(166 days)
Not Found
No
The description focuses on hardware changes, software environment updates, and power supply modifications, with no mention of AI or ML algorithms for data processing, analysis, or decision-making.
Yes
The device is intended for the "Stimulation of Peripheral Nerves," which is a therapeutic function.
No
The "Intended Use" section states "Stimulation of Peripheral Nerves," which describes a therapeutic or interventional function, not a diagnostic one. The entire text also focuses on changes to the device's architecture and power supply for stimulation, without mentioning any diagnostic capabilities.
No
The device description explicitly mentions replacing hardware components (external laptop, power supplies, coils) and describes changes to the system architecture involving embedded interests and control systems, indicating it is a hardware device with associated 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." This is a therapeutic or diagnostic procedure performed directly on a patient, not a test performed on a sample taken from the body.
- Device Description: The description focuses on the hardware components and how they deliver magnetic stimulation. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The device is clearly designed for direct interaction with the patient's nervous system for stimulation purposes.
N/A
Intended Use / Indications for Use
Stimulation of Peripheral Nerves.
Product codes (comma separated list FDA assigned to the subject device)
GWF
Device Description
This submission is being made because the Magstim Company, referred to as Magsimil, has mounted the device marked under K992911 to replace the external Magsimil, has mounted the device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral Nerves
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)
Software documentation and testing, environmental and EMC testing, as well as Software documentation and testing, on measurements where provided to demonstrate safety and performance.
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.
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
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 +44 (0) 1994 242905 +44 (0) 1994 240061 Fax Email: Anthony.thomas@magstim.com
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.
1
K05 1864
Page 2 of 3
Intended Use: Stimulation of Peripheral Nerves.
Substantial Equivalence:
| Parameter | Magstim Rapid2 &
Magstim Super Rapid2 | K992911 |
|----------------------|------------------------------------------------------------|--------------------------------------------------------|
| Field Strength | 1.2 Tesla for Double
70mm Coil supplied with
System. | 1.2 Tesla (depends on coil
type and power level) |
| Super Frequency | 60Hz (Magstim Super
Rapid2) | 50Hz (Super Rapid) |
| Frequency | 36Hz (Magstim Rapid2) | 25Hz (Rapid) |
| Frequency Resolution | 1Hz Steps (user
controllable) | 1Hz Steps (User
controllable) |
| Train Duration | Up to 10 Seconds
depending on frequency
and coil | Up to 10 seconds
depending on frequency
and coil |
| Train Resolution | 0.1 seconds | 0.1 seconds |
| Single Stimulus Mode | Yes | Yes |
| Interpulse Spacing | Up to 250 stimuli per
stimulus train | Up to 250 stimuli per
stimulus train |
| Number of Stimuli | Up to 250 stimuli per
stimulus train | Up to 250 stimuli per
stimulus train |
| Coil Temperature | 5-40°C Operating Range | 5-40°C Operating Range |
60Hz Comparison
| Parameter | Magstim Rapid²/ Magstim
Super Rapid² | Caldwell High Speed
Magnetic Stimulator
K905059 |
|------------|-----------------------------------------|-------------------------------------------------------|
| 36Hz/60Hz | Max 30% of power/ Max
37% of power | Unknown/ Max 40% of
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.
2
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.
3
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.
4
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
5
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