(210 days)
The SE-2003/SE-2012 Holter System (including recorder and analysis software) is intended to record, analyze, display, edit and generate report of ambulatory ECG. The Holter System is intended to be used by trained personnel under the direction of doctors. The analysis results are offered to doctors on an advisory basis only. The Holter System is intended for adult, pediatric patients including infants weighing less than 10 kg.
It can be used for the following indications:
-
- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
-
- Evaluation of patients for ST segment changes.
-
- Evaluation of drug response in patients taking anti-arrhythmic medications.
-
- Evaluation of patients with pacemakers.
The Holter System, composed of a Holter recorder and Holter software, is designed to record and analyze continuous long-time (24-192 hours) ECG data. The Holter recorder contains lead wires and removable SD flash card to record ECG signals. The Holter software is installed in generally used PC to analyze recorded ECG data from Holter recorder. Typical recording time of Holter recorder powered by one AAA size battery with removable SD flash card is more than 24 hours up to 192 hours. Recorders are carried around by patients with a set of electrodes arranged by certain rules on them which are connected to recorders by lead wires. Patients are requested to come back to medical treatment site after recording time. The ECG data recorded in Holter recorders will be transferred into PCs and then analyzed, displayed and edited with the Holter software. An analysis report may be finally generated.
The provided text is a 510(k) Summary for the Edan Instruments, Inc. Holter System, models SE-2003 and SE-2012. It discusses the substantial equivalence to predicate devices and presents non-clinical performance data.
However, the document does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes for test and training sets for algorithmic performance, expert qualifications for ground truth, or adjudication methods that would typically be found in a study proving a device meets acceptance criteria for an AI/algorithm-driven device.
The "Performance Data" section details non-clinical testing related to safety (biocompatibility, electrical safety, EMC) and software verification/validation, but not the clinical performance of the Holter system's analytical capabilities in terms of accuracy for rhythm or other ECG interpretations.
Therefore, many of the requested items cannot be extracted from the provided text.
Based on the available information, here's what can be provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection) of the device's analytical software. It only states that "all the results show pass" for bench testing and compliance with safety and EMC standards.
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility (ISO 10993-1) | All required tests passed. |
| Electrical Safety (IEC 60601-1:2005/A1: 2012) | Complies with the standard. |
| EMC (IEC 60601-1-2: 2007) | Complies with the standard. |
| Bench Testing (IEC 60601-2-47: 2012) | All results show pass. |
| Software Verification & Validation | Conducted and documented per FDA guidance; considered "moderate" level of concern. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document. The document states "Clinical data: Not applicable."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in the document.
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
Not provided in the document. The document states "Clinical data: Not applicable." This suggests no such clinical study was conducted or submitted for this 510(k).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not provide details on standalone algorithmic performance. It indicates that the "analysis results are offered to doctors on an advisory basis only," which implies a human-in-the-loop scenario, but does not quantify the algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not provided in the document.
8. The sample size for the training set
Not provided in the document.
9. How the ground truth for the training set was established
Not provided in the document.
Summary of what is present in the document versus what is requested for AI/algorithmic device evaluation:
The provided document focuses on demonstrating substantial equivalence primarily through comparisons of technical specifications and non-clinical safety testing (biocompatibility, electrical safety, EMC, and general software verification/validation) against predicate devices. It does not contain the detailed performance data for the analytical software's diagnostic capabilities that would be expected for a comprehensive evaluation of an AI-driven or algorithm-driven medical device, especially regarding its accuracy in ECG interpretation. The statement "Clinical data: Not applicable" confirms the absence of a clinical study assessing the device's diagnostic performance in patients.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2016
Edan Instruments, Inc. % Mr. Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Ave., Suite 200 Sunnyvale, California 94086
Re: K151787
Trade/Device Name: Holter System, models SE-2003 and SE-2012 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, MWJ Dated: December 29, 2015 Received: January 4, 2016
Dear Mr. Worth:
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
{1}------------------------------------------------
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.
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,
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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Indications for Use
510(k) Number (if known) K151787
Device Name
Holter System, models SE-2003 and SE-2012
Indications for Use (Describe)
The SE-2003/SE-2012 Holter System (including recorder and analysis software) is intended to record, analyze, display, edit and generate report of ambulatory ECG. The Holter System is intended to be used by trained personnel under the direction of doctors. The analysis results are offered to doctors on an advisory basis only. The Holter System is intended for adult, pediatric patients including infants weighing less than 10 kg.
