(375 days)
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.
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.
Based on the provided text, the device in question is the Quantitative Electrocardiographic Detector (QED 2000), an electrocardiograph. The acceptance criteria and the study proving the device meets them are primarily described in Section 5, specifically in subsections 10 and 11, and further supported by Table 3.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
The document presents the device's performance against two types of ECGs: IEC calibration ECGs and Biological ECGs from the CSE Database. The acceptance criteria are "Standard" values provided in the "IEC 60601-2-25 Standard" column for IEC calibration ECGs and "Standard" column for Biological ECGs. The reported device performance is listed under "ACME QED2000".
| Metric (ms) | Acceptance Criteria (Mean ± SD) - IEC 60601-2-25 Standard | Reported Performance (ACME QED2000 Mean ± SD) |
|---|---|---|
| IEC calibration ECGs: | ||
| PR-interval | ±10 (Mean), 8 (SD) | 4.5 (Mean), 5.4 (SD) |
| QRS-duration | ±6 (Mean), 5 (SD) | -0.1 (Mean), 2.2 (SD) |
| QT-Interval | ±12 (Mean), 10 (SD) | -0.8 (Mean), 1.1 (SD) |
| Biological ECGs: CSE Database: | ||
| PR-interval | ±10 (Mean), 10 (SD) | 0.7 (Mean), 7.4 (SD) |
| QRS-duration | ±10 (Mean), 10 (SD) | -0.3 (Mean), 8.3 (SD) |
| QT-Interval | ±25 (Mean), 30 (SD) | 4.9 (Mean), 11.5 (SD) |
Interpretation of Table:
For all measured parameters (PR-interval, QRS-duration, QT-interval), the Mean and Standard Deviation of the ACME QED2000's measurements fall within or are superior to the specified standard acceptance criteria for both IEC calibration ECGs and Biological ECGs. For instance, for IEC calibration ECGs, the PR-interval "Standard" mean is ±10 and SD is 8, while the QED2000 showed a mean of 4.5 and SD of 5.4, indicating better or equivalent performance. Similar observations can be made for other parameters. This demonstrates that the device meets the defined performance standards.
2. Sample size used for the test set and the data provenance
The text refers to the use of "IEC calibration ECGs" and "Biological ECGs: CSE Database" for testing the algorithm. However, the specific sample size (number of ECGs/patients) for these test sets is not explicitly stated in the provided document.
Regarding data provenance:
- IEC calibration ECGs: These are standardized synthetic waveforms, not from human subjects directly, used for calibrating devices according to the IEC 60601-2-25 standard.
- Biological ECGs: CSE Database: This refers to the Common Standards for Quantitative Electrocardiography (CSE) Database. While the document doesn't explicitly state the country of origin or if it's retrospective/prospective, the CSE Database is a well-known, established and publicly available database for ECG research, typically comprised of retrospective human ECG data collected over time from various sources for standardization purposes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions that the QED2000's algorithm provides "data presentations, graphical presentations, and measurements" that are "presented for review and interpretation by a trained physician or clinician in determining a diagnosis..." However, the provided text does not specify the number of experts used to establish the ground truth for the test sets (IEC calibration ECGs or CSE Database), nor does it detail their qualifications. For the CSE database, ground truth is typically established by consensus of multiple cardiologists/electrophysiologists based on clinical findings, but this process is not described in this document for this specific study.
4. Adjudication method for the test set
The document does not explicitly state any adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth for the test sets. The ground truth for the IEC calibration ECGs is inherent in their design as reference signals. For the CSE Database, the ground truth is pre-established within the database itself, usually via expert consensus during its creation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The study described in this document is focused on the standalone performance of the QED2000's algorithm against established standards and predicate devices' algorithms. It does not mention or present any multi-reader multi-case (MRMC) comparative effectiveness study involving human readers with and without AI assistance. Therefore, no effect size of human improvement with AI assistance is provided.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone study was done. The performance data presented in Table 3 directly compares the QED2000's algorithm (ACME 12-lead ECG measurement algorithm) measurements against standard criteria and the results obtained from predicate devices' algorithms (Marquette 12SL ECG analysis program and Philips 12-lead ECG algorithm) on IEC calibration ECGs and Biological ECGs from the CSE Database. This is a direct evaluation of the algorithm's performance without human interaction in the measurement process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The types of ground truth used are:
- IEC calibration ECGs: These are synthetic reference standards, which act as a ground truth for measuring device accuracy.
- Biological ECGs: CSE Database: These are expert-annotated biological ECGs. The CSE database's ground truth annotations (measurements) were derived through a rigorous, often expert consensus-based, process during the database's creation. The document implies that the "Standard" values provided in Table 3 for the CSE database are considered the ground truth for comparison.
8. The sample size for the training set
The document does not provide any information regarding the sample size used for training the ACME 12-lead ECG measurement algorithm. This detail is not typically included in 510(k) summaries unless specific claims are made about the training process or dataset.
9. How the ground truth for the training set was established
The document does not provide any information on how the ground truth for the training set (if any, as the algorithm's development process is not detailed) was established.
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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.
