(237 days)
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.
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.
The provided text is a Summary of Safety and Effectiveness for the Ad-Tech's Foramen Ovale Electrode, submitted as part of a 510(k) premarket notification to the FDA.
Based on the provided document, the device did NOT undergo a study to demonstrate performance against specific acceptance criteria.
This document describes a "substantial equivalence" determination, which is a regulatory pathway where a new device is compared to a legally marketed predicate device rather than undergoing a de novo clinical study to establish its own performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not present in this type of regulatory submission. The information provided focuses on demonstrating that the new device is essentially the same as an existing, approved device.
Here's an attempt to answer the questions based only on the provided text, highlighting what is missing or not applicable:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated or defined. The basis for acceptance is "substantial equivalence" to a predicate device.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, impedance) are reported for this specific device. The document states that the device has "similar intended uses, materials, technological characteristics, sterilization procedures, and packaging" as the predicate device.
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated as measured performance for this device) |
|---|---|
| Implicit: Substantial equivalence to predicate | Implicit: Similar intended uses, materials, technological characteristics, etc. to predicate |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable / Not provided. No test set was used for a performance study.
- Data Provenance: Not applicable. No new data from a performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable / Not provided. No ground truth was established for a test set for performance evaluation.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable / None described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This device is an electrode for recording brain signals, not an AI-powered diagnostic tool, and no such study is mentioned or relevant to this type of device.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This device is an electrode, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable. No ground truth for performance evaluation was established for this device.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable / Not provided. This document describes a medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- How Ground Truth was Established for Training Set: Not applicable.
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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 II882.1330 Depth Electrode |
| Intended Use: | Ad-Tech's Foramen Ovale/Depth Electrodeis intended for intra-operative monitoring(for surgical use only / not intended forimplantation) and eeg recording of electricalsignals of the brain for epilepsy monitoring. |
| Predicate Device: | Ad-Tech's Depth Electrode510(k) K891920 B |
| Manufacturing Facility Address: | Ad-Tech Medical Instrument Corp.1901 William StreetRacine, WI 53404 |
| Performance Standard: | No applicable performance standards havebeen 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 414-634-1555Ad-Tech Medical Instrument Corp.1901 William StreetRacine, 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
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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.
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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
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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)
§ 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).