(267 days)
3586, 3587A, 3982, 3983, 3993, 3483S
Not Found
No
The summary describes a passive implantable lead for delivering electrical pulses, with no mention of computational or adaptive capabilities.
Yes
The device is indicated for the management of chronic pain, either as a sole agent or as an adjunct to other therapies. This indicates its role in treating a medical condition, qualifying it as a therapeutic device.
No
The device is described as an implantable lead used to deliver electrical pulses for chronic pain management, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is an "implantable, permanent lead" with physical components like lead bodies, a paddle, electrodes, and contacts, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the management of chronic pain by delivering electrical pulses to the spinal cord. This is a therapeutic intervention performed in vivo (within the living body).
- Device Description: The device is an implantable lead designed to be placed in the epidural space of the spinal cord. This is a physical device used for direct electrical stimulation of tissue.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests on bodily samples.
The device described is a spinal cord stimulator lead, which is a type of active implantable medical device used for pain management.
N/A
Intended Use / Indications for Use
The Medtronic® Model 3998 Specify™ Lead is indicated in the management of chronic pain of the trunk and limbs, either as a sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach to chronic pain alleviation.
Product codes
GZB
Device Description
The Medtronic Specify Model 3998 Lead is an implantable, permanent lead. It is used to deliver electrical pulses to the dorsal aspect of the spinal cord.
The lead consists of two polyurethane lead bodies joined to one silicone rubber paddle. The lead has two parallel rows of four platinum iridium electrodes on the distal end.
At the proximal end of each lead body are the lead contacts, which fit into a Medtronic in-line, four-conductor connector. The Model 3998 lead can be used with any Medtronic products that have two in-line connectors, including:
- The Mattrix system, Model 3272 receiver .
- The Bifurcated Y-extension, Model 7498, which can be used with the . Itrel or Xtrel system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space of the spinal cord
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
Medtronic, Inc., has provided descriptive data on the test plan and test results for the Specify Model 3998 Lead. These data support that the function and characteristics of the device are suitable for its intended use.
Paddle flex testing was performed which indicated the Model 3998 Specify lead to equal the flex characteristics of other currently available Medtronic leads.
Tensile strength testing was performed to evaluate the separation strength of the lead. This testing indicated the lead to have adequate strength to perform its intended use.
DC Resistance testing was performed to evaluate the electrode impedance. This testing indicated adequate connections exist.
Additionally, cross circuit impedance testing was performed to evaluate the effectiveness of circuit isolation. This testing concluded isolation to be adequate.
Key Metrics
Not Found
Predicate Device(s)
Medtronic® Model 3586 Resume® Lead, Medtronic® Model 3587A Resume II® Lead, Medtronic® Model 3982 SymMix® Lead, Medtronic® Model 3983 Lead, Medtronic® Model 3993 TTL Lead, Medtronic® Model 3483S Pisces-Sigma® Lead
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).
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Image /page/0/Picture/0 description: The image shows the word "Medtronic" in a bold, sans-serif font. To the right of the word is a square logo. The logo contains a stylized image of a face.
Medtronic Neurological 800 53rd Avenue NE P.O. Box 1250 Minneapolis, MN 55440-9087 (612) 572-5000 1-800-328-0810 FAX: (612) 572-5078
12971756
FEB - 3 N88
SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTER L
Name and Address:
Medtronic, Inc. 800 53rd Avenue N.E. Minneapolis, MN 55421
Lisa L. Pritchard
Contact Person:
August 29, 1997 Date of Summary Preparation:
Establishment Registration Number: 2182207
II. DEVICE NAME
Device Common or Usual Name:
Device Trade Name:
Device Classification Name:
Lead for Implanted Spinal Cord Stimulation
Medtronic® SpecifyTM Model 3998 Lead
Implanted Spinal Cord Stimulator for Pain Relief (21 CFR 882.5880)
III. PREDICATE DEVICE
Leads for Implanted Spinal Cord Stimulators for Pain Relief:
- Medtronic® Model 3586 Resume® Lead .
- Medtronic® Model 3587A Resume II® Lead ●
- . Medtronic® Model 3982 SymMix® Lead
- Medtronic® Model 3983 Lead
- Medtronic® Model 3993 TTL Lead ●
- Medtronic® Model 3483S Pisces-Sigma® Lead ●
1
Medtronic &
t
Medtronic Neurological 800 53rd Avenue NE P.O. Box 1250 Minneapolis, MN 55440-9087 (612) 572-5000 1-800-328-0810 FAX: (612) 572-5078
IV. DEVICE DESCRIPTION
The Medtronic Specify Model 3998 Lead is an implantable, permanent lead. It is used to deliver electrical pulses to the dorsal aspect of the spinal cord.
