(359 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ECG acquisition and data management features without mentioning any AI/ML capabilities for interpretation or analysis.
No.
The device is described as an "ECG Acquisition Systems" intended to acquire diagnostic 12-lead ECGs for display and subsequent upload, with the purpose of providing uninterpreted data as a reference for medical diagnosis, not as a replacement for diagnosis or a sole means of diagnosis. This indicates it is a diagnostic tool, not a therapeutic one that delivers treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to acquire a resting, diagnostic 12-lead ECG" and enables users "to acquire, process, display, store, and print diagnostic 12-lead ECGs." Although it provides "uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis," its primary function is to collect data for diagnostic purposes.
No
The device description explicitly states that the "ECG Acquisition Systems consists of ECG Acquisition Recorder, Patient Cable and vhECG Pro software," indicating it includes hardware components (recorder and cable) in addition to the software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device acquires electrical signals from the body's surface (ECG).
- The intended use is to acquire and display electrical signals related to heart activity. It does not involve the analysis of biological samples.
- The device description focuses on the acquisition and display of ECG data. It doesn't mention any components or processes related to sample handling or analysis.
Therefore, this ECG Acquisition System falls under the category of a medical device that interacts directly with the patient's body to acquire physiological data, rather than an IVD which analyzes samples taken from the body.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
DPS
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.
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 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)
Intended User / Care Setting
clinicians, or trained care personnel who are acting on the orders of a licensed physician.
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.
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)
The nonclinical tests of the ECG Acquisition Systems are listed as below table:
Tests Item: Electric Safety
Test Standards/ Guidance: IEC 60601-1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Results: Pass
Tests Item: EMC
Test Standards/ Guidance:
- 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;
- 47 CFR PART 15 Subpart C, Radio Frequency Devices Subpart C – Intentional Radiators
- 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;
- 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;
- ESTI EN 300328 V1.8.1 (2012), Electromagnetic compatibility and Radio spectrum Matters(ERM); Wideband transmission systems; Data transmission equipment operating in the 2.4 GHz ISM band and using wide band modulation techniques; Harmonized EN covering the essential requirements of article 3.2 of the R & TTE Directive.
Results: Pass
Tests Item: QoS testing
Test Standards/ Guidance: Guidance for Industry and Food and Drug Administration Staff: Radio Frequency Wireless Technology in Medical Devices
Results: Pass
Tests Item: Wireless coexistence
Test Standards/ Guidance: 47 CFR PART 15 Subpart C, Radio Frequency Devices Subpart C - Intentional Radiators; EN 300328 V1.8.1, Electromagnetic compatibility and Radio spectrum Matters(ERM); Wideband transmission systems; Data transmission equipment operating in the 2.4 GHz ISM band and using wide band modulation techniques; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
Results: Pass
Tests Item: ECG performance
Test Standards/ Guidance: IEC 60601-2-25, Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
Results: Pass
Tests Item: Patient cable performance
Test Standards/ Guidance: AAMI ANSI EC53, Ecg trunk cables And patient leadwires
Results: Pass
Tests Item: Software Verification and Validation Testing
Test Standards/ Guidance: Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Results: Pass
Clinical data is not applicable for this submission.
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.
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). 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) |
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3
Version:A/0
VOL_005: 001_510(k) Summary
1. Administrative Information
| Submission Date | Dec, 12, 2016 |
|---|---|
| Manufacturer | |
| information | Submitter's Name: VALES & HILLS BIOMEDICAL |
| TECH. LTD. | |
| Address: Bldg. 46-1, No.2 North Street Jingyuan, | |
| Beijing Economic-technological Development Aera, | |
| 100176 Beijing, China Guangdong, China 518101 | |
| Contact person: Melody Huang | |
| TEL: +86-10-51665548 | |
| FAX: +86-10-67856343 | |
| E-Mail: liu@vhmedical.com | |
| Submission | |
| Correspondent | Company Name: Shenzhen Joyantech Consulting |
| Co., Ltd. | |
| Address: Room 1122, International Mayors | |
| Communication Centre, NO. 55 Shizhou Zhong | |
| road, Nanshan District, Shenzhen,China. | |
| Contact person: Mr. Field Fu | |
| E-Mail: cefda13485@163.com | |
| Image: logo | |
| Establishment | |
| 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
(K150564), Spaulding
Clinical | Subject Device | Comparison |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Intended use/
Indications for
use | The Spaulding
Electrocardiograph 2100iQ is
intended to acquire a resting,
diagnostic 12-lead ECG for
display and subsequent
upload to a Medical Device
Data System (MDDS). 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 | 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 pediatric populations,
diseased or non-diseased
and is not intended for use | Same |
| Items | Predicate Device (K150564), Spaulding Clinical | Subject Device | Comparison |
| | lead ECGs. The Spaulding
Electrocardiograph 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 in highly invasive
environments, or as a vital
signs physiological monitor.