It can be used for the following indications:
-
- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
-
- Evaluation of patients for ST segment changes.
-
- Evaluation of drug response in patients taking anti-arrhythmic medications.
-
- Evaluation of patients with pacemakers.
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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510(K) Summary
Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc.3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,Shekou, Nanshan Shenzhen,518067 P.R. ChinaTel: +86(0755) 26858736Fax: +1 (408) 418-4059 |
|---|---|
| Contact person: | Queena Chen |
| Preparing date: | December 29, 2015 |
| 2. Device name andclassification: | Device Name: Holter System, models SE-2003 and SE-2012Classification Name/ Product code:870.1425 Computer, Diagnostic, Programmable/DQK870.2800 Electrocardiograph, Ambulatory (WithoutAnalysis)/MWJRegulatory Class: Class II |
| 3.PremarketNotification Class IIICertification andSummary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | 1) Mortara Instrument, Inc. H3+, K043010 (SE-2003)2) Mortara Instrument, Inc. H12+, K050896 (SE-2012)3) GE Healthcare, MARS Holter Analysis Workstation, K1324374) North East Monitoring, Inc. DR300 Holter Monitor, K1424245) CardioNet, Inc. Model CIN 1006 - CardioNet ECG Monitor with Arrhythmia Detection, K093288 |
| 5. Reason forSubmission | New Device. |
| 6. Pre-Submission,IDE | Not applicable, there is no prior submission. |
| 7. Device Description: | The Holter System, composed of a Holter recorder and Holtersoftware, is designed to record and analyze continuouslong-time (24-192 hours) ECG data. The Holter recorder |
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contains lead wires and removable SD flash card to record ECG signals. The Holter software is installed in generally used PC to analyze recorded ECG data from Holter recorder. Typical recording time of Holter recorder powered by one AAA size battery with removable SD flash card is more than 24 hours up to 192 hours. Recorders are carried around by patients with a set of electrodes arranged by certain rules on them which are connected to recorders by lead wires. Patients are requested to come back to medical treatment site after recording time. The ECG data recorded in Holter recorders will be transferred into PCs and then analyzed, displayed and edited with the Holter software. An analysis report may be finally generated. The introduction of the Holter recorder and Holter software is as follows:
- Holter recorder has two models, the SE-2003 and SE-2012 with the same performance such as sampling rate, analog-to-digital converter (ADC), filter and so on. The only two differences is the number of channels of ECG Waveform and the recording time: SE-2003 is a three channel ECG with 5 or 7 Electrodes cable, with a 192-hour recording capability, and SE-2012 is a twelve channel ECG with 10 Electrodes cable,with a 144-hour recording capability. Both Holter recorders have the following functions:
- Digital Sampling Rate 128~1024 Hz
- Frequency Response 0.05 ~60Hz
- A/D Conversion 8, 12, 16, 18bit
- Record Times of the SE-2003 are 24
192 hours, and SE-2012 are 24144 hours 1.46 inch OLED
Holter software has the following functions:
- Supporting multi-channel beat detection
- Accurate classification of QRS morphology
- Supporting automatic detection of arrhythmia
- Supporting re-analysis
- Strips can be reviewed, edited and saved
- Supporting full disclosure
- Analysis functions including Template, Events, Atrial Fibrillation/ Atrial Flutter (AFib/AFlut), Strips, ST
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analysis, Pacing analysis, Heart Rate Variability (HRV) analysis. Heart Rate Turbulence (HRT) analysis. Obstructive Sleep Apnea (OSA) analysis, QT analysis, The Alternans of T Wave (TWA) analysis, Waterfall analysis, Ventricular Late Potential (VLP) analysis and Vector ECG (VCG) analysis.
- Supporting creating or modifying scenarios or function pages
8. Intended Use: The SE-2003/SE-2012 Holter System (including recorder and analysis software) is intended to record, analyze, display, edit and generate report of ambulatory ECG. The Holter System is intended to be used by trained personnel under the direction of doctors. The analysis results are offered to doctors on an advisory basis only. The Holter System is intended for adult, pediatric patients including infants weighing less than 10 kg.
It can be used for the following indications:
- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
-
- Evaluation of patients for ST segment changes.