The lead consists of two polyurethane lead bodies joined to one silicone rubber The lead has two parallel rows of four platinum iridium electrodes on the paddle. distal end.
At the proximal end of each lead body are the lead contacts, which fit into a Medtronic in-line, four-conductor connector. The Model 3998 lead can be used with any Medtronic products that have two in-line connectors, including:
- The Mattrix system, Model 3272 receiver .
- The Bifurcated Y-extension, Model 7498, which can be used with the . Itrel or Xtrel system.
INDICATION FOR USE V.
The Medtronic® Model 3998 Specify™ Lead is indicated in the management of chronic pain of the trunk and limbs, either as a sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach to chronic pain alleviation.
VI. COMPARISON TO PREDICATE DEVICES
The Medtronic Specify Model 3998 Lead is substantially equivalent to other Medtronic Spinal Cord Stimulation leads currently in commercial distribution.
- a. Product Labeling
Product labeling for each of the Medtronic Spinal Cord Stimulation Leads is substantially equivalent to the proposed product labeling for the Specify Model 3998 lead.
2
Medtronic &
Medtronic Neurological 800 53rd Avenue NE P.O. Box 1250 Minneapolis, MN 55440-9087 (612) 572-5000 1-800-328-0810 FAX: (612) 572-5078
"
b. Intended Use
The Medtronic Specify Model 3998 Lead has the same intended use as many of the current Medtronic Spinal Cord Stimulation Leads. The Medtronic Specify Model 3998 Lead is indicated in the management 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 to chronic pain alleviation.
Physical Characteristics C.
In the existing Medtronic Spinal Cord Stimulation leads, and the Specify Model 3998 Lead, the lead consists of two lead bodies attached to a paddle containing eight stimulating electrodes. Electrically and functionally, the Model 3998 Lead is the same as two of Medtronic's current leads combined within one paddle. Medtronic, Inc., supplied an equivalence table comparing the similarities and differences within this physical structure. Materials used are identical to predicate device leads.
d. Anatomical Sites
In the existing Medtronic Spinal Cord Stimulation leads, and the Specify Model 3998 Lead, the lead is placed within an epidural space of the spinal cord.
Performance Testing e.
Medtronic, Inc., has provided descriptive data on the test plan and test results for the Specify Model 3998 Lead. These data support that the function and characteristics of the device are suitable for its intended use.
Paddle flex testing was performed which indicated the Model 3998 Specify lead to equal the flex characteristics of other currently available Medtronic leads.
Tensile strength testing was performed to evaluate the separation strength of the lead. This testing indicated the lead to have adequate strength to perform its intended use.
3
Medtronic &
Medtronic Neurological 800 53rd Avenue NE P.O. Box 1250 Minneapolis, MN 55440-9087 (612) 572-5000 1-800-328-0810 FAX: (612) 572-5078
DC Resistance testing was performed to evaluate the electrode impedance. This testing indicated adequate connections exist.
Additionally, cross circuit impedance testing was performed to evaluate the effectiveness of circuit isolation. This testing concluded isolation to be adequate.
In summary, Medtronic, Inc. has provided information within the 510(k) Premarket Notification to indicate that the Specify™ Model 3998 Lead is safe and effective for its intended use in the treatment of chronic intractable pain of the trunk and limbs. Additionally, the Specify Model 3998 Lead has been shown to be comparable in terms of intended use and technological characteristics to the Spinal Cord Stimulation Leads currently in commercial distribution. The data and information provided within this 510(k) premarket notification adequately support that the Specify Model 3998 Lead is substantially equivalent to other Medtronic Spinal Cord Stimulation Leads currently in commercial distribution.
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Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the head, body, and tail feathers. The logo is simple and recognizable, and it is often used on official documents and websites related to health and human services in the United States.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 3 1998
Ms. Lisa L. Pritchard Senior Product Regulation Manager Medtronic, Incorporated 800 53rd Avenue, NE P.O. Box 1250 Minneapolis, Minnesota 55440-9087
Re: K971756 Trade Name: Medtronic Specify Model 3998 Lead Regulatory Class: II Product Code: GZB Dated: December 10, 1997 Received: December 11, 1997
Dear Ms. Pritchard:
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 forannual 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 requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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
5
Page 2 - Ms. Pritchard
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 vour 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
Enclosure
6
510(k) Number (if Known)
Device Name: Specify™ Model 3998 Spinal Cord Stimulation Lead
Indications for Use:
The Medtronic® Model 3998 Specify™ Lead is indicated in the management 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 to chronic pain alleviation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) 510k) Num OR Over-The Counter Use
Prescription Use (Per 21 CFR 801.109)