TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM

K100155 · Biomedical Systems Corp. · DSI · Apr 20, 2010 · Cardiovascular

Device Facts

• Record ID: K100155
• Device Name: TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM
• Applicant: Biomedical Systems Corp.
• Product Code: DSI · Cardiovascular
• Decision Date: Apr 20, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The TruVue™ System is intended for use by patients who experience transient events that may suggest cardiac arrhythmia. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation). Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath). Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring. ECG data recorded by the device can be analyzed by other processing systems, such as the BMS Century Holter system to provide Holter style reports. Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Device Story

TruVue system provides continuous ambulatory ECG monitoring; collects 2-channel ECG via body-worn sensor. Sensor transmits data via Bluetooth to handheld communications device; handheld transmits data to attended monitoring center via cellular or landline telephony. Data center provides full disclosure ECG for analysis by proprietary server-side algorithm and review by monitoring technician or physician. System aids in detecting cardiac arrhythmias in outpatient settings. Output allows clinicians to assess cardiac rhythm, evaluate drug efficacy, or generate Holter-style reports via external systems (e.g., BMS Century Holter). Device does not provide automated diagnostic interpretations; physician remains responsible for diagnosis.

Clinical Evidence

Bench testing only. Device performance validated against AAMI EC-38 (Ambulatory Electrocardiographs) and ANSI/AAMI EC-57 (Testing and Reporting - Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms) standards. No clinical trial data presented.

Technological Characteristics

2-channel ambulatory ECG monitor. Components: body-worn sensor, handheld communication device. Connectivity: Bluetooth (PAN), cellular/POTS (WAN). Standards: AAMI EC-38, ANSI/AAMI EC-57, IEC 60601-1, IEC 60601-1-2. Software: Proprietary server-side arrhythmia detection algorithm.

Indications for Use

Indicated for patients experiencing transient symptoms suggesting cardiac arrhythmia, requiring drug effect monitoring for atrial arrhythmias, or recovering from cardiac surgery. Symptoms include dizziness, lightheadedness, syncope of unknown etiology, or dyspnea. Contraindicated for patients requiring attended, in-hospital monitoring for life-threatening arrhythmias.

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

• CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector (K081257)
• NUVANT, Mobile Cardiac Telemetry System (K091971)
• Medicalgorithmics Real-Time ECG Monitor and Arrhythmia Detector (K090037)

Submission Summary (Full Text)

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K100155
pi/3

| 510(k) Summary of Safety & Effectiveness | Date: Jan 14, 2010 | |
|------------------------------------------|------------------------------------------------------------------------------|-------------|
| 1.) Submitter Name & Address: | Biomedical Systems, Inc<br>77 Progress Parkway<br>Maryland Heights, MO 63043 | APR 20 2010 |
| 2.) Contact Person: | K. Michael Kroehnke<br>Phone: [phone]<br>Fax: [phone] | |
| 3) Device: | | |
| Trade Name: | TruVue™ System | |
| Classification Name | Arrhythmia Detector and Alarm | |
| Product Code: | DSI | |
| Regulation No: | 870.1025 | |
| Class: | Class II, Special Controls | |
| 4) Substantial Equivalence: | | |

The TruVue™ System is substantially equivalent to following previously cleared devices:

- 1) CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector, K081257
- 2) NUVANT, Mobile Cardiac Telemetry System, K091971

3) Medicalgorithmics Real-Time ECG Monitor and Arrhythmia Detector, K090037

| | TruVue™ | CG-6108<br>ACT-3L | PocketECG | NUVANT | SE<br>Determination |
|-----------------------------------------------|---------------------------------------------------|---------------------------------------------------|---------------------------------------------------|---------------------------------------------------|---------------------|
| ECG Channels | 2 | 2 | 1 | 1 | SE, see note a |
| Ambulatory<br>ECG<br>performance<br>standards | EC 38<br>compliant | EC 38<br>compliant | EC 38<br>compliant | EC 38<br>compliant | SE, see note b |
| ECG<br>Acquisition /<br>WAN<br>communications | Body worn<br>sensor,<br>handheld<br>WAN<br>device | Body worn<br>sensor,<br>handheld<br>WAN<br>device | Body worn<br>sensor,<br>handheld<br>WAN<br>device | Body worn<br>sensor,<br>handheld<br>WAN<br>device | SE |

