Confirm Rx Insertable Cardiac Monitor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue. March 29, 2019 Abbott Laura Sparks Regulatory Affairs Specialist 15900 Valley View Ct. Sylmar. California 91342 ### Re: K182981 Trade/Device Name: Confirm Rx Insertable Cardiac Monitor (ICM) System, Model DM3500 Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MXC, DSI Dated: March 1, 2019 Received: March 4, 2019 ### Dear Laura Sparks: 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 (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 located 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. 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 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jessica E. Paulsen -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use 510(k) Number (if known) K182981 Device Name Confirm RxIM Insertable Cardiac Monitor (ICM) System, Model DM3500 Indications for Use (Describe) The Confirm RxIM ICM is indicated for the monitoring and diagnostic evaluation of patients who experience wersplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. The Confirm RxIM ICM has not been specifically tested for pediatric use. Type of Use (Select one or both, as applicable) 2 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." FORM FDA 3881 (7/17) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ | Date Prepared: | November 16, 2018 | | |---------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | Submitter: | Abbott (formerly St. Jude Medical), Cardiac Rhythm Management<br>Division | | | Address: | 15900 Valley View Ct.<br>Sylmar, CA 91342<br>USA | | | Phone: | (818) 362-6822 | | | Establishment Registration: | 2017865 | | | Contact Person: | Laura Sparks<br>Regulatory Affairs Specialist<br>(818) 493-2734<br>laura.sparks@abbott.com | Jennifer Dunham<br>Manager, Regulatory Affairs<br>(818) 493-2363<br>jennifer.dunham@abbott.com | | Trade Name/Proprietary<br>Name: | Confirm RxTM ICM | | | Common Name: | Insertable Cardiac Monitor | | | Model Number: | DM3500 | | | Classification Name: | Telephone electrocardiograph transmitter and receiver (21 CFR 870.2920) | | | Product Code: | MXC, DSI | | | Classification: | Class II | | | Pediatric Use: | The Confirm RxTM ICM has not been specifically tested in pediatric<br>patients below the age of 18 years. | | ### LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED 510(k) K163407: Confirm Rx™ Insertable Cardiac Monitor (ICM) System ### INDICATIONS FOR USE There are no changes to the Indications for Use as a result of this submission. The Indications for Use for the Confirm RxTM ICM system are as follows: The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. The Confirm RxTM ICM has not been specifically tested for pediatric use. {4}------------------------------------------------ ### PRODUCT DESCRIPTION The device description of the Confirm Rx™ Insertable Cardiac Monitor (ICM) Model DM3500 is as follows: - . Confirm Rx™ ICM Model DM3500 Implantable Device: The ICM is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias. It has a two-year longevity, MR conditional labeling, sensing and detection algorithms, and Bluetooth communication. Specific features include: - Patient-initiated triggering of EGM storage using the myMerlin™™ Patient App for o mobile devices. This includes capability for the patient to identify symptoms, which are stored with the EGM for physician review. - Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are o detected; with physician-programmable values for pause duration, bradycardia rate, tachycardia rate, and number of tachycardia intervals. - Automated triggering of EGM storage when atrial fibrillation (AF) is detected, with O physician programmable values for AF duration. - The ability to identify EGM anomalies as a consequence of noise or vigorous activity o and inhibit EGM storage as applicable. - Remote care monitoring. o #### TECHNOLOGICAL CHARACTERISTICS The Confirm RxTM ICM (DM3500) is 4.95 x 0.95 x 0.33 cm in dimension and uses Bluetooth® wireless telemetry to communicate with external devices, including the Merlin PCS programmer and the myMerlin™ mobile application. An external magnet facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions). The remote monitoring equipment for the Confirm Rx™ ICM is the myMerlin™ for Confirm RxTM mobile application, installed on a patient's or Abbott-provided mobile device, using built-in cellular and Wi-Fi connectivity. The myMerlin™ for Confirm RxTM mobile application provides the means for the patient to activate EGM recording in the Confirm Rx™ device, with data passthrough functionality to enable physician follow-up via the Merlin.net Patient Care Network (clinician portal). The Confirm Rx™ ICM (DM3500) will continue to use