SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08

K073147 · Transoma Medical · MXC · Dec 3, 2007 · Cardiovascular

Device Facts

• Record ID: K073147
• Device Name: SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08
• Applicant: Transoma Medical
• Product Code: MXC · Cardiovascular
• Decision Date: Dec 3, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

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

Device Story

The Sleuth Implantable ECG Monitoring System is an implantable device for continuous and episodic subcutaneous ECG recording. The system consists of an Implantable Monitoring Device (IMD), an activator, and a base station. This modification introduces an 8 cm antenna accessory (Model 3000-08) for the IMD (Model 2010), providing physicians an alternative to the standard 6 cm antenna. The antenna connects to the IMD via an IS-1 connector. The device is used by patients to monitor cardiac activity; data is recorded and reviewed by physicians to assist in the diagnosis of cardiac arrhythmias. The modification does not change the fundamental operation of the system.

Clinical Evidence

Bench testing only. Testing included visual/dimensional inspection, IS-1 compatibility, resistance, impedance, tensile/flexural strength, protection from external defibrillation/high-power electrical fields, radiated immunity, ESD immunity, and electrical environmental effects (E3).

Technological Characteristics

Implantable ECG monitoring system component. 8 cm antenna with IS-1 connector. Materials and design are consistent with the predicate 6 cm antenna. Connectivity via standard implantable lead interface. Bench testing performed for mechanical and electrical integrity.

Indications for Use

Indicated for patients at increased risk of cardiac arrhythmias or experiencing transient symptoms suggestive of cardiac arrhythmia.

Regulatory Classification

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.

Predicate Devices

• Sleuth Implantable ECG System (K063035)

Submission Summary (Full Text)

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

| 1<br>General Information | DEC 0 3 2007 |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name and Address: | Transoma Medical, Inc.<br>4358 West Round Lake Road<br>Arden Hills, MN 55112<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Lisa Stone<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 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 Recorder<br>Product Code - MXC<br>21 CFR Part 870.2800<br>Device Class II |
| Legally Marketed Device to<br>Which Substantial Equivalence<br>is Claimed: | Sleuth Implantable ECG System<br>K063035 |

#### 2 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.

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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

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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 [phone]. 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 [phone] or [phone] 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)

OR

Over the Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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