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| Transmission<br>Technology<br>(PAN) | Bluetooth | Bluetooth | Bluetooth | Bluetooth | SE |
|-------------------------------------|---------------------------------|---------------------------------|-------------------------------|---------------------------------|----------------|
| Transmission<br>Technology<br>(WAN) | Cellular<br>POTS<br>Modem | Cellular<br>POTS<br>Modem | Cellular | Cellular | SE, see note c |
| User Event<br>Trigger | Handheld<br>user<br>Interface | Handheld<br>User<br>Interface | Handheld<br>User<br>Interface | Patient<br>Magnet | SE, see note d |
| Algorithm | Proprietary<br>/ Server<br>side | Proprietary<br>/ Device<br>side | Proprietary<br>/ Device side | Proprietary<br>/ Device<br>side | SE, see note e |

- a) All predicates devices provide at least one channel of ECG, the minimum requirement cited in AAMI-EC38 for ambulatory arrhythmia monitoring.
- b) All predicate devices meet the ECG performance requirements (or claim SE to a predicate device that meets the performance requirements) of AAMI EC-38 and are therefore SE.
- c) All predicate devices use public communication networks for transmission of data to a monitoring center, whether cellular, POTS, or both and are therefore SE.
- d) All predicate devices have a means for the patient to indicate a symptomatic event and are therefore SE.
- e) All predicate devices contain an analysis algorithm with SE capabilities between the signal acquisition point and the reviewer of the data and are therefore SE.

### 5) Device Description

The TruVue™ system is a continuous ECG monitor and Arrhythmia detector. The system is comprised of a body worn sensor that collects, stores and transmits 2 channels of ECG, a handheld communications device that transmits the ECG to an attended monitoring center and analysis software that continuously analyzes the ECG signal for arrhythmia.

The sensor communicates with the handheld over a Bluetooth link, the handheld communicates with the data center over the cellular telephony network or a land line telephony network. Full disclosure ECG is available at the data center for use by the analysis algorithm or for review and further analysis by a monitoring technician or physician.

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# 6) Indications for use

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

# Indications:

- 1. The TruVue System is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia.
- Patients who require monitoring of effect of drugs to control ventricular rate 2. in various atrial arrhythmias (e.g. atrial fibrillation)
- 3. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath)
- 4. Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring
- 5. ECG data recorded by the device can be analyzed by other processing systems, such as the BMS Century Holter system to provide Holter style reports

### Contraindications

The TruVue System is contraindicated for those patients requiring attended, Inhospital monitoring for life threatening arrhythmias.

# Note

The TruVue system does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.

# 7) Conclusions

The TruVue system has the same intended use, similar operating principles and similar technological characteristics as the predicate devices. As supported by the describtive information and performance validation it is concluded that the TruVye system.ip as safe and effective as its predicates.

# 8) Referenced standards

FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm

-IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety

-IEC 60601-1-2 Medical Electrical Equipment -- Part 1: General Requirements for Safety; Electromagnetic Compatibility

-AAMI EC 38-2007, Ambulatory Electrocardiographs

-ANSVAAMI-EC 57:1998, Testing and Reporting - Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Biomedical Systems Corporation c/o Mr. K. Michael Kroehnke Director of Quality Management 77 Progress Parkway St. Louis, MO 63043

# APR 2 0 2010

K100155 Re:

> Trade/Device Name: TruVue™ Wireless Ambulatory ECG Regulatory Number: 21 CFR 870.1025 Regulation Name: Detector and Alarm, Arrhythmia · Regulatory Class: II (two) Product Code: 74 DSI Dated: March 18, 2010 Received: March 19, 2010

Dear Mr. Kroehnke:

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. Insting 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 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 -- Mr. K. Michael Kroehnke

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. 1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

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:_TruVue™ Wireless Ambulatory ECG

Indications For Use:

- 1. The TruVue™ System is intended for use by patients who experience transient events that may suggest cardiac arrhythmia
- Patients who require monitoring of effect of drugs to control ventricular rate in various atrial 2. arrhythmias (e.g. atrial fibrillation)
- 3. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath)
- 4. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring.
- 5. ECG data recorded by the device can be analyzed by other processing systems, such as the BMS Century Holter system to provide Holter style reports

#### Contraindications:

The TruVue™ System is contraindicated for those patients requiring attended, In-hospital monitoring for life threatening arrhythmias.

Note: The TruVue™ System does not provide interpretive statements. Interpretation and diagnosis is the responsibility of the physician.

Prescription Use (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)

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| (Division Sign-Off) |
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| Division of Cardiovascular Devices |

| 510(k) Number | K100155 |
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