(103 days)
None
Not Found
No
The summary describes a device for creating lesions in neural tissue using radiofrequency probes and catheters. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on the physical mechanism of lesion creation.
Yes
The device is intended to "create lesions in neural tissue," which is a direct therapeutic intervention.
No
The device is intended to "create lesions in neural tissue," which is a treatment function, not a diagnostic one.
No
The device description is not found, but the intended use clearly states the device is used "to create lesions in neural tissue" and is used "with separately approved lesion/temperature probes." This strongly implies a hardware component (the device itself) that interacts with probes to perform a physical action (creating lesions).
Based on the provided information, the NT 1000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "create lesions in neural tissue." This is a therapeutic procedure performed directly on the patient's body, not a diagnostic test performed on samples taken from the body.
- Device Description (or lack thereof): While the description is "Not Found," the intended use clearly points to a device used for treatment, not diagnosis.
- No mention of samples or in vitro testing: The description doesn't mention analyzing blood, urine, tissue, or any other biological samples outside of the body, which is characteristic of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NT 1000's function of creating lesions in neural tissue falls under the category of a therapeutic or surgical device.
N/A
Intended Use / 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.
Product codes
GXD
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neural tissue
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with three curved lines representing the eagle's body and wings.
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
1
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
2
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)
tearbura brehMD for mxm
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
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510(k) Number K052878