K Number
K233943
Device Name
Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
Manufacturer
Date Cleared
2024-03-08

(85 days)

Product Code
Regulation Number
870.1425
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The summary describes a computerized storage and display system using magnetic localization technology for cardiac mapping. There is no mention of AI, ML, or any algorithms that would typically fall under those categories. The focus is on real-time visualization, display of maps, and tracking of catheters using established magnetic principles.

No.
The device is described as a mapping system for visualizing and recording cardiac signals during electrophysiological procedures, but it does not directly treat a disease or condition. It is used as a tool to aid in diagnosis and guide other therapeutic interventions like ablation.

Given the information provided:

Yes.
The Affera Mapping System is explicitly intended for "catheter based cardiac electrophysiological mapping" and acquires and displays "patient signals, including intracardiac electrograms," which are used to display "cardiac maps in multiple formats." This involves analyzing biological signals to understand the physiological state of the heart, which is a diagnostic function.

No

The device description explicitly mentions hardware components like a magnetic field generator, passive magnetic sensors embedded in catheters, and a disposable Location Reference Patch Kit containing passive magnetic location sensors. While software is a key component, it is integrated with and relies on these hardware elements for its intended function.

Based on the provided information, the Affera Mapping System and Location Reference Patch Kit are not IVD (In Vitro Diagnostic) devices.

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is performed outside the body.
  • Affera System Function: The Affera Mapping System and Location Reference Patch Kit are used in vivo (inside the body) during catheter-based cardiac electrophysiological mapping procedures. They track the location of catheters within the heart, display real-time visualization, and record intracardiac signals.
  • Intended Use: The intended use clearly describes a procedure performed directly on the patient's heart, not the analysis of specimens taken from the patient.
  • Device Description: The description details a system that interacts with catheters inside the body and uses external patches on the skin.
  • Anatomical Site: The specified anatomical site is "Cardiac," indicating use within the heart.

Therefore, the Affera Mapping System and Location Reference Patch Kit are medical devices used for in vivo procedures, not for in vitro diagnostic testing of specimens.

N/A

Intended Use / Indications for Use

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.

Product codes

DOK

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cardiac

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Design Verification Testing: Verification and validation activities conducted on the Affera Mapping System and Location Reference Patch Kit confirm that all user requirements and product specifications have been met.
Performance-based Characterization Testing: Tracking and navigation performance of the Affera Mapping System was further evaluated via separate characterization testing.
Summative Usability Evaluation: Critical tasks related to the Affera Mapping System and Location Reference Patch Kit were independently evaluated via summative usability studies. All tasks were completed with no uncorrected Serious Use Errors attributable to the design of the user interfaces.
Pre-clinical Animal Testing: A chronic GLP study was completed to evaluate the safety and performance of the Affera Mapping System, including electroanatomical mapping (EAM) in all four chambers and an evaluation performance as compared to prior experience with existing mapping systems. All study endpoints were met through the GLP study.
Software Verification and Validation Testing and Cybersecurity: Software verification and validation was successfully completed to ensure that all specifications are met and that risk mitigations have been successfully implemented. Controls have been implemented as part of the design and development of the Affera Mapping System to assure medical device functionality and safety with respect to cybersecurity.
Electrical Safety and EMC Testing: System safety and electrical testing, including IEC 60601 and EMC/EMI testing, has been successfully completed on the Affera Mapping System.
Biocompatibility Testing (AFR-00007): The Location Reference Patch Kit (AFR-00007) is a patient contacting device intended for placement on intact skin for a limited duration (

§ 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).

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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)

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.

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 NE
Mounds View, MN U.S.A. 55112
1.800.328.2518
Establishment Registration No. 3001504994
Official Correspondent:Matthew Lobeck
Principal Regulatory Affairs Specialist
Medtronic
8200 Coral Sea Street
Mounds View, MN 55112
Mobile: 612-202-5925
Fax: 763.367.9903
Email: matthew.lobeck@medtronic.com
Device Trade Name and
Model:Affera™ Mapping System, AFR-00003
Location Reference Patch Kit, AFR-00007
System 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) NumberK233943
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 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.

5

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 sensorequipped 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.

  • 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 EP
Navigation System
Version 7.2
(K213264) | Affera Mapping System,
Location Reference
Patch Kit
(K233943) |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Intended Use | Catheter-based electrophysiological mapping and stimulation. | Same |
| Fundamental
Scientific
Technology
(Navigation/
localization) | Magnetic-based tracking of embedded sensor Impedance-based tracking of catheter electrodes | Magnetic-based tracking of embedded sensor |
| Key System
Components | 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 |
| Location
Patch
Configuration | 3 back patches 3 chest patches | 1 back patch 1 chest patch |
| Location
Patch 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

8

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:

TestingOutcome
Design Verification
TestingVerification and validation activities conducted
on the Affera Mapping System and Location
Reference Patch Kit confirm that all user
requirements and product specifications have
been met.
Design Validation
Performance-based
Characterization
TestingTracking and navigation performance of the
Affera Mapping System was further evaluated
via separate characterization testing.
Summative
Usability
EvaluationCritical tasks related to the Affera Mapping
System and Location Reference Patch Kit were
independently evaluated via summative
usability studies. All tasks were completed with
no uncorrected Serious Use Errors attributable
to the design of the user interfaces.
Pre-clinical Animal
TestingA chronic GLP study was completed to
evaluate the safety and performance of the
Affera Mapping System, including
electroanatomical mapping (EAM) in all four
chambers and an evaluation performance as
compared to prior experience with existing
mapping systems. All study endpoints were
met through the GLP study.
Software
Verification and
Validation Testing
and CybersecuritySoftware verification and validation was
successfully completed to ensure that all
specifications are met and that risk mitigations
have been successfully implemented. Controls
have been implemented as part of the design
and development of the Affera Mapping
System to assure medical device functionality
and safety with respect to cybersecurity.
Electrical Safety
and EMC TestingSystem safety and electrical testing, including
IEC 60601 and EMC/EMI testing, has been
successfully completed on the Affera Mapping
System.
Biocompatibility
Testing
(AFR-00007)The Location Reference Patch Kit (AFR-
  1. is a patient contacting device intended
    for placement on intact skin for a limited
    duration (