(249 days)
Wyler Sphenoidal Electrode (K861031)
Not Found
No
The device description and intended use focus solely on the physical electrode and its function in recording electrical signals. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device is used for recording electrical signals for epilepsy monitoring, which is a diagnostic purpose, not a therapeutic intervention.
Yes
Explanation: The device is described as "Intraoperative recording of electrical signals for Epilepsy monitoring." Recording electrical signals for monitoring epilepsy is a diagnostic function, as it helps identify and characterize the condition.
No
The device description clearly details a physical electrode made of wire with a connector, an introducer, and states it is provided sterile for single use. This indicates a hardware medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This testing happens outside the body (in vitro).
- Device Function: The PMT Sphenoidal Electrode is used to record electrical signals directly from within the brain during surgery. It is an invasive device used in vivo (within the living body).
- Intended Use: The intended use is for "Intraoperative recording of electrical signals for Epilepsy monitoring at the surface and subsurface levels of the brain." This is a direct measurement of physiological activity within the body, not the analysis of a specimen taken from the body.
Therefore, based on the provided information, the PMT Sphenoidal Electrode is a medical device used for physiological monitoring in vivo, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PMT Sphenoidal Electrode is indicated for Intraoperative recording of electrical signals for epilepsy monitoring at the surface and subsurface levels of the brain.
The PMT SPHENOIDAL Electrode is indicated for Intraoperative recording of electrical signals for Epilepsy monitoring at the surface and subsurface levels of the brain. It is not intended for long term monitoring.
Product codes
GZL
Device Description
The PMT Sphenoidal electrode consists of an insulated Platinum/lridum or Stainless Steel wire with an exposed distal portion used to record EEG activity. The proximal end of the wire terminates in a connector. The connector attaches to an Interconnection cable external to the patient and connected to the EEG equipment.
The PMT Sphenoidal electrode is introduced to the recording site via an introducer. Once in place, the introducer is removed leaving the electrode available for recording EEG patterns from the inferior mesial temporal lobe.
The PMT Sphenoidal Electrode is provided sterile for single use and for Intraoperative use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surface and subsurface levels of the 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
tests confirm the equivalence to predicated devices. The Mechanical biocompatibility testing will comply with ASTM, ANSI/AAMI standards.
Key Metrics
Not Found
Predicate Device(s)
Wyler Sphenoidal Electrode (K861031)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
PMT® Corporation
Premarket Notification [510(k)] Summary .
| Submitters name: | PMT CORPORATION |
|---|---|
| Submitters Address: | PMT Corporation |
| 1500 Park Road | |
| Chanhassen, MN 55317 | |
| Phone: | (952) 470-0866 |
| Fax: | (952) 470-0865 |
| Contact name: | Eric Caillé |
| Date: | Tuesday, November 25, 2003 |
| Trade name: | PMT Sphenoidal Electrode |
| Common name: | Sphenoidal Electrode |
| Classification name: | Electrode, Depth (per 21 CFR section 882.1330) |
Substantial Equivalence claim:
The PMT Sphenoidal Electrode is substantially equivalent, for the purpose of this 510(K), to the Wyler Sphenoidal Electrode (K861031) manufactured by AD-Tech Medical.
Device Description:
The PMT Sphenoidal electrode consists of an insulated Platinum/lridum or Stainless Steel wire with an exposed distal portion used to record EEG activity. The proximal end of the wire terminates in a connector. The connector attaches to an Interconnection cable external to the patient and connected to the EEG equipment.
The PMT Sphenoidal electrode is introduced to the recording site via an introducer. Once in place, the introducer is removed leaving the electrode available for recording EEG patterns from the inferior mesial temporal lobe.
The PMT Sphenoidal Electrode is provided sterile for single use and for Intraoperative use only.
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Indications for Use:
The PMT Sphenoidal Electrode is indicated for Intraoperative recording of electrical signals for epilepsy monitoring at the surface and subsurface levels of the brain.
Summary of testing:
tests confirm the equivalence to predicated devices. The Mechanical biocompatibility testing will comply with ASTM, ANSI/AAMI standards.
Sterility:
The PMT Sphenoidal Electrode is manufacture in a clean room environment and is double bagged in Tyvek sterilization pouches. It is provided sterilized by the ethylene oxide method to provide a sterility assurance level (SAL) of 10 °
The PMT Sphenoidal Electrode is provided pyrogen free. The method of determination is the Limulus Amebocyte Lysate Test.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with text around the perimeter and a stylized eagle-like symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle symbol is composed of three curved lines, suggesting movement or flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2004
Mr. Eric Caillé Neuro Division General Manager PMT Corporation 1500 Park Road Box 610 Chanhassen, Minnesota 55317
Re: K033730
KUSS 730
Trade/Device Name: PMT Sphenoidal Electrode and Accessory Model 2101-31and 2102-31 Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: II Product Code: GZL Dated: June 10, 2004 Received: June 14, 2004
Dear Mr. Caillé:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premainted instantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate referenced above and nave uetchildled the devices marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manced provice Americal Device Ameridants, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the enactivent and other of the Federal Food, Drug, devices that have been reclassince in accordance was as remarket approval arplication (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval argui and Cosmetic Act (Act) that to not require approvide of the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general contro You may, merelore, market the device, bacycer to the general registration, listing of
general controls provisions of the Act include requirements for annual registereding and general controls provisions of the rict merade required in the summer misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mis elisitive major regulations alfecting your device can
may be subject to such additional controls. Existing major regulations ED may be subject to such additional controls. Little 21. Parts 800 to 898. In addition. FDA may
be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. ne found in the Code of Peacharting your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a backannel with other requirements of the Act that FDA has made a decemination that your seee by other Federal agencies. You must or any Pederal Statures and regulations dammitters a 07 not limited to: registration and listing (2 l
eat CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sets CFR Part 807), labeling (21 CFR Part 801), good and and 120); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Eric Caillé
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and with Jourse of substantial equivalence of your device to a legally prematication " 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 If you desire spocitie arrivier - J 01) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour responser 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,
Miriam C. Provost
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
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Indications for Use
510(k) Number (if known): козз730
Device Name:
Indications For Use:
PMT SPHENOIDAL ELECTRODE AND ACCESSORY MODEL 2101-31 AND 2102-31
The PMT SPHENOIDAL Electrode is indicated for Intraoperative recording of electrical signals for Epilepsy monitoring at the surface and subsurface levels of the brain. It is not intended for long term monitoring.
Prescription Use ਮ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number_6033730_________________________________________________________________________________________________________________________________________________________