The Transoma Medical Sleuth Implantable ECG 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

Device Description

The Sleuth Implantable ECG 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 Implantable ECG System comprises three interrelated components: Implantable Monitoring Device (IMD), Activator and Base Station.

The modification described in this Special 510(k) is the addition of an 8 cm Antenna Accessory Kit option (Model 3000-08) for use with the IMD, Model 2010.

The 8 cm antenna gives the physician an additional option. The Accessory Kit contains an 8 cm antenna and torque wrench. No changes have been made to the torque wrench.

The only difference between the original 6 cm antenna and the 8 cm antenna is the length. The antenna measures 8 cm from the IS-1 connector to tip.

AI/ML Overview

The provided document is a 510(k) summary for the Transoma Medical Model 3000-08 Antenna Accessory Kit, which is an accessory to the Sleuth Implantable ECG System. This submission is for a modification to an existing device, specifically the addition of an 8 cm antenna. The summary focuses on demonstrating substantial equivalence to a predicate device (Sleuth Implantable ECG System K063035 with a 6 cm antenna). As such, the study design described is primarily non-clinical bench testing to prove the accessory's safety and performance and its substantial equivalence to the previously cleared device.

Therefore, many of the typical elements of a study proving a new device meets acceptance criteria, particularly clinical performance metrics, reader studies, and ground truth establishment, are not applicable in this context. The document aims to show that the new 8 cm antenna has comparable features and performance to the 6 cm antenna through engineering and physical tests.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Test Category)	Reported Device Performance (Summary of Findings)
Visual/dimensional inspection	Demonstrated to be substantially equivalent to the predicate device (6 cm antenna). The only difference is the length (8 cm from IS-1 connector to tip).
IS-1 testing	Demonstrated to be substantially equivalent to the predicate device.
Resistance testing	Demonstrated to be substantially equivalent to the predicate device.
Impedance testing	Demonstrated to be substantially equivalent to the predicate device.
Tensile/flexural strength testing	Demonstrated to be substantially equivalent to the predicate device.
Protection of the device from external defibrillation and high-power electrical fields testing	Demonstrated to be substantially equivalent to the predicate device.
Radiated immunity testing	Demonstrated to be substantially equivalent to the predicate device.
ESD immunity testing	Demonstrated to be substantially equivalent to the predicate device.
Electrical environmental effects (E3) testing	Demonstrated to be substantially equivalent to the predicate device.
Overall Conclusion (Substantial Equivalence)	Based on the non-clinical test summary, the 8 cm Antenna Accessory Kit is concluded to be substantially equivalent to the 6 cm Antenna Accessory Kit, suggesting it meets the same safety and performance standards established for the predicate device. The only stated difference is the length (8cm vs 6cm).

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

Sample Size: The document does not specify a numerical sample size for each bench test conducted. Non-clinical bench tests often involve testing a small batch of devices (e.g., 3-5 units) per test, but this information is not explicitly stated.
Data Provenance: The data is generated from non-clinical bench testing. The tests were likely performed in a laboratory setting by the manufacturer, Transoma Medical, Inc., located in Arden Hills, MN. This is prospective data generation for the purpose of this 510(k) submission. No specific country of origin for patients or previous data is applicable here as it's a bench test for an accessory.

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

This information is not applicable as the evaluation is based on non-clinical bench testing against established engineering and regulatory standards, not on clinical assessment by medical experts to establish a "ground truth" for diagnostic accuracy. The "ground truth" for these tests would be the established performance characteristics and safety standards for medical device accessories, as demonstrated by the predicate device.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies when multiple human readers interpret data that might be subjective. For bench testing, results are typically objective measurements or pass/fail criteria against a specification, not subject to adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is used to evaluate the impact of a device (often AI) on human reader performance for diagnostic tasks. Since this 510(k) is for an antenna accessory and relies on bench testing for substantial equivalence, such a study would not be relevant.

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

N/A. This device (an antenna accessory) does not involve an algorithm. The "standalone performance" concept usually applies to AI/software as a medical device. Here, the performance is evaluated through physical and electrical characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly the engineering specifications and safety standards that the predicate 6 cm antenna successfully met, and the regulatory requirements for medical devices. The new 8 cm antenna needed to demonstrate compliance with these same non-clinical performance benchmarks to establish substantial equivalence. It is not based on expert consensus, pathology, or outcomes data in the traditional sense.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or algorithms that require a "training set." The performance evaluation is based on direct measurement and testing of the physical accessory.

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

Not applicable as there is no training set for this device.

Summary

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510(k) Summary of Safety and Attachment 7: Effectiveness

1General Information	DEC 0 3 2007
Submitter's Name and Address:	Transoma Medical, Inc.4358 West Round Lake RoadArden Hills, MN 55112Phone: 651-481-7444Fax: 651-481-7413
Contact Person:	Lisa StonePhone: 651-414-5521Fax: 651-481-7415Email: Istone@transomamedical.com
Date of Summary:	November 7, 2007
Proprietary Name of Device:	Model 3000-08 Antenna Accessory Kit
Common/Usual Name:	Implantable ECG Monitoring System
Classification Name:	Cardiac Implantable Event RecorderProduct Code - MXC21 CFR Part 870.2800Device Class II
Legally Marketed Device toWhich Substantial Equivalenceis Claimed:	Sleuth Implantable ECG SystemK063035

2 Device Description

The modification described in this Special 510(k) is the addition of an 8 cm Antenna Accessory Kit option (Model 3000-08) for use with the IMD, Model 2010.

The 8 cm antenna gives the physician an additional option. The Accessory Kit contains an 8 cm antenna and torque wrench. No changes have been made to the torque wrench.

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K073147
p 2/2

The only difference between the original 6 cm antenna and the 8 cm antenna is the length. The antenna measures 8 cm from the IS-1 connector to tip.

3 Intended Use

The Transoma Medical Sleuth Implantable ECG 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 8 cm Antenna Accessory Kit 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 the 8 cm Antenna Accessory Kit has been demonstrated via bench testing, including:

Visual/dimensional inspection -
IS-1 testing -
Resistance testing -
Impedance testing *
Tensile/flexural strength testing =
Protection of the device from external defibrillation and high-power electrical fields testing
-Radiated immunity testing
ESD immunity testing -
Electrical environmental effects (E3) testing -

6 Conclusion

Based on the information provided above, the 8 cm Antenna Accessory Kit is substantially equivalent to the 6 cm Antenna Accessory Kit.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that form the silhouette of a person's head and shoulders.

DEC 0 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Transoma Medical, Inc. c/o Ms. Lisa J. Stone, RAC Principal Regulatory Affairs Specialist 4211 Lexington Ave. North, Suite 2244 St. Paul, MN 55126-6164

Re: K073147

Trade/Device Name: Sleuth Implantable ECG System 8 cm Antenna Accessory Kit Regulation Number: 21 CFR 870.2800 Regulation Name: Implantable Cardiac Event Recorder (without Arrhythmia Detection) Regulatory Class: Class II (two) Product Code: MXC Dated: November 7, 2007 Received: November 8, 2007

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. Iisting 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.

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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 Biometric's (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.

Bzimmerma 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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Indications for Use Statement Attachment 4:

K073147 510(k) Number ____

Device Name: Transoma Medical Sleuth Implantable ECG Monitoring System

Indications for Use:

The Transoma Medical Sleuth Implantable ECG 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

Prescription Use_ ____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart D)

Over the Counter Use (21 CFR 801 Subpart C)

THE COLLECTION COLLECTION COLLECTION COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSU

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhummon
Division Sign Off

Devices Division of Cardlove 510iki 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).