EQUIVITAL

K113054 · Hidalgo Limited · MHX · Feb 17, 2012 · Cardiovascular

Device Facts

• Record ID: K113054
• Device Name: EQUIVITAL
• Applicant: Hidalgo Limited
• Product Code: MHX · Cardiovascular
• Decision Date: Feb 17, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The Equivital™ Vital Signs Physiological Monitor is an ambulatory multiparameter vital signs telemetry device intended for monitoring of adults (16 - 65 years) in hospital care facilities, the home, workplace, and alternate care settings. The device consists of a chest belt harness and a body worn electronics module (SEM) supported by the chest belt. The device collects and transmits ECG data and rate, respiration data and rate, skin temperature, body orientation and motion. The monitor is indicated for use as a general patient monitor, to provide physiological information as part of an occupational welfare monitoring system, and for general research and performance measurement purposes. Federal Law (US) restricts this device to sale by or on the order of a physician.

Device Story

Equivital EQ02 is an ambulatory multiparameter telemetry monitor consisting of a chest belt harness with integrated skin electrodes and expansion sensors, plus a body-worn electronics module (SEM). It continuously monitors ECG (two views), respiratory breathing frequency (via thoracic movement), skin temperature, body orientation, and activity level. The device digitizes and transmits physiological data wirelessly via low-power radio or Bluetooth to a receiving display device (standalone PC or third-party monitoring application). It provides secondary heart rate detection via R-wave processing and secondary skin temperature via infrared thermometer. The system alerts users if physiology exceeds predefined boundaries. Used in hospitals, homes, and workplaces; operated by clinicians or patients. Benefits include continuous, non-invasive physiological tracking for clinical, occupational, or research purposes.

Clinical Evidence

Bench testing only. Performance verified against standards: EN60601-1 (safety), IEC60601-1-2 (EMC), ISO 10993-1 (biocompatibility), ANSI/AAMI EC13 (cardiac monitors), ASTM E1965-98 (infrared thermometers), and IP67 (environmental). No clinical trial data presented.

Technological Characteristics

System includes chest belt harness and battery-powered electronics module. Sensors: skin electrodes, expansion sensor, movement sensor, infrared thermometer. Connectivity: Bluetooth and low-power 40.68MHz radio. Power: rechargeable or primary disposable cells. Software developed per EN60601-1-4. Materials: biocompatible per ISO 10993-1. Form factor: body-worn.

Indications for Use

Indicated for ambulatory monitoring of adults (16-65 years) in hospitals, homes, workplaces, and alternate care settings. Used as a general patient monitor for physiological data collection, occupational welfare monitoring, and research/performance measurement.

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

• Hidalgo Equivital EQ01 (K061993)
• GMP Wireless Medicine LifeSync™ (K030795)
• Dymedix Inc Re-usable Respiratory Effort Belt Sensor (K040605)
• Nexan Inc NX-300 (K003520)
• Protocol Systems Propaq Encore 200 (K012451)
• Respironics Actiheart® (K052489)
• Vivometrics Life Shirt™ Real Time (K043604)

Submission Summary (Full Text)

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# KII3054 hidalgo

FEB 1 7 2012

## 510(k) Summary Equivital Vital Signs Physiological Monitor EQ02

| Submitter: | Hidalgo Ltd |
|------------|------------------------------------------------------------------------------------------------------------|
| | Unit F<br>Buckingway Business Park<br>Anderson Road<br>Swavesey<br>Cambridge<br>CB24 4UQ<br>United Kingdom |
| Contact: | Dr Ekta Sood - Clinical Director<br>Tel: [phone] |
| Date: | 2011-10-10 |

#### Name of Device:

| Device Trade Name: | Equivital™ Vital Signs Physiological Monitor EQ0 |
|---------------------|--------------------------------------------------|
| Device Common Name: | Ambulatory Patient Monitor |

#### Device Classification and Product Code:

- Class Ilb EU:
Medical Device Directive: 93/42/EEC as amended by 2007/47/EC

- USA: Class II
- Panel: Cardiovascular

Product Code: MHX

Regulation Number: 870.1025

Classification Name: Monitor, Physiological, Patient

(With Arrhythmia Detection Or Alarms)

Image /page/0/Picture/16 description: The image shows the logo for Jaltek. The logo consists of the word "jaltek" in lowercase letters, with a stylized globe above it. The globe appears to have land masses and oceans depicted on its surface.

