Digital Electrocardiograph

K171517 · Biocare Bio-Medical Equipment Co., Ltd. · DPS · Jan 11, 2018 · Cardiovascular

Device Facts

• Record ID: K171517
• Device Name: Digital Electrocardiograph
• Applicant: Biocare Bio-Medical Equipment Co., Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Jan 11, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Digital Electrocardiograph (iE 10) acquires 12-lead ECG signals via disposable body surface electrodes; signals amplified, filtered, and processed for display on integrated LCD; output includes ECG waveforms and automated measurements/interpretive statements. Device is portable, battery-powered, and operated by physicians or trained healthcare professionals in clinical settings. Output provided on advisory basis to assist clinicians in heart disease diagnosis; supports manual, automatic, and rhythm recording formats. Benefits include portable diagnostic capability for cardiac assessment.

Clinical Evidence

Bench testing only. Device performance verified against IEC 60601-1 (general safety), IEC 60601-2-25 (particular safety for electrocardiographs), and IEC 60601-1-2 (EMC). No clinical data provided.

Technological Characteristics

Portable 12-lead ECG unit; 194mm x 117mm x 25mm; 0.5kg. Powered by 3.7V/5800mAh rechargeable lithium battery. Features touch screen interface. CMRR >110dB; frequency response 0.01-250Hz. Complies with IEC 60601-1, IEC 60601-2-25, and IEC 60601-1-2. Connectivity via patient cable; output to LCD or external printer.

Indications for Use

Indicated for adult and pediatric patients for the acquisition of ECG signals via body surface electrodes to assist in the analysis and diagnosis of heart disease. Intended for use by doctors and trained healthcare professionals in hospitals or healthcare facilities.

Regulatory Classification

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.

Predicate Devices

• Digital Electrocardiograph (K141946)

Submission Summary (Full Text)

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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);

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### 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 ([e-mail]) or phone [phone] 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

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## Indications for Use

510(k) Number (if known)

K171517

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) | |
|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"><b></b></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 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:

- 1. Date of Preparation: 04/12/2017
- 2. 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: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

### Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 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.

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- న్. Identification of Predicate Device
510(k) Number: K141946 Product Name: Digital Electrocardiograph; Manufacturer: Shenzhen Biocare Bio-Medical Equipment Co., Ltd.

- 6. 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:

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.

- 7. 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<br>acquire ECG signals from adult and pediatric<br>patients through body surface ECG<br>electrodes. The electrocardiograph is only<br>intended to be used in hospitals or healthcare<br>facilities by doctors and trained healthcare<br>professionals. The cardiogram recorded by<br>the electrocardiograph can help users to<br>analyze and diagnose heart disease. However<br>the ECG with measurements and interpretive<br>statements is offered to clinician on an<br>advisory basis only. | The intended use of electrocardiograph is<br>to acquire ECG signals from adult and<br>pediatric patients through body surface<br>ECG electrodes. The electrocardiograph is<br>only intended to be used in hospitals or<br>healthcare facilities by doctors and trained<br>healthcare professionals. The cardiogram<br>recorded by the electrocardiograph can<br>help users to analyze and diagnose heart<br>disease. However the ECG with<br>measurements and interpretive statements<br>is offered to clinician on an advisory basis<br>only. |
| Patient Population | Adult and pediatric patients | Adult and pediatric patients |
| Intended<br>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,<br>built-in printer and reusable electrodes |
| Contraindication | Not specified | Not specified |
| Automated<br>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<br>current | $ <10μΑ $ | $ <10μΑ $ |
| Frequency<br>response | 0.01~250Hz | 0.05~150Hz |
| Noise level | $ <15μVp-p $ | $ <15µVp-p $ |
| AC Power supply | 100 V~240 V, 50 Hz/60 Hz | 100 V~240 V, 50 Hz/60 Hz |
| DC Power supply<br>(battery) | Rechargeable lithium battery, 3.7 V/<br>5800mAh | Sealed maintenance-free rechargeable<br>battery, 14.8V-2200mAh |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| Particular Safety | Comply with IEC 60601-2-25 | Comply with IEC 60601-2-25 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |

Table 1 Substantially Equivalent Comparison

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The main differences between proposed device and predicate device include product portability, size, weight, configuration, touch screen type, CMRR and battery specification. The proposed device and predicate device has the same indications for use, target population, using environment and functional modes including automated analysis. Both proposed device and predicate device comply with the same standards and the relevant tests demonstrate the safety and effectiveness.

The proposed device, Digital Electrocardiograph iE 10, is determined to be Substantially Equivalent (SE) to the predicate device, Digital Electrocardiograph iE 12, (K141946), in respect of safety and effectiveness.