(76 days)
Not Found
Not Found
No
The summary describes a device for recording EEG signals, with no mention of AI, ML, or any computational analysis beyond basic signal acquisition. The differences noted are material and sterilization methods, not algorithmic.
No.
The device is used for recording cortical surface EEG activity to help guide surgical procedures, not for directly treating a condition.
Yes
Explanation: The device is used to record EEG activity from the surface of the brain during surgery to "help guide your progress during tumor resections, epilepsy surgery, etc." This indicates that it provides information used to aid in the diagnosis or treatment of a medical condition.
No
The device description explicitly mentions physical components like "electrode plates" and "electrodes" made of specific materials (Lexan plastic, stainless steel), and a sterilization method (EtO). This indicates it is a hardware device, not software-only.
Based on the provided text, 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 description clearly states the device is used for "intraoperative, short-term recording of cortical surface EEG activity" and "recording of EEG potentials from the surface of the brain during surgery." This involves direct interaction with the patient's brain inside the body during a surgical procedure.
Therefore, the device is an in vivo diagnostic or monitoring device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
"The use of the Model CMU Cortical Mapping Unit is indicated where intraoperative, short-term recording of cortical surface EEG activity is required."
"AD-TECH's CMU, like other cortical mapping instruments, is designed to facilitate the recording of EEG potentials from the surface of the brain during surgery. This EEG information can help guide your progress during tumor resections, epilepsy surgery, etc."
"This device should only be used by physicians/surgeons trained in the use of cortical mapping devices."
Product codes
84GYC
Device Description
AD-TECH's Model CMU Cortical Mapping Unit has similar intended uses, materials and technological characteristics as the predicate device. There are only three differences of note: (1) Our electrode plates are made of clear Lexan plastic while theirs are stainless steel. We maintain that the clear plates are a marketing feature. (2) Our electrodes are made of stainless steel; theirs use cotton wicks. (3) Our device is sterilized via EtO: theirs may be autoclaved.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surface of the exposed human brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians/surgeons trained in the use of cortical mapping devices / intraoperative
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)
Model CE-1 Cortical Electrode
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1310 Cortical electrode.
(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY - 21 CFR 807.92
A. Executive Summary
This 510(k) Premarket Notification, details AD-TECH Medical Instrument Corporation's Model CMU Cortical Mapping Unit. Its indication for use is to facilitate the recording of EEG potentials from the surface of the exposed human brain during surgery. It is an enhanced version of a pre-amendment device. The CMU and is not implanted, but does need to be EtO sterilized prior to each use.
B. APPLICANT INFORMATION
Applicant's Name:
Contact Person:
AD-TECH Medical Instrument Corporation Address: 1901 William Street, Racine, WI 53404 USA
John Ziobro, COO (262)* 634-1555
Telephone: Fax: (262)* 634-5668 Signature of Applicant:
6.24-9
John Ziobro, COO (date)
*OUR AREA CODE WILL REMAIN (414) UNTIL SEPTEMBER 25, 1999
C. Device Information
-
- TRADE NAME
-
- COMMON NAME
-
- FDA Registration Number
-
- MANUFACTURING ADDRESS
- PRODUCT CODE & CLASSIFICATION
-
- REASON
-
- EQUIVALENT DEVICE
Model CMU Cortical Mapping Unit
Cortical Electrode
2183456
1901 William Street, Racine, WI 53404 This product and its accessories are shipped nonsterile, therefore no sterilization sites are listed.
84GYC, Class II (21 CFR 882.1310)
New Device
Model CE-1 Cortical Electrode. Grass Instruments (Astro-Med) 600 East Greenwich Avenue, West Warwick, RI 02893 (marketed before May 28th, 1976)
-
- PERFORMANCE STANDARD
None established under Section 514
- PERFORMANCE STANDARD
D. SAFETY & EFFECTIVENESS INFORMATION
1. GENERAL SAFETY & EFFECTIVENESS CONCERNS
- a. AD-TECH'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.
2. DESCRIPTION OF THE DEVICE & BASIS OF SUBSTANTIAL EQUIVALENCE.
- a. AD-TECH's Model CMU Cortical Mapping Unit has similar intended uses, materials and technological characteristics as the predicate device. There are only three differences of note:
- (1) Our electrode plates are made of clear Lexan plastic while theirs are stainless steel. We maintain that the clear plates are a marketing feature.
- (2) Our electrodes are made of stainless steel; theirs use cotton wicks.
- (3) Our device is sterilized via EtO: theirs may be autoclaved.
- b. None of these difference are material to the safety & effectiveness of the device.
- o. Both devices nave received indicallons for use, mamely to facilitate the reachting of EEG potentials from the surface of the exposed human brain rimin rimin riming surgery.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 3 1999
Mr. John F. Ziobro Chief Operating Officer Ad-Tech Medical Instrument Corporation 1901 William Street Racine, Wisconsin 53404
Re: K992194
Trade Name: Model CMU Cortical Mapping Unit Regulatory Class: II Product Code: GYC Dated: June 24, 1999 Received: June 29, 1999
Dear Mr. Ziobro:
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. John F. Ziobro
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
3
K992194 510(k) Number if Known: Unknown
Device Name: Model CMU Cortical Mapping Unit
Indications For Use:
"The use of the Model CMU Cortical Mapping Unit is indicated where intraoperative, short-term recording of cortical surface EEG activity is required."
"AD-TECH's CMU, like other cortical mapping instruments, is designed to facilitate the recording of EEG potentials from the surface of the brain during surgery. This EEG information can help guide your progress during tumor resections, epilepsy surgery, etc."
"This device should only be used by physicians/surgeons trained in the use of cortical mapping devices."
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 810.109) | X |
|---|---|
| OR | |
| Over-The Counter Use_ (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General Restorative Devices K992194