The SJM Confirm® Implantable Cardiac Monitor is indicated for monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, shortness of breath, and patients who are at risk for other cardiac arrhythmias.

Device Description

The SJM Confirm® Implantable Cardiac Monitor 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) and the external patient activator (Model DM2100A). The third component is the programmer the physician uses 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 510(k) premarket notification (K122090) from St. Jude Medical, CRMD, for the SJM Confirm® Implantable Cardiac Monitor (Model DM2100) describes a change to an existing device, specifically the use of an alternate collector cell battery. The submission uses substantial equivalence to a legally marketed predicate device (SJM Confirm® Implantable Cardiac Monitor System, K081365).

The provided text does not include acceptance criteria for the device's performance in detecting or diagnosing arrhythmias, nor does it detail a study proving such performance specific to this 510(k) submission. Instead, the core of this submission focuses on demonstrating that the new battery component does not negatively impact the device's existing performance, which was presumably established in the predicate device's original clearance.

Therefore, many of the requested sections (e.g., sample size, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted directly from this document.

Here's a breakdown of the information that can be extracted or inferred based on the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for Battery Change)	Reported Device Performance (Summary)
No degradation in product and system specifications due to alternate battery	"Confirms that alternate collector cell battery has no effects on the device performance."
Biological safety (biocompatibility) maintained	No change to blood/tissue contact materials; therefore, no biocompatibility testing was conducted.
Sterilization effectiveness maintained	Same validated 100% Ethylene Oxide (EtO) sterilization process as the predicate device.
Fundamental technological characteristics (intended use, technology, design, material composition, energy source) remain the same.	The device "has the same fundamental technological characteristics as the currently marketed SJM Confirm® ICM model DM2100."

Explanation: This 510(k) is about a component change. The acceptance criteria are implicitly that the device, with the new battery, performs identically to the predicate device in all relevant aspects (electrical performance, safety, sterilization, etc.). The reported performance is a summary statement that this equivalence has been confirmed through testing.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: The document mentions "Device testing (documented in 60041954, Attachment 3) and component level testing (documented in QTR40008803, Attachment 4)." However, it does not specify the sample size of devices or components used for these tests. The testing would have been conducted on a representative sample of devices containing the new battery.
Data Provenance: The testing was conducted by St. Jude Medical, CRMD. Given it's a premarket submission, the testing would be considered prospective in the context of validating the new battery component. The country of origin of the data is not specified but is inferred to be from St. Jude Medical's internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Provided: This submission focuses on engineering and component-level performance validation post-battery change, not on diagnostic accuracy against a clinical ground truth. Therefore, there's no mention of experts establishing a ground truth for clinical performance.

4. Adjudication method for the test set

Not Applicable / Not Provided: As explained above, this submission does not involve clinical performance assessment requiring ground truth adjudication.

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: This device is an implantable cardiac monitor with diagnostic capabilities (detecting arrhythmias), but the submission focuses on a battery change, not on an AI algorithm or human reader interaction. Therefore, no MRMC study, AI component, or effect size is discussed.

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

Not Applicable: This submission relates to the hardware component change of an existing implantable cardiac monitor, not a standalone algorithm. The device itself performs sensing and EGM storage as part of its diagnostic function, but the approval here is for the battery, not a new or modified detection algorithm.

7. The type of ground truth used

Engineering Specifications and Existing Device Performance: For this 510(k), the "ground truth" for the battery change is that the device with the new battery must meet the established engineering specifications for the original device and exhibit performance equivalent to the device with the original battery. This would involve electrical performance metrics, mechanical integrity, and other product and system specifications established for the predicate device. There is no clinical "ground truth" (like pathology or outcomes data) established in this document for the purpose of demonstrating diagnostic accuracy.

8. The sample size for the training set

Not Applicable / Not Provided: As this submission is about a hardware component change, there is no "training set" in the context of an algorithm.

