(145 days)
No
The document describes a standard electrocardiograph with basic recording and printing functions. There is no mention of AI, ML, or any advanced analytical capabilities beyond displaying and printing ECG waveforms.
No
The device is described as an electrocardiograph for non-invasive recording and display of ECG waveforms, and specifically states, "The product is not a conventional diagnostic tool." It does not mention any therapeutic function.
No
The text explicitly states, "The product is not a conventional diagnostic tool." While it provides data relevant to cardiac rhythm and can help determine cardiac rhythm, it's not labeled as a diagnostic device itself.
No
The device description explicitly mentions a "thermo sensitive printer" and describes it as a "single channel, standard 12 leads electrocardiograph," indicating it includes hardware components for acquiring and printing ECG data.
Based on the provided information, 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.
- Device Function: The ECG80A is an electrocardiograph. It records and displays electrical activity of the heart by placing electrodes on the surface of the body. This is a non-invasive procedure and does not involve testing samples taken from the body.
- Intended Use: The intended use clearly states "non-invasive recording and displaying ECG waveform".
- Device Description: The description details its function as a standard 12-lead electrocardiograph that records waveforms using a thermo sensitive printer.
Therefore, the ECG80A falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ECG80A Single-Channel Handheld Electrocardiograph is intended for use in non-invasive recording and displaying ECG waveform of adult patients. In addition, it also can provide to the treating physician with relevant data on the cardiac rhythm in hospital patients. It is immediately available at any time to manually record transient cardiac events, suitable for patient and professional use, helpful in determining the cardiac rhythm at the time of symptoms. This device allows the patient to record their ECG data for displaying or print on the paper.
The product is not a conventional diagnostic tool.
Product codes
DPS
Device Description
This product is single channel, standard 12 leads electrocardiograph ,can be widely applied in ECG check-up under different circumstances such as in family ,hospital consultation, doctor's diagnosis, physical check-up, social medical organizations etc. it can implement real time continuous records of clear and exact single-channel ECG waveform using thermo sensitive printer at the same time. waveforms also can be freezed at any time. it has manual and automatic modes to be chosen and Chinese/English operation interface, it is easy to be used.
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
adult patients
Intended User / Care Setting
family, hospital consultation, doctor's diagnosis, physical check-up, social medical organizations. suitable for patient and professional use.
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
Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications, including electrical safety, EMC, specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Section 3 510(k) Summary
As required by 807.97 The assigned 510(k) Number is
Sponsor
Submission Correspondent Contec Medical Systems Co., Ltd No. 24, West Huanghe Road Qinhuangdao, Hebei, 066000, China
Mr. Li Xueyong, Quality Manager Tel:+86-335-8015490 Fax: +86-335-8015505 Email: lxyong1011@163.com
Ms. Diana Hong / Mr. Tarzan Wang Shanghai Mid-Link Business Consulting Co., Ltd Sute 8D, No. 19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China Tel: +86-21-64264467 Fax: 240-238-7587 Email: diana.hong@mid-link.net
Proposed Product
Trade Name Model Product Code: Regulation Number: Device Class:
Submission Purpose:
Predicate Device:
ECG80A DPS 21 CFR 870.2340 Class II
ECG MONITOR
New Device
Cardiette microtel K082124 Manufactured by: Et medical devices spa Via De Zinis 6, 38011 Cavareno (Trento) ITALY
CARDIOLINE AR1200 K051534
AUG
25 2009
(090936
オリス
1
Manufactured by:
Et medical devices spa Via De Zinis 6, 38011 Cavareno (Trento) ITALY
Device Description
This product is single channel, standard 12 leads electrocardiograph ,can be widely applied in ECG check-up under different circumstances such as in family ,hospital consultation, doctor's diagnosis, physical check-up, social medical organizations etc. it can implement real time continuous records of clear and exact single-channel ECG waveform using thermo sensitive printer at the same time. waveforms also can be freezed at any time. it has manual and automatic modes to be chosen and Chinese/English operation interface, it is easy to be used.
Test Conclusion
SE Determination
Intended Use/Indication for Use Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications, including electrical safety, EMC, specifications.
The proposed device, ECG80A Single-Channel Handheld Electrocardiograph, is substantially equivalent (SE) to the predicate device Cardiette microtel (K082124) and CARDIOLINE AR1200 (K051534).
The ECG80A Single-Channel Handheld Electrocardiograph is intended for use in non-invasive recording and displaying ECG waveform of adult patients. In addition, it also can provide to the treating physician with relevant data on the cardiac rhythm in hospital patients. It is immediately available at any time to manually record transient cardiac events, suitable for patient and professional use, helpful in determining the cardiac rhythm at the time of symptoms. This device allows the patient to record their ECG data for displaying or print on the paper.
The product is not a conventional diagnostic tool.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with stylized wings and tail feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
AUG 2 5 2009
Contec Medical System Co., Ltd. c/o Ms. Diana Hong General Manager Shanghai Midlink Business Consulting Co., Ltd. Suite 8D, No. 19, Zhongxin Zhongshan Mansion, Lane 999 Zhongshan No. 2 Road (S) Shanghai CHINA 200030
Re: K090936
Trade/Device Name: Single-Channel Handheld Electrocardiograph, Model ECG80A Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (Two) Product Code: DPS Dated: July 21, 2009 Received: July 23, 2009
Dear Ms. Hong:
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 premarket 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.
3
Page 2 - Ms. Diana Hong
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. 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Bram D. Zuckerman, M.D.
am D. Zuckerman, M.D. B Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication For Use
510(k) Number (if known): Pending
Device Name: ___ECG80A Single-Channel Handheld Electrocardiograph
Indications for Use:
The ECG80A Single-Channel Handheld Electrocardiograph is intended for use in non-invasive recording and displaying ECG waveform of adult patients. In addition, it also can provide to the treating physician with relevant data on the cardiac rhythm in hospital patients. It is immediately available at any time to manually record transient cardiac events, suitable for patient and professional use, helpful in determining the cardiac rhythm at the time of symptoms. This device allows the patient to record their ECG data for displaying or print on the paper.
The product is not a conventional diagnostic tool.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Dvision Sign-Off)
Division of Cardlovascular Devices
510(k) Number K090 936
Page _I_of