ECG Acquisition Systems

K163607 · Vales & Hills Biomedical Tech. , Ltd. · DPS · Dec 15, 2017 · Cardiovascular

Device Facts

• Record ID: K163607
• Device Name: ECG Acquisition Systems
• Applicant: Vales & Hills Biomedical Tech. , Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Dec 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ECG Acquisition Systems is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent upload to vhECG Pro, which installed in iPad or iPhone. This enables clinicians, or trained care personnel who are acting on the orders of a licensed physician, to acquire, process, display, store, and print diagnostic 12-lead ECGs. The ECG Acquisition Systems is for use on adult and pediatic populations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use as a vital signs physiological monitor. The subject device is intended to be used for clinical use rather than home use. It can be used in a professional healthcare facility, or a clinical environment such as clinics. It cannot be used in transport environment, such as ambulance. The ECG Acquisition Systems provides uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis.

Device Story

Hand-held, battery-powered 12-lead resting electrocardiograph system; includes ECG Acquisition Recorder, patient cable, and vhECG Pro software. Device acquires ECG signals; transfers data via Bluetooth 4.0 to mobile device (iPhone/iPad) running vhECG Pro. Software displays, stores, and prints uninterpreted ECG data; supports upload to vhCloud for remote review by authorized medical staff. Used in professional healthcare facilities or clinics by clinicians or trained personnel. Provides uninterpreted data as a reference for diagnosis; not a sole diagnostic tool. Benefits include portable, real-time ECG acquisition and streamlined data management for clinical workflows.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), wireless coexistence, ECG performance (IEC 60601-2-25), and software verification/validation.

Technological Characteristics

Hand-held 12-lead ECG recorder; ABS/Polycarbonate enclosure. Powered by two 1.5V AA LR06 batteries. Bluetooth 4.0 connectivity. Frequency response 0.05-150 Hz; sampling rate 500 Hz. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, and AAMI/ANSI EC53. Type CF applied part.

Indications for Use

Indicated for adult and pediatric patients, diseased or non-diseased, requiring resting, diagnostic 12-lead ECG acquisition. Contraindicated for neonates (birth to 28 days) and infants (29 days to 2 years). Not for use as a vital signs physiological monitor or in transport environments.

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

• Spaulding Electrocardiograph 2100iQ (K150564)

Reference Devices

• K160840
• K160876
• K102830

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 15, 2017

Vales & Hills Biomedical Tech. Ltd. % Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd. No. 55 Shizhou Middle Road, Nanshan District Shenzhen, 518000 CN

Re: K163607

Trade/Device Name: ECG Acquisition Systems Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: November 11, 2017 Received: November 17, 2017

Dear Field Fu:

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 - Ren Yunhua

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 medical devices and radiation-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,

M.A. Wilhelm

for Bram D. Zuckerman, M.D.
Director 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) K163607

Device Name ECG Acquisition Systems

#### Indications for Use (Describe)

The ECG Acquisition Systems is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent upload to vhECG Pro, which installed in iPad or iPhone. This enables clinicians, or trained care personnel who are acting on the orders of a licensed physician, to acquire, process, display, store, and print diagnostic 12-lead ECGs.

The ECG Acquisition Systems is for use on adult and pediatic populations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use as a vital signs physiological monitor.

The subject device is intended to be used for clinical use rather than home use. It can be used in a professional healthcare facility, or a clinical environment such as clinics. It cannot be used in transport environment, such as ambulance.

The ECG Acquisition Systems provides uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis.

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Version:A/0

# VOL_005: 001_510(k) Summary

### 1. Administrative Information

| Submission Date | Dec, 12, 2016 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer<br>information | Submitter's Name: VALES & HILLS BIOMEDICAL<br>TECH. LTD.<br>Address: Bldg. 46-1, No.2 North Street Jingyuan,<br>Beijing Economic-technological Development Aera,<br>100176 Beijing, China Guangdong, China 518101<br>Contact person: Melody Huang<br>TEL: [phone]<br>FAX: [phone]<br>E-Mail: [e-mail] |
| Submission<br>Correspondent | Company Name: Shenzhen Joyantech Consulting<br>Co., Ltd.<br>Address: Room 1122, International Mayors<br>Communication Centre, NO. 55 Shizhou Zhong<br>road, Nanshan District, Shenzhen,China.<br>Contact person: Mr. Field Fu<br>E-Mail: [e-mail] |
| | Image: logo |
| Establishment<br>registration number | Unknown. |

### 2. Device Information

Type of 510(k) Traditional submission: ECG Acquisition Systems Trade Name:

