(258 days)
Not Found
No
The description mentions "measuring and diagnosing ECG waveform parameters automatically" and "diagnostic interpretation functions, which are offered to clinician on an advisory basis," but it does not explicitly state or imply the use of AI or ML for these functions. The technical description focuses on standard signal processing and control systems. There is no mention of AI/ML terms, training data, or performance metrics typically associated with AI/ML algorithms.
No.
The device is used to acquire, analyze, and display ECG signals for diagnostic purposes, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The obtained ECG records can help users to analyze and diagnose heart disease" and that the device has "measurements and diagnostic interpretation functions."
No
The device description explicitly details multiple hardware components including a printing system, power supply system, LCD display system, signal collection system, and control system, in addition to the software functions.
Based on the provided information, the CONTEC™ Electrocardiograph, ECG90A, is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The ECG90A acquires electrical signals directly from the patient's body surface using electrodes. It does not examine specimens derived from the body.
- Intended Use: The intended use is to acquire ECG signals and help users analyze and diagnose heart disease based on these signals. This is a direct measurement of physiological activity, not an analysis of a biological specimen.
Therefore, the CONTEC™ Electrocardiograph, ECG90A, falls under the category of a medical device that performs a physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CONTECTM Electrocardiograph, ECG90A, is intended to acquire ECG signals from adult or children patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. The proposed devices also have measurements and diagnostic interpretation functions, which are offered to clinician on an advisory basis. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/ or trained healthcare professionals.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
This product is an electrocardiograph collecting 12-lead ECG signal simultaneously and printing ECG waveform with thermal printing system, which features in, recording and displaying ECG waveform with manual or auto mode, measuring and diagnosing ECG waveform parameters automatically, prompting for "Lead off" and "Lack of paper", optional interface languages(Chinese/ English), case database management.
This product is used to assist doctors to analyze and print the ECG waveform of children and adults, which can be applied to ECG room, ward, hospital, etc.
The ECG machine provides medical department human ECG wave group for pattern and rhythm analysis that applied in clinical diagnosis and research.
Essential Performance:Sync collection and display of 12-lead ECG.Display of HR.Print ECG wave with different format,Filter settings,and Auto-measurement of ECG data.
ECG90A is divided into button system, printing system, power supply system, LCD display system, signal collection system, control system
Button system: to collect the user's key operation input, send the control system to process,
Printing system: print the print data sent by the control system, heat the printer head to record the waveform on the thermal printing paper, and feedback whether the lack of paper;
Power system: provide power supply for each system module;
The proposed device adopts two kinds of power supply modes: build-in lithium battery DC power supply and AC-DC adapter power supply.
AC-DC adapter power supply: after the external power adapter connecting with the proposed device, the AC voltage is reduced to 12V via the AC-DC power adapter. The 12V voltage is used to charge the lithium battery via the charging management chip;meanwhile the 12V voltage is reduced to 8.6V via a voltage converter, which is used to power the following circuit and printer. Then the 8.6V voltage is reduced again to 5.0V voltage via the voltage converter, and the 5.0V voltage pass through power isolation and is used to power the signal collection and processing module; meanwhile the 5V voltage will be reduces to 3.3 Vvoltage, which is used to power the control module. Build-in lithium battery DC power supply: when the proposed device is connected with AC-DC adapter power supply, the build-in lithium battery will be charged automatically. The charged battery will power the whole system as DC power supply when the proposed device is not connected with the external AC-DC adapter power supply
LCD display system: display various of settings of waveform information to the user for viewing :
Signal collection system: collect the waveform data,submit the final data to the control system to process; the signal acquisition and process module adopts floating and optical isolation to reduce the external disturbance to signal. After filtering and amplification, the A/C conversion of acquired ECG signal is completed on MCU (Micro Controller Unit); and then the data is transmitted to control system.
after processing the data will be displayed on the LCD screen and the waveform will be printed on the thermal paper. MCU can identify and response the key operation through connecting line, and MCU can connect and communicate with the SD card and USB through the signal line.
Control system: the MCU is used to control the whole system operation. The device parameters setting, the processing of acquired signal, the printing, screen display and charging are all controlled by this module.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body surface
Indicated Patient Age Range
adult or children patients
Intended User / Care Setting
Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1:2005+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2007, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
- IEC 60601-2-25:2011 Medical Electrical Equipment Part 2-25: Particular Requirements For The Basic Safety And Essential Performance Of Electrocardiographs. (Cardiovascular)
- ISO 10993-5:2009. Biological Evaluation of Medical Device. Part 5-Tests for Vitro cytotoxicity.
- ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
January 22, 2018
Contec Medical Systems Co., Ltd. % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-402, Building #27, YangGuangYiShang, No.56, LiangXiang East Rd. FangShan District, Beijing, 102401 China
Re: K171360
Trade/Device Name: CONTEC™ Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 20, 2017 Received: December 22, 2017
Dear Ray Wang:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Zillehemen
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name CONTECTM Electrocardiograph
Indications for Use (Describe)
CONTECTM Electrocardiograph, ECG90A, is intended to acquire ECG signals from adult or children patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. The proposed devices also have measurements and diagnostic interpretation functions, which are offered to clinician on an advisory basis. Digital Electrocardiographs shall be used in healthcare facilities by doctors and or trained healtheare professionals.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ✔ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Tab #7 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: _________
-
- Date of Preparation: 05/05/2017
-
- Sponsor Identification
Contec Medical System Co., Ltd. No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei, 066004, China. Establishment Registration Number: 3006979678
Contact Person: Xueyong Li Position: Quality Manager Tel: 86-355-8015490 Fax: 86-355-8015490 Email:_lxy1011@163.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe Technology Service Co., Ltd.
5-402, Building #27, YangGuangYiShang, No. 56, LiangXiang East Rd., FangShan District, BeiJing, China 102401
Tel: +86-18910677558 Fax: +86-10-52214696 Email: ray.wang@believe-med.com
4
510(k) Summary
- Identification of Proposed Device
Trade Name: CONTECTMElectrocardiograph Common Name: Electrocardiograph Model(s): ECG90A
Regulatory Information Classification Name: Electrocardiograph Classification:II Product Code:DPS Regulation Number: CFR 870.2340 Review Panel:Cardiovascular;
Intended Use Statement:
CONTEC™ Electrocardiograph, ECG90A, is intended to acquire ECG signals from adult or children patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. The proposed devices also have measurements and diagnostic interpretation functions, which are offered to clinician on an advisory basis. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Device Description
This product is an electrocardiograph collecting 12-lead ECG signal simultaneously and printing ECG waveform with thermal printing system, which features in, recording and displaying ECG waveform with manual or auto mode, measuring and diagnosing ECG waveform parameters automatically, prompting for "Lead off" and "Lack of paper", optional interface languages(Chinese/ English), case database management.
This product is used to assist doctors to analyze and print the ECG waveform of children and adults, which can be applied to ECG room, ward, hospital, etc.
The ECG machine provides medical department human ECG wave group for pattern and rhythm analysis that applied in clinical diagnosis and research.
Essential Performance:Sync collection and display of 12-lead ECG.Display of HR.Print ECG wave with different format,Filter settings,and Auto-measurement of ECG data.
Fig 7-1 Working Frame of ECG90A
5
Image /page/5/Figure/2 description: The image shows a block diagram of a system. The diagram includes the following components: button system, printing system, control system, power supply system, signal collection system, and LCD display system. The control system is in the center of the diagram, and the other components are connected to it via arrows.
ECG90A is divided into button system, printing system, power supply system, LCD display system, signal collection system, control system
Button system: to collect the user's key operation input, send the control system to process,
Printing system: print the print data sent by the control system, heat the printer head to record the waveform on the thermal printing paper, and feedback whether the lack of paper;
Power system: provide power supply for each system module;
The proposed device adopts two kinds of power supply modes: build-in lithium battery DC power supply and AC-DC adapter power supply.
AC-DC adapter power supply: after the external power adapter connecting with the proposed device, the AC voltage is reduced to 12V via the AC-DC power adapter. The 12V voltage is used to charge the lithium battery via the charging management chip;meanwhile the 12V voltage is reduced to 8.6V via a voltage converter, which is used to power the following circuit and printer. Then the 8.6V voltage is reduced again to 5.0V voltage via the voltage converter, and the 5.0V voltage pass through power isolation and is used to power the signal collection and processing module; meanwhile the 5V voltage will be reduces to 3.3 Vvoltage, which is used to power the control module. Build-in lithium battery DC power supply: when the proposed device is connected with AC-DC adapter power supply, the build-in lithium battery will be charged automatically. The charged battery will power the whole system as DC power supply when the proposed device is not connected with the external AC-DC adapter power supply
LCD display system: display various of settings of waveform information to the user for viewing :
Signal collection system: collect the waveform data,submit the final data to the control system to process; the signal acquisition and process module adopts floating and optical isolation to reduce the external disturbance to signal. After filtering and amplification, the A/C conversion of acquired ECG signal is completed on MCU (Micro Controller Unit); and then the data is transmitted to control system.
