(681 days)
No
The summary describes a device for electrical stimulation and recording of responses, with no mention of AI or ML in the device description, performance studies, or key metrics.
No
Explanation: The device is described as being for "diagnostic purposes" to obtain responses of stimulated structures for "further diagnostic evaluation," not for treating a condition or disease.
Yes
The "Intended Use / Indications for Use" states "Stimulation of peripheral nerves for diagnostic purposes." The "Device Description" also reiterates that it is "intended for stimulation of peripheral nerves for diagnostic purposes" and that the "obtained responses of stimulated structures is recorded with an EMG system for further diagnostic evaluation."
No
The device description explicitly states that the device introduces electrical stimulation to tissue through magnetic induction generated from a coil. This indicates the presence of hardware components (coil, electrical stimulation mechanism) beyond just software. The performance studies also mention electrical and mechanical safety testing, further confirming the presence of hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The MEGA-TMS device directly stimulates peripheral nerves using magnetic induction. It does not analyze specimens taken from the body.
- Intended Use: The intended use is "Stimulation of peripheral nerves for diagnostic purposes." This involves interacting directly with the patient's body, not analyzing samples.
- Mechanism: The device generates a magnetic field to induce electrical stimulation in the nerves. This is an in vivo (within the living body) process, not an in vitro (in glass/outside the living body) process.
- Paired Device: It is paired with an EMG system, which records the in vivo electrical responses of the stimulated nerves.
The MEGA-TMS is a device used for neurological diagnostic procedures that involve direct interaction with the patient's nervous system. It falls under the category of devices used for physiological measurement and stimulation, not IVDs.
N/A
Intended Use / Indications for Use
Stimulation of peripheral nerves for diagnostic purposes.
Product codes
GWF
Device Description
The MEGA-TMS is intended for stimulation of peripheral nerves for diagnostic purposes. The device introduces electrical stimulation to tissue through magnetic induction generated from the coil. The obtained responses of stimulated structures is recorded with an EMG system for further diagnostic evaluation. The MEGA-TMS device is intended to be paired with a Focus EMG device cleared under FDA 510(k): K102610. Magnetic stimulation is used for peripheral nerve conduction studies and to evaluate peripheral nervous system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Periphery other than brain
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
Safety and EMC: Electrical and mechanical safety and electromagnetic compatibility testing were conducted to demonstrate that the MEGA-TMS device is compliant with IEC 60601-1 (Edition 3.1) and IEC 60601-1-2 (Edition 4).
Design: Design verification demonstrated that the device functions as intended. Design validation was demonstrated using software validation testing and literature review. Validation testing confirmed that the device met end-user needs, intended use and evidence of device operation in actual use conditions.
Software: Following FDA's Guidance for Industry and Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," software verification and validation was conducted.
Risk Management: The potential risks of MEGA-TMS were identified and evaluated in compliance with ISO 14971. All risks were determined to be appropriately mitigated with risk control measures to acceptable residual levels.
Electric and Magnetic Field Characteristics: For electric field, actual measurements were recorded and simulations performed. For magnetic field, pulse shape information, magnetic field spatial distribution, magnetic field strength gradient, linearity, and reliability information were collected. Bench top measurements of field strength were taken at coil surface and 20 mm above to determine spatial distribution of magnetic field.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
August 13, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Soterix Medical, Inc. Abhishek Datta, Ph.D. Chief Technology Officer 237 West 35 Street, #1401 New York, New York 10001
Re: K192823
Trade/Device Name: MEGA-TMS Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF Dated: July 14, 2021 Received: July 14, 2021
Dear Dr. Abhishek Datta:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Xiaolin Zheng, Ph.D. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192823
Device Name MEGA-TMS
Indications for Use (Describe) Stimulation of peripheral nerves for diagnostic purposes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
| Date Prepared: | August 26, 2019 |
|---|---|
| Submitter Information: | |
| Company Name: | Soterix Medical, Inc. |
| Company Address: | 237 W 35th Street |
| Suite 1401 | |
| New York, NY 10001 | |
| Contact Person: | Abhishek Datta |
| Phone: 888-990-8327 | |
| Fax: 212-315-3232 | |
| Device Information: | |
| Trade Name: | MEGA-TMS |
| Common Name: | MEGA-TMS |
| Classification Name: | GWF - Evoked Response Electrical Stimulator (21 CFR 882.1870) |
| Device Class: | Class II |
| Predicate Devices: | Magstim 200² with Double 70mm Remote Coil (K060847) |
| Magstim Company US, LLC. (Primary Predicate) | |
| Class II | |
| MagPro R30 incl. MagOption, X100, X100 incl. MagOption (K091940) | |
| Tonica Elektronik A/S (Secondary Predicate) | |
| Class II | |
| Device Description: | The MEGA-TMS is intended for stimulation of peripheral nerves for |
| diagnostic purposes. |
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The device introduces electrical stimulation to tissue through magnetic induction generated from the coil. The obtained responses of stimulated structures is recorded with an EMG system for further diagnostic evaluation. The MEGA-TMS device is intended to be paired with a Focus EMG device cleared under FDA 510(k): K102610. Magnetic stimulation is used for peripheral nerve conduction studies and to evaluate peripheral nervous system.