Hidalgo Ilmited - A Jaltek Group Company

Unit F, Buckingway Business Park, Anderson Road, Swavesey, Cambridge, CB24 4UQ Fax: [phone] Web: www.hidalgo.co.uk Tel: [phone] Registered in England under Company No. 3315718. VAT No. 688 647 072.

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#### Predicate Devices

The device has been compared to the following predicate:

| Hidalgo | EQ01 | - K061993 |
|------------------------|------------------------------------------|-----------|
| Additional Predicates: | | |
| GMP Wireless Medicine | LifeSync™ | - K030795 |
| Dymedix Inc | Re-usable Respiratory Effort Belt Sensor | - K040605 |
| Nexan Inc | NX-300 | - K003520 |
| Protocol Systems | Propaq Encore 200 | - K012451 |
| Respironics | Actiheart® | - K052489 |
| Vivometrics | Life Shirt™ Real Time | -K043604 |

#### Device Description

The Equivital™ Vital Signs Physiological Monitor comprises two components:

i) A chest belt containing skin electrodes and an expansion sensor

ii) A battery powered electronics module which connects directly to the chest belt and which acts to record, digitise and transmit the physiological information wirelessly to a receiving display device.

The device offers continuous monitoring of two views of the user's heart electrical activity (ECG) and respiratory breathing frequency inferred from thoracic cavity movement and uses this data to derive a Heart Rate and a Breathing Effort Rate.

The sensor also provides the following information:

- ECG and Respiration physiological waveforms .
- An indication of the user's activity level derived from a movement detection sensor .
- Body orientation and indications for change in orientation .
- Skin surface temperature .
- Alternate secondary measurement of heart rate based on the detection of the user's R . wave using a separate hardware processing function
- . Indications and alerts if physiology exceeds predefined boundaries
- Alternate secondary skin temperature measurement using infrared thermometer .

The device offers two variants for the wireless interface: a low power radio interface and a general purpose interface using Bluetooth™ technology.

The device offers two battery power options for the user, rechargeable or primary disposable cells.

The wireless data provided by the sensor may be viewed using a standalone PC based viewing application, or integrated into third party monitoring applications.

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# KII.3054 hidalao……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

#### intended Use Summary

The Equivital™ Vital Signs Physiological Monitor is an ambulatory multiparameter vital signs telemetry device intended for monitoring of adults (16 - 65 years) in hospital care facilities, the home, workplace, and alternate care settings.

The device consists of a chest belt harness and a body worn electronics module (SEM) supported by the chest belt.

The device collects and transmits ECG data and rate, respiration data and rate, skin temperature, body orientation and motion.

The monitor is indicated for use as a general patient monitor, to provide physiological information as part of an occupational welfare monitoring system, and for general research and performance measurement purposes.

### Technological Characteristics

The device does not contain tissues of animal origin as referred to in EC commission directive 2003/32/EC.

Substantial equivalence has been demonstrated by technological review and comparison fo the predicate Equivital EQ01 device and verified by the Design Control Process.

