(375 days)
Not Found
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 performance studies focus on standard electrical safety and software verification, not AI/ML model performance.
No
The device is used for acquiring, displaying, analyzing, and storing ECG signals for diagnosis, not for providing therapy.
Yes
The device acquires, displays, records, analyzes, and stores ECG signals, and these outputs are used by a trained physician or clinician in determining a diagnosis.
No
The device description explicitly mentions hardware components such as body surface ECG electrodes, an external printer, optional removable storage, an optional USB barcode reader, and a magnetic card scanner. It also references standards related to medical electrical equipment and electrocardiographs, which typically cover hardware aspects.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- QED2000 Function: The QED2000 records 12-lead ECG signals directly from the patient's body surface using electrodes. This is a measurement of electrical activity within the living body (in vivo).
- Intended Use: The intended use clearly states it records signals from the patient's heart activity through body surface ECG electrodes. It analyzes these signals, but the analysis is based on the electrical activity measured directly from the body, not on a sample taken from the body.
Therefore, based on the provided information, the QED2000 is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the QED2000 is to record 12-lead ECG signals from patient's heart activity through body surface ECG electrodes. This device can acquire, display, record, analyze, and store these ECG signals from adult patients for review by the user. Analysis of the ECG signals is accomplished with algorithms that provide data presentations, graphical presentations, and measurements. These are presented for review and interpretation by a trained physician or clinician in determining a diagnosis based upon knowledge of the result of physical examination, and other clinical findings.
The QED2000 is intended to be used in hospital and general physician's office by trained healthcare professionals.
Indications for Use:
The QED2000 is intended to be used to acquire, display, record, analyze, and store 12-lead ECG waveforms from adult patients through body surface ECG electrodes. Using algorithms to generate data presentations, graphical presentations, and measurements for review and interpretation by a trained physician in determining a diagnosis based upon knowledge of the patient, the result of physical examination, and other relevant clinical findings.
The QED2000 is intended to be used in hospital and general physician's office by trained healthcare professionals. The QED2000 is not intended to be used as a cardiac monitor.
Product codes
DPS
Device Description
The Quantitative Electrocardiographic Detector (QED2000) is a 12-lead resting electrocardiograph. It is a device for acquiring, displaying, analyzing and storing the 12-lead electrocardiogram.
The device can print the resting ECG report via the external printer including USB printer and network printer. The device has optional removable storage to store resting ECG records. The device also can export the resting ECG record to SD card/shared directory/FTP server as an optional function. An optional USB barcode reader and magnetic card scanner to enter patient information is also available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body surface (for ECG electrodes)
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Trained physician or clinician; trained healthcare professionals. Intended to be used in hospital and general physician's office.
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 tests were conducted to verify that the proposed device meets all design specifications as is substantially equivalent to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1:2005 + CORR.1(2006) + CORR.2(2007) +AM1(2012), Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
EN 60601-1-2:2007+AC:2010, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
IEC 60601-2-25:2011, Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.
IEC 60601-2-27:2011, Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance of electrocardiographic monitoring equipment.
Software Verification Test was performed to verify the software functions against its intended use.
The collective results of the non-clinical testing demonstrate that the QED2000 meets the established specifications and complies with the aforementioned standards.
Performance data is provided for IEC calibration ECGs and Biological ECGs (CSE Database) comparing the QED2000 to predicate devices for PR-interval, QRS-duration, and QT-Interval measurements in terms of Mean and Standard Deviation. The QED2000 measurements for these intervals fall within or are comparable to the standard deviations of the predicate devices.
Key Results:
- ACME QED2000 PR-interval (ms): Mean 4.5, Standard Deviation 5.4 (IEC 60601-2-25 Standard: ±10, 8) and Mean 0.7, Standard Deviation 7.4 (Biological ECGs Standard: ±10, 10).
- ACME QED2000 QRS-duration (ms): Mean -0.1, Standard Deviation 2.2 (IEC 60601-2-25 Standard: ±6, 5) and Mean -0.3, Standard Deviation 8.3 (Biological ECGs Standard: ±10, 10).
