Confirm Rx Insertable Cardiac Monitor by Abbott

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.

Device Description

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

AI/ML Overview

Here's an analysis of the provided text regarding the Abbott Confirm Rx Insertable Cardiac Monitor (ICM) System, Model DM3500, focusing on acceptance criteria and the supporting study:

Important Note: The provided document is a 510(k) clearance letter and related submission materials. It primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a detailed standalone performance study with comprehensive acceptance criteria and results for the new device. Therefore, some of the requested information (like specific performance metrics and their ranges) is not explicitly listed as "acceptance criteria" and "reported device performance" in the way one might expect for a de novo device clearance. The document emphasizes that the fundamental technological characteristics are not changing, and the focus is on minor firmware updates and a manufacturing material change.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, the document doesn't explicitly define a table of new acceptance criteria with numerical performance targets and reported results for the DM3500 in the way a clinical study report would. Instead, it states that the device "meets its predetermined design and performance specifications" and "performs as intended and is safe for its intended use."

The "acceptance criteria" are implied by the verification and validation activities conducted to ensure the device with the minor changes:

Functions in accordance with product specifications.
Performs as intended.
Is safe for its intended use.
Is substantially equivalent to the predicate (K163407).

The reported device performance is therefore that these criteria were met, specifically through:

Firmware Verification and System Validation: This would ensure the updated firmware functions correctly and that the overall system operates as specified.
Mechanical Performance Testing: This would verify the mechanical integrity and function of the device with the new UV Cure material.

Acceptance Criteria (Implied)	Reported Device Performance
Device functions in accordance with product specifications	Confirmed by Firmware Verification & System Validation
Device performs as intended	Confirmed by Firmware Verification & System Validation
Device is safe for its intended use	Confirmed by various testing, including Firmware & Mechanical
Device remains substantially equivalent to predicate (K163407) (incl. same Indications for Use, operating rules, device functionality, longevity)	Confirmed by comparison, minor differences do not raise new issues
ERI (End of Service Indicator) alert clearing in shipped settings	Updated firmware contains minor changes, implying successful testing
Response to magnet placement in shipped settings	Updated firmware contains minor changes, implying successful testing
Mechanical integrity with UV Cure material	Confirmed by Mechanical Performance testing

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" sample size in terms of patient data or clinical cases. The testing conducted was primarily bench testing and system validation for the firmware and mechanical changes. No clinical study on human subjects is mentioned for this particular 510(k) submission.

Sample Size: Not applicable in the context of human clinical data. For engineering verification and validation, it would refer to the number of devices or test units, which is not stated.
Data Provenance: Not applicable for clinical data. The testing described is internal engineering and validation testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This submission is for a device modification (firmware update and material change) and relies on engineering verification and validation, not on expert adjudication of diagnostic performance on a test set of clinical cases. The "ground truth" here would be the predefined functional and performance specifications of the device.

4. Adjudication Method for the Test Set

Not applicable. As no clinical test set requiring human adjudication is described, there is no adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done and none is described. This device is an insertable cardiac monitor, and its capabilities are assessed through its detection algorithms and hardware performance, not through human interpretation of its outputs in a comparative effectiveness study involving reader performance improvement with AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device's core function is automatic detection of cardiac events (tachycardia, bradycardia, pauses, AF). The document states:

"Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected"
"Automated triggering of EGM storage when atrial fibrillation (AF) is detected"
"The ability to identify EGM anomalies as a consequence of noise or vigorous activity and inhibit EGM storage as applicable."

The "Firmware Verification and System Validation" would have evaluated the performance of these algorithms in a standalone manner (without human intervention) against known inputs. However, no specific metrics (e.g., sensitivity, specificity for AF detection) from such a study are provided in this regulatory document. The statement implies that the existing algorithms (from the predicate) have been verified with the updated firmware.

7. Type of Ground Truth Used

For the Firmware Verification and System Validation, the ground truth would be:

Predefined system specifications: The expected behavior and output of the device's firmware and algorithms under various conditions.
Known input signals: Simulated or recorded ECG/EGM data with precisely defined events (e.g., specific heart rates, AF episodes, pauses) to test the detection algorithms.
Mechanical engineering standards: For the mechanical performance testing.

8. Sample Size for the Training Set

Not applicable. The document does not describe the development of new AI algorithms that require a "training set." The firmware updates are described as "minor changes" to an existing ERI detection algorithm and magnet response, implying fine-tuning or bug fixes rather than a re-training of a predictive model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for new AI algorithms is described.

Summary

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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

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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

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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 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)

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Date Prepared:	November 16, 2018
Submitter:	Abbott (formerly St. Jude Medical), Cardiac Rhythm ManagementDivision
Address:	15900 Valley View Ct.Sylmar, CA 91342USA
Phone:	(818) 362-6822
Establishment Registration:	2017865
Contact Person:	Laura SparksRegulatory Affairs Specialist(818) 493-2734laura.sparks@abbott.com	Jennifer DunhamManager, Regulatory Affairs(818) 493-2363jennifer.dunham@abbott.com
Trade Name/ProprietaryName:	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 pediatricpatients 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.

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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.

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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:

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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.

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).