Affera Integrated Mapping System: The Affera Integrated 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 body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system's display screen.

Impedance Localization Patch Kit: Refer to the instructions for use accompanying the compatible electrophysiology catheter(s) used with the compatible mapping system for the specific indications for use.

Device Description

Affera Integrated Mapping System: The Affera Integrated Mapping System (integrated 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 compatible catheters within the body. The integrated mapping system provides real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The integrated 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 electromagnetic sensors embedded in the catheter. In addition to magneticbased tracking and navigation, the integrated mapping system provides optional capability for hybrid electromagnetic-impedance tracking and navigation, including the ability to visualize Medtronic and third-party therapeutic and diagnostic devices that do not contain electromagnetic location sensors.

The integrated mapping system collects and displays surface electrocardiogram (ECG) signals using commercially available body surface electrodes. Electrogram signals from electrodes on connected catheters can also be collected. Data derived from these signals can be overlayed on the reconstructed anatomy to display cardiac maps in multiple formats. The integrated mapping system can connect to electrophysiology (EP) catheter lab equipment such as external stimulators to deliver pacing stimuli through thirdparty intracardiac (IC) catheters. Internally generated pacing stimuli can also be routed directly from the integrated mapping system CIU.

The integrated mapping system can be used with compatible cardiac ablation systems for tracking and navigation of catheters during ablation procedures. When connected via a communication link to a compatible ablation system, the integrated mapping system displays ablation data such as temperature and power on the user interface.

Impedance Localization Patch Kit: The Impedance Localization Patch Kit is an accessory device used with the Affera Integrated Mapping System that includes 6 surface localization patches. Patches are placed in fixed positions in contact with the patient's skin to deliver low energy patient auxiliary signals to enable the integrated mapping system to allow visualization of catheters that do not contain electromagnetic location sensors, and to support detection of respiratory motion and to provide information regarding patient position and movement.

AI/ML Overview

The provided text is a 510(k) summary for the Affera Integrated Mapping System and Impedance Localization Patch Kit. Unfortunately, this document does not contain the detailed acceptance criteria and performance study results in the format requested.

Here's an analysis of what is available and what is missing:

What is present in the document:

Device Name: Affera Integrated Mapping System; Impedance Localization Patch Kit
Intended Use: Catheter-based electrophysiological mapping and stimulation.
Indications for Use: Detailed for both the mapping system and the patch kit.
Predicate Devices:
- Affera Integrated Mapping System: Affera Mapping System – K233943
- Impedance Localization Patch Kit: EnSite Precision Surface Electrode Kit – K201148
Technological Characteristics Comparison: Provides a high-level comparison of the subject device with its predicate devices, highlighting similarities and differences in intended use, technology (magnetic vs. hybrid electromagnetic-impedance tracking), key components, mapping capabilities, stimulation, and ECG/EGM acquisition.
Safety and Performance Data Overview: States that "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." It lists categories of testing performed:
- Design verification testing
- Design validation
- Summative usability evaluation
- Pre-clinical animal testing
- Electrical safety and EMC testing
- Biocompatibility testing (AFR-00015)
- Packaging validation
- Software validation and cybersecurity testing
Conclusion: The device is considered substantially equivalent to the predicate devices, and "all acceptance criteria were met in accordance with appropriate standards."

What is missing from the document (and therefore cannot be provided in the table/answers):

A table of acceptance criteria and the reported device performance: The document explicitly states "all acceptance criteria were met," but it does not provide a table detailing those criteria or the quantitative results of the device's performance against them. For example, it doesn't specify what constitutes "met" for design verification or what the specific performance metrics (e.g., accuracy, precision, latency) were for localization or mapping.
Sample size used for the test set and the data provenance: There is no mention of the specific sample sizes for any performance tests, nor their origin (e.g., country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
Adjudication method for the test set: This information is not present.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: The document does not mention an MRMC study or any quantitative improvement metrics for human readers with AI assistance. The device is a "mapping system" and "patch kit," not primarily an AI algorithm for reader interpretation.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done: While it's a mapping system with embedded software, the document doesn't explicitly describe standalone algorithm performance studies in the way requested for AI/diagnostic devices. The description focuses on its function with human interaction (e.g., displaying information to the user).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This is not specified for any of the mentioned testing.
The sample size for the training set: There is no mention of a "training set" or its size, as this document focuses on the performance testing for regulatory clearance, not the development process of an AI/ML model for which a training set would be typical.
How the ground truth for the training set was established: Not applicable, as no training set is mentioned.