-
- Evaluation of drug response in patients taking anti-arrhythmic medications.
-
- Evaluation of patients with pacemakers.
9. Predicate Device Comparison
The subject devices share the same characteristics in all items with the predicate device, concluding from using the same technology and principle. All the technological differences existed between the subject and predicate devices are only some performance parameters items, detailed comparison can be found in the following tables.
| Item | SE-2003(Edan Instruments, Inc) | H3+(Mortara Instrument, Inc) | ComparisonResult |
|---|---|---|---|
| 510(k) Number | Current Submission | K043010 | — |
| Indications for Use | The SE-2003/SE-2012 Holter System (including analysis software and recorder) is intended to record, analyze, display, edit and generate report of ambulatory ECG. | The H3+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory | Different |
| Item | SE-2003(Edan Instruments, Inc) | H3+(Mortara Instrument, Inc) | ComparisonResult |
| The Holter System isintended to be used bytrained personnel under thedirection of doctors. Theanalysis results are offered todoctors on an advisory basisonly. The Holter System isintended for adult, pediatricpatients including infantsweighing less than 10 kg.It is mainly used for (but notlimited to) the followingindications:Evaluation of symptomssuggesting arrhythmia ormyocardial ischemia. Evaluation of patientsfor ST segment changes. Evaluation of drugresponse in patientstaking anti-arrhythmicmedications. Evaluation of patientswith pacemakers. | (Holter) monitoring of 24hours. The Mortara HolterRecorder H3+ is not alife-supporting device. It isdiagnostic tool intended toacquire, record and store ECGdata of patients requiringambulatory (Holter)monitoring of 24 or 48 hours.Such monitoring is mostfrequently used for thepurpose of prospective andretrospective cardiac data andarrhythmia analysis.Holter analysis is appropriatefor the indications below:Evaluation of adultpatients with symptomssuggesting arrhythmia Evaluation of adultpatients with pacemakers Reporting of time domainheart rate variability Evaluation of patientsresponse after resumingoccupational orrecreational activities(e.g., after M.I. or cardiacsurgery.) Evaluation of ECGdocumenting therapeuticinterventions inindividual patients orgroups of patients Clinical andepidemiological researchstudies Infant patient evaluationis limited to QRSdetection only | ||
| Energy | A single AAA alkaline | A single AAA alkaline battery | Same |
| Item | SE-2003(Edan Instruments, Inc) | H3+(Mortara Instrument, Inc) | ComparisonResult |
| used and/ordelivered | battery | ||
| Channels | 1,2,3-Channel | 2,3-Channel | Different |
| Leads | Channel 1, Channel 2,Channel 3 | Channel 1, Channel 2,Channel 3 | Same |
| PhysicalDesign | Length: 76 mmWidth: 49 mmThick: 16 mmWeight: 50 g | Length: 64 mmWidth: 25 mmThick: 19 mmWeight: 28 g | Different |
| DigitalSamplingRate | 128~1024 Hz | 180 Hz | Different |
| A/DConversion | 8, 12, 16, 18 bit | 12 bit | Different |
| FrequencyResponse | 0.05 Hz ~60 Hz | 0.05 Hz ~60 Hz | Same |
| Inputimpedance | ≥20 MΩ | ≥47 MΩ | Different |
| SafetyStandards | IEC 60601-1IEC 60601-1-2IEC 60601-2-47 | IEC 60601-1IEC 60601-1-2IEC 60601-2-47 | Same |
| PatientContactMaterials | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| RecordTimes | 24~192 hours | 24~48 hours | Different |
Table 1: Comparison to Predicate Device(s) between SE-2003 and H3+
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Table 2: Comparison to Predicate Device(s) between SE-2012 and H12+
| Item | SE-2012(Edan Instruments, Inc) | H12+(Mortara Instrument, Inc) | Remark |
|---|---|---|---|
| 510(k)Number | Current Submission | K050896 | — |
| Indicationsfor Use | The SE-2003/SE-2012 HolterSystem (including analysissoftware and recorder) isintended to record, analyze,display, edit and generatereport of ambulatory ECG.The Holter System isintended to be used by trained | The H12+ is indicated for usein a clinical setting, byqualified medicalprofessionals only, forrecording ECG data ofpatients requiring ambulatory(Holter) monitoring of up to48 hours. Such monitoring is | Different |
| Item | SE-2012 | H12+ | Remark |
| (Edan Instruments, Inc) | (Mortara Instrument, Inc) | ||
