(237 days)
K891920B
K891920B
No
The summary describes a passive electrode for recording electrical signals and makes no mention of AI/ML processing or algorithms.
No
The device is described as being used for "monitoring brain electrical activity (eeg) or defining the location of epileptogenic foci" and "recording of electrical brain signals for epilepsy monitoring," which are diagnostic rather than therapeutic functions.
Yes
The device is designed for "monitoring brain electrical activity (eeg) or defining the location of epileptogenic foci in patients with intractable epilepsy," which involves identifying a condition or its characteristics.
No
The device description explicitly states it is an "electrode," which is a hardware component used for recording electrical signals. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The foramen ovale electrode is designed for monitoring brain electrical activity (EEG) and defining the location of epileptogenic foci. This involves directly interacting with the patient's brain inside the body.
- Intended Use: The intended use explicitly states "Surgical Use Only" and "Not Intended for Implantation," indicating it's used during a surgical procedure on the patient.
- Device Description: The description reinforces its use for "intraoperative monitoring" and "recording of electrical brain signals... on the surface and sub-surface of the brain."
All of these points indicate that the device is used in vivo (within the living body) for monitoring and recording, which is fundamentally different from the in vitro nature of IVDs.
N/A
Intended Use / Indications for Use
Ad-Tech's Foramen Ovale/Depth Electrode is intended for intra-operative monitoring (for surgical use only / not intended for implantation) and eeg recording of electrical signals of the brain for epilepsy monitoring.
The foramen ovale electrode is designed for monitoring brain electrical activity (eeg) or defining the location of epileptogenic foci in patients with intractable epilepsy. The foramen ovale electrode is intended for "Surgical Use Only" and "Not Intended for Implantation" This product should only be used by a physician/surgeon trained in the use of foramen ovate electrodes.
Product codes
84GYC, 84GZL
Device Description
Ad-Tech's Foramen Ovale Electrode has similar intended uses, naterials, technological characteristics, sterilization procedures, and packaging as the commercially available Ad-Tech Depth Electrode (K 891920B). The Foramen Ovale Electrodes are used for intraoperative monitoring ( for surgical use only / not for implantation) and recording of electrical brain signals for epilepsy monitoring on the surface and sub-surface of the brain.
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
physician/surgeon; intra-operative, surgical use
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)
K891920B
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
990 788
Summary of Safety and Effectiveness
I. General Information
| Common Name: | Depth Electrode |
|---|---|
| Device Trade Name: | Ad-Tech's Foramen Ovale Electrode |
| Classification: | Class II |
| 882.1330 Depth Electrode | |
| Intended Use: | Ad-Tech's Foramen Ovale/Depth Electrode |
| is intended for intra-operative monitoring | |
| (for surgical use only / not intended for | |
| implantation) and eeg recording of electrical | |
| signals of the brain for epilepsy monitoring. | |
| Predicate Device: | Ad-Tech's Depth Electrode |
| 510(k) K891920 B | |
| Manufacturing Facility Address: | Ad-Tech Medical Instrument Corp. |
| 1901 William Street | |
| Racine, WI 53404 | |
| Performance Standard: | No applicable performance standards have |
| been issued under section 514 of the Food, | |
| Drug, and Cosmetic Act. | |
| Establishment Registration Number: | 2183456 |
| Product Code/Classification Panel: | 84GYC & 84GZL/Neurology |
| Contact Name: | David Putz 414-634-1555 |
| Ad-Tech Medical Instrument Corp. | |
| 1901 William Street | |
| Racine, WI 53404 |
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Page 2 Summary of Safety and Effectiveness
II. Safety and Effectiveness Information Supporting the Substantial Equivelance Determination.
A summary of the information contained in this "PMN" that addresses saftey and effectiveness follows.
General Safety and Effectiveness Concerns
Ad-Tech's Foramen Ovale Electrode's labeling contains instructions for the proper use of this product. It includes a description of the product, directions for use, and applicable safety information. These instructions ensure safe And effective use of the device when followed by the physician.
Description of the Device and Basis for Substantial Equivalence
Ad-Tech's Foramen Ovale Electrode has similar intended uses, naterials, technological characteristics, sterilization procedures, and packaging as the commercially available Ad-Tech Depth Electrode (K 891920B). The Foramen Ovale Electrodes are used for intraoperative monitoring ( for surgical use only / not for implantation) and recording of electrical brain signals for epilepsy monitoring on the surface and sub-surface of the brain.
File: fda 03 01 .doc
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of a bird or eagle, with three curved lines representing its wings or feathers.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 2 1999
Mr. David Putz Ad-Tech Medical Instrument Corporation 1901 William Street Racine, Wisconsin 53404
K990788 Re: Ad-Tech's Foramen Ovale Electrode Trade Name: Requlatory Class: II Product Code: GZL August 30, 1999 Dated: Received: August 31, 1999
Dear Mr. Putz:
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 The general controls provisions of the Act 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 requlations 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 (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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.
3
Page 2 - Mr. David Putz
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) 594-4659. 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" (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,
coll
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
510(k) Number (if known): unknown
Device Name: Ad-Tech's Foramen Ovale Electrode
Indications For Use:
The foramen ovale electrode is designed for monitoring brain electrical activity (eeg) or defining the location of epileptogenic foci in patients with intractable epilepsy. The foramen ovale electrode is intended for "Surgical Use Only" and "Not Intended for Implantation" This product should only be used by a physician/surgeon trained in the use of foramen ovate electrodes.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)