(104 days)
Not Found
No
The document describes a magnetic stimulator with power electronics and a user interface, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The "Intended Use / Indications for Use" states that the device is "intended to be used for stimulation of peripheral nerves for diagnostic purposes," not for therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used for stimulation of peripheral nerves for diagnostic purposes."
No
The device description explicitly states that the MagPro R20 consists of power electronics, a built-in computer, displays, and connects to a magnetic coil, indicating it is a hardware device with integrated software for control.
Based on the provided information, the MagPro R20 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "stimulation of peripheral nerves for diagnostic purposes." This involves stimulating the body directly, which is an in vivo (within the living body) process.
- Device Description: The description details a magnetic stimulator that applies magnetic fields to tissue. This is a physical interaction with the body, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting analytes or biomarkers
- Performing tests in a laboratory setting
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MagPro R20's function is to stimulate nerves within the body for diagnostic purposes, which falls under the category of a therapeutic or diagnostic device that interacts directly with the patient.
N/A
Intended Use / Indications for Use
MagPro R20 is intended to be used for stimulation of peripheral nerves for diagnostic purposes.
Product codes
GWF
Device Description
MagPro R20 is a Magnetic stimulator used for Magnetic stimulation. Magnetic stimulation is a non-invasive technique for stimulating neural tissue. Application areas of magnetic stimulation are a sub-set of the application areas for current stimulation.
The MagPro R20 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue.
The MagPro R20 consists of power electronics to generate the magnetic field in the Magnetic Coil. The MagPro R20 is controlled via a user interface, enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The MagPro R20 has a built-in computer and 2 small displays.
The magnetic pulse is Biphasic waveform and the stimulator can stimulate with a frequency of up to 20 pulses per second (pps).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The MagPro R20 complies with the standard for electrical safety standard, IEC 60601-1 v3.1, and has been tested at a certified test center, UL Demko. EMC testing has been performed for compliance with the EMC standard, IEC 60601-1-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MagPro R30, K061645
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2016
Tonica Elektronik A/S Lise Terkelsen QA/RA Manager Lucernemarken 15 DK-3520 Farum, Denmark
Re: K160280
Trade/Device Name: MagPro R20 Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF Dated: February 1, 2016 Received: February 2, 2016
Dear Lise Terkelsen:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
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" (21 CFR 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, William J. Heetderks -A cn=William J. Heetderks -A
Date: 2016.05.16 16:55:59 -04'00 for Carlos L. Peña, PhD, MS 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) K160280
Device Name MagPro R20
Indications for Use (Describe)
MagPro R20 is intended to be used 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's Information
| Name of 510(k) owner: | Tonica Elektronik A/S
Lucernemarken 15
DK-3520 Farum, Denmark |
|-------------------------------------|---------------------------------------------------------------------|
| Phone: | +45 4499 8444 |
| Fax: | +45 4499 1544 |
| Contact person: | Lise Terkelsen |
| Preparation date: | May 13th, 2016 |
| Trade name: | MagPro R20 |
| Common name: | MagPro R20 |
| Classification name: | Evoked Response Electrical Stimulator |
| Classification: | Class II Medical Device |
| Product Code: | GWF |
| Regulation number: | 21 CFR 882.1870 |
| Identification of predicate device: | MagPro R30, K061645 |
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Device description
MagPro R20 is a Magnetic stimulator used for Magnetic stimulation. Magnetic stimulation is a non-invasive technique for stimulating neural tissue. Application areas of magnetic stimulation are a sub-set of the application areas for current stimulation.
The MagPro R20 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue.
The MagPro R20 consists of power electronics to generate the magnetic field in the Magnetic Coil. The MagPro R20 is controlled via a user interface, enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The MagPro R20 has a built-in computer and 2 small displays.
The magnetic pulse is Biphasic waveform and the stimulator can stimulate with a frequency of up to 20 pulses per second (pps).
Intended Use:
The MagPro R20 is intended for stimulation of peripheral nerves for diagnostic purposes.
Substantial Equivalence:
The MagPro R20 in this submission has the same characteristics as the predicate device, MagPro R30 (K061645). Stimulation of peripheral nerves is the intended application which applies to both devices.
They consist of a unit comprising power electronic to generate the magnetic fields in a Magnetic Coil. All includes a user interface to control the device via knobs and a display on the front panel.
The waveforms for the MagPro R20 and the MagPro R30 are biphasic. The maximum stimuli frequency is 30 pulses per second for MagPro R30 while 20 pulses per second for MagPro R20.
