(30 days)
Not Found
No
The summary describes a passive lead extension for a neurostimulation system and contains no mention of AI, ML, or any related concepts.
Yes
The device is indicated for the treatment of chronic pain, which is a therapeutic purpose.
No
The device is described as a lead extension for neuromodulation systems used in the treatment of chronic pain. Its purpose is to provide additional length for connecting leads to a receiver, not to diagnose a condition.
No
The device description explicitly details physical components like a silicone connector body, Platinum/Iridium contacts, braided wire cable, and a polyurethane sheath, 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 for the treatment of chronic pain of the trunk and limbs. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is an implantable lead extension used to connect to other components of a neurostimulation system. This is a medical device used for treatment, not for analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
ANS Renew Lead Extensions are indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. Lead extensions are intended to be used with Advanced Neuromodulation Systems, leads, receivers, transmitters, and antennae.
Product codes (comma separated list FDA assigned to the subject device)
GZB
Device Description
The Renew Lead Extension consists of a silicone connector body, with Platinum/Iridium contacts, and braided wire cable inside a polyurethane sheath. Lead extensions are designed to be implanted to add additional length to the lead for connection to a receiver or externalized for use during a trial stimulation period not to exceed 30 days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trunk and limbs (Spinal cord stimulation)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
The biocompatible materials used to construct the lead extension are the same type as those used for predicate devices with the same classification regulation, for the same intended use. The addition of this extension raises no significant safety or effectiveness questions.
Verification testing was performed as required by the risk analysis for this modification. The results demonstrated that the acceptance criteria were met for the following tests: Insulation Resistance, Conductor Resistance System Impedance, Dielectric Strength, Accelerated Contact Resistance, Connector Pull Test, Lead Body Flex Life, Strain Relief Flex Life, Stiffness, and Setscrew Block Retention.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN 2 4 1999
Image /page/0/Picture/1 description: The image shows the logo "ANS" in bold, black letters. To the left of the letters is a square grid pattern, also in black. The grid is made up of small squares arranged in a 6x6 pattern. The letters are large and fill most of the horizontal space in the image.
.
Page 1 of 3
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: | May 21, 1999 |
|---|---|
| Company: | Advanced Neuromodulation Systems, Inc. |
| One Allentown Parkway | |
| Allen, TX 75002-4211 | |
| Contact: | Katryna Warren |
| Phone Number: | 972-390-9800 Ext. 332 or |
| 972-309-8000 | |
| Fax Number: | 972-390-2881 or (972) 309-8150 |
1
Image /page/1/Picture/0 description: The image shows the logo for ANS, which is a professional organization for people in the nuclear industry. The logo consists of a grid of small squares on the left, followed by the letters "ANS" in a bold, sans-serif font. The grid of squares is likely meant to represent a nuclear reactor core, while the letters "ANS" stand for the American Nuclear Society.
Page 2 of 3
Lead Extension 510(k) Summary of Safety and Effectiveness
Device Information:
| Trade Names: | Renew Lead Extension Model 3382
Renew Lead Extension Model 3383
Renew Dual Lead Extension Model 3341
Renew Dual Lead Extension Model 3342
Renew Dual Lead Extension Model 3343 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Spinal Cord Stimulator |
| Classification Name:
Relief | Implanted Spinal Cord Stimulator for Pain |
Predicate Device:
Advanced Neuromodulation Systems, Inc., currently markets One Step Connect™ Leads under 510(k) # K960728 and Octrode Neurostim Receiver under 510(k) # K930536.
Device Description:
The Renew Lead Extension consists of a silicone connector body, with Platinum/Iridium contacts, and braided wire cable inside a polyurethane sheath. Lead extensions are designed to be implanted to add additional length to the lead for connection to a receiver or externalized for use during a trial stimulation period not to exceed 30 days.
Intended Use:
ANS Renew Lead Extensions are indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. Lead extensions are intended to be used with Advanced Neuromodulation Systems, leads, receivers, transmitters, and antennae.
Comparison To Predicate Device:
The following table illustrates the comparison between the modified device, and the original legally marketed device.
2
Image /page/2/Picture/0 description: The image shows the letters 'ANS' in a bold, sans-serif font. To the left of the letters is a square grid pattern composed of smaller filled squares. The letters and the grid pattern are all in black, contrasting with the white background.
Page 3 of 3
| | ANS Predicate Device
510(k) K960728, K930536 | ANS Modified Device
K# Under Review |
|---------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Intended Use: | Stimulation of spinal cord for
treatment of chronic pain of
the trunk and limbs | Stimulation of spinal cord for
treatment of chronic pain of
the trunk and limbs |
| Materials: | | |
| • Electrode: | Platinum/Iridium | N/A |
| • Contact Terminal: | Stainless Steel 304 | Platinum/Iridium |
| • Insulator: | Polyurethane | Polyurethane |
| • Connector Coating | Silicone
(K930536) | Silicone |
| Design Features: | Braided Wire Cable | Braided Wire Cable |
| | 4,8,or 16 electrodes | N/A – The extension
connects with the terminal
end of the lead |
| | Percutaneous Introduction | Percutaneous
Introduction/
External Use |
| Dimensions: | | |
| • Length: | 58 - 80 cm | 10 - 30 cm |
| Sterilization | 100% ETO | 100% ETO |
| | Sterility Assurance Level
(SAL) 1x 10-6 | Sterility Assurance Level
(SAL) 1x 10-6 |
| Packaging: | Tray w/ Tyvek Lid | Tray w/ Tyvek Lid |
| Labeling: | Labeled as sterile,
prescription device | Labeled as sterile,
prescription device |
Non-clinical Testing:
The biocompatible materials used to construct the lead extension are the same type as those used for predicate devices with the same classification regulation, for the same intended use. The addition of this extension raises no significant safety or effectiveness questions.
Verification testing was performed as required by the risk analysis for this modification. The results demonstrated that the acceptance criteria were met for the following tests: Insulation Resistance, Conductor Resistance System Impedance, Dielectric Strength, Accelerated Contact Resistance, Connector Pull Test, Lead Body Flex Life, Strain Relief Flex Life, Stiffness, and Setscrew Block Retention.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing to the right, arranged in a way that they resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1999
Ms. Katryna Warren Advanced Neuromodulation Systems One Allentown Parkway Allen, Texas 75002-4211
K991784 Re: Trade Name: Renew TM Lead Extension Regulatory Class: II Product Code: GZB Dated: May 21, 1999 Received: May 25, 1999
Dear Ms. Warren:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Ms. Katryna Warren
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Page 1of 1
510(k) Number (if known): K 99/787
Device Name: Lead Extension
Indications For Use:
ANS Lead Extensions are indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. Lead extensions are intended to be used with Advanced Neuromodulation Systems', leads, receivers, transmitters, and antennae.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
les
eral Restorative Devices
0000000