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 Sleuth AT Implantable Cardiac System is an electrocardiogram (ECG) monitoring system that includes an implantable component and that provides continuous ECG monitoring and episodic or segmented ECG recording. The Sleuth AT Implantable Cardiac System comprises three interrelated components: Implantable Loop Recorder (ILR), Personnel Diagnostic Manager (PDM) and Base Station.
The Sleuth AT System incorporates modified brady, asystole, and tachy detection algorithms; additional trending capabilities; EMG detection/rejection; and program pending mode when compared to the original Sleuth System. There are no changes to the Indications for Use and only minor mechanical updates to the ILR and PDM.

AI/ML Overview

Here's an analysis of the provided text, extracting the requested information about acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance Study

The provided document describes the Sleuth AT Implantable Cardiac Monitoring System, a device designed to monitor and record ECGs for diagnosing cardiac arrhythmias. The primary study referenced is the PULSE study, initially conducted on the predicate device (Sleuth system, Model 2010), and its findings are applied to the new Sleuth AT system due to substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance (Sleuth AT)
PULSE Study (Predicate Sleuth System):
Adequacy of ECG signal viability for arrhythmia diagnosis	Supported (adequate)
True Positive Rate for auto-triggers	0.23% (based on predicate study)
False Positive Rate for auto-triggers	99.77% (based on predicate study)
Sleuth AT (using standard ECG databases & clinical data from predicate study):
Sensitivity of R-wave detection	98.6% (MIT-BIH database)
Positive Predictive Value of R-wave detection	99.5% (MIT-BIH database)
Percentage of auto-triggered events that were False Positives (clinical data)	95.96%
Fraction of True Positive auto-triggers (clinical data)	4.04%

Note: The document explicitly states that the PULSE study results "still support the new device Sleuth AT, due to the similarities between the two devices and verifications presented in the 510(k) Notification." The performance metrics reported for Sleuth AT are derived from applying its arrhythmia detector to standard databases and the collected clinical data from the predicate study.

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

Sample Size for PULSE Study (Predicate Device): 28 patients.
Data Provenance (PULSE Study): Four major medical centers in Panama. The study was prospective in nature for the original Sleuth system.
Sample Size for Sleuth AT Evaluation:
- MIT-BIH database: Not specified, but this is a widely recognized public ECG database.
- Collected clinical data: This refers to the ECGs collected from the 28 patients in the PULSE study, which were then applied to the Sleuth AT detector.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts used or their qualifications for establishing the ground truth in the PULSE study or for the MIT-BIH database. It mentions that the study aimed to "evaluate the diagnostic viability of the ECG signals," implying expert review, but details are absent.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for establishing the ground truth in the PULSE study or for the MIT-BIH database.

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

No MRMC comparative effectiveness study was done or reported in the provided text. The evaluation focuses on the device's standalone performance rather than comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was done. The document explicitly states:
"Based on the similarity of the two devices, the new Sleuth AT's arrhythmia detector was verified using standard ECG databases, and ECGs collected in the above study of the predicate Sleuth system. The sensitivity and positive value of R-wave detection was 98.6% and 99.5% (MIT-BIH data base)... Furthermore, when the collected clinical data was applied to the Sleuth AT detector, the percentage of auto-triggered events that were false positives was found to be 95.96%, while the fraction of true positive autotriggers was 4.04%."
This indicates that the algorithm's performance was assessed independently of human interpretation in these tests.

7. Type of Ground Truth Used

PULSE Study (Predicate Device): The ground truth for the "diagnostic viability of the ECG signals" and "true and false positive rates" for auto-triggers would likely have been established through expert consensus/clinical diagnosis based on the monitored ECGs. No explicit mention of pathology or outcomes data for ground truth.
Sleuth AT Evaluation (using MIT-BIH & clinical data):
- MIT-BIH database: This database is widely used and provides expert-annotated ground truth for ECG events.
- "Collected clinical data": Ground truth for this data would be based on the clinical diagnoses derived from the original PULSE study, likely established by expert review.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set of the Sleuth AT's arrhythmia detection algorithms. It only refers to verification using standard databases and collected clinical data.

9. How Ground Truth for the Training Set Was Established

The document does not specify how the ground truth for the training set was established. Given the nature of cardiac arrhythmia detection, it would typically involve expert cardiologists or electrophysiologists annotating ECG recordings. However, this information is not provided for the Sleuth AT.

