(287 days)
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.
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.
The provided text is a 510(k) submission for the Magstim® Double 70mm Air Film™ Coil. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the context of an AI/ML device.
Therefore, many of the requested items (e.g., acceptance criteria for reported device performance, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable (N/A) because the submission's purpose is not to evaluate the diagnostic or treatment effectiveness of an AI/ML model.
This submission is for a physical medical device (a stimulating coil) that is an accessory to another device. Its clearance is based on demonstrating that it is as safe and effective as existing legally marketed predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied from 510(k) comparison) | Reported Device Performance (Magstim® Double 70mm Air Film™ Coil) |
|---|---|
| Average Inductance (Comparable to predicates) | 12 µH (Predicate 1: 16.35 µH, Predicate 2: 15.50 µH) - Note: Lower value, considered acceptable if overall safety/effectiveness is maintained. |
| Manner of Stimulation (Peripheral) | Peripheral |
| Cooling (Feature comparison) | Yes (Predicates: No) - Note: This is a distinguishing feature, not an acceptance criterion in the traditional sense, but part of the comparison. |
| Multiple Use (Yes) | Yes |
| Sterile (No) | No |
| Weight (Comparable to predicates) | 3kg (Predicate 1: 1.6kg, Predicate 2: 1.8kg) - Note: Higher value, considered acceptable if overall safety/effectiveness is maintained. |
| Integral Adapter (Feature comparison) | Yes (Predicates: No) - Note: Distinguishing feature, not an acceptance criterion. |
| Safety and Effectiveness (Demonstrated as similar to predicates) | "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. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This submission does not involve a "test set" in the context of evaluating an AI/ML model's performance on clinical data. The comparison is based on device specifications and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. No ground truth established by experts for a test set in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable, as there is no test set for clinical performance evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. No MRMC study was conducted. This is a physical device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. Not applicable, as this is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. Not applicable, as there is no ground truth generation in the context of clinical performance evaluation for this device. The "ground truth" for the submission is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- N/A. Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- N/A. Not applicable.
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Magstim® Double 70mm Air Film™ FDA 510(k) Submission
DEC 0 8 2008
SECTION 5: 510(k) Summary or 510(k) Statement
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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
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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 Double70mm Air FilmCoil (SubjectDevice) | Magstim Double70mm Remote Coil(Predicate Device) | Magstim 2ndGeneration Double70mm Coil(Predicate Device) | |
|---|---|---|---|
| Averageinductance | $12\mu H$ | $16.35\mu H$ | $15.50\mu H$ |
| Manner ofstimulation | 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
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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 (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
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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
Page 1 of 1
510(k) Number_
§ 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).