(359 days)
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.
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.
The provided text is a 510(k) Summary for the "ECG Acquisition Systems" device. It describes the device, its intended use, comparison to a predicate device, and results of nonclinical tests. However, it explicitly states that clinical data is not applicable for this submission and does not contain any information about a study proving the device meets specific acceptance criteria based on clinical performance metrics (like sensitivity, specificity, or reader improvement with AI).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as no such clinical performance study is described in the provided document. The document focuses on demonstrating substantial equivalence through nonclinical testing (electrical safety, EMC, QoS, wireless coexistence, ECG performance, patient cable performance, and software verification/validation) and comparison of technological characteristics to a predicate device, not on diagnostic accuracy or efficacy studies involving human readers or AI.
The response below reflects what could be extracted if such a study were present, but indicates the absence of this information in the provided text.
This document outlines the substantial equivalence of the "ECG Acquisition Systems" to a predicate device for FDA 510(k) clearance. It specifies the device's technical characteristics and nonclinical test results. However, it explicitly states that "Clinical data is not applicable for this submission." Therefore, the provided text does not contain information about acceptance criteria for clinical performance (e.g., diagnostic accuracy, sensitivity, specificity, or human reader improvement with AI) or a study that proves the device meets such criteria through clinical evaluation.
The document primarily relies on nonclinical testing and comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical performance study.
Here's what can be gathered, alongside the confirmation that the requested clinical performance study details are absent:
1. Table of Acceptance Criteria and Reported Device Performance:
As no clinical performance study is described, there are no acceptance criteria for metrics like sensitivity, specificity, or other diagnostic performance indicators. The "acceptance criteria" discussed in this document pertain to adherence to technical standards and nonclinical test results.
| Category | Acceptance Criteria (Standard/Guidance) | Reported Device Performance |
|---|---|---|
| Electric Safety | IEC 60601-1: 2012 | Pass |
| EMC | IEC 60601-1-2: 2007; 47 CFR PART 15 Subpart C; ESTI EN (various) | Pass |
| QoS Testing | Guidance for Industry and FDA Staff: Radio Frequency Wireless Technology in Medical Devices | Pass |
| Wireless Coexistence | 47 CFR PART 15 Subpart C; EN 300328 V1.8.1 | Pass |
| ECG Performance | IEC 60601-2-25 | Pass |
| Patient Cable Performance | AAMI ANSI EC53 | Pass |
| Software V&V Testing | Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Pass |
2. Sample size used for the test set and the data provenance:
No clinical test set data is described. The nonclinical tests refer to compliance with technical standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical performance test set or ground truth establishment by experts is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was done, as the device provides "uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis" and does not involve AI assistance for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as the device primarily acquires and displays raw ECG data, and does not provide automated interpretation (explicitly states: "The ECG Acquisition Systems provides uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis.").
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical performance study requiring ground truth is described.
8. The sample size for the training set:
Not applicable, as the document does not describe a machine learning model or a training set.
9. How the ground truth for the training set was established:
Not applicable.
{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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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 |
|---|---|
| Manufacturerinformation | Submitter's Name: VALES & HILLS BIOMEDICALTECH. LTD.Address: Bldg. 46-1, No.2 North Street Jingyuan,Beijing Economic-technological Development Aera,100176 Beijing, China Guangdong, China 518101Contact person: Melody HuangTEL: +86-10-51665548FAX: +86-10-67856343E-Mail: liu@vhmedical.com |
| SubmissionCorrespondent | Company Name: Shenzhen Joyantech ConsultingCo., Ltd.Address: Room 1122, International MayorsCommunication Centre, NO. 55 Shizhou Zhongroad, Nanshan District, Shenzhen,China.Contact person: Mr. Field FuE-Mail: cefda13485@163.com |
| Image: logo | |
| Establishmentregistration 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(K150564), SpauldingClinical | Subject Device | Comparison |
|---|---|---|---|
| Intended use/Indications foruse | The SpauldingElectrocardiograph 2100iQ isintended to acquire a resting,diagnostic 12-lead ECG fordisplay and subsequentupload to a Medical DeviceData System (MDDS). Thisenables clinicians, or trainedcare personnel who areacting on the orders of alicensed physician, toacquire, process, display,store, and print diagnostic 12 | The ECG AcquisitionSystems is intended toacquire a resting,diagnostic 12-lead ECG fordisplay and subsequentupload to vhECG Pro,which installed in iPad oriPhone. This enablesclinicians, or trained carepersonnel who are actingon the orders of a licensedphysician, to acquire,process, display, store,and print diagnostic 12lead ECGs.The ECG AcquisitionSystems is for use on adultand pediatric populations,diseased or non-diseasedand is not intended for use | Same |
