The Boston Scientific Tracking diagnostic catheters are indicated for cardiac electrophysiological mapping and delivering pacing stimuli. In addition, the Tracking and Reference Catheters are used with the Real-time Positions Management (RPM™) System to provide catheter location information.

Device Description

Signal Acquisition Module (SAM): One of three main components of the RPM™ System that includes the Arrhythmia Mapping Computer (AMC) and the Position Acquisition Module (PAM). The SAM is an amplifier that filters cardiac signal data and transfers it to the AMC for processing and display. The SAM collects the following input signals, applies gain and filter settings as programmed through the Mapping System software and transfers them to the computer over the fiber optic data link for further processing and display.

1. one or more standard EP catheter electrodes (up to 48 catheter inputs)
1. two pacing inputs from an external pacing stimulator, which the Mapping System software can route to any catheter bipole or unipole
1. a synch output channel that can be used with pacing stimulators to synchronize pacing inputs
1. a 12-lead EKG
1. two pressure transducer inputs
1. One 64 electrode Constellation™ Catheter or up to 64 individual catheter inputs through bedside Expansion Pods

AI/ML Overview

The provided text is a 510(k) summary for the Boston Scientific Arrhythmia Mapping System with Real-time Position Management (RPM™). However, it does not contain the specific details required to fully address your request regarding acceptance criteria and the study proving the device meets them.

Here's what can be extracted and what information is missing based on your questions:

1. A table of acceptance criteria and the reported device performance

Missing. The document states that "non-clinical tests conducted for the Device showed the device met its design-input criteria," but it does not provide a table specifying these criteria or the reported performance data.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Missing. No details are provided about specific test sets, sample sizes, or data provenance. The document mentions "non-clinical tests," which typically refer to bench testing or simulations rather than human subject data.

3. 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)

Missing. This information would be relevant for studies involving human interpretation or expert evaluation, which are not described in this 510(k) summary.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Missing. Similar to the above, adjudication methods are typically described for studies involving multiple expert readers, which is not detailed here.

5. 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

Missing. This document is for a medical device (Signal Acquisition Module) that is an amplifier and data transfer unit. It is not an AI diagnostic device, so an MRMC study comparing human readers with and without AI assistance would not be relevant or expected for this type of device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Partially Addressed (by implication of device type): The device is a "Signal Acquisition Module (SAM)," described as an amplifier that filters and transfers cardiac signal data to a computer for processing and display. It is an hardware component for data acquisition. Its performance would be evaluated based on its technical specifications (e.g., signal fidelity, noise reduction, accuracy of data transfer), not as a standalone diagnostic algorithm. Therefore, "standalone performance" in the context of an algorithm or AI is not applicable. Its "standalone" performance would be its technical specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Missing (and likely not applicable in the requested format): Given the device's function, the "ground truth" would likely relate to the accuracy of signal acquisition and transfer compared to known electrical signals or established standards, rather than clinical ground truth like pathology or outcomes. The document briefly mentions "design-input criteria," suggesting that performance was checked against predetermined technical specifications.

8. The sample size for the training set

Missing. No training set is mentioned, as this is a hardware device for signal acquisition, not a machine learning model.

9. How the ground truth for the training set was established

Missing. Not applicable, as there's no mention of a training set.

Summary of Device and Study Information Present:

Device Name: Signal Acquisition Module (SAM), part of the Arrhythmia Mapping System with Real-time Position Management (RPM™).
Intended Use: Filters cardiac signal data and transfers it to the Arrhythmia Mapping Computer (AMC) for processing and display. It supports the use of tracking diagnostic catheters for cardiac electrophysiological mapping and delivering pacing stimuli, and providing catheter location information with the RPM™ System.
Study Type: Non-clinical tests were conducted.
Compliance: Testing conformed to 21 CFR Part 58 (Good Laboratory Practices (GLP)) where appropriate.
Outcome: The non-clinical tests showed the device met its design-input criteria and was safe and effective for its intended use.
Key Modification (from predicate): The modified device makes sole use of the Driven Right Leg Reference, removing options for other system references. Dynamic Diode and Post Pace Blanking Interval features were also removed.
Data Provenance (implied): "Non-clinical tests" generally imply lab-based bench testing and simulations, not human subject data from a specific country or collected prospectively/retrospectively.

Summary

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K043257/SI
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FEB - 3 2005

1. 510(k) Summary

a. General Information

Modified Device Information

Category:	Comments:
Sponsor:	Boston Scientific Corporation2710 Orchard ParkwaySan Jose, Ca 95134 -
Correspondent:	Todd G. BrillSenior Specialist, Regulatory AffairsBoston Scientific Corporation2710 Orchard ParkwaySan Jose, Ca 95134
Contact Information:	E-mail: brillt@bsci.comPhone: (408) 895-3564Fax: (408) 895-2202
Device Common Name:	Signal Acquisition Module (SAM)
Device Proprietary Name:	Arrhythmia Mapping System with Real-timePosition Management (RPM™)
Device Classification:	21 CFR §870.1220

Predicate Device Information

Predicate Device:	Arrhythmia Mapping and Tracking System(K992912)
Predicate Device Manufacturer:	Boston Scientific Corporation
Predicate Device Common Name	Signal Acquisition Module (SAM)
Predicate Device Classification:	21 CFR §870.1220
Predicate Device Classification Number:	Class II

b. Date Summary Prepared

January 13, 2005

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Description of Device C.

