CONSTELLATION CATHETERS, MODEL 8039

K992777 · Boston Scientific Corp · MTD · Nov 12, 1999 · Cardiovascular

Device Facts

• Record ID: K992777
• Device Name: CONSTELLATION CATHETERS, MODEL 8039
• Applicant: Boston Scientific Corp
• Product Code: MTD · Cardiovascular
• Decision Date: Nov 12, 1999
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The EP Technologies (EPT) Constellation® Multiple Electrode Catheter is used to detect and record electrical potentials from the endocardial surfaces of the heart, and to deliver externally generated pacing stimuli.

Device Story

Sterile, single-use electrode recording and pacing catheter; features distal expandable basket assembly with 64 platinum-iridium ring electrodes mounted on eight splines. Used in right atrium; delivered via guiding catheter; basket expands to contact endocardium. Connects to external pacing switchbox, EGM recorder, or pulse wave generator. Physician-operated in clinical electrophysiology setting. Detects/records endocardial electrical potentials; delivers pacing stimuli. Assists diagnosis of complex arrhythmias. Warning: increased risk of adverse events (cardiac perforation, myocardial infarction, air embolism, hematoma) if used with radiofrequency ablation.

Clinical Evidence

Clinical data from IDE G940162 (supporting K983171) involved 116 patients in the Constellation group and 25 in a standard catheter group. Complication rates were 16% (17/116) for the Constellation group versus 14% (3/25) for the standard group.

Technological Characteristics

Basket assembly with 64 platinum-iridium ring electrodes (1.25mm length) on eight splines. Available in unipolar or bipolar configurations. Optional Duraflo® coating. Connectivity via accessory cables to external EGM recorders or pulse generators. No active circuitry; passive electrical signal transmission. Sterilized via ethylene oxide (EO).

Indications for Use

Indicated for use in right atrial electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). May also be used for delivery of externally generated pacing stimuli.

Regulatory Classification

Identification

An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

Predicate Devices

• Constellation® Multiple Electrode Recording and Pacing Catheter (K983171)

Submission Summary (Full Text)

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

Nov i 2 1999

# Attachment 4 510(k) Summary

| Category: | Comments |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Boston Scientific Corporation<br>2710 Orchard Parkway<br>San Jose, CA 95134 |
| Correspondent: | Steve Jwanouskos<br>Senior Director, Regulatory Affairs and<br>Quality Compliance<br>2710 Orchard Parkway<br>San Jose, CA 95134 |
| Contact Numbers: | Phone: [phone]<br>Fax: [phone] |
| Device Common Name | Electrode Recording and Pacing Catheter |
| Device Proprietary Name | Constellation® Multiple Electrode<br>Recording and Pacing Catheter |
| Device Classification | Class II, 74 DRF |
| Predicate Device | Electrode Recording and Pacing Catheter |
| Predicate Device Manufacturer(s) | Boston Scientific/EP Technologies Inc. |
| Predicate Device Proprietary<br>Name(s) | Constellation® Multiple Electrode<br>Recording and Pacing Catheter |
| Predicate Device Classification<br>Number | 74 DRF |
| Predicate Device Classification(s) | 21 CFR § 870.1220 |

### Date Summary Was Prepared:

August 17, 1999

# Description of the Device:

The Boston Scientific/EP Technologies (EPT) Constellation® Multiple Electrode Recording and Pacing Catheter is a sterile, single use device used to detect and record electrical potentials from the endocardial surfaces of the heart, and to deliver externally generated pacing stimuli. The distal, expandable "basket" assembly is, in essence, eight miniature octapolar "catheters". The basket assembly contains an array of 64 electrodes mounted along eight resilient support structures called "splines". Two configurations are available, unipolar (electrodes evenly spaced) and bipolar (electrodes evenly distributed into 32 pairs). EPT furnishes the Constellation® Catheter either with or without the

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

Duraflo® coating (Baxter CVG). EPT also furnishes accessories that include EPT Constellation Accessory Cables (sterile, re-useable), an EPT Constellation Pacing Switchbox (non-sterile, re-useable), and EPT Constellation extension cables (nonsterile, re-useable).

### Intended Use:

The EP Technologies (EPT) Constellation® Multiple Electrode Catheter is used to detect and record electrical potentials from the endocardial surfaces of the heart, and to deliver externally generated pacing stimuli.

