(175 days)
Not Found
Not Found
No
The provided 510(k) summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies.
Yes
The device is indicated for pain management in adults with severe intractable chronic pain, which is a therapeutic purpose.
No
The StimRouter Neuromodulation System is described as being "indicated for pain management" and "an adjunct to other modes of therapy," which indicates a therapeutic rather than a diagnostic purpose.
No
The description explicitly refers to a "StimRouter Neuromodulation System," which strongly implies a hardware component (the stimulator) is part of the system, not just software. The lack of a detailed device description prevents a definitive "Yes" for software-only.
Based on the provided information, the StimRouter Neuromodulation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for pain management in adults with chronic pain of peripheral nerve origin. This is a therapeutic application, not a diagnostic one.
- Device Description (Not Found): While the description is missing, the intended use clearly points away from in vitro testing.
- No mention of biological samples: IVDs typically involve testing biological samples (blood, urine, tissue, etc.) outside of the body ("in vitro"). The StimRouter is a neuromodulation system, which implies it interacts directly with the body.
- No mention of diagnostic purpose: The purpose is pain management, not diagnosing a disease or condition.
Therefore, the StimRouter Neuromodulation System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.
Product codes
GZF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerve origin (excluding craniofacial region)
Indicated Patient Age Range
adults
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
(a)
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2015
Bioness Inc. Robert Schulz, RAC Global Director, Regulatory Affairs and Quality Assurance, 25103 Rye Canyon Loop Valencia, CA 91355
Re: K142432
Trade/Device Name: StimRouter Neuromodulation System Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted peripheral nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZF Dated: Jan 16th 2015 Received: Jan 20th 2015
Dear Mr. Schulz,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): __ K142432 _________________________________________________________________________________________________________________________________________
Device Name:
StimRouter Neuromodulation System
Indications for Use:
The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.
Image /page/2/Picture/8 description: The image contains a single Chinese character. The character is "风", which means wind. The character is inside of a square.
Prescription Use (Part 21 CFR 801 Subpart D)
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Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED
Concurrence of Center for Devices and Radiological Health (CDRH)