(90 days)
Neuromed, Inc.'s One-Step Connect™ Leads are intended to be used with Neuromed trial extensions and/or receivers, transmitters, and antennae to electrically stimulate spinal cord fiber tracts for treatment of chronic pain of the extremities and/or trunk. The proposed device modification does not affect the original intended use of the legally marketed device.
Neuromed, Inc.'s One-Step Connect™ Leads are implantable devices consisting of spaced electrodes connected by wires within a cover sheath. These percutaneous leads are introduced into the epidural space superior to the spinal segment responsible for pain impulse transmission, and connected to a radiofrequency (RF) receiver or pulse generator.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Neuromed K960728 device:
Based on the provided document, the device in question is an Implanted Spinal Cord Stimulator Lead (specifically One-Step Connect™ Leads with various trade names like Quattrode Plus™, Octrode Plus™, Cervitrode Plus™). The 510(k) is for a modification where the material of the lead insulator is changed from Polyethylene to Polyurethane.
The document describes non-clinical testing to demonstrate that this material change does not affect the safety and effectiveness of the device.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as would be common for diagnostic AI/ML devices. Instead, the acceptance criteria are implicitly met by demonstrating equivalence or superiority to the predicate device in specific non-clinical tests related to material properties and durability.
| Acceptance Criteria Category (Implicit) | Reported Device Performance (Modified Device vs. Predicate) |
|---|---|
| Biostability | Biostability testing of the polyurethane material (via Stokes method) is provided and presumably found acceptable (referenced to manufacturer's Master File). This suggests the polyurethane is stable in the biological environment. |
| Fatigue Strength / Durability | Equivalent or better durability than the original polyethylene insulators. |
| Tensile Strength / Bond Strength | Equivalent or better bond strength between the polyurethane insulator material and the electrodes compared to the original polyethylene. |
| Biocompatibility | Raises no significant safety or effectiveness questions relating to biocompatibility, based on Master File information and supplemental testing. |
Explanation: The "acceptance criteria" here are based on demonstrating that the new material performs at least as well as, or better than, the predicate in critical physical and biological properties.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable or not provided in the context of the type of study described.
- Sample Size: The document describes non-clinical, comparative material and mechanical testing (biostability, fatigue strength, tensile strength). These typically involve a different type of "sample" (e.g., material specimens, device components) and statistical analysis than clinical trials or AI/ML validation sets. The specific number of test specimens or replicates used for these tests is not mentioned.
- Data Provenance: Not applicable as it's not human data or image data. The tests are laboratory-based.
- Retrospective/Prospective: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or not provided. The "ground truth" here is established via standardized laboratory testing methods and material science principles, not expert medical consensus.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Since the "ground truth" is derived from objective laboratory measurements, there is no need for expert adjudication.
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
This information is not applicable or not provided. This is not an AI/ML-based diagnostic or assistive device. The submission is for a material change in an implanted medical device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable or not provided. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the equivalence/superiority of the modified device's material properties is based on:
- Laboratory Testing / Objective Measurements: Biostability testing (Stokes method), comparative fatigue strength testing, comparative tensile strength testing.
- Biocompatibility Standards/Guidelines: Referenced to Master File information, implying compliance with established biocompatibility requirements.
8. The Sample Size for the Training Set
This information is not applicable or not provided. This is not an AI/ML device, and therefore, no training set for an algorithm is involved.
9. How the Ground Truth for the Training Set was Established
This information is not applicable or not provided. This is not an AI/ML device.
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ROMED K960728
Fax Number:
Image /page/0/Picture/1 description: The image shows a date written in a bold, sans-serif font. The date reads "MAY 22 1986". The month is abbreviated to "MAY", followed by the day "22", and the year "1986".
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Date Prepared: | February 21, 1996 |
|---|---|
| Company: | Neuromed, Inc., a wholly owned subsidiary ofQuest Medical, Inc.One Allentown ParkwayAllen, TX 75002-4211 |
| Contact: | Krista Oakes |
| Phone Number: | 214-390-9800 |
214-390-2881
T Medical Inc. 9 DE DESE FROND TRONT FOR LA LED 1 7 305 594 866 1 1 395 594 866 1 1 3 5 5001 7 558 105 580
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Implanted Spinal Cord Stimulator Lead 510(k) Summary of Safety and Effectiveness
Device Information:
| Trade Names: | Quattrode Plus™ One Step Connect™ Lead | |
|---|---|---|
| Octrode Plus™ One Step Connect™ Lead | ||
| Cervitrode Plus™ One Step Connect™ Lead | ||
| Common Name: | Spinal Cord Stimulator | |
| Classification Name: | Implanted Spinal Cord Stimulator for Pain Relief |
Predicate Device:
Neuromed, Inc., currently markets spinal cord stimulator systems with polyethylene lead insulators under 510(k) # K810182A and K860158A.
Device Description:
Neuromed, Inc.'s One-Step Connect™ Leads are implantable devices consisting of spaced electrodes connected by wires within a cover sheath. These percutaneous leads are introduced into the epidural space superior to the spinal segment responsible for pain impulse transmission, and connected to a radiofrequency (RF) receiver or pulse generator.
Intended Use:
Neuromed, Inc.'s One-Step Connect™ Leads are intended to be used with Neuromed trial extensions and/or receivers, transmitters, and antennae to electrically stimulate spinal cord fiber tracts for treatment of chronic pain of the extremities and/or trunk. The proposed device modification does not affect the original intended use of the legally marketed device.
Comparison To Predicate Device:
The following table illustrates the comparison between the modified device and the original, legally marketed device.
| Predicate Device510(k) K810182A,K860158A | Modified Device | |
|---|---|---|
| Intended Use: | Stimulation of spinalcord for treatment ofchronic pain | Stimulation of spinalcord for treatment ofchronic pain |
| Materials:• Electrode:• Contact Terminal:• Insulator: | Platinum/IridiumStainless Steel 304Polyethylene | Platinum/IridiumStainless Steel 304Polyurethane |
| Design Features: | Multi-electrode | Multi-electrode |
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| Catheter | Catheter | |
|---|---|---|
| Braided Wire Cable | Braided Wire Cable | |
| Platinum/IridiumElectrode | Platinum/IridiumElectrode | |
| 4 or 8 Stainless SteelContact Terminals | 4, 7, or 8 StainlessSteel ContactTerminals | |
| PercutaneousIntroduction | PercutaneousIntroduction | |
| Dimensions:• Length: | 66 cm | 58 - 66 cm |
| • Catheter Size: | 4 Fr. | 4 Fr |
| Packaging: | Tray w/ Tyvek Lid | Tray w/ Tyvek Lid |
| Labeling: | Labeled as sterile,prescription device | Labeled as sterile,prescription device |
Non-clinical Testing:
Biostability testing of the polyurethane material using the Stokes method is provided in the manufacturer's Master File.
Comparative testing of product fatigue strength indicates that the polyurethane lead insulators have equivalent or better durability than the original polyethylene insulators.
Comparative tensile strength testing of the original polyethylene lead insulators and the proposed new polyurethane lead insulators demonstrates an equivalent or better bond strength between the polyurethane insulator material and the electrodes.
Master File biocompatibility information, combined with supplemental testing performed by Neuromed, Inc., demonstrates that the change from polyethylene to polyurethane raises no significant safety or effectiveness questions relating to biocompatibility.
§ 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).