H3+ Holter Recorder

K152626 · Mortara Instrument, Inc. · MWJ · Feb 26, 2016 · Cardiovascular

Device Facts

• Record ID: K152626
• Device Name: H3+ Holter Recorder
• Applicant: Mortara Instrument, Inc.
• Product Code: MWJ · Cardiovascular
• Decision Date: Feb 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The H3+ Holter recorder is intended to acquire, record and store continuous ECG data as directed by a clinician from adult, adolescent, pediatric, infant and neonate patient populations for a maximum recording time of 14 days in a hospital, clinic or home environment. The H3+ is intended to be used with a compatible ambulatory ECG (Holter) analysis system which will analyze the recorded data. The H3+ data and the data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis. The H3+ Holter Recorder is not a life-supporting device.

Device Story

H3+ Holter Recorder is a small, lightweight, battery-powered device for continuous multi-day ECG data acquisition and storage. It features a graphic display for lead connection quality checks and waveform preview, and a patient-activated event button. The device records ECG data to internal non-volatile memory; data is subsequently transferred via USB to a compatible Holter analysis system (e.g., HScribe or Vision). It is operated by clinicians for patient hook-up and by patients for event marking. The recorded data is analyzed by external software and reviewed by medical personnel to assist in clinical diagnosis. The device provides pacemaker spike detection markers. It is not life-supporting.

Clinical Evidence

No clinical data was required to support substantial equivalence. Performance was verified through bench testing, software validation, and compliance with recognized international standards (IEC 60601-1, IEC 60601-2-47, IEC 60601-1-2, IEC 62304).

Technological Characteristics

Digital Holter recorder; 3-channel ECG acquisition; 180 sps sampling rate; 12-bit resolution; 6.25 uV amplitude resolution; internal flash memory storage; USB connectivity; powered by 1 AAA alkaline battery; graphic LCD display; 1-button keypad; compliant with IEC 60601-1, IEC 60601-2-47, and IEC 60601-1-2.

Indications for Use

Indicated for adult, adolescent, pediatric, infant, and neonate patients requiring continuous ECG monitoring for up to 14 days in hospital, clinic, or home settings.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Predicate Devices

• H3+ Holter Recorder (K043010)

Reference Devices

• HScribe (K004017)
• Vision (K945985)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 26, 2016

Mortara Instrument, Inc. Margaret Mucha Director of Global Regulatory Affairs 7865 North 86th St. Milwaukee, Wisconsin 53224

Re: K152626

Trade/Device Name: H3+ Holter Recorder Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MWJ Dated: December 22, 2015 Received: December 23, 2015

Dear Margaret Mucha:

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,

Mitchell Stein

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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#### Indications for Use

510(k) Number (if known) K152626

Device Name H3+ Holter Recorder

#### Indications for Use (Describe)

The H3+ Holter recorder is intended to acquire, record and store continuous ECG data as directed by a clinician from adult, adolescent, pediatric, infant and neonate patient populations for a maximum recording time of 14 days in a hospital, clinic or home environment. The H3+ performs no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system which will analyze the recorded data. The H3+ data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis. The H3+ Holter Recorder is not a life-supporting device.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-size: 16px;">☑</span> 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 Statement

## 1. Submitter

| Mortara Instrument, Inc.<br>7865 North 86th Street<br>Milwaukee, WI 53224 | Primary Contact<br>Margaret Mucha<br>Director of Global Regulatory<br>Affairs<br>[e-mail] |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Telephone [phone]<br>Fax [phone] | Secondary Contact<br>Eleanore Dias<br>Regulatory Specialist<br>[e-mail] |

#### 2. Product Names

Device Trade Name Common/ Usual Name Classification

H3+ Holter Recorder Holter Recorder Medical Magnetic Tape Recorder 870.2800 MWJ Cardiovascular

### 3. Predicate Device to which this is Substantially Equivalent

H3+ Holter Recorder

K043010

#### 1. Device Description

The H3+ Holter Recorder is part of a Holter Analysis system. The H3+ Holter Recorder provides multiple channels of continuous multi-day ECG data recording and pacemaker spike detection markers.

The H3+ Holter Recorder is extremely small and lightweight. The H3+ includes a display that allows the clinician to confirm patient identification, preview the waveform, and check the quality of lead connections during patient hook-up. The H3+ also has a patient activated event button which allows the insertion of event marks into the recorded data if directed by the clinician.

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The H3+ uses a single battery and stores acquired data in digital form on internal, non-volatile memory. Stored data is then imported for analysis at a compatible Holter analysis system [ e.g. HScribe (K004017) or Vision (K945985)]. The recorded data will remain in memory until it has been cleared by the clinician.

The data provided by H3+ to the Holter Analysis system is used by trained medical personnel to assist in the diagnosis of patient conditions.

#### 2. Intended Use

The H3+ Holter recorder is intended to acquire, record and store continuous ECG data as directed by a clinician from adult, adolescent, pediatric, infant and neonate patient populations for a maximum recording time of 14 days in a hospital, clinic or home environment. The H3+ is intended to be used with a compatible ambulatory ECG (Holter) analysis system which will analyze the recorded data. The H3+ data and the data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis.

The H3+ Holter Recorder is not a life-supporting device.

#### 3. Technological characteristics

The H3+ is employs the same functional scientific technology as its predicate device H3+ (K043010).

#### 4. Determination of Substantial Equivalence - Non-clinical

The H3+ was designed and tested for compliance with the applicable clauses of the following standards:

- . IEC 60601-1::2012 reprint) -- Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 62304:2006, Medical device software -- Software life cycle processes ●
- IEC 60601-2-47:2012, Medical Electrical Equipment -- Part 2-47: Particular . Requirements for the Basic Safety and Essential Performance of Ambulatory Electrocardiographic Systems. (Cardiovascular)
- IEC 60601-1-2: 2007, Medical Electrical Equipment part 1: 2. Electromagnetic ● Compatibility

The H3+ was designed and manufactured by Mortara Instrument according to 21 CFR Part 820. The H3+ has undergone software validation as well as performance verification and validation to ensure it meets all design inputs and performance requirements.

