(201 days)
The STM9000 is intended for stimulation of peripheral nerves for diagnostic purposes.
The STM 9000 are magnetic stimulators used for magnetic stimulation. Magnetic stimulation is a noninvasive technique for stimulating neural and cortical tissue. Application areas of magnetic stimulation are a subset of the application areas for current stimulation. The STM 9000 is connected to a magnetic coil which transfers the magnetic stimulation to the tissue. The STM 9000 consists of power electronics to generate the magnetic field in the magnetic coil. The STM 9000 is controlled via a simple user interface, enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The magnetic pulse is capable of biphasic and monophasic waveforms and the stimulate with a frequency up to 100 pulses per second (pps).
This document is a 510(k) Premarket Notification for the STM9000 device, which is an evoked response electrical stimulator. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This type of submission relies heavily on showing that the new device has similar technological characteristics and performance to existing devices, rather than comprehensive clinical trial data for novel claims.
Therefore, the structure of the provided text does not contain the specific information typically found in a study proving a device meets acceptance criteria for an AI/Machine Learning (ML) enabled medical device. The STM9000 is a magnetic stimulator, and the performance data presented is focused on demonstrating its safety and basic functionality in comparison to a predicate device, as required for a traditional 510(k).
The document addresses:
- Biocompatibility Testing: To ensure the device materials are safe for contact with the human body.
- Electrical Safety and Electromagnetic Compatibility (EMC): To ensure the device operates safely in its electromagnetic environment and does not pose electrical hazards.
- Software Verification and Validation Testing: To ensure the software functions correctly and reliably, commensurate with its "Moderate" level of concern.
It does not contain the kind of performance data (e.g., sensitivity, specificity, AUC, accuracy) that would be derived from a study proving an AI/ML diagnostic or prognostic device meets acceptance criteria. There are no mentions of:
- A test set of patient data (e.g., images, physiological signals).
- Ground truth established by experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- Training set details for an ML model.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert involvement, or MRMC studies, as this information is not present in the provided 510(k) document for the STM9000. The performance data provided is about the device's inherent safety and functional compliance, not its diagnostic or prognostic accuracy on a dataset.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 19, 2015
EB Neuro, S.p.A. c/o Allison Scott Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 Indianapolis IN 46268
Re: K150220
Trade/Device Name: STM9000 Basic, STM9000 Standard, STM9000 Fast, STM9000 Ultra-Fast Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF Dated: July 16, 2015 Received: July 20, 2015
Dear Ms. Scott,
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
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 8091); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Michael J. Hoffmann -S
- for Carlos L. Peña, PhD, MS Division 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) K150220
Device Name
STM9000 Basic, STM9000 Standard, STM9000 Fast, STM9000 Ultra-Fast
Indications for Use (Describe)
The STM9000 is intended for stimulation of peripheral nerves for diagnostic purposes.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Submitter Information l.
EB Neuro, S.p.A. Via Pietro Fanfani 97/a Florence, Italy 50127
| Contact Person: | Allison Scott |
|---|---|
| 317.228.8719 | |
| Allison.Scott@Navigant.com |
Date Prepared: July 17, 2015
807.92(a)(2)
II. Devices
| Trade Name: | STM9000 Basic, STM9000 Standard, STM9000 Fast, STM9000 Ultra-Fast |
|---|---|
| Common Name: | Evoked Response Electrical Stimulator |
| Classification Name(s): | Evoked Response Electrical Stimulator (21 CFR 882.1870) |
| Product Code: | GWF |
| Regulatory Class: | Class II |
III. Predicate & Reference Device(s)
| Device | Owner | 510(k) | |
|---|---|---|---|
| MagPro, Model R30 | Tonica Elektronik A/S | K061645 | Predicate |
| MagPro R30 incl. MagOption, MagProX100, MagPro X100 incl. MagOption | Tonica Elektronik A/S | K091940 | Reference |
These devices have not been subject to a design-related recall.
IV. Device Description
The STM 9000 are magnetic stimulators used for magnetic stimulation. Magnetic stimulation is a noninvasive technique for stimulating neural and cortical tissue. Application areas of magnetic stimulation are a subset of the application areas for current stimulation.
The STM 9000 is connected to a magnetic coil which transfers the magnetic stimulation to the tissue. The following coils can be used with the STM 9000 family of magnetic stimulators:
| Code | Description |
|---|---|
| B9621086002 | Circular Coil 90 mm |
| B9621086001 | Circular Coil 70 mm |
| B9621086003 | Butterfly Coil 70 mm |
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| B9621086004 | Butterfly Coil 70 mm air cooled |
|---|---|
| B9621086005 | Butterfly Coil 80 mm, 120° |
| B9621086006 | Circular Coil 90 mm air cooled |
The STM 9000 consists of power electronics to generate the magnetic field in the magnetic coil. The STM 9000 is controlled via a simple user interface, enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The magnetic pulse is capable of biphasic and monophasic waveforms and the stimulate with a frequency up to 100 pulses per second (pps).
V. Intended Use
The STM9000 is intended for stimulation of peripheral nerves for diagnostic purposes.
VI. Comparison of Technological Characteristics
The technological characteristics of STM9000 are similar to those of MagPro X100. The devices are magnetic stimulators used for magnetic stimulation as a non-invasive technique for stimulating neural tissue. All devices are capable of single stimulation mode and repetitive stimulation mode.
The subject and predicate devices are connected to magnetic coils which transfer the magnetic stimulation to the tissue. The operator controls the functions and status of the devices through an interface consisting of a graphic LCD, a keyboard and a multifunction knob, integrated in the stimulator. The mechanical, electrical, and magnetic parameters of the coils in this submission are very near to the parameters of the predicate coils.
The main differences between the subject device and predicate are:
- -In some configurations, the STM9000 has a lower maximum repetition rate and/or allowable energy level than the predicate configurations
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VII. Performance Data
Biocompatibility Testing
The biocompatibility evaluation for the STM9000 was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity
- . Sensitization
- . Irritation
The STM9000 coils are considered a surface device contacting intact skin for a duration of less than 24 hours.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the STM9000. The system complies with the IEC 60601-1, IEC 60601-1-4 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the patient or operator.
VIII. Conclusion
The biocompatibility, electrical safety and EMC, and software verification and validation demonstrate that the STM9000 should perform as well as the predicate device in the specified use conditions.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).