Holter System

K151787 · Edan Instruments, Inc. · DQK · Jan 27, 2016 · Cardiovascular

Device Facts

• Record ID: K151787
• Device Name: Holter System
• Applicant: Edan Instruments, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Jan 27, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Pediatric

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: 1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2. Evaluation of patients for ST segment changes. 3. Evaluation of drug response in patients taking anti-arrhythmic medications. 4. Evaluation of patients with pacemakers.

Device Story

Holter system (SE-2003/SE-2012) records, analyzes, and reports ambulatory ECG data. Recorder (worn by patient) captures ECG signals via electrodes and stores data on removable SD flash card; SE-2003 (3-channel, 192-hour capacity) and SE-2012 (12-channel, 144-hour capacity). Data transferred to PC for analysis via Holter software. Software performs multi-channel beat detection, QRS classification, and arrhythmia detection; provides analysis for AFib/AFlut, ST segment, pacing, HRV, HRT, OSA, QT, TWA, VLP, and VCG. Used in clinical settings by trained personnel under physician direction. Results provided on advisory basis to assist physician interpretation. Benefits include diagnostic evaluation of cardiac symptoms and therapeutic monitoring.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing per IEC 60601-2-47.

Technological Characteristics

Holter recorder with 1.46-inch OLED, AAA battery power, SD flash card storage. Sampling rate 128-1024 Hz; 8, 12, 16, 18-bit A/D conversion; frequency response 0.05-60 Hz. Input impedance ≥20 MΩ. Patient contact materials comply with ISO 10993. Software performs automated ECG analysis. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-47.

Indications for Use

Indicated for adult and pediatric patients, including infants <10 kg, requiring ambulatory ECG monitoring for evaluation of symptoms suggesting arrhythmia or myocardial ischemia, ST segment changes, drug response to anti-arrhythmic medications, and pacemaker function.

Regulatory Classification

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.

Predicate Devices

• Mortara Instrument, Inc. H3+ (K043010)
• Mortara Instrument, Inc. H12+ (K050896)
• GE Healthcare, MARS Holter Analysis Workstation (K132437)
• North East Monitoring, Inc. DR300 Holter Monitor (K142424)
• CardioNet, Inc. Model CIN 1006 - CardioNet ECG Monitor with Arrhythmia Detection (K093288)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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:

- 1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
- 2. Evaluation of patients for ST segment changes.
- 3. Evaluation of drug response in patients taking anti-arrhythmic medications.
- 4. Evaluation of patients with pacemakers.

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|

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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.<br>3/F - B, Nanshan Medical<br>Equipments Park, Nanhai Rd 1019#,<br>Shekou, Nanshan Shenzhen,<br>518067 P.R. China<br>Tel: [phone]<br>Fax: [phone] |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Queena Chen |
| Preparing date: | December 29, 2015 |
| 2. Device name and<br>classification: | Device Name: Holter System, models SE-2003 and SE-2012<br>Classification Name/ Product code:<br>870.1425 Computer, Diagnostic, Programmable/DQK<br>870.2800 Electrocardiograph, Ambulatory (Without<br>Analysis)/MWJ<br>Regulatory Class: Class II |
| 3.Premarket<br>Notification Class III<br>Certification and<br>Summary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | 1) Mortara Instrument, Inc. H3+, K043010 (SE-2003)<br>2) Mortara Instrument, Inc. H12+, K050896 (SE-2012)<br>3) GE Healthcare, MARS Holter Analysis Workstation, K132437<br>4) North East Monitoring, Inc. DR300 Holter Monitor, K142424<br>5) CardioNet, Inc. Model CIN 1006 - CardioNet ECG Monitor with Arrhythmia Detection, K093288 |
| 5. Reason for<br>Submission | New Device. |
| 6. Pre-Submission,<br>IDE | Not applicable, there is no prior submission. |
| 7. Device Description: | The Holter System, composed of a Holter recorder and Holter<br>software, is designed to record and analyze continuous<br>long-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 24~144 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:

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.

