(258 days)
Not Found
No
The summary describes a spinal cord stimulation lead with physical modifications and does not mention any AI/ML components or functionalities.
Yes
The device is indicated for use in the treatment of chronic intractable pain, indicating a therapeutic purpose.
No
The document states that the device is "indicated for use for epidural spinal cord stimulation (SCS) as an aid in the treatment of chronic intractable pain," which describes a therapeutic rather than a diagnostic function.
No
The device description explicitly details physical components (leads, wires, paddle, crimps, ferrules, radiopaque markers) which are hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The description clearly states this is a "Spinal Cord Stimulation (SCS)" lead. These leads are implanted inside the body to deliver electrical stimulation to the spinal cord.
- Intended Use: The intended use is for "epidural spinal cord stimulation (SCS) as an aid in the treatment of chronic intractable pain of the trunk and/ or limbs." This is a therapeutic intervention performed on the patient, not a diagnostic test performed on a specimen.
Therefore, based on the provided information, the Medtronic Model 3991A Series Leads are a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Medtronic Model 3991a series of Transverse Tripolar™ Leads, or TTL™ leads are indicated for use for SCS for chronic intractable pain of truck or limbs, as for the Model 3982 Symmix®, Model 3883, Model 3586 and Model 3487A leads.
Model 3991A Series Leads are indicated for use for epidural spinal cord stimulation (SCS) as an aid in the treatment of chronic intractable pain of the trunk and/ or limbs.
Product codes (comma separated list FDA assigned to the subject device)
84GZB
Device Description
Medtronic Model 3991a, 3992a, 3993a, 3994a Leads. There are three modifications in the Model 3991a series of leads from the original Model 3991C (K952459). These modifications are: A. Spiral-wound wires in lead body. B. Crimps and ferrules in the paddle. C. Radiopaque markers in the tips of the paddle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
trunk or limbs, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
K913993, K952459, K923931, K910199, K923567, K884948
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).
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del 3991A . K964172, Response to Questions
June 30, 1997
JUL - 3 1997
RE: 510(k) Notification: Medtronic Model 3991a, 3992a, 3993a, 3994a Leads
In order to comply with the Safe Medical Devices Act of 1990, these two pages will provide safety and effectiveness information to interested persons.
SUMMARY OF SAFETY AND EFFECTIVENESS
The Medtronic Model 3991a series of Transverse Tripolar™ Leads, or TTL™ leads are indicated for use for SCS for chronic intractable pain of truck or limbs, as for the Model 3982 Symmix®, Model 3883, Model 3586 and Model 3487A leads.
Medtronic considers the Model 3991a series of spinal cord stimulation leads to be substantially equivalent to the current Model 3982 Symmix lead K913993 in paddle size, the Model 3991 series of SCS leads (K952459) in paddle and electrode configuration, the Models 3487A (K923931), 3888 (K910199, K923567), and 3587A (K884948) leads for the lead body design and composition, and other commercially available spinal cord stimulation leads.
There are three modifications in the Model 3991a series of leads from the original Model 3991C (K952459). These modifications are discussed as follows:
A. Spiral-wound wires in lead body.
This change was recommended by Medtronic mechanical engineers as a result of Returned Product Analysis of one explanted lead and bench tests on similar Model 3991C leads. Hence it was done as a result of a single device failure. The new design minimizes forces being applied to the welds between lead body wires and connector rings in the proximal end of the lead, which was the site of the failure of the single returned lead.
B. Crimps and ferrules in the paddle.
This change was recommended by Medtronic mechanical engineers as the best way to have the spiral-wound wires of the lead body connect to the most lateral (edge) contacts of the paddle. Hence it was done to allow the modification a. (above) to be used.
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
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C. Radiopaque markers in the tips of the paddle.
This change was recommended by physicians so that they could best determine the orientation of the paddle relative to vertebral bones using fluoroscopy. Since the electrodes are all located in a relatively small area (10 mm x 10 mm), this helps to align certain contacts, E0, E1 and E2, transversely to the spinal cord.
Therefore, the Model 3991a TTL leads family with alternate design are substantially equivalent to current Medtronic spinal cord stimulation leads.
Sincerely,
MEDTRONIC, INC.
Neurological Division
David R. Zeller
David H. Mueller Regulatory Affairs Manager NeuroStimulation Business
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 1997
Mr. David H. Mueller Regulatory Affairs Manager NeuroStimulation Business Medtronic Neurological 800 53rd Avenue NE P.O. Box 1250 Minneapolis, Minnesota 55440-9087
Re: K964172 Trade Name: Medtronic TTL® Leads (Models 3991A, 3993A, and 3994A) Requlatory Class: II Product Code: 84GZB Dated: April 3, 1997 Received: April 4, 1997
Dear Mr. Mueller:
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 Requiations, Title 21, Farts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
Image /page/2/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three distinct head profiles, suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circular emblem, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.
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Page 2 - Mr. David H. Mueller
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.
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 leqally 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) 594-4648. 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,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Medtronic Model 3991A Lead Series
Indications For Use Statement
Model 3991A Series Leads are indicated for use for epidural spinal cord stimulation (SCS) aid in the treatment of chronic intractable pain of the trunk and/ or limbs.
All other uses are considered investigational.
| Prescription Use
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:
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Thomas J. Callahon
as an
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(Division Sign-Off) Division of Cardiovascular, R and Neurological Devices 510(k) Number