| personnel under the directionof doctors. The analysisresults are offered to doctorson an advisory basis only. TheHolter System is intended foradult, pediatric patientsincluding infantsweighing less than 10 kg.It is mainly used for (but notlimited to) the followingindications:Evaluation of symptomssuggesting arrhythmia ormyocardial ischemia. Evaluation of patients forST segment changes. Evaluation of drugresponse in patientstaking anti-arrhythmicmedications. Evaluation of patientswith pacemakers. | most frequently used for thepurpose of prospective andretrospective cardiac data andarrhythmia analysis.Holter analysis is appropriatefor the indications below:Evaluation of adultpatients with symptomssuggesting arrhythmia ormyocardial ischemia. Evaluation of adultpatients for ST segmentchanges Evaluation of adultpatients with pacemakers Reporting of timedomain heart ratevariability Evaluation of a patientsresponse after resumingoccupational orrecreational activities(e.g., after MI. or cardiacsurgery.) Evaluation of ECGdocumenting therapeuticinterventions inindividual patients orgroups of patients Clinical andepidemiological researchstudies Infant patient evaluationis limited to QRSdetection only | ||
| Energyused and/ordelivered | A single AAA alkaline battery | A single AA alkaline battery | Different |
| Channels | 12 Channel | 12 Channel | Same |
| Leads | I, II, III, aVR, aVL, aVF, V1,V2, V3, V4, V5, V6 | I, II, III, aVR, aVL, aVF, V1,V2, V3, V4, V5, V6 | Same |
| Physical | Length:76 mm | Length: 64 mm | Different |
| Item | SE-2012(Edan Instruments, Inc) | H12+(Mortara Instrument, Inc) | Remark |
| Design | Width:49 mmThick:16 mmWeight: 50 g | Width:91 mmThick:25 mmWeight: 125 g | |
| DigitalSamplingRate | 128~1024 Hz | 180 Hz | Different |
| A/DConversion | 8, 12, 16, 18 bit | 20 bit | Different |
| FrequencyResponse | 0.05 Hz ~60 Hz | 0.05 Hz ~60 Hz | Same |
| Inputimpedance | ≥20 MΩ | ≥47 MΩ | Different |
| SafetyStandards | IEC 60601-1IEC 60601-1-2IEC 60601-2-47 | IEC 60601-1IEC 60601-1-2IEC 60601-2-47 | Same |
| PatientContactMaterials | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| RecordTimes | 24~144 hours | 24~48 hours | Different |
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Table 3: Comparison to Predicate Device(s) between Holter analysis software and the MARS
| Item | Holter Analysis Software(Edan Instruments, Inc) | MARS(GE Healthcare) | Remark |
|---|---|---|---|
| 510(k)Number | Current Submission | K132437 | — |
| Indications forUse | The SE-2003/SE-2012Holter System (includinganalysis software andrecorder) is intended torecord, analyze, display, editand generate report ofambulatory ECG. The HolterSystem is intended to beused by trained personnelunder the direction ofdoctors. The analysis resultsare offered to doctors on anadvisory basis only. TheHolter System is intendedfor adult, pediatric patients | MARS Holter AnalysisWorkstation is designed foracquisition, analysis, edit,review, report and storage ofambulatory EGG andmulti-parameter data. Resultsof the automated analysis areintended to assist thephysician in the interpretationof the recorded data. Thisinformation is not intended toserve as a substitute for thephysician overread of therecorded EGG data. TheMARS Holter Analysis | Different |
| Item | Holter Analysis Software(Edan Instruments, Inc) | MARS(GE Healthcare) | Remark |
| including infantsweighing less than 10 kg.It is mainly used for (but notlimited to) the followingindications:Evaluation of symptomssuggesting arrhythmiaor myocardial ischemia. Evaluation of patientsfor ST segmentchanges. Evaluation of drugresponse in patientstaking anti-arrhythmicmedications. Evaluation of patientswith pacemakers. | Workstation is intended to beused by trained operatorsunder the direct supervisionof a licensed healthcarepractitioner in a hospital orclinic environment. Patientpopulation includes bothadult and pediatric (greaterthan 10Kg) human patients.The MARS Holter AnalysisWorkstation provides the userarrhythmia studies and Holteranalysis capabilities.Data acquired may be usedfor the following indications:Evaluation of symptomsthat may be caused bycardiac arrhythmiaand/or conductiondisturbances Evaluation of symptomsthat may be due tomyocardial ischemia Detection of EGG eventsthat alter prognosis incertain forms of heartdisease Detection and analysis ofpacemaker function andfailure Determination of cardiacresponse to lifestyle Evaluation of therapeuticinterventions Investigations inepidemiology andclinical trials | ||