6
K171360
510(k) Summary
after processing the data will be displayed on the LCD screen and the waveform will be printed on the thermal paper. MCU can identify and response the key operation through connecting line, and MCU can connect and communicate with the SD card and USB through the signal line.
Control system: the MCU is used to control the whole system operation. The device parameters setting, the processing of acquired signal, the printing, screen display and charging are all controlled by this module.
- న్. Identification of Predicate Device(s)
Predicate Device :
510(k) Number: K131900 Product Name: CONTECTM Electrocardiograph Model Name: ECG300G Manufacturer: Contec Medical System Co., Ltd.
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Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
IEC 60601-1:2005+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic a. safety and essential performance
-
b. IEC 60601-1-2:2007, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
-
IEC 60601-2-25:2011 Medical Electrical Equipment Part 2-25: Particular Requirements For The C. Basic Safety And Essential Performance Of Electrocardiographs. (Cardiovascular)
-
ISO 10993-5:2009. Biological Evaluation of Medical Device. Part 5-Tests for Vitro cytotoxicity. d.
-
ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation e. and delay-type hypersensitivity
-
- Clinical Test Conclusion
No clinical study is included in this submission.
7
8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device(s) | Predicate Device(s) | |
|---|---|---|---|
| Device name | ECG90A CONTEC™ Electrocardiograph | ECG300G CONTEC™ Electrocardiograph | |
| Classification Name | Electrocardiograph | Electrocardiograph | |
| Product Code | DPS | DPS | |
| Regulation Number | CFR 870.2340 | CFR 870.2340 | |
| Comparison Statement | The proposed device has same classification information as the predicate device. | ||
| Intended Use | CONTEC™ Electrocardiographs, ECG90A, are intended to acquire | ||
| ECG signals from adult or children patients through body surface ECG | |||
| electrodes. The obtained ECG records can help users to analyze and | |||
| diagnose heart disease. The proposed devices also have measurements | |||
| and diagnostic interpretation functions, which are | |||
| offered to clinician on an advisory basis. Digital Electrocardiographs | |||
| shall be used in healthcare facilities by doctors and/or trained | |||
| healthcare professionals. | CONTEC™ Electrocardiographs, ECG300G, are intended to acquire | ||
| ECG signals from adult patients through body surface ECG | |||
| electrodes. The obtained ECG records can help users to analyze and | |||
| diagnose heart disease. The proposed devices also have measurements | |||
| and diagnostic interpretation functions, which are offered to clinician | |||
| on an advisory basis. Digital Electrocardiographs shall be used in | |||
| healthcare facilities by doctors and/or trained healthcare | |||
| professionals. | |||
| Comparison Statement | The proposed device has similar intended use as the predicate device. | ||
| Main Unit Technical Specifications | |||
| Channel | 3 channel | 3 channel | |
| collection mode | Simultaneous 12-lead collection | Simultaneous 12-lead collection | |
| Recording mode | Automatic /Manual/rhythm | Automatic /Manual/rhythm | |
| Patient leak current | 60 dB, >100 dB(filter) | >60 dB, >100 dB(filter) | |
| Input way | Floating and defibrillation protection | Floating and defibrillation protection | |
| Measurement Function | Have measurement function | Have measurement function | |
| Input CIR current | ≤50nA | ≤50nA | |
| Input impedance | ≥50 ΜΩ | ≥50 ΜΩ | |
| Paper | Auto record | 6.25 mm/s、12.5 mm/s、25 mm/s、50 mm/s, error: ±5 % | 25mm/s, 50mm/s, error: ±5% |
