REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539)

K071641 · Medtronic, Inc. · DSI · Nov 21, 2007 · Cardiovascular

Device Facts

• Record ID: K071641
• Device Name: REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539)
• Applicant: Medtronic, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Nov 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The Reveal XT Insertable Cardiac Monitor 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 The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal Insertable Cardiac Monitor: - To verify whether the implanted device has detected a suspected arrhythmia or device related event. - To initiate recording of cardiac event data in the implanted device memory.

Device Story

Reveal XT (Model 9529) is a leadless, subcutaneous implantable cardiac monitor (ICM) placed in the chest; continuously monitors subcutaneous ECG via two electrodes. Automatically detects and records arrhythmias (AT/AF, bradyarrhythmia, asystole, ventricular tachyarrhythmia) and stores ECG/marker channels. Patient Assistant (Model 9539) is a handheld, battery-operated telemetry device for patient use outside clinical settings; allows patients to manually trigger event recording and query device status/notifications. Data management features assist physicians in diagnosing cardiac events. Benefits include detection of arrhythmias in patients who may not manually trigger the device.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included electromagnetic compatibility (EMC), electrical safety, environmental, sterilization, firmware, MRI compatibility, and sensing/detection performance validation. Functional, mechanical, and usability testing performed for the Patient Assistant.

Technological Characteristics

Leadless, subcutaneous implantable device. Sensing via two electrodes on device body. EtO sterilization. Firmware-based arrhythmia detection. Handheld telemetry Patient Assistant. MRI compatible.

Indications for Use

Indicated for patients at increased risk of cardiac arrhythmias or those experiencing transient symptoms suggestive of cardiac arrhythmia. Patient Assistant intended for unsupervised use by patients to trigger recordings or verify device status.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Medtronic Reveal Plus (Model 9526) ILR (K994331, K003667)
• Instromedix King of Hearts Express AF Recorder (K020825)
• Novacor Vista Plus Holter Recorder (K042108)
• IM Systems Activity Monitor (K992410)
• Invivo Corporation Model 3160 MRI Patient Monitor (K053462)
• Medtronic Model 6191 Patient Activator (K994331)

Submission Summary (Full Text)

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# 510(K) SUMMARY

NOV 2 1 2007

| Date Prepared: | June 14, 2007 |
|-----------------------|-------------------------------------------------------------------------------------------------------------|
| Submitter: | Medtronic, Inc.<br>Cardiac Rhythm Disease Management<br>710 Medtronic Parkway<br>Minneapolis, MN 55432-5604 |
| Contact: | Sara Christiansen<br>Senior Regulatory Affairs Specialist |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Proprietary Name: | Reveal XT Insertable Cardiac Monitor<br>Reveal XT Patient Assistant |
| Common Name: | Insertable Cardiac Monitor |
| Device Classification | Class II, 21 CFR 870.1025, Arrhythmia<br>detector and alarm |
| Product Code: | DSI |

#### Summary of Substantial Equivalence

The intended use, design, materials and performance of the Reveal XT Insertable Cardiac Monitor (Model 9529) are substantially equivalent to the following predicate devices:

- · Medtronic Reveal Plus (Model 9526) ILR K994331. Cleared 21 January 2000/K003667, Cleared 14 February 2001
- · Instromedix King of Hearts Express AF Recorder K020825, Cleared 05 April 2002
- · Novacor Vista Plus Holter Recorder K042108, Cleared 19 January 2005
- · IM Systems Activity Monitor K992410, Cleared 15 October 1999
- · Invivo Corporation Model 3160 MRI Patient Monitor (MRI compatible multiparameter patient monitor) -- K053462, Cleared 18 January 2005

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The intended use, design, materials and performance of the Reveal XT Patient Assistant (Model 9539) are substantially equivalent to the following predicate devices.

