Confirm Rx Insertable Cardiac Monitor by Abbott (St. Jude Medical)

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.

Device Description

The Confirm Rx™ Insertable Cardiac Monitor (ICM) Model DM3500 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 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 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 physician programmable values for AF duration.
The ability to identify EGM anomalies as a consequence of noise or vigorous activity and inhibit EGM storage as applicable.
Remote care monitoring.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Abbott Confirm Rx™ Insertable Cardiac Monitor (ICM) System, Model DM3500, with updated firmware. The purpose of this submission is to demonstrate substantial equivalence to a predicate device (K182981).

The document details the device description, technological characteristics, and the testing conducted to support the substantial equivalence claim. However, it does NOT contain a detailed study proving the device meets specific acceptance criteria for AI/algorithm performance as would be typically found for new AI-driven diagnostic devices. Instead, the focus is on demonstrating that the updated firmware, particularly its detection algorithms, functions as intended without raising new issues of safety and effectiveness compared to the predicate device.

Specifically, the acceptance criteria and performance data are described in terms of verification and validation activities showing the device meets its "predetermined design and performance specifications" and "functions in accordance with product specifications." The changes in the firmware relate to "detection algorithms for the diagnosis of bradycardia, asystole (pause), and atrial fibrillation (AF)," including "second pass undersensing discriminators" and a "P-wave detection discriminator."

Given the information provided, it's not possible to present a table of acceptance criteria and reported device performance in the context of an AI study as you described.

However, I can extract the relevant information regarding the firmware update validation and
address the closest approximations to your questions for this type of medical device submission.

Analysis of the Provided Document Regarding Acceptance Criteria and Study:

The document describes an update to the firmware of an existing, already cleared device. The "study" here is the validation of the firmware update to ensure it doesn't negatively impact safety or effectiveness and that the new algorithms perform as intended.

1. A table of acceptance criteria and the reported device performance

The document states that the "Completion of all verification and validation activities demonstrated that the device with updated firmware meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate Confirm Rx™ ICM device (K182981)." It also states, "The results of the testing show that the candidate Confirm RxTM ICM performs as intended and is safe for its intended use."

The updated firmware includes changes to detection algorithms for bradycardia, asystole (pause), and atrial fibrillation (AF). The acceptance criteria would inherently be related to the accuracy and reliability of these detections compared to established benchmarks or the predicate device, although specific numerical performance metrics (e.g., sensitivity, specificity, accuracy percentages) are not detailed in this summary.

Acceptance Criteria (Implied)	Reported Device Performance
Device meets predetermined design and performance specifications for detection algorithms (bradycardia, asystole, AF) including new discriminators.	Device with updated firmware meets its predetermined design and performance specifications.
Device performs as intended for its specified use (monitoring and diagnostic evaluation of arrhythmias).	Device performs as intended and is safe for its intended use.
Updated firmware does not raise new issues of safety and effectiveness compared to the predicate device.	The minor differences (firmware update) do not raise new issues of safety and effectiveness.
Maintenance of device longevity with updated firmware.	Accounted for the current drain and time used to execute the undersensing and P-wave discriminators within the battery longevity calculation.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size (number of patients, number of EGM recordings) used for the verification and validation (V&V) testing. It also does not specify the data provenance (country of origin, retrospective/prospective). This type of detail is typically found in the full testing report, not usually summarized in this section of a 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not specify the number or qualifications of experts used to establish ground truth. For embedded device algorithm testing, ground truth might often be established through simulated signals, pre-recorded clinical data with confirmed diagnoses, or expert review of EGMs, but this detail is not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not specify any adjudication method for ground truth establishment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not conducted or described. This is a device firmware update, not a new AI-assisted diagnostic tool where human reader performance would be compared. The focus is on the device's internal algorithm performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the testing described appears to be a standalone validation of the algorithm's performance within the device, given the context of "Software/Firmware Verification and System Verification" and "Design Validation." The purpose is to confirm the algorithm's internal logic and detection capabilities. The document states:

"Second pass undersensing discriminators added to the Asystole and Bradycardia detection algorithms to reject false Pause and Bradycardia detections."
"Second pass P-wave detection discriminator to reject false AF detections."

This implies that the algorithm itself was tested for its ability to correctly identify and reject false detections, which is a standalone performance metric.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The type of ground truth is not explicitly stated. For cardiac rhythm detection algorithms, ground truth typically involves a highly accurate reference ECG/EGM interpretation, which could be established via:

Expert Consensus: Review by multiple cardiologists or electrophysiologists.
Manual Annotation: Beat-by-beat or episode-by-episode annotation of EGM data by trained personnel, often adhering to specific criteria.
Validation against high-fidelity recordings: Comparing device output to a gold-standard recording from a different, validated system.

Given the focus on "reject[ing] false detections," it implies that there was a reference against which the algorithm's detection (true positive/false positive) was measured.

