ASTRONOMER PLUS SYSTEM

K013349 · Ep Technologies, Inc. · DQK · Apr 9, 2002 · Cardiovascular

Device Facts

• Record ID: K013349
• Device Name: ASTRONOMER PLUS SYSTEM
• Applicant: Ep Technologies, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Apr 9, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The Astronomer Plus™ System is a computerized system to assist in the diagnosis of complex cardiac arrhythmias. The Astronomer Plus System can be used to: - Display the relative location of catheters during cardiac mapping procedures (used exclusively with the Constellation® Catheter); - Route externally generated pacing stimuli and transmit cardiac electrogram (EGM) signals to electrophysiology recorders; and - To document electrophysiological procedures which make use of the Constellation® Catheter.

Device Story

Data management system for cardiac electrophysiology labs; assists in diagnosis of complex cardiac arrhythmias. Inputs: signals from Constellation catheter and auxiliary (roving) catheter. System components: workstation with proprietary GUI, catheter interface (Switching & Locating Device). Operation: displays relative catheter location, roving catheter proximity, and user-defined markers; routes pacing stimuli and EGM signals 1-to-1 to external EP recorders for storage/display; documents procedures. Used in clinical EP labs by physicians. Benefits: provides visualization and signal routing to support arrhythmia diagnosis.

Clinical Evidence

Bench testing and in vivo testing performed to confirm safety and effectiveness. No specific clinical trial data or performance metrics (sensitivity/specificity) provided in the summary.

Technological Characteristics

System comprises a Switching & Locating Device (SLD) and a computer workstation running proprietary GUI software. Connectivity: routes signals to stand-alone EP recorders. Used exclusively with the Constellation® Catheter. No specific materials or software architecture details provided.

Indications for Use

Indicated for patients undergoing cardiac electrophysiology studies for the diagnosis of complex cardiac arrhythmias.

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

• BSC/EPT Astronomer Plus™ (K003362)
• Cardiac Pathways Arrhythmia Mapping and Tracking System (K992912)
• Biosense CARTO™ System (K992968)
• Endocardial Solutions EnSite 3000® System (K001437)
• Medtronic LocaLisa® Cardiac Navigation System (K002869)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

| Category: | Comments |
|------------------|--------------------------------------|
| Sponsor: | Boston Scientific Corporation |
| | 2710 Orchard Parkway |
| | San Jose, CA 95134 |
| Correspondent: | Andrea L. Ruth, RAC |
| | Senior Associate, Regulatory Affairs |
| | 2710 Orchard Parkway |
| | San Jose, CA 95134 |
| Contact Numbers: | Phone: [phone] |
| | Pager: 888.509.6375 |
| | Fax: [phone] |

## Table 1 - Sponsor Information

#### Table 2 - Device Information

| Device Common Name | Programmable Diagnostic Computer |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name | Astronomer PlusTM with SLD |
| Device Classification Name | Programmable Diagnostic Computer |
| Device Classification | Class II DQK 21 CFR §870.1425 |
| Predicate Devices | BSC/EPT Astronomer PlusTM;<br>Cardiac Pathways Arrhythmia Mapping and Tracking System;<br>Biosense CARTOTM System;<br>Endocardial Solutions EnSite 3000® System;<br>Medtronic LocaLisa® Cardiac Navigation System |
| Predicate Device Reference(s) | K003362; K992912; K992968; K001437; K002869 |
| Predicate Device Classification<br>Name(s) | Programmable Diagnostic Computer |
| Predicate Device<br>Classification(s) | Class II DQK 21 CFR §870.1425 |

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October 5, 2001. Date Summary Was Prepared:

Description of the Device: This device is a data management system intended for use within a cardiac electrophysiology lab for the creation, maintenance, and review of patient files generated during a typical electrophysiology study to assist in the diagnosis of complex cardiac arrhythmias. The device consists of a workstation running proprietary software, and catheter interface.

#### Intended Use:

The Astronomer Plus™ System is a computerized system to assist in the diagnosis of complex cardiac arrhythmias. The Astronomer Plus System can be used to:

- Display the relative location of catheters during cardiac mapping * procedures (used exclusively with the Constellation® Catheter);
- Route externally generated pacing stimuli and transmit cardiac * electrogram (EGM) signals to electrophysiology recorders; and
- * To document electrophysiological procedures which make use of the Constellation® Catheter.

The Astronomer Plus System is an accessory for the Technological Characteristics: Constellation Catheter. Its function and intended use are similar to several commercially available systems, such as Cardiac Pathways' Arrhythmia Mapping and Tracking System, Biosense's CARTO® System, and Endocardial Solutions' EnSite 3000. Like these other systems, the Astronomer Plus™ system is comprised of a catheter input box (the Switching & Locating Device) and a Computer, running a proprietary GUI (Astronomer Plus™). The system provides data to the physician obtained from the Constellation Catheter and a Roving (or auxiliary) Catheter (typically a quad catheter). The System has two window displays that simultaneously show: Constellation catheter orientation, roving catheter proximity indication, and user-defined markers. Additionally, the SLD routes signals received from the Constellation and Roving Catheters 1-to-1 to stand-alone EP recorders for acquisition, storage, and display purposes.

Summary of Testing Performed: Tests were performed both in vitro and in vivo to confirm Further, conformance to several recognized standards is safety and effectiveness. maintained.

BOSTON SCIENTIFIC CORPORATION / EP TECHNOLOGIES, INC. ABBREVIATED 510(K) - ASTRONOMER PLUSTM SYSTEM

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 9 2002

Ms. Andrea L. Ruth Senior Associate, Regulatory Affairs Boston Scientific/EP Technologies, Inc. 2710 Orchard Parkway San Jose, CA 95134

Re: K013349

Trade Name: Astronomer Plus™ System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II (two) Product Code: DQK Dated: January 16, 2002 Received: January 18, 2002

Dear Ms. Ruth:

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.

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#### Page 2 - Ms. Andrea L. Ruth

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 (QS) 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 [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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Oktell

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Intended Use Statement

510(k) Number (if known): 1

Astronomer Plus™ System Device Name:

Indication for Use:

The Astronomer Plus™ System is a computerized system to assist in the diagnosis of complex cardiac arrhythmias. The Astronomer Plus™ System can be used to:

- Display the relative location of catheters during cardiac * mapping procedures (used exclusively with the Constellation® Catheter);
- Route externally generated pacing stimuli and transmit * cardiac electrogram (EGM) signals to electrophysiology recorders; and
- Document electrophysiological procedures which make use * of the Constellation® Catheter.

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

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use

Over-The-Counter Use_

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number R013349

BOSTON SCIENTIFIC CORPORATION / EP TECHNOLOGIES, INC. Abbreviated 510(k) - Astronomer Plus™ System

Confidential