(681 days)
Stimulation of peripheral nerves for diagnostic purposes.
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.
The provided text is a 510(k) summary for the MEGA-TMS device, which is an evoked response electrical stimulator used for diagnostic purposes. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a study to establish acceptance criteria for an AI/CADe device's performance.
Therefore, I cannot extract the requested information regarding AI/CADe acceptance criteria or the study proving a device meets them. The document mentions performance testing, but this refers to safety, EMC, design verification, and risk management for the electrical stimulator, not an AI or CADe system.
The closest relevant information, though not directly applicable to an AI device's performance, is under "Electric and Magnetic Field Characteristics," where measurements and simulations were performed for electric and magnetic fields. However, this pertains to the physical and electrical characteristics of the stimulator itself, not the diagnostic performance of an AI.
To directly answer your request based on the provided text, the document does not contain the specific information you are looking for regarding acceptance criteria and a study proving an AI/CADe device meets those criteria.
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August 13, 2021
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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
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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
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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 StreetSuite 1401New York, NY 10001 |
| Contact Person: | Abhishek DattaPhone: 888-990-8327Fax: 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 IIMagPro 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 fordiagnostic 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-TMSProposed | Magstim 2002 withDouble 70mm RemoteCoil (PrimaryPredicate) | MagPro R30 incl.MagOption, X100,X100 incl. MagOption(Secondary Predicate) | Comparison |
|---|---|---|---|---|
| 510(k) | K192823 | K060847 | K091940 | - |
| Parameter | MEGA-TMSProposed | Magstim 2002 withDouble 70mm RemoteCoil (PrimaryPredicate) | MagPro R30 incl.MagOption, X100,X100 incl. MagOption(Secondary Predicate) | Comparison |
| Device Name andModel | MEGA-TMS | Magstim 2002 | MagPro X100, MagProX100 withMagOptionMagPro R30 withMagOption | - |
| Manufacturer | Neurosoft Ltd. | Magstim Company US,Llc. | Tonica Elektronik A/S | - |
| Indications ForUse | Stimulation ofperipheral nervesfor diagnosticpurposes. | Stimulation ofperipheral nerves fordiagnostic purposes. | The magneticstimulators are intendedto be used forstimulation ofperipheral nerves fordiagnostic purposes. | Identical |
| ContraindicationsFor Use | MEGA-TMS/Neuro-MS and itsaccessories shouldnot be used on or inthe vicinity ofpatients or users withcardiac demandpacemakers,implanted electronicdevices, cochlearimplants, pregnantwomen. | Magstim 2002 and itsaccessories should not beused on or in the vicinityof patients or users withcardiac demandpacemakers, implanteddefibrillators and/orimplantedneurostimulators. | Do not use theequipment on patientswith cardiacpacemakers, cochlearimplants or otherimplanted electronicdevices. Do not applythe magnetic stimuli tothe head, neck orabdomen of pregnantwomen. | MEGA-TMS includesadditional contraindications tothe ones mentioned in thePrimary Predicate. MEGA-TMS contraindications areidentical to the SecondaryPredicate. |
| Parameter | MEGA-TMSNeurosoft, Ltd.Proposed | Magstim 2002 withDouble 70mm RemoteCoil Magstim Company,Lic. (Primary Predicate) | MagPro R30 incl.MagOption, X100,X100 incl. MagOption(Secondary Predicate) | Comparison |
| MaximumVoltage | 2.8 kV | 2.8 kV | 1.8 kV | MagPro has a smaller rangeof maximum voltage. |
| MaximumRepetition Rate | 30% - 0.7 sec /1.42 Hz50% - 1 sec / 1 Hz100%- 3.3 sec /0.3 Hz | 30% - 2 sec / 0.5 Hz50% - 3 sec / 0.33 Hz100%- 4 sec /0.25 Hz | 30% - 0.05 sec / 20 Hz45% - 0.1 sec / 10 Hz100%- 0.5 sec / 2 Hz | Differences in maximumrepetition rate |
| Pulse Width | 80+/-15 µsec(monophasic)120 +/- 15 µsec(power) | 100 µsec (monophasic) | 70 µsec (monophasic)100 µsec (powermonophasic) | MEGA-TMS has a slightlylower pulse width in themonophasic mode incomparison to the primarypredicate. MEGA-TMS has aslightly higher pulse width inthe monophasic mode incomparison to the secondarypredicate. |
| Parameter | MEGA-TMSNeurosoft, Ltd.Proposed | Magstim 2002 with Double70mm Remote Coil MagstimCompany, Llc. (PrimaryPredicate) | MagPro R30 incl.MagOption, X100,X100 incl.MagOption(SecondaryPredicate) | Comparison |
| Stimulus Intensity | 0-100% Adjustable | 0-100% Adjustable | 0-100% Adjustable | Identical |
| Coil Positioning | Periphery other thanbrain | Periphery other than brain | Periphery other thanbrain | Identical |
| Core Material | Air Core | Air Core | Air Core | Identical |
| Peak MagneticField | 2.5 T | 2.1 T | N/A | MEGA-TMS has aslightly larger peakmagnetic field than |
| Certificates:IEC 60601-1 | YES | YES | YES | Identical |
| Dimensions (in.)[L x W x H] | 20.87" x 19.69" x7.09" | 18.11" x 14.76" x 6.30" | MagPro: 210 x 530 x 400mmMagOption: 130 x 530 x 400mm | MEGA-TMS has aslightly largerstimulator unit. |
| Parameter | MEGA-TMSNeurosoft, Ltd.Proposed | Magstim 2002 withDouble 70mm RemoteCoil MagstimCompany, Llc.(Primary Predicate) | MagPro R30 incl.MagOption, X100,X100 incl.MagOption(SecondaryPredicate) | Comparison |
| Weight (lbs.,oz.) [withoutbattery orelectrodecables] | ~66 lbs | ~50 lbs | MagPro X100:35kg / 77lbsMagOption: 25kg/ 55lbs | MEGA-TMShas a slightlylarger stimulatorunit. |
| MenuDisplay | Coil TemperatureandIntensity Indicators:Coil TypeCoil StateArmed/DisarmedStatePowerCharging/DischargingStatusHigh VoltageReplace Coil | Coil Temperature andIntensity Indicators:Coil StateArmed/Disarmed StatePowerStatusDefault ConditionReplace Coil | MagPro X100 has1 display. Allparameter settingscan be shown onthe display.· Intensity· Repetition rate· Pulses in train· Number of trains· Inter train interval· Start delay· Amplitude· Realized di/dtStatus:enable/disable· Coil temperature· Coil type· Available stimuli· Event loginformationanddate/time· Treatmentsequence can bestored and reused.Event log andAmplitude logcan be exported.· Continuouslyreadout of di/dtcontrolling thestability of theproduced magneticstimulation | MEGA-TMShas a slightlymore indicatorsshown in themenu displaycompared to thepredicate device |
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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.
§ 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).