K Number
K992777
Device Name
CONSTELLATION CATHETERS, MODEL 8039
Date Cleared
1999-11-12

(86 days)

Product Code
Regulation Number
870.1220
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
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 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).
More Information

Not Found

No
The description focuses on the hardware (catheter with multiple electrodes) and its function (recording electrical potentials, pacing). There is no mention of software analysis, algorithms, or learning capabilities that would indicate AI/ML.

No.
The device's intended use is primarily for diagnosis of arrhythmias and delivery of pacing stimuli, not for treating or curing a disease or condition.

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "to assist in the diagnosis of complex arrhythmias."

No

The device description explicitly details a physical catheter with electrodes, a basket assembly, splines, and associated hardware accessories (cables, switchbox). This is a hardware device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. This examination is performed outside of the living body.
  • Device Function: The Constellation Catheter is used inside the human body (specifically, the right atrium) to record electrical signals and deliver pacing stimuli. It is a medical device used in an invasive procedure.
  • Intended Use: The intended use clearly states it's for "use in right atrial electrophysiology procedures to assist in the diagnosis of complex arrhythmias". This is a diagnostic procedure performed in vivo.

Therefore, the Constellation Multiple Electrode Recording and Pacing Catheter System is a medical device used for in vivo diagnosis and treatment, not an in vitro diagnostic device.

N/A

Intended Use / Indications for 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.
"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. "

Product codes (comma separated list FDA assigned to the subject device)

MTD

Device Description

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 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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

endocardial surfaces of the heart, right atrium

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Complication rates: 16% (17/116) for the Constellation Group and 14% (3/25) for the standard group.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K983171

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a)
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.(b)
Classification. Class II (performance standards).

0

Nov i 2 1999

Attachment 4 510(k) Summary

Category:Comments
Sponsor:Boston Scientific Corporation
2710 Orchard Parkway
San Jose, CA 95134
Correspondent:Steve Jwanouskos
Senior Director, Regulatory Affairs and
Quality Compliance
2710 Orchard Parkway
San Jose, CA 95134
Contact Numbers:Phone: 408.895.3529
Fax: 408.895.2202
Device Common NameElectrode Recording and Pacing Catheter
Device Proprietary NameConstellation® Multiple Electrode
Recording and Pacing Catheter
Device ClassificationClass II, 74 DRF
Predicate DeviceElectrode Recording and Pacing Catheter
Predicate Device Manufacturer(s)Boston Scientific/EP Technologies Inc.
Predicate Device Proprietary
Name(s)Constellation® Multiple Electrode
Recording and Pacing Catheter
Predicate Device Classification
Number74 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
48, 60 & 75 mm | 38 mm Constellation®
Catheter |
|------------------|------------------------------------------------------------|----------------------------------|
| 510(k) Reference | K983171 | Current Submission |
| Intended Use | Intracardiac electrophysiological
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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 oc
t and in and address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Assistance at its toll-free number (800) 636-2011 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)