeutic treatment for pain, not a diagnostic tool.

No

The device description explicitly details physical components (y-extension, screening cables, connectors, IPG plug) and performance studies related to physical properties (flex strength, tensile strength), indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "Spinal Cord Stimulation to treat chronic intractable pain." This is a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
  • Device Description: The device is described as an extension and screening cable for a Spinal Cord Stimulation system. These are components of an implantable medical device used for electrical stimulation, not for analyzing biological samples.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in biological samples
    • Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.

Therefore, the bifurcated y-extension described is a medical device used for therapy, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

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

Product codes

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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 inline, 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).

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Model 7495 extension, Model 3470 receiver extensions, Model 3983, Model 3982, Model 3991, Model 3825

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 882.5880 Implanted spinal cord stimulator for pain relief.

(a)
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.(b)
Classification. Class II (performance standards).

0


K953742

510(k) SUMMARY

Updated - 11/18/96

NOV 19 1996

A. Submitter Information

Medtronic, Inc. Submitter's Name:

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

Telephone 612/572-5633 Number:

612/572-5654 Fax Number:

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 | | |

1

source system: the Model 3983, the Model 3982 and the Model 3991. The current screening cable for use with the Model 3825 is substantially equivalent to the proposed bifurcated y- screening cable.

The proposed y-extension and screening cables are Device Description: identical to previously approved extensions and screening cables except for the addition of a second inline, 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).

  • The intended use of the bifurcated y-extension is Intended Use: 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 yextension 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 COMMERCIALLY RELEASED MODEL 7495 EXTENSIONS AND SCREENING CABLES. The extensions and screening cables are unchanged in other aspects of device design, function, and intended use.

2

| 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 |

Table 2. Comparison of Required Characteristics

  • 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.