(185 days)
Not Found
No
The summary describes a magnetic stimulation coil and its intended use for peripheral nerve stimulation. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is intended for diagnostic purposes (peripheral nerve stimulation for diagnostic purposes), not for therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the coil is "intended for use... for the purpose of peripheral nerve stimulation for diagnostic purposes."
No
The device description clearly states it is a physical coil that delivers a magnetic pulse and is an accessory to a stimulating unit, indicating it is a hardware 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 for diagnostic purposes." This involves stimulating the body directly, not analyzing samples taken from the body.
- Device Description: The description details how the device non-invasively delivers a magnetic pulse to stimulate nerves. This is a physical interaction with the body, not an in vitro test.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device stimulates the body itself.
N/A
Intended Use / Indications for Use
The Magstim D702 coil is a stimulating coil intended for use with the Magstim® 2002 Stimulating Unit or the Magstim® Rapid2 Stimulating Unit for the purpose of peripheral nerve stimulation for diagnostic purposes. The coil is an accessory to the Magstim ® 2002 Stimulating Unit, and the coil is an accessory to the Magstim® Rapid2 Stimulating Unit.
Product codes
GWF
Device Description
The Magstim D702 coil is designed for use with the Magstim 2002 stimulator or the Magstim Rapid2 stimulator. The Magstim D70 coil provides a method of non-invasively delivering its output to a target such as the peripheral nerves. Discharge current through the coil generates a brief, high intensity magnetic pulse. When the coil is applied to a conductive medium such as the human body, eddy currents are produced in the medium by electromagnetic induction. This stimulation method enables deep and otherwise inaccessible nerves to be stimulated easily and relatively painlessly. In addition, no skin preparation is required and stimulation can be achieved through clothing. The coil is a non-sterile reusable device intended for multipatient use. The coil is transportable and is intended to be used in a laboratory, consulting room or equivalent environment. The coil is intended for short-term patient contact where single or cumulative contact does not exceed 24 hours.
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
used in a laboratory, consulting room or equivalent environment.
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
Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the modified device and to assess any of the differences between the subject device and the predicate device. Testing involved safety testing from the risk analysis, including laboratory studies for electrical safety testing, EMC testing, usability testing for consumer accuracy as well as magnetic field measurement testing. Acceptance criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KI304023
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 C.F.R. §807.92.
The submitter of this J. P. Quellette premarket notification Principal is: Custom Microbiology Associates 101 Milk Street Methuen, Massachusetts 01844 Tel: (978) 682-8085 Fax: (207) 912-8085 e-mail: jpouellette01@gmail.com
AUG 2 3 2013
Date of summary March 19, 2013
D702 Coil Device name
Common name Evoked Response Electrical Stimulator
| Classification names Regulation Number | ProCode | Classification Name | |
|---|---|---|---|
| 882.1870 | GWF | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| Evoked Response | |||
| Clootrion Stimulator |
Device Description The Magstim D702 coil is designed for use with the Magstim 2002 stimulator or the Magstim Rapid2 stimulator. The Magstim D70 coil provides a method of non-invasively delivering its output to a target such as the peripheral nerves. Discharge current through the coil generates a brief, high intensity magnetic pulse. When the coil is applied to a conductive medium such as the human body, eddy currents are produced in the medium by electromagnetic induction. This stimulation method enables deep and otherwise inaccessible nerves to be stimulated easily and relatively painlessly. In addition, no skin preparation is required and stimulation can be achieved through clothing. The coil is a non-sterile reusable device intended for multipatient use. The coil is transportable and is intended to be used in a laboratory, consulting room or equivalent environment. The coil is intended for short-term patient contact where single or cumulative contact does not exceed 24 hours.
Predicate Devices
This device is substantially equivalent to the current Magstim Model 2002 with Double 70mm Remote Coil (K060847) and the Magstim Model Rapid2 with Double 70mm Remote Coil (K051864).