{4}------------------------------------------------

VALES & HILLS BIOMEDICAL TECH. LTD. Proposed product: ECG Acquisition Systems

Version:A/0

| Model: | iCV200(BLE) |
|----------------------|--------------------|
| Classification name: | Electrocardiograph |
| Review Panel: | Cardiovascular |
| Product Code: | DPS |
| Device Class: | II |
| Regulation Number: | 870.2340 |

#### 3. Predicate Device Information

| Sponsor: | Spaulding Clinical Research, LLC |
|----------------|-------------------------------------|
| Device: | Spaulding Electrocardiograph 2100iQ |
| 510(K) Number: | K150564 |

### 4. Device Description

The ECG Acquisition Systems is a hand-held, battery powered, 12-lead resting electrocardiograph system with vhECG Pro software. The ECG Acquisition Systems consists of ECG Acquisition Recorder, Patient Cable and vhECG Pro software. ECG data is transferred via Bluetooth® 4.0 Technology and displayed on mobile screen in real-time before, during and after acquisition. With vhECG Pro, resting ECGs can be recorded, viewed and printed in various formats. Besides, ECGs can also be uploaded to vhCloud ( cloud platform) by vhECG Pro, they can be reviewed by other medical staff authorized via its iPhone or iPad in which vhCloud is installed. The device is intended to provide reference for medical diagnosis, not intended for a replacement of diagnosis of clinicians.

#### 5. Intended Use/ Indications for Use

The ECG Acquisition Systems is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent upload to vhECG Pro, which installed in iPad or iPhone. This enables clinicians, or trained care personnel who are acting on the

{5}------------------------------------------------

| VALES & HILLS BIOMEDICAL TECH. LTD. | VOL_005: 001_510(k) Summary |
|-------------------------------------------|-----------------------------|
| Proposed product: ECG Acquisition Systems | Version:A/0 |

orders of a licensed physician, to acquire, process, display, store, and print diagnostic 12 lead ECGs.

The ECG Acquisition Systems is for use on adult and pediatric populations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use as a vital signs physiological monitor.

The subject device is intended to be used for clinical use rather than home use. It can be used in a professional healthcare facility, or a clinical environment such as clinics. It cannot be used in transport environment, such as ambulance.

The ECG Acquisition Systems provides uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis.

