The NT 2000 is intended for use for lesioning of neural tissue. The NT 2000 is indicated for use in the peripheral nervous system. The NT 2000 is to be used only with FDA cleared NeuroTherm RF probes and Smith & Nephew SPINECATH and ACUTHERM catheters.

Device Description

The NeuroTherm NT 2000 is a desktop RF lesioning generator, which is used for the lesioning of neural tissue. The device is a second generation device that is a modification of the NeuroTherm NT 1000 (K052878) previously cleared by FDA. The NT 2000 is a multi-lesioning, 4 channel portable generator that can provide continuous or pulsed RF output at 460 KHz, monopolar or dual electrode modes, and a Simplicity mode for large lesion creation. The device includes sensory and motor stimulation functions to fine tune electrode placement for procedures, and is also designed to connect to various lesioning probes which are inserted into patients for lesioning of neural tissue during medical procedures. Device features include a touch screen monitor incorporating microprocessor and graphics display for user interface as well as self diagnostics, calibration checks, and recordkeeping functions.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NeuroTherm NT 2000 Lesioning Generator based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical efficacy through extensive studies. Therefore, much of the requested information (like detailed sample sizes for test/training sets, number of experts for ground truth, MRMC studies, standalone performance with metrics like AUC, sensitivity, specificity) is not typically found in this type of submission for this class of device. The "performance testing" described is primarily bench and software testing to ensure the device operates as designed and meets electrical safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a radiofrequency lesion generator, the "acceptance criteria" are primarily related to substantial equivalence to existing, legally marketed predicate devices, and demonstrating that the new device performs as intended and safely according to its design specifications. Actual quantitative performance metrics for disease detection (like sensitivity, specificity, AUC) are not applicable or presented here for this type of device.

Acceptance Criteria Category	Specific Criterion (Implicit/Explicit)	Reported Device Performance
Intended Use	Intended for lesioning of neural tissue; indicated for use in the peripheral nervous system; to be used only with FDA cleared NeuroTherm RF probes and Smith & Nephew SPINECATH and ACUTHERM catheters. (Matches predicate devices).	The NT 2000's stated "Intended Use" and "Indication for Use" are consistent with the predicate devices, specifically the NeuroTherm NT 1000, and align with the general purpose of RF lesion generators.
Technology	Based on the same fundamental radiofrequency lesioning technology as predicate devices (e.g., 460 kHz frequency for RF energy delivery).	The NT 2000 utilizes RF energy delivery for neural tissue lesioning, similar to its predicates. It operates at 460 kHz, which is comparable to the 480 kHz of the NT 1000 and Cosman G4.
Functional Modes	Should include continuous RF thermal and pulsed RF modes, sensory and motor stimulation functions, and multi-channel capabilities (e.g., monopolar, bipolar/dual electrode modes).	The NT 2000 offers continuous and pulsed RF modes, sensory and motor stimulation, and both monopolar (4 channels) and bipolar ("dual") electrode modes. It introduces "Continuous independent simultaneous energy delivery" during multi-channel RF, which is an enhancement over the sequential delivery of the NT 1000 but is also present in the Cosman G4.
Technical Specifications (Key)	Power output (e.g., comparable maximum output), frequency, number of channels, safety features (excess power, excess temperature), electrical safety/EMC compliance.	Power Output: Max 50W into 100 Ω (comparable to Stryker Multi-Gen and Cosman G4, an increase from NT 1000's 30W into 200 Ω).Frequency: 460 kHz (comparable to predicates).Channels: 4 monopolar channels (similar to Stryker and Cosman, an increase from NT 1000's 3 channels).Safety Features: Yes (excess power, excess temperature), mimicking predicates.Electrical Safety/EMC: IEC 60601 compliant (same as all predicates).Physical Design: While dimensions and weight vary slightly, they are within the general range for this type of device.
Safety and Effectiveness (Overall)	Any differences between the NT 2000 and the predicate 4-channel devices should not raise new issues of safety or effectiveness. This is the overarching acceptance criterion for a 510(k) submission – demonstrating that the device is as safe and effective as a legally marketed predicate device.	The conclusion explicitly states: "Any differences between the NT 2000 and the predicate 4-channel devices do not raise new issues of safety or effectiveness." This is supported by bench and software testing.
Performance Testing	Device should operate as designed according to internal specifications for hardware and software.	Bench Testing: "Bench testing supports that the NT 2000 performs as expected."Software Testing: "Software testing supports that the NT 2000 performs as expected."
Compliance with Standards	Compliance with relevant industry standards, particularly for electrical medical equipment.	"This device is IEC 60601 compliant as appropriate."

