LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM

K092037 · Hoana Medical, Inc. · DRT · Oct 2, 2009 · Cardiovascular

Device Facts

• Record ID: K092037
• Device Name: LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM
• Applicant: Hoana Medical, Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: Oct 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The LifeGurney™ Network Patient Vigilance System is intended for use with adult patients by health care professionals in the continuous measurement of heart rate, respiratory rate, and as an integral part of fall prevention protocols.

Device Story

System monitors adult patients in clinical settings via piezo-electric sensors embedded in mattress coverlets. Sensors detect heart/respiration-induced motion and bed presence; signals transmitted to Vigilance Display unit. Signal processing block converts motion data into heart rate, respiratory rate, and presence status. Logic block compares data against user-defined thresholds to trigger alerts for rate violations or bed exit. Display unit features LCD for parameter visualization, keypad for settings/event logging, and nurse call integration. System supports network connectivity to external data systems (e.g., EMR). Healthcare professionals operate system to assist in fall prevention and patient monitoring. Benefits include continuous, non-contact vital sign tracking and automated notification of patient status changes.

Clinical Evidence

Bench testing only. Electrical, mechanical, and EMC testing performed on patient-vicinity and non-patient-vicinity components; results met applicable standards.

Technological Characteristics

Piezo-electric sensing; contact-less monitoring. Components: sensing unit, control unit, battery/controller enclosure, wireless adapter. Power: 100-240 VAC or battery. Connectivity: TCP/IP network. Software: same as predicate (K083534).

Indications for Use

Indicated for continuous monitoring of heart rate, respiratory rate, and bed exit in adult patients (age 18+, weight 45-227 kg) by healthcare professionals. Contraindicated for patients experiencing excessive motion due to seizures, therapeutic equipment, or transport.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• LifeBed Network Patient Vigilance System (K083534)

Submission Summary (Full Text)

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## 510(k) Notification LifeGurney™ Network Patient Vigilance System

| Section 5 - 510(k) Summary | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Hoana Medical, Inc.<br>828 Fort Street Mall, Suite 620<br>Honolulu, HI 96813<br>Phone: [phone]<br>[phone]<br>Fax: [phone] |
| Contact: | Dr. Larry Burgess<br>Chief Medical Officer |
| Date Summary Prepared: | June 24, 2009 |
| Trade Name: | LifeGurney™ Network Patient Vigilance System |
| Common/Classification Name | Monitor, Cardiac<br>74DRT, 870.2300 |
| Substantially Equivalent Devices | LifeBed Network Patient Vigilance System<br>(K083534) |

# Device Description

The Vigilance Display is a modification of the LifeBed Display previously submitted and cleared as K083534. The Vigilance Display differs from the Lifebed Display in that it has additional enclosures attached which contain batteries, a battery controller, an auxiliary nurse call system, and a wireless adapter. The battery and controller are attached to the Display, the auxiliary nurse call system and wireless adapter are attached to the top.

User interaction is the same as on the LifeBed Display—the front panel keypad (hidden behind a door in the above photos) is used to change settings and mark events in the log. The large button on the front of the Display is used to acknowledge events. The software for the same as in the predicate system. The nurse call connector and the Display power switch are located under a hatch on the right side of the Display (as viewed from the front). The Display power switch controls the power from the batteries to the Display.

The AC power connection is on the side of the battery and controller enclosure. Above the AC power connection is the main power switch. This switch controls the AC power to the battery controller. When the switch is on and an AC power source is connected the batteries are charging. When the switch is off or no AC power source is connected, then power is drawn from the batteries. On the opposite side are the slots for the removable batteries. These batteries are typically installed in pairs, but only one is required to operate the system (with reduced run time).

An optional external battery charger and spare batteries are available, enabling the operation of the system in areas where AC power is not available or is difficult to use.

