NT-1000

K052878 · Neuro Therm, Inc. · GXD · Jan 23, 2006 · Neurology

Device Facts

• Record ID: K052878
• Device Name: NT-1000
• Applicant: Neuro Therm, Inc.
• Product Code: GXD · Neurology
• Decision Date: Jan 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NT 1000 is intended for use to create lesions in neural tissue. The NT 1000 is to be used with separately approved lesion/temperature probes such as NeuroTherm radiofrequency probes, Smith & Nephew Spinecath™ and Acutherm™ catheters, and Radionics DiskTrode™ radiofrequency probes.

Device Story

Neurotherm NT 1000 RF Lesioning System is a radiofrequency generator designed to create lesions in neural tissue. Device operates by delivering radiofrequency energy through compatible, separately approved lesion/temperature probes (e.g., NeuroTherm probes, Smith & Nephew Spinecath/Acutherm catheters, Radionics DiskTrode). Used in clinical settings by healthcare professionals to perform radiofrequency lesioning procedures. System provides controlled energy delivery to target neural tissue, facilitating therapeutic outcomes through thermal ablation. Clinical utility involves precise tissue destruction for pain management or neurological intervention.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiofrequency lesion generator; energy source: RF electrical current; compatible with various third-party RF probes/catheters; intended for neural tissue ablation.

Indications for Use

Indicated for the creation of lesions in neural tissue. Patient population not specified.

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.

Reference Devices

• NeuroTherm radiofrequency probes
• Smith & Nephew Spinecath™ catheters
• Smith & Nephew Acutherm™ catheters
• Radionics DiskTrode™ radiofrequency probes

Submission Summary (Full Text)

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Public Health Service

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JAN 2 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William Rittman Regulatory Manager Neurotherm, Inc. 2 Debush Road Middleton, Massachusetts 01949

Re: K052878

Trade/Device Name: Neurotherm NT 1000 RF Lesioning System Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: II Product Code: GXD Dated: January 12, 2006 Received: January 12, 2006

Dear Mr. Rittman:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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## Page 2 - Mr. Rittman

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Harbau Muchus
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number : K052878

Device Name: Neurotherm NT 1000 RF Lesioning System

Indications for Use:

The NT 1000 is intended for use to create lesions in neural tissue. The NT 1000 is to be used with separately approved lesion/temperature probes such as NeuroTherm radiofrequency probes, Smith & Nephew Spinecath™ and Acutherm™ catheters, and Radionics DiskTrode™ radiofrequency probes.

Prescription Use × (Part 21 CFR 801 Subpart D)

a market manager and service and the second

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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510(k) Number K052878