(232 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard signal acquisition and display, with interpretation offered on an advisory basis without mentioning AI/ML.
No
The device is an electrocardiograph used for acquiring ECG signals to help analyze and diagnose heart disease; it is a diagnostic tool, not one that provides therapy.
Yes
The device is described as an electrocardiograph, and its intended use states that "The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease," which clearly indicates a diagnostic purpose. While it states "ECG with measurements and interpretive statements is offered to clinician on an advisory basis only," the primary function is still to aid in diagnosis.
No
The device description explicitly states it acquires ECG signals via electrodes, amplifies, filters, and transfers them for display on an LCD and printing, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device acquires ECG signals directly from the patient's body surface using electrodes. It is measuring electrical activity, not analyzing a biological specimen.
The description clearly states the device acquires signals "from adult and pediatric patients through body surface ECG electrodes" and that the signals are acquired "from patient body surface". This is a direct measurement from the patient, not an in vitro analysis of a sample.
N/A
Intended Use / Indications for Use
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
Product codes
DPS
Device Description
The proposed device can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal. The ECG electrical signals from patient body surface are acquired by disposable ECG electrodes; after been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper via an external printer.
The proposed device is a modification to the predicate device. Digital Electrocardiograph, cleared under K141946.
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 and pediatric patients
Intended User / Care Setting
hospitals or healthcare facilities by doctors and 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
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+CORR.1:2006+CORR.2:2007+AM1:2012, Medical electrical equipment – Part 1: General requirements for basic safety, and essential performance.
IEC 60601-2-25:2011, Medical electrical equipment -- Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.
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 teats.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.
January 11, 2018
Biocare Bio-Medical Equipment Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN
Re: K171517
Trade/Device Name: Digital Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 12, 2017 Received: December 14, 2017
Dear Diana 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. 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
Page 2 - Diana Hong
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,
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 Digital Electrocardiograph
Indications for Use (Describe)
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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 is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number:
-
- Date of Preparation: 04/12/2017
-
- Sponsor Identification
Shenzhen Biocare Bio-Medical Equipment Co.,Ltd.
#16-1, Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan New District, 518102 Shenzhen, China
Establishment Registration Number: 3008457078
Contact Person: Mr. Hongbo Zhong Position: R&D Director Tel: +86-0755-36615333 Fax: +86-0755-27960643 Email: hb-zhong@tom.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Digital Electrocardiograph; Common Name: Electrocardiograph; Models: iE 10
Regulatory Information Classification Name: Electrocardiograph; Classification: II Product Code: DPS; Regulation Number: 21 CFR 870.2340; Review Panel: Cardiovascular;
Intended Use Statement:
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
Device Description:
The proposed device can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal. The ECG electrical signals from patient body surface are acquired by disposable ECG electrodes; after been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper via an external printer.
The proposed device is a modification to the predicate device. Digital Electrocardiograph, cleared under K141946.
5
-
న్. Identification of Predicate Device
510(k) Number: K141946 Product Name: Digital Electrocardiograph; Manufacturer: Shenzhen Biocare Bio-Medical Equipment Co., Ltd. -
- Non-Clinical Test Conclusion
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:
- Non-Clinical Test Conclusion
IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical electrical equipment – Part 1: General requirements for basic safety, and essential performance.
IEC 60601-2-25:2011, Medical electrical equipment -- Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.
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 teats.
-
- Substantially Equivalent
| ITEM | Proposed Device, Digital | Predicate Device, Digital |
|---|---|---|
| Electrocardiograph | Electrocardiograph, K141946 | |
| Model | iE 10 | iE 12 |
| Product Code | DPS | DPS |
| Regulation No. | 21 CFR 870.2340 | 21 CFR 870.2340 |
| Class | II | II |
| Intended Use | The intended use of electrocardiograph is to | |
| acquire ECG signals from adult and pediatric | ||
| patients through body surface ECG | ||
| electrodes. The electrocardiograph is only | ||
| intended to be used in hospitals or healthcare | ||
| facilities by doctors and trained healthcare | ||
| professionals. The cardiogram recorded by | ||
| the electrocardiograph can help users to | ||
| analyze and diagnose heart disease. However | ||
| the ECG with measurements and interpretive | ||
| statements is offered to clinician on an | ||
| advisory basis only. | The intended use of electrocardiograph is | |
| to acquire ECG signals from adult and | ||
| pediatric patients through body surface | ||
| ECG electrodes. The electrocardiograph is | ||
| only intended to be used in hospitals or | ||
| healthcare facilities by doctors and trained | ||
| healthcare professionals. The cardiogram | ||
| recorded by the electrocardiograph can | ||
| help users to analyze and diagnose heart | ||
| disease. However the ECG with | ||
| measurements and interpretive statements | ||
| is offered to clinician on an advisory basis | ||
| only. | ||
| Patient Population | Adult and pediatric patients | Adult and pediatric patients |
| Intended | ||
| Environment | Hospital or Healthcare facilities | Hospital or Healthcare facilities |
| Portable | Yes | No |
| Size | $194 mm \times 117 mm \times 25 mm$ | $345mm \times 260mm \times 80mm$ |
| Weight | About 0.5 kg | About 4.6 kg |
| Configuration | ECG unit, patient cable, power adaptor | ECG unit, patient cable, power adaptor, |
| built-in printer and reusable electrodes | ||
| Contraindication | Not specified | Not specified |
| Automated | ||
| analysis | Yes | Yes |
| Lead | Standard 12-lead | Standard 12-lead |
| Acquisition mode | Simultaneous 12-lead acquisition | Simultaneous 12-lead acquisition |
| Recording format | Automatic / Manual / Rhythm | Automatic / Manual / Rhythm |
| Key mode | Touch screen | Keyboard |
| CMRR | >110dB | >60dB, >100 with AC filter |
| Time reference | 6.25 mm/s, 12.5mm/s, 25 mm/s, 50 mm/s | 6.25 mm/s, 12.5mm/s, 25 mm/s, 50 mm/s |
| Input CIR current | $ ≤ 0.1μΑ $ | $ ≤0.1μΑ $ |
| Patient leak | ||
| current | $ |