MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00

K051864 · The Magstim Company , Ltd. · GWF · Dec 21, 2005 · Neurology

Device Facts

• Record ID: K051864
• Device Name: MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00
• Applicant: The Magstim Company , Ltd.
• Product Code: GWF · Neurology
• Decision Date: Dec 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stimulation of Peripheral Nerves.

Device Story

Magstim Rapid2 and Super Rapid2 are magnetic stimulators for peripheral nerve stimulation. The system delivers magnetic pulses via external coils to induce electrical currents in nerve tissue. The device architecture features a dedicated, in-house, embedded touch-screen display module, replacing the previous external laptop interface. It utilizes single and dual module power supplies. The system is operated by healthcare professionals in a clinical setting. The device allows for user-controllable frequency (up to 36Hz for Rapid2, 60Hz for Super Rapid2) and power levels. Output parameters include train duration and interpulse spacing. The device is used to stimulate peripheral nerves, aiding in clinical diagnostic or therapeutic procedures as determined by the physician.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including software documentation and testing, as well as environmental and EMC testing.

Technological Characteristics

Magnetic stimulator system; utilizes single and dual module power supplies; integrated touch-screen display module; operating temperature range 5-40°C; field strength 1.2 Tesla; frequency resolution 1Hz; train resolution 0.1 seconds. Connectivity is internal via dedicated embedded system. No specific material standards or software algorithm architecture details provided.

Indications for Use

Indicated for stimulation of peripheral nerves.

Regulatory Classification

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.

Predicate Devices

• Magstim Rapid (K992911)
• Cadwell High Speed Magnetic Stimulator (K902059)
• Dantec Mag Pro (K926516)

Submission Summary (Full Text)

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K051864

DEC 2 1 2005 Page 1 of 3

#### 510(K) SUMMARY

Magstim Company Ltd - Magstim Rapid2 and Magstim Super Rapid2

Anthony Thomas Preparer/ Contact The Magstim Company Limited Spring Gardens, Whitland. Carmarthenshire, Wales, UK. SA34 OHR Phone [phone] [phone] Fax Email: [e-mail]

Manufacturer

Magstim Company Limited

Date Summary was prepared: Name of the Device:

June 16th 2005 Magstim Rapid2 and Magstim Super Rapid2

Identification of predicate device(s): Magstim Rapid K992911 Cadwell High Speed Magnetic Stimulator K902059 Dantec Mag Pro K926516

#### Description of the device and modifications:

This submission is being made because the Magstim Company, referred to as This submission is being made because eted under K992911 to replace the external Magsimil, has mounted the device marked marked with the system is via a computer with an embedded interest. Previously, a laptop interfaced with the main bespoke touch-screen display moduler. The new system architecture means that unnt via the I CNCD I V or of also ove controlling the system, resulting in it no longer there is dedicated, in-nouse, so Microsoft Windows operating environment. The requiring all external laptop of Interesses wo and four booster modules, which has been replaced with single and dual module power supplies in the Rapid'. 2001 has been replaced with single are of coils are also introduced with this 510(k), generation contral Magstim Rapid coil family in K992911 can be used with the Rapid2, and the differenced between the 2nd generation and the original coils do not Rapid , and the unrelemed between ss. The intended use of the Magstim Rapid2 and Talse Issues of Salery and Chrostrents in K992911, and the frequency output has been Magstin Super Rapid '15 the Same as also as a power levels, which is consistent with the Changed High Speed Magnetic Stimulator in K905059.

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K05 1864

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Intended Use: Stimulation of Peripheral Nerves.

## Substantial Equivalence:

| Parameter | Magstim Rapid2 &<br>Magstim Super Rapid2 | K992911 |
|----------------------|------------------------------------------------------------|--------------------------------------------------------|
| Field Strength | 1.2 Tesla for Double<br>70mm Coil supplied with<br>System. | 1.2 Tesla (depends on coil<br>type and power level) |
| Super Frequency | 60Hz (Magstim Super<br>Rapid2) | 50Hz (Super Rapid) |
| Frequency | 36Hz (Magstim Rapid2) | 25Hz (Rapid) |
| Frequency Resolution | 1Hz Steps (user<br>controllable) | 1Hz Steps (User<br>controllable) |
| Train Duration | Up to 10 Seconds<br>depending on frequency<br>and coil | Up to 10 seconds<br>depending on frequency<br>and coil |
| Train Resolution | 0.1 seconds | 0.1 seconds |
| Single Stimulus Mode | Yes | Yes |
| Interpulse Spacing | Up to 250 stimuli per<br>stimulus train | Up to 250 stimuli per<br>stimulus train |
| Number of Stimuli | Up to 250 stimuli per<br>stimulus train | Up to 250 stimuli per<br>stimulus train |
| Coil Temperature | 5-40°C Operating Range | 5-40°C Operating Range |

## 60Hz Comparison

| Parameter | Magstim Rapid²/ Magstim<br>Super Rapid² | Caldwell High Speed<br>Magnetic Stimulator<br>K905059 |
|------------|-----------------------------------------|-------------------------------------------------------|
| 36Hz/60Hz | Max 30% of power/ Max<br>37% of power | Unknown/ Max 40% of<br>power |
| 100% Power | 11Hz/22Hz | 25Hz |

Software documentation and testing, environmental and EMC testing, as well as Software documentation and testing, on measurements where provided to demonstrate safety and performance.

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K051864

Page 3 of 3

#### Conclusion

:

The modified device, the Magstim Rapid² (Magstim SuperRapid') is substantially, the Alabantially, the Caldwell High The modified device, the Magstim Rapid (Magstim Super Rapid) and the Caldwell High Speed Magnetic Stimulator.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the HHS emblem, which is a stylized representation of a human figure with outstretched arms, symbolizing care and protection. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2005

Mr. Anthony Thomas The Magstim Company Limited Spring Gardens, Whiteland Carmarthenshire, Wales UNITED KINGDOM

Re: K051864

K05780+
Trade/Device Name: Magstim Rapid2, Magstim Super Rapid2 Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: GWF Dated: November 21, 2005 Received: November 21, 2005

Dear Mr. Thomas:

We have reviewed your Section 510(k) premarket notification of intent to narket the device We have reviewed your because 310(1) for device is substantially equivalent (for the referenced above and have determined and to legally marketed predicate devices marketed in indications for use stated in the enclosates, to regional date of the Medical Device interstate collinered prior to May 20, 1978, as secured with the provisions of Amendinents, of to devrees that have a Act (Act) that do not require approval of a premarket the Federal Pood, Drug, and Oosmetis , therefore, market the device, subject to the general approval application (1 Miry) - 1 ou - general controls provisions of the Act include controls provisions of the Feat - tion Jisting 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 IT your device to such additional controls. Existing major regulations affecting (FMA), it may of subject to sach adatof Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the South no nouncements 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 mean that I 177 mas made a and regulations administered by other Federal agencies. of the Act of any I oderal bables is requirements, including, but not limited to: registration r od linese comply while a 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 OF R Part 807), quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality sion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Thomas

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocent marieming of substantial equivalence of your device to a premarket notification. The PDF mails 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), IT you desire specific advice for your de at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours,

Sincerely yours,

Barbace Fuehub

Mark Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Revised

# Indications for Use

510(k) Number (if known): K051864 510(k) Number (if Khown): 100 Norshim Super Rapid2
Device Name: Magstim Rapid2, Magstim Super Stimulation Device Name: "Magstini Rupla", Magstin Theree Stimulation

AND/OR Prescription Use _X_ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE

Concurrence of CDRH, Office of Device Evaluation (ODE)

charbare Buchind for mixon

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K051864