1
The primary modification to this device is the overlapping windings in the Modifications coil resulting in improved achievement of motor thresholds with less stimulator output. The modified device has the same intended use as the legally marketed Intended Use predicate devices. The Magstim D70+ coil is a stimulating coil intended for use with the Magstim 2002 Stimulating Unit or the Magstim Rapid-Stimulating Unit for the purpose of peripheral nerve stimulation for diagnostic purposes. The coil is an accessory to the Magstim 200-Stimulating Unit and the coil is an accessory to the Magstim Rapid2 Stimulating Unit. The modified device has the same technological characteristics as the Technological characteristics legally marketed predicate devices. Verification and validation testing activities were conducted to establish the Testing performance and reliability characteristics of the modified device and to assess any of the differences between the subject device and the predicate device. Testing involved safety testing from the risk analysis, including laboratory studies for electrical safety testing, EMC testing, usability testing for consumer accuracy as well as magnetic field measurement testing. Acceptance criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The Magstim Model 2002 with D702 coil and the Magstim Model Rapid2 Standards with D704 coil were designed to comply with the applicable portions of the following product standards: 1. IEC 60601-1:1998 2. IEC 60601-1-2:2007 3. ISO 10993-1:2009 Conclusion This device is substantially equivalent to the predicate device and does not present any new issues of safety or effectiveness. The intended use of the modified device, as described in its labeling, has not changed from that of the predicate device as a result of the modifications. The only difference between the subject device and the predicate device were qualified with appropriate testing. The fundamental scientific technology employed in the operation of this device has not changed from the predicate device.
2
5.0 Substantial Equivalence
.
·
5.1-Similarities and Differences The similarities and differences between the predicate and subject
device are listed in Table 5.1.
Table 5.1 Comparison of Similarities and Differences
| Comparative
Characteristic | Subject Device
Magstim D70² Coil
P/N 4102-00 | Predicate Device
Magstim 2ⁿᵈ Generation
Double 70mm Coil
P/N 3191-00
(Reference K060847) | Predicate Device
Magstim 2ⁿᵈ Generation
Double 70mm Coil
P/N 3191-00
(Reference K051864) |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Intended Use | The Magstim D70² coil is a
stimulating coil intended for
use with the Magstim 200²
Stimulating Unit or the
Magstim Rapid² Stimulating
Unit for the purpose of
peripheral nerve stimulation
for diagnostic purposes. The
coil is an accessory to the
Magstim 200² Stimulating Unit
and the coil is an accessory to
the Magstim Rapid²
Stimulating Unit. | The Magstim Model 200²
is a magnetic nerve
stimulator intended for
the purpose of peripheral
nerve stimulation for
diagnostic purposes. | The Magstim Model
Rapid², Magstim Super
Rapid² is indicated for
stimulation of peripheral
nerves |
| Indications for
Use | The Magstim D70² coil is a
stimulating coil intended for
use with the Magstim 200²
Stimulating Unit or the
Magstim Rapid² Stimulating
Unit for the purpose of
peripheral nerve stimulation
for diagnostic purposes. The
coil is an accessory to the
Magstim 200² Stimulating Unit
and the coil is an accessory to
the Magstim Rapid²
Stimulating Unit. | The Magstim Model 200²
is a magnetic nerve
stimulator intended for
the purpose of peripheral
nerve stimulation for
diagnostic purposes | The Magstim Model
Rapid², Magstim Super
Rapid² is indicated for
stimulation of peripheral
nerves |
| Average
inductance | 13μH | 15.50μH | 15.50μH |
| Number of Turns | 11 | 9 | 9 |
.
