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 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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the LifeGurney™ Network Patient Vigilance System. It describes the device and claims substantial equivalence to a predicate device (LifeBed Network Patient Vigilance System, K083534).

However, the document does not contain acceptance criteria for device performance nor a detailed study report that proves the device meets specific acceptance criteria related to its performance characteristics (heart rate, respiratory rate, bed exit detection accuracy).

Instead, it asserts substantial equivalence based on technological characteristics and functional capabilities being the same as the predicate device, and states that "All verification and validation testing conducted demonstrate that the LifeGurney Network Patient Vigilance System is substantially equivalent to the LifeBed Network Patient Vigilance System." without providing the specifics of this testing.

Therefore, I cannot fully answer your request for a table of acceptance criteria and reported device performance, nor can I provide details on sample size, ground truth, expert qualifications, or MRMC studies for performance metrics.

Based on the available information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The document states that performance characteristics are the "Same" as the predicate device. For example:

"Measures heart rate and respiration rate" - No specific accuracy or precision metrics are provided.
"Detects bed exit" - No specific sensitivity or specificity metrics are provided.
"Notifies nurse or caregiver of change in condition (e.g., heart rate or respiration rate exceeds set limits)" - No specific latency or reliability metrics are provided.

The "Measurement Limits" define the range over which the device is expected to operate, not its performance accuracy:

Heart rate from 35 - 200 BPM
Respiration rate from 4 - 70 BPM

2. Sample size used for the test set and the data provenance

This information is not provided in the document. The document mentions "verification and validation testing" but does not detail the methodology, sample size, or data provenance (e.g., country of origin, retrospective/prospective nature) for these tests regarding the performance characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document.

4. Adjudication method for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or implied in this document. The device is a patient vigilance system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The document describes the "LifeGurney™ Network Patient Vigilance System" as having various functional blocks (Sensors, Signal Processing, Logic, User Interface, Data Interface) and states that "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." and these "numbers are then used by the Logic block to detect the conditions which are being monitored". This implies an algorithm-only or standalone performance component, but no specific standalone performance study results (e.g., accuracy metrics for heart rate, respiratory rate, or bed exit detection against a gold standard) are provided. The document states "All verification and validation testing conducted demonstrate that the LifeGurney Network Patient Vigilance System is substantially equivalent to the LifeBed Network Patient Vigilance System", but the details of these tests are absent.

7. The type of ground truth used

This information is not provided in the document. Given the nature of the device (measuring heart rate, respiratory rate, and bed exit), the ground truth would likely involve simultaneous measurement with a clinical gold standard (e.g., ECG for heart rate, capnography for respiration, direct observation for bed exit), but the document does not specify this.

8. The sample size for the training set

The document does not mention a training set as it describes the device and substantial equivalence, not the development or training of its algorithms.

9. How the ground truth for the training set was established

This information is not provided as a training set is not mentioned.

Summary

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Image /page/0/Picture/0 description: The image shows the text "K092037 pg 1 of 5 HOANA MEDICAL". The text appears to be handwritten, with the exception of the words "HOANA MEDICAL", which are printed. The text is arranged in two lines, with the first line containing the code and the second line containing the page number and the company name. The image is simple and straightforward, with a clear focus on the text.

510(k) Notification LifeGurney™ Network Patient Vigilance System

Section 5 - 510(k) Summary
Submitted By:	Hoana Medical, Inc.828 Fort Street Mall, Suite 620Honolulu, HI 96813Phone: (808) 294-6934(808) 523-0745Fax: (808) 523-5480
Contact:	Dr. Larry BurgessChief Medical Officer
Date Summary Prepared:	June 24, 2009
Trade Name:	LifeGurney™ Network Patient Vigilance System
Common/Classification Name	Monitor, Cardiac74DRT, 870.2300
Substantially Equivalent Devices	LifeBed Network Patient Vigilance System(K083534)

Device Description

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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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 Systemis solely responsible for establishing thenotification parameters for patients on the system.Parameters other than heart rate, respiratory rate,and bed exit are not monitored.
	The system is not intended for use with patientsunder the age of 18 years or patients who weighless than 45 kg (99 lbs) or more than 227 kg (499lbs).
	The system is not intended for use while thepatient is experiencing excessive motion due toseizure, therapeutic equipment, or transport.
Performance Limitations	Mattress overlays, "toppers", or anything placedbetween the patient and coverlet may decreaseperformance of the system.
	More than one person in the bed may interferewith 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(K083534)	LifeGurney Network PatientVigilance System	Same/Different
SystemComponents	Sensing unit, control unit, software	Sensing unit, control unit, software	Same
TechnologicalCharacteristics	Piezo-electric sensing	Piezo-electric sensing	Same
Mode ofOperation	Contact-less monitoring	Contact-less monitoring	Same
PerformanceCharacteristics	Sensor in mattress coverlet	Sensor in mattress coverlet	Same
	Measures heart rate andrespiration rate	Measures heart rate andrespiration rate	Same
	Detects bed exit	Detects bed exit	Same
	Notifies nurse or caregiver ofchange in condition (e.g., heartrate or respiration rate exceeds setlimits)	Notifies nurse or caregiver ofchange in condition (e.g., heartrate or respiration rate exceeds setlimits)	Same
	Notifies nurse or caregiver of bedexit	Notifies nurse or caregiver of bedexit	Same
	Control unit receives the electricsignals, processes them, andcalculates, logs, displays thepatient's parameters andgenerates alerts as per setthresholds, when needed.	Control unit receives the electricsignals, processes them, andcalculates, logs, displays thepatient's parameters andgenerates alerts as per setthresholds, when needed.	Same

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के द्वारा कर रहा है। इस बार को बाद में बाद में बाद में बाद में बाद में बाद में बाद में बाद में कि में बाद में कि में कि में कि में कि में कि में कि में कि कि

में ब्र

Lifebed Network Patient VigilanceSystem(K083534)	LifeGurney Network PatientVigilance System	Same/Different
Intended Use	Lifebed Network Patient VigilanceSystem is intended to measureheart rate, respiratory rate, andbed exit in adult patients for useby health care professionals.	The LifeGurney Network PatientVigilance System is intended foruse with adult patients by healthcare professionals in thecontinuous measurement of heartrate, respiratory rate, and as anintegral part of fall preventionprotocols.	Same(Wording changes toimprove readabilityandunderstandability)

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 (800) 638-2041 or (301) 796-7100 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:

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

Page 1 of 1

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
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.(b)
Classification. Class II (performance standards).