2. Sample Size for the Test Set and Data Provenance

Sample Size for the Test Set: Not applicable. For this type of device (RF lesion generator), the "test set" isn't a dataset of patient images or clinical outcomes. The testing primarily involves bench testing (physical device performance under various conditions) and software testing (functionality, robustness, safety of the embedded software). The document does not specify numbers of test cases or samples for these engineering tests, as it's standard industry practice to ensure comprehensive testing within internal development.
Data Provenance: Not applicable. There is no patient-derived data for this type of testing. The "data" here would be measurements from bench tests and outputs from software verification/validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts and Qualifications: Not applicable. The "ground truth" for an RF lesion generator's performance is its ability to consistently and safely deliver radiofrequency energy according to its specifications, and to function reliably. This is established through engineering and software verification and validation, not through expert clinical consensus on a "test set" of patient data.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no "adjudication" in the clinical sense for this type of device's testing. The device's performance against its specifications would be objectively measured and verified during engineering and software tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study / Effect Size for Human Readers: Not applicable. This device is a therapeutic/interventional medical device (a radiofrequency lesion generator), not an AI-powered diagnostic or interpretive tool that assists human "readers" (e.g., radiologists interpreting images). Therefore, an MRMC study and related metrics are not relevant to its regulatory submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable as this is not an AI algorithm. The device, by its nature, is a "standalone" system in terms of its ability to generate RF energy, but it always requires a human operator for its clinical application (human-in-the-loop). Its "performance" is measured by its engineering specifications and safety features, which are evaluated in bench and software testing.

7. The type of ground truth used

Type of Ground Truth: For this device, the "ground truth" is defined by its engineering specifications and international safety standards (IEC 60601). For example, if the device is spec'd to output 50W, the ground truth for that parameter is "50W +/- tolerance." For software, the ground truth is the documented functional requirements and logic.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device does not employ machine learning or AI that would require a "training set."

9. How the ground truth for the training set was established

Ground Truth for Training Set Establishment: Not applicable. As there is no training set, there is no method for establishing its ground truth.

Summary

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SEP 2 0 2011

6

Traditional 510(k) Summary

A) SUBMITTED BY:	NeuroTherm, Inc.
	30 Upton Drive, Suite 2
	Wilmington, MA 01887-1083
	Registration # 1226344

CONTACT: Sharyn Orton, PhD MEDIcept Inc. 200 Homer Ave Ashland. MA 01721 401-330-8264 508-231-8861 Fax

B) DEVICE NAME: NT 2000 Lesioning Generator

COMMON NAME: Generator, Lesion, Radiofrequency

DEVICE CLASS: 21 CFR 882.4400 Radiofrequency lesion generator, Class II

PRODUCT CODE: GXD

C) PREDICATES:

NeuroTherm NT 1000 RF Lesioning Generator (K052878) .
. Stryker Multi-Gen Lesioning Generator (K071482)
. Cosman G4 Radiofrequency Generator (K082051)

D) DEVICE DESCRIPTION:

The NT 2000 is a multi-lesioning, 4 channel portable generator that can provide continuous or pulsed RF output at 460 KHz, monopolar or dual electrode modes, and a Simplicity mode for large lesion creation. The device includes sensory and motor stimulation functions to fine tune electrode placement for procedures, and is also designed to connect to various lesioning probes which are inserted into patients for lesioning of neural tissue during medical procedures.

Device features include a touch screen monitor incorporating microprocessor and graphics display for user interface as well as self diagnostics, calibration checks, and recordkeeping functions.

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NeuroTherm MEDIcept, Inc. Traditional 510(K) N1 2000 200 Homer Ave

revised August 23, 2011 Ashland, MA 01721

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E) INTENDED USE: The NT 2000 is intended for lesioning of neural tissue. It is to be used only with FDA cleared lesion/temperature probes (NeuroTherm radiofrequency probes and Smith & Nephew SPINECATH™ and ACUTHERM™ catheters). It is indicated for use in the peripheral nervous system.

F) SUBSTANTIAL EQUIVALENCE COMPARISON AND DISCUSSION

	NeuroThermNT 2000Generator	NeuroThermNT 1000Generator	Stryker Multi-Gen	CosmanG4 RFGenerator
Product codes		K052878	K071482	K082051
		GXD	GXD, GEI	GXD
Intended UseIndication forUse	Intended for usefor lesioning ofneural tissue.	Intended for useto create lesionsin neural tissue.	With Strykerelectrodes isintended forcoagulation ofsoft tissues inorthopedic,spinal andneurosurgicalapplications.	Indicated for usein procedures tocreate RF lesionsfor treatment ofpain, or forlesioning nervetissue forfunctionalneurosurgicalprocedures.
	Indicated for usein the peripheralnervous system.	Intended for usein painmanagement	With Smith &NephewSPINECATHandACUTHERMcatheters, isintended forcoagulation anddecompression ofdisc material.	Used withCosman RFprobes.
	To be used onlywith FDA clearedNeuroTherm RFprobes.	To be used withNeuroTherm RFprobes, Smith &NephewSPINECATH,ACUTHERMcatheters,RadionicsDiskTroderadiofrequencyprobes
	To be used onlywith FDA clearedthe Smith &NephewSPINECATH andACUTHERMcatheters.

