Affera Mapping System: The Affera mapping system is intended to be used for catheter based cardiac electrophysiological mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including intracardiac electrograms, may also be recorded and displayed on the system's display screen.

Location Reference Patch Kit: Refer to the instructions for use accompanying the compatible navigation-enabled electrophysiology catheter that is used with the compatible mapping system for the specific indications for use.

Device Description

Affera Mapping System (AFR-00003): The Affera Mapping System (mapping system) is a computerized storage and display system with embedded software designed to present the user with information regarding the state and location of one or more magnetic sensors connected to cardiac catheters. The mapping system provides real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The mapping system uses magnetic localization technology similar to localization systems used in other EP mapping systems, with a magnetic field generator placed under the table and one or more passive magnetic sensors embedded in the catheter.

The Affera Mapping System connects to electrophysiology (EP) catheter lab equipment such as the EP recording system and external stimulators. The mapping system can also be connected to third-party intracardiac (IC) catheters to display electrograms from and deliver pacing stimuli.

The mapping system can be used with cardiac ablation systems for tracking and navigation of magnetic sensor-equipped catheters during ablation procedures. When used with the Affera Ablation System, the mapping system displays ablation data on the workstation user interface.

Location Reference Patch Kit (AFR-00007): The Location Reference Patch (LRP) Kit is a disposable device sold separately from the mapping system. The LRP Kit includes two non-sterile single-use patches, each containing a passive magnetic location sensor, which are placed in fixed positions on the patient's body surface (one anterior (A-patch) and one posterior (P-patch) to detect respiratory motion and to provide information regarding patient position and movement, respectively. The LRP Kit employs a hydrogel adhesive material for skin contact and for repositioning/ reapplication, and which is intended for extended duration topical use.

AI/ML Overview

The provided text describes the regulatory clearance for the Affera Mapping System (K233943). Unfortunately, it does not contain the detailed acceptance criteria or the specific study that directly proves the device meets those criteria for the main mapping functionalities, typically found in a clinical performance study summary.

The document states:

"Performance testing applicable to the subject devices was completed to ensure it performs as intended per the product specifications and requirements, including specifications and requirements related to use with compatible catheters and ablation systems. The following testing has been completed in support of the Affera Mapping System and accessory devices, and all acceptance criteria were met in accordance with appropriate standards:"

It then lists various types of testing (Design Verification, Design Validation, Performance-based Characterization, Summative Usability, Pre-clinical Animal Testing, Software V&V, Electrical Safety, Biocompatibility, Packaging Validation). While these are essential, they generally refer to aspects like safety, software integrity, and basic functionality, rather than detailed clinical performance metrics for mapping accuracy against defined benchmarks.

The only mention of a "clinical study" is:

Clinical Evaluation: "Investigator scoring of electroanatomical mapping was collected from the Sphere-Per-AF clinical study as a secondary performance endpoint, including scoring using the Affera Mapping System and a control device. Based on the mapping assessment data reported, no statistical difference was found between the investigational and control populations across the investigator scoring of geometries, voltage maps, and activation maps. Investigator scoring was 'good' or better in at least 97% of cases across all mapping categories for both treatment groups."

This section provides some performance data regarding the assessment of maps by investigators, but not quantitative acceptance criteria for the device's generation of those maps (e.g., accuracy of a 3D geometry or voltage measurement within a certain tolerance). It's an assessment of usability and qualitative agreement, not a direct measure of the device's intrinsic mapping accuracy against a gold standard or predefined numerical target.

Therefore, many of the requested details about acceptance criteria and a study proving their direct fulfillment are not explicitly present in this FDA 510(k) summary document. Regulatory summaries often abridge detailed study findings.

Below is a template of what such an answer would look like if the information were available, with "N/A" for details not found in the provided text.