3
| Number of
| Windings | 2 | 2 | 2 | |
|---|---|---|---|---|
| Wire Cross | ||||
| Sectional Area (1) | 12.5 mm2 | 9 mm2 | 9 mm2 | |
| Coil Cable | ||||
| Length | 1.8m | 2.0m | 2.0m | |
| Manner of | ||||
| stimulation | Peripheral | Peripheral | Peripheral | |
| Peak Magnetic | ||||
| Field | 2.1T (2) | |||
| (Magstim 2003) | 1.2T | |||
| (Magstim Rapid2) | 1.7T (2) | 1.2T | ||
| Number of | ||||
| pulses the coil | ||||
| can be operated | ||||
| at 80% | ||||
| stimulator output | ||||
| before reaching | ||||
| maximum | ||||
| operating | ||||
| temperature (1) | >290 | |||
| (Magstim 2003) | >600 | |||
| (Magstim Rapid1) | 110 | 110 | ||
| Cooling | No | No | No | |
| Multiple Use | Yes | Yes | Yes | |
| Sterile | No | No | No | |
| Weight | 1.95kg | 1.8kg | 1.8kg | |
| Integral adapter | Yes | No | No |
Notes:
5.3 Similarities
- (1) Larger cross sectional wire area reduces resistance and heat generation. As a result the coil can run longer before warming up. This does not mean it will be used to deliver more stimuli: the number of stimuli delivered is ultimately up to the physicians conducting the test.
- (2) Peak magnetic field strengths were measured using a very thin magnetic field probe (0.8mm) in order to get as close to the coil surface as possible. Since magnetic field strength reduces with distance away from a coil, probe size does affect the measurement outcome. At typical stimulation depths magnetic field figures are, therefore, lower.
The predicate device is the Magstim 2nd Generation Double 70mm 5.2 Predicate devices Coil p/n 3191-00 evaluated with the Magstim Rapid² TMS unit in K051864 and with the Magstim 2002 TMS unit in K060847.
The subject device and the predicate device are similar with respect to respect to indications for use and intended use, fundamental scientific technology as well as the number of windings, the lack of the need for cooling, the ability to be used multiple times and are limited to peripheral stimulation only.
4
5.4 Differences
The subject device and the predicate devices are different due to the overlapping of the windings in the D70-coil (P/N 4102-00) which results in improved achievement of motor thresholds with less stimulator output. This design feature also manifests different values for peak magnetic field and pulses generated when the subject device is used with one or the other stimulating unit. When the subject device is used with the Magstim Rapid", more pulses are generated than with the Magstim 2002 until the peak temperature is achieved and the coil shuts down, This design feature allows the practitioner the flexibility to use the D70- coil and the Magstim Rapid2 for a longer period until the peak temperature is achieved and the coil shuts down. When the subject device is used with the Magstim 2002, a slightly higher peak magnetic field value is achieved on the coil surface. This is due to the higher efficiency of the coil as well as the thickness of the plastic cover and the inner coil insulation of the subject device. Peak magnetic field figure of 2.1 tesla is below that used inside 3 tesla MRI scanners.
Based upon the analysis of the similarities and differences, the Magstim D702 Coil as described in this 510(k) is substantially equivalent to the predicate device and does not present any new issues of safety or effectiveness.
5.5 Conclusion
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized symbol that resembles an abstract caduceus or a person embracing a globe.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002
August 23, 2013
The Magstim Company Limited c/o Mr. J.P. Quellette, Custom Microbiology Associate 101 Milk Street Methuen, MA 01844
Re: K130403
Trade/Device Name: D702 coil Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: Class II Product Code: GWF Dated: July 8, 2013 Received: July 11, 2013
Dear Mr. Ouellette:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
6
Page 2 - Mr. J.P. Ouellette
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Victor Krauthamer -S
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K130403
Device Name: D702 Coil
Indications For Use:
The Magstim D702 coil is a stimulating coil intended for use with the Magstim® 2002 Stimulating Unit or the Magstim® Rapid2 Stimulating Unit for the purpose of peripheral nerve stimulation for diagnostic purposes. The coil is an accessory to the Magstim ® 2002 Stimulating Unit, and the coil is an accessory to the Magstim® Rapid2 Stimulating Unit.
Prescription Use × (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)
Victor Krauthamer - S 2013.08.23 15:37:34 -04'00'
Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K130403
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