(116 days)
No
The document explicitly states that the H3+ Holter recorder performs no cardiac analysis by itself and is intended to be used with a separate Holter analysis system (H-Scribe). The H3+ is solely a data acquisition and storage device. There is no mention of AI or ML being used in the H3+ itself.
No
The device is described as a "diagnostic tool intended to acquire, record and store ECG data," and it "performs no cardiac analysis by itself," indicating its role in data collection for diagnosis rather than direct therapy.
No
The device description explicitly states: "The H3+ performs no cardiac analysis by itself and is intended to be used with the Mortara H-Scribe Holter analysis system (K004017) or other compatible Holter Analyzer." It further clarifies, "It is diagnostic tool intended to acquire, record and store ECG data... Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis." This indicates the H3+ is solely a data acquisition and storage tool, not a diagnostic device that performs analysis for diagnosis. The analysis and subsequent diagnosis are performed by a separate system (H-Scribe) and medical personnel.
No
The device description clearly states it is a "Holter Recorder" and describes physical components like patient cables, an LCD screen, an Enter button, a battery, and internal memory, indicating it is a hardware device that records and stores ECG data.
Based on the provided text, the Mortara H3+ Holter recorder itself is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- H3+ Function: The H3+ Holter recorder's primary function is to acquire, record, and store ECG data from a patient's body. It does not perform any analysis or testing on biological specimens.
- Analysis is Separate: The text explicitly states that the H3+ "performs no cardiac analysis by itself" and is intended to be used with the Mortara H-Scribe Holter analysis system (K004017) or other compatible Holter Analyzer. The analysis of the ECG data, which is used for diagnosis, is performed by the separate analysis system.
Therefore, the H3+ is a medical device that collects physiological data, but it does not fit the definition of an In Vitro Diagnostic device. The Holter analysis system (H-Scribe), which processes the data from the H3+ and provides information for diagnosis, is more likely to be considered a diagnostic device, although whether it specifically falls under the IVD category would depend on its exact classification and regulatory requirements.
N/A
Intended Use / Indications for Use
The H3+ Holter recorder is intended to acquire, record and store ECG data of patients that have been connected to the Mortara H3+ recorder and are undergoing Holter monitoring. The H3+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter analysis system. The H3+ performs no cardiac analysis by itself and is intended to be used with the H-Scribe Holter analysis system (K004017). 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 analysis system will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
The H3+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory (Holter) monitoring of up to 48 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis. Holter analysis is appropriate for the indications below:
- Evaluation of adult patients with symptoms suggesting arrhythmia .
- Evaluation of adult patients with pacemakers .
- Reporting of time domain heart rate variability .
- Evaluation of a patients response after resuming occupational or recreational . activities (e.q., after M.I. or cardiac surgery.)
- Evaluation of ECG documenting therapeutic interventions in individual patients or . groups of patients
- Clinical and epidemiological research studies .
- Infant patient evaluation is limited to QRS detection only .
Product codes
MWJ
Device Description
The H3+ Holler Recorder is intended for use as part of a Holter Analysis system and is designed to be used in conjunction with the Mortara H-Scribe Holter Analysis system. The H3+ Holter Recorder provides two or three channels of continuous ECG data recorded over a 24-hour or 48-hour period.
The H3+ is a Holter Recorder offering micro-sized, extremely lightweight patient utility. Using existing Mortara approved technology, the H3+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter System. The H-Scribe analyzes prerecorded patient's ECG data that has been stored by the H3+ recorder. The cardiac data provided by H-Scribe is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.
The H3+ provides the ability to choose between a 3-Channel patient cable to record modified leads II, III and V; and a 2-Channel patient cable to record bipolar leads positioned according to clinician preference. The 3-Channel 5-lead patient cable allows for recording modified leads II, III and V. The 2-Channel 5-lead patient cable allows for recording two bipolar leads. Either patient cable can be used with the H3+ according to user preference. A LCD screen and Enter button allow for checking the lead quality during palient hook-up and starting the recording.
The H3+ uses a single AAA alkaline battery and stores acquired ECG data in internal, non-volatile memory. Stored ECG data will be downloaded for analysis to the H-Scribe, a PC based Holter Analysis system, via a standard USB interface. The recorded data will remain in memory until it has been cleared by the clinician.
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 patients, Infant patient
Intended User / Care Setting
Clinical setting, by qualified medical professionals only
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)
Not Found
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
Abbreviated 510(k) Notification: Device Summary
Submitter:
Harlan Van Matre, Manager of Quality Assurance / Regulatory Affairs Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, WI 53224 (414) 354-4760 Fax: (414) 354-1600 Phone: Harlan Van Matre (see above) Contact:
| Trade Name: | H3+ |
|---|---|
| Common Name: | Holter Analysis Recorder |
| Classification Name: | Medical Magnetic Tape Recorder (based on classification for original parent device.) |
| (Per 21 CFR 870.2800) |
Legally marketed devices to which S. E. is claimed
The H3+ Holter Recorder is an addition to the Mortara Holter Recorder family and is substantially equivalent to the following legally marketed predicate devices:
- . Mortara H12+ Holter Recorder (K021373)
- . Ela Medical Spiderview (K032466)
- Braemer / Phillips Digitrack Plus (K993617) .