8. The sample size for the training set

The document does not provide any information about a training set size. This indicates that this submission is about validating a firmware update for an already cleared device, not seeking de novo clearance for a new machine learning algorithm that typically requires a distinct training phase. While the algorithms were likely "trained" or designed using data at some point in their development, that information is not part of this 510(k) summary for a firmware update.

9. How the ground truth for the training set was established

Since there is no mention of a training set in this document, there is no information on how its ground truth was established.

Summary

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April 10, 2019

Abbott (St. Jude Medical) Laura Sparks Sr. Regulatory Affairs Specialist 15900 Valley View Ct. Sylmar, California 91342

Re: K190295

Trade/Device Name: Confirm Rx Insertable Cardiac Monitor Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MXC, DSI Dated: February 8, 2019 Received: February 11, 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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 mediation-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,

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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Date Prepared:	February 8, 2019
Submitter:	Abbott (formerly St. Jude Medical), Cardiac Rhythm Management Division
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) 383-1630jennifer.dunham@abbott.com
Trade Name/ProprietaryName:	Confirm Rx TM Insertable Cardiac Monitor System
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 Rx TM Insertable Cardiac Monitor has not been specificallytested in pediatric patients below the age of 18 years.

LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED

510(k) K182981 Confirm Rx™ Insertable Cardiac Monitor 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 Insertable Cardiac Monitor (ICM) system are as follows:

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™ for Confirm Rx™ 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 RxTM ICM is the myMerlin™ for Confirm Rx ™ mobile application, installed on a patient's or Abbott-provided mobile device, using built-in cellular or Wi-Fi connectivity. The myMerlin™ for Confirm RxTM mobile application provides the means for the patient to activate EGM recording in the Confirm Rx™ ICM device. with data pass-through 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/4/Figure/3 description: This image shows a block diagram of an insertable cardiac monitor (ICM) system. The ICM is connected to the heart for sensing and communicates via telemetry to a patient application. The patient application consists of a patient activator and a patient transmitter, and it communicates with a clinician portal 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 (K182981) 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 Rx™ ICM DM3500 (K182981), the candidate Confirm RxTM ICM DM3500 with modified FW has the same:

Intended Use and Indications for Use
Operating rules ●
Device functionality
Packaging materials and process
Shelf life ●
o Device Longevity

In comparison to the predicate Confirm RxTM ICM device (K182981), the candidate Confirm RxTM ICM DM3500 with modified firmware has the following differences:

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The candidate Confirm Rx™ ICM with updated firmware contains changes pertaining to ● its detection algorithms for the diagnosis of bradycardia, asystole (pause), and atrial fibrillation (AF):
- Second pass undersensing discriminators added to the Asystole and Bradycardia o detection algorithms to reject false Pause and Bradycardia detections.
- Second pass P-wave detection discriminator to reject false AF detections. o
The candidate Confirm Rx™ ICM with updated firmware also contains the following ● changes:
- o Accounted for the current drain and time used to execute the undersensing and Pwave discriminators within the battery longevity calculation.
- Added a check for the presence of non-AF Electrogram Triggers within an AF o Entry Post-Trigger duration.
- Added a check if Atrial Summary Diagnostics were cleared during an ongoing AF o Episode.
- Modified the AF Episode Alert to be triggered 15 seconds after meeting the o defined episode duration threshold.
- Modified firmware to start its first periodic check of FRAM integrity on O launching the Therapy Application.
- Modified firmware to monitor duty cycle values to detect and log occurrences of o duty cycle values that have a higher value and duration than the defined thresholds.
- 0 Modified Bluetooth Low Energy (BLE) driver firmware to add the capability to reset the Real Time (RT) EGM buffer upon buffer overflows.

SUBSTANTIAL EQUIVALENCE

The Confirm Rx™ ICM with updated firmware is substantially equivalent to the predicate Confirm Rx™ ICM DM3500 (K182981). The indications for use are not impacted by the updated firmware. Both the candidate and the predicate device (K182981) have the same function and fundamental scientific technology. The minor differences do not raise new issues of safety and effectiveness. Thus, the candidate Confirm RxTM ICM (DM3500) with FW F9.3.0F is substantially equivalent to the predicate Confirm RxTM ICM (DM3500) (K182981).

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:

o Software/Firmware Verification and System Verification
Clip Testing ●
Design Validation 0

Completion of all verification and validation activities demonstrated that the device with updated firmware meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate Confirm Rx™ ICM device (K182981). The results of

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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 (K182981). The results of the verification and validation tests have demonstrated the candidate Confirm Rx™ ICM DM3500 with updated firmware functions in accordance with product specifications. The fundamental scientific technology of the Confirm Rx™ ICM DM3500 remains unchanged. The candidate Confirm RxTM ICM with updated firmware is substantially equivalent to the predicate Confirm Rx™ ICM (K182981) in terms of technological characteristics, intended use, and performance.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K190295

Device Name

The Confirm RxTM Insertable Cardiac Monitor (ICM) System, Model DM3500

Indications for Use (Describe)

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 indients 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.

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)

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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).