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

Not Applicable / Not Provided: As there is no training set for an algorithm in this submission, this question is not applicable.

Summary of Device Performance Study:

The study described is an internal engineering and component-level validation. It involved:

Device testing: Documented in St. Jude Medical record 60041954, Attachment 3.
Component level testing: Documented in St. Jude Medical record QTR40008803, Attachment 4.

The conclusion of these tests was that the alternate collector cell battery "has no effects on the device performance." No further details on methodologies, specific results, or quantitative metrics are provided in this summary. The focus is on demonstrating equivalence to the predicate device, not on re-proving the predicate device's efficacy.

Summary

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K122090

PREMARKET NOTIFICATION [510(K)] SUMMARY

Date Prepared:	July 10, 2012
Submitter:	St. Jude Medical, CRMD
Address:	15900 Valley View CourtSylmar, CA 9134
Phone:	818 493 3134
Fax:	818 493 3615
Contact Person:	Plessy Paul
Trade Name/ProprietaryName:	SJM Confirm® Implantable Cardiac Monitor
Common Name:	Implantable Cardiac MonitorModel Numbers: DM2100
Classification:	Class II, 21 CFR 870.2800
Legally marketed deviceto which your firm isclaiming equivalence:	SJM Confirm® Implantable Cardiac Monitor System

Device Description:

The indication for use is as follows:

Technological Characteristics of the Device Compared to the Predicate Device:

The SJM Confirm® ICM with the alternate collector cell battery has the same fundamental technological characteristics as the currently marketed SJM Confirm® ICM model DM2100, including same intended use, technology, design, material composition and energy source. The new implantable grade, collector design, Li-Thionyl Chloride Battery (LTC-3PN-S35) will be used as an alternate battery to our existing spike design LTC-3PN-S33. Both

NOV 1 5 2012

K081365

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collector design and spike design are manufactured by EaglePicher. No modifications are being made to the external patient activator component or the associated programmer software.

Summary of Testing:

In order to ensure that the SJM Confirm® ICM model DM2100, with alternate collector cell battery, meets the product and system specification tests were performed. Device testing (documented in 60041954, Attachment 3) and component level testing (documented in QTR40008803, Attachment 4), confirms that alternate collector cell battery has no effects on the device performance.

Biocompatibility:

There is no change to the blood/tissue contact materials of the SJM Confirm® ICM device with alternate collector cell battery as compared to legally marketed St. Jude Medical Confirm® ICM Model DM2100 (K081365). Therefore, no biocompatibility testing was conducted.

Sterilization:

The SJM Confirm® ICM with alternate collector cell battery is sterilized using the same validated 100% Ethylene Oxide (EtO) sterilization process as legally marketed St. Jude Medical Confirm device, DM2100 (K081365).

Conclusion:

St. Jude Medical considers the SJM Confirm® ICM model DM2100, with alternate collector cell battery to be substantially equivalent to the legally marketed predicate and referenced device through the data and information presented.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

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

NOV 15 2012

St. Jude Medical, CRMD c/o Ms. Plessy Paul Regulatory Affairs Specialist 15900 Valley View Court Sylmar, CA 91324

Re: K122090

Trade/Device Names: SJM Confirm® Implantable Cardiac Monitor, Model DM2100 Regulatory Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (Two) Product Code: MXC, DXH and DSH Dated: November 1, 2012 Received: November 5, 2012

Dear Ms. Paul:

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.

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.

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Page 2 - Ms. Plessy Paul

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owe
201
-05'

Owen P. Faris -S 2012.11.15 15:51:53 -05.00.

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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K122090

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Device Name: SJM Confirm® ICM Model DM2100

Indications for Use:

The SJM Confirm® Implantable Cardiac Monitor is indicated for monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest cannot syncope, shortness of breath, and patients who are at risk for other cardiac arrhythmias.

Prescription Use X (21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 801 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 Sign-on)
Division of Cardiovascular Devices

510(k) Numbe

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).