- ACME QED2000 QT-Interval (ms): Mean -0.8, Standard Deviation 1.1 (IEC 60601-2-25 Standard: ±12, 10) and Mean 4.9, Standard Deviation 11.5 (Biological ECGs Standard: ±25, 30).
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.
Not Found
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem that resembles an abstract caduceus, with three stylized human profiles forming the staff and a serpent-like shape winding around them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 9, 2016
ACME Portable Machines, Inc. James Cheng General Manager 1330 Mountain View Circle Azusa, California 91702
Re: K152135
Trade/Device Name: Ouantitative Electrocardiographic Detector (OED 2000) Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: July 7, 2016 Received: July 11, 2016
Dear James Cheng:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 4 - Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152135
Device Name Quantitative Electrocardiographic Detector (QED2000)
Indications for Use (Describe) Intended Use:
The intended use of the QED2000 is to record 12-lead ECG signals from patient's heart activity through body surface ECG electrodes. This device can acquire, display, record, analyze, and store these ECG signals from adult patients for review by the user. Analysis of the ECG signals is accomplished with algorithms that provide data presentations, graphical presentations, and measurements. These are presented for review and interpretation by a trained physician or clinician in determining a diagnosis based upon knowledge of the result of physical examination, and other clinical findings.
The QED2000 is intended to be used in hospital and general physician's office by trained healthcare professionals.
Indications for Use:
The QED2000 is intended to be used to acquire, display, record, analyze, and store 12-lead ECG waveforms from adult patients through body surface ECG electrodes. Using algorithms to generate data presentations, graphical presentations, and measurements for review and interpretation by a trained physician in determining a diagnosis based upon knowledge of the patient, the result of physical examination, and other relevant clinical findings.
The QED2000 is intended to be used in hospital and general physician's office by trained healthcare professionals. The QED2000 is not intended to be used as a cardiac monitor.
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
Section 5 – 510(k) Summary
1. Submitter
ACME Portable Machines, Inc.
1330 Mountain View Circle, Azusa, California 91702
2. Contact Person
Karen Ngai, specialist
Phone: (626) 610-1888
Email: karen@acmeportable.com
Date Prepared ന്
April 22, 2015
4. Trade Name
Quantitative Electrocardiographic Detector (QED 2000)
Classification 5.
Class II
Electrocardiograph
21 CFR 870.2340
6. Product Code DPS
7. Predicate Device(s)
The subject device is equivalent to the following devices:
K113144: "Pagewriter TC 20, 30, 50, 70"; Philips Medical Systems
K110266: "MAC 5500 HD, MAC 3500"; GE Medical Systems Information
Technologies, Inc.
8. Device Description
The Quantitative Electrocardiographic Detector (QED2000) is a 12-lead resting electrocardiograph. It is a device for acquiring, displaying, analyzing and storing the 12-lead electrocardiogram.
The device can print the resting ECG report via the external printer including USB printer and network printer. The device has optional removable storage to store resting ECG records. The device also can export the resting ECG record to SD card/shared directory/FTP server as an optional function. An optional USB barcode reader and magnetic card scanner to enter patient information is also available.
Intended Use 9.
The intended use of the QED2000 is to record 12-lead ECG signals from patient's heart activity through body surface ECG electrodes. This device can acquire, display, record, analyze, and store these ECG signals from adult patients for review by the user. Analysis of the ECG signals is accomplished with algorithms that provide data presentations, graphical presentations, and measurements. These are presented for review and interpretation by a trained physician or clinician in determining a diagnosis based upon knowledge of the result of physical examination, and other clinical findings.
The QED2000 is intended to be used in hospital and general physician's office by trained healthcare professionals.
10. Non-clinical Testing In Support of Substantial Equivalence Determination
Non-clinical tests were conducted to verify that the proposed device meets all design specifications as is substantially equivalent to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1:2005 + CORR.1(2006) + CORR.2(2007) +AM1(2012), Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
EN 60601-1-2:2007+AC:2010, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
4
IEC 60601-2-25:2011, Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.