| Manual record | 6.25 mm/s、12.5 mm/s、25 mm/s、50 mm/s, error: ±5 % | 5mm/s,6.25mm/s,10mm/s,12.5mm/s,25mm/s,50mm/s,error:±5% | |
| Rhythm record | 6.25 mm/s、12.5 mm/s、25 mm/s、50 mm/s, error: ±5 % | 25mm/s, 50mm/s, error: ±5% | |
| EMG interference filter | 25 Hz or 35 Hz (-3 dB) | 25Hz/35Hz (-3dB) | |
| Recording way | Thermal printing system | Thermal printing system | |
| Specification of | |||
| recording paper | 50 mm (W)×20 m(L) high-speed thermal paper | 80mm (W)*20m (L) High-speed thermal paper | |
| Sensitivity selections | 5/10/20 mm/mV, error: ±5 %, Standard sensitivity is | ||
| 10 mm/mV±0.2 mm/mV | 2.5/5/10/20/40mm/mV,error:±5%.Standard sensitivity is | ||
| 10mm/mV±0.2mm/mV | |||
| Net weight | 0.5 Kg | 1.7kg | |
| Power supply | 12 V adapter/7.4 V, 2000 mAh rechargeable lithium battery | AC: 100-240V, 50/60Hz/DC: 7.4V, 3700 mAh lithium rechargeable | |
| battery | |||
| Dimensions(mm) | 207 mm(L)×96 mm(W)×62 mm(H) | 315mm (L)*215mm (W)*77mm (H) | |
| Skin Contacted Material | Chest Suction ball ( silicone, nickel plated copper) | Chest Suction Electrode (Tin Alloy) | |
| Limb Clamp Electrode (ABS, PMO +10%fiberglass, nickel plated | |||
| brass) | Limb Clamp Electrode(Tin Alloy and ABS) | ||
| ECG lead cable (TPU) | ECG lead cable (TPU) | ||
| Operation Environment | Temperature: +5℃~ +40℃ | Temperature: +5°C~ +40°C | |
| Relative humidity: ≤80 % | Relative humidity: ≤80 % | ||
| Atmosphere pressure: 700 hPa ~ 1060 hPa | Atmosphere pressure: 700 hPa ~ 1060 hPa | ||
| Temperature: -40°C~+55°C, | Temperature: -40°C~+55°C, | ||
| Storage environment | Relative Humidity: ≤95%, no condensation | Relative Humidity: ≤95%, no condensation | |
| Atmosphere pressure: 500 hPa ~ 1060 hPa, | Atmosphere pressure: 500 hPa ~ 1060 hPa, | ||
| Sterile | No | No | |
| Single Use | No | No | |
| Comparison Statement: | The proposed device has the similar main unit specifications with the predicate device. | ||
| Applied Standards: | |||
| Biocompatibility | ISO10993-5&ISO10993-10 | ISO10993-5&ISO10993-10 | |
| Electrical Safety | IEC60601-1 | IEC60601-1 | |
| EMC | IEC60601-1-2 | IEC60601-1-2 | |
| Performance | IEC 60601-2-25 | IEC 60601-2-25 | |
| Comparison Statement | The proposed probe has same applied Standards with the predicate device. |
Table 7-1 Comparison of Technology Characteristics
8
510(k) Summary
9
10
- Substantially Equivalent (SE) Conclusion SE Analysis :
The subject device has same classification information, same intended use, same indication for use, similar product design, similar specification, same safety elements, similar applied Standards as predicate device.
The differences are included as followings:
Analyse 1: The device and predicate device have difference in Paper speed, paper speed is a manifestation of ECG reporting on paper, per IEC 60601-2-25:2011 Section 201.12.4.108.3 ECG reporting on paper, it stated that the device shall provide at least two recording speeds. 25mm/s and 50mm/s. the proposed device has passed the IEC60601-2-25 test , therefore the paper speed of the proposed device meet the requirements of the standard. we believe these differences will not affect the effectiveness and safety compared with the predicate device.
Analyse 2 : Although the Power supply specifications of ECG90A is different from the predicate device.but both the predicate device and the proposed device has passed the IEC60601-1 safety test. we believe these differences will not affectiveness and safety compared with the predicate device.
Analyse 3: Although the skin Contacted Material of ECG90A is different from the predicate device, but both the predicate device and the proposed device has passed the ISO10993 series test, we believe these differences will not affect the effectiveness and safety compared with the predicate device.
Conclusion: The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness.