(164 days)
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.
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.
The provided text describes the H3+ Holter Recorder (K152626) and its substantial equivalence to a predicate device. However, a detailed study proving the device meets specific acceptance criteria with reported performance metrics is not included in this document. This submission primarily focuses on demonstrating substantial equivalence to a previous version of the H3+ Holter Recorder (K043010) by outlining technological characteristics and compliance with standards.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a table format with reported device performance for specific clinical metrics. Instead, it compares the current device (H3+ version 3.0.0) with its predicate device (H3+ version 2.09) across various technical specifications. The changes are largely related to increased recording duration, updated standards compliance, and minor hardware modifications. The statement "The H3+ was designed and tested for compliance with the applicable clauses of the following standards" implies that meeting these standards serves as the acceptance criteria for technical performance, but no specific performance values are reported against them in this document.
| Feature | Predicate Device (H3+ version 2.09) | Current Device (H3+ version 3.0.0) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|---|
| Indications for Use | Max 48 hours for adult patients | Max 14 days for all patient populations | Equivalent, expanded patient population and use environment | Achieved (stated as equivalent in terms of functionality) |
| Record Duration | 24 and 48 Hours | Up to 14 days | Equivalent technology but larger storage capacity | Achieved: Up to 14 days |
| Channels | 2 or 3 | 3 | Removed 2-channel functionality (still considered equivalent) | Achieved: 3 channels |
| Sampling Rate | 180 sps | 180 sps | Identical to predicate | Achieved: 180 sps |
| Frequency Response | Meets ANSI/AAMI EC38 requirements | Meets IEC 60601-2-47 requirements | Equivalent (meeting updated standard) | Achieved: Meets IEC 60601-2-47 requirements |
| Dynamic Range Amplitude | 12-bit | 12-bit | Identical to predicate | Achieved: 12-bit |
| Digital Resolution | 6.25 uV | 6.25 uV | Identical to predicate | Achieved: 6.25 uV |
| Power (battery life) | 1 AAA Alkaline battery up to 48 H | 1 AAA Alkaline battery up to 14 days | Equivalent (implied improved battery life for extended recording) | Achieved: Up to 14 days |
| Pacemaker Detection | Yes | Yes | Identical to predicate | Achieved: Yes |
| Compliance with Standards | (Implied compliance with relevant standards) | IEC 60601-1, IEC 62304, IEC 60601-2-47, IEC 60601-1-2 | Full compliance with listed standards | Document states "designed and tested for compliance" (achieved) |
| Software Validation | (Implied prior validation) | Yes | Meet all design inputs and performance requirements | Document states "undergone software validation" (achieved) |
| Performance Verification/Validation | (Implied prior verification/validation) | Yes | Ensure it meets all design inputs and performance requirements | Document states "performance verification and validation" (achieved) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily focuses on technical and regulatory compliance. It does not mention any specific sample size for a test set or clinical data. It explicitly states in Section 5, item 5: "The subject of this premarket notification did not require clinical data to support substantial equivalence." This implies that the testing performed was primarily non-clinical, focusing on engineering validation and adherence to standards. Therefore, information on data provenance (country, retrospective/prospective) is also not available.
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)
Since no clinical data or clinical test set was required for this submission, there is no information regarding the number of experts or their qualifications used to establish ground truth for a test set. The device's output (ECG data) is intended to be reviewed by "trained medical personnel for the purpose of forming a clinical diagnosis," suggesting that human experts interpret the device's output, but this is not part of the device's acceptance criteria study in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical test set requiring adjudication was used for this submission, there is no information on any adjudication method.
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
This document describes a Holter recorder, which acquires, records, and stores ECG data. It explicitly states the device "performs no analysis by itself." Therefore, it does not incorporate AI and no MRMC comparative effectiveness study with or without AI assistance was performed or would be relevant to this device's function.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The H3+ Holter Recorder is a data acquisition and recording device. It "performs no analysis by itself." Therefore, there is no standalone algorithm performance to report. Its function is to capture data that will then be analyzed by a separate Holter analysis system, with the final interpretation by trained medical personnel.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance evaluations mentioned (e.g., related to standards compliance), the "ground truth" would be established by the definitions and requirements specified within those engineering and medical electrical equipment standards. For instance, frequency response or signal resolution are directly measurable against predefined norms. Since no clinical claims were made or clinical data was required for this submission, there is no ground truth related to clinical diagnoses (expert consensus, pathology, or outcomes data) established or reported for the device itself.
