(469 days)
The intended use of the bifurcated y-extension is Spinal Cord Stimulation to treat chronic intractable pain.
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).
The provided document does not contain information about acceptance criteria or a study that proves a device meets those criteria in the traditional sense of AI algorithm evaluation (e.g., accuracy, sensitivity, specificity for diagnostic devices).
Instead, this K953742 summary describes a medical device (Medtronic Model 7498 Bifurcated Y-extension and related screening cable) and focuses on demonstrating its substantial equivalence to previously approved devices. The "performance" mentioned refers to mechanical and safety aspects, not diagnostic or AI-driven performance.
Therefore, many of the requested fields are not applicable to this document. I will fill in the relevant information and indicate "N/A" for those not addressed by this submission.
Acceptance Criteria and Device Performance (for Substantial Equivalence)
The acceptance criteria here is "Substantially Equivalent" to predicate devices, meaning it does not raise new questions of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (for Substantial Equivalence) | Reported Device Performance (Model 7498) | Pass/Fail |
|---|---|---|
| Product Labeling Substantially Equivalent | Substantially equivalent | Pass |
| Intended Use Identical | Identical | Pass |
| Physical Characteristics Substantially Equivalent | Substantially equivalent | Pass |
| Anatomical Sites Identical | Identical | Pass |
| Target Population Identical | Identical | Pass |
| Performance Testing Substantially Equivalent | Substantially equivalent | Pass |
| Safety Characteristics Substantially Equivalent | Substantially equivalent | Pass |
| Flex Strength Requirements Met | Passed requirements | Pass |
| Tensile Strength Requirements Met | Passed requirements | Pass |
| No new questions of safety and effectiveness | No new questions identified | Pass |
2. Sample size used for the test set and the data provenance:
- Test Set Description: The "test set" here refers to the actual physical devices (Model 7498 extension and y-screening cable) that underwent nonclinical laboratory testing.
- Sample Size: Not specified (e.g., how many units were tested for flex/tensile strength).
- Data Provenance: Laboratory tests (likely internal Medtronic laboratories). No information on geographical origin or retrospective/prospective nature as would apply to clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth in this context is based on engineering specifications and mechanical testing standards, not expert medical opinion on diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable to mechanical device testing for substantial equivalence.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a passive medical device (extension/cable for a spinal cord stimulator), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is a passive medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering specifications and performance standards. The "ground truth" for the nonclinical tests (flex strength, tensile strength) would be the pre-defined acceptable limits for these mechanical properties according to internal design specifications and relevant industry standards for such medical device components.
8. The sample size for the training set:
- N/A. This device does not involve a "training set" in the context of an AI/machine learning algorithm. It is a manufactured physical device.
9. How the ground truth for the training set was established:
- N/A. Not applicable.
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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 | ||
| ClassificationName: | Class II spinal cord stimulation devices (21 CFR882.5880) | ||
| Predicate Device: | This 510(k) summary identifies the Model 7495extension as substantially equivalent to the proposedModel 7498 bifurcated y-extensions. The y-extensionis also substantially equivalent to the previouslyapproved Model 3470 receiver extensions when tworeceivers are implanted together with two leads andtwo extensions. Additionally, the two side by sideleads resulting from use of a y-extension are equivalentto the following leads which use horizontally side byside electrodes in a single channel or a single power |
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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.
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| Characteristics | Current andProposedY- Extensions(Models 7495YC and7498) | Current Single-lineExtensions andProposed Y-Extension | Current ScreeningCable and theY-Screening Cable |
|---|---|---|---|
| a. Product Labeling | Substantially equivalent | Substantially equivalent | Substantially equivalent |
| b. Intended Use | Identical | Identical | Identical |
| c. PhysicalCharacteristics | Substantially equivalent | Substantially equivalent | Substantially equivalent |
| d. Anatomical Sites | Identical | Identical | Identical |
| e. Target Population | Identical | Identical | Identical |
| f. PerformanceTesting | Substantially equivalent | Substantially equivalent | Substantially equivalent |
| g. SafetyCharacteristics | 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.
§ 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).