(60 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe functionalities typically associated with these technologies in medical devices (like image analysis or complex pattern recognition for diagnosis/treatment planning).
Yes
The intended use states that the device "is indicated for the treatment of chronic pain." This directly indicates a therapeutic purpose.
No
The device is described as a stimulator system for the treatment of chronic pain, indicating a therapeutic rather than a diagnostic purpose. It "deliver[s] targeted paresthesia" for "trial stimulation," but this is part of assessing the effectiveness of potential therapy, not diagnosing a condition.
No
The intended use describes a "Multiprogram Trial Stimulator System" which is a hardware device used for delivering electrical stimulation. The summary does not mention any software-only components or functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "treatment of chronic pain of the trunk and limbs" and for "trial stimulation" to deliver "targeted paresthesia." This describes a therapeutic device that interacts directly with the patient's body to alleviate symptoms.
- IVD Definition: In vitro diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such tests on specimens.
- Lack of IVD Indicators: The description does not mention any activities related to analyzing biological samples, laboratory procedures, or diagnostic testing.
Therefore, the Advanced Neuromodulation Systems, MTSm Multiprogram Trial Stimulator System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Advanced Neuromodulation Systems, MTSm Multiprogram Trial Stimulator System is 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.
The MTSm Multiprogram Trial Stimulator System is intended to be used with ANS Trial Leads (percutaneous) and External Test Extensions, to deliver targeted paresthesia to single or multiple painful sites for trial stimulation either intraoperatively or post operatively for up to a maximum of thirty days.
Product codes
GZB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Trunk and limbs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three horizontal lines above it, representing the agency's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2004
Katryna Warren Senior Regulatory Affairs Specialist Advanced Neuromodulation Systems, Inc. 6501 Windcrest Drive, Suite 100 Plano, Texas 75024
Re: K033757
Trade/Device Name: MTS Multiprogram Trial Stimulation System Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: November 26, 2003 Received: December 9, 2003
Dear Ms. Warren:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
1
Page 2 - Ms. Katryna Warren
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 vours.
Mark A. Millman
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
Enclosure
2
510(k) Number (if known):
Device Name: MTS™ Multiprogram Trial Stimulator System
Indications for Use:
Advanced Neuromodulation Systems, MTSm Multiprogram Trial Stimulator System is 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.
The MTSm Multiprogram Trial Stimulator System is intended to be used with ANS Trial Leads (percutaneous) and External Test Extensions, to deliver targeted paresthesia to single or multiple painful sites for trial stimulation either intraoperatively or post operatively for up to a maximum of thirty days.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
f Mark H. Melkerson
(Division Sign-Off)
Division of General, Restorative
Neurological Devices
Prescription Use
(Per 21 CFR 801.109)
Or
Over-The-Counter Use