(238 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the analysis using "algorithms" without specifying them as AI/ML. The description focuses on standard ECG and spirometry functions and data management.
No.
This device is for diagnostic purposes, providing analysis and information about a patient's heart and respiratory condition, rather than directly treating or mitigating a disease.
Yes
The device is described as providing "interpretive analysis" and "analytical information about the patient's heart condition," performing "spirometry diagnostic tests," and measuring "patient respiratory parameters." It also states it provides "parameters necessary for diagnosis" and "automatic diagnosis."
No
The device description explicitly states it is "12-channel ECG (Electrocardiogram) recording equipment that measures and records the patient's ECG" and mentions a "battery pack, which can be stored inside as an optional component," indicating it includes hardware components.
Based on the provided information, the Cardio Q50 / Cardio Q70 ECG Analysis System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Cardio Q50 / Q70 Function: The Cardio Q50 / Q70 directly measures and records electrical activity of the heart (ECG) and respiratory parameters (spirometry) from the patient's body. It does not analyze specimens in vitro.
- Intended Use: The intended use describes acquiring, analyzing, displaying, and recording ECG and spirometry information from the patient. This is a direct measurement from the living body, not an analysis of a specimen outside the body.
Therefore, the Cardio Q50 / Cardio Q70 falls under the category of a medical device that performs physiological measurements, but it is not an IVD.
N/A
Intended Use / Indications for Use
The Cardio Q50 / Cardio Q70 ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations.
- Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older
The system provides 12-lead ECG and interpretive analysis.
The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information.
Sending and receiving ECG data to and from the Hospital Information System is optional.
The Cardio Q50 / Cardio Q70 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.
In addition, the Cardio Q50 / Cardio Q70 is intended for prescription use only to perform spirometry diagnostic tests in adults and pediatic patients aged 5 and older in general practice, specialist and hospital settings is intended to be used what measures patient respiratory parameters including FVC, FEV1/FEV6, SVC, MVV
Product codes
DPS, BZG
Device Description
Cardio Q50 / Cardio Q70 is a 12-channel ECG (Electrocardiogram) recording equipment that measures and records the patient's ECG. It not only provides parameters necessary for diagnosis, patient's ECG record and automatic diagnosis, but also increases chart management efficiency by providing ECG records and printing reports when patient or user information is entered. At the same time, it can transmit the saved data to a PC for file management. Its useroriented design enables ECG examination with a single push of a button. It saves, transfers and prints the data that has been acquired by automatic diagnosis.
It provides the user with the necessary parameters, which are necessary for patient diagnosis, along with the spirometry record. After spirometry tests, you can print out a report on A4/letter paper together with the spirometer record to efficiently manage the patient's or user's chart. The stored data is forwarded to a PC that is in charge of managing digital files. In addition, the battery pack, which can be stored inside as an optional component, ensures high portability and makes it possible to inspect or use the equipment in an emergency.
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.
Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older
For spirometry diagnostic tests: adults and pediatric patients aged 5 and older
Intended User / Care Setting
personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.
general practice, specialist and hospital settings
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)
Non-Clinical Test Summary
- Electrical Safety, Electromagnetic Compatibility and Performance: The Cardio Q50, Cardio Q70 comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Testing to confirm compliance with IEC 60601-1 Edition 3.2 2020-08 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- Testing to confirm compliance with 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- Testing to confirm compliance with 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- Testing to confirm compliance with IEC 60601-2-25: 2011 Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
- Testing to confirm compliance with ISO 26782:2009 Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans
- Testing to confirm compliance with ISO 23747:2009 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
- ANSI AAMI EC53
- Software Validation: The Cardio Q50, Cardio Q70 contain Moderate level of concern software as firmware. The software was designed and developed according to a software development process and was verified and validated.
- Biocompatibility: Most of the contents are prepared by being referenced the following standards:
- Cytotoxicity test by EN ISO 10993-5
- Sensitization test by EN ISO 10993-10
- Intracutaneous reactivity test by ISO 10993-10
- #95-1 Biocompatibility Flow Chart for Selection of Toxicity tests for 510(k)s, FDA.