IEC 60601-2-27:2011, Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance of electrocardiographic monitoring equipment.
Software Verification Test was performed to verify the software functions against its intended use.
The collective results of the non-clinical testing demonstrate that the QED2000 meets the established specifications and complies with the aforementioned standards.
11. Substantially Equivalent (SE) Conclusion
| Characteristic | ACME
QED2000 | GE
MAC® 5500 HD | Philips
PageWriter ® |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K110266 | K113144 |
| 510(k)
Decision Date | | 04/29/2011 | 04/03/2012 |
| Manufacturer | Acme Portable
Machine, Inc. | GE Medical Systems
Information Technologies,
Inc. | Philips Medical Systems |
| Classification | Electrocardiograph | Electrocardiograph | Electrocardiograph |
| Product Code | DPS | DPS | DPS |
| Regulation | 870.2340 | 870.2340 | 870.2340 |
| Indications for
Use | The QED2000 is
intended to be used to
acquire, display,
record, analyze, and
store 12-lead ECG
waveforms from adult
patients through body
surface ECG
electrodes. Using
algorithms to generate
data presentations,
graphical
presentations, and
measurements for
review and
interpretation by a
trained physician or
clinician in determining
a diagnosis based
upon knowledge of the
patient, the result of
physical examination,
and other relevant
clinical findings.
The QED2000 is
intended to be used in
hospital and general
physician's office by
trained healthcare
professionals. The
QED2000 is not | MAC 5500 HO: The MAC
5500 HD ECG Analysis
System is intended to
acquire, analyze, display,
and record
electrocardiographic
information from adult
and pediatric populations.
Basic systems deliver 3;
6, 12, or 15 lead ECGs;
interpretive analysis,
vector loops. and can be
upgraded to provide
software analysis options
such as high resolutions
signal averaging of QHS
and P wave portions of
the electrocardiogram.
Transmission and
reception of ECG data to
and from a central ECG
cardiovascular
information system is
optional. The MAC 5500
HD 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. | To acquire multi-channel
EGG signals from adult
and pediatric patients
from body surface
electrodes and to record,
display, analyze and
store these EGG signals
for review by the user.
To be used in healthcare
facilities by trained
healthcare
professionals. Analysis
of the EGG signals is
accomplished with
algorithms accomplished
with algorithms that that
provide measurements,
data presentations,
graphical presentations
and interpretations for
review by the user.
The interpreted EGG
with measurements and
interpretive statements
is offered to the clinician
on an advisory basis
only. It is to be used in
conjunction with
conjunction with the
clinician's knowledge of
the patient, the results of |
| | intended to be used as
a cardiac monitor. | | the physical
examination, the EGG
tracings, and other
clinical findings. A
qualified physician is
asked to over read and
validate (or change)
computer generated
ECG interpretation. |
| Data
Acquisition:
Sampling Rate | 3000 sample/s | 4000 sample/s | 2000 sample/s |
| ECG Leads | 12 leads | 12 leads | 12 leads |
| Data Entry
Interface | Touch Display | Keyboard | Keyboard |
| Gain Settings | 5, 10, 20 mm/mV | 2.5, 5, 10, 20 mm/mV | 2.5, 5, 10, 20 mm/mV |
| Time base
Settings | 25, 50 mm/s | 5, 25, 50 mm/s | 25, 50 mm/s |
| Filter
Frequency | 0.067 Hz
40,100,150 Hz | 0.04 Hz
40,100,150 Hz | 0.05 Hz
40,100,150 Hz |
| Algorithms | ACME 12-lead ECG
measurement
algorithm | Marquette 12SL ECG
analysis program | Phillips 12-lead ECG
algorithm |
| Display Type | Color TFT | Color TFT | Color TFT |
| Display Pixel
Resolution | 1920 x 1080 | 800 x 480 | 640 x 480 |
| Electrical
Safety | Comply with IEC
60601-1 | Same | Same |
| EMC | Comply with IEC
60601-1-2 | Same | Same |
| Particular
requirements | Comply with IEC
60601-2-25 | Same | Same |
Table 1 Comparison with Predicate Devices
5
Note:
-
- The proposed device provides different sampling rate with those of the predicate devices. This difference will not affect the safety and effectiveness of the proposed devices.