| Items | Predicate Device<br>(K150564), Spaulding<br>Clinical | Subject Device | Comparison |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Intended use/<br>Indications for<br>use | The Spaulding<br>Electrocardiograph 2100iQ is<br>intended to acquire a resting,<br>diagnostic 12-lead ECG for<br>display and subsequent<br>upload to a Medical Device<br>Data System (MDDS). This<br>enables clinicians, or trained<br>care personnel who are<br>acting on the orders of a<br>licensed physician, to<br>acquire, process, display,<br>store, and print diagnostic 12 | The ECG Acquisition<br>Systems is intended to<br>acquire a resting,<br>diagnostic 12-lead ECG for<br>display and subsequent<br>upload to vhECG Pro,<br>which installed in iPad or<br>iPhone. This enables<br>clinicians, or trained care<br>personnel who are acting<br>on the orders of a licensed<br>physician, to acquire,<br>process, display, store,<br>and print diagnostic 12<br>lead ECGs.<br>The ECG Acquisition<br>Systems is for use on adult<br>and pediatric populations,<br>diseased or non-diseased<br>and is not intended for use | Same |
| Items | Predicate Device (K150564), Spaulding Clinical | Subject Device | Comparison |
| | lead ECGs. The Spaulding<br>Electrocardiograph is for use<br>on adult and pediatric<br>populations, diseased or non-<br>diseased and is not intended<br>for use on neonatal (birth to<br>28 days) or infants (29 days<br>up to 2 years). The device is<br>not for use in highly invasive<br>environments, or as a vital<br>signs physiological monitor.<br>The Spaulding<br>Electrocardiograph provides<br>uninterpreted 12-lead ECG<br>data and is not to be a sole<br>means of diagnosis. | on neonatal (birth to 28<br>days) or infants (29 days<br>up to 2 years). The device<br>is not for use as a vital<br>signs physiological<br>monitor.<br>The subject device is<br>intended to be used for<br>clinical use rather than<br>home use. It can be used<br>in a professional<br>healthcare facility, or a<br>clinical environment such<br>as clinics. It cannot be<br>used in transport<br>environment, such as<br>ambulance.<br>The ECG Acquisition<br>Systems provides<br>uninterpreted 12-lead ECG<br>data and is not to be a sole<br>means of diagnosis. | |
| Patient Cable | Proprietary 12-Lead Patient<br>Cable | iCV200(BLE) 12-Lead<br>Patient Cable | Different<br>( <b>Note01</b> ) |
| Leads | 12-Lead | 12-Lead | Same |
| Power source | An internal polymer lithium<br>ion 3.7V rechargeable battery | Two internal AA LR06<br>batteries each at 1.5V<br>non-rechargeable batteries | SE |
| ECG Data<br>Transfer | Data transfer via Bluetooth®<br>Technology | Data transfer via<br>Bluetooth® Technology | Same |
| Bluetooth<br>Version | Bluetooth 2.0+ | Bluetooth 4.0 | SE |
| Software | Spaulding Client Application | vhECG Pro Software | Different |
| Items | Predicate Device<br>(K150564), Spaulding<br>Clinical | Subject Device | Comparison |
| Component | Software | | (Note02) |
| Client Software<br>platform | Mobile device | Mobile device (iPhone, iPad) | SE |
| ECG<br>Interpretation | No | No | Same |
| ECG Display | ECG data is displayed on<br>mobile screen in real-time<br>before, during, and after<br>acquisition. Acquired ECG<br>displayed before and after<br>upload. | ECG data is displayed on<br>mobile screen in real-time<br>before, during, and after<br>acquisition. Acquired ECG<br>displayed before and after<br>upload. | Same |
| Filter | High pass filter to remove<br>baseline wander ;<br>Adaptive band-reject filter for<br>power line noise | Highpass filter, Lowpass<br>filter, AC notch filter,<br>Baseline wander erase<br>and EMG filter | SE |
| Internet access | Internet access is required<br>for ECG data upload and<br>retrieval. | Internet access is required<br>for ECG data upload and<br>retrieval. | Same |
| Materials | Device enclosure: ABS<br>Polycarbonate. | Device enclosure: ABS<br>Polycarbonate. | SE |
| Gain | 2.5, 5, 10, 20, 40 mm/mV | 5, 10, 20 mm/mV | SE |
| Sampling Rate | 500 s/sec/channel (Hz) | 500 Hz | SE |
| Chart Speed | 5, 10, 12.5, 25, 50 mm/s | 12.5mm/s, 25mm/s,<br>50mm/s | SE |
| Frequency<br>Response | 0.05 to 250 Hz | 0.05 to 150 Hz | Different<br>(Note03) |
| ECG display | User Selectable | User Selectable | SE |
| Items | Predicate Device<br>(K150564), Spaulding<br>Clinical | Subject Device | Comparison |
| formats | 12-Lead, 12×1, 6×1, 4×1,<br>3×1, 2×1, 1×1, 6×2, 4×2,<br>3×2, 2×2, 1×2 | 3×4, 6×2, 12×1 | |
| Performance | IEC 60601-2-25:2011<br>Particular requirements for<br>the basic safety and essential<br>performance of<br>electrocardiographs | IEC 60601-2-25:2011<br>Particular requirements for<br>the basic safety and<br>essential performance of<br>electrocardiographs | SE |
| Biocompatibility<br>Safety | ISO 10993 Part 1, Part 5,<br>Part 10 | ISO 10993 Part 1 | Different<br>(Note04) |
| Electric and<br>EMC Safety | IEC 60601-1 3rd edition:<br>2005, IEC 60601-1-2: 2007,<br>IEC 60601-2-25:2013 | IEC 60601-1 3rd edition:<br>2005, IEC 60601-1-2:<br>2007, IEC 60601-2-<br>25:2013 | SE |
| Water ingress<br>and particulate<br>matter rating | IP22 | IPX0 | Different<br>(Note05) |
| Applied Part<br>Classification | TYPE CF | TYPE CF | Same |
| Patient Cable<br>Safety | AAMI/ANSI EC53:2013 ECG<br>Trunk Cables and Patient<br>Leadwires | AAMI/ANSI EC53:2013<br>ECG Trunk Cables and<br>Patient Leadwires | SE |
| Cleaning/<br>disinfection | The ECG device, the 12-lead<br>ECG Patient Cable, and<br>leadwires are cleaned by a<br>mild detergent and warm<br>water solution. | The ECG device<br>(Recorder), the 12-lead<br>ECG Patient Cable, and<br>leadwires are cleaned and<br>disinfected by 70% | Different<br>(Note06) |
| Items | Predicate Device<br>(K150564), Spaulding Clinical | Subject Device | Comparison |
| | | alcohol. | |

# 6. Technological characteristics of the subject device compared to the predicate device

{6}------------------------------------------------

### VALES & HILLS BIOMEDICAL TECH. LTD. Proposed product: ECG Acquisition Systems

{7}------------------------------------------------

### VALES & HILLS BIOMEDICAL TECH. LTD. Proposed product: ECG Acquisition Systems

{8}------------------------------------------------

### VOL_005: 001_510(k) Summary

### Proposed product: ECG Acquisition Systems

VALES & HILLS BIOMEDICAL TECH. LTD.

