The SJM Confirm™ ICM 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 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 Version 6.8.1 (or higher)).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SJM Confirm Implantable Cardiac Monitor System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating quantitative "acceptance criteria" and direct "device performance" metrics in the same way a clinical trial might. However, we can infer the "acceptance criteria" through the comparison to the predicate device and the "reported device performance" through the SJM Confirm's specifications. The core acceptance criterion is that the SJM Confirm ICM is at least as good as, or substantially equivalent to, the predicate device (Medtronic Reveal Plus ILR) in its technological characteristics and intended use.

Acceptance Criterion (Inferred from Predicate Equivalence)	Target/Predicate Performance (Medtronic Reveal Plus ILR)	Reported Device Performance (SJM Confirm ICM)
Recording Type	Subcutaneous ECG	Yes
Pre and Post Event Storage	Yes	Yes
EGM Storage Capacity	21 minutes (without compression)	33 minutes
Sampling Rate	100 Hz	128 Hz
Dimensions (Width)	19 mm	18 mm
Dimensions (Volume)	8 cc	6.5 cc
Dimensions (Weight)	17 g	12 g
Electrode Spacing	38.5 mm	39 mm
Shelf Life	14 months	12 months
Auto Activation Triggers	Yes	Yes
Manual (Patient) Activation Trigger	Yes	Yes
High Rate Trigger	Yes	Yes
Programmable High Rate Count	Yes	Yes
Low Rate Trigger	Yes	Yes
Asystole Trigger	Yes	Yes
Biocompatibility	Equivalent to legally marketed SJM pacemakers/ICDs	Equivalent (no change to blood/tissue contact materials)
Sterilization Assurance Level (SAL)	Validated EtO process (Implied: At least 10^-6)	10^-6 (implied from "same validated 100% Ethylene Oxide (EtO) sterilization process as legally marketed St. Jude Medical pacemakers")
Fulfillment of System Requirements	(Not explicitly stated quantitatively, but implied)	Successfully performed and documented (QTR2288, QTR2280, QTR2286, QTR2267, Firmware SVRs, QRS Detection Accuracy and AF Detection Algorithm Report, System Validation Report, GLP Study Report)

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

The provided document does not specify a sample size for a "test set" in the context of clinical performance or algorithm evaluation with specific patient data. The studies mentioned are primarily engineering verification and validation (e.g., mechanical, electrical, EMC, firmware, system validation).

The "QRS Detection Accuracy and AF Detection Algorithm Report" (Appendix 7.6) hints at an algorithm evaluation, which would typically involve a test set. However, the details about the size, country of origin, or retrospective/prospective nature of this data are not provided in this summary.

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

Given the lack of detailed information regarding a test set for algorithm performance, the number and qualifications of experts used to establish ground truth are not provided in this document.

4. Adjudication Method for the Test Set

As information about a specific test set for algorithm performance is not provided, the adjudication method is not mentioned.

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

An MRMC comparative effectiveness study is not mentioned in the document. The filing focuses on demonstrating substantial equivalence through technical specifications and engineering testing, not through human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The "QRS Detection Accuracy and AF Detection Algorithm Report" (Appendix 7.6) suggests that some form of standalone algorithm evaluation was performed for QRS detection accuracy and AF detection. However, the document does not provide details about the specific design, results, or full scope of this standalone study.

7. Type of Ground Truth Used

For the engineering tests (e.g., mechanical, electrical), the "ground truth" would be engineering specifications and standards.

For algorithms related to QRS detection and AF detection, the ground truth would typically be established by expert review of ECGs, possibly correlated with other clinical data. However, the specific type of ground truth (e.g., expert consensus, pathology, outcomes data) used for the "QRS Detection Accuracy and AF Detection Algorithm Report" is not explicitly stated in this summary.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This information would typically be provided if there was a detailed description of an algorithm's development and evaluation.

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

Since no training set is explicitly mentioned, the method for establishing its ground truth is also not provided.

Summary

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K081365
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PREMARKET NOTIFICATION [510(K)] SUMMARY

AUG 1 5 2008

Date Prepared:	August 11, 2008
Submitter:	St. Jude Medical, CRMD
Address:	701 E. Evelyn AvenueSunnyvale, CA 94086
Phone:	408 522 6494
Fax:	408 522 6440
Contact Person:	Elisabeth E. Neely
Trade Name/Proprietary Name:	SJM Confirm Implantable Cardiac Monitor System
Common Name:	Implantable Cardiac Monitor
	Model Numbers: DM2100, DM2100A
Classification:	Class II, 21 CFR 870.2800, 21 CFR 870.2920
Legally marketed deviceto which your firm isclaiming equivalence:	Medtronic Reveal Plus ILR K994331

Device Description:

The indication for use is as follows:

The SJM Confirm™ ICM 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

Technological Characteristics of the Device Compared to the Predicate Device:

The SJM Confirm ICM uses similar technology; has similar intended use, functions, materials and method of operation of the following predicate device described in Table 1 below.