Summary

{0}------------------------------------------------

SECTION 012 - SUMMARY OF SAFETY AND EFFECTIVENESS

1 General Information

Submitter's Name and Address:

Contact Person:

Date of Summary:

Proprietary Name of Device:

Common/Usual Name:

Classification Name:

Transoma Medical, Inc. 119 14th Street NW St. Paul. MN 55112 Phone: 651-414-5521 Fax: 651-481-7415

K083828 p. 1/3

FEB 1 1 2009

Lisa Stone Phone: 651-414-5521 Fax: 651-481-7415 Email: Istone@transomamedical.com

February 3, 2009

Sleuth AT Implantable Cardiac Monitoring System

Implantable ECG Monitoring System

Cardiac Implantable Event Recorder Product Code - MXC 21 CFR Part 870.2800 Device Class II

Legally Marketed Device to Which Substantial Equivalence is Claimed:

Sleuth Implantable ECG System K063035 and K073147

2 Device Description

The Sleuth AT System incorporates modified brady, asystole, and tachy detection algorithms; additional trending capabilities; EMG detection/rejection; and program pending mode when compared to the original Sleuth System. There are no changes to the Indications for Use and only minor mechanical updates to the ILR and PDM.

Section 012-1

{1}------------------------------------------------

SECTION 012 - SUMMARY OF SAFETY AND EFFECTIVENESS

Intended Use 3

The Transoma Medical Sleuth AT Implantable Cardiac Monitoring System is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:

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

Summary of Technological Characteristics 4

The Sleuth AT System incorporates substantially equivalent technology, comparable features, labeling, and intended use, and is similar to the predicate device currently available on the market.

Non-clinical Test Summary 5

The substantial equivalence of Sleuth AT System has been demonstrated via bench testing, including:

Mechanical
Electrical Safety, Immunity and Compatibility
Heart Rate Detection
Event Detection
ECG Measurement Accuracy
General Electrical Operation
ECG Input Tolerance
Communication Interface
RF Communication Performance
Battery Life
ASIC Accelerated Life -
ASIC Battery Voltage Measurement
System Function and Environment
Evaluation of New Algorithm

Clinical Study Summary 6

A clinical study (PULSE study) was conducted on the original version of the Sleuth system (Model 2010) at four major medical centers in Panama. The results of that study still support the new device Sleuth AT, due to the similarities between the two devices and verifications presented in the 510(k) Notification. The primary objectives of the PULSE study were to evaluate the diagnostic viability of the ECG signals and the performance of

Transoma Medical Special 510(k) - Sleuth AT System Confidential and Proprietary Information Section 012-2

K083828

2/3

{2}------------------------------------------------

SECTION 012 - SUMMARY OF SAFETY AND EFFECTIVENESS Ko83828

the system. Twenty-eight (28) patients were enrolled in the study. The patients had of 3/3
unavalained syncones prosone or were at risk of archythmias The results support unexplained syncope/ pre-syncope or were at risk of arrhythmias. The results supported adequate viability of the ECG signals for the diagnosis of various arrhythmias. In the autotriggers from the population studied, it was found that the true and false positive rates were 0.23% and 99.77%, respectively.

Based on the similarity of the two devices, the new Sleuth AT's arrhythmia detector was verified using standard ECG databases, and ECGs collected in the above study of the predicate Sleuth system. The sensitivity and positive value of R-wave detection was 98.6% and 99.5% (MIT-BIH data base), which is similar or better than the predicate Sleuth system. Furthermore, when the collected clinical data was applied to the Sleuth AT detector, the percentage of auto-triggered events that were false positives was found to be 95.96%, while the fraction of true positive autotriggers was 4.04%.

7 Conclusion

Based on the information provided above, the Sleuth AT System is substantially equivalent to the Sleuth System.

Transoma Medical Special 510(k) - Sleuth AT System Confidential and Proprietary Information

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines representing its wings and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2009

Transoma Medical, Inc. c/o Ms. Lisa J. Stone, RAC Regulatory Affairs Manager 119 14th Street NW St. Paul, MN 55112

Re: K083828

Trade/Device Name: Sleuth AT Implantable Cardiac Monitoring System Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MXC Dated: January 29, 2009 Received: January 30, 2009

Dear Ms. Stone:

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.

{4}------------------------------------------------

Page 2 - Ms. Lisa J. Stone, RAC

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); 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 yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K083828

Device Name: Sleuth AT Implantable Cardiac Monitoring System

Indications for Use:

The Sleuth AT system is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:

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 X (Part 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)

Mitchell Sile for B Zuckerman

(Division Sign-Off) Division of Cardiovascular 510(k) Number

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).