CARDIOVIEW TRANSTELEPHONIC SOFTWARE

K955891 · Micromedical, Inc. · DPS · Oct 8, 1996 · Cardiovascular

Device Facts

• Record ID: K955891
• Device Name: CARDIOVIEW TRANSTELEPHONIC SOFTWARE
• Applicant: Micromedical, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Oct 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

CardioView is a computerized, enhanced electronic Transtelephonic Software System designed for clinical applications to allow physicians or other health care providers to remotely view and analyze patient ECG data. This system is suited for small to medium health care monitoring facilities. If offers a 12 lead ECG remote monitoring system which is more comprehensive than conventional single lead transtelephonic Software.

Device Story

CardioView software system; enables remote viewing/analysis of patient ECG data. Inputs: ECG signals transmitted via telephone lines from remote user input device. Processing: Modem at host site receives data; DOS-based computer running Windows environment executes proprietary mathematical algorithms on stored ECG samples. Output: Display resembling conventional ECG. Usage: Clinical settings (small/medium monitoring facilities); operated by physicians/healthcare providers. Benefit: Facilitates remote convenience and rapid clinical response for ECG monitoring.

Clinical Evidence

Bench testing only. No clinical data provided. Device safety and efficacy confirmed through design, development, and production procedures conforming to Good Manufacturing Procedures.

Technological Characteristics

Software-based system; runs on DOS-based computer in Windows environment. Connectivity via switched telephone network using host-site modem. Proprietary mathematical algorithm for ECG signal processing. 12-lead ECG capability.

Indications for Use

Indicated for clinical remote viewing and analysis of patient ECG data by physicians or healthcare providers in small to medium monitoring facilities.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• CardioMagic™ Software (K925639)

Submission Summary (Full Text)

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K955891
OCT - 8 1996

# Exhibit 14 Summary of Safety & Effectiveness for CardioView™ Transtelephonic Software, Part Number 268-400-004

*CardioView* is a computerized, enhanced electronic Transtelephonic Software System designed for clinical applications to allow physicians or other health care providers to remotely view and analyze patient ECG data. This system is suited for small to medium health care monitoring facilities. If offers a 12 lead ECG remote monitoring system which is more comprehensive than conventional single lead transtelephonic Software.

As such, this device is a Class II device, having Classification Name: Monitor, Electrograph, Product Code: 74FYW as described in 21 CFR Part 870.2340. *MICROMEDICAL INC.* has determined that this device is substantially equivalent to a *predicate* medical device which is currently in commerce and has been submitted to the FDA via K925639 as an electronic Transtelephonic Software and is identified as CardioMagic™ Software, marketed by Instromedix.

A determination of substantial equivalence is based upon:

Both the *CardioView* and CardioMagic™ are electronic Transtelephonic Software for clinical applications to allow physicians or other health care providers to remotely view and analyze patient ECG data.

Both devices use a remote user input device that retains the ECG signal and transmits it over the telephone lines. Both devices can use a switched telephone network. Both devices use a modem at the Host site to communicate with the remote device and uplink the data into the Computer. Both devices use a DOS based Computer which runs in *Windows™* to display data.

Both devices: output a display that resembles a conventional ECG display. Both devices retain a electronically stored sample. Both act on that sample using mathematical computations. Both use a proprietary algorithm. Both use computer programming in a *Windows™* environment.

Neither device have claims or, are offered as, laboratory analysis equipment. Both are for remote convenience and easy response.

The *CardioView* has benefited from design, development, testing and production procedures that conform to Good Manufacturing Procedures. This device has performance characteristics substantially equivalent to its predicate device yet includes improvements to facilitate the various clinical applications for which it is intended.

This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy. *MICROMEDICAL INC.* continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.

## CERTIFICATION:

I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.

Mr. Malcom Castle
President
*MICROMEDICAL INC.*
255 Revere Drive, Suite 111
Northbrook, IL 60062
Tel [phone]
Fax [phone]

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