(259 days)
Easy ECG is designed and used for recording and visualizing the ECG tracing through personal computers.
Easy ECG is consisting of intelligent tracing modules witch can be completed to a PC's serial port and software for completed to a PC's serial port and software for cing on any laser or inkjet printer.
The provided FDA letter (K972996) is a 510(k) clearance for the Easy ECG PC Based Electrocardiograph. This type of clearance indicates substantial equivalence to a legally marketed predicate device, rather than a de novo approval based on rigorous clinical trials demonstrating specific performance metrics against pre-defined acceptance criteria.
Therefore, the document does not contain the detailed information required for a study proving device performance against acceptance criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance (country, retrospective/prospective).
- Number and qualifications of experts for ground truth establishment.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study details or effect size.
- Standalone algorithm performance (algorithm only without human-in-the-loop).
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The letter primarily focuses on the regulatory determination of substantial equivalence. The "Indications for Use" section (Page 3) briefly describes the device's function: "Easy ECG is designed and used for recording and visualizing the ECG tracing through personal computers. It is consisting of intelligent tracing modules which can be connected to a PC's serial port and software for processing and printing on any laser or inkjet printer." It also mentions "East ECG acquired simultaneously 12 leads for 4/8 seconds and then display the tracing on the monitor's screen." However, these are functional descriptions, not performance metrics or acceptance criteria for accuracy or diagnostic capability, which would be expected in a performance study report.
To answer your request, a different type of document, such as a clinical study report or a detailed premarket submission, would be necessary.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads facing right, representing health, human services, and the public. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
ﻟﻪ ﺑﻪ ﺑﻪ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 1998
Mr. Michael Davidson ATES Medical S.R.L. c/o Futuremed America Inc. 15700 Devonshire Street Granada Hills, CA 91344-7225
K972996 Re : Easy ECG PC Based Electrocardiograph Regulatory Class: II (two) 74 DPS Product Code: Dated: April 6, 1998 ---Received: April 8, 1998
Dear Mr. Davidson:
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, Druq, 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 requirements, as setforth in the Quality System Regulation (QS) 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.
{1}------------------------------------------------
Page 2 - Mr. Michael Davidson
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) 594-4648. 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
-+ CDRH ODE
REMED
Futuremed America Inc. 15700 Devonshire Street Granada Hills. CA 91344-7225 USA
Telephone: 1-818-830-2500 Fax: 1-818-891-4755
K 972996
INDICATION FOR USE
Subject: 510(k) Number K972996 Product: PC Based Electrocardiograph Device : Easy ECG
Easy ECG is designed and used for recording and visualizing the ECG tracing through personal computers. It is consisting of intelligent tracing chrough personal completed to a PC's serial port and software for modules witch can be comeoser cing on any laser or inkjet printer.
East ECG acquired simultaneously 12 leads for 4/8 seconds and then display the tracing on the monitor's screen.
The advantage of PC Based EAST ECG is enabling physicians and cardiologists to use it with existing computers.
M. P
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_
Prescription Use ✓
(Per 21 CFR 801.109)
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).