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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 | ACMEQED2000 | GEMAC® 5500 HD | PhilipsPageWriter ® |
|---|---|---|---|
| 510(k) Number | K110266 | K113144 | |
| 510(k)Decision Date | 04/29/2011 | 04/03/2012 | |
| Manufacturer | Acme PortableMachine, Inc. | GE Medical SystemsInformation Technologies,Inc. | Philips Medical Systems |
| Classification | Electrocardiograph | Electrocardiograph | Electrocardiograph |
| Product Code | DPS | DPS | DPS |
| Regulation | 870.2340 | 870.2340 | 870.2340 |
| Indications forUse | The QED2000 isintended to be used toacquire, display,record, analyze, andstore 12-lead ECGwaveforms from adultpatients through bodysurface ECGelectrodes. Usingalgorithms to generatedata presentations,graphicalpresentations, andmeasurements forreview andinterpretation by atrained physician orclinician in determininga diagnosis basedupon knowledge of thepatient, the result ofphysical examination,and other relevantclinical findings.The QED2000 isintended to be used inhospital and generalphysician's office bytrained healthcareprofessionals. TheQED2000 is not | MAC 5500 HO: The MAC5500 HD ECG AnalysisSystem is intended toacquire, analyze, display,and recordelectrocardiographicinformation from adultand pediatric populations.Basic systems deliver 3;6, 12, or 15 lead ECGs;interpretive analysis,vector loops. and can beupgraded to providesoftware analysis optionssuch as high resolutionssignal averaging of QHSand P wave portions ofthe electrocardiogram.Transmission andreception of ECG data toand from a central ECGcardiovascularinformation system isoptional. The MAC 5500HD is intended to be usedunder the directsupervision, of a licensedhealthcare practitioner, bytrained operators in ahospital or medicalprofessional's facility. | To acquire multi-channelEGG signals from adultand pediatric patientsfrom body surfaceelectrodes and to record,display, analyze andstore these EGG signalsfor review by the user.To be used in healthcarefacilities by trainedhealthcareprofessionals. Analysisof the EGG signals isaccomplished withalgorithms accomplishedwith algorithms that thatprovide measurements,data presentations,graphical presentationsand interpretations forreview by the user.The interpreted EGGwith measurements andinterpretive statementsis offered to the clinicianon an advisory basisonly. It is to be used inconjunction withconjunction with theclinician's knowledge ofthe patient, the results of |
| intended to be used asa cardiac monitor. | the physicalexamination, the EGGtracings, and otherclinical findings. Aqualified physician isasked to over read andvalidate (or change)computer generatedECG interpretation. | ||
| DataAcquisition:Sampling Rate | 3000 sample/s | 4000 sample/s | 2000 sample/s |
| ECG Leads | 12 leads | 12 leads | 12 leads |
| Data EntryInterface | 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 baseSettings | 25, 50 mm/s | 5, 25, 50 mm/s | 25, 50 mm/s |
| FilterFrequency | 0.067 Hz40,100,150 Hz | 0.04 Hz40,100,150 Hz | 0.05 Hz40,100,150 Hz |
| Algorithms | ACME 12-lead ECGmeasurementalgorithm | Marquette 12SL ECGanalysis program | Phillips 12-lead ECGalgorithm |
| Display Type | Color TFT | Color TFT | Color TFT |
| Display PixelResolution | 1920 x 1080 | 800 x 480 | 640 x 480 |
| ElectricalSafety | Comply with IEC60601-1 | Same | Same |
| EMC | Comply with IEC60601-1-2 | Same | Same |
| Particularrequirements | Comply with IEC60601-2-25 | Same | Same |
Table 1 Comparison with Predicate Devices
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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.
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| Characteristic | ACMEQED2000 | GEMAC® 5500HD | PhilipsPageWriter ® |
|---|---|---|---|
| AlgorithmsName | ACME 12-lead ECGmeasurement algorithm | Marquette* 12SL* ECGAnalysis Program | Phillips 12-lead Algorithm |
| Analyze DataType | 12 leads 10 secondsunfiltered ECG data with1000 sampling rate | 12 leads 10 secondsunfiltered ECG data with500 sampling rate | 12 leads 10 secondsunfiltered ECG data with500 sampling rate |
| Measurementparameters | All 12 leads P, QRS, Tamplitudes and intervals.Global values with Heartrate, P duration, PRinterval, QRS duration,QT interval, QTc and P,QRS, T axes. | All 12 leads P, QRS, Tamplitudes andintervals. Global valueswith Heart rate, Pduration, PR interval,QRS duration, QTinterval, QTc and P,QRS, T axes. | All 12 leads P, QRS, Tamplitudes and intervals.Global values with Heartrate, 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 60601-2-25Standard | ACMEQED2000 | GEMAC5500 | PhilipsTC30 | |||||
| Mean | StandardDeviation | Mean | StandardDeviation | Mean | StandardDeviation | Mean | StandardDeviation | |
| 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 | ACMEQED2000 | GEMAC5500 | PhilipsTC30 | |||||
| Mean | StandardDeviation | Mean | StandardDeviation | Mean | StandardDeviation | Mean | StandardDeviation | |
| 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.
§ 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).