(166 days)
No
The description mentions "automatically analyze" and "automatically detects arrhythmia and ST events," but there is no mention of AI, ML, or related technologies. The analysis appears to be based on predefined algorithms rather than learned patterns.
No.
The device is described as a diagnostic tool that analyzes pre-recorded ECG data to assist in the diagnosis of cardiac conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" section states: "The cardiac data and analysis provided by H-Scribe Holter system is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various cardiac rhythm patterns." The "Device Description" also mentions: "The H-Scribe Holter Analysis system is a PC based diagnostic tool".
No
The device description explicitly states it is a "PC based diagnostic tool consisting of a Holter analysis software application running on a commercial PC". While the core function is software analysis, the system includes hardware components like a commercial PC, DVD RAM drive, modem, and network card, making it a system that includes hardware, not a software-only device.
Based on the provided information, the H-Scribe Holter system 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.
- H-Scribe Function: The H-Scribe Holter system analyzes prerecorded ECG data. ECG data is electrical activity from the heart, acquired non-invasively from the surface of the body. It is not a biological specimen derived from the human body in the way that IVDs analyze.
- Intended Use: The intended use clearly states it analyzes "prerecorded ECG data" and provides "cardiac data and analysis" to assist in the diagnosis of patients with "various cardiac rhythm patterns." This is consistent with a device that analyzes physiological signals, not biological samples.
Therefore, the H-Scribe Holter system falls under the category of a medical device that analyzes physiological signals for diagnostic purposes, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The H-Scribe Holter system is intended to acquire, automatically analyze, edit, review, report and store prerecorded ECG data of patients that have been connected to the Mortara H-12 digital recorder or to other compatible tape or digital recorders. The cardiac data and analysis provided by H-Scribe Holter system is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various cardiac rhythm patterns.
The H-Scribe Holter system is intended for use in a clinical setting, by qualified medical professionals, for patients requiring ambulatory (Holter) monitoring of 24 - 48 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis. The analysis software package includes, among others, detection and reporting features appropriate to the indications below:
- Evaluation of adult patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmia.
- Evaluation of adult patients for ST segment changes
- Evaluation of adult patients with pacemakers
- Reporting of time domain heart rate variability
- Infant patient evaluation is limited to QRS .
- Evaluation of infant patients limited to QRS detection only .
Product codes
74 MLO
Device Description
The H-Scribe Holter Analysis system is a PC based diagnostic tool consisting of a Holter analysis software application running on a commercial PC using Windows 98 operating system. Designed in conjunction with the Mortara H-12 Holter recorder, the H-Scribe analyzes prerecorded patient's ECG data that has been stored by the H-12 recorder, or other compatible tape or digital recorders. The system provides three channels of full disclosure for arrhythmia analysis and 12-lead ST segment analysis. The software automatically detects arrhythmia and ST events, and creates summary tables, trends and a final report regarding a variety of cardiac data indices. The cardiac data provided by H-Scribe is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.
System features and options include a DVD RAM drive provided for long term archival of full disclosure recordings on DVD disks, an included modem for remote technical support, a network card for remote printing and data transfer, and networking capability allowing interface to Hospital Information Systems, through standard protocols.
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 patients (limited to QRS detection only)
Intended User / Care Setting
trained medical personnel, clinical setting, qualified medical professionals
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)
Not Found
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
004017
510(k) Summary
Submitter:
Harlan Van Matre, Manager of Quality Assurance / Regulatory Affairs Mortara Instrument. Inc. 7865 N. 86" Street Milwaukee, WI 53224 Fax: (414) 354-4760 Phone: (414) 354-1600 Contact: Harlan Van Matre (see above)
Trade Name: H-Scribe Common Name: Holter Analysis System Classification Name: Programmable Diagnostic Computer (Per 21 CFR 870.1425)
Legally marketed devices to which S.E. is claimed
Cardiodata MK5 Holter Analvsis System - 510(k) K900607 Zymed Holter Scanner, Model 2010 Plus - 510(k) K 955015
Description:
The H-Scribe Holter Analysis system is a PC based diagnostic tool consisting of a Holter analysis software application running on a commercial PC using Windows 98 operating system. Designed in conjunction with the Mortara H-12 Holter recorder, the H-Scribe analyzes prerecorded patient's ECG data that has been stored by the H-12 recorder, or other compatible tape or digital recorders. The system provides three channels of full disclosure for arrhythmia analysis and 12-lead ST segment analysis. The software automatically detects arrhythmia and ST events, and creates summary tables, trends and a final report regarding a variety of cardiac data indices. The cardiac data provided by H-Scribe is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.