Description:
The H3+ Holler Recorder is intended for use as part of a Holter Analysis system and is designed to be used in conjunction with the Mortara H-Scribe Holter Analysis system. The H3+ Holter Recorder provides two or three channels of continuous ECG data recorded over a 24-hour or 48-hour period.
The H3+ is a Holter Recorder offering micro-sized, extremely lightweight patient utility. Using existing Mortara approved technology, the H3+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter System. The H-Scribe analyzes prerecorded patient's ECG data that has been stored by the H3+ recorder. The cardiac data provided by H-Scribe is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.
The H3+ provides the ability to choose between a 3-Channel patient cable to record modified leads II, III and V; and a 2-Channel patient cable to record bipolar leads positioned according to clinician preference. The 3-Channel 5-lead patient cable allows for recording modified leads II, III and V. The 2-Channel 5-lead patient cable allows for recording two bipolar leads. Either patient cable can be used with the H3+ according to user preference. A LCD screen and Enter button allow for checking the lead quality during palient hook-up and starting the recording.
The H3+ uses a single AAA alkaline battery and stores acquired ECG data in internal, non-volatile memory. Stored ECG data will be downloaded for analysis to the H-Scribe, a PC based Holter Analysis system, via a standard USB interface. The recorded data will remain in memory until it has been cleared by the clinician.
1
Intended 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 (K004017) 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 Hotter system will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
Indications for use:
The H3+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory (Holter) monitoring of 24 hours. The Mortara Holter Recorder H3+ is not a life-supporting device. It is diagnostic tool intended to acquire, record and store ECG data of patients requiring ambulatory (Holter) monitoring of 24 or 48 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis.
Holter analysis is appropriate for the indications below:
- . Evaluation of adult patients with symptoms suggesting arrhythmia
- . Evaluation of adult patients with pacemakers
- . Reporting of time domain heart rate variability
- Evaluation of a patients response after resuming occupational activities (e.g., after M.I. or . cardiac surgery.)
- . Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients
- Clinical and epidemiological research studies .
- Infant patient evaluation is limited to QRS detection only .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2005
Mortara Instrument Inc. c/o Mr. Harlan L. Van Matre Manager, Quality Assurance and Regulatory Affairs 7865 North 86th Street Milwaukee, WI 53224-3431
Re: K043010
Trade Name: Mortara Holter Recorder H3+ Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: II (two) Product Code: MWJ Dated: January 21, 2005 Received: January 25, 2005
Dear Mr. Van Matre:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreours) is togally to togend Device Amendments, or to commerce provi to May 20, 1978, the encordance with the provisions of the Federal Food, DNA devices mat have been reciasmed in assess approval of a premarket approval application (PMA). and Costine Ace (11ct) that to nevice, subject to the general controls provisions of the Act. The I ou may, mercrore, market the Act include requirements for annual registration, listing of general controls pro risturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is clussified (itsonal controls. Existing major regulations affecting your device can may be subject to back as a sues as a regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 -- Mr. Harlan L. Van Matre
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease of advised that I Dr o interest that your device complies with other requirements of the Act that I Drinas made a cond regulations administered by other Federal agencies. You must of any I cacal statutes and regarients including, but not limited to: registration and listing (21 Confpry with an the Fiel 811 CFR Part 801); good manufacturing practice requirements as set CI K Fart 6077, adoning (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation oon. of pro nevice as described in your device as described in your Section 510(k) This letter will and will you'ls ough finding of substantial equivalence of your device to a legally premated predicated device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you attire Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other goternational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Bhimman for
D. Zuckerman, M.D.
Bram D. Zuckerman, M.De Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K 043010 510(k) Number (if known):
Mortara Holter Recorder H3+ Device Name:
The H3+ Holter recorder is intended to acquire, record and store ECG data of patients that have been connected to the Mortara H3+ recorder and are undergoing Holter monitoring. The H3+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter analysis system. The H3+ performs no cardiac analysis by itself and is intended to be used with the H-Scribe Holter analysis system (K004017). 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 analysis system will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
The H3+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory (Holter) monitoring of up to 48 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis. Holter analysis is appropriate for the indications below:
- Evaluation of adult patients with symptoms suggesting arrhythmia .
- Evaluation of adult patients with pacemakers .
- Reporting of time domain heart rate variability .
- Evaluation of a patients response after resuming occupational or recreational . activities (e.q., after M.I. or cardiac surgery.)
- Evaluation of ECG documenting therapeutic interventions in individual patients or . groups of patients
- Clinical and epidemiological research studies .
- Infant patient evaluation is limited to QRS detection only .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21CFR801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Blummenstiel