Clinical Test Summary: Clinical testing is not required
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s):
Reference Device(s):
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 15, 2023
Bionet Co., Ltd. Kyungeun Park Assistant Manager 5F, 61 Digital-ro 31 gil, Guro-gu Seoul, 08375 Korea. South
Re: K231160
Trade/Device Name: Cardio Q50, Cardio Q70 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, BZG Dated: November 17, 2023 Received: November 17, 2023
Dear Kyungeun Park:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jennifer W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231160
Device Name Cardio 050. Cardio 070
Indications for Use (Describe)
The Cardio Q50 / Cardio Q70 ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations.
- Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older
The system provides 12-lead ECG and interpretive analysis.
The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information.
Sending and receiving ECG data to and from the Hospital Information System is optional.
The Cardio Q50 / Cardio Q70 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.
In addition, the Cardio Q50 / Cardio Q70 is intended for prescription use only to perform spirometry diagnostic tests in adults and pediatic patients aged 5 and older in general practice, specialist and hospital settings is intended to be used what measures patient respiratory parameters including FVC, FEV1/FEV6, SVC, MVV
| 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
Image /page/3/Picture/0 description: The image shows the word "bionet" in a stylized font. The first three letters, "bio", are in a light blue color, while the last three letters, "net", are in black. The font is rounded and sans-serif, giving the word a modern and clean appearance. The letters are closely spaced, creating a compact and unified design.
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
April 14, 2023
Submitter's Information [21 CFR 807.92(a)(1)] 2.
- Name of Manufacturer: Bionet Co., Ltd. ●
- Address: 5F, 61 Digital-ro 31 gil, Guro-gu, Seoul, Republic of Korea 08375 ●
- Contact Name: Kyungeun Park / Assistant Manager ●
- Telephone No.: +82-2-6292-6410 ●
- Fax No.: +82-2-6499-7788
- Email Address: kepark@ebionet.com ●
- Registration No.: 3003681187 ●
3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]
| Trade/Device Name | Cardio Q50, Cardio Q70 |
|---|---|
| K Number | K231160 |
| Common Name | Electrocardiograph & Spirometer |
| Regulation Number | 870.2340 / 868.1840 |
| Regulation Name | Electrocardiograph / Diagnostic spirometer |
| Regulation Class | 2 |
| Product Code | DPS / BZG |
4
K231160
4. Identification of Predicate Device(s) [21 CFR 807.92[a)(3)[
The identified predicate devices within this submission are shown as follow;
Primary Predicate device
- 510(k) Number: K220535 ●
- Applicant: Bionet Co., Ltd.
- Trade/Device Name Cardio10 ●
- Regulation Number 870.2340 / 868.1840
- Regulation Name: Electrocardiograph / Diagnostic spirometer
- . Regulation Class: ನ
- Product Code: DPS / BZG .
Reference device
●
●
| ● | 510(k) Number: | K160840 |
|---|---|---|
| ● | Applicant: | Cardioline S.p.A |
| ● | Trade/Device Name | ECG100+, ECG200+ |
| ● | Regulation Number | 870.2340 |
| ● | Regulation Name: | Electrocardiograph |
| ● | Regulation Class: | 2 |
| ● | Product Code: | DPS |
The predicate device and reference device have not been subject to a design-related recall.
5. Description of the Device [21 CFR 807.92(a)(4)]
Cardio Q50 / Cardio Q70 is a 12-channel ECG (Electrocardiogram) recording equipment that measures and records the patient's ECG. It not only provides parameters necessary for diagnosis, patient's ECG record and automatic diagnosis, but also increases chart management efficiency by providing ECG records and printing reports when patient or user information is entered. At the same time, it can transmit the saved data to a PC for file management. Its useroriented design enables ECG examination with a single push of a button. It saves, transfers and prints the data that has been acquired by automatic diagnosis.