8. The sample size for the training set
Since this device does not perform analysis and does not incorporate AI or machine learning algorithms, there is no training set used for the device itself.
9. How the ground truth for the training set was established
As there is no training set for this device, information on how its ground truth was established is not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular 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
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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 (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
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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) | |
|---|---|
| ☑ 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 StreetMilwaukee, WI 53224 | Primary ContactMargaret MuchaDirector of Global RegulatoryAffairsmeg.mucha@mortara.com |
|---|---|
| Telephone 414-354-1600Fax 414-354-4760 | Secondary ContactEleanore DiasRegulatory Specialisteleanore.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.
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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.
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K152626
The H3+ is substantially equivalent to its predicate device H3+ (K043010) as shown in the table below.
| HOLTERRECORDERMODEL | Predicate Device | Current Device | Changeexplanation |
|---|---|---|---|
| COMPANY | H3+ version 2.09Mortara Instrument, Inc. | H3+ version 3.0.0Mortara Instrument, Inc. | Identical |
| 510 (K)Number | K043010 | Present Application | NA |
| Indications forUse | The H3+ Holter recorder isintended to acquire, recordand store up to 48 hours ofECG data of patients thathave been connected to theMortara H3+ recorder andare undergoing Holtermonitoring. The H3+performs no cardiac analysisby itself and is intended to beused with the Mortara H-Scribe Holter analysissystem(K0040170) or othercompatible Holter Analyzer.ECG data prerecorded by theH3+ is acquired and analyzedby the H-Scribe. In turn thecardiac data and analysisprovided by H-Scribe Holtersystem will be reviewed,confirmed, and used bytrained medical personnel inthe diagnosis of patients withvarious rhythm patterns. | The H3+ Holter recorder isintended to acquire, recordand store continuous ECGdata as directed by aclinician from adult,adolescent, pediatric, infantand neonate patientpopulations for a maximumrecording time of 14 days ina hospital, clinic or homeenvironment. The H3+ isintended to be used with acompatible ambulatory ECG(Holter) analysis systemwhich will analyze therecordeddata. The H3+ data and thedata analysis are thenreviewed by trained medicalpersonnel for the purpose offorming a clinical diagnosis.The H3+ Holter Recorder isnot a life-supporting device. | Equivalent,Indicationsfor useupdated toincludepatientpopulationand useenvironment |
| Type | Digital | Digital | Identical |
| Recordduration | 24 and 48 Hours | Up to 14 days | Equivalenttechnologybut largerstoragecapacity |
| Recordingmedium | Internal Flash Memory | Internal Flash Memory | Identical |
| Data transfermethod | Via USB port | Via USB port | Identical |
| Signalcompression | Yes | Yes | Identical |
| Channels | 2 or 3 | 3 | Identicalequivalent,removed 2-channelfunctionality |
| sampling rate | 180 sps | 180 sps | Identical |
| FrequencyResponse | Meets the requirements ofANSI/AAMI EC38 | Meets the requirements ofIEC 60601-2-47 | equivalent |
| HOLTERRECORDERMODEL | Predicate DeviceH3+ version 2.09 | Current DeviceH3+ version 3.0.0 | Changeexplanation |
| DynamicRangeAmplitude (orDigital)Resolution | 12-bit | 12-bit | Identical |
| 6.25 uV | 6.25 uV | Identical | |
| SetupECG Channelpreview | With the graphic display andEnter key / Automatic startafter 10 minutes | With the graphic display andEnter key / Automatic startafter 10 minutes | Identical |
| Yes | Yes | Identicalequivalent,removed 2-channelfunctionality | |
| Cable | 2-Channel 5-wires or 3-Channel 5-wires | 3-Channel 5-wires | |
| Test Cable | No | No | Identical |
| Impedancemeasurement | No | No | Identical |
| Power | 1 AAA Alkaline battery up to48 H | 1 AAA Alkaline battery up to14 days | equivalent |
| PacemakerDetection | 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 | Identicalreusablepouch; addeddisposablepouch |
| Keyboard | 1-button keypad | 1-button keypad | Identical |
| Sound | No | No | Identical |
| Patient EventMarker | Yes | Yes | Identical |
| Replay andAnalysissystem | H-Scribe | HScribe and Vision | equivalent-added H3+support in theVisionproduct |
| 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.
§ 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).