- · Medtronic Model 6191 Patient Activator K994331. Cleared 21 January 2000
- · Instromedix King of Hearts Express AF Recorder K020825, Cleared 05 April 2002/ K003667, Cleared 14 February 2001

### Device Description

The Reveal XT Model 9529 Insertable Cardiac Monitor (ICM) is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial tachyarrhythmia/atrial fibrillation (AT/AF), bradyarrhythmia. asystole, or (fast) ventricular tachyarrhythmia. The Reveal XT ICM provides storage of ECG and marker channels during patient-activated and automaticallydetected (auto-activated) events. Auto activation may help to detect abnormal heart rhythms in patients who may not activate/trigger the ICM.

The Reveal XT ICM Model 9529 is a small, leadless device that is typically implanted under the skin, in the chest. Two clectrodes on the body of the device continuously monitor the patient`s subcutaneous ECG.

The Reveal XT Patient Assistant Model 9539 is a hand-held, battery-operated telemetry device that enables the patient to start recording cardiac information in the Reveal XT ICM after experiencing symptoms of a possible cardiac event. A query function enables the patient to check his or her device and receive notification when an arrhythmia has occurred or when the device status has changed. The Reveal XT Patient Assistant query function enables the patient to check the status of physician-programmed parameters.

#### Indications for Use

The Reveal XT Insertable Cardiac Monitor is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous FCG 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

The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal Insertable Cardiac Monitor:

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Traditional 510(k) 510(k) Summary

- · To verify whether the implanted device has detected a suspected arrhythmia or device related event.
- · To initiate recording of cardiac event data in the implanted device memory.

#### Technoloqical Characteristics

Intended use, design, materials, performance and technological characteristics are substantially equivalent to the predicate devices referenced.

### Summary of Testing

Device verification testing was performed to demonstrate the Reveal XT Model 9529 Insertable Cardiac Monitor and Reveal XT Patient Assistant Model 9539 meet established performance criteria and to support equivalency to the reference predicate devices. Electromagnetic compatibility (EMC), electrical safety. component, environmental handling, sterilization, firmware. MRI compatibility, and sensing and detection performance validation testing were completed for the Reveal XT Model 9529 Insertable Cardiac Monitor. Functional and mechanical performance testing, firmware testing and usability testing was completed for the Reveal XT Patient Assistant Model 9539. System verification and validation and packaging testing were also completed. The results of the testing indicate that the Reveal XT Insertable Cardiac Monitor Model 9529 and Reveal XT Patient Assistant Model 9539 perform as intended and are safe for their intended use.

Biocompatibility testing was not required because blood-contacting materials of the Reveal XT Model 9529 Insertable Cardiac Monitor implanted device are similar to the predicate device, the Medtronic Reveal Plus ILR.

The Reveal XT Model 9529 Insertable Cardiac Monitor will be sterilized using a validated EtO sterilization process.

#### Conclusion

Medtronic considers the Reveal XT Insertable Cardiac Monitor system to be substantially equivalent to legally marketed predicate devices through the data and information presented. No safety or effectiveness issues were identified.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2007

Medtronic, Inc. c/o Ms. Michelle Nivala Regulatory Affairs Specialist Cardiac Rhythm Disease Management 8200 Coral Sea Street NW Mounds View. MN 55112

Re: K071641

Trade/Device Name: Reveal XT (Model 9529) and Reveal Patient Assistant (Model 9539) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class II (two) Product Code: DSI Dated: November 1, 2007 Received: November 2, 2007

Dear Ms. Nivala:

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.

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Page 2 - Ms. Michelle Nivala

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 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 yours.

R. Lochner

A 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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K

## INDICATIONS FOR USE

510(k) Number (if known): __ Ko71641

Device Name: Reveal XT Insertable Cardiac Monitor and Reveal XT Patient Assistant

Indications for Use:

The Reveal XT Insertable Cardiac Monitor 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

The Reveal XT Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal Insertable Cardiac Monitor:

- To verify whether the implanted device has detected a . suspected arrhythmia or device related event.
- To initiate recording of cardiac event data in the implanted . device memory.

Prescription Use

AND/OR

Confidential

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Holmes
(Division

vascular Devices

510(k) Number

1-27