(90 days)
K810182A, K860158A
Not Found
No
The summary describes a spinal cord stimulation lead, a hardware component, and focuses on material changes and mechanical testing. There is no mention of software, algorithms, or any terms related to AI/ML.
Yes
The document explicitly states "treatment of chronic pain of the extremities and/or trunk" in the "Intended Use" section, which describes a therapeutic purpose.
No
The device is described as an implantable lead system used to electrically stimulate spinal cord fiber tracts for pain treatment, indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states that the device is an "implantable device consisting of spaced electrodes connected by wires within a cover sheath." This describes a physical, hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "electrically stimulate spinal cord fiber tracts for treatment of chronic pain of the extremities and/or trunk." This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is an "implantable device consisting of spaced electrodes connected by wires within a cover sheath." It is designed to be implanted and deliver electrical stimulation directly to the spinal cord.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for therapeutic purposes.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space superior to the spinal segment
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
K810182A, K860158A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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 of |
| Quest Medical, Inc. | |
| One Allentown Parkway | |
| Allen, 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
1
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 Device
510(k) K810182A,
K860158A | Modified Device |
|-------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|
| Intended Use: | Stimulation of spinal
cord for treatment of
chronic pain | Stimulation of spinal
cord for treatment of
chronic pain |
| Materials:
• Electrode:
• Contact Terminal:
• Insulator: | Platinum/Iridium
Stainless Steel 304
Polyethylene | Platinum/Iridium
Stainless Steel 304
Polyurethane |
| Design Features: | Multi-electrode | Multi-electrode |
2
| Catheter | Catheter | |
|---|---|---|
| Braided Wire Cable | Braided Wire Cable | |
| Platinum/Iridium | ||
| Electrode | Platinum/Iridium | |
| Electrode | ||
| 4 or 8 Stainless Steel | ||
| Contact Terminals | 4, 7, or 8 Stainless | |
| Steel Contact | ||
| Terminals | ||
| Percutaneous | ||
| Introduction | Percutaneous | |
| Introduction | ||
| 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.