(30 days)
No
The document does not mention AI, ML, or related terms, and the description focuses on established technologies like magnetic and impedance localization, signal processing, and display.
No.
The device is described as a mapping system that provides real-time visualization of catheters and display of cardiac maps, and collects and displays various signals. While it can connect to ablation systems, its primary function described is diagnostic (mapping and display of information) rather than directly therapeutic. It assists in therapeutic procedures but does not deliver therapy itself.
Yes
The "Affera Integrated Mapping System" is intended for "cardiac electrophysiological mapping," which is a diagnostic procedure. It allows for "pacing and real-time visualization of compatible catheters as well as display of cardiac maps," and can record and display "body surface electrocardiograms and intracardiac electrograms." These functions are all indicative of a device used to identify, characterize, and provide information for the diagnosis of cardiac conditions.
No
The device description explicitly mentions hardware components such as a magnetic field generator, passive electromagnetic sensors embedded in catheters, surface electrocardiogram (ECG) signals using commercially available body surface electrodes, and connections to electrophysiology (EP) catheter lab equipment. The Magnetic Localization Patch Kit is also described as an accessory device with physical patches and cables. While there is embedded software, the system relies on significant hardware components for its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cardiac electrophysiological mapping," "pacing and real-time visualization of compatible catheters," and "display of cardiac maps." These activities are performed in vivo (within the living body) to assess the electrical activity and structure of the heart.
- Device Description: The description details a system that tracks and visualizes catheters within the body using magnetic and impedance technology. It collects and displays in vivo signals like surface ECG and intracardiac electrograms.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the human body in vitro to diagnose or monitor conditions. This device operates directly on the patient's body to guide procedures and visualize internal structures and electrical activity.
N/A
Intended Use / Indications for Use
The Affera Integrated Mapping System is intended to be used 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.
Magnetic 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.
The Magnetic Localization Patch Kit is intended for catheter-based electrophysiological mapping and stimulation.
Product codes
DOK, DQK
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 magnetic-based 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 third-party 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.
Magnetic Localization Patch Kit: The Magnetic Localization Patch Kit is an accessory device that includes 2 surface localization patches and is used with the Affera Integrated Mapping System for electromagnetic-based tracking and navigation only. The patches are placed in fixed positions in contact with the patient's skin and provide a provide a stable mounting point for magnetic sensors within the intended connecting cable, which are used to provide information regarding patient position and movement during electromagnetic-based tracking and navigation procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiac / heart
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)
Performance testing applicable to the subject device was completed to ensure it performs as intended per the product specifications and requirements. The following testing has been completed in support of the Magnetic Localization Patch Kit, and all acceptance criteria were met in accordance with appropriate standards: Design verification testing Design validation Pre-clinical animal testing Biocompatibility testing Packaging validation. No new questions of safety or effectiveness are raised as a result of the testing, and the subject device is considered substantially equivalent to the predicate device based on the performance data collected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 5, 2024
Medtronic, Inc. Matthew Lobeck Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112
Re: K243435
Trade/Device Name: Affera Integrated Mapping System; Magnetic Localization Patch Kit Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DOK Dated: November 5, 2024 Received: November 5, 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.
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"
1
(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 OS 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.
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 Rue"). 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-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
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
3
Indications for Use
510(k) Number (if known) K243435
Device Name Affera Integrated Mapping System; Magnetic Localization Patch Kit
Indications for Use (Describe)
Affera Integrated Mapping System:
The Affera Integrated Mapping System is intended to be used 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.
Magnetic 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)
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."
4
510(k) Summary
| Date Summary Prepared: | December 3, 2024 |
|---|---|
| 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 | |
| Fax: 763.367.9903 | |
| Email: matthew.lobeck@medtronic.com | |
| Device Trade Name: | Affera Integrated Mapping System; |
| Magnetic Localization Patch Kit | |
| 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; Impedance Localization |
| Patch Kit (K241828) | |
| 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 magnetic- | |
| based tracking and navigation, the integrated mapping |
5
K243435
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.
Magnetic Localization Patch Kit:
The Magnetic Localization Patch Kit is an accessory device that includes 2 surface localization patches and is used with the Affera Integrated Mapping System for electromagneticbased tracking and navigation only. The patches are placed in fixed positions in contact with the patient's skin and provide a provide a stable mounting point for magnetic sensors within the intended connecting cable, which are used to provide information regarding patient position and movement during electromagnetic-based tracking and navigation procedures.
| Intended Use: | The Magnetic Localization Patch Kit is intended for catheter-
based electrophysiological mapping and stimulation. |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | 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 |
6
K243435
signals, including body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system's display screen.
Magnetic 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.
Comparison of Technological Characteristics:
There are no changes to the Affera Integrated Mapping System in scope of K243435. This premarket notification involves changes to the Impedance Localization Patch Kit only, resulting in a modified subject device that will be commercialized as the Magnetic Localization Patch kit under model AFR-00021.
A comparative overview of the subject and predicate devices is provided in the following table:
| Attribute | Predicate Device
Impedance
Localization Patch Kit
(K241828) | Subject Device
Magnetic Localization
Patch Kit (K243435) |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Intended Use | Catheter-based
electrophysiological
mapping | Same |
| Supported
Tracking and
Navigation
Modalities | Electromagnetic-
based tracking Impedance-based
tracking | Electromagnetic-
based tracking |
| Localization
patch
Configuration | 6 surface
electrodes/patches:
Anterior Patch Posterior Patch Left Patch Right Patch Superior Patch Inferior Patch | 2 surface
electrodes/patches:
Anterior Patch Posterior Patch |
| Localization
patch
dimension | 100 mm x 65 mm | 50mm x 40mm |
| Sterility | Non-sterile | Same |
| Use
Limitations | Single-use | Same |
The Magnetic Localization Patch Kit shares the following same or similar technological characteristics with the predicate device:
7
- Supports electromagnetic-based tracking
- . Contains similar patch contents as the predicate device (Anterior and Posterior patches)
The differences in technological characteristics involve the following:
| The Magnetic Localization Patch Kit is intended for electromagnetic-based tracking and navigation and does not support hybrid impedance-based tracking and navigation, which is supported by the predicate device. The Magnetic Localization Patch Kit does not include Left, Right, Superior, or Inferior patches, which are not needed for electromagnetic-based tracking and navigation. The dimensions of the Anterior and Posterior patches of the Magnetic Localization Patch Kit have been reduced as compared to the predicate. These differences do not raise different questions of safety and effectiveness and do not preclude a meaningful comparison with the predicate device. |
|---|
| Safety and Performance Data: Performance testing applicable to the subject device was completed to ensure it performs as intended per the product specifications and requirements. The following testing has been completed in support of the Magnetic Localization Patch Kit, and all acceptance criteria were met in accordance with appropriate standards: Design verification testing Design validation Pre-clinical animal testing Biocompatibility testing Packaging validation No new questions of safety or effectiveness are raised as a result of the testing, and the subject device is considered substantially equivalent to the predicate device based on the performance data collected. |
The subject and predicate devices share the same intended Conclusion: use and have the same or similar underlying technological
8
K243435
characteristics. Differences between the subject and predicate devices do not result in differences in overall device performance or fundamental scientific technology, and the subject device is considered substantially equivalent to the respective predicate device.