Indications for Use:
Stimulation of peripheral nerves for diagnostic purposes.
Comparison of Technological Characteristics with the Predicate Devices:
At a high level, the subject and predicate devices (K060847 and K091940) are based on the following technological elements:
- . Introduction of electrical stimulation through tissue, through magnetic induction generated from coils
- Induced electrical current in nearby tissue causing nerve impulse ●
- . Stimulus intensity control, core material and coil positioning
The following technical differences exist between the subject device and predicate devices:
- Smaller pulse width
- . Change in maximum repetition rate
- Coil temperature/intensity indicators for stimulation graphical user interface ●
- Maximum voltage generated ●
- Peak magnetic field generated
| Parameter | MEGA-TMS
Proposed | Magstim 2002 with
Double 70mm Remote
Coil (Primary
Predicate) | MagPro R30 incl.
MagOption, X100,
X100 incl. MagOption
(Secondary Predicate) | Comparison |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K192823 | K060847 | K091940 | - |
| Parameter | MEGA-TMS
Proposed | Magstim 2002 with
Double 70mm Remote
Coil (Primary
Predicate) | MagPro R30 incl.
MagOption, X100,
X100 incl. MagOption
(Secondary Predicate) | Comparison |
| Device Name and
Model | MEGA-TMS | Magstim 2002 | MagPro X100, MagPro
X100 with
MagOption
MagPro R30 with
MagOption | - |
| Manufacturer | Neurosoft Ltd. | Magstim Company US,
Llc. | Tonica Elektronik A/S | - |
| Indications For
Use | Stimulation of
peripheral nerves
for diagnostic
purposes. | Stimulation of
peripheral nerves for
diagnostic purposes. | The magnetic
stimulators are intended
to be used for
stimulation of
peripheral nerves for
diagnostic purposes. | Identical |
| Contraindications
For Use | MEGA-TMS/Neuro-
MS and its
accessories should
not be used on or in
the vicinity of
patients or users with
cardiac demand
pacemakers,
implanted electronic
devices, cochlear
implants, pregnant
women. | Magstim 2002 and its
accessories should not be
used on or in the vicinity
of patients or users with
cardiac demand
pacemakers, implanted
defibrillators and/or
implanted
neurostimulators. | Do not use the
equipment on patients
with cardiac
pacemakers, cochlear
implants or other
implanted electronic
devices. Do not apply
the magnetic stimuli to
the head, neck or
abdomen of pregnant
women. | MEGA-TMS includes
additional contraindications to
the ones mentioned in the
Primary Predicate. MEGA-
TMS contraindications are
identical to the Secondary
Predicate. |
| Parameter | MEGA-TMS
Neurosoft, Ltd.
Proposed | Magstim 2002 with
Double 70mm Remote
Coil Magstim Company,
Lic. (Primary Predicate) | MagPro R30 incl.
MagOption, X100,
X100 incl. MagOption
(Secondary Predicate) | Comparison |
| Maximum
Voltage | 2.8 kV | 2.8 kV | 1.8 kV | MagPro has a smaller range
of maximum voltage. |
| Maximum
Repetition Rate | 30% - 0.7 sec /
1.42 Hz
50% - 1 sec / 1 Hz
100%- 3.3 sec /
0.3 Hz | 30% - 2 sec / 0.5 Hz
50% - 3 sec / 0.33 Hz
100%- 4 sec /0.25 Hz | 30% - 0.05 sec / 20 Hz
45% - 0.1 sec / 10 Hz
100%- 0.5 sec / 2 Hz | Differences in maximum
repetition rate |
| Pulse Width | 80+/-15 µsec
(monophasic)
120 +/- 15 µsec
(power) | 100 µsec (monophasic) | 70 µsec (monophasic)
100 µsec (power
monophasic) | MEGA-TMS has a slightly
lower pulse width in the
monophasic mode in
comparison to the primary
predicate. MEGA-TMS has a
slightly higher pulse width in
the monophasic mode in
comparison to the secondary
predicate. |
| Parameter | MEGA-TMS
Neurosoft, Ltd.
