(164 days)
No
The device description explicitly states that the H3+ Holter recorder performs no analysis by itself and is intended to be used with a separate analysis system. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".
No
Explanation: The H3+ Holter recorder is intended to acquire, record, and store continuous ECG data for diagnosis and performs no analysis by itself, nor does it provide therapy. It is used with an analysis system which then aids trained medical personnel in forming a clinical diagnosis.
Yes
The device, combined with a compatible analysis system, is used to acquire, record, and store continuous ECG data, which is then analyzed by medical personnel to form a clinical diagnosis.
No
The device description explicitly states it is a "Holter Recorder" and describes physical components like a display, patient activated event button, battery, and internal memory, indicating it is a hardware device that records ECG data.
Based on the provided information, the H3+ Holter recorder is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- H3+ Function: The H3+ Holter recorder acquires, records, and stores ECG data, which is electrical activity from the heart. This is a physiological measurement taken directly from the patient's body, not an analysis of a biological specimen.
- Analysis System: The description explicitly states that the H3+ performs no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system. The analysis, which contributes to the diagnostic process, is performed by a separate device.
Therefore, the H3+ Holter recorder is a device that collects physiological data from a patient, which is then analyzed by a separate system. This falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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+ 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.
Product codes
MWJ
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, adolescent, pediatric, infant and neonate patient populations
Intended User / Care Setting
hospital, clinic or home environment. The H3+ data and the data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket notification did not require clinical data to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other, with flowing lines extending from the bottom profile.
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
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,
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows a white heart shape inside of a blue square. The heart shape is formed by two curved lines that meet at the bottom and extend upwards to form the top of the heart. Below the image is the text "K152626".
Section 5
510(k) Summary Statement
1. Submitter
| Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224 | Primary Contact
Margaret Mucha
Director of Global Regulatory
Affairs
meg.mucha@mortara.com |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Telephone 414-354-1600
Fax 414-354-4760 | Secondary Contact
Eleanore Dias
Regulatory Specialist
eleanore.dias@mortara.com |
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
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.
4
Image /page/4/Picture/0 description: The image shows a blue and white heart-shaped design. The heart is white and is surrounded by a blue border. Below the heart is the text "K152626".
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.
5
K152626
The H3+ is substantially equivalent to its predicate device H3+ (K043010) as shown in the table below.
| HOLTER
RECORDER
MODEL | Predicate Device | Current Device | Change
explanation |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| COMPANY | H3+ version 2.09
Mortara Instrument, Inc. | H3+ version 3.0.0
Mortara Instrument, Inc. | Identical |
| 510 (K)
Number | K043010 | Present Application | NA |
| Indications for
Use | The H3+ Holter recorder is
intended to acquire, record
and store up to 48 hours of
ECG data of patients that
have been connected to the
Mortara H3+ recorder and
are undergoing Holter
monitoring. The H3+
performs no cardiac analysis
by itself and is intended to be
used with the Mortara H-
Scribe Holter analysis
system(K0040170) or other
compatible Holter Analyzer.
ECG data prerecorded by the
H3+ is acquired and analyzed
by the H-Scribe. In turn the
cardiac data and analysis
provided by H-Scribe Holter
system will be reviewed,
confirmed, and used by
trained medical personnel in
the diagnosis of patients with
various rhythm patterns. | 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. | Equivalent,
Indications
for use
updated to
include
patient
population
and use
environment |
| Type | Digital | Digital | Identical |
| Record
duration | 24 and 48 Hours | Up to 14 days | Equivalent
technology
but larger
storage
capacity |
| Recording
medium | Internal Flash Memory | Internal Flash Memory | Identical |
| Data transfer
method | Via USB port | Via USB port | Identical |
| Signal
compression | Yes | Yes | Identical |
| Channels | 2 or 3 | 3 | Identical
equivalent,
removed 2-
channel
functionality |
| sampling rate | 180 sps | 180 sps | Identical |
| Frequency
Response | Meets the requirements of
ANSI/AAMI EC38 | Meets the requirements of
IEC 60601-2-47 | equivalent |
| HOLTER
RECORDER
MODEL | Predicate Device
H3+ version 2.09 | Current Device
H3+ version 3.0.0 | Change
explanation |
| Dynamic
Range
Amplitude (or
Digital)
Resolution | 12-bit | 12-bit | Identical |
| | 6.25 uV | 6.25 uV | Identical |
| Setup
ECG Channel
preview | With the graphic display and
Enter key / Automatic start
after 10 minutes | With the graphic display and
Enter key / Automatic start
after 10 minutes | Identical |
| | Yes | Yes | Identical
equivalent,
removed 2-
channel
functionality |
| Cable | 2-Channel 5-wires or 3-
Channel 5-wires | 3-Channel 5-wires | |
| Test Cable | No | No | Identical |
| Impedance
measurement | No | No | Identical |
| Power | 1 AAA Alkaline battery up to
48 H | 1 AAA Alkaline battery up to
14 days | equivalent |
| Pacemaker
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-
use pouch | Identical
reusable
pouch; added
disposable
pouch |
| Keyboard | 1-button keypad | 1-button keypad | Identical |
| Sound | No | No | Identical |
| Patient Event
Marker | Yes | Yes | Identical |
| Replay and
Analysis
system | H-Scribe | HScribe and Vision | equivalent-
added H3+
support in the
Vision
product |
| Weight | 28 grams | 28 grams | Identical |
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Image /page/6/Picture/0 description: The image shows a white heart shape against a blue background. The heart is formed by the negative space within the blue area. Below the heart shape, there is a text string that reads "K152626".
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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Image /page/7/Picture/0 description: The image shows a white heart shape against a blue background. The heart is positioned at the top of the image. Below the heart, the text "K152626" is displayed in a sans-serif font.
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.