the same technology. See Figure 1 for a block diagram of the Confirm RxTM ICM system. {5}------------------------------------------------ Image /page/5/Figure/3 description: The image shows a diagram of an insertable cardiac monitor (ICM) system. The system includes several components, such as a clinician, programmer, external magnet, heart, patient, clinician portal, patient application, patient activator, and patient transmitter. The ICM is connected to the heart via sensing, and it communicates with the programmer and patient application via telemetry communications. The clinician can access the system through the clinician portal, which is connected to the patient application via the internet. ### Figure 1: Block Diagram of Confirm RxTM ICM System Only the Confirm Rx™ ICM DM3500 is the subject of this premarket notification. The Merlin PCS 3650 programmer and Merlin.net MN5000 are already FDA approved, with Confirm Rx™ supported on programmer software model 3330 v23.0.1 or higher (per P910023/S382 approved on October 20, 2017) and on Merlin.net v7.5 or higher (per P910023/S381 approved on October 20, 2017). The myMerlin™ for Confirm RxTM mobile applications are FDA cleared per 510(k) K163407 on September 29, 2017 (Android app, APP1000) and K173232 on November 2, 2017 (iOS app. APP1001). The magnet, Model 3111. is Class I exempt MDDS. The Confirm RxTM ICM (both predicate (K1634097) and candidate) is MR Conditional. The Confirm Rx™ ICM is encased in parylene-coated titanium that incorporates two subcutaneous electrodes. The header material on the Confirm RxTM ICM is molded thermoplastic polyurethane (TPU). The battery chemistry of the Confirm Rx™ device is lithium carbon monofluoride. The fundamental technological characteristics of the Confirm RxTM ICM are not changing. In comparison to the predicate device, the Confirm RxTM (cleared on September 29, 2017 per 510(k) K163407), the candidate Confirm RxTM ICM DM3500 with modified FW and UV Cure material have the same: - Intended Use and Indications for Use ● - Operating rules - Device functionality ● - Packaging materials and process ● - Shelf life - Device Longevity . In comparison to the predicate Confirm RxTM ICM device (K163407), the candidate Confirm RxTM ICM DM3500 with modified FW and addition of UV Cure material has the following differences: {6}------------------------------------------------ - The candidate Confirm Rx™ ICM with updated firmware contains minor changes to its ● ERI detection algorithm: - o ERI alert clearing in shipped settings - Response to magnet placement in shipped settings o - The candidate Confirm Rx™ ICM contains minor design change to its in-process battery ● insertion: - O UV Cure material applied to battery terminal base ### SUBSTANTIAL EQUIVALENCE The Confirm RxTM with updated firmware and UV Cure material is substantially equivalent to the predicate Confirm Rx™ ICM DM3500 (K163407). The indications for use are not impacted by the updated FW or the addition of the UV Cure material. Both the candidate and the predicate device (K163407) have the same function and fundamental scientific technology. The minor differences do not raise any new issues of safety and effectiveness. Thus, the candidate Confirm RxTM ICM (DM3500) with UV Cure material and FW F9.3.06 is substantially equivalent to the predicate Confirm RxTM ICM (DM3500). ### TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION All necessary testing was conducted on the candidate Confirm Rx™ ICM DM3500 to support a determination of substantial equivalence to the predicate device, including: - . Firmware Verification and System Validation - Mechanical Performance ● Completion of all verification and validation activities demonstrated that the device with updated firmware and UV Cure material meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate Confirm Rx™ ICM device (K163407). The results of the testing show that the candidate Confirm RxTM ICM performs as intended and is safe for its intended use. ### CONCLUSION The Confirm RxTM ICM is an implantable cardiovascular monitoring device, for which the candidate device shares its design and mechanism of action, as well as the indications for use, with the identified predicate Confirm RxTM ICM (K163407). The results of the verification and validation tests have demonstrated the candidate Confirm Rx™ ICM DM3500 with updated firmware and UV Cure material functions in accordance with product specifications. The fundamental scientific technology of the Confirm Rx™ ICM DM3500 remains unchanged. The candidate Confirm Rx™ ICM with updated firmware and UV Cure material is substantially equivalent to the predicate Confirm RxTM (K163407) in terms of technological characteristics, intended use, and performance.