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# K152626

The H3+ is substantially equivalent to its predicate device H3+ (K043010) as shown in the table below.

| HOLTER<br>RECORDER<br>MODEL | Predicate Device | Current Device | Change<br>explanation |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| COMPANY | H3+ version 2.09<br>Mortara Instrument, Inc. | H3+ version 3.0.0<br>Mortara Instrument, Inc. | Identical |
| 510 (K)<br>Number | K043010 | Present Application | NA |
| Indications for<br>Use | The H3+ Holter recorder is<br>intended to acquire, record<br>and store up to 48 hours of<br>ECG data of patients that<br>have been connected to the<br>Mortara H3+ recorder and<br>are undergoing Holter<br>monitoring. The H3+<br>performs no cardiac analysis<br>by itself and is intended to be<br>used with the Mortara H-<br>Scribe Holter analysis<br>system(K0040170) or other<br>compatible Holter Analyzer.<br>ECG data prerecorded by the<br>H3+ is acquired and analyzed<br>by the H-Scribe. In turn the<br>cardiac data and analysis<br>provided by H-Scribe Holter<br>system will be reviewed,<br>confirmed, and used by<br>trained medical personnel in<br>the diagnosis of patients with<br>various rhythm patterns. | The H3+ Holter recorder is<br>intended to acquire, record<br>and store continuous ECG<br>data as directed by a<br>clinician from adult,<br>adolescent, pediatric, infant<br>and neonate patient<br>populations for a maximum<br>recording time of 14 days in<br>a hospital, clinic or home<br>environment. The H3+ is<br>intended to be used with a<br>compatible ambulatory ECG<br>(Holter) analysis system<br>which will analyze the<br>recorded<br>data. The H3+ data and the<br>data analysis are then<br>reviewed by trained medical<br>personnel for the purpose of<br>forming a clinical diagnosis.<br>The H3+ Holter Recorder is<br>not a life-supporting device. | Equivalent,<br>Indications<br>for use<br>updated to<br>include<br>patient<br>population<br>and use<br>environment |
| Type | Digital | Digital | Identical |
| Record<br>duration | 24 and 48 Hours | Up to 14 days | Equivalent<br>technology<br>but larger<br>storage<br>capacity |
| Recording<br>medium | Internal Flash Memory | Internal Flash Memory | Identical |
| Data transfer<br>method | Via USB port | Via USB port | Identical |
| Signal<br>compression | Yes | Yes | Identical |
| Channels | 2 or 3 | 3 | Identical<br>equivalent,<br>removed 2-<br>channel<br>functionality |
| sampling rate | 180 sps | 180 sps | Identical |
| Frequency<br>Response | Meets the requirements of<br>ANSI/AAMI EC38 | Meets the requirements of<br>IEC 60601-2-47 | equivalent |
| HOLTER<br>RECORDER<br>MODEL | Predicate Device<br>H3+ version 2.09 | Current Device<br>H3+ version 3.0.0 | Change<br>explanation |
| Dynamic<br>Range<br>Amplitude (or<br>Digital)<br>Resolution | 12-bit | 12-bit | Identical |
| | 6.25 uV | 6.25 uV | Identical |
| Setup<br>ECG Channel<br>preview | With the graphic display and<br>Enter key / Automatic start<br>after 10 minutes | With the graphic display and<br>Enter key / Automatic start<br>after 10 minutes | Identical |
| | Yes | Yes | Identical<br>equivalent,<br>removed 2-<br>channel<br>functionality |
| Cable | 2-Channel 5-wires or 3-<br>Channel 5-wires | 3-Channel 5-wires | |
| Test Cable | No | No | Identical |
| Impedance<br>measurement | No | No | Identical |
| Power | 1 AAA Alkaline battery up to<br>48 H | 1 AAA Alkaline battery up to<br>14 days | equivalent |
| Pacemaker<br>Detection | Yes | Yes | Identical |
| Display | Graphic LCD | Graphic LCD | Identical |
| Time Displayed | Yes | Yes | Identical |
| Carrying Case | Pouch with Belt clip & strap | Pouch with Belt clip or single-<br>use pouch | Identical<br>reusable<br>pouch; added<br>disposable<br>pouch |
| Keyboard | 1-button keypad | 1-button keypad | Identical |
| Sound | No | No | Identical |
| Patient Event<br>Marker | Yes | Yes | Identical |
| Replay and<br>Analysis<br>system | H-Scribe | HScribe and Vision | equivalent-<br>added H3+<br>support in the<br>Vision<br>product |
| Weight | 28 grams | 28 grams | Identical |

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## 5. Determination of Substantial Equivalence – Clinical

The subject of this premarket notification did not require clinical data to support substantial equivalence

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#### 6. Conclusion

The H3+ Holter Recorder is now able to store data from ambulatory recordings for a maximum of 14 days whereas the previous version of H3+ could only store data for 24 to 48 hours. This change required an updated intended use which is reflected in this submission. Other changes that were incorporated into the H3+ include removal of the 2 channel 5 wires option, compatibility with HScribe and Vision Holter Analysis Systems, updated hardware components that meet the EU Restriction of Hazardous Substances Directive, addition of a Holter Prep kit and single use pouch to the list of accessories, and an added log file for service support for device use if needed.

Mortara has determined these changes did not impact the safety and efficacy of the H3+ Holter recorder. The H3+ Holter Recorder performance is substantially equivalent to the predicate device.