It provides the user with the necessary parameters, which are necessary for patient diagnosis, along with the spirometry record. After spirometry tests, you can print out a report on A4/letter paper together with the spirometer record to efficiently manage the patient's or user's chart. The stored data is forwarded to a PC that is in charge of managing digital files. In addition, the battery pack, which can be stored inside as an optional component, ensures high portability and makes it possible to inspect or use the equipment in an emergency.
5
Image /page/5/Picture/0 description: The image shows the word "bionet" in a sans-serif font. The first three letters, "bio", are in a light blue color, while the last three letters, "net", are in black. The letters are all lowercase and connected, giving the impression of a single word.
6. Indications for use [21 CFR 807.92(a)(5)]
The Cardio 050 / Cardio 070 ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations.
- Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older
The system provides 12-lead ECG and interpretive analysis.
The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information.
Sending and receiving ECG data to and from the Hospital Information System is optional.
The Cardio Q50 / Cardio Q70 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.
In addition. the Cardio 050 / Cardio 070 is intended for prescription use only to perform spirometry diagnostic tests in adults and pediatric patients aged 5 and older in general practice, specialist and hospital settings. The device is intended to be used what measures patient respiratory parameters including FVC, FEV1/FEV6, SVC, MVV.
Determination of Substantial Equivalence 7.
The Cardio Q50, Cardio Q70 is substantially equivalent to legally marketed predicate device and reference device with respect to indications for use and technology characteristics.
| Proposed Device | Predicate Device | Reference device | |
|---|---|---|---|
| Product Name | Cardio Q50, Cardio Q70 | Cardio10 | ECG100+, ECG200+ |
| 510(k) | |||
| Number | K231160 | K220535 | K160840 |
| Manufacturer | Bionet Co., Ltd. | Bionet Co., Ltd. | Cardioline S.p.A |
| Product Code | DPS / BZG | DPS / BZG | DPS |
| Device Class | 2 | 2 | 2 |
| Common specification | |||
| Indications | |||
| for Use | The Cardio Q50 / Cardio Q70 | ||
| ECG Analysis System is | |||
| intended to acquire, analyze, | |||
| display and record ECG | |||
| information from adult and | |||
| pediatric populations. |
- Bionet Algorithm - 3 years
or older / Glasgow Algorithm
- 0 years or older
The system provides 12-lead
ECG and interpretive
analysis. | The Cardio10 ECG Analysis
System is intended to
acquire, analyze, display, and
record electrocardiographic
information from adult and
pediatric populations.
Pediatric population is
defined as patients between
the ages from 3 and less than
16 years.
Basic systems deliver 12 lead
ECG's, interpretive analysis, | ECGxxx(z)(+) is a high-
performance, multi-
channel, interpretative
resting electrocardiograph.
The ECG signal is acquired
with a 10-wires patient
cable and is displayed in
real time on a LCD screen
integrated in the device.
The electrocardiograph
can analyse and store the
ECG traces, send them to
an external peripheral via |
| | | K231160 | |
| Proposed Device | Predicate Device | Reference device | |
| The 12-Lead ECG
interpretation algorithm
provides analytical
information about the
patient's heart condition,
which must be confirmed by
a qualified medical
professional along with other
relevant clinical information.
Sending and receiving ECG
data to and from the Hospital
Information System is
optional.
The Cardio Q50 / Cardio Q70
is intended to be used by
personnel trained in
hospitals or medical
professional facilities under
the direct supervision of a
licensed healthcare
practitioner.
In addition, the Cardio Q50 /
Cardio Q70 is intended for
prescription use only to
perform spirometry
diagnostic tests in adults and
pediatric patients aged 5 and
older in general practice,
specialist and hospital
settings. The device is
intended to be used what
measures patient respiratory
parameters including FVC.
FEV1/FEV6, SVC, MVV | and can be upgraded to
provide software analysis
options such as a high
resolution signal averaging of
QRS and P wave portions of
the electrocardiogram. The
12-lead ECG interpretive
algorithm provides a
computer-generated analysis
of potential patient cardiac
abnormalities, which must
be confirmed by a physician
with other relevant clinical
information.
