H-SCRIBE

K004017 · Mortara Instrument, Inc. · MLO · Jun 11, 2001 · Cardiovascular

Device Facts

• Record ID: K004017
• Device Name: H-SCRIBE
• Applicant: Mortara Instrument, Inc.
• Product Code: MLO · Cardiovascular
• Decision Date: Jun 11, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

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.

Device Story

H-Scribe is a PC-based Holter analysis system running on Windows 98. It processes prerecorded ECG data from the Mortara H-12 recorder or compatible digital/tape recorders. The system performs three-channel full disclosure arrhythmia analysis and 12-lead ST segment analysis. It automatically detects arrhythmia and ST events, generating summary tables, trends, and reports. Used in clinical settings by trained medical personnel to assist in diagnosing cardiac rhythm patterns. Features include DVD-RAM for archival, modem for remote support, and network connectivity for integration with Hospital Information Systems. Healthcare providers review and confirm automated findings to support clinical decision-making and patient diagnosis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PC-based diagnostic software running on Windows 98. Inputs: prerecorded ECG data from digital/tape recorders. Outputs: arrhythmia/ST event reports, trends, summary tables. Connectivity: network card for HIS integration, modem for remote support. Storage: DVD-RAM. Analysis: automated detection of cardiac indices.

Indications for Use

Indicated for clinical use by qualified medical professionals for patients requiring 24-48 hour ambulatory (Holter) monitoring. Includes evaluation of adult patients with rhythm disturbances, arrhythmia symptoms, ST segment changes, or pacemakers; reporting of time domain heart rate variability; and infant patient evaluation limited to QRS detection.

Regulatory Classification

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.

Predicate Devices

• Cardiodata MK5 Holter Analysis System (K900607)
• Zymed Holter Scanner, Model 2010 Plus (K955015)

Submission Summary (Full Text)

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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: [phone] Phone: [phone] 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 .

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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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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### 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.

K004017

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 .

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21CFR801.109) | ✓ |
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OR

| Over-The-Counter Use (Optional Format 1-2-96) | |
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Division of Cardiovascular & Respiratory Devices

| 510(k) Number | K004017 |
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