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).

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Constellation® Multiple Electrode Recording and Pacing Catheter). It describes the device, its intended use, and comparison to a predicate device. However, it does not contain acceptance criteria for specific device performance metrics, nor does it detail a study proving the device meets particular acceptance criteria in the way a performance study for, for example, an AI/ML diagnostic would.

The "Abstract of the Clinical Data" section briefly mentions a clinical study (IDE G940162) used to support a previous 510(k) (K983171) for the Constellation catheter, where it was used in the right atrium of 116 patients. This study focused on reporting complication rates of the device compared to standard catheters, but it does not evaluate specific performance metrics or acceptance criteria related to its primary electrophysiological recording and pacing functions.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this type of information is not present in the provided text. The document focuses on regulatory submission details, device description, and a general safety overview from a prior clinical study.

To directly answer your numbered points based only on the provided text:

A table of acceptance criteria and the reported device performance: This information is not present in the document.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test set sample size: 116 patients (for the Constellation Group in the clinical data abstract), and 25 patients (for the standard catheter group).
- Data provenance: Not specified in terms of country of origin. The study was part of IDE G940162, which implies it was a prospective investigational device exemption study.
- Additional details: The data was for the Constellation catheter used in the right atrium.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the document. The clinical study described recorded complication rates, not performance metrics requiring expert ground truth in the context of, for example, diagnostic image interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrode catheter, not an AI/ML driven diagnostic device that would involve human readers interpreting output.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrode catheter used by clinicians, not a standalone automated algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The clinical data abstract reports "complication rates," which are a form of outcomes data. No specific ground truth for performance metrics is mentioned.
The sample size for the training set: Not applicable. This is a hardware device; no "training set" in the context of AI/ML algorithms is mentioned.
How the ground truth for the training set was established: Not applicable.

Summary

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Nov i 2 1999

Attachment 4 510(k) Summary

Category:	Comments
Sponsor:	Boston Scientific Corporation2710 Orchard ParkwaySan Jose, CA 95134
Correspondent:	Steve JwanouskosSenior Director, Regulatory Affairs andQuality Compliance2710 Orchard ParkwaySan Jose, CA 95134
Contact Numbers:	Phone: 408.895.3529Fax: 408.895.2202
Device Common Name	Electrode Recording and Pacing Catheter
Device Proprietary Name	Constellation® Multiple ElectrodeRecording 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 ProprietaryName(s)	Constellation® Multiple ElectrodeRecording and Pacing Catheter
Predicate Device ClassificationNumber	74 DRF
Predicate Device Classification(s)	21 CFR § 870.1220

Date Summary Was Prepared:

August 17, 1999

Description of the Device:

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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® Catheter48, 60 & 75 mm	38 mm Constellation®Catheter
510(k) Reference	K983171	Current Submission
Intended Use	Intracardiac electrophysiologicalmapping 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

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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.

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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:

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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

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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

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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)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).