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 between 32 to 64 electrodes mounted along eight resilient support structures called "splines". Several configurations are available, including unipolar (electrodes evenly spaced), bipolar (electrodes evenly distributed into pairs), and lower density arrays. EPT furnishes the Constellation® Catheter either with or without the Duraflo® coating. EPT also furnishes accessories that include EPT Constellation Accessory Cables (sterile, reuseable), an EPT Constellation Pacing Switchbox (non-sterile, re-useable), and EPT Constellation extension cables (non-sterile, re-useable).

AI/ML Overview

The provided document is limited to a 510(k) summary for a medical device (Constellation® Multiple Electrode Recording and Pacing Catheter System) and primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way one might expect for a new AI/software-driven device.

The study described is a non-clinical bench test. Here's a breakdown based on the available information:

Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a detailed performance report in the context of specific metrics. The "performance testing" mentioned is qualitative and aimed at demonstrating "substantial equivalence" to a predicate device, rather than meeting predefined numerical targets of a new device.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. The document only mentions "electrical integrity testing."
- Data provenance: Not applicable, as this was non-clinical bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth is not established by human experts for this type of non-clinical device testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no mention of adjudication for this non-clinical testing.
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
- No. This is a medical device (catheter), not an AI-driven diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in a sense. The "bench testing" represents the device's standalone non-clinical performance to confirm its functional characteristics. However, this is not an "algorithm-only" performance in the AI context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical testing, the "ground truth" would be established by the expected design specifications and engineering standards for electrical integrity and physical characteristics of the device.
The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established
- Not applicable. No training set was used.

Summary

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MAY 1 6 2002

Attachment 4

510(k) Summary

Category:	Comments
Sponsor:	Boston Scientific Corporation2710 Orchard ParkwaySan Jose, CA 95134
Correspondent:	Christina L. RoweAssociate II, Regulatory Affairs2710 Orchard ParkwaySan Jose, CA 95134
Contact Information:	E-mail: rowec@bsci.comPhone: 408.895.3526Fax: 408.895.2202
Device Common Name	Catheter, Intracardiac, High Density Array
Device Proprietary Name	Constellation® Multiple ElectrodeRecording and Pacing Catheter
Device Classification	Class II, MTD
Predicate Device	Catheter, Intracardiac, High Density Array
Predicate Device Manufacturer(s)	Boston Scientific/EP Technologies Inc.
Predicate Device Proprietary Name(s)	Constellation® Multiple ElectrodeRecording and Pacing Catheter
Predicate Device Classification Number	MTD
Predicate Device Classification(s)	21 CFR § 870.1220

Date Summary Was Prepared:

April 17, 2002

Description of the Device:

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Constellation® Catheter either with or without the Duraflo® coating. EPT also furnishes accessories that include EPT Constellation Accessory Cables (sterile, reuseable), an EPT Constellation Pacing Switchbox (non-sterile, re-useable), and EPT Constellation extension cables (non-sterile, re-useable).

Intended Use:

Additionally, all Constellation® Catheter Directions for Use (DFU) contain a boxed warning with text which is 2 points larger than the surrounding text.

The use of this device in conjunction with radiofrequency ablation, as part of the diagnosis and therapeutic treatment of atrial 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.

Technological Characteristics:

Constellation® identical technological catheter features The modified characteristics to currently approved Constellation® models under K983171, K992777, K000277, and K003782. The only new characteristic of the proposed Constellation® model 8031M is electrode spacing reduced from a range between 2 -- 13mm to a range between 1 -- 13mm.

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Comparison to Predicate Device:

	Constellation® Catheter38, 48, 60 & 75 mm	Modified Device
510(k) Reference	K983171; K992777; K000277;K003782	Current Submission
Intended Use	Intracardiac electrophysiologicalmapping and or pacing	Same
DeviceDescription	Multiple Electrode Mapping andPacing Catheter	Same
Electrode Spacing	2 - 13 mm	1 - 13 mm
Single Use?	Yes	Same
EO Sterilized?	Yes	Same
Manufacturer	BSC/EPT	Same
DeviceClassification	Class II / MTD21 CFR 870.1220	Same

Summary of the Non-clinical Data:

Performance testing with the new configuration demonstrated substantial equivalence with the predicate device. Specifically, non-clinical tests included electrical integrity testing.

Abstract of the Clinical Data:

Bench testing was sufficient to assess safety and effectiveness and, thus, to establish the substantial equivalence of the new configuration. Clinical data was therefore determined to be unnecessary.

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Image /page/3/Picture/1 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or profiles, possibly representing the department's focus on people and well-being.

MAY 1 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Christina L. Rowe Associate II, Regulatory Affairs Boston Scientific Corporation 2710 Orchard Parkway San Jose, CA 95134

Re: K021232

Trade Name: Constellation® Multiple Electrode Recording and Pacing Catheters System Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II (two) Product Code: MTD Dated: April 17, 2002 Received: April 18, 2002

Dear Ms. Rowe:

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). 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 registration, 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 cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

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 in 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.

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Page 2 - Ms. Christina L. Rowe

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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.

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 Section 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 Part 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 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours

Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K021232

Device Name: Constellation® Multiple Electrode Recording and Pacing Catheters System

Indications For Use for device:

For use in right atrial electrophysiology procedures to assist in the diagnosis of complex r or aso in right anal blockeply words on the conventional mapping systems alone (i.e., linear mapping catheters). The Constellation® Multiple Electrode Recording and Pacing Catheters System may also be used for delivery of externally generated pacing stimuli.

Prescription Use X (Per 21 CFR 801.109) Over-The-Counter Use_

Nela Ten
Division of Cardiovascular & Reani
510(k) Number K021232

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).