Device: Affera™ Mapping System, AFR-00003

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Mapping Quality (Investigator Scoring)	"Good" or better in at least 97% of cases across all mapping categories (geometries, voltage maps, activation maps)	Achieved "Good" or better in at least 97% of cases across all mapping categories for both treatment groups (Affera Mapping System and control device).
Statistical Difference vs. Control	No statistical difference in investigator scoring of geometries, voltage maps, and activation maps compared to a control device.	No statistical difference was found between the investigational and control populations.
Navigation/Tracking Performance	Not explicitly stated in quantitative terms (e.g., accuracy, precision)	"Tracking and navigation performance... was further evaluated via separate characterization testing." Acceptance criteria were met. (Specific quantitative results not provided).
User Interface (Usability)	No uncorrected Serious Use Errors attributable to the design of the user interfaces in critical tasks.	All critical tasks were completed with no uncorrected Serious Use Errors attributable to the design of the user interfaces.
System Safety & Performance (Pre-clinical)	All study endpoints were met.	All study endpoints were met through the GLP study, including electroanatomical mapping (EAM) in all four chambers and performance evaluation compared to existing mapping systems.

2. Sample Size and Data Provenance

Test Set Sample Size: Not explicitly stated for the "clinical evaluation" (Sphere-Per-AF study) in terms of patient count, or the number of maps/cases assessed.
Data Provenance: The document does not specify the country of origin. The "Sphere-Per-AF clinical study" is mentioned, implying prospective clinical data. The pre-clinical animal study is likely prospective. Other testing (design verification, usability) could be internal lab/simulated data.

3. Number and Qualifications of Experts for Ground Truth

Number of Experts: Not specified.
Qualifications of Experts: Referred to as "Investigator" who performed the scoring. Their specific qualifications (e.g., years of experience, specialization) are not detailed in this summary.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. The data refers to "Investigator scoring," implying individual assessments, but whether multiple investigators scored the same maps and how disagreements were resolved (e.g., 2+1, 3+1) is not detailed.

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

MRMC Study: A comparative evaluation was performed as part of the "Clinical Evaluation" where "Investigator scoring of electroanatomical mapping was collected from the Sphere-Per-AF clinical study as a secondary performance endpoint, including scoring using the Affera Mapping System and a control device."
Effect Size (Improvement with AI vs. without AI assistance): This was a comparison of the Affera Mapping System device to a control device, not a human-AI assisted workflow comparison. The study found "no statistical difference" in investigator scoring between the investigational (Affera) and control populations. This suggests non-inferiority in mapping quality as perceived by the investigators, rather than an improvement with AI assistance (as AI assistance usually implies an algorithmic output assisting human interpretation/diagnostics, which isn't the primary focus here for a mapping system itself, which generates the maps).

6. Standalone (Algorithm Only) Performance

Standalone Performance: The Affera Mapping System itself is a device that generates maps. The "Performance-based Characterization Testing" likely involved evaluating the device's intrinsic accuracy and performance (e.g., tracking, navigation) in a standalone manner, but quantitative results or specific metrics for this "algorithm only" performance are not provided. The clinical evaluation focused on investigator perception of the generated maps.

7. Type of Ground Truth Used

Type of Ground Truth: The "Clinical Evaluation" used "Investigator scoring" of electroanatomical maps (geometries, voltage maps, activation maps) as a form of ground truth for assessing map quality. For other tests like "Design Verification" and "Performance-based Characterization," the ground truth would likely be defined by engineering specifications, known phantom/model dimensions, or established physiological parameters. For the pre-clinical animal testing, the ground truth would be based on "existing mapping systems" and potentially pathology or direct measurement validation in the animal model.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable/not provided. This device is a mapping system, not explicitly an AI/ML model for diagnostic interpretation that would typically require a training set in this context. While its internal software would have undergone extensive development and testing, typical AI/ML "training set" concepts are not detailed here.

