(106 days)
No
The description focuses on standard RF lesioning technology, microprocessor control for user interface and basic functions, and does not mention any AI or ML capabilities.
Yes
The device is used for "lesioning of neural tissue," which is a medical procedure intended to treat conditions by destroying specific nerve tissues, thus qualifying it as a therapeutic device.
No
The device is described as an "RF lesioning generator" which is used for the "lesioning of neural tissue," indicating a therapeutic rather than diagnostic function.
No
The device description explicitly states it is a "desktop RF lesioning generator" and a "portable generator," indicating it is a physical hardware device. It also mentions connecting to "various lesioning probes which are inserted into patients." While it includes software features like a touch screen monitor and microprocessor, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "lesioning of neural tissue" and is indicated for use in the "peripheral nervous system." This describes a procedure performed on a patient's body, not a test performed on a sample taken from a patient.
- Device Description: The description details a "desktop RF lesioning generator" that "can provide continuous or pulsed RF output" and connects to "lesioning probes which are inserted into patients." This is consistent with a device used for surgical or interventional procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
In summary, the NT 2000 is a therapeutic device used for performing a medical procedure (lesioning), not a diagnostic device used for testing samples to provide information about a patient's health status.
N/A
Intended Use / Indications for 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.
Product codes
GXD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neural tissue, peripheral nervous system
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench - Bench testing supports that the NT 2000 performs as expected. Software - Software testing supports that the NT 2000 performs as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
್ಕೆ ಮಾ
NeuroTherm MEDIcept, Inc. Traditional 510(K) N1 2000 200 Homer Ave
revised August 23, 2011 Ashland, MA 01721
1
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
NT 2000
Generator | NeuroTherm
NT 1000
Generator | Stryker Multi-
Gen | Cosman
G4 RF
Generator |
|---------------------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product codes | | K052878 | K071482 | K082051 |
| | | GXD | GXD, GEI | GXD |
| Intended Use
Indication for
Use | Intended for use
for lesioning of
neural tissue. | Intended for use
to create lesions
in neural tissue. | With Stryker
electrodes is
intended for
coagulation of
soft tissues in
orthopedic,
spinal and
neurosurgical
applications. | Indicated for use
in procedures to
create RF lesions
for treatment of
pain, or for
lesioning nerve
tissue for
functional
neurosurgical
procedures. |
| | Indicated for use
in the peripheral
nervous system. | Intended for use
in pain
management | With Smith &
Nephew
SPINECATH
and
ACUTHERM
catheters, is
intended for
coagulation and
decompression of
disc material. | Used with
Cosman RF
probes. |
| | To be used only
with FDA cleared
NeuroTherm RF
probes. | To be used with
NeuroTherm RF
probes, Smith &
Nephew
SPINECATH,
ACUTHERM
catheters,
Radionics
DiskTrode
radiofrequency
probes | | |
| | To be used only
with FDA cleared
the Smith &
Nephew
SPINECATH and
ACUTHERM
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
2
Table 2 Predicate comparisons
| | NeuroTherm
NT 2000
Generator | NeuroTherm
NT 1000
Generator | Stryker Multi-
Gen | Cosman
G4 RF
Generator |
|------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------|
| Power output | Max power
output 50W
into 100 Ω. | Max power
output 30W
into 200 Ω. | 50W max
into 100 Ω | 50W |
| Continuous RF
Frequency | 460 kHz | 480 kHz | 1 MHz | 480 kHz |
| Stimulation –
sensory and
motor | Yes | Yes | Yes | Yes |
| Energy delivery
during multi
channel RF
treatment | Continuous
independent
simultaneous
energy delivery | Sequential non
simultaneous
energy delivery | Sequential non
simultaneous
energy delivery | Continuous
independent
simultaneous
energy delivery |
| RF energy
delivery modes: | | | | |
| Continuous
thermal | Yes | Yes | Yes | Yes |
| Pulsed RF | Yes | Yes | Yes | Yes |
| RF energy
delivery channel
types | | | | |
| Monopolar | 4 | 3 | 4 | 4 |
| Bipolar* | Yes
aka “dual” | Yes
aka “dual” | Yes
aka “parallel
bipolar” | Yes
aka “bipolar pair” |
- current between two monopolar electrodes
| | NeuroTherm
NT 2000
Generator | NeuroTherm
NT 1000
Generator | Stryker Multi-
Gen | Cosman
G4 RF
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
safety feature | Yes | Yes | Yes | Yes |
| Excess
temperature
safety feature | Yes | Yes | Yes | Yes |
| Foot print | 370 x 320 x 430
mm (W x H x D) | 400 x 300 x 415
mm (W x H x D) | 317 x 203 x 381
mm (W x H x D) | 362 x 241 x 300
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
・・・・・・・
3
| Touch screen
dimensions | 14" diagonal | 12" diagonal | 5.5 in x 8 in.
160° viewing
angle | 12 in |
|----------------------------|-----------------------|-----------------------|-----------------------------------------|-----------------------|
| Electrical
safety/EMC | IEC
60601compliant | IEC
60601compliant | IEC
60601compliant | IEC
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
4
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
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