(269 days)
No
The document does not mention AI, ML, or related terms, and the device description focuses on hardware and waveform control.
No
The device is described as being used for "stimulation of peripheral nerves for diagnostic purposes," not for treating or rehabilitating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The devices are intended to be used for stimulation of peripheral nerves for diagnostic purposes."
No
The device description explicitly states that the devices are "Magnetic stimulators" and are "connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue." This indicates the presence of significant hardware components beyond just software.
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 a living patient to gather information, not a test performed on a sample (like blood, urine, or tissue) outside of the body.
- Device Description: The device is a "Magnetic stimulator" that applies magnetic stimulation to neural tissue. This is a physical intervention on the body, not a method for analyzing a biological sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information about a patient's health status based on sample analysis.
Therefore, the device falls under the category of a therapeutic or diagnostic device that interacts directly with the patient's body, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The magnetic stimulators are 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 incl. MagOption, MagPro X100 and MagPro X100 incl. MagOption are Magnetic stimulators used for Magnetic stimulation. These three devices are, together with the predicate device MagPro R30, called "MagPro Family". Hereafter we name the three devices in this submission "the new devices".
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 new devices are connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. All Standard coils as well as the Fluid and Cool coils can be used with the MagPro devices, (K926516, K061645, K071821).
The new devices are magnetic stimulators, featuring Biphasic, Monophasic, Halfsine, Biphasic Burst waveform, stimulation rates up to 100 pulses per second (pps), stimulus sequences and protocols controlled via a built-in computer and 8,4" display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 R30, K061645, 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.
Keypoint (K944547), Digitimer DS7A (K051357)
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)
. .
Ko91940
MagPro R30 incl. MagOption, X100, X100 incl. MagOption
510(k) Summary
| Name of 510(k) owner: | Tonica Elektronik A/S
Lucernemarken 15
DK-3520 Farum
Denmark |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Phone: | +45 4499 8444 |
| Fax: | +45 4499 1544 |
| Contact: | Lise Terkelsen |
| Preparation date: | June 19, 2009 |
| Trade name: | MagPro R30 incl. MagOption
MagPro X100
MagPro X100 incl. MagOption |
| Common name: | MagPro R30 incl. MagOption
MagPro X100
MagPro X100 incl. MagOption |
| Classification name: | Evoked Response Electrical Stimulator |
| Identification of predicate devices: | MagPro R30, K061645
MagPro, K926516
Magstim Super Rapid², K051864
Keypoint (K944547)
Digitimer DS7A (K051357) |
MAR 2 6 2010ﺘﺮ
1
MagPro R30 incl. MagOption, X100, X100 incl. MagOption
Device description
MagPro R30 incl. MagOption, MagPro X100 and MagPro X100 incl. MagOption are Magnetic stimulators used for Magnetic stimulation. These three devices are, together with the predicate device MagPro R30, called "MagPro Family". Hereafter we name the three devices in this submission "the new devices".
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 new devices are connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. All Standard coils as well as the Fluid and Cool coils can be used with the MagPro devices, (K926516, K061645, K071821).
The new devices are magnetic stimulators, featuring Biphasic, Monophasic, Halfsine, Biphasic Burst waveform, stimulation rates up to 100 pulses per second (pps), stimulus sequences and protocols controlled via a built-in computer and 8,4" display.
Intended Use:
The magnetic stimulators are intended to be used for stimulation of peripheral nerves for diagnostic purposes.
Substantial Equivalence:
The new devices in this submission have the same characteristics as the predicate devices, MagPro R30 (K061645), MagPro (K926516) and Magstim Super Rapid² (K051864). Stimulation of peripheral nerves is the intended application which applies for all these magnetic stimulator 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 or touch screen and a display on the front panel.
The difference in performance between the new devices and the predicate devices are thoroughly compared and discussed in the "Substantial Equivalence" section. Evidence for the higher repetition rate of 100pps is documented and found substantial equivalent to current stimulators, Keypoint (K944547) and Digitimer DS7A (K051357), which are able to perform at more powerful repetition rates.
The new devices are CE-marked and comply with the Medical Device Directive 93/42/EEC and also the Canadian CMDR. The new devices are developed and manufactured according to EN13485, "Medical devices - Quality management systems -Requirement for regulatory purposes". The new devices comply with the standard for electrical safety standard, IEC 60601-1, and have been tested at a certified test center, UL Demko. EMC testing has been performed for compliance with the EMC standard, IEC 60601-1-2. The MagPro devices fulfill the requirements in the standard IEC 60601-1-6 Usability.
2
MagPro R30 incl. MagOption, X100, X100 incl. MagOption
Conclusion:
ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ
The MagPro R30 incl. MagOption, MagPro X100 and MagPro X100 incl. MagOption have the same intended use as the predicate magnetic stimulator devices and the same technological features. The difference in performance is shown equivalent to various predicate devices.
The new devices do not raise new issues of safety and effectiveness and are substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Tonica Elektronik A/S c/o Ms. Lise Terkelsen Lucernemarken 15 DK-3520 Farum Denmark
MAR 2 6 2010
Re: K091940
Trade/Device Name: MagPro R30 with Magoption, MagPro X100, and MagPro X100 with MagOption Regulation Number: 21 CFR 882.1870
Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF Dated: March 15, 2010 Received: March 18, 2010
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 includions for use stated in the enclosure) to legally marketed predicate devices marketed in intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr to 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, into not 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 mastering.
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.
4
Page 2 - Ms. Lise Terkelsen
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Malvina B. Eydelman, M. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) number: K091940
| Div/Branch | Last Name | Date | Div/Branch | Last Name | Date |
|---|---|---|---|---|---|
| DONEDINNOB | HUTTER | 25MARC | |||
For Office of Compliance Contact Information:
http://insideport.lets.fda.gov:9010/portal/page?_pageid=197,415881&_dad=portal&_schema=PO RTAL&org=318
For Office of Surveillance and Biometrics Contact Information:
http://insideportlets.fda.gov:9010/portal/page?_pageid=197,415881&_dad=portal&_schema=PO RTAL&org=423
| Date of Update | By | Description of Update |
|---|---|---|
| 7/27/09 | Brandi Stuart | Added Updates to Boiler Table |
| 8/7/09 | Brandi Stuart | Updated HFZ Table |
| 1/11/10 | Diane Garcia | Liability/Warranty sentence added at bottom of 1st page |
Drafted: Joseph Hutter, Ph.D. Edited: Final: Typed: Marisol Lendor, March 25, 2010
6
MagPro R30 incl. MagOption, X100, X100 incl. MagOption
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
MagPro R30 with MagOption MagPro X100 MagPro X100 with MagOption
The devices are intended to be used for stimulation of peripheral nerves for diagnostic purposes.
Prescription Use X (Part 21 CFR 801 Subpart D)
and/or Over-The-Counter Use (Part 21 CFR 801 Subpart C)
JOE HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
· ' ^/k) Number.