(287 days)
Not Found
No
The summary describes a physical stimulating coil and its intended use for peripheral nerve stimulation. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The device appears to be a hardware accessory.
No
Justification: The device is described as a stimulating coil for peripheral nerve stimulation, which is a therapeutic intervention. However, it is an accessory to the Magstim Rapid2 Stimulating Unit. The prompt asks if "this device" is a therapeutic device, and since the coil itself doesn't perform the therapy but is a component of a therapeutic system, it is not a standalone therapeutic device. It is an accessory to a therapeutic device.
No
The device is described as a stimulating coil for peripheral nerve stimulation, which is a therapeutic rather than a diagnostic function. The text explicitly states its purpose is for "stimulation...easily and relatively painlessly" and does not mention any diagnostic capabilities.
No
The device description clearly states it is a "stimulating coil," which is a hardware component, and an "accessory of the Magstim® Rapid2 Unit," also a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "peripheral nerve stimulation." This is a direct interaction with the patient's body for therapeutic or diagnostic purposes, not for examining specimens in vitro (outside the body).
- Device Description: The description reinforces the intended use by stating it's for "peripheral stimulation of the nerves."
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (within the body).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GWF
Device Description
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 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.
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
medical practitioner only.
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.
Magstim Double 70mm Remote Coil (reference K060847), Magstim 2nd Generation Double 70mm Coil (reference 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
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: +44 (0) 1994 242902 Fax: +44 (0) 1994 240061 E-mail: anwen.evans@magstim.com
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
1
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
70mm Air Film
Coil (Subject
Device) | Magstim Double
70mm Remote Coil
(Predicate Device) | Magstim 2nd
Generation Double
70mm Coil
(Predicate Device) |
|--------------------------|-------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------|
| Average
inductance | $12\mu H$ | $16.35\mu H$ | $15.50\mu H$ |
| Manner of
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.
2
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.
3
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 (240) 276-0120. 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 (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
4
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
Page 1 of 1
510(k) Number_