| ReviewModes | Strip review, Templatereview, Event review,Trend reviewer, Tabularand Page review | Strip review, Templatereview, Event review, Trendreviewer, and Page review | Different |
| Trend Graphs | HR, RR, ST, SVE, VE, | HR, RR, ST, SVE, VE | Different |
| Item | Holter Analysis Software(Edan Instruments, Inc) | MARS(GE Healthcare) | Remark |
| SDNN | |||
| RhythmAnalysis | Bradycardia, Tachycardia,Ventricular pairs,Ventricular tachycardia,Supraventricular pairs,Long R-R interval, Pause,Min/max heart rate, STdepression, ST elevation | Bradycardia, Tachycardia,Ventricular pairs,Ventricular tachycardia,Supraventricular pairs, LongR-R interval, Pause,Min/max heart rate,STdepression, ST elevation | Same |
| ST SegmentMeasurement | 3/12 lead ST segmentmeasurement, max STdepression, max STelevation, 3/12 lead trends | 3/12 lead ST segmentmeasurement, max STdepression, max STelevation, 3/12 lead trends | Same |
| PacemakerAnalysis | Atrial, ventricular and dualpacemaker detection;capture failure, Outputfailure, undersensing | Atrial, ventricular and dualpacemaker detection;capture failure, Outputfailure, undersensing | Same |
| QT analysis | QT Measurement | QT Measurement | Same |
| HRV analysis | Frequency domainanalysis, Time domainanalysis | Frequency domain analysis,Time domain analysis | Same |
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Table 4: Comparison to Predicate Device(s) between Holter analysis software and the DR300
| Item | Holter Analysis Recorder &Software(Edan Instruments, Inc) | DR300North East Monitoring | Remark |
|---|---|---|---|
| 510(k)Number | Current Submission | K142424 | |
| Indicationsfor Use | The SE-2003/SE-2012 HolterSystem (including analysissoftware and recorder) isintended to record, analyze,display, edit and generate reportof ambulatory ECG. The HolterSystem is intended to be used bytrained personnel under thedirection of doctors. Theanalysis results are offered todoctors on an advisory basisonly. The Holter System isintended for adult, pediatricpatients including infants | Holter Mode: Detection ofArrhythmias, Efficacy ofPharmacological Treatmentand Pacemaker Evaluation.Event Recorder: The eventrecorder module is a patientactivated device designedto record and for diagnosticevaluation of transientsymptoms (such asdizziness, palpitations,syncope, and chest pain).Once data is recorded, the | Different |
| Item | Holter Analysis Recorder &Software(Edan Instruments, Inc) | DR300North East Monitoring | Remark |
| weighing less than 10 kg.It is mainly used for (but notlimited to) the followingindications:● Evaluation of symptomssuggesting arrhythmia ormyocardial ischemia.● Evaluation of patients forST segment changes.● Evaluation of drug responsein patients takinganti-arrhythmicmedications.● Evaluation of patients withpacemakers. | data is transmitted forevaluation. | ||
| TargetPopulation | for adult, pediatric patientsincluding infants weighing lessthan 10 kg | patients (including infantsweighing less than 10 kg)who may benefit fromsuch monitoring | Same |
| Energyused and/ordelivered | A single AAA alkaline battery | A single AA battery | Different |
| PhysicalDesign | Length:76 mmWidth:49 mmThick:16 mmWeight: 50 g | Length 86mm (3.9in)Width: 60mm (2.4in)Thick: 20mm (0.8in)Weight: 70.9g (2.5 oz) | Different |
| DigitalSamplingRate | 128~1024 Hz | 180 Hz | Different |
| A/DConversion | 8, 12, 16, 18 bit | 12 bit | Different |
| FrequencyResponse | 0.05 Hz ~60 Hz | 0.05 – 70 Hz | Different |
| RecordTimes | 24~144 hours | 336 hours | Different |
| Item | Holter Analysis Recorder &Software(Edan Instruments, Inc) | CIN 1006 - CardioNetECG Monitor(CardioNet Inc.) | Remark |
| 510(k)Number | Current Submission | K093288 | |
