(175 days)
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.
Not Found
This FDA Premarket Notification (510(k)) K142432 for the StimRouter Neuromodulation System does not contain the detailed clinical study information requested.
Here's why and what's missing:
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Nature of the Document: This is a 510(k) clearance letter. It states that the device is "substantially equivalent" to legally marketed predicate devices. This regulatory pathway typically relies heavily on demonstrating similarity to existing devices through design, materials, and often, non-clinical (bench and animal) testing, rather than extensive new human clinical trials to prove efficacy against specific acceptance criteria in the same way a PMA (Pre-Market Approval) would.
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Focus of the Letter: The letter focuses on the FDA's regulatory decision and administrative details (registration, labeling, reporting, etc.). It does not include the detailed study report or clinical data that the manufacturer would have submitted.
Therefore, I cannot extract the following information from the provided text:
- 1. A table of acceptance criteria and the reported device performance: This information would be in a clinical study report, which is not present here.
- 2. Sample sized used for the test set and the data provenance: Not available in this document.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- 4. Adjudication method for the test set: Not available.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a neuromodulation system for pain, not an AI-powered diagnostic imaging tool. Thus, an MRMC study is not relevant and certainly not included.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Again, this is a directly implantable neuromodulation device, not an AI algorithm.
- 7. The type of ground truth used: Not applicable in the context of demonstrating substantial equivalence for a neuromodulation device in a 510(k). The "ground truth" would be the clinical outcome (pain reduction), but the document does not detail studies proving this with specific criteria.
- 8. The sample size for the training set: Not applicable as this is not an AI/machine learning device that uses training sets in the conventional sense.
- 9. How the ground truth for the training set was established: Not applicable.
What is available from the document:
- Device Name: StimRouter Neuromodulation System
- Indications for Use: 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). Not intended to treat pain in the craniofacial region.
- Regulatory Class: Class II
- Product Code: GZF
To find the kind of detailed study information you're asking for, you would generally need to look for a clinical study report (CSR), a publication in a peer-reviewed journal, or a more detailed FDA document like a PMA review memo, which contains more in-depth data for devices requiring higher evidence. A 510(k) clearance letter itself does not provide this level of detail.
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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
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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)
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Concurrence of Center for Devices and Radiological Health (CDRH)
§ 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).