(30 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, or related concepts like DNN, image processing, or training/test sets, which are typically associated with AI/ML-powered medical devices.
Yes
The device is indicated for the management of chronic, intractable pain, which is a therapeutic purpose.
No
The device is described as a neurostimulation system used to manage chronic, intractable pain, which is a therapeutic rather than a diagnostic function.
No
The summary describes a neurostimulation system, which inherently involves hardware components (stimulator, leads, receiver) to deliver electrical stimulation. The description focuses on the system's indication for use in pain management via electrical stimulation, not on a software application that processes data or provides analysis.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage chronic, intractable pain by stimulating nerves. This is a therapeutic intervention performed in vivo (within the body).
- Device Description (or lack thereof): While the description is "Not Found," the intended use clearly points to a device that interacts directly with the patient's nervous system.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed for testing samples outside of the body. This device is a neurostimulator, which is a type of medical device used for treatment inside the body.
N/A
Intended Use / Indications for Use
The Medtronic X-trel® and Mattrix® Neurostimulation systems are indicated as an aid in the management of chronic, intractable pain of the trunk or limbs. X-trel and Mattrix Receiver Model 3272 systems are also indicated for peripheral nerve stimulation.
Peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.
Product codes
GZB, GZF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trunk or limbs, peripheral nerve
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and human needs. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle's perimeter.
JUN 2 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David H. Mueller Regulatory Affairs Manager NeuroStimulation Business Medtronic, Inc. 800 53rd Avenue NE Minneapolis, Minnesota 55421-1200
Re: K011584
Trade/Device Names: Medtronic Spinal Cord and Peripheral Nerve Stimulation Systems for Pain Relief (see enclosed list) Regulation Numbers: 21 CFR 882.5880 and 21 CFR 882.5870 Regulatory Class: II Product Codes: GZB and GZF Dated: May 22, 2001 Received: May 23, 2001
Dear Mr. Mueller:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 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 devices 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.
1
Page 2 – David H. Mueller
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Mark N. Milhurn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
2
FDA REQUIRED INDICATIONS PAGE
510(k) Number: K011584
Device Name(s): Medtronic Spinal Cord Stimulation Systems for Pain Relief and Medtronic Peripheral Nerve Stimulation Systems for Pain Relief
Indications for Use:
The Medtronic X-trel® and Mattrix® Neurostimulation systems are indicated as an aid in the management of chronic, intractable pain of the trunk or limbs. X-trel and Mattrix Receiver Model 3272 systems are also indicated for peripheral nerve stimulation.
Peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.
(Please do not write below this line-continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Melkerson
ral. Restorative and Neurological Devices KO 11584
510(k) Number -
(Option Format 3-10-98)