## Technological

## Characteristics:

The basket assembly contains an array of 64 electrodes mounted along eight resilient support structures called "splines". The Constellation® Catheter is delivered to the right atrium using a Guiding Catheter. After proper position has been achieved, the Guiding Catheter is withdrawn allowing the basket assembly to expand and achieve intimate contact with the endocardium. The physician either connects the electrical connector of the catheter to an accessory pacing switchbox, or selects the output of cardiac electrograms according to the electrode, or electrode pair, of interest. Alternatively, the catheter may be connected to a commercially available EGM recorder or an external pulse wave generator. No new technology or circuitry is with the transmission of electrical signals to or from the endocardium -- the Constellation® Catheter relies on platinum-iridium alloy, ring electrodes (1.25mm in length) whose circuitty is identical to standard electrode and pacing catheters. Additionally, the electrical connections made are similar to those for commercially available electrode recording and pacing catheters.

## Comparison to Predicate Device:

| Predicate Device | Constellation® Catheter<br>48, 60 & 75 mm | 38 mm Constellation®<br>Catheter |
|------------------|------------------------------------------------------------|----------------------------------|
| 510(k) Reference | K983171 | Current Submission |
| Intended Use | Intracardiac electrophysiological<br>mapping and or pacing | Same |
| Device | Multiple Electrode Mapping and | Same |
| Description | Pacing Catheter | Same |
| Single Use? | Yes | Same |
| EO Sterilized? | Yes | Same |
| Manufacturer | BSC/EPT | Same |
| Device | Class II / 74DRF | Same |
| Classification | 21 CFR 870.1220 | Same |

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

# Summary of the Non-clinical Data:

Where appropriate, testing conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices (GLP). Specifically, non-clinical tests conducted for the EPT Mapping and Ablation System, included biocompatibility, sterility, in vivo performance, reliability, physical integrity, and electrical integrity testing.

# Abstract of the

### Clinical Data:

As part of IDE G940162, used to support approved 510(k) K983171, the Constellation catheter was used in the right atrium in 116 patients. Twenty-five atrial patients received standard catheters. The complication rates for the atrial patients were 16% (17/116) for the Constellation Group and 14% (3/25) for the standard group.

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three wing-like shapes extending from its body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 2 1999

Steve Jwanouskos Senior Director, Regulatory Affairs and Quality Compliance Boston Scientific/EP Technologice, Inc. 2710 Orchard Parkway San Jose, CA 95134

K992777 Re: Constellation Multiple Electrode Pacing and Recording System - 38mm (see attached list of model numbers) Regulatory Class: II Rroduct Code: MTD Dated: August 17, 1999 Received: August 18, 1999

Dear Mr: Jwanouskos:

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 and the limitations described below. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could Therefore, in accordance with Section 513(i)(1)(E) of the cause harm. Act, the following limitation must appear in the Warnings section of the device's labeling:

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

wARNING: The use of this device in conjunction with radiofrequency ablation, as part of the diagnosis and treatment of cardiac arrhythmias, may pose an increased risk of adverse events, such as cardiac perforation, myocardial infarction, air embolism, and hematoma requiring surgical repair and/or blood transfusion.

The Warning must be presented within a black box, and the font size of the text should be at least 2 points larger than any surrounding text. The Warning must be present on the first page of your Operator's Manual, and on the packaging for each individual device.

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 additional concrease 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 comply with the GMP regulation may result in regulatory 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.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

If you desire specific information about the application of other labeling requirements to your device (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 Other general information on your responsibilities under the 807.97). Act may be obtained from the Division of Small Manufacturers

{5}------------------------------------------------

Page 3 - Mr. Steve Jwanouskos

Assistance at its toll-free number [phone] or [phone] oc
t and in and address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Assistance at its toll-free number [phone] of (801) 1991-1991
at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Ching D. Ching

Feigal, Jr., M.D., M.D., M.P.H. Pavic Acting Director Acting of Device Evaluation Center for Devices and Radiological Health

Enclosures

.

{6}------------------------------------------------

Page of

510(k) Number (if known): K992777

Device Name: Boston Scientific 38mm Constellation

Indications For Use:

"For use in right atrial electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Constellation Multiple Electrode Recording and Pacing Catheter System may also be used for delivery of externally generated pacing stimuli. "

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular, Respir and Neurological Devic 510(k) Number

Prescription Use 2 (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)