The MagPro R20 is CE-marked and complies with the Medical Device Directive 93/42/EEC. The MagPro R20 is developed and manufactured according to EN13485, "Medical devices - Quality management systems - Requirement for regulatory purposes".
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| Area | New Device | Predicate Device | Conclusion |
|---|---|---|---|
| MagPro R20 | MagPro R30 | ||
| Tonica Elektronik A/S | Tonica Elektronik A/S | ||
| Is intended to be used for stimulation of | |||
| peripheral nerves for diagnostic purposes. | Is intended to be used for stimulation of | ||
| peripheral nerves for diagnostic purposes. | Identical | ||
| Power Supply via Isolation Transformer | |||
| Power Supply: 120V~, 50/60 Hz. | |||
| Power consumption: Maximum 800VA | Power Supply via Isolation Transformer | ||
| Power Supply: 120V~, 50/60Hz | |||
| Power consumption: Maximum 2300VA | Identical | ||
| Lower power consumption | |||
| Dimensions (HxWxD): | |||
| 150 x 390 x 440mm | |||
| Weight: 20 kg / 44 lbs | Dimensions (HxWxD): | ||
| 210 x 530 x 400mm | |||
| Weight: 36kg / 79 lbs | R30 bigger and heavier than R20. | ||
| 280 µsec Biphasic | 280 µsec Biphasic | Identical | |
| MagPro R20 consists of a power module, a | |||
| processor module and built in displays. The | |||
| optional trolley supports the R20 and makes it | |||
| moveable. The complete system is powered from | |||
| an Isolation Transformer. | MagPro R30 consists of a power module, a | ||
| processor module and a built in display. The | |||
| optional trolley supports the R30 and makes it | |||
| moveable. The complete system is powered from | |||
| an Isolation Transformer. | Identical | ||
| MagPro R20 has 2 displays | |||
| • Intensity display | |||
| • Coil temperature | |||
| • Intensity | |||
| • Menu display and indicators can show | |||
| • Repetition rate | |||
| • Pulses in train | |||
| • Number of trains | |||
| • Inter train interval | |||
| • Start delay | MagPro R30 has 1 display | ||
| All parameter settings can be shown on the | |||
| display. | |||
| • Intensity | |||
| • Repetition rate | |||
| • Pulses in train | |||
| • Number of trains | |||
| • Inter train interval | |||
| • Start delay | |||
| • Amplitude | Primary readout equivalent. | ||
| MagPro R30 has a more complex interface. MagPro R20 | |||
| is meant for everyday diagnostic purposes | |||
| Same level of safety. | |||
| Area | New Device | Predicate Device | Conclusion |
| MagPro R20 | MagPro R30 | ||
| Tonica Elektronik A/S | Tonica Elektronik A/S | ||
| • Status: enable/disable | • Status: enable/disable | ||
| • Coil type | • Coil temperature | ||
| • Coil type | |||
| • Available stimuli | |||
| • Event log information and date/time | |||
| • Treatment sequence can be stored and | |||
| reused. Event log and Amplitude log can be | |||
| exported. | |||
| • Continuously readout of di/dt controlling the | |||
| stability of the produced magnetic | |||
| stimulation |
6
7
Testing
The MagPro R20 complies with the standard for electrical safety standard, IEC 60601-1 v3.1, and has been tested at a certified test center, UL Demko. EMC testing has been performed for compliance with the EMC standard, IEC 60601-1-2.
List of latest test reports:
| Electrical Safety reports | Electromagnetic Compatibility Reports | |
|---|---|---|
| Tests performed by: | Tests performed by: | |
| UL International Demko A/S | Delta (Danish Electronics, Light & Acoustics) | |
| www.ul-europe.com | www.delta.dk | |
| Test report no. | Test report name | Test report no. Test report name |
| E360406-D1-CB | UL IEC 60601-1 Medical | |
| electrical equipment | ||
| ANSI/AAMI ES60601- | ||
| 1:2005/A2:2010 | T206073-1 | |
| DANAK- | ||
| 19/13416 | ||
| Rev. A | ||
| DK-38637-UL | CB certificate | DELTA Test Report: |
| EMC test of MagPro R20 |
TABLE 1
Conclusion:
The MagPro R20 has the same intended use as the predicate device and the same technological features. The MagPro R20 does not raise new issues of safety and effectiveness and is substantially equivalent to the predicate device.