MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00

K080499 · The Magstim Company , Ltd. · GWF · Dec 8, 2008 · Neurology

Device Facts

• Record ID: K080499
• Device Name: MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00
• Applicant: The Magstim Company , Ltd.
• Product Code: GWF · Neurology
• Decision Date: Dec 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Magstim® Double 70mm Air Film™ Coil is a stimulating coil solely intended for use with the Magstim® Rapid2 Stimulating Unit for the purposes of peripheral nerve stimulation. The coil is an accessory of the Magstim® Rapid2 Unit.

Device Story

Magstim Double 70mm Air Film Coil is an accessory for the Magstim Rapid2 Stimulating Unit; used for peripheral nerve stimulation. Device enables stimulation of deep or otherwise inaccessible nerves; allows stimulation through clothing without skin preparation. Operated by or under supervision of medical practitioner. Coil features integrated air-cooling system to manage thermal output during use. Output is electrical stimulation delivered to peripheral nerves; clinical benefit includes relatively painless stimulation of deep nerves. Device is non-sterile and intended for multiple use.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technical specifications (inductance, cooling, weight) against predicate devices.

Technological Characteristics

Air-cooled stimulating coil; 12µH inductance; 3kg weight; integrated adapter; non-sterile; multiple-use. Operates as an accessory to the Magstim Rapid2 Stimulating Unit for peripheral nerve stimulation.

Indications for Use

Indicated for peripheral nerve stimulation in patients requiring such therapy, to be used by or under the supervision of a medical practitioner.

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 Double 70mm Remote Coil (K060847)
• Magstim 2nd Generation Double 70mm Coil (K051864)

Submission Summary (Full Text)

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K080499

Magstim® Double 70mm Air Film™ FDA 510(k) Submission

DEC 0 8 2008

SECTION 5: 510(k) Summary or 510(k) Statement

Image /page/0/Picture/4 description: The image shows the word "magstim" in a bold, sans-serif font. The letters are black, and the word is slightly curved upwards. There is a small, circular graphic above the "i" in "magstim."

Spring Gardens . Whitlan Carmarthenshire . Wales

> (0) 1994 2 4 (0) 1994 nfo@magstim .com www.magstim.com

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 04 December 2008

# Contact information:

Anwen Evans (Ms) The Magstim Company Ltd Spring Gardens, Whitland Carmarthenshire, Wales, UK SA34 OHR Tel: [phone] Fax: [phone] E-mail: [e-mail]

The product information is as follows:

| Product: | Magstim Double 70mm Air Film Coil |
|---------------|-----------------------------------|
| Class: | Class CFR 882.1870 |
| Panel: | Neurology |
| Product Code: | GWF |

| Classification name: | Stimulator, Electrical, Evoked Response |
|------------------------|-----------------------------------------|
| Common or usual names: | Cooled Coil |
| Proprietary name: | Magstim Double 70mm Air Film Coil |

#### 5.1 Description of the Device

The Magstim Double 70mm Air Film Coil is an air-cooled coil intended for peripheral stimulation of the nerves. This coil enables deep, and otherwise inaccessible, nerves to be

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### Magstim® Double 70mm Air Film™ FDA 510(k) Submission

### SECTION 5: 510(k) Summary or 510(k) Statement

stimulated easily and relatively painlessly. Additionally, no skin preparation is required and stimulation can be achieved through clothing. The Magstim Double 70mm Air Film Coil is for use by, or under the supervision of, a medical practitioner only.

#### 5.2 Intended Use of the Device

The Magstim Double 70mm Air Film Coil is a stimulating coil solely intended for use with the Magstim Rapid2 Stimulating Unit for the purposes of peripheral nerve stimulation. The coil is an accessory of the Magstim Rapid2 Unit.

#### 5.3 Predicate Devices

The predicate devices used in this submission are:

- . Magstim Double 70mm Remote Coil (reference K060847).
- Magstim 2nd Generation Double 70mm Coil (reference K051864). .

#### 5.3.1 Comparison with the predicate devices

| | Magstim Double<br>70mm Air Film<br>Coil (Subject<br>Device) | Magstim Double<br>70mm Remote Coil<br>(Predicate Device) | Magstim 2nd<br>Generation Double<br>70mm Coil<br>(Predicate Device) |
|--------------------------|-------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------|
| Average<br>inductance | $12\mu H$ | $16.35\mu H$ | $15.50\mu H$ |
| Manner of<br>stimulation | Peripheral | Peripheral | Peripheral |
| Cooling | Yes | No | No |
| Multiple use | Yes | Yes | Yes |
| Sterile | No | No | No |
| Weight | 3kg | 1.6kg | 1.8kg |
| Integral adapter | Yes | No | No |

### 5.4 Conclusions

The Magstim Double 70mm Air Film Coil is both safe and effective and is similar in its risks and benefits, as well as its manner of performance, to the predicate devices listed above.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design, with the eagle's head facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Magstim Company Limited % Ms. Anwen Evans Spring Gardens, Whitland Carmarthenshire, Wales United Kingdom SA34 OHR

DEC 0 8 2008

Re: K080499

Trade/Device Name: Magstim® Double 70mm Air Film™ Coil Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: Class II Product Code: GWF Dated: November 20, 2008 Received: December 1, 2008

Dear Ms. Evans:

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 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); 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.

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## Page 2 - Ms. Anwen Evans

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millman

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

Enclosure

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# Indications for Use

510(k) Number (if known): K

Device Name: Magstim® Double 70mm Air Film™ Coil

Indications for Use:

The Magstim® Double 70mm Air Film™ Coil is a stimulating coil solely intended for use with the Magstim® Rapid2 Stimulating Unit for the purposes of peripheral nerve stimulation. The coil is an accessory of the Magstim® Rapid2 Unit.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Melker

(Division Sign-Off) (Division Sign-On)
Division of General, Restorative, Division of South of Sevices

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**510(k) Number**_