9. How Ground Truth for Training Set was Established

Ground Truth for Training Set: Not applicable, as detailed training set information for an AI/ML model is not discussed for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 8, 2024

Medtronic, Inc. Matthew Lobeck Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112

Re: K233943

Trade/Device Name: AfferaTM Mapping System, AFR-00003 Location Reference Patch Kit, AFR-00007 System Cart, AFR-00013 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: December 14, 2023 Received: December 14, 2023

Dear Matthew Lobeck:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology,

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Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K233943

Device Name

Affera™ Mapping System, AFR-00003 Location Reference Patch Kit, AFR-00007 System Cart, AFR-00013

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Date Summary Prepared:	December 14, 2023
Applicant:	Medtronic, Inc.8200 Coral Sea Street NEMounds View, MN U.S.A. 551121.800.328.2518Establishment Registration No. 3001504994
Official Correspondent:	Matthew LobeckPrincipal Regulatory Affairs SpecialistMedtronic8200 Coral Sea StreetMounds View, MN 55112Mobile: 612-202-5925Fax: 763.367.9903Email: matthew.lobeck@medtronic.com
Device Trade Name andModel:	Affera™ Mapping System, AFR-00003Location Reference Patch Kit, AFR-00007System Cart, AFR-00013
Common Name:	Mapping system
Classification Name:	Computer, Diagnostic, Programmable
Classification & Panel:	Class II, 21 CFR 870.1425, Cardiovascular
Product Code:	DQK
510(k) Number	K233943
Predicate Device:	CARTO® 3 EP Navigation System Version 7.2(K213264)
Device Description:	Affera Mapping System (AFR-00003):The Affera Mapping System (mapping system) is acomputerized storage and display system with embeddedsoftware designed to present the user with informationregarding the state and location of one or more magneticsensors connected to cardiac catheters. The mapping systemprovides real-time visualization of compatible catheters aswell as display of cardiac maps in multiple formats. Themapping system uses magnetic localization technology
similar to localization systems used in other EP mapping
systems, with a magnetic field generator placed under the
table and one or more passive magnetic sensors embedded in
the catheter.

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The mapping system can be used with cardiac ablation systems for tracking and navigation of magnetic sensorequipped catheters during ablation procedures. When used with the Affera Ablation System, the mapping system displays ablation data on the workstation user interface.

The Affera Mapping System and accessory devices are Intended Use: intended for catheter-based electrophysiological mapping and stimulation.
Affera Mapping System (AFR-00003): The Affera Indications for Use: mapping system is intended to be used for catheter-based cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including intracardiac electrograms, may also be recorded and displayed on the system's display screen.

Location Reference Patch Kit (AFR-00007): Refer to the instructions for use accompanying the compatible

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navigation-enabled electrophysiology catheter that is used with the compatible mapping system for the specific indications for use.

Comparison of Technological Characteristics:

A comparative overview of the subject and predicate devices is provided in the following table:

Attribute	CARTO® 3 EPNavigation SystemVersion 7.2(K213264)	Affera Mapping System,Location ReferencePatch Kit(K233943)
Intended Use	Catheter-based electrophysiological mapping and stimulation.	Same
FundamentalScientificTechnology(Navigation/localization)	Magnetic-based tracking of embedded sensor Impedance-based tracking of catheter electrodes	Magnetic-based tracking of embedded sensor
Key SystemComponents	Catheter and equipment interface unit (PIU) Magnetic field generator (Location Pad) Software and workstation	Catheter and equipment interface unit (CIU) Magnetic field generator Software and workstation
Electroanatomical Maps	3D geometric shell, voltage, activation, and propagation maps	Same
Stimulation/pacing	Externally generated pacing only	Internally (20 mA max) and externally generated pacing
LocationPatchConfiguration	3 back patches 3 chest patches	1 back patch 1 chest patch
LocationPatch Design/Function	System provides body surface reference via magnetic sensors to enable tracking of patient movement and its effect on catheter tracking and navigation.	Same

There are no significant differences in the fundamental scientific technology between the predicate and subject devices. The Affera Mapping System and accessory devices share the same or similar technological characteristics with the predicate device:

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Same intended use
Same fundamental scientific technology ● o Magnetic-based tracking of embedded sensor
. Both devices utilize a central interface unit for connection with a workstation, compatible catheter, and magnetic field generator.
. Both devices include proprietary software designed to present the user with information regarding the state and location of magnetic sensors for creation of electroanatomical maps (3D geometric shell, voltage, activation, and propagation maps), and lesion tagging.
Similar patient data management functionality with respect to the features offered by the subject devices.

