The SJM Confirm® Implantable Cardiac Monitor is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:

patients with clinical syndromes or situations at increased risk of cardiac arrhythmias .
patients who experience transient symptoms that may suggest a cardiac arrhythmia .

Device Description

The SJM Confirm® Implantable Cardiac Monitor (MR Conditional) is a minimally invasive, implantable diagnostic monitoring device with subcutaneous electrodes that are used for sensing and a looping memory for storage of electrograms (EGM). The device is comprised of three main components: the implantable cardiac monitor (Model DM2100), an external patient activator (Model DM2100A) and a programmer. The programmer is used by the physician to communicate to the cardiac monitor and associated programmer software. The programmer is the legally marketed SJM Merlin PCS programmer Model 3650 (with Software Model 3330).

AI/ML Overview

This document describes the SJM Confirm® Implantable Cardiac Monitor (MR Conditional) (Model DM2100) and its 510(k) submission (K122161). The submission claims substantial equivalence to two predicate devices: the SJM Confirm® ICM Model DM2100 (K081365) and the Medtronic Reveal DX Insertable Cardiac Monitor (K071655).

The submission focuses heavily on the new "MR Conditional" labeling.

Here's an analysis of the provided information concerning acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria or a direct performance table in terms of diagnostic accuracy (e.g., sensitivity, specificity for arrhythmia detection) for the SJM Confirm® Implantable Cardiac Monitor.

Instead, the "acceptance criteria" for this 510(k) submission appear to be focused on demonstrating:

Substantial Equivalence: The device is substantially equivalent to the predicate devices in terms of technological characteristics and intended use.
MRI Compatibility: The device performs safely and effectively in MRI environments.
Compliance with Predetermined Design and Performance Specifications: As confirmed by verification and validation activities.

Based on the provided text, the "reported device performance" is largely qualitative and focused on meeting these criteria, rather than specific numerical diagnostic performance metrics.

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Substantial Equivalence	Identical technological characteristics (scientific technology, design, materials, energy source, software, hardware, electrical hardware, shelf life, packaging, sterilization, manufacturing processes) to the predicate SJM Confirm® ICM Model DM2100 (K081365).	The SJM Confirm® ICM (MR Conditional) is stated to be identical to the SJM Confirm® ICM Model DM2100 (K081365) in all these technological characteristics. It is also claimed to be substantial equivalent to the Medtronic Reveal DX.
MRI Compatibility	Device remains functional after MRI exposure. Device performance is maintained after exposure to combined MRI fields.Acceptable MRI-induced force and torque. Acceptable RF field and gradient field induced heating.	Bench testing was performed for: Post-MRI Exposure Functional testing, Device Performance Testing after Exposure to Combined Fields, MRI Induced Force and Torque Testing, and RF Field and Gradient Field Induced Heating Tests. Test results demonstrate that the SJM Confirm® ICM is compatible for use in MRI environments.
Electrical Safety	Compliance with relevant electrical safety and electromagnetic compatibility standards.	Electrical safety and electromagnetic compatibility testing performed for the predicate device (K081365) applies to this device because the hardware configuration is identical.
Biocompatibility	Use of biocompatible materials.	No new biocompatibility testing was warranted as there are no changes to components or materials; they are identical to the predicate (K081365). Biocompatibility testing was conducted for the predicate device per FDA guidance document.
General Performance	Meet predetermined design and performance specifications.	Verification and validation activities were performed to ensure that the SJM Confirm® ICM devices meet their predetermined design and performance specifications.

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

The provided text does not describe a clinical test set with human patient data for evaluating arrhythmia detection or diagnostic performance. All listed tests are "nonclinical tests" (bench tests) related to MRI compatibility and product safety/functionality.

Test Set (for MRI compatibility, electrical safety, biocompatibility): Not applicable in terms of patient data. The "test set" would consist of the device itself and associated components.
Data Provenance: Not applicable in terms of country of origin or retrospective/prospective clinical study, as these were bench tests.

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

Not applicable. No clinical test set requiring ground truth established by experts is described in the provided nonclinical test summary.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is described.

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

Not applicable. The device is an implantable cardiac monitor, not an AI-assisted diagnostic imaging or ECG interpretation system that would involve human readers improving with AI.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The device itself is a standalone monitoring system that automatically detects and records ECGs. The document confirms that "verification and validation activities were performed to ensure that the SJM Confirm® ICM devices meet their predetermined design and performance specifications," implying that the device's inherent functional performance (including its algorithms for detection) was tested. However, no specific details about the methodology or results of these "algorithm only" tests are provided beyond the general statement. The focus of this 510(k) is MRI compatibility.

7. The Type of Ground Truth Used

For the nonclinical tests described:

MRI Compatibility: Ground truth would be defined by the specifications of MRI machines, industry standards (e.g., for heating, force, torque), and post-exposure functional criteria (e.g., does the device still operate to spec?).
Electrical Safety, Biocompatibility: Ground truth is established by adherence to recognized national and international standards (e.g., ISO-10993-1 for biocompatibility).
"Predetermined Design and Performance Specifications": The ground truth here is the engineering and functional requirements established during the device's design phase.