Proposed | Magstim 2002 with Double
70mm Remote Coil Magstim
Company, Llc. (Primary
Predicate) | MagPro R30 incl.
MagOption, X100,
X100 incl.
MagOption
(Secondary
Predicate) | Comparison |
| Stimulus Intensity | 0-100% Adjustable | 0-100% Adjustable | 0-100% Adjustable | Identical |
| Coil Positioning | Periphery other than
brain | Periphery other than brain | Periphery other than
brain | Identical |
| Core Material | Air Core | Air Core | Air Core | Identical |
| Peak Magnetic
Field | 2.5 T | 2.1 T | N/A | MEGA-TMS has a
slightly larger peak
magnetic field than |
| Certificates:
IEC 60601-1 | YES | YES | YES | Identical |
| Dimensions (in.)
[L x W x H] | 20.87" x 19.69" x
7.09" | 18.11" x 14.76" x 6.30" | MagPro: 210 x 530 x 400mm
MagOption: 130 x 530 x 400mm | MEGA-TMS has a
slightly larger
stimulator unit. |
| Parameter | MEGA-TMS
Neurosoft, Ltd.
Proposed | Magstim 2002 with
Double 70mm Remote
Coil Magstim
Company, Llc.
(Primary Predicate) | MagPro R30 incl.
MagOption, X100,
X100 incl.
MagOption
(Secondary
Predicate) | Comparison |
| Weight (lbs.,
oz.) [without
battery or
electrode
cables] | ~66 lbs | ~50 lbs | MagPro X100:
35kg / 77lbs
MagOption: 25kg
/ 55lbs | MEGA-TMS
has a slightly
larger stimulator
unit. |
| Menu
Display | Coil Temperature
and
Intensity Indicators:
Coil Type
Coil State
Armed/Disarmed
State
Power
Charging/Discharging
Status
High Voltage
Replace Coil | Coil Temperature and
Intensity Indicators:
Coil State
Armed/Disarmed State
Power
Status
Default Condition
Replace Coil | MagPro X100 has
1 display. All
parameter settings
can be shown on
the display.
· Intensity
· Repetition rate
· Pulses in train
· Number of trains
· Inter train interval
· Start delay
· Amplitude
· Realized di/dt
Status:
enable/disable
· Coil temperature
· Coil type
· Available stimuli
· Event log
information
and
date/time
· Treatment
sequence can be
stored and reused.
Event log and
Amplitude log
can be exported.
· Continuously
readout of di/dt
controlling the
stability of the
produced magnetic
stimulation | MEGA-TMS
has a slightly
more indicators
shown in the
menu display
compared to the
predicate device |
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7
8
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Performance Testing:
The following performance data were provided in support of the substantial equivalence determination.
Safety and EMC
Electrical and mechanical safety and electromagnetic compatibility testing were conducted to demonstrate that the MEGA-TMS device is compliant with IEC 60601-1 (Edition 3.1) and IEC 60601-1-2 (Edition 4).
Design
Design verification demonstrated that the device functions as intended. Design validation was demonstrated using software validation testing and literature review. Validation testing confirmed that the device met end-user needs, intended use and evidence of device operation in actual use conditions.
Software
Following FDA's Guidance for Industry and Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," software verification and validation was conducted.
Risk Management
The potential risks of MEGA-TMS were identified and evaluated in compliance with ISO 14971. All risks were determined to be appropriately mitigated with risk control measures to acceptable residual levels.
Electric and Magnetic Field Characteristics
For electric field, actual measurements were recorded and simulations performed. For magnetic field, pulse shape information, magnetic field spatial distribution, magnetic field strength gradient, linearity, and reliability information were collected. Bench top measurements of field strength were taken at coil surface and 20 mm above to determine spatial distribution of magnetic field.
Conclusion:
The non-clinical data demonstrates that the differences in technological characteristics between the subject device and predicate devices do not raise new or different questions of safety and effectiveness and is therefore comparable to the predicate devices that are currently marketed for the same intended use.