-
- The proposed device provides a bandwidth slightly narrower than those of the predicate devices. This difference will not affect the safety and effectiveness of the proposed devices.
- The proposed device provides different gain and time base with those of the predicate 3. devices. This difference will not affect the safety and effectiveness of the proposed devices.
- The proposed device provides higher display resolution than those of the predicate devices. 4. This difference will not affect the safety and effectiveness of the proposed devices.
6
| Characteristic | ACME
QED2000 | GE
MAC® 5500HD | Philips
PageWriter ® |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Algorithms
Name | ACME 12-lead ECG
measurement algorithm | Marquette* 12SL* ECG
Analysis Program | Phillips 12-lead Algorithm |
| Analyze Data
Type | 12 leads 10 seconds
unfiltered ECG data with
1000 sampling rate | 12 leads 10 seconds
unfiltered ECG data with
500 sampling rate | 12 leads 10 seconds
unfiltered ECG data with
500 sampling rate |
| Measurement
parameters | All 12 leads P, QRS, T
amplitudes and intervals.
Global values with Heart
rate, P duration, PR
interval, QRS duration,
QT interval, QTc and P,
QRS, T axes. | All 12 leads P, QRS, T
amplitudes and
intervals. Global values
with Heart rate, P
duration, PR interval,
QRS duration, QT
interval, QTc and P,
QRS, T axes. | All 12 leads P, QRS, T
amplitudes and intervals.
Global values with Heart
rate, P duration, PR interval,
QRS duration, QT interval,
QTc and P, QRS, axes. |
| Table 2 Algorithms Comparison with Predicate Devices | ||
|---|---|---|
| Table 3 Comparison with Predicate Devices | ||||
|---|---|---|---|---|
| -- | -------------------------------------------- | -- | -- | -- |
| IEC calibration ECGs | ||||||||
|---|---|---|---|---|---|---|---|---|
| IEC 60601-2-25 | ||||||||
| Standard | ACME | |||||||
| QED2000 | GE | |||||||
| MAC5500 | Philips | |||||||
| TC30 | ||||||||
| Mean | Standard | |||||||
| Deviation | Mean | Standard | ||||||
| Deviation | Mean | Standard | ||||||
| Deviation | Mean | Standard | ||||||
| Deviation | ||||||||
| PR-interval | ||||||||
| (ms) | ±10 | 8 | 4.5 | 5.4 | -6.8 | 1.7 | -4.9 | 2.8 |
| QRS-duration | ||||||||
| (ms) | ±6 | 5 | -0.1 | 2.2 | 1.4 | 1.5 | 2.5 | 3.0 |
| QT-Interval | ||||||||
| (ms) | ±12 | 10 | -0.8 | 1.1 | -0.2 | 5.1 | 2.2 | 3.2 |
| Biological ECGs: CSE Database | ||||||||
| Standard | ACME | |||||||
| QED2000 | GE | |||||||
| MAC5500 | Philips | |||||||
| TC30 | ||||||||
| Mean | Standard | |||||||
| Deviation | Mean | Standard | ||||||
| Deviation | Mean | Standard | ||||||
| Deviation | Mean | Standard | ||||||
| Deviation | ||||||||
| PR-interval | ||||||||
| (ms) | ±10 | 10 | 0.7 | 7.4 | -4.2 | 4.5 | 2.9 | 6.1 |
| QRS-duration | ||||||||
| (ms) | ±10 | 10 | -0.3 | 8.3 | -5.6 | 5.2 | -3.2 | 3.8 |
| QT-Interval | ||||||||
| (ms) | ±25 | 30 | 4.9 | 11.5 | 0.5 | 8.3 | 0.9 | 7.9 |
12. Conclusion
Based on the performance testing and comparison with predicate devices, the results of the nonclinical testing, technical and functional characteristics demonstrate that the QED 2000 is substantially equivalent to the predicate devices and as safe as effective as the predicates.