QMS MAPPING SYSTEM,MODEL 2000

K990058 · Cathdata, Inc. · DQK · Dec 15, 1999 · Cardiovascular

Device Facts

• Record ID: K990058
• Device Name: QMS MAPPING SYSTEM,MODEL 2000
• Applicant: Cathdata, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Dec 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The intended use of this device is only upon prescription by a trained medical practitioner (who decides this device is suitable to map a patient's heart activity (to published specifications). This device is not to be offered on a non-prescription basis and will not be available to physicians having specific qualified electrophysiology amplifiers.

Device Story

OMS Mapping System Model 2000 is a computerized cardiographic QMS mapping system; collects, computes, maps, records, and displays patient diagnostic data to provide electrophysiological maps of the heart. Input: electrical signals from an ancillary basket catheter via a proprietary QMS switchbox and qualified electrophysiology amplifier. Operation: computer algorithm derives mapping information from complex electrical signal configurations. Output: visual representation of cardiac electrical properties on computer screens. Used in clinical settings by trained medical practitioners/electrophysiologists. Assists in mapping heart activity for arrhythmia diagnosis; enables visualization of cardiac depolarization events.

Clinical Evidence

No clinical data. Non-clinical testing conducted to verify device accuracy, calibration, and maintenance of calibration over the device's useful life.

Technological Characteristics

Computerized QMS mapping software; interfaces with proprietary switchbox and external electrophysiology amplifier. Displays data on computer screens. Operates via computer algorithm to process complex electrical signals. Conforms to Quality Systems (21 CFR Part 820).

Indications for Use

Indicated for use in monomorphic, stationary atrial and ventricular arrhythmias. Collects, records, and displays cardiac depolarization events for patients under the care of a skilled health care practitioner.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• Integrated Mapping Software Module from Prucka Engineering, Inc. (K902716)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string starts with the letter 'K', followed by the numbers '99005', and ends with the number '8'. The characters are written in a cursive style, with some of the numbers connected to each other.

## Exhibit 19 Summary of Safety & Effectiveness

The OMS Mapping System™ , Model 2000 is a computerized Cardiographic QMS Mapping system designed for clinical applications to allow health care providers to collect, compute, map, record and display patient diagnostic data to provide a detailed electrophysiological map of the inside of the heart. As such, this device is a Class II device, having Regulation Number: 21 CFR Part 870.1875, Classification Number: 74- DQD.

This summary is submitted in behalf of

CathData Inc. 801 York Mill Road, Suite 314 Don Mills, Ontario, Canada M3B 1X7 Voice phone number-416 383 1520 Fax phone number- 416 383 1533

this summary is submitted by:

Richard Keen Compliance Consultants 1151 Hope Street Stamford, Connecticut, 06907 voice phone number [phone]) fax phone number [phone].

This device can be described as QMS software which receives signals from a proprietary QMS switchbox that connects to an ancillary "basket catheter" {not part of this system} and interfaces with a qualified electrophysiology amplifier {not part of this system}. This device receives signals from the "basket catheter" and uses a computer algorithm to derive the patient mapping information.

This device functions by receiving signals from the "basket catheter" and uses a computer algorithm to derive the patient mapping information.

The scientific concept on which this device is based on is the principle that by receiving a complex configuration of electrical signals from the heart {via the "basket catheter" }, reliable data concerning the electrical properties of the heart can be derived and that data can be represented in meaningful views.

The intended use of this device is only upon prescription by a trained medical practitioner (who decides this device is suitable to map a patient's heart activity (to published specifications). This device is not to be offered on a non-prescription basis and will not be available to physicians having specific qualified electrophysiology amplifiers.

{1}------------------------------------------------

# Exhibit 19 Summarv of Safety & Effectiveness

This device is indicated for use in monomorphic, stationary atrial and ventricular arrhythmias. This device collects, records, and displays cardiac depolarization events for patients under the care of a skilled health care practitioner.

CathData Inc. has determined that the QMS Mapping System"", Model 2000 is substantially equivalent to the performance of a an existing medical device: Integrated Mapping Software Module from Prucka Engineering, Inc. {K-902716}. The differences between these systems are incidental and not significant. Both devices use a similar technology and principles. ) is a device having a similar product offering and is distributed only as a prescription device.

CathData Inc. has determined that this device is substantially equivalent to the predicate device and has similar technological characteristics

both systems display data on computer screens, both systems displays patient information which relates to a unique patient; both uses computer programming to operate and record patient data. both use a computer algorithm to compute complex signals,

A series of non-clinical tests were conducted to verify the device is accurate and calibrated and can maintain calibration over its useful life.

The QMS Mapping System" , Model 2000 has benefited from design, development, testing and production procedures that conform to Quality Systems.

This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy. CathData 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 this Summary of Safety and Effectiveness applies for the above indicated device.

Mr. Anthony King

Product Manager CathData Inc. 801 York Mill Road, Suite 314 Don Mills, Ontario, Canada M3B 1X7 Voice 416 383 1520 Fax Fax Fax [phone]

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 1999

Cathdata, Inc. c/o Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, CT 06907

K990058 Re : OMS Mapping System, Model 2000 Regulatory Class: II (two) Product Code: 74 DQK September 24, 1999 Dated: October 7, 1999 Received:

Dear Mr. Keen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 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 Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

#### Page 2 - Mr. Richard Keen

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 requlation (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"(21 CFR 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,

Nancy C. Brogdon for

Celia M. Witte Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

The QMS 3000 "" is indicated for use in the storage, display, retrieval and measurement of ECG signals obtained from intracardiac catheters.

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dan Tich

Prescription Use XX (Per 21 CFR 801.109)

OR

Over - The - Counter Use

(Optional Format 1-2-96)