Transmission and reception
of ECG data to and from a
central ECG cardiovascular
information system is
optional.
The Cardio10 is intended to
be used under the direct
supervision of a licensed
healthcare practitioner, by
trained operators in a
hospital or medical
professional's facility.
Cardio10 is intended for
prescription use only to
conduct diagnostic
spirometry testing of adults
and pediatric patients, 5
years and older, in general
practice, specialty physician,
and hospital settings. The
device is intended to be used
as a spirometer which
measures patient respiratory
parameters including FVC,
COPD, SVC, MVV. | network or via USB, print
the 12 lead ECG in
automatic or manual mode
by means of a thermal
printer. ECGxxx(z)(+) is
intended for assessment
and diagnosis of cardiac
functions. In any case the
results of analysis
performed by the
electrocardiograph must
be validated by a Physician.
ECGxxx(z)(+) is intended
for use in hospitals, in
medical clinics and
doctor's offices of any size. - The device is indicated
for use to acquire, analyse,
display and print
electrocardiograms. - The
device is intended to
provide the physician with
an automatic
interpretation of the ECG
to be reviewed by a
physician. - The device is
indicated for use in a
clinical setting, by a
physician or by trained
personnel who are acting
on the orders of a licensed
physician. It is not
intended as a sole means of
diagnosis. - The
interpretations of ECG
offered by the device are
only significant when used
in conjunction with a
physician overread as well
as consideration of all
other relevant patient data. - The device is indicated
for use on adult and
pediatric populations. -
The device is not intended
to be used as a vital signs
physiological monitor. | |
| | Proposed Device | Predicate Device | Reference device |
| Battery | Replaceable and
Rechargeable Lithium Ion,
10.8V, 6500mA | Replaceable and
Rechargeable Lithium Ion,
10.8V, 6500mA | Internal rechargeable batte
ry (NiMH), 12Vdc 2200 mA
h |
| | 10 hours of normal use or
print 350 ECG (12 channel
format at 25mm/s and
10mm/mV) or Spiro pages.
Battery recharge to full | 10 hours of normal use or
print 350 ECG(12 channel
format at 25mm/s and
10mm/mV) or Spiro pages.
Battery recharge to full | |
| | capacity in 3 hours. (The
device is turned off) | capacity in 3hours. (The
device is turned off) | |
| Data storage | Internal Storage for 500
Data : Built- in Memory | Internal Storage for 500
data : Built in memory | Up to 100 ECGs |
| Dimension | 1) Main Body - 286(W) x 350(D) x 140(H)
mm (Cardio Q50) - 286(W) x 350(D) x 144(H)
mm (Cardio Q70) | 1) Main Body - 300(W) x 299(H) x 123(D)
mm (monitor tilt down) - 300(W) x 299(H) x
237(D)mm | 285 x 204 x 65 mm
1.8kg |
| | - Approx. 4.5kg (Max) | (monitor tilt up)296 - Approx. 4kg | |
| | 2) Spiro Handle - 48(W) x 39(D) x 201(H) | 2) Spiro Handle
- 48(W) x 39(D) x 201(H) | |
| | mm - Approx. 250g | mm
- Approx. 250g | |
| Target
Population | Adult and pediatric patients | Adult and pediatric patients | Adults and pediatric patients |
| | | | |
| ECG Leads | Simultaneous 12 channel
