EQUIVITAL, MODEL EQ-01

K061993 · Hidalgo Limited · MHX · Nov 3, 2006 · Cardiovascular

Device Facts

• Record ID: K061993
• Device Name: EQUIVITAL, MODEL EQ-01
• Applicant: Hidalgo Limited
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 3, 2006
• Decision: SESE
• Submission Type: Traditional
• 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 - 65years) in hospital care facilities, the home, workplace, and alternate care settings. The device consists of a chest belt hamess and a body wom 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™ Vital Signs Physiological Monitor; ambulatory multiparameter telemetry system. Components: chest belt with skin electrodes/expansion sensor; body-worn electronics module (SEM). Inputs: ECG signals, thoracic movement (respiration), skin temperature, motion/orientation. Processing: digitizes signals; derives heart rate, breathing rate, activity level (none/low/high); detects R-waves via hardware processing. Outputs: physiological waveforms, vital sign rates, alerts for predefined boundaries. Connectivity: Bluetooth or low-power radio (40.68MHz). Usage: hospital, home, workplace, research; operated by clinicians or users. Data viewed via PC application or third-party integration. Benefits: continuous remote monitoring of patient physiology; facilitates occupational welfare and performance tracking.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified against standards: EN60601-1 (safety), IEC60601-1-2 (EMC), ISO 10993-1 (biocompatibility), ANSI/AAMI EC13 (cardiac monitors), and ASTM E 1112-00 (temperature). Additional functional and environmental performance testing conducted.

Technological Characteristics

Chest belt with skin electrodes and expansion sensor; body-worn electronics module (SEM). Energy: rechargeable or primary disposable batteries. Connectivity: Bluetooth or 40.68MHz low-power radio. Standards: EN60601-1, IEC60601-1-2, ISO 10993-1, ANSI/AAMI EC13, ASTM E 1112-00. Software: structured lifecycle per EN60601-1-4.

Indications for Use

Indicated for ambulatory monitoring of adults (16-65 years) in hospitals, homes, workplaces, and alternate care settings. Provides physiological data including ECG, respiration, skin temperature, body orientation, and motion for general patient monitoring, occupational welfare, 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

• 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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "hidalgo" followed by four filled circles. Below the circles, there is handwritten text that reads "K061993" and "P 1/4". The text appears to be a label or identifier associated with the image.

## 510(k) Summary

#### Submitter

NOV - S 2006

: :

Hidalgo Ltd Stable Block at the Grange 20 Market St Cambridge CB4 5QG United Kingdom

Contact: J.Pisani - Operations Director Tel: [phone]

#### Manufacturer

Hidalgo Ltd Stable Block at the Grange 20 Market St Cambridge CB4 5QG United Kingdom

Hidalgo propose to register as the manufacturer of the device in accordance with 21CFR Part 807.

#### Name of Device

Equivital™ Vital Signs Physiological Monitor Device Trade Name:

Device Common Name: Ambulatory Patient Monitor

### Device Classification and Product Code:

| 74 DRT | 870.2300 - Monitor, Cardiac (incl Cardiotachometer & rate alarm) |
|--------|------------------------------------------------------------------|
| 74DPS | 870.2340 - Electrocardiograph |
| 73BZQ | 868.2375 - Monitor, Breathing Frequency |
| 80FLL | 880.2910 - Thermometer, Electronic, Clinical |

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the word "hidalgo" followed by five filled circles. Below the circles, there is handwritten text that reads "K061993 p2/4". The text appears to be a label or identifier for the image.

#### Predicate Devices

| 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 |

The device has been compared to the following predicates:

#### 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 (none, low or high) derived from a movement . detection sensor.
- . Body orientation.
- Chest 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. .

The device offers two variants for the wireless interface: a low power radio interface designed for military applications 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.

#### Intended Use Summary

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

{2}------------------------------------------------

The device consists of a chest belt hamess and a body wom 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.

hidalo

#### Technological Characteristics

Substantial equivalence has been measured by the technological review and comparison of performance data for the following.

| Function | Predicate 1 | Additional Predicates |
|----------------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------|
| ECG Heart Rate,<br>Breathing Rate<br>Temperature and<br>General Physical<br>Properties | Protocol Systems Propaq<br>Encore 200<br>K003520 | Nexan Inc NX-300<br>K003520 |
| Chest Expansion<br>Respiration | Dymedix<br>Re-usable Respiratory<br>Effort Belt - K040605 | Nexan Inc NX-300<br>K003520<br>Vivometrics LifeShirt<br>Real Time<br>K043604 |
| Activity/Motion<br>Detection | Respironics<br>Actiheart - K052489 | Vivometrics LifeShirt<br>Real Time<br>K043604 |
| Bluetooth telemetry<br>and ECG transmission | GMP Wireless Medicine -<br>LifeSyncTM K030795 | |
| Low Power 40.68MHz<br>PAN | Respironics<br>Actiheart - K052489 | |

The device technological characteristics compare to the following predicates:

#### 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 guidrance from the agency:

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "hidalgo" followed by four solid black circles. Below the circles, there is handwritten text that reads "K061993" and "P 4/4". The text is in black ink and appears to be a label or identifier for the image.

- 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 E 1 12-00 Standard Specification for intermittent determination of patient . temperature.

Additional voluntary testing has been undertaken to the following:

- . General functional test.
- Environmental Performance Test. .

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

This pre-market notification has demonstrated the substantial equivalence of the Equivital™ Vital Signs Physiological Monitor to the predicates identified, by comparison to the describition material and performance testing of the device.

{4}------------------------------------------------

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2006

Hidalgo Limited c/o Mr. Justin Pisani Operations Director 20 Market Street Cambridge, CB4 5QG United Kingdom

Re: K061993

Equivital Vital Signs Physiological Monitor Regulation Number: 21 CFR 870 1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: MHX Dated: September 29, 2006 Received: October 5, 2006

Dear Mr. Pisani:

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 max publish further announcements concerning your device in the Federal Register.

{5}------------------------------------------------

Page 2 - Mr. Justin Pisani

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that vour 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

B.Bimmofor for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

# Indications for Use

510(k) Number (if known): K061993

Device Name: Equivital™ Vital Signs Physiological Monitor

Indications For Use:

The Equivital™ Vital Signs Physiological Monitor is an ambulatory multiparameter vital signs The Equivilal™ Vital Signs Friyslological Rions and and States (16 - 65years) in hospital care facilities, the home, workplace and alternate care settings.

The device consists of a chest belt hamess 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 The monitor is inalcated for ose as a general patient maniforing 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

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)

B/Bummerman

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K011993