Table 1 – Intended Use/Indication for Use

NeuroTherm MEDIcept, Inc. Traditional 510(k) NT 2000 200 Homer Ave

revised August 23, 2011 Ashland, MA 01721

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Table 2 Predicate comparisons

	NeuroThermNT 2000Generator	NeuroThermNT 1000Generator	Stryker Multi-Gen	CosmanG4 RFGenerator
Power output	Max poweroutput 50Winto 100 Ω.	Max poweroutput 30Winto 200 Ω.	50W maxinto 100 Ω	50W
Continuous RFFrequency	460 kHz	480 kHz	1 MHz	480 kHz
Stimulation –sensory andmotor	Yes	Yes	Yes	Yes
Energy deliveryduring multichannel RFtreatment	Continuousindependentsimultaneousenergy delivery	Sequential nonsimultaneousenergy delivery	Sequential nonsimultaneousenergy delivery	Continuousindependentsimultaneousenergy delivery
RF energydelivery modes:
Continuousthermal	Yes	Yes	Yes	Yes
Pulsed RF	Yes	Yes	Yes	Yes
RF energydelivery channeltypes
Monopolar	4	3	4	4
Bipolar*	Yesaka “dual”	Yesaka “dual”	Yesaka “parallelbipolar”	Yesaka “bipolar pair”

current between two monopolar electrodes

	NeuroThermNT 2000Generator	NeuroThermNT 1000Generator	Stryker Multi-Gen	CosmanG4 RFGenerator
Printer	Yes	Yes	No	Yes
Wireless mouse	No	No	No	Yes
Touch screen	Full operation	Set up only	Full operation	Full operation
Excess powersafety feature	Yes	Yes	Yes	Yes
Excesstemperaturesafety feature	Yes	Yes	Yes	Yes
Foot print	370 x 320 x 430mm (W x H x D)	400 x 300 x 415mm (W x H x D)	317 x 203 x 381mm (W x H x D)	362 x 241 x 300mm (W x H x D)
Weight	11.4 kg	12.5 kg	8.2 kg	10 kg

NeuroTherm MEDIcept, Inc.

ﺮ Traditional 510(k) NT 2000 200 Homer Ave

revised August 23, 2011

・・・・・・・

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Touch screendimensions	14" diagonal	12" diagonal	5.5 in x 8 in.160° viewingangle	12 in
Electricalsafety/EMC	IEC60601compliant	IEC60601compliant	IEC60601compliant	IEC60601compliant

CONCLUSION

The NT 2000 is similar to or the same as the predicate devices as follows:

. Technology
. Intended use/Indication for Use
t Technical specifications, or ranges of technical specifications
Functional modes compared to other 4-channel devices .

Where the NT 2000 differs from the NT 1000, it is similar to or the same as the other predicate devices.

Any differences between the NT 2000 and the predicate 4-channel devices do not raise new issues of safety or effectiveness. Therefore, the NT 2000 is substantially equivalent to the predicate devices based upon the Intended Use, technology, functional modes, hardware and software components, and performance.

G) PERFORMANCE TESTING

There are no applicable performance Consensus Standards or Guidance documents associated with this device.

Bench - Bench testing supports that the NT 2000 performs as expected. Software - Software testing supports that the NT 2000 performs as expected.

H) OTHER - Compliance with Standards

This device is IEC 60601compliant as appropriate.

NeuroTherm MEDIcept, Inc. Traditional 510(k) NT 2000 200 Homer Ave

revised August 23, 2011 Ashland, MA 01721

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Neurotherm, Inc. c/o Mr. F. David Rothkopf President MEDicept. Inc. 200 Homer Avenue Ashland. MA 01721

SEP 2 0 2011

Re: K111576

Trade/Device Name: NT 2000 Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: II Product Code: GXD Dated: August 23, 2011 Received: August 24, 2011

Dear Mr. Rothkopf:

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

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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 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 go to http://www.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Keoia Alexander

Image /page/5/Picture/7 description: The image contains a handwritten word that appears to be "for". The writing is cursive, with the "f" having a large loop extending below the baseline and a cross stroke. The "o" and "r" are connected and smaller in size compared to the "f". The writing is in black ink on a white background.

Malvina B. Eydelman. M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K111576

Device Name: NT 2000

Indication for Use: The NT 2000 is intended for use for lesioning of neural tissue. The NT 2000 is indicated for use in the peripheral nervous system.

The NT 2000 is to be used only with FDA cleared NeuroTherm RF probes and Smith & Nephew SPINECATH and ACUTHERM catheters.

Prescription Use X 21CFR 801, Subpart D OR Over-the-Counter Use _ 21CFR 801.109

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ochthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K111576

Regulation Number and Section

§ 882.4400 Radiofrequency lesion generator.

(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).