(152 days)
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Not Found
No
The summary describes a system for recording, stimulating, and lesioning nervous tissue using electrodes and a stereotactic frame. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the physical components and their function in determining lesion placement based on recorded signals, which is a standard neurosurgical technique.
Yes
The device is used for stimulating and lesioning nervous tissue for functional neurosurgical procedures, which are considered therapeutic interventions.
No
The device is described as being used to record signals for determining the placement of lesions during functional neurosurgical procedures. While it collects data (signals), its primary function is to guide an intervention (lesion placement) rather than to diagnose a condition or disease. It serves as a tool within a surgical procedure rather than a standalone diagnostic tool for identifying a medical state.
No
The device description explicitly lists physical components (recording electrode, sheath, adaptor bushing, spacer, passing cannula) and states it is used with other hardware systems (Nueromap System, CRW Stereotaxtic frame, lesion generator). This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "recording, stimulating and lesioning nervous tissue for functional neurosurgical procedures." This describes a device used in vivo (within a living organism) for surgical intervention and monitoring.
- Device Description: The description details components used for direct interaction with nervous tissue (electrode, sheath, cannula) and its use with other systems for recording and lesioning. This aligns with an in vivo surgical device.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health. The provided information does not mention the analysis of any biological specimens.
Therefore, this device is clearly intended for direct use on nervous tissue within the body during surgery, which is the definition of an in vivo device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For recording, stimulating and lesioning nervous tissue for functional neurosurgical procedures such as but not limited to: cordotomies, tractotomies, myelotomies, thalamotomies and pallidotomies.
Product codes
GXI
Device Description
The above device consists of a recording electrode, sheath, adaptor bushing, spacer and passing cannula. It is used with the Nueromap System, CRW Stereotaxtic frame and lesion generator to record signals in determining the placement of lesions.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
nervous tissue
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).
0
SEP 2 1 1999 1991399 7.0 510(k) Summary:
This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. 807.92.
1.0 The submitter of this premarket notification is:
Kevin J. O'Connell Regulatory Engineer Radionics Software Applications, Inc, 22 Terry Avenue Burlington, MA 01803 Tel .: (781) 272-1233 Fax: (781) 272-2428
This summary was prepared on April 19, 1999.
- 2.0 The name of the device is the Radionics Microelectrode Kit (MEK). The common name is recording and lesioning electrode kit, and its classification names are Depth electrode and Radiofrequency lesion probe
- 3.0 The above device is substantial equivalent to the TM and TCM electrodes which where commercially available prior to May 28, 1976.
- 4.0 The above device consists of a recording electrode, sheath, adaptor bushing, spacer and passing cannula. It is used with the Nueromap System, CRW Stereotaxtic frame and lesion generator to record signals in determining the placement of lesions.
- 5.0 The device like its predicates is intended for recording, stimulating and lesioning nervous tissue for functional neurosurgical procedures such as but not limited to: cordotomies, tractotomies, myelotomies, thalamotomies and pallidotomies.
- 6.0 The technological characteristics are the same or similar to those found with the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three overlapping profiles, representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 1999
Mr. Kevin J. O'Connell Regulatory Engineer Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803-2516
Re: K991399 Trade Name: Radionics Microelectrode Kit Regulatory Class: II Product Code: GXI Dated: July 20, 1999 Received: July 22, 1999
Dear Mr. O'Connell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Kevin J. O'Connell
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K991139
Device Name: Radionics Microelectrode Kit
Indications for use: For recording, stimulating and lesioning nervous tissue for functional neurosurgical procedures such as but not limited to: cordotomies, tractotomies, myelotomies, thalamotomies and pallidotomies.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of General Restorative Devices K99/399
510(k) Number
PRESCRIPTION USE
(Per 21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)