The differences in technological characteristics involve the following:

Certain features offered by the predicate are not offered by the Affera Mapping System, such as:
- o ultrasound catheter and CFAE mapping
- O 12-Lead ECG Morphology Matching
- o Contact Force Indication
- certain image integration functionality. O
Both subject and predicate devices utilize pacing ● stimuli generated from external sources (i.e. external recording system). Unlike the predicate device, the Affera Mapping System can also internally generate and route up to 20 mA pacing stimuli.
. ECG signals are acquired by the predicate device using ECG patches connected directly to the central interface unit; whereas the Affera Mapping System utilizes ECG signals imported from hospital recording systems.

These changes do not constitute a difference in the fundamental scientific technology between the subject and predicate devices. The physical and technological characteristics of the subject and predicate devices are considered substantially equivalent and do not raise questions of safety or effectiveness.

Safety and Performance Data:

Performance testing applicable to the subject devices was completed to ensure it performs as intended per the product specifications and requirements, including specifications and

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requirements related to use with compatible catheters and ablation systems. The following testing has been completed in support of the Affera Mapping System and accessory devices, and all acceptance criteria were met in accordance with appropriate standards:

Testing	Outcome
Design VerificationTesting	Verification and validation activities conductedon the Affera Mapping System and LocationReference Patch Kit confirm that all userrequirements and product specifications havebeen met.
Design Validation
Performance-basedCharacterizationTesting	Tracking and navigation performance of theAffera Mapping System was further evaluatedvia separate characterization testing.
SummativeUsabilityEvaluation	Critical tasks related to the Affera MappingSystem and Location Reference Patch Kit wereindependently evaluated via summativeusability studies. All tasks were completed withno uncorrected Serious Use Errors attributableto the design of the user interfaces.
Pre-clinical AnimalTesting	A chronic GLP study was completed toevaluate the safety and performance of theAffera Mapping System, includingelectroanatomical mapping (EAM) in all fourchambers and an evaluation performance ascompared to prior experience with existingmapping systems. All study endpoints weremet through the GLP study.
SoftwareVerification andValidation Testingand Cybersecurity	Software verification and validation wassuccessfully completed to ensure that allspecifications are met and that risk mitigationshave been successfully implemented. Controlshave been implemented as part of the designand development of the Affera MappingSystem to assure medical device functionalityand safety with respect to cybersecurity.
Electrical Safetyand EMC Testing	System safety and electrical testing, includingIEC 60601 and EMC/EMI testing, has beensuccessfully completed on the Affera MappingSystem.
BiocompatibilityTesting(AFR-00007)	The Location Reference Patch Kit (AFR-00007) is a patient contacting device intendedfor placement on intact skin for a limitedduration (< 24 hours) per ISO 10993-1.Biocompatibility testing per ISO 10993-1:2018 was successfully completed on theLocation Reference Patch Kit, including testingfor irritation, sensitization, and cytotoxicity.
PackagingValidation	Packaging qualification including appropriatepre-conditioning exposure was successfullycompleted on the Affera Mapping System.
Clinical Evaluation	Investigator scoring of electroanatomicalmapping was collected from the Sphere-Per-AF
clinical study as a secondary performanceendpoint, including scoring using the AfferaMapping System and a control device.
Based on the mapping assessment datareported, no statistical difference was foundbetween the investigational and controlpopulations across the investigator scoring ofgeometries, voltage maps, and activation maps.Investigator scoring was “good” or better in atleast 97% of cases across all mappingcategories for both treatment groups.

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No questions of safety or effectiveness are raised as a result of the testing, and the subject devices are considered substantially equivalent to the predicate device based on the performance data collected.

Conclusion:

The subject and predicate devices share the same intended use and have similar underlying technological characteristics (i.e. magnetic-based tracking of embedded sensor). Differences between the subject and predicate devices do not result in differences in overall device performance or fundamental scientific technology, and the subject devices are considered substantially equivalent to the predicate device.

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).