← Product Code [DQK](/productcode/DQK) · K262005 # Affera Integrated Mapping System (K262005) _Medtronic, Inc. · DQK · Aug 21, 2026 · Cardiovascular · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K262005 ## Device Facts - **Applicant:** Medtronic, Inc. - **Product Code:** [DQK](/productcode/DQK.md) - **Decision Date:** Aug 21, 2026 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.1425 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use 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. ## Device Story Computerized storage/display system; uses magnetic field generator and passive electromagnetic sensors in catheters; employs 'synergy navigation' (combination of electromagnetic and impedance tracking) to determine catheter electrode location; visualizes compatible Medtronic and third-party diagnostic/therapeutic devices. Collects surface ECG and intracardiac electrograms; overlays data on reconstructed anatomy to generate cardiac maps. Connects to external stimulators or uses internal pacing stimuli. Displays ablation data (temperature/power) when linked to compatible ablation systems. Used in EP labs by clinicians; provides real-time visualization and mapping to guide cardiac procedures; aids in navigation and clinical decision-making during ablation. ## Clinical Evidence Bench testing only. Evidence includes software verification testing, pre-clinical animal testing, and cybersecurity/penetration testing. All acceptance criteria were met. ## Technological Characteristics Computerized diagnostic system; magnetic localization (field generator under table, passive sensors in catheters); impedance tracking; synergy navigation; connectivity to external stimulators and ablation systems; software-based mapping and visualization; embedded software. ## Regulatory 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. ## Predicate Devices - Affera Integrated Mapping System ([K243892](/device/K243892.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **FDA U.S. FOOD & DRUG** ADMINISTRATION August 21, 2026 Medtronic, Inc. Matthew Lobeck Sr. Principal Regulatory Affairs Specialist 8200 Coralsea St. N.E, Mounds View, Minnesota 55112 Re: K262005 Trade/Device Name: Affera Integrated Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQK Dated: June 15, 2026 Received: June 15, 2026 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262005 - Matthew Lobeck Page 2 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K262005 - Matthew Lobeck Page 3 assistance/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, for: # MARCO CANNELLA -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 | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262005 | ? | | Please provide the device trade name(s). | | ? | | Affera Integrated Mapping System | | | | Please provide your Indications for Use below. | | ? | | 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. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☐ Adults (22 years old and greater) | ? | {4} K262005 # 510(k) Summary | Date Summary Prepared: | June 15, 2026 | | --- | --- | | 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 Sr. 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: | Affera Integrated Mapping System | | 510(k) Number | K262005 | | Common Name: | Mapping system | | Classification Name: | Computer, Diagnostic, Programmable | | Classification & Panel: | Class II, 21 CFR 870.1425, Cardiovascular | | Product Code: | DQK | | Predicate Device: | Affera Integrated Mapping System – K243892 | | Device Description: | 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. The integrated | Page 1 of 3 {5} K262005 mapping system is designed to operate using a combination of electromagnetic and impedance tracking and navigation known as “synergy navigation” to determine the location of the catheter electrodes. In addition to tracking compatible sensor-based catheters, synergy navigation also provides the ability to visualize Medtronic and third-party therapeutic and diagnostic devices without utilizing 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. # **Intended Use:** The Affera Integrated Mapping System is intended for catheter-based electrophysiological mapping and stimulation. # **Indications for Use:** 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. # **Comparison of Technological Characteristics:** The Affera Integrated Mapping System predicate and subject devices have the same intended use and indications for use. They utilize the same key system components and operate using the same fundamental scientific technology operate using a combination of electromagnetic and impedance tracking and navigation to determine the location of the catheter electrodes. The software of the subject device has been revised to include the following updates: - Addition of mapping features and functionality - Beat Matching - Pace Tagging Page 2 of 3 {6} K262005 - ○ Catheter tagging hotkeys - ○ Isochronal map - ○ Filtered voltage map - ○ Updated ventricular triggering functionality - • Compatibility with additional Affera catheters - • Software ecosystem enhancements and architecture changes All risks were mitigated to acceptable levels. No new or different questions of safety or effectiveness were raised. **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 requirements related to use with compatible catheters and ablation systems. The following testing has been completed in support of the subject device, and all acceptance criteria were met in accordance with appropriate standards: - • Software verification testing - • Pre-clinical animal testing - • Cybersecurity and penetration testing No new or different 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. **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 device is considered substantially equivalent to the predicate device. Page 3 of 3 --- **Source:** [https://fda-staging.innolitics.com/device/K262005](https://fda-staging.innolitics.com/device/K262005) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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