Image /page/0/Picture/12 description: The image shows the logo for St. Jude Medical. The logo consists of a 3x3 grid of black squares on the left, with one square rotated. To the right of the grid is the text "ST. JUDE MEDICAL" in a serif font. Below the text is the tagline "MORE CONTROL LESS RISK" in a smaller, sans-serif font.

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Feature	SJM Confirm	Medtronic Reveal Plus
Subcutaneous ECG	Yes	Yes
Recording
Pre and Post Event	Yes	Yes
Storage
EGM Storage	33 minutes	21 minutes (without compression)
Sampling Rate	128 Hz	100 Hz
Dimensions (mm)	18 x 56 x 8	19 x 61 x 8
Width
Volume	6.5 cc	8 cc
Weight	12 g	17 g
Electrode Spacing	39 mm	38.5 mm
Shelf life	12 months	14 months
Auto Activation	Yes	Yes
Triggers
Manual (Patient)	Yes	Yes
Activation Trigger
High Rate Trigger	Yes	Yes
Programmable High	Yes	Yes
Rate Count
Low Rate Trigger	Yes	Yes
Asystole Trigger	Yes	Yes

Table 1: SJM Confirm ICM Compared to Predicate Device

Image /page/1/Picture/3 description: The image contains the logo for St. Jude Medical. The logo consists of a grid of nine squares on the left, with one square rotated. To the right of the grid is the text "ST. Jude Medical" in a serif font. Below the text is the tagline "More control. Less risk."

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Summary of Studies:

Verification and validation activities necessary to ensure that the SJM Confirm ICM product and system requirements were fulfilled, and to ensure that the product design conforms to the user needs and intended uses were identified and successfully performed. Product verification was successfully performed and is documented in the following reports:

Appendix 7.1	QTR2288: Confirm ICM Mechanical Test Report
Appendix 7.2	QTR2280: Confirm ICM Electrical Test Report
Appendix 7.3	QTR2286: Confirm ICM EMC Test Report
Appendix 7.4	QTR2267: Patient Activator Test Report
Appendix 7.5	Firmware SVRs
Appendix 7.6	QRS Detection Accuracy and AF DetectionAlgorithm Report
Appendix 7.7	System Validation Report
Appendix 7.8	GLP Study Report

Biocompatibility:

There is no change to the blood/tissue contact materials of the SJM Confirm ICM device as compared to legally marketed St. Jude Medical pacemakers and ICDs (e.g., Epic + ICD P910023/S65 and Affinity pacemaker P880086/S61). Therefore, no additional biocompatibility testing was considered necessary per ISO 10993-1. See Table 2 below.

Image /page/2/Picture/6 description: The image shows the logo for St. Jude Medical. The logo consists of a square grid of smaller squares on the left, followed by the text "ST. JUDE MEDICAL" in a bold, sans-serif font. Below the text, there is a smaller tagline that reads "MORE CONTROL. LESS RISK."

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Component	Material	Trade Name of Material	Predicate SJMDevice	PMA Number(Approval Date)
Can	Titanium (grade 1)	n/a	Epic + ICD, Atlas+ ICD	P910023/S65(4/23/03) ,P910023/S69(10/17/03)
HeaderElectrode	Titanium (grade 1)	n/a	Epic + ICD, Atlas+ ICD	P910023/S65(4/23/03) ,P910023/S69(10/17/03)
Header	Epoxy	Hysol High Purity Epoxy	Epic + ICD, Atlas+ ICD	P910023/S65(4/23/03) ,P910023/S69(10/17/03)
ParyleneCoat	Parylene	Parylene-C ConformingCoating polymer	Affinity SR	P880086/S61(6/17/99)

			Table 2: SJM Confirm ICM Patient Contact Materials
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Sterilization Validation:

The SJM Confirm ICM is sterilized using the same validated 100% Ethylene Oxide (EtO) sterilization process as legally marketed St. Jude Medical pacemakers. The sterility assurance level (SAL) is 10 % A sterilization assessment report is provided in Appendix 6. The patient activator, Model DM2100A, is not sterile.

Conclusion:

St. Jude Medical considers the SJM Confirm ICM system to be substantially equivalent to the legally marketed predicate and referenced device.

The results of the tests and compliance with applicable standards (reference Section 6) provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use.

Image /page/3/Picture/8 description: The image shows the logo for St. Jude Medical. The logo consists of a 3x3 grid of black squares on the left, followed by the text "St. Jude Medical" in a serif font. Below the company name is the tagline "More Control. Less Risk."

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2008

St. Jude Medical c/o Ms. Elizabeth Neely Regulatory Affairs Cardiac Rhythm Management Division 701 East Evelyn Avenue Sunnyvale, CA 94086

Rc: K081365

Trade/Device Name: Confirm Model DM2100 Implantable Cardiac Monitor Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MXC, DSH, DXH Dated: July 9, 2008 Received: July 10, 2008

Dear Ms. Neely:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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);

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labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

ell.mall

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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Indications for Use

510(k) Number (if known):

Device Name:____Confirm Model DM2100 Implantable Cardiac Monitor

Indications For Use:

The SJM Confirm ICM 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
(Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW 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	K081365
Page 1 of	1

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).