Quantitative Electrocardiographic Detector (QED 2000)
Device Facts
| Record ID | K152135 |
|---|---|
| Device Name | Quantitative Electrocardiographic Detector (QED 2000) |
| Applicant | Acme Portable Machines, Inc. |
| Product Code | DPS · Cardiovascular |
| Decision Date | Aug 9, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2340 |
| Device Class | Class 2 |
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.
Device Story
12-lead resting electrocardiograph; acquires, displays, analyzes, stores ECG signals from adult patients via body surface electrodes. Operated by trained healthcare professionals in hospitals/clinics. Input: 12-lead ECG signals (3000 samples/s). Processing: proprietary measurement algorithm generates data/graphical presentations and measurements (P, QRS, T amplitudes/intervals; heart rate; axes). Output: ECG reports via external/network printers; optional export to SD card/FTP/shared directory. Patient info entry via optional USB barcode/magnetic card scanner. Device provides advisory data for physician interpretation; not for cardiac monitoring. Benefits: facilitates diagnostic decision-making based on physical exam and clinical findings.
Clinical Evidence
Bench testing only. Performance validated against IEC 60601-2-25 standards using IEC calibration ECGs and CSE database biological ECGs. Metrics included mean and standard deviation for PR-interval, QRS-duration, and QT-interval. Results demonstrated compliance with established specifications and substantial equivalence to predicate devices.
Technological Characteristics
12-lead resting ECG; 3000 sample/s sampling rate; 0.067 Hz filter; 5, 10, 20 mm/mV gain; 25, 50 mm/s time base. Color TFT display (1920 x 1080). Connectivity: USB, network, SD card, FTP. Safety/EMC compliance: IEC 60601-1, EN 60601-1-2, IEC 60601-2-25, IEC 60601-2-27.
Indications for Use
Indicated for adult patients to acquire, display, record, analyze, and store 12-lead ECG waveforms via body surface electrodes. Used by trained healthcare professionals in hospitals and physician offices. Not intended for use as a cardiac monitor.
Regulatory Classification
Identification
An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.
Predicate Devices
Submission Summary (Full Text)
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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.
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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
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# 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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## 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.
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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<br>QED2000 | GE<br>MAC® 5500 HD | Philips<br>PageWriter ® |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K110266 | K113144 |
| 510(k)<br>Decision Date | | 04/29/2011 | 04/03/2012 |
| Manufacturer | Acme Portable<br>Machine, Inc. | GE Medical Systems<br>Information Technologies,<br>Inc. | Philips Medical Systems |
| Classification | Electrocardiograph | Electrocardiograph | Electrocardiograph |
| Product Code | DPS | DPS | DPS |
| Regulation | 870.2340 | 870.2340 | 870.2340 |
| Indications for<br>Use | The QED2000 is<br>intended to be used to<br>acquire, display,<br>record, analyze, and<br>store 12-lead ECG<br>waveforms from adult<br>patients through body<br>surface ECG<br>electrodes. Using<br>algorithms to generate<br>data presentations,<br>graphical<br>presentations, and<br>measurements for<br>review and<br>interpretation by a<br>trained physician or<br>clinician in determining<br>a diagnosis based<br>upon knowledge of the<br>patient, the result of<br>physical examination,<br>and other relevant<br>clinical findings.<br>The QED2000 is<br>intended to be used in<br>hospital and general<br>physician's office by<br>trained healthcare<br>professionals. The<br>QED2000 is not | MAC 5500 HO: The MAC<br>5500 HD ECG Analysis<br>System is intended to<br>acquire, analyze, display,<br>and record<br>electrocardiographic<br>information from adult<br>and pediatric populations.<br>Basic systems deliver 3;<br>6, 12, or 15 lead ECGs;<br>interpretive analysis,<br>vector loops. and can be<br>upgraded to provide<br>software analysis options<br>such as high resolutions<br>signal averaging of QHS<br>and P wave portions of<br>the electrocardiogram.