(185 days)
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 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.
The provided text is a 510(k) Summary for the Magstim D702 Coil, a medical device for peripheral nerve stimulation. It details how the device is considered substantially equivalent to predicate devices, primarily through engineering and performance testing, rather than studies involving human readers or extensive clinical trials.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Magstim D702 Coil) |
|---|---|---|
| Intended Use | Peripheral nerve stimulation for diagnostic purposes | Peripheral nerve stimulation for diagnostic purposes |
| Indications for Use | Peripheral nerve stimulation for diagnostic purposes | Peripheral nerve stimulation for diagnostic purposes |
| Average Inductance | 15.50 µH | 13 µH |
| Number of Turns | 9 | 11 |
| Number of Windings | 2 | 2 |
| Wire Cross Sectional Area | 9 mm² | 12.5 mm² |
| Coil Cable Length | 2.0m | 1.8m |
| Manner of Stimulation | Peripheral | Peripheral |
| Peak Magnetic Field (Magstim 2002) | 1.7T (or 1.2T for Rapid2) | 2.1T |
| Peak Magnetic Field (Magstim Rapid2) | 1.2T | 1.2T |
| Number of pulses before exceeding max operating temp (Magstim 2002) | 110 | >290 |
| Number of pulses before exceeding max operating temp (Magstim Rapid2) | >600 (Rapid1) / 110 | >600 (Rapid1) - Note: Discrepancy in table for Rapid2 vs Rapid1 |
| Cooling | No | No |
| Multiple Use | Yes | Yes |
| Sterile | No | No |
| Weight | 1.8kg | 1.95kg |
| Integral Adapter | No | Yes |
Interpretation of "Acceptance Criteria": In this context, the "acceptance criteria" are not explicitly stated as numerical thresholds for success (e.g., "must achieve X% accuracy"). Instead, the acceptance criteria are implicitly defined by demonstrating that the modified device (Magstim D702 Coil) is substantially equivalent to the predicate devices. This means that:
- Its intended use and indications for use are the same.
- Its technological characteristics are similar, and any differences do not raise new questions of safety or effectiveness.
- Testing shows performance is comparable or improved and meets applicable safety standards.
The specific performance metrics for inductance, peak magnetic field, and number of pulses before overheating are compared directly to the predicate device's characteristics, and the device is deemed acceptable if these differences are understood and do not negatively impact safety or effectiveness, or in some cases, show improvement (e.g., higher pulse count due to better heat dissipation).
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe "test sets" in the context of patient data or clinical imaging. The "testing activities" mentioned involved:
- Safety testing from risk analysis.
- Laboratory studies for electrical safety testing.
- EMC testing.
- Usability testing for consumer accuracy (this might involve human interaction but isn't elaborated as a clinical study).
- Magnetic field measurement testing.
Therefore, there is no stated sample size for a patient test set or data provenance because the evaluation was primarily engineering and performance-based, comparing device specifications to a predicate. It was not a study involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. The evaluation was engineering-focused. There was no "ground truth" derived from expert consensus on medical images or clinical outcomes from a patient test set.
4. Adjudication Method for the Test Set
Not Applicable. As there was no patient test set requiring expert interpretation or consensus, there was no adjudication method used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. The document does not describe an MRMC study. The comparison is between the new device and predicate devices based on engineering specifications and laboratory testing, not human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This device is a hardware component (a stimulating coil) for a medical stimulator, not an algorithm. Therefore, "standalone algorithm performance" is not relevant. The device's 'performance' is its ability to generate magnetic fields and deliver pulses according to its specifications.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established performance characteristics and safety profiles of the legally marketed predicate devices, along with relevant international standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-1). The new device's performance was measured against these benchmarks through laboratory testing.
8. The Sample Size for the Training Set
Not Applicable. As this is a hardware device and not an AI/ML algorithm that requires training data, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not Applicable. See point 8.
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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).
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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.
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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
| ComparativeCharacteristic | Subject DeviceMagstim D70² CoilP/N 4102-00 | Predicate DeviceMagstim 2ⁿᵈ GenerationDouble 70mm CoilP/N 3191-00(Reference K060847) | Predicate DeviceMagstim 2ⁿᵈ GenerationDouble 70mm CoilP/N 3191-00(Reference K051864) |
|---|---|---|---|
| Intended Use | The Magstim D70² coil is astimulating coil intended foruse with the Magstim 200²Stimulating Unit or theMagstim Rapid² StimulatingUnit for the purpose ofperipheral nerve stimulationfor diagnostic purposes. Thecoil is an accessory to theMagstim 200² Stimulating Unitand the coil is an accessory tothe Magstim Rapid²Stimulating Unit. | The Magstim Model 200²is a magnetic nervestimulator intended forthe purpose of peripheralnerve stimulation fordiagnostic purposes. | The Magstim ModelRapid², Magstim SuperRapid² is indicated forstimulation of peripheralnerves |
| Indications forUse | The Magstim D70² coil is astimulating coil intended foruse with the Magstim 200²Stimulating Unit or theMagstim Rapid² StimulatingUnit for the purpose ofperipheral nerve stimulationfor diagnostic purposes. Thecoil is an accessory to theMagstim 200² Stimulating Unitand the coil is an accessory tothe Magstim Rapid²Stimulating Unit. | The Magstim Model 200²is a magnetic nervestimulator intended forthe purpose of peripheralnerve stimulation fordiagnostic purposes | The Magstim ModelRapid², Magstim SuperRapid² is indicated forstimulation of peripheralnerves |
| Averageinductance | 13μH | 15.50μH | 15.50μH |
| Number of Turns | 11 | 9 | 9 |
.
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| Number ofWindings | 2 | 2 | 2 | |
|---|---|---|---|---|
| Wire CrossSectional Area (1) | 12.5 mm2 | 9 mm2 | 9 mm2 | |
| Coil CableLength | 1.8m | 2.0m | 2.0m | |
| Manner ofstimulation | Peripheral | Peripheral | Peripheral | |
| Peak MagneticField | 2.1T (2)(Magstim 2003) | 1.2T(Magstim Rapid2) | 1.7T (2) | 1.2T |
| Number ofpulses the coilcan be operatedat 80%stimulator outputbefore reachingmaximumoperatingtemperature (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.
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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
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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
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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
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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
Page 1 of 1
§ 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).