- 2. Evaluation of patients for ST segment changes.
- 3. Evaluation of drug response in patients taking anti-arrhythmic medications.
- 4. 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<br>(Edan Instruments, Inc) | H3+<br>(Mortara Instrument, Inc) | Comparison<br>Result |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 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<br>(Edan Instruments, Inc) | H3+<br>(Mortara Instrument, Inc) | Comparison<br>Result |
| | The Holter System is<br>intended to be used by<br>trained personnel under the<br>direction of doctors. The<br>analysis results are offered to<br>doctors on an advisory basis<br>only. The Holter System is<br>intended for adult, pediatric<br>patients including infants<br>weighing less than 10 kg.<br>It is mainly used for (but not<br>limited to) the following<br>indications:<br>Evaluation of symptoms<br>suggesting arrhythmia or<br>myocardial ischemia. Evaluation of patients<br>for ST segment changes. Evaluation of drug<br>response in patients<br>taking anti-arrhythmic<br>medications. Evaluation of patients<br>with pacemakers. | (Holter) monitoring of 24<br>hours. The Mortara Holter<br>Recorder H3+ is not a<br>life-supporting device. It is<br>diagnostic tool intended to<br>acquire, record and store ECG<br>data of patients requiring<br>ambulatory (Holter)<br>monitoring of 24 or 48 hours.<br>Such monitoring is most<br>frequently used for the<br>purpose of prospective and<br>retrospective cardiac data and<br>arrhythmia analysis.<br>Holter analysis is appropriate<br>for the indications below:<br>Evaluation of adult<br>patients with symptoms<br>suggesting arrhythmia Evaluation of adult<br>patients with pacemakers Reporting of time domain<br>heart rate variability Evaluation of patients<br>response after resuming<br>occupational or<br>recreational activities<br>(e.g., after M.I. or cardiac<br>surgery.) Evaluation of ECG<br>documenting therapeutic<br>interventions in<br>individual patients or<br>groups of patients Clinical and<br>epidemiological research<br>studies Infant patient evaluation<br>is limited to QRS<br>detection only | |
| Energy | A single AAA alkaline | A single AAA alkaline battery | Same |
| Item | SE-2003<br>(Edan Instruments, Inc) | H3+<br>(Mortara Instrument, Inc) | Comparison<br>Result |
| used and/or<br>delivered | battery | | |
| Channels | 1,2,3-Channel | 2,3-Channel | Different |
| Leads | Channel 1, Channel 2,<br>Channel 3 | Channel 1, Channel 2,<br>Channel 3 | Same |
| Physical<br>Design | Length: 76 mm<br>Width: 49 mm<br>Thick: 16 mm<br>Weight: 50 g | Length: 64 mm<br>Width: 25 mm<br>Thick: 19 mm<br>Weight: 28 g | Different |
| Digital<br>Sampling<br>Rate | 128~1024 Hz | 180 Hz | Different |
| A/D<br>Conversion | 8, 12, 16, 18 bit | 12 bit | Different |
| Frequency<br>Response | 0.05 Hz ~60 Hz | 0.05 Hz ~60 Hz | Same |
| Input<br>impedance | ≥20 MΩ | ≥47 MΩ | Different |
| Safety<br>Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-47 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-47 | Same |
| Patient<br>Contact<br>Materials | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| Record<br>Times | 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<br>(Edan Instruments, Inc) | H12+<br>(Mortara Instrument, Inc) | Remark |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 510(k)<br>Number | Current Submission | K050896 | — |
| Indications<br>for Use | The SE-2003/SE-2012 Holter<br>System (including analysis<br>software and recorder) is<br>intended to record, analyze,<br>display, edit and generate<br>report of ambulatory ECG.<br>The Holter System is<br>intended to be used by trained | The H12+ is indicated for use<br>in a clinical setting, by<br>qualified medical<br>professionals only, for<br>recording ECG data of<br>patients requiring ambulatory<br>(Holter) monitoring of up to<br>48 hours. Such monitoring is | Different |
| Item | SE-2012 | H12+ | Remark |
| | (Edan Instruments, Inc) | (Mortara Instrument, Inc) | |
| | personnel under the direction<br>of doctors. The analysis<br>results are offered to doctors<br>on an advisory basis only. The<br>Holter System is intended for<br>adult, pediatric patients<br>including infants<br>weighing less than 10 kg.<br>It is mainly used for (but not<br>limited to) the following<br>indications:<br>Evaluation of symptoms<br>suggesting arrhythmia or<br>myocardial ischemia. Evaluation of patients for<br>ST segment changes. Evaluation of drug<br>response in patients<br>taking anti-arrhythmic<br>medications. Evaluation of patients<br>with pacemakers. | most frequently used for the<br>purpose of prospective and<br>retrospective cardiac data and<br>arrhythmia analysis.<br>Holter analysis is appropriate<br>for the indications below:<br>Evaluation of adult<br>patients with symptoms<br>suggesting arrhythmia or<br>myocardial ischemia. Evaluation of adult<br>patients for ST segment<br>changes Evaluation of adult<br>patients with pacemakers Reporting of time<br>domain heart rate<br>variability Evaluation of a patients<br>response after resuming<br>occupational or<br>recreational activities<br>(e.g., after MI. or cardiac<br>surgery.) Evaluation of ECG<br>documenting therapeutic<br>interventions in<br>individual patients or<br>groups of patients Clinical and<br>epidemiological research<br>studies Infant patient evaluation<br>is limited to QRS<br>detection only | |
| Energy<br>used and/or<br>delivered | 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,<br>V2, V3, V4, V5, V6 | I, II, III, aVR, aVL, aVF, V1,<br>V2, V3, V4, V5, V6 | Same |
| Physical | Length:76 mm | Length: 64 mm | Different |
| Item | SE-2012<br>(Edan Instruments, Inc) | H12+<br>(Mortara Instrument, Inc) | Remark |
| Design | Width:49 mm<br>Thick:16 mm<br>Weight: 50 g | Width:91 mm<br>Thick:25 mm<br>Weight: 125 g | |
| Digital<br>Sampling<br>Rate | 128~1024 Hz | 180 Hz | Different |
| A/D<br>Conversion | 8, 12, 16, 18 bit | 20 bit | Different |
| Frequency<br>Response | 0.05 Hz ~60 Hz | 0.05 Hz ~60 Hz | Same |
| Input<br>impedance | ≥20 MΩ | ≥47 MΩ | Different |
| Safety<br>Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-47 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-47 | Same |
| Patient<br>Contact<br>Materials | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| Record<br>Times | 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<br>(Edan Instruments, Inc) | MARS<br>(GE Healthcare) | Remark |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 510(k)<br>Number | Current Submission | K132437…