8. The Sample Size for the Training Set

Not applicable. The device is not described as an AI/machine learning system requiring a training set in the conventional sense. Its "algorithms" for arrhythmia detection would have been developed through traditional embedded software engineering.

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

Not applicable. As there's no described AI/machine learning training set.

Summary

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Traditional 510(k) Notification

PREMARKET NOTIFICATION 510(K) SUMMARY

Date Prepared:	July 18, 2012
Submitter:	St. Jude Medical, CRMD
Address:	701 E. Evelyn AvenueSunnyvale, CA 94086
Phone:	408 522 6832
Fax:	408 522 6440
Contact Person:	Saket Bhatt
Trade Name/Proprietary Name:	SJM Confirm® Implantable Cardiac Monitor System
Common Name:	Implantable Cardiac MonitorModel Number: DM 2100
Classification:	Class II, 21 CFR 870.2800
Product Code:	MXC
Legally marketed devices to which substantial equivalence is claimed:	SJM Confirm® (Model DM2100) Implantable Cardiac Monitor 510(k) K081365Medtronic Reveal DX Insertable Cardiac Monitor 510(k) K071655

Device Description:

Indications for Use:

The SJM Confirm® Implantable Cardiac Monitor is an implantable patient-activated and automaticallyactivated monitoring system that records subcutaneous ECG and is indicated in the following cases:

patients with clinical syndromes or situations at increased risk of cardiac arrhythmias .
patients who experience transient symptoms that may suggest a cardiac arrhythmia .

Technological Characteristics of the Device Compared to the Predicate Device:

The SJM Confirm® ICM (MR Conditional) is identical to the SJM Confirm® ICM Model DM2100 (K081365) in terms of technological characteristics including scientific technology, design, materials, energy source, software, hardware, electrical hardware, shelf life, packaging, sterilization and manufacturing processes. The SJM Confirm® ICM (MR Conditional) with MRI labeling modifications is also substantial equivalent to the Medtronic Reveal DX (K071655). Similar to the SJM Confirm@ ICM, Medtronic's Reveal DX is an implantable, single-use programmable device with two surface electrodes to continuously monitor a patient's subcutaneous ECG.

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Traditional 510(k) Notification

SJM Confirm® ICM

Summary of the Nonclinical Tests Performed:

Verification and validation activities were performed to ensure that the SJM Confirm® ICM devices meet their predetermined design and performance specifications and that the product is substantially equivalent to the predicate device, the SJM Confirm® ICM Model DM2100 (K081365).

In order to ensure MRI compatibility, the following bench testing was performed: Post-MRI Exposure Functional testing after individual field exposure, Device Performance Testing after Exposure to Combined Fields, MRI Induced Force and Torque Testing and RF Field and Gradient Field Induced Heating Tests. Test results demonstrate that the SJM Confirm® ICM is compatible for use in MRI environments.

Since the hardware configuration of the SJM Confirm® ICM (MR Conditional) is identical to its predicate device, the SJM Confirm® ICM Model DM2100 (K081365), the electrical safety and electromagnetic compatibility testing that was performed for the predicate device, also applies to the SJM Confirm® ICM with MRI compatibility. The electrical safety and electromagnetic compatibility test reports were submitted in 510(k) K081365 cleared by FDA on August 15, 2008.

There have been no changes to the components or materials for the SJM Confirm® ICM (MRI Conditional); they are identical to the SJM Confirm® ICM Model DM2100 (K081365). Since there are no new components or materials for the SJM Confirm® ICM (MRI Conditional), no new biocompatibility testing was warranted. Biocompatibility testing of all components and materials was conducted for the SJM Confirm® ICM Model DM2100 (K081365) pursuant to FDA's Guidance Document (#G95-1), Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (1995)".

Conclusion

St. Jude Medical considers the SJM Confirm® Implantable Cardiac Monitor with MRI labeling to be substantially equivalent to legally marketed predicates: SJM Confirm® Implantable Cardiac Monitor System (K081365) and the Medtronic Reveal DX Insertable Cardiac Monitor 510(k) K071655.

The test results and compliance with applicable standards provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

NOV 2 8 2012

St Jude Medical, Inc. (CRMD) c/o: Saket Bhatt Sr. Regulatory Affairs Specialist 701 E. Evelyn Avenue Sunnyvale, CA 94086

Re: K122161

Trade Name: SJM confirm implantable cardiac monitor- (MR conditional) Regulatory Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: II (two) Product Code: MXC Dated: November 2, 2012 Received: November 5, 2012

Dear Mr. Saket Bhatt:

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. 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.

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Page 2 - Mr. Saket Bhatt

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

Owen P. Faris -S

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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SJM Confirm® ICM

Indications for Use

510(k) Number (if known):

Device Name: SJM Confirm® Implantable Cardiac Monitor (MR Conditional); Model DM2100

Indications For Use:

The SJM Confirm® Implantable Cardiac Monitor is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:

patients with clinical syndromes or situations at increased risk of cardiac arrhythmias .
patients who experience transient symptoms that may suggest a cardiac arrhythmia .

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	K122161
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Page 1 of 1St. Jude Medical, Inc. (CRMD)

CONFIDENTIAL

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).