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The coverlet is the component that provides the interface between the patient and the Vigilance Display unit. It contains the sensors, wiring, and electronics necessary to measure the patient's heart rate, respiration rate, and bed presence and transmit signals to the Vigilance Display.

The LifeGurney Network Patient Vigilance System is compatible with and uses the same series of coverlets as the LifeBed Network Patient Vigilance System. Gurney specific coverlets will be sized to fit specific gurney mattresses.

The coverlet contains the sensing elements and interface electronics for connecting the coverlet to the Display with a coverlet cable. The sensing elements and electronics are separated from the patient by a layer of coated fabric; there is no contact between the patient and the sensors. Additional separation of the sensors is provided by the bed sheets, pads, and the patients' garments. The coverlet encases the existing mattress. The coverlet contains all necessary conductors to carry sensor signals within the coverlet.

## Indications for Use

The LifeGurney Network Patient Vigilance System is intended for use with adult patients by health care professionals in the continuous measurement of heart rate, respiratory rate, and as an integral part of fall prevention protocols.

## Principles of Operation

Image /page/1/Figure/8 description: The image shows a block diagram of a system. The system starts with a block labeled "Patient", which is connected to a block labeled "Sensors". The "Sensors" block is connected to a block labeled "Signal Processing", which is connected to a block labeled "Logic". The "Logic" block is connected to two blocks: "User Interface" and "Data Interface". The "User Interface" block is connected to a block labeled "External Data System", and the "Data Interface" block is also connected to a block labeled "External Data System".

The LifeGurney Network Patient Vigilance System has 5 functional blocks: Sensors, Signal Processing, Logic, User Interface, and the Data Interface. The Sensors provide an interface to the patient, the User Interface to the User, and the Data Interface to an External Data System.

There are two classes of sensors, one for heart and respiration rate and one for detecting the presence of a patient. The sensors translate the motion of the heart beating and lungs breathing to electronic signals which are transmitted to the Signal Processing Block.

The Signal Processing block transforms the signals from the sensors into a set of three numbers; a heart rate, a respiratory rate, and a patient presence indication.

These numbers are then used by the Logic block to detect the conditions which are being monitored (e.g. rate violations, patient presence). The heart rate and respiratory rate are handled independently of

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each other. The patient presence indication is calculated independently also, and this is fed back to the heart rate and respiratory alert state machines, When a monitored condition is detected, the Logic block will communicate this to the User and Data Interfaces. Additionally the data received by the Logic block from the Signal Processing block is passed on to these interfaces.

The User Interface block is responsible for presenting the data to the User via the LCD display. The User Interface also allows the user to control parameters and acknowledge alerts.

The Data Interface block is similar in function to the User Interface block except that it interacts with an External Data System over a network connection. The External Data System may represent a variety of entities such as an Electronic Medical Record System or a server supporting remote users.

| Measurement Limits | Heart rate from 35 - 200 BPM |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Respiration rate from 4 - 70 BPM |
| Operating Limitations | Environment: 10-40° C, 20-80% Relative Humidity |
| Power | 100-240 VAC, 50-60 Hz, 1.75A @ 100V |
| Available settings | Patient Select |
| | Heart Rate High/Low Limits |
| | Respiration Rate High/Low Limits |
| | Bed Exit Monitoring |
| | TCP/IP Network Settings |
| | Auxiliary Alert Enable |
| | LCD Display Contrast/Brightness |
| Functional Limitations | The LifeGurney Network Patient Vigilance System<br>is solely responsible for establishing the<br>notification parameters for patients on the system.<br>Parameters other than heart rate, respiratory rate,<br>and bed exit are not monitored. |
| | The system is not intended for use with patients<br>under the age of 18 years or patients who weigh<br>less than 45 kg (99 lbs) or more than 227 kg (499<br>lbs). |
| | The system is not intended for use while the<br>patient is experiencing excessive motion due to<br>seizure, therapeutic equipment, or transport. |
| Performance Limitations | Mattress overlays, "toppers", or anything placed<br>between the patient and coverlet may decrease<br>performance of the system. |
| | More than one person in the bed may interfere<br>with monitoring. |

Summary of Technological Characteristics

ANA MEDICAL

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Electrical, Mechanical and EMC Testing for the LifeGurney Patient Vigilance System, patient vicinity components:

Testing has been completed and results meet applicable standards.