| Items | Predicate Device (K150564), Spaulding Clinical | Subject Device | Comparison |
| lead ECGs. The SpauldingElectrocardiograph is for useon adult and pediatricpopulations, diseased or non-diseased and is not intendedfor use on neonatal (birth to28 days) or infants (29 daysup to 2 years). The device isnot for use in highly invasiveenvironments, or as a vitalsigns physiological monitor.The SpauldingElectrocardiograph providesuninterpreted 12-lead ECGdata and is not to be a solemeans of diagnosis. | on neonatal (birth to 28days) or infants (29 daysup to 2 years). The deviceis not for use as a vitalsigns physiologicalmonitor.The subject device isintended to be used forclinical use rather thanhome use. It can be usedin a professionalhealthcare facility, or aclinical environment suchas clinics. It cannot beused in transportenvironment, such asambulance.The ECG AcquisitionSystems providesuninterpreted 12-lead ECGdata and is not to be a solemeans of diagnosis. | ||
| Patient Cable | Proprietary 12-Lead PatientCable | iCV200(BLE) 12-LeadPatient Cable | Different( Note01 ) |
| Leads | 12-Lead | 12-Lead | Same |
| Power source | An internal polymer lithiumion 3.7V rechargeable battery | Two internal AA LR06batteries each at 1.5Vnon-rechargeable batteries | SE |
| ECG DataTransfer | Data transfer via Bluetooth®Technology | Data transfer viaBluetooth® Technology | Same |
| BluetoothVersion | Bluetooth 2.0+ | Bluetooth 4.0 | SE |
| Software | Spaulding Client Application | vhECG Pro Software | Different |
| Items | Predicate Device(K150564), SpauldingClinical | Subject Device | Comparison |
| Component | Software | (Note02) | |
| Client Softwareplatform | Mobile device | Mobile device (iPhone, iPad) | SE |
| ECGInterpretation | No | No | Same |
| ECG Display | ECG data is displayed onmobile screen in real-timebefore, during, and afteracquisition. Acquired ECGdisplayed before and afterupload. | ECG data is displayed onmobile screen in real-timebefore, during, and afteracquisition. Acquired ECGdisplayed before and afterupload. | Same |
| Filter | High pass filter to removebaseline wander ;Adaptive band-reject filter forpower line noise | Highpass filter, Lowpassfilter, AC notch filter,Baseline wander eraseand EMG filter | SE |
| Internet access | Internet access is requiredfor ECG data upload andretrieval. | Internet access is requiredfor ECG data upload andretrieval. | Same |
| Materials | Device enclosure: ABSPolycarbonate. | Device enclosure: ABSPolycarbonate. | 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,50mm/s | SE |
| FrequencyResponse | 0.05 to 250 Hz | 0.05 to 150 Hz | Different(Note03) |
| ECG display | User Selectable | User Selectable | SE |
| Items | Predicate Device(K150564), SpauldingClinical | Subject Device | Comparison |
| formats | 12-Lead, 12×1, 6×1, 4×1,3×1, 2×1, 1×1, 6×2, 4×2,3×2, 2×2, 1×2 | 3×4, 6×2, 12×1 | |
| Performance | IEC 60601-2-25:2011Particular requirements forthe basic safety and essentialperformance ofelectrocardiographs | IEC 60601-2-25:2011Particular requirements forthe basic safety andessential performance ofelectrocardiographs | SE |
| BiocompatibilitySafety | ISO 10993 Part 1, Part 5,Part 10 | ISO 10993 Part 1 | Different(Note04) |
| Electric andEMC Safety | IEC 60601-1 3rd edition:2005, IEC 60601-1-2: 2007,IEC 60601-2-25:2013 | IEC 60601-1 3rd edition:2005, IEC 60601-1-2:2007, IEC 60601-2-25:2013 | SE |
| Water ingressand particulatematter rating | IP22 | IPX0 | Different(Note05) |
| Applied PartClassification | TYPE CF | TYPE CF | Same |
| Patient CableSafety | AAMI/ANSI EC53:2013 ECGTrunk Cables and PatientLeadwires | AAMI/ANSI EC53:2013ECG Trunk Cables andPatient Leadwires | SE |
| Cleaning/disinfection | The ECG device, the 12-leadECG Patient Cable, andleadwires are cleaned by amild detergent and warmwater solution. | The ECG device(Recorder), the 12-leadECG Patient Cable, andleadwires are cleaned anddisinfected by 70% | Different(Note06) |
| Items | Predicate Device(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- 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 -Collateral Standard: Electromagnetic compatibility - Requirements and tests;2) 47 CFR PART 15 Subpart C, Radio Frequency Devices Subpart C – Intentional Radiators3) 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;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;5) ESTI EN 300328 V1.8.1 (2012), Electromagnetic compatibility and Radio | Pass |
| Tests Item | Test Standards/ Guidance | Results |
| spectrum Matters(ERM); Widebandtransmission systems; Data transmissionequipment operating in the 2.4 GHz ISM bandand using wide band modulation techniques;Harmonized EN covering the essentialrequirements of article 3.2 of the R & TTEDirective. | ||
| QoS testing | Guidance for Industry and Food and DrugAdministration Staff: Radio Frequency WirelessTechnology in Medical Devices | Pass |
| 47 CFR PART 15 Subpart C, Radio FrequencyDevices Subpart C - Intentional Radiators;EN 300328 V1.8.1, Electromagneticcompatibility and Radio spectrum | ||
| Wirelesscoexistence | Matters(ERM); Wideband transmissionsystems; Data transmission equipmentoperating in the 2.4 GHz ISM band and usingwide band modulation techniques; HarmonizedEN covering the essential requirements ofarticle 3.2 of the R&TTE Directive | Pass |
| IEC 60601-2-25, Medical electrical equipment –Part 2-25: Particular requirements for the basicsafety and essential performance ofelectrocardiographs | ||
| ECGperformance | Pass | |
| Patient cableperformance | AAMI ANSI EC53, Ecg trunk cables And patientleadwires | Pass |
| SoftwareVerification andValidationTesting | Guidance for Industry and FDA Staff, "Guidancefor the Content of Premarket Submissions forSoftware 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.
§ 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).