(107 days)
Advanced Neuromodulation Systems Lamitrode Spinal Cord Stimulation Leads 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 and is intended to be used with Advanced Neuromodulation Systems extensions and/or receivers, transmitters, and antennae. The proposed device modification does not affect the original intended use of the legally marketed device.
Advanced Neuromodulation Systems, Inc.'s Lamitrode Leads are implantable devices consisting of spaced electrodes connected by wires within a cover sheath. These lamitrode leads are introduced into the epidural space via a hemilaminectomy, superior to the spinal segment responsible for pain impulse transmission, and connected to a radio-frequency (RF) receiver or pulse generator.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for a spinal cord stimulator lead, focusing on device description, comparison to predicate devices, and non-clinical testing related to material changes. It does not detail specific performance metrics, clinical study design, or results in the context of acceptance criteria.
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3 JUN
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990469
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: | February 1, 1999 |
|---|---|
| Company: | Advanced Neuromodulation Systems, IncOne Allentown ParkwayAllen, TX 75002-4211 |
| Contact: | Drew Johnson |
| Phone Number: | 972-390-9800 Ext. 327 |
| Fax Number: | 972-390-2881 |
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Lamitrode Spinal Cord Stimulator Lead 510(k) Summary of Safety and Effectiveness
Device Information:
| Trade Names: | Lamitrode® Model 1916L Lead |
|---|---|
| Lamitrode® Model 1944L Lead | |
| Lamitrode® Model 1992LS Lead | |
| Lamitrode® Model 1995L Lead | |
| Lamitrode® Model 1998L Lead | |
| Common Name: | Spinal Cord Stimulator |
| Classification Name: | Implanted Spinal Cord Stimulator for Pain Relief |
Predicate Device:
Advanced Neuromodulation Systems, Inc.,., currently markets spinal cord stimulator systems with Silicone lead insulators under 510(k) # K853643 and K905255 and K960728.
Device Description:
Advanced Neuromodulation Systems, Inc.'s Lamitrode Leads are implantable devices consisting of spaced electrodes connected by wires within a cover sheath. These lamitrode leads are introduced into the epidural space via a hemilaminectomy, superior to the spinal segment responsible for pain impulse transmission, and connected to a radio-frequency (RF) receiver or pulse generator.
Intended Use:
Advanced Neuromodulation Systems, Inc.'s Lamitrode Leads are intended to be used with Advanced Neuromodulation Systems 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, the original legally marketed device and other legally marketed devices.
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| ANS Predicate Device510(k) K853643,K905255, K960728 | Medtronic PredicateDevice 510(k)K884948, K811655,and K905407 | ANS Modified DeviceK# Under Review | |
|---|---|---|---|
| Intended Use: | Stimulation of spinalcord for treatment ofchronic pain of thetrunk and limbs | Stimulation of spinalcord for the treatmentof chronic pain of thetrunk and limbs | Stimulation of spinalcord for treatment ofchronic pain of thetrunk and limbs |
| Materials:• Electrode: | Platinum/Iridium | Same | Platinum/Iridium |
| • Contact Terminal: | Stainless Steel 304 | Stainless Steel 304 | |
| • Insulator: | Silicone(K960728)Polyurethane | SiliconePolyurethane | Polyurethane |
| Design Features: | Multi-electrodeCatheter | Multi-electrodeCatheter | |
| Braided Wire Cable | Braided Wire Cable | ||
| Platinum/IridiumElectrode | Platinum/IridiumElectrode | Platinum/IridiumElectrode | |
| 4,8,or 16 electrodes | 4 and 8 staggeredelectrodes | 4,8, or 16 electrodes | |
| LaminectomyIntroductionPercutaneousIntroduction(K960728) | LaminectomyIntroduction | LaminectomyIntroduction | |
| Dimensions:• Length: | 58 - 80 cm | 10 - 100 CM | 58 - 80 cm |
| Packaging: | Tray w/ Tyvek Lid | Tray w/ Tyvek Lid | Tray w/ Tyvek Lid |
| Labeling: | Labeled as sterile, | Labeled as sterile, | Labeled as sterile,prescription device |
Non-clinical Testing:
Biostability testing of the polyuethane and silicone material is provided in the manufacturer's Master File. Master File biocompatibility information demonstrates that the change to polyurethane and platinum cured silicone raises no significant safety or effectiveness questions relating to biocompatibility.
Comparative testing of product bond strength indicates that the polyurethane lead insulator to the platinum cured paddle has a better bond strength than the current product.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1999 JUN
Mr. Drew Johnson Director, Regulatory Affairs Advanced Neuromodulation Systems, Inc. One Allentown Parkway 75002-4211 Allen, Texas
K990469 Re : Lamitrode Spinal Cord Stimulation Leads, Trade Name: Lamitrode® 1916L, 1944L, 1992LS, 1995L, and 1998L Requlatory Class: II Product Code: GZB May 17, 1999 Dated: May 18, 1999 Received:
Dear Mr. Johnson:
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 The general controls provisions of the Act 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. ਸੈ 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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.
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Page 2 - Mr. Drew Johnson
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, JPh.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K990469
Device Name: Lamitrode Spinal Cord Stimulation Lead
Indications For Use:
Advanced Neuromodulation Systems Lamitrode Spinal Cord Stimulation Leads 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 and is intended to be used with Advanced Neuromodulation Systems extensions and/or receivers, transmitters, and antennae. The proposed device modification does not affect the original intended use of the legally marketed device.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
b coello
Restorative Devices
Prescription Use . (Per 21 CFR 801.109)
§ 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).