VITALSENS, AINGEAL, V-POD

K110015 · Intelesens Limited · MHX · May 20, 2011 · Cardiovascular

Device Facts

• Record ID: K110015
• Device Name: VITALSENS, AINGEAL, V-POD
• Applicant: Intelesens Limited
• Product Code: MHX · Cardiovascular
• Decision Date: May 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The Intelesens Vital Signs Monitor Aingeal (VS200) is used to monitor and transmit physiological data to a web based host application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation. This re-usable device is intended to be used on the patient for short term periods only. The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting. The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful. The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device transmits the data to the host application at user defined intervals or upon the detection of an arrhythmia event.

Device Story

Aingeal (VS200) is a wearable, lightweight device connected to an accessory electrode; monitors ECG (1-lead), heart rate, respiration, skin temperature, and motion. Device wirelessly transmits data via WiFi to a web-based host application for clinician review. On-board algorithms continuously monitor for seven cardiac arrhythmias; automatically records and transmits ECG data upon detection or at user-defined intervals. Used in healthcare environments by clinical staff to support routine observations or monitor patients in otherwise unobserved situations. Output displayed on host application; alerts clinicians to heart rate changes outside pre-defined limits. Enables remote monitoring and timely clinical intervention for arrhythmia events.

Clinical Evidence

No clinical data provided. Performance validation based on bench testing in accordance with internal test plans and recognized standards, including AAMI/ANSI EC57 for cardiac rhythm and ST-segment measurement algorithms. Risk analysis and mitigation documented per ISO 9001:2008 and ISO 13485:2003 quality systems.

Technological Characteristics

Wearable, lightweight device; 1-lead ECG, accelerometer, temperature, and respiration sensors. WiFi connectivity. Conforms to IEC 60601-1 (safety), IEC 60601-1-2 (EMC), AAMI/ANSI EC12 (electrodes), and AAMI/ANSI EC57 (algorithm performance).

Indications for Use

Indicated for adult patients in healthcare settings for short-term monitoring of ECG, respiration, heart rate, skin temperature, and activity levels. Supports clinical staff in routine observations or unmonitored situations. No contraindications.

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

• Datascope NetGuard Automated Clinician Alert System (K071805)
• Proteus Biomedical Raisin Personal Monitor (K093976)
• CADI Scientific CADI SmartSense Wireless Temperature Monitor (K083185)
• Welch Allyn Vital Signs Monitor Propaq Lt (K033378)

Submission Summary (Full Text)

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K110015 pg 1 of 3

Premarket Notification 510(k) Section 5 - 510(k) Summary

Intelesens VS200

MAY 2 0 2011

| Official Contact: | Patricia Pepper<br>Regulatory Affairs Officer<br>Intelesens Ltd.<br>4 Heron Road<br>Belfast BT3 9LE<br>Tel - 44 (0) 845 5838 6243<br>Fax - 44 (0) 845 5838 6241<br>e-mail: [e-mail] |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | Aingeal (VS200) |
| Common/Usual Name: | Physiological Patient Monitor |
| Classification Name: | Monitor, physiological, patient (with arrhythmia<br>Detection or alarms)<br>MHX<br>Arrhythmia detector and alarm (including ST-segment<br>measurement and alarm)<br>DSI |
| Predicate Device: | K071805<br>Datascope<br>NetGuard Automated Clinician Alert System<br>K093976<br>Proteus Biomedical<br>Raisin Personal Monitor<br>K083185<br>CADI Scientific<br>CADI SmartSense Wireless Temperature Monitor<br>K033378<br>Welch Allyn<br>Vital Signs Monitor Propaq Lt |

510(k) Summary

Page 1 of 3 April 20, 2011

#### Device Description:

The Aingeal (VS200) is a small, lightweight wearable device that is connected to an accessory electrode that is applied to the patient's body. The device wirelessly transmits physiological data relating to ECG, heart rate, respiration, skin temperature and motion to a receiving station via a WiFi connection for display or for analysis by a clinician. The device alerts clinicians when a patient's heart rate changes outside of pre-defined that can be modified by clinical

> Page I of 3 Page 19 of 236

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K110015 pg 2 of 3

Intelesens VS200

Premarket Notification 510(k) Section 5 - 510(k) Summary

## 510(k) Summary Page 2 of 3 April 20, 2011

staff. There are also on-board algorithms that continuously monitor for, and record ECG on detection of seven cardiac arrhythmias.

| Feature / Device | Aingeal (VS200) |
|----------------------|-----------------------------------|
| ECG | 1 lead |
| Arrhythmia Detection | 7 arrhythmia detection algorithms |
| Accelerometer | Yes |
| Temperature | Yes |
| Respiration | Yes |
| Data Transmission | WiFi |

### Indications for Use:

The Intelesens Vital Signs Monitor Aingeal (VS200) is used to monitor and transmit physiological data to a web based host application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation.

This re-usable device is intended to be used on the patient for short term periods only.

The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting.

The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful.

The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device transmits the data to the host application at user defined intervals or upon the detection of an arrhythmia event.

Patient Population: Adult

Environment of Use: Healthcare environment

Contraindications: None

> Page 2 of 3 Page 20 of 236

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K110015 pg 3 of 3

Intelesens VS200

## 510(k) Summary Page 3 of 3 April 20, 2011

## Technology:

The Aingeal (VS200) conforms to the following standards:

- IEC 60601-1:2005: Medical Electrical Equipment Part 1: General requirements . for basic safety and essential performance
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements . for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
- AAMI / ANSI EC12:2000/(R) 2005, Disposable ECG electrodes. .
- AAMI / ANSI EC57:1998/(R) 2008, Testing and reporting performance results of . cardiac rhythm and ST-segment measurement algorithms

#### Materials:

See Section 15 of this submission.

#### Summary of Performance Data

The Intelesens Aingeal (VS200) was tested in accordance with the relevant test plans/reports included with this 510(k) submission using the production equivalent units prior to release to market.

A risk analysis identifying potential hazards and documenting mitigation of the hazards has been developed and applied as part of Intelesens' product development procedure. Intelesens' Quality System conforms to 21CFR820 and is certified by SGS UK Itd., to ISO9001:2008 and ISO13485:2003.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned above a series of wavy lines, possibly representing water or movement. Encircling the bird and wavy lines are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 2-0 2011

Intelesens Ltd. c/o Mr. Paul Dryden President, Regulatory Consultant Promedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134

Re: K110015

Trade/Device Name: Aingeal VS200 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: May 16, 2011 Received: May 17, 2011

Dear Mr. Dryden:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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## Page 2 - Mr. Paul Dryden

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.

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/CDRHOffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Page I of 1

510(k) Number:

(10015 (To be assigned)

Device Name:

Intelesens Vital Signs Monitor Aingeal (VS200)

Indications for Use:

The Intelesens Vital Signs Monitor Aingeal (VS200) is used to monitor and transmit physiological data to a web based host application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation.

This re-usable device is intended to be used on the patient for short term periods only.

The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting.

The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful.

The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device transmits the data to the host application at user defined intervals or upon the detection of an arrhythmia event.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <b>X</b> |
|-------------------------------------------------|----------|
|-------------------------------------------------|----------|

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)

Wision Sign-Off

or

Division of Cardiovascular Devices

510(k) Number K11 0015