The Spaulding
Electrocardiograph provides
uninterpreted 12-lead ECG
data and is not to be a sole
means of diagnosis. | 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. | |
| Patient Cable | Proprietary 12-Lead Patient
Cable | iCV200(BLE) 12-Lead
Patient Cable | Different
( Note01 ) |
| Leads | 12-Lead | 12-Lead | Same |
| Power source | An internal polymer lithium
ion 3.7V rechargeable battery | Two internal AA LR06
batteries each at 1.5V
non-rechargeable batteries | SE |
| ECG Data
Transfer | Data transfer via Bluetooth®
Technology | Data transfer via
Bluetooth® Technology | Same |
| Bluetooth
Version | Bluetooth 2.0+ | Bluetooth 4.0 | SE |
| Software | Spaulding Client Application | vhECG Pro Software | Different |
| Items | Predicate Device
(K150564), Spaulding
Clinical | Subject Device | Comparison |
| Component | Software | | (Note02) |
| Client Software
platform | Mobile device | Mobile device (iPhone, iPad) | SE |
| ECG
Interpretation | No | No | Same |
| ECG Display | ECG data is displayed on
mobile screen in real-time
before, during, and after
acquisition. Acquired ECG
displayed before and after
upload. | ECG data is displayed on
mobile screen in real-time
before, during, and after
acquisition. Acquired ECG
displayed before and after
upload. | Same |
| Filter | High pass filter to remove
baseline wander ;
Adaptive band-reject filter for
power line noise | Highpass filter, Lowpass
filter, AC notch filter,
Baseline wander erase
and EMG filter | SE |
| Internet access | Internet access is required
for ECG data upload and
retrieval. | Internet access is required
for ECG data upload and
retrieval. | Same |
| Materials | Device enclosure: ABS
Polycarbonate. | Device enclosure: ABS
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,
50mm/s | SE |
| Frequency
Response | 0.05 to 250 Hz | 0.05 to 150 Hz | Different
(Note03) |
| ECG display | User Selectable | User Selectable | SE |
| Items | Predicate Device
(K150564), Spaulding
Clinical | 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 60601-2-25:2011
Particular requirements for
the basic safety and essential
performance of
electrocardiographs | IEC 60601-2-25:2011
Particular requirements for
the basic safety and
essential performance of
electrocardiographs | SE |
| Biocompatibility
Safety | ISO 10993 Part 1, Part 5,
Part 10 | ISO 10993 Part 1 | Different
(Note04) |
| Electric and
EMC 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 ingress
and particulate
matter rating | IP22 | IPX0 | Different
(Note05) |
| Applied Part
Classification | TYPE CF | TYPE CF | Same |
| Patient Cable
Safety | AAMI/ANSI EC53:2013 ECG
Trunk Cables and Patient
Leadwires | AAMI/ANSI EC53:2013
ECG Trunk Cables and
Patient Leadwires | SE |
| Cleaning/
disinfection | The ECG device, the 12-lead
ECG Patient Cable, and
leadwires are cleaned by a
mild detergent and warm
water solution. | The ECG device
(Recorder), the 12-lead
ECG Patient Cable, and
leadwires are cleaned and
disinfected 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;
- 47 CFR PART 15 Subpart C, Radio Frequency Devices Subpart C – Intentional Radiators
- 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;
- 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;
- ESTI EN 300328 V1.8.1 (2012), Electromagnetic compatibility and Radio | Pass |
| Tests Item | Test Standards/ Guidance | Results |
| | spectrum Matters(ERM); Wideband
transmission systems; Data transmission
equipment operating in the 2.4 GHz ISM band
and using wide band modulation techniques;
Harmonized EN covering the essential
requirements of article 3.2 of the R & TTE
Directive. | |
| QoS testing | Guidance for Industry and Food and Drug
Administration Staff: Radio Frequency Wireless
Technology in Medical Devices | Pass |
| | 47 CFR PART 15 Subpart C, Radio Frequency
Devices Subpart C - Intentional Radiators;
EN 300328 V1.8.1, Electromagnetic
compatibility and Radio spectrum | |
| Wireless
coexistence | Matters(ERM); Wideband transmission
systems; Data transmission equipment
operating in the 2.4 GHz ISM band and using
wide band modulation techniques; Harmonized
EN covering the essential requirements of
article 3.2 of the R&TTE Directive | Pass |
| | IEC 60601-2-25, Medical electrical equipment –
Part 2-25: Particular requirements for the basic
safety and essential performance of
electrocardiographs | |
| ECG
performance | | Pass |
| Patient cable
performance | AAMI ANSI EC53, Ecg trunk cables And patient
leadwires | Pass |
| Software
Verification and
Validation
Testing | Guidance for Industry and FDA Staff, "Guidance
for the Content of Premarket Submissions for
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.