In summary, while the document confirms that performance testing was conducted and acceptance criteria were met, it does not provide the granular details required to complete your request. It primarily serves as a regulatory summary for substantial equivalence, not a detailed technical report of performance metrics.

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.

November 1, 2024

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

Re: K241828

Trade/Device Name: Affera Integrated Mapping System; Impedance Localization Patch Kit Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: June 24, 2024 Received: June 24, 2024

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/cdrh/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.

FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not

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required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.

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 (OS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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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 medical devices and radiation-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, 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

Submission Number (if known)

K241828

Device Name

Affera Integrated Mapping System; Impedance Localization Patch Kit

Indications for Use (Describe)

Affera Integrated Mapping System:

stem;
za Kit

The Affera integrated 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 body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system's display screen.

Impedance Localization Patch Kit:

Refer to the instructions for use accompanying the compatible electrophysiology catheter(s) used with the compatible mapping system for the specific indications for use.

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

Prescription Use (Part 21 CFR 801 Subpart D)

The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Summary Prepared:	October 31, 2024
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:	Affera Integrated Mapping System Impedance Localization Patch Kit
510(k) Number:	K241828
Common Name:	Mapping system
Classification Name:	Computer, Diagnostic, Programmable
Classification & Panel:	Class II, 21 CFR 870.1425, Cardiovascular
Product Code:	DQK
Predicate Devices:	Affera Integrated Mapping System: Affera Mapping System – K233943 Impedance Localization Patch Kit: EnSite Precision Surface Electrode Kit – K201148
Device Description:	Affera Integrated Mapping SystemThe Affera Integrated Mapping System (integrated 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 compatible catheters within the body. The integrated mapping system provides real-time visualization of compatible catheters as

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well as display of cardiac maps in multiple formats. The integrated 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 electromagnetic sensors embedded in the catheter. In addition to magneticbased tracking and navigation, the integrated mapping system provides optional capability for hybrid electromagnetic-impedance tracking and navigation, including the ability to visualize Medtronic and third-party therapeutic and diagnostic devices that do not contain electromagnetic location sensors.

Impedance Localization Patch Kit

The Impedance Localization Patch Kit is an accessory device used with the Affera Integrated Mapping System that includes 6 surface localization patches. Patches are placed in fixed positions in contact with the patient's skin to deliver low energy patient auxiliary signals to enable the integrated mapping system to allow visualization of catheters that do not contain electromagnetic location sensors, and to support detection of respiratory motion and to provide information regarding patient position and movement.

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Intended Use:		The Affera Integrated Mapping System and ImpedanceLocalization Patch Kit are intended for catheter-basedelectrophysiological mapping and stimulation.
Indications for Use:	Affera Integrated Mapping SystemThe Affera Integrated Mapping System is intended to beused for catheter-based cardiac electrophysiologicalmapping. The mapping system allows pacing and real-timevisualization of compatible catheters as well as display ofcardiac maps in multiple formats. The acquired patientsignals, including body surface electrocardiograms andintracardiac electrograms, may also be recorded anddisplayed on the system's display screen.Impedance Localization Patch KitRefer to the instructions for use accompanying thecompatible electrophysiology catheter(s) used with thecompatible mapping system for the specific indications foruse.
Comparison ofTechnologicalCharacteristics:	A comparative overview of the subject and predicate devices isprovided in the following tables:Affera Integrated Mapping SystemAffera Integrated