1. one or more standard EP catheter electrodes (up to 48 catheter inputs)
1. two pacing inputs from an external pacing stimulator, which the Mapping System software can route to any catheter bipole or unipole
1. a synch output channel that can be used with pacing stimulators to synchronize pacing inputs
1. a 12-lead EKG
1. two pressure transducer inputs
1. One 64 electrode Constellation™ Catheter or up to 64 individual catheter inputs through bedside Expansion Pods

d. Intended Use

The Boston Scientific Tracking diagnostic catheters are indicated for cardiac electrophysiological mapping and delivering pacing stimuli. In addition, the Tracking and Reference Catheters are used with the Real-time Position Management (RPMTM) System to provide catheter location information.

The Signal Acquisition Module (SAM) is a component of the RPM™ System and supports the above indication.

Comparison to Predicate Device e.

The Modified Signal Acquisition Module (SAM) has the same intended use as the predicate device and was validated to perform as the original device without the

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options of choosing a system reference for the catheters. The modified device makes sole use of the Driven Right Leg Reference.

Table 1 - Comparison of Device Characteristics to Predicate
-------------------------------------------------------------	--	--	--

Component	Arrhythmia Mapping and TrackingSystem	Real-time Position Management(RPMTM)
	K992912	K043257
	64 Channel Signal Processing Unit	128 Channel Signal Processing Unit:
	> 48 Intra-cardiac	> 112 Intra-cardiac
	> 12 EKG	> 12 EKG
	> System Reference - EKG Input -	> System Reference - Driven Right
	2 Options	Leg
	o Catheter Reference
SignalAcquisitionModule (SAM)	o Right Leg Reference
	> 2 Pressure	> 2 Pressure
	> 2 Pacing	> 2 Pacing
	> Dynamic Diode - MinimizePacing Artifacts	> Dynamic Diode - Removed
	> Post Pace Blanking Interval -Software to support DynamicDiode	> Post Pace Blanking Interval -Removed

Summary of the Non-clinical Data f.

Where appropriate, testing conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices (GLP)). Specifically, non-clinical tests conducted for the Device showed the device met its design-input criteria, and was safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/11 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three curved lines that appear to be flowing or waving. The text is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 3 2005

Boston Scientific Corporation c/o Mr. Todd Brill Senior Specialist, Regulatory Affairs 2710 Orchard Parkway San Jose, CA 95134

Re: K043257

Trade Name: Real-Time Position Management (RPMTM) System Regulation Number: 21 CFR 870.1220 Regulation Name: 21 CFFC 87072220
Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: II (two) Product Code: DRF Dated: January 12, 2005 Received: January 14, 2005

Dear Mr. Brill:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 9 ro(x) premained is substantially equivalent (for the indications felerenced above and nave determined we are and and the marketed in interstate for use stated in the encrosule) to regary manological Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderel Food. Drug commerce prof to May 20, 1978, the enaordance with the provisions of the Federal Food. Drug. devices that have been reclassified in accordance with as personal application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application and Cosment Act (Act) that do not require approvinces of the general controls provisions of the Act. The You may, mercefore, market the devices, boys requirements for annual registration, listing of
general controls provisions of the Act include requirements for annual registere general controls provisions of the flections and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing may on and divises EDA may be subject to such additional connoits. Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oous of events concerning your device in the Federal Register.

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Page 2 - Mr. Todd Brill

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 Dris issuated on a substition.
that FDA has made a determination that your device complies with other requirements of the Act that IDA has made a colorimiation administered by other Federal agencies. You must of ally rederal statutes and regulanents ancluding, but not limited to: registration and listing (21 Comply with an the Act 31equirements, networks, welling practice requirements as set CFK Part 807), labeling (21 CFR Part 807), good ff applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro neeting your device as described in your Section 510(k) This letter witi anow you to oegin mainer of substantial equivalence of your device to a legally premarket notification. The FDA miding of castion 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), please If you desire specific advice ion your are (301) 594-4646. Also, please note the regulation entitled, Contact the Office of Companies and (21CFR Part 807.97) you may obtain. Misorallumg by reference to premarkoonsibilities under the Act may be obtained from the Other general mionmation on your responsional 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, _

B/Zimmerman for
B. Zimmerman, M.D.

Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K043257 510(k) Number: Real-time Position Management (RPM™) Device Name: Indications for Use:

Prescription Use (Part 21CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IS NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blumima

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K0/3257

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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).