The RHYTHMIA HDx™ Mapping System and accessories are indicated for catheter-based atrial and ventricular mapping. The mapping system allows real-time visualization of intracardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system's display screen.

Device Description

The RHYTHMIA HDx™ Mapping System is a catheter-based atrial and ventricular mapping system designed to display 3D anatomical and electroanatomical maps of the human heart in real-time. The mapping system is intended to be used during electrophysiology procedures for cardiac mapping and storage of cardiac electrophysiological data. In addition, based on user-defined criteria, the system is able to acquire data over multiple cardiac beats. It is capable of real-time display through construction of maps using catheter magnetic and impedance localization technology and data from intracardiac and surface electrograms.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the RHYTHMIA HDx™ Mapping System. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving that the device meets specific acceptance criteria through a rigorous clinical study involving AI algorithms and human reader performance metrics.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., MRMC study, effect size of AI assistance, expert consensus ground truth, training set details) are not applicable or not explicitly detailed in this type of regulatory submission. This submission primarily focuses on engineering verified performance through bench testing, animal studies, and software verification/validation, rather than clinical performance metrics in humans.

Here's a breakdown based on the provided text, addressing what is available and indicating what is not:

Device Name: RHYTHMIA HDx™ Mapping System
Regulation Number: 21 CFR 870.1425
Regulation Name: Programmable Diagnostic Computer
Product Code: DQK
Regulatory Class: Class II

1. Acceptance Criteria and Reported Device Performance

The text does not present a formal table of "acceptance criteria" with specific quantitative metrics (e.g., sensitivity, specificity, accuracy targets) for clinical performance in humans, nor does it report these performance metrics. Instead, it describes various types of testing and their successful completion, aimed at demonstrating substantial equivalence and device functionality.

Acceptance Criteria Category	Reported Device Performance (Summary from text)
Biocompatibility	"Passed all tests in accordance with appropriate test criteria and standards." (for accessories with limited skin contact, using same materials/processes as predicate system)
Electrical Safety & EMC	"Demonstrat[ed] compliance to the following standards: IEC 60601-1 +A1; IEC 60601-2-27; IEC 60601-1-2; and IEC 60601-1-6."
Software Verification & Validation	"Conducted in accordance with FDA Guidance... The software for this device was considered a 'major' level of concern because the software provides diagnostic information that directly drives a decision regarding treatment or therapy that could lead to serious injury." (Implies successful V&V for this classification).
Bench Performance - Mapping & Visualization	"Confirmed that the subject mapping system may be used to accurately create 3D maps of the cardiac chambers of the heart as well as support visualization of magnetic and impedance tracked BSC and 3rd party catheters."
Bench Performance - Hardware Performance	"Confirmed that: (1) the subject system devices and accessories meet the functional requirements; and (2) the accessories can be connected to the Signal Station as intended according to their intended use."
Bench Performance - System Level Performance	"Confirmed system level functionality under expected and worst case use conditions."
Animal Study - Clinical Acceptability	"Demonstrate that the subject mapping system: (1) conforms to the intended customer requirements; and (2) is clinically acceptable in comparison to the predicate CARTO® 3 EP Navigation System."
Animal Study - Safety	"No procedure related complications or premature deaths occurred due to the use of the subject mapping system."

2. Sample Size for Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated for any human performance test, as such a test is not described. For the animal study, it refers to "a canine model" but a specific number of animals is not provided.
Data Provenance: Not applicable for human clinical data, as it's not a clinical performance study. The animal study involved a "canine model," implying lab animals, but the country of origin is not specified. The studies were likely internal to Boston Scientific or conducted by a contracted research organization.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided as the submission does not detail a study involving human experts establishing ground truth for a diagnostic AI algorithm. The device is a "mapping system" and "programmable diagnostic computer," implying it provides data for medical professionals to interpret, rather than itself making a diagnosis that requires expert-established ground truth validation.

4. Adjudication Method for Test Set

Not applicable as there is no mention of a human-read test set or ground truth establishment process that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done according to the provided text. The submission focuses on substantial equivalence based on technological characteristics, bench performance, and animal study observations, not a human reader study comparing AI-assisted vs. unassisted performance.
Effect Size of Human Readers Improvement: Not measurable or reported as an MRMC study was not conducted.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

The text describes the "RHYTHMIA HDx™ Mapping System" as a device for "catheter-based atrial and ventricular mapping" that allows "real-time visualization... and display of cardiac maps" and "acquired patient signals... may also be recorded and displayed." This implies it provides raw data and processed maps for a human clinician to interpret rather than an autonomous diagnostic outcome that would have a "standalone performance" metric. Therefore, the concept of a standalone AI performance study as typically understood for diagnostic AI is not directly applicable or reported here. Its "performance" is described in terms of its ability to accurately create and display maps and signals.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" would be engineering specifications and known physical properties, confirmed by validation against established standards.
For the animal study, "clinical acceptability" was compared to a predicate device. This implies the existing understanding of what constitutes a correct and useful cardiac map in a preclinical setting, likely evaluated by veterinary cardiologists or equivalent experts in electrophysiology. It's not a "pathology" or "outcomes data" ground truth in the sense of confirming a disease state.

8. Sample Size for Training Set

Not applicable. This submission doesn't describe the development of an AI/ML algorithm requiring a training set in the modern sense. The "software" mentioned is for functionality and processing, not for learning from data to perform diagnostic interpretation.