Attribute	Affera Mapping System (K233943)	Affera Integrated Mapping System (K241828)
Intended Use	Catheter-based electrophysiological mapping	Same
Fundamental Scientific Technology (Navigation/localization)	Magnetic-based tracking of embedded sensor	Magnetic-based tracking of embedded sensor Hybrid electromagnetic-impedance tracking of catheter electrodes
Key System Components	Catheter and equipment interface unit (CIU) Magnetic field generator Software and workstation	Same
Electroanatomical Maps	3D geometric shell, voltage, activation, and propagation maps	Same

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Stimulation/Pacing	Internally (20 mA max)and externallygenerated pacing	Same
ECG SignalAcquisition	Body surface ECGsignals imported fromhospital recordingsystem	Body surface ECGsignals recorded directlyby the Affera IntegratedMapping System
EGMAcquisition	Intracardiacelectrogram signalsgenerated fromelectrodes from theconnected catheters	Same

Impedance Localization Patch Kit
Attribute	EnSite PrecisionSurface Electrode Kit(K201148)	ImpedanceLocalization Patch Kit(K241828)
Intended Use	Catheter-basedelectrophysiologicalmapping	Same
SupportedTracking andNavigationModalities	Magnetic-based tracking Impedance-based tracking	Same
PatchConfiguration	6 surface electrodes/patches 2 additional patches forconnection of magnetic sensors	6 surface electrodes/patches
Sterility	Non-sterile	Same
UseLimitations	Single-use	Same

The Affera Integrated Mapping System and Impedance Localization Patch Kit share the following same or similar technological characteristics with the predicate device:

. Same intended use. Differences in indications for use statements between the subject and predicate devices do not constitute a different intended use.
Magnetic-based tracking of sensor-equipped ● compatible catheters
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,

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	activation, and propagation maps), and lesiontagging.
	• Same patient data management functionality withrespect to the features offered by the subject devices.
	• The Impedance Localization Patch Kit contains asubset of the contents of the predicate device (6surface electrodes/patches)
The differences in technological characteristics involve thefollowing:
	• The Affera Integrated Mapping System is designedand intended for magnetic-based tracking ofembedded sensors as well as hybrid electromagnetic-impedance tracking of catheter electrodes; whereasthe predicate device includes magnetic-based trackingonly.
	• The Affera Integrated Mapping System has thecapability to directly acquire ECG signals, while thepredicate device can only acquire ECG signals fromthe hospital recording system.
	• The Impedance Localization Patch Kit does notinclude a reference electrode or separate patches forconnection of magnetic sensors, which are includedin the predicate device, as these components are notrequired for use.
	These differences do not raise different questions of safetyand effectiveness and do not preclude a meaningfulcomparison with the predicate devices.
Safety and PerformanceData:	Performance testing applicable to the subject devices wascompleted to ensure it performs as intended per the productspecifications and requirements, including specifications andrequirements related to use with compatible catheters andablation systems. The following testing has been completedin support of the Affera Integrated Mapping System andImpedance Localization Patch Kit, and all acceptance criteriawere met in accordance with appropriate standards:
	• Design verification testing• Design validation• Summative usability evaluation• Pre-clinical animal testing
Electrical safety and EMC testing Biocompatibility testing (AFR-00015) Packaging validation No new questions of safety or effectiveness are raised as a result of the testing, and the subject devices are considered substantially equivalent to the predicate devices based on the performance data collected.
Pre-determined Change Control Plans (PCCPs)Within K241828, Medtronic has included notification of two PCCPs for planned modifications for devices in scope, to be implemented after market authorization: The shelf life for the Impedance Localization Patch Kit is planned to be changed from 6-months to 24-months, post submission, supported by appropriate design verification evidence. Subsequent to clearance of K241828, Medtronic intends to incorporate AFR-00016 software updates and hardware modifications to support compatibility with additional third-party, 510k-cleared mapping catheters.
Conclusion:The subject and predicate devices share the same intended use and have similar underlying technological characteristics. 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 respective predicate devices.

Software validation and cybersecurity testing .

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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).