<br>Transmission and<br>reception of ECG data to<br>and from a central ECG<br>cardiovascular<br>information system is<br>optional. The MAC 5500<br>HD is intended to be used<br>under the direct<br>supervision, of a licensed<br>healthcare practitioner, by<br>trained operators in a<br>hospital or medical<br>professional's facility. | To acquire multi-channel<br>EGG signals from adult<br>and pediatric patients<br>from body surface<br>electrodes and to record,<br>display, analyze and<br>store these EGG signals<br>for review by the user.<br>To be used in healthcare<br>facilities by trained<br>healthcare<br>professionals. Analysis<br>of the EGG signals is<br>accomplished with<br>algorithms accomplished<br>with algorithms that that<br>provide measurements,<br>data presentations,<br>graphical presentations<br>and interpretations for<br>review by the user.<br>The interpreted EGG<br>with measurements and<br>interpretive statements<br>is offered to the clinician<br>on an advisory basis<br>only. It is to be used in<br>conjunction with<br>conjunction with the<br>clinician's knowledge of<br>the patient, the results of |
| | intended to be used as<br>a cardiac monitor. | | the physical<br>examination, the EGG<br>tracings, and other<br>clinical findings. A<br>qualified physician is<br>asked to over read and<br>validate (or change)<br>computer generated<br>ECG interpretation. |
| Data<br>Acquisition:<br>Sampling Rate | 3000 sample/s | 4000 sample/s | 2000 sample/s |
| ECG Leads | 12 leads | 12 leads | 12 leads |
| Data Entry<br>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<br>Settings | 25, 50 mm/s | 5, 25, 50 mm/s | 25, 50 mm/s |
| Filter<br>Frequency | 0.067 Hz<br>40,100,150 Hz | 0.04 Hz<br>40,100,150 Hz | 0.05 Hz<br>40,100,150 Hz |
| Algorithms | ACME 12-lead ECG<br>measurement<br>algorithm | Marquette 12SL ECG<br>analysis program | Phillips 12-lead ECG<br>algorithm |
| Display Type | Color TFT | Color TFT | Color TFT |
| Display Pixel<br>Resolution | 1920 x 1080 | 800 x 480 | 640 x 480 |
| Electrical<br>Safety | Comply with IEC<br>60601-1 | Same | Same |
| EMC | Comply with IEC<br>60601-1-2 | Same | Same |
| Particular<br>requirements | Comply with IEC<br>60601-2-25 | Same | Same |
Table 1 Comparison with Predicate Devices
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### Note:
- 1. 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.
- 2. 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.
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| Characteristic | ACME<br>QED2000 | GE<br>MAC® 5500HD | Philips<br>PageWriter ® |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Algorithms<br>Name | ACME 12-lead ECG<br>measurement algorithm | Marquette* 12SL* ECG<br>Analysis Program | Phillips 12-lead Algorithm |
| Analyze Data<br>Type | 12 leads 10 seconds<br>unfiltered ECG data with<br>1000 sampling rate | 12 leads 10 seconds<br>unfiltered ECG data with<br>500 sampling rate | 12 leads 10 seconds<br>unfiltered ECG data with<br>500 sampling rate |
| Measurement<br>parameters | All 12 leads P, QRS, T<br>amplitudes and intervals.<br>Global values with Heart<br>rate, P duration, PR<br>interval, QRS duration,<br>QT interval, QTc and P,<br>QRS, T axes. | All 12 leads P, QRS, T<br>amplitudes and<br>intervals. Global values<br>with Heart rate, P<br>duration, PR interval,<br>QRS duration, QT<br>interval, QTc and P,<br>QRS, T axes. | All 12 leads P, QRS, T<br>amplitudes and intervals.<br>Global values with Heart<br>rate, P duration, PR interval,<br>QRS duration, QT interval,<br>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<br>Standard | | ACME<br>QED2000 | | GE<br>MAC5500 | | Philips<br>TC30 | |
| | Mean | Standard<br>Deviation | Mean | Standard<br>Deviation | Mean | Standard<br>Deviation | Mean | Standard<br>Deviation |
| PR-interval<br>(ms) | ±10 | 8 | 4.5 | 5.4 | -6.8 | 1.7 | -4.9 | 2.8 |
| QRS-duration<br>(ms) | ±6 | 5 | -0.1 | 2.2 | 1.4 | 1.5 | 2.5 | 3.0 |
| QT-Interval<br>(ms) | ±12 | 10 | -0.8 | 1.1 | -0.2 | 5.1 | 2.2 | 3.2 |
| Biological ECGs: CSE Database | | | | | | | | |
| | Standard | | ACME<br>QED2000 | | GE<br>MAC5500 | | Philips<br>TC30 | |
| | Mean | Standard<br>Deviation | Mean | Standard<br>Deviation | Mean | Standard<br>Deviation | Mean | Standard<br>Deviation |
| PR-interval<br>(ms) | ±10 | 10 | 0.7 | 7.4 | -4.2 | 4.5 | 2.9 | 6.1 |
| QRS-duration<br>(ms) | ±10 | 10 | -0.3 | 8.3 | -5.6 | 5.2 | -3.2 | 3.8 |
| QT-Interval<br>(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.
