(57 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is limited to "an EEG Amplifier System" without mentioning any advanced processing capabilities.
No
The device is described as an EEG amplifier system intended for recording EEG, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The intended use states it is for "recording routine EEG and EEG associated with long term monitoring for epilepsy," which are activities performed to diagnose conditions.
No
The device description explicitly states it is an "EEG Amplifier System," which is a hardware component used to amplify electrical signals from the brain. The summary does not mention any software-only aspects.
Based on the provided information, the ADAM amplifier system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "recording routine EEG and EEG associated with long term monitoring for epilepsy." This involves measuring electrical activity from the brain, which is a physiological signal from within the body.
- Device Description: It's described as an "EEG Amplifier System." EEG devices are used for in-vivo measurements.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a patient's health. The ADAM system directly interacts with the patient's body to record signals.
Therefore, the ADAM amplifier system falls under the category of a medical device for in-vivo measurement, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ADAM amplifier system is intended for recording routine EEG and EEG associated with long term monitoring for epilepsy. This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in electroencephalography.
Product codes
GWQ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians, technicians, or other medical professionals that are trained in electroencephalography.
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)
Reference Device(s)
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
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
FEB 1 8 2004
Image /page/0/Picture/2 description: The image shows a handwritten alphanumeric string. The string starts with the letter 'K', followed by the numbers '033978'. The handwriting is somewhat cursive, with the numbers being connected to each other.
510 (K) Summary 2
This summary is submitted in accordance with the requirements of 807.92. This summary was prepared on Dec 11, 2003
| Submitted By: | Grass-Telefactor Product Group
Astro-Med, Inc.
600 East Greenwich Ave
West Warwick, RI 02893
Tel: (401) 828-4000
Fax: (401) 822-2480 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael J. Sullivan
VP Engineering
Tel: 401-828-4000 x212
Email: msullivan@astromed.com |
| Proprietary Name : | ADAM |
| Common Name: | EEG Amplifier System |
| Product Category: | Electroencephalograph |
| Regulation number: | 882.1400 |
| Medical Speciality: | NE |
| Product Code: | GWQ |
| Product Class: | Class II Device |
This device claims substantial equivalence to the following: Telefactor H2O: 510(k) numbers K992291 and K974587 Grass - Telefactor AS-40 Amplifier System 510(k) number K021807
Intended Use:
The ADAM amplifier system is intended for recording routine EEG and EEG associated with long term monitoring for epilepsy. This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in electroencephalography.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2004
Mr. Michael J. Sullivan Vice President of Engineering Grass-Telefactor Product Group Astro-Med, Inc. 600 East Greenwich Avenue West Warwick, Rhode Island 02893
Re: K033978
Trade/Device Name: Grass-Telefactor ADAM Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: December 19, 2003 Received: January 5, 2004
Dear Mr. Sullivan:
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 promarket 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.
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Page 2 - Mr. Michael J. Sullivan
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), please contact the Office of Compliance at (301) 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 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.
Mark N. Millians
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): 《 033978
Device Name: Grass-Telefactor ADAM
Indications For Use:
:
The ADAM amplifier system is intended for recording routine EEG and EEG associated with long term monitoring for epilepsy.
This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in electroencephalography.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N Millersen
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K033978 |
|---|---|
| --------------- | --------------------------------------------------------- |
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