In addition substantial equivalence remains to the Equivital EQ01 predicate devices cited in that device's submission.

| Function | Predicate Device | Additional Predicates |
|----------------------------------------------------------------------------------------|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| ECG Heart Rate,<br>Breathing Rate<br>Temperature and<br>General Physical<br>Properties | Hidalgo Equivital EQ01 –<br>K061993 | Protocol Systems<br>Propaq Encore 200 –<br>K012451<br>Nexan Inc NX-300 –<br>K003520 |
| Chest Expansion<br>Respiration | Hidalgo Equivital EQ01 –<br>K061993 | Dymedix Re-usable<br>Respiratory Effort Belt –<br>K040605<br>Nexan Inc NX-300 –<br>K003520<br>Vivometrics LifeShirt<br>Real Time –<br>K043604 |
| Activity/Motion<br>Detection | Hidalgo Equivital EQ01 –<br>K061993 | Respironics Actiheart –<br>K052489<br>Vivometrics LifeShirt<br>Real Time – |

Technological Characteristics Compared:

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K113054

| Function | Predicate Device | Additional Predicates |
|---------------------------------------------|-------------------------------------|-------------------------------------------------|
| | | K043604 |
| Bluetooth telemetry<br>and ECG transmission | Hidalgo Equivital EQ01 -<br>K061993 | GMP Wireless<br>Medicine - LifeSync™<br>K030795 |
| Low Power 40.68MHz<br>PAN | Hidalgo Equivital EQ01 -<br>K061993 | Respironics Actiheart -<br>K052489 |

#### Performance Measurement Summary

Performance measurement and review to the applicable sections of the following standards has been undertaken and successfully demonstrated as recommended by available guidance from the agency:

- EN60601-1: Medical Electrical Equipment Part 1 General Requirements for Safety. .
- . IEC60601-1-2: 2001 Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic Compatibility.
- ISO 10993-1: Biological Evaluation of Medical Devices: Evaluation and Testing. ●
- ANSI/AAMI EC13: 2002 Cardiac Monitors, heart rate meters, and alarms. The device was . not evaluated against the criteria for defibrillation and pacemaker immunity as it is not indicated for use in either of these cases.
- ASTM E1965 98 (2009) Standard Specification for Infrared Thermometers for internittent . determination of patient temperature.
- . IP67: Environmental Performance Testing

The device software has been developed using a structured software lifecycle which meets the requirements of EN60601-1-4 Programmable Systems, which also applies to ongoing maintenance of the software.

#### Substantial Equivalence Conclusion

EQ02 has the same intended use and fundamental scientific technology as EQ01. The changes made do not raise any new questions of safety and effectiveness.

In addition the testing undertaken has demonstrated that the Equivital EQ02 device is as safe, as effective and performs as well as the legally marketed predicate Equivital EQ01 device.

To conclude substantial equivalence of the Equivital™ Vital Signs Physiological Monitor EQ02 has been demonstrated to the identified predicate Equivital™ Vital Signs Physiological Monitor EQ01.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

FEB 1 7 2012

Hidalgo Limited c/o Dr. Ekta Sood Unit F, Buckingway Business Park Anderson Road Swavesey Cambridge Cambridgeshire CB24 4UQ GB

Re: K113054 Trade/Device Name: Equivital Regulation Number: 21 CFR 870.1025 Regulation Name: Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms) Regulatory Class: Class II Product Code: MHX Dated: January 27, 2012 Received: January 30, 2012

Dear Dr. Sood:

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.

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#### Page 2 - Dr. Ekta Sood

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.

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,

R. D. Zaharov, M.P.

fo

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):_K113054

Device Name: Equivital™ EQ02 Vital Signs Physiological Monitor

Indications For Use:

The Equivital™ Vital Signs Physiological Monitor is an ambulatory multiparameter vital signs telemetry device intended for monitoring of adults (16 - 65years) in hospital in the mital in the mater vital care facilities, the home, workplace for monitoning of addits (11)
facilities, the home, workplace and alternate care settings.

The device consists of a chest belt harness and a body worn electronics module (SEM) supported by the chest belt.

The device collects and transmits ECG data and rate, respiration data and rate, skin
temperature, body orientation and motion temperature, body orientation and motion.

The monitor is indicated for use as a general patient monitor, to provide physiological information as part of an occupational welfare monitor, to provide physiology
research and performance measuroment purpos research and performance measurement purposes.

Federal Law (US) restricts this device to sale by or on the order of a physician

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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)

ion Slanovascular Devices inn of Car

510(k) Number K113054