(57 days)
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.
The ADAM amplifier system is an EEG Amplifier System.
The provided text is a 510(k) summary for the Grass-Telefactor ADAM EEG Amplifier System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot populate the table or answer the questions you've posed based on the given input text. The 510(k) summary is primarily concerned with establishing substantial equivalence, not with detailing performance studies with specific statistical metrics and ground truth methods.
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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 GroupAstro-Med, Inc.600 East Greenwich AveWest Warwick, RI 02893Tel: (401) 828-4000Fax: (401) 822-2480 |
|---|---|
| Contact Person: | Michael J. SullivanVP EngineeringTel: 401-828-4000 x212Email: 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 |
|---|---|
| --------------- | --------------------------------------------------------- |
5
§ 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).