| Indicationsfor Use | The SE-2003/SE-2012 HolterSystem (including analysissoftware and recorder) isintended to record, analyze,display, edit and generatereport of ambulatory ECG.The Holter System is intendedto be used by trainedpersonnel under the directionof doctors. The analysis resultsare offered to doctors on anadvisory basis only. TheHolter System is intended foradult, pediatric patientsincluding infants weighingless than 10 kg.It is mainly used for (but notlimited to) the followingindications:● Evaluation of symptomssuggesting arrhythmia ormyocardial ischemia.● Evaluation of patients forST segment changes.● Evaluation of drugresponse in patientstaking anti-arrhythmicmedications.● Evaluation of patientswith pacemakers.● Evaluation of patientswith obstructive sleepapnea to evaluate possiblenocturnal arrhythmias. | The CardioNetAmbulatoryECGGMonitorwith Arrhythmia Detectionintended use is for:1. Patients who have ademonstrated need forcardiac Monitoring. Thesemay include but are notlimited to patients whorequire Monitoring for: a)non-life threateningarrhythmias such assupraventriculartachycardias (e.g. atrialfibrillation, atrial flutter,PACS, PSVT) andventricular ectopy; b)evaluation ofbradyarrhythmias andintermittent bundle branchblock, including aftercardiovascular surgery andmyocardial infarction; andc) arrhythmias associatedwith co-morbid conditionssuch as hyperthyroidism orchronic lung disease.2. Patients with symptomsthat may be due to cardiacarrhythmias. These mayinclude but are not limitedto symptoms such as: a)dizziness orlightheadedness; b)syncope of unknownetiology in whicharrhythmias are suspected orneed to be excluded; c)dyspnea (shortness of | Different |
| Item | Holter Analysis Recorder &Software(Edan Instruments, Inc) | CIN 1006 - CardioNetECG Monitor(CardioNet Inc.) | Remark |
| breath).3. Patients with palpitationswith or without knownarrhythmias to obtaincorrelation of rhythm withsymptoms.4. Patients who requireoutpatient monitoring ofantiarrhythmic therapy: a)Monitoring of therapeuticand potential proarrhythmiceffects of membrane activedrugs, b) Monitoring ofeffect of drugs to controlventricular rate in variousatrial arrhythmias (e.g. atria]fibrillation).5. Patients recovering fromcardiac surgery who areindicated for outpatientarrhythmia Monitoring.6. Patients with diagnosedsleep disordered breathingincluding sleep apnea(obstructive, central) toevaluate possible nocturnalarrhythmias7. Patients requiringarrhythmia evaluation ofetiology of stroke ortransient cerebral ischemia,possibly secondary to atrialfibrillation or atrial flutter.8. Patients requiringmeasurement, analysis andreporting of QT interval,excluding patients with adocumented history ofsustained atrial fibrillationor atrial flutter | |||
| Item | Holter Analysis Recorder &Software(Edan Instruments, Inc) | CIN 1006 - CardioNetECG Monitor(CardioNet Inc.) | Remark |
| RecordTimes | 24~144 hours | monitoring for potentialarrhythmias based on riskfactors (e.g. atrialfibrillation).10. Patients requiringmeasurement of ST segmentchanges. The device is notintended to sound anyalarms for ST segmentchanges.720 hours | Different |
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Table 5: Comparison to Predicate Device between Holter analysis software and CIN 1006 - CardioNet ECG Monitor
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All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion.
10. Performance Data:
Non-clinical data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Holter System were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests:
- Σ Cytotoxicity
- Σ Skin Sensitization
- Σ Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Holter System, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012 and the IEC 60601-1-2: 2007 standard for EMC.
Bench Testing
Bench testing was conducted per IEC 60601-2-47: 2012, and all the results show pass.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was
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provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software will not directly result in serious injury or death to the patient or operator, and the software device is an accessory to a medical device that has a Moderate Level of Concern.
Clinical data: Not applicable.
Summary
Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.
11. Conclusion
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the Holter System device should perform as intended in the specified use conditions, and all the data demonstrate that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use. In other words, the subject Holter System devices are substantially equivalent to the predicate devices.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).