NT 2000 LESIONING GENERATOR
Device Facts
| Record ID | K111576 |
|---|---|
| Device Name | NT 2000 LESIONING GENERATOR |
| Applicant | Neuro Therm, Inc. |
| Product Code | GXD · Neurology |
| Decision Date | Sep 20, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
NT 2000 is a desktop, 4-channel radiofrequency (RF) lesioning generator for neural tissue. It accepts inputs from RF probes/catheters inserted into patients. Device provides continuous or pulsed RF output at 460 KHz, supporting monopolar or dual (bipolar) electrode modes, plus a Simplicity mode for large lesions. Features include sensory and motor stimulation for electrode placement, self-diagnostics, calibration checks, and recordkeeping. Operated by clinicians in medical settings via a 14-inch touch screen monitor with microprocessor-based graphics. Output allows clinicians to perform controlled thermal coagulation of neural tissue. Benefits include precise lesion creation for pain management and functional neurosurgical procedures. Device includes safety features for excess power and temperature monitoring.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by bench testing and software verification/validation testing confirming the device performs as expected.
Technological Characteristics
Desktop RF generator; 4-channel; 460 KHz output frequency; monopolar and dual (bipolar) modes; 14-inch touch screen interface; microprocessor-controlled; IEC 60601 compliant; connectivity for RF probes/catheters; includes self-diagnostics and recordkeeping functions.
Indications for Use
Indicated for lesioning of neural tissue in the peripheral nervous system. For use only with specific FDA-cleared NeuroTherm RF probes and Smith & Nephew SPINECATH and ACUTHERM catheters. Prescription use only.
Regulatory Classification
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.
Predicate Devices
- NeuroTherm NT 1000 RF Lesioning Generator (K052878)
- Stryker Multi-Gen Lesioning Generator (K071482)
- Cosman G4 Radiofrequency Generator (K082051)
Related Devices
- K220122 — APEX 6 · Rf Innovations, Inc. · Mar 15, 2023
- K201610 — IonicRF Generator · ABBOTT MEDICAL · Oct 21, 2020
- K232632 — Racz Neurostat RF Generator · Epimed International · May 24, 2024
- K070336 — STOCKERT NEURO N50, MODEL12267 · Stockert GmbH · Jun 14, 2007
- K052878 — NT-1000 · Neuro Therm, Inc. · Jan 23, 2006
Submission Summary (Full Text)
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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 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.
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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
| | NeuroTherm<br>NT 2000<br>Generator | NeuroTherm<br>NT 1000<br>Generator | Stryker Multi-<br>Gen | Cosman<br>G4 RF<br>Generator |
|---------------------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product codes | | K052878 | K071482 | K082051 |
| | | GXD | GXD, GEI | GXD |
| Intended Use<br>Indication for<br>Use | Intended for use<br>for lesioning of<br>neural tissue. | Intended for use<br>to create lesions<br>in neural tissue. | With Stryker<br>electrodes is<br>intended for<br>coagulation of<br>soft tissues in<br>orthopedic,<br>spinal and<br>neurosurgical<br>applications. | Indicated for use<br>in procedures to<br>create RF lesions<br>for treatment of<br>pain, or for<br>lesioning nerve<br>tissue for<br>functional<br>neurosurgical<br>procedures. |
| | Indicated for use<br>in the peripheral<br>nervous system. | Intended for use<br>in pain<br>management | With Smith &<br>Nephew<br>SPINECATH<br>and<br>ACUTHERM<br>catheters, is<br>intended for<br>coagulation and<br>decompression of<br>disc material. | Used with<br>Cosman RF<br>probes. |
| | To be used only<br>with FDA cleared<br>NeuroTherm RF<br>probes. | To be used with<br>NeuroTherm RF<br>probes, Smith &<br>Nephew<br>SPINECATH,<br>ACUTHERM<br>catheters,<br>Radionics<br>DiskTrode<br>radiofrequency<br>probes | | |
| | To be used only<br>with FDA cleared<br>the Smith &<br>Nephew<br>SPINECATH and<br>ACUTHERM<br>catheters. | | | |
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
| | NeuroTherm<br>NT 2000<br>Generator | NeuroTherm<br>NT 1000<br>Generator | Stryker Multi-<br>Gen | Cosman<br>G4 RF<br>Generator |
|------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------|
| Power output | Max power<br>output 50W<br>into 100 Ω. | Max power<br>output 30W<br>into 200 Ω. | 50W max<br>into 100 Ω | 50W |
| Continuous RF<br>Frequency | 460 kHz | 480 kHz | 1 MHz | 480 kHz |
| Stimulation –<br>sensory and<br>motor | Yes | Yes | Yes | Yes |
| Energy delivery<br>during multi<br>channel RF<br>treatment | Continuous<br>independent<br>simultaneous<br>energy delivery | Sequential non<br>simultaneous<br>energy delivery | Sequential non<br>simultaneous<br>energy delivery | Continuous<br>independent<br>simultaneous<br>energy delivery |
| RF energy<br>delivery modes: | | | | |
| Continuous<br>thermal | Yes | Yes | Yes | Yes |
| Pulsed RF | Yes | Yes | Yes | Yes |
| RF energy<br>delivery channel<br>types | | | | |
| Monopolar | 4 | 3 | 4 | 4 |
| Bipolar* | Yes<br>aka “dual” | Yes<br>aka “dual” | Yes<br>aka “parallel<br>bipolar” | Yes<br>aka “bipolar pair” |
* current between two monopolar electrodes
| | NeuroTherm<br>NT 2000<br>Generator | NeuroTherm<br>NT 1000<br>Generator | Stryker Multi-<br>Gen | Cosman<br>G4 RF<br>Generator |
|-----------------------------------------|------------------------------------|------------------------------------|-----------------------------------|-----------------------------------|
| Printer | Yes | Yes | No | Yes |
| Wireless mouse | No | No | No | Yes |
| Touch screen | Full operation | Set up only | Full operation | Full operation |
| Excess power<br>safety feature | Yes | Yes | Yes | Yes |
| Excess<br>temperature<br>safety feature | Yes | Yes | Yes | Yes |
| Foot print | 370 x 320 x 430<br>mm (W x H x D) | 400 x 300 x 415<br>mm (W x H x D) | 317 x 203 x 381<br>mm (W x H x D) | 362 x 241 x 300<br>mm (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 screen<br>dimensions | 14" diagonal | 12" diagonal | 5.5 in x 8 in.<br>160° viewing<br>angle | 12 in |
|----------------------------|-----------------------|-----------------------|-----------------------------------------|-----------------------|
| Electrical<br>safety/EMC | IEC<br>60601compliant | IEC<br>60601compliant | IEC<br>60601compliant | IEC<br>60601compliant |
#### 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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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
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
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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