System features and options include a DVD RAM drive provided for long term archival of full disclosure recordings on DVD disks, an included modem for remote technical support, a network card for remote printing and data transfer, and networking capability allowing interface to Hospital Information Systems, through standard protocols.
Intended use:
The H-Scribe Holter system is intended to acquire, automatically analyze, edit, review, report and store prerecorded ECG data of patients that have been connected to the Mortara H-12 digital recorder or to other compatible tape or digital recorders. The cardiac data and analysis provided by H-Scribe Holter system is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various cardiac rhythm patterns.
Indications for use:
The H-Scribe Holter system is intended for use in a clinical setting, by qualified medical professionals, for patients requiring ambulatory (Holter) monitoring of 24 - 48 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis. The analysis software package includes, among others, detection and reporting features appropriate to the indications below:
- Evaluation of adult patients with symptoms related to rhythm disturbances or symptoms suggesting . arrhythmia.
- . Evaluation of adult patients for ST segment changes
- . Evaluation of adult patients with pacemakers
- . Reporting of time domain heart rate variability
- Infant patient evaluation is limited to QRS .
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a symbol of three stylized human profiles facing to the right, with flowing lines connecting them. The profiles are silhouetted in black against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 2001
Mr. Harlan Van Matre Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224
Re: K004017
Trade Name: Mortara H-Scribe Holter Analysis System Regulation Number: 870.2800 Regulatory Class: II (two) Product Code: 74 MLO Dated: March 6, 2001 Received: March 7, 2001
Dear Mr. Van Matre:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your becally be is substantially equivalent (for the indications for use above and we nave actored to legally marketed predicate devices marketed in interstate commerce stated in the encrosure) to legally interest of the Medical Device Amendments, or to devices that prior to may 20, 1978, a.accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (11ct). " ou may, accessors) s provisions of the Act include requirements for annual provisions of the Fee. "The Free - Proctice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 centuries in be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspections, the Food and Dation may result in regulatory action. In addition, FDA may publish compy while and Concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might
2
Page 2 - Mr. Harlan Van Matre
have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
h
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):_
Device Name:
Mortara H-Scribe Holter Analysis System
The H-Scribe Holter system is intended to acquire, automatically analyze, edit, review, report and store prerecorded ECG data of patients that have been connected to the 10port and other alrest or to other compatible tape or digital recorders. The cardiac Mortard PTE anglian Fooded by H-Scribe Holter system is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various cardiac rhythm patterns.
The H-Scribe Holter system is indicated for use in a clinical setting, by qualified medical professionals only, for patients requiring ambulatory (Holter) monitoring of 24 - 48 hours. professionals only, for pations ntq uned for the purpose of prospective and retrospective cardiac data and arrhythmia analysis. The analysis software package includes, among others, detection and reporting features appropriate to the indications below:
- Evaluation of adult patients with symptoms related to rhythm disturbances or . symptoms suggesting arrhythmia
- Evaluation of adult patients for ST segment changes .
- Evaluation of adult patients with pacemakers .
- Reporting of time domain heart rate variability .
- Evaluation of infant patients 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) | |
|---|---|
| ----------------------------------------------- | -- |
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | K004017 |
|---|---|
| --------------- | --------- |