(87 days)
Not Found
No
The summary describes a passive electrode for recording and stimulating, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is used for brain mapping during neurosurgical procedures, specifically to record electrical activity or evoke a response through stimulation, which are diagnostic and procedural guidance functions, not directly therapeutic.
Yes
The device is used to record electrical activity and evoke responses for brain mapping, which is a diagnostic purpose to understand brain function during surgery.
No
The device description explicitly states it is a "passive probe," which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body.
- Device Function: The description clearly states the device is a "passive probe guided stereotactically to record electrical activity or evoke a response through stimulation for the purpose of brain mapping during functional neurosurgical procedures." This involves direct interaction with the brain inside the body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens taken from the patient.
Therefore, this device falls under the category of a surgical or neurological device used for direct intervention and monitoring within the body, not an IVD.
N/A
Intended Use / Indications for Use
To record electrical activity or evoke a response through stimulation for the purpose of brain mapping during functional neurosurgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GZL, GYC
Device Description
The Recording and Stimulating Electrode is a passive probe guided stereotactically to record electrical activity or evoke a response through stimulation for the purpose of brain mapping during foretional neurosurgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).
0
K 012850
Section 5: 510(k) Summary
Recording and Stimulating Electrode 510(k) Summary
This summary of the 510(k) salety and clicctiveness information is submitted in accordance with the requirements of the Sale Medical Devices Act of 1990 and 21 CFR §807.92.
Submitter of Premarket Notification:
Kevin J. O'Connell Sr. Regulatory Associato Radionics, a Division of Tyco Healthcare Group, LP 22 Torry Avenue Burlington, MA 01803 Telephone: (781) 272-1233 Fax: (781) 238-0606
Performance Standards:
No applicable porformance standards have been issued under section 514 of the Food, Drug & Cosmotic Act.
Device Name:
| Proprietary Name: | Recording and Stimulating Electrode |
|---|---|
| Common/Usual Name: | Recording Electrode and/or Stimulating Electrode |
| Classification Name: | Depth Electrode |
Predicate Device(s):
Radionies Microelectrode Kit, 510(k) number K991399, dated Scplomber 21, 1999.
Microrecording Systems Consultants, LLC, Microelectrocncephalography Professional System 5000 for Surgical Neurophysiological Recording, 510(k) number K991077, dated June 9, 1999.
Intended Use:
To record electrical activity or evoke a response through stimulation for the purpose of brain mapping during functional neurosurgical procedures.
Device Description:
The Recording and Stimulating Electrode is a passive probe guided stereotactically to record electrical activity or evoke a response through stimulation for the purpose of brain mapping during foretional neurosurgical procedures.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized image of an eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2001
Mr. Kevin J. O'Connell Senior Regulatory Associate Radionics, a Division of Tyco Healthcare Group, LP 22 Terry Avenue Burlington, Massachusetts 01803
Re: K012850
Trade/Device Name: Recording and Stimulating Electrode Regulation Number: 882.1330, 882.1310 Regulation Name: Depth electrode, Cortical electrode Regulatory Class: II Product Code: GZL, GYC Dated: August 23, 2001 Received: August 24, 2001
Dear Mr. O'Connell:
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 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.
2
Page 2 - Mr. Kevin J. O'Connell
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Susan Walker, MD
Image /page/2/Picture/5 description: The image shows a black and white drawing of a cursive letter. The letter appears to be a 'P' or a similar looping character. The lines are thick and slightly uneven, suggesting it may have been drawn by hand. The overall impression is simple and abstract.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
NOV 1 9 2001
ODE Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Recording and Stimulating Electrode Device Name:
Indications for Use:
To record clectrical activity or evoke a response through stimulation for the purpose of brain mapping during functional neurosurgical procedures.
(I'LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE II: NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR § 801.109)
ાર
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Susan Walk~
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012850