9. How Ground Truth for Training Set Was Established

Not applicable. See point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2017

Boston Scientific Corporation Regina Holmes Principal Regulatory Affairs Specialist 125 Cambridgepark Drive Suite 600 Cambridge, Massachusetts 01752

Re: K162793

Trade/Device Name: RHYTHMIA HDx Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: February 8, 2017 Received: February 9, 2017

Dear Regina Holmes:

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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Mude Yellm
for

Bram D. 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

510(k) Number (if known) K162793

Device Name RHYTHMIA HDx™ Mapping System

Indications for Use (Describe)

The RHYTHMA HDx™ Mapping System and accessories are indicated for catheter-based atrial and ventricular mapping. The mapping system allows real-time visualization of intracardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system's display screen.

Type of Use (Select one or both, as applicable)

☑Prescription Use (Part 21 CFR 801 Subpart D)
☐Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY 510(K) SUMMARY COMPLYING WITH 21 CFR 807.92

I. SUBMITTER

Boston Scientific Corporation 125 Cambridgepark Drive Suite 600 Cambridge, MA 02140

Phone: 617-218-3873 Fax: 617-218-3850

Contact Person: Regina Holmes Date Prepared: February 8, 2017

II. DEVICE

Name of Device: RHYTHMIA HDx™ Mapping System Common or Usual Name: Cardiac mapping System Classification Name: Programmable diagnostic computer (21 CFR 870.1425) Regulatory Class: Class II Product Code: DOK

III. PREDICATE DEVICE

CARTO® 3 EP Navigation System version 3.2, Biosense Webster, Ltd (K132782, S.E. 01/24/2014)

RHYTHMIA Mapping System, Boston Scientific Corporation (K130750, S.E. 07/22/2013)

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

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The Signal Station and related accessories provide data connection pathways for external input/output devices (e.g. catheters and recording systems) and serve as the data conduit to the system Workstation computer and software.

The subject device is reusable capital equipment that is intended to be used in an electrophysiology laboratory by physicians fully trained in cardiac electrophysiology.

V. INDICATIONS FOR USE

The RHYTHMIA HDx™ Mapping System and accessories are indicated for catheterbased atrial and ventricular mapping. The mapping system allows real-time visualization of intracardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system's display screen.

The Indications for Use statement for the RHYTHMIA HDxTM Mapping System is identical to the predicate RHYTHMIA Mapping System.

The differences in the Indications for Use state for the subject RHYTHMIA HDx™ Mapping System and predicate CARTO® EP Navigation System do not alter the intended diagnostic use of the device nor do they affect the safety and effectiveness of the subject device relative to the predicate. Both the subject and predicate devices have the same intended use of catheter-based 3D mapping and real-time visualization of cardiac chambers, as well as acquisition and storage of cardiac electrophysiological data.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Substantial equivalence of the RHYTHMIA HDx™ Mapping System was established in terms of design features, performance testing and indications for use as compared to the predicate CARTO® 3 EP Navigation System and RHYTHMIA Mapping System. At a high level, the subject device has a similar design as the predicate device to include the same primary system components, operating principle, catheter tracking methods, and same intended use.

The following technological difference exists between the subject device and the predicate CARTO® 3 EP Navigation System.

Use of a conditioning workflow in conjunction with a magnetically tracked . diagnostic catheter.

VII. PERFORMANCE DATA

Extensive testing was performed to support the substantial equivalence determination. The subject RHYTHMIA HDx Mapping System passed all tests in accordance with

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appropriate test criteria and standards. No new questions of safety and effectiveness were raised.

Biocompatibility

Biocompatibility assessment of systems accessories was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and International Standard ISO 10993-1 Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA.

The affected accessories are classified as limited skin contact, for a duration of less than 24 hours. These devices employ the same materials and manufacturing processes as the predicate Rhythmia Mapping System.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing was performed by an independent laboratory to demonstrate compliance to the following standards: IEC 60601-1 +A1; IEC 60601-2-27; IEC 60601-1-2; and IEC 60601-1-6.

Software Verification and Validation

Software verification and validation testing were conducted in accordance with FDA Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software for this device was considered a 'major' level of concern because the software provides diagnostic information that directly drives a decision regarding treatment or therapy that could lead to serious injury.

Bench Performance Testing

Mapping and Visualization - Confirmed that the subject mapping system may be used to accurately create 3D maps of the cardiac chambers of the heart as well as support visualization of magnetic and impedance tracked BSC and 3th party catheters.
Hardware Performance Confirmed that: (1) the subject system devices and ● accessories meet the functional requirements; and (2) the accessories can be connected to the Signal Station as intended according to their intended use.
System Level Performance Confirmed system level functionality under ● expected and worst case use conditions.

Animal Study

Electroanatomical maps were created using a canine model. Pre-clinical testing was performed to demonstrate that the subject mapping system: (1) conforms to the

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intended customer requirements; and (2) is clinically acceptable in comparison to the predicate CARTO® 3 EP Navigation System.

No procedure related complications or premature deaths occurred due to the use of the subject mapping system.

VIII. CONCLUSIONS

The non-clinical data supports the safety of the subject device and the hardware and software verification and validation demonstrate that the RHYTHMIA HDx™ Mapping System should perform as intended in the specified use conditions. This data demonstrate that the RHYTHMIA HDx™ Mapping System performs comparably to the identified predicate devices that are currently marketed for the same intended use.

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).