ECG and acquisition | Simultaneous 12 channel
ECG and acquisition | 12 Leads Standard / Cabre
ra |
| Gain | 2.5, 5, 10, 20, Auto (IaVF:V6: 5) mm/mV | 2.5, 5, 10, 20, Auto (I
10, V1aVF:V6: 5) mm/mV | 5, 10, 20 mm/mV |
10, V1
| Sampling
Rate | Analysis Sampling Rate -
500Hz | Analysis Sampling Rate -
500Hz | 500 samples/second/chan
nel |
| | Digital Sampling Rate -
8,000Hz | Digital Sampling Rate -
8,000Hz | |
| Filters | AC (50/60 Hz, -20dB or
better),
Muscle (2535Hz, -3dB or35Hz, -3dB or
better), | AC (50/60 Hz, -20dB or
better),
Muscle (25
better), | AC (50/60 Hz)
diagnostic fully digital high
pass filter; adaptive digital
AC interference filter (50/ |
| | Proposed Device | Predicate Device | Reference device |
| | Bionet Baseline Drift
(0.05Hz, 0.1Hz, 0.2Hz, -3dB
or better)
Low Pass Filter(off, 40Hz,
100Hz, 150Hz) | Base line drift (0.05Hz,
0.1Hz, 0.2Hz, -3dB or better),
Low pass filter(off, 40Hz,
100Hz, 150Hz) | 60 Hz); digital low pass filt
er muscular filter 25 and 4
0 Hz (only for display and
printing) |
| Patient data | ID, Name, Date of Birth, Age,
Gender, Height, Weight, Race,
Smoke, Department, Room
No., Study Desc., Accession
No., Referring Physician | ID, Name, Birthday, Age,
Gender, Height, Weight, Race,
Smoke, Department, Room
no., Study desc., Accession
No., Referring Physician | Not known |
| Basic
Measurement
&
Interpretatio
n | Heart Rate (30300bpm,300bpm ±3),
±3bpm), PR/RR Int, QRS Dur,
QT/QTc Int,
P-R-T axis, SV1/RV5/R+S
Amp
Bionet ECG analysis
algorithm(V 3.26),
the University of Glasgow
ECG analysis algorithm(V
30.4) | Heart rate(30
PR/RR int. , QRS dur., QT/QTc
int.,
P-R-T axis, SV1/RV5/R+S
amp.
Bionet ECG analysis
algorithm(V 3.26) | Heart rate(30~300bpm),
Average RR, PR interval,
QRS duration, QT/QTc int,
P-R-T axis, Skolow-Lyon
index, max R[V5]or[V6]
and S[V1], J-Tp and Tp-Te
intervals
Glasgow resting ECG
interpretation algorithm (V
28.6) |
| Spirometer (Option) | | | |
| Measuring
values | - FVC : FVC, FEV1, FEV1/FVC,
FEF 0.2-1.2L, FEF 25-75%,
FEF 75-85%, PEF, FEF 25%,
FEF 50%, FEF 75%, FIVC,
FEV6, PEFT, FET 100%, Error
Code, Extrapolation volume - FEV1/FEV6 : FEV1, FEV6,
FEV1/FEV6, LFI - SVC : SVC, TV, ERV, IRV, EC
- MVV : MVV, FB, TV | - FVC : FVC, FEV1, FEV1/FVC,
FEF 0.2-1.2L, FEF 25-75%,
FEF 75-85%, PEF, FEF 25%,
FEF 50%, FEF 75%, FIVC,
FEV6, PEFT, FET 100%, Error
Code, Extrapolation volume - COPD : FEV1, FEV6,
FEV1/FEV6, LFI - SVC : SVC, TV, ERV, IRV, EC
- MVV : MVV, FB, TV | Not Applicable |
| Presentation | Flow Volume loop
Volume Time Graph
Measurement values table | Flow Volume loop
Volume Time Graph
Measurement values table | |
| Measuring
range | Flow : 0 to 14 L/s
Volume : 0 to 12 L | Flow : 0 to 14 L/s
Volume : 0 to 12 L | |
| Measuring
method | Differential pressure method | Differential pressure method | |
| | Proposed Device | Predicate Device | Reference device |
| Prediction
Equation | Morris-Polgar, Knudson-ITS,
ECCS-Quanjer, Korea CJK,
Pereira, GLI-2012 | Morris-Polgar, Knudson-ITS,
ECCS-Quanjer, Korea CJK,
Pereira, GLI-2012 | |
| Sample Rate | 200 samples/sec | 200 samples/sec | |
| Flow
Impedance |