Electrical, Mechanical and EMC Testing for the LifeGurney Patient Vigilance System, non-patient vicinity components:

Testing has been completed and results meet applicable standards.

### Conclusion

A MEDICAL

All verification and validation testing conducted demonstrate that the LifeGurney Network Patient Vigilance System is substantially equivalent to the LifeBed Network Patient Vigilance System.

| | Lifebed Network Patient Vigilance System<br>(K083534) | LifeGurney Network Patient<br>Vigilance System | Same/Different |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| System<br>Components | Sensing unit, control unit, software | Sensing unit, control unit, software | Same |
| Technological<br>Characteristics | Piezo-electric sensing | Piezo-electric sensing | Same |
| Mode of<br>Operation | Contact-less monitoring | Contact-less monitoring | Same |
| Performance<br>Characteristics | Sensor in mattress coverlet | Sensor in mattress coverlet | Same |
| | Measures heart rate and<br>respiration rate | Measures heart rate and<br>respiration rate | Same |
| | Detects bed exit | Detects bed exit | Same |
| | Notifies nurse or caregiver of<br>change in condition (e.g., heart<br>rate or respiration rate exceeds set<br>limits) | Notifies nurse or caregiver of<br>change in condition (e.g., heart<br>rate or respiration rate exceeds set<br>limits) | Same |
| | Notifies nurse or caregiver of bed<br>exit | Notifies nurse or caregiver of bed<br>exit | Same |
| | Control unit receives the electric<br>signals, processes them, and<br>calculates, logs, displays the<br>patient's parameters and<br>generates alerts as per set<br>thresholds, when needed. | Control unit receives the electric<br>signals, processes them, and<br>calculates, logs, displays the<br>patient's parameters and<br>generates alerts as per set<br>thresholds, when needed. | Same |

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| Lifebed Network Patient Vigilance<br>System<br>(K083534) | LifeGurney Network Patient<br>Vigilance System | Same/Different | |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Intended Use | Lifebed Network Patient Vigilance<br>System is intended to measure<br>heart rate, respiratory rate, and<br>bed exit in adult patients for use<br>by health care professionals. | The LifeGurney Network Patient<br>Vigilance System is intended foruse with adult patients by health<br>care professionals in the<br>continuous measurement of heart<br>rate, respiratory rate, and as an<br>integral part of fall prevention<br>protocols. | Same<br>(Wording changes to<br>improve readability<br>and<br>understandability) |

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- 12:41 来源: 2017-04-04 11:42:13

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized symbol that resembles an abstract caduceus, a symbol often associated with medicine and healthcare.

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

Hoana Medical, Inc c/o Ms. Cindy Green NorthWest Regulatory Support, LLC 21031 SE 20200 Street Renton, WA 98058

OCT = 2 2009

Re: K092037

Trade/Device Name: LifeGurney Network Patient Vigilance System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor Regulatory Class: Class II (two) Dated: June 24, 2009 Received: July 6, 2009

Dear Ms. Green:

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 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. Cindy Green

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 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/ReportalProblem/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.

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): K0912037

Device Name: LifeGurney™ Network Patient Vigilance System

#### Indications for Use:

The LifeGurney™ Network Patient Vigilance System is intended for use with adult patients by health care professionals in the continuous measurement of heart rate, respiratory rate, and as an integral part of fall prevention protocols.

Prescription Use_ ਮ (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)

CORH, Office of Device Evaluation (ODE)

(Division Sian-Off) on of Cardiovascular Devices

510(k) Number

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