(141 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware and basic user interface controls for generating magnetic pulses. There is no mention of any data analysis, pattern recognition, or adaptive algorithms that would suggest AI/ML is incorporated.
No
The device is described as being used for "stimulation of peripheral nerves for diagnostic purposes," not for treating a condition or disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "stimulation of peripheral nerves for diagnostic purposes."
No
The device description explicitly states that the MagPro R30 is a magnetic stimulator consisting of power electronics and is connected to a magnetic coil, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "stimulation of peripheral nerves for diagnostic purposes." This describes a procedure performed on the patient's body to gather information, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a magnetic stimulator that applies magnetic pulses to neural tissue. This is an external device interacting directly with the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to stimulate nerves directly on the patient.
N/A
Intended Use / Indications for Use
The MagPro R30 is intended to be used for stimulation of peripheral nerves for diagnostic purposes.
Product codes (comma separated list FDA assigned to the subject device)
GWF
Device Description
MagPro R30 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 R30 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-125 and MC-B70 in K926516 can be used with the MagPro R30 as well as the coils C-100, C-B60 and MMC-140-II.
The MagPro R30 consists of power electronics to generate the magnetic field in the Magnetic Coil. The MagPro R30 is controlled via a simple user interface, enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The MagPro R30 has a built-in computer and a 8.4" display. The magnetic pulse is Biphasic waveform and the stimulator can stimulate with a frequency of up to 30 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MagPro, K926516, Magstim Super Rapid2, K051864
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
510(k) Summary
Name of 510(k) owner:
Tonica Elektronik A/S Lucernemarken 15 DK-3520 Farum Denmark
0C7 3 1 2006
Phone: Fax:
+45 4499 8444 +45 4499 1544
Contact:
Lise Terkelsen
Preparation date:
Trade name: Common name: Classification name: August 31, 2006
MagPro R30 MagPro R30 Evoked Response Electrical Stimulator
Identification of predicate devices:
MagPro, K926516 Magstim Super Rapid2, K051864
1
Device description
MagPro R30 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 R30 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-125 and MC-B70 in K926516 can be used with the MagPro R30 as well as the coils C-100, C-B60 and MMC-140-II.
The MagPro R30 consists of power electronics to generate the magnetic field in the Magnetic Coil. The MagPro R30 is controlled via a simple user interface, enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The MagPro R30 has a built-in computer and a 8.4" display. The magnetic pulse is Biphasic waveform and the stimulator can stimulate with a
frequency of up to 30 pulses per second (pps).
Intended Use:
The MagPro R30 is intended to be used for stimulation of peripheral nerves for diagnostic purposes.
Substantial Equivalence:
The MagPro R30 in this submission has the same characteristics as the predicate devices. MagPro (K926516) and Magstim Super Rapid2 (K051864). Stimulation of peripheral nerves is the intended application which applies for all three 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 R30 and the Magstim Super Rapid² are biphasic, for the MagPro the waveforms are biphasic and monophasic. The Max. stim. frequency is 30 pulses per second for MagPro R30 and Magpro, while for the Magstim Super Rapid² the frequency is 60 pulses per second.
The realized magnetic field the stimulator is produced together with the connected coil, is comparable to the old MagPro in K926516. The mechanical, electrical and magnetic parameters of the coils in this submission are very near to the parameters of the predicate coils. All coils are based on the same technology, design and material used.
The MagPro R30 is CE-marked and complies with the Medical Device Directive 93/42/EEC. The MagPro R30 is developed and manufactured according to EN13485. "Medical devices – Quality management systems – Requirement for regulatory purposes". The MagPro R30 complies with the standard for electrical safety standard, IEC 60601-1, 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.
2
Conclusion:
The MagPro R30 has the same intended use as the predicate devices and the same technological features.
All coils are a variant to the original approved in K926516.
The clinical performance of the magnetic field to the patient is unchanged from the predicate coils to the proposed coils.
The MagPro R30 and coils do not raise new issues of safety and effectiveness and is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/2 description: The image shows a logo for the Department of Health. The logo is a stylized human figure with three lines representing the head, body, and legs. The figure is facing to the right. The text "DEPARTMENT OF HEALTH" is written vertically along the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lise Terkelsen Tonica Elektronik A/S Lucernemarken 15 DK-3520 Farum Denmark
OCT 3 1 2006
Re: K061645
Trade/Device Name: MagPro R30 Magnetic Stimulator used with Model MC-125, MC-B70, C-100, C-B60, and MMC-140-II Coils Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: Class II Product Code: GWF Dated: September 19, 2006 Received: September 22, 2006
Dear Ms. 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.
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 egencies. You must comply with all the Act's requirements, including, but not imited to: registerion
4
Page 2 – Ms. Lise Terkelsen
and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
MagPro R30
The device is intended to be used for stimulation of peripheral nerves for diagnostic purposes.
Prescription Use
Over-The-Counter Use
Pelo Rhm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number L061645
Rev. 2.0, August 31 2006, Page 4- 1