(57 days)
K9110977
No
The device description explicitly states that the H12+ performs no cardiac analysis by itself and is intended to be used with a separate analysis system (H-Scribe). The H12+ is solely a data acquisition and storage device.
No
The device is a Holter recorder used to acquire, record, and store ECG data for diagnostic purposes, not to treat a condition.
No
The device is a recorder of ECG data, which states it "performs no cardiac analysis by itself". The recorded data is then used by a separate system (H-Scribe Holter analysis system) for analysis, and then reviewed by medical personnel for diagnosis. Therefore, the H12+ itself is not a diagnostic device.
No
The device description clearly states that the Mortara H12+ is a "Holter Recorder" and describes physical components like a keypad, LCD screen, battery, and memory card, indicating it is a hardware device.
Based on the provided information, the Mortara H12+ Holter recorder is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis. The H12+ records electrical signals from the body's surface (ECG data). It does not analyze biological specimens.
- The H12+'s function is to acquire, record, and store ECG data. It explicitly states that it "performs no cardiac analysis by itself."
- The analysis and diagnosis are performed by the separate H-Scribe Holter analysis system (K004017) and reviewed by trained medical personnel. The H12+ is a data acquisition and storage device, not an analytical device that directly provides diagnostic information from a specimen.
Therefore, the H12+ falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The H12+ Holter recorder is intended to acquire, record and store up to 24 hours of ECG data of patients that have been connected to the Mortara H12+ recorder and are undergoing Holter monitoring. The H12+ 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 H12+ 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 H12+ 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. 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 or myocardial ischemia. .
- Evaluation of adult patients for ST segment changes •
- . 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
Product codes
MWJ
Device Description
The Mortara H12+ is a Holter Recorder designed to be used in conjunction with the Mortara H-Scribe Holter Analysis system. The H12+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter System. The H12+ utilizes a 10-lead electrode hookup and placement to provide the H-Scribe system with three channels of full disclosure for Holter analysis. 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 H12+ Holter recorder stores 12 leads continuously for a 24-hour period. A keypad is available to set up system configuration, to enter patient's ID, to check lead quality during hook-up, and to start the recording. During the recording, the keypad can be used to enter event markers.
H12+ has a LCD screen to allow ECG display during the hook-up. lead quality check. system configuration and various messages for the hook-up technician.
H12+ uses one AA battery, and a removable memory card for data storage.
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, Infant
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)
K9110977
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
JUN 2 7 2002
Special 510(k): Device Modification 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: | H12+ |
|---|---|
| Common Name: | Holter Recorder |
| Classification Name: | Medical Magnetic Tape Recorder (based on classification for original device.) |
| (Per 21 CFR 870.2800) |
Legally marketed devices to which S. E. is claimed
The H12+ Holter Recorder is a modification of a legally marketed Mortara predicate device.
- Mortara PR4 Holter Recorder (K9110977) .
Note: For commercial reasons, Mortara changed the proprietary name from PR 4 to H-12 in 1995 and has continued to distribute the device under the H-12 name. The "new" H12+ is the latest evolution of this Mortara predicate device.
Description:
The Mortara H12+ is a Holter Recorder designed to be used in conjunction with the Mortara H-Scribe Holter Analysis system. The H12+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter System. The H12+ utilizes a 10-lead electrode hookup and placement to provide the H-Scribe system with three channels of full disclosure for Holter analysis. 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 H12+ Holter recorder stores 12 leads continuously for a 24-hour period. A keypad is available to set up system configuration, to enter patient's ID, to check lead quality during hook-up, and to start the recording. During the recording, the keypad can be used to enter event markers.
H12+ has a LCD screen to allow ECG display during the hook-up. lead quality check. system configuration and various messages for the hook-up technician.
H12+ uses one AA battery, and a removable memory card for data storage.
Intended use:
The H12+ Holter recorder is intended to acquire, record and store up to 24 hours of ECG data of patients that have been connected to the Mortara H12+ recorder and are undergoing Holter monitoring. The H12+ 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 H12+ 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.
1
Indications for use:
The H12+ 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. 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 or myocardial ischemia. .
- Evaluation of adult patients for ST segment changes •
- . 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
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle with three human profiles incorporated into its design. The eagle's wings are stylized and appear as flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2002
Mortara Instrument, Inc. c/o Mr. Harlan L. Van Matre Manager of Quality Assurance and Regulatory Affairs 7865 North 86th Street Milwaukee, WI 53224-3431
Re: K021373
Trade Name: Mortara Holter Recorder H12+ Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MWJ Dated: May 29, 2002 Received: May 31, 2002
Dear Mr. Van Matre:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Harlan L. Van Matre
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsma/dsmamain.html
Sincerely yours,
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respirator Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Device Name: Mortara H12+ Holter Recorder
The H12+ Holter recorder is intended to acquire, record and store ECG data of patients that have been connected to the Mortara H12+ recorder and are undergoing Holter monitoring. The H12+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter system. The H12+ 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 H12+ 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 H12+ 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. 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 or myocardial . ischemia.
- Evaluation of adult patients for ST segment changes
- . 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.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 ORS detection only
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH/Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular and Respiratory Devices |
| Prescription Use
| (Per 21CFR801.109) | 510(k) Number | Over-The-Counter Use |
|---|---|---|
| K012 373 |
(Optional Format 1-2-96)