{9}------------------------------------------------

VALES & HILLS BIOMEDICAL TECH. LTD.

VOL_005: 001_510(k) Summary

#### Proposed product: ECG Acquisition Systems Version:A/0

Note01: The iCV200(BLE) 12-Lead Patient Cable had passed the safety test according to AAMI/ANSI EC53:2013.

Note02: The vhECG Pro Software has been validated and the hazards and risks have been indentified and controlled in relevant software information documents. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.

Note03: The bandwidth 0.05 to 150 Hz is the common frequency range, such as the products marketed in US through clearance K160840, K160876 and K102830 (cited in K160876 summary) .

Note04: A biocompatibility test evaluation report has been provided to explain the reason for exempting the biocompatibility tests.

Note05: The subject device provides no degrees of protection against water, thus it is not suitable for use in the environment with water.

Note06: The Cleaning method has been described in the instruction for use.

The subject device and the predicate device have the same intended use and similar technological characteristics. They both use Bluetooth® Technology to transfer ECG data. They are compact, small and light-weight. Though they are different in Biocompatibility Safety, Water ingress and particulate matter rating and Cleaning/ disinfection, these differences do not raise any new questions.

{10}------------------------------------------------

Proposed product: ECG Acquisition Systems

VALES & HILLS BIOMEDICAL TECH. LTD.

Thus, the subject device is substantially equivalent to the predicate devices.

### 7. Brief discussion of the nonclinical tests

The nonclinical tests of the ECG Acquisition Systems are listed as below table:

| Tests Item | Test Standards/ Guidance | Results |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Electric Safety | IEC 60601-1: 2012 Medical electrical equipment<br>- Part 1: General requirements for basic safety and essential performance | Pass |
| EMC | 1) IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -<br>Collateral Standard: Electromagnetic compatibility - Requirements and tests;<br>2) 47 CFR PART 15 Subpart C, Radio Frequency Devices Subpart C – Intentional Radiators<br>3) ESTI EN 301 489-1 V1.9.2 (2011), Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements;<br>4) ESTI EN 301 489-17 V2.2.1 (2012), Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions for Broadband Data Transmission Systems;<br>5) ESTI EN 300328 V1.8.1 (2012), Electromagnetic compatibility and Radio | Pass |
| Tests Item | Test Standards/ Guidance | Results |
| | spectrum Matters(ERM); Wideband<br>transmission systems; Data transmission<br>equipment operating in the 2.4 GHz ISM band<br>and using wide band modulation techniques;<br>Harmonized EN covering the essential<br>requirements of article 3.2 of the R & TTE<br>Directive. | |
| QoS testing | Guidance for Industry and Food and Drug<br>Administration Staff: Radio Frequency Wireless<br>Technology in Medical Devices | Pass |
| | 47 CFR PART 15 Subpart C, Radio Frequency<br>Devices Subpart C - Intentional Radiators;<br>EN 300328 V1.8.1, Electromagnetic<br>compatibility and Radio spectrum | |
| Wireless<br>coexistence | Matters(ERM); Wideband transmission<br>systems; Data transmission equipment<br>operating in the 2.4 GHz ISM band and using<br>wide band modulation techniques; Harmonized<br>EN covering the essential requirements of<br>article 3.2 of the R&TTE Directive | Pass |
| | IEC 60601-2-25, Medical electrical equipment –<br>Part 2-25: Particular requirements for the basic<br>safety and essential performance of<br>electrocardiographs | |
| ECG<br>performance | | Pass |
| Patient cable<br>performance | AAMI ANSI EC53, Ecg trunk cables And patient<br>leadwires | Pass |
| Software<br>Verification and<br>Validation<br>Testing | Guidance for Industry and FDA Staff, "Guidance<br>for the Content of Premarket Submissions for<br>Software Contained in Medical Devices | Pass |

{11}------------------------------------------------

### VALES & HILLS BIOMEDICAL TECH. LTD.

Proposed product: ECG Acquisition Systems

{12}------------------------------------------------

VALES & HILLS BIOMEDICAL TECH. LTD.

Proposed product: ECG Acquisition Systems

Version:A/0

### 8. Clinical test conclusion

Clinical data is not applicable for this submission.

### 9. Conclusions

Based on the above information, we conclude the subject device, iCV200(BLE)

ECG Acquisition Systems, is substantially equivalent to the predicate device.