LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM

K052446 · Hoana Medical, Inc. · DRT · Feb 2, 2006 · Cardiovascular

Device Facts

• Record ID: K052446
• Device Name: LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM
• Applicant: Hoana Medical, Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: Feb 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The LG1™ Intelligent Medical Vigilance System is intended to measure heart rate and respiratory rate in adult patients, in bed, in a general care hospital environment. The system will also monitor bed exit.

Device Story

L1 Intelligent Medical Vigilance System provides non-contact patient monitoring in general care hospital settings. System utilizes Passive Sensor Array (PSA) mattress coverlet to detect physiological stimuli; Bedside Unit processes signals via proprietary algorithms to calculate heart rate, respiratory rate, and bed exit status. Data displayed on integrated GUI; system interfaces with existing nurse call infrastructure to trigger alarms when vitals exceed preset limits or patient attempts to exit bed. Enables continuous monitoring without electrodes, wires, or leads; provides trend data in 10-minute to 12-hour views. Benefits include reduced patient burden and automated vigilance for fall prevention and physiological deterioration.

Clinical Evidence

Clinical testing conducted to demonstrate performance requirements met. Results indicate the system performs as well as predicate devices for heart rate, respiratory rate, and bed exit monitoring.

Technological Characteristics

Non-contact sensor array integrated into mattress coverlet; Bedside Unit with digital signal processing. Biocompatibility per ISO 10993 for skin contact <24 hrs. Electrical/mechanical safety per IEC 60601. Connectivity via nurse call system interface. Proprietary signal processing algorithms.

Indications for Use

Indicated for adult patients in general care hospital environments to measure heart rate, respiratory rate, and monitor bed exit status.

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

• Escort 100/300 Series B Patient Monitor (K992413)
• Hill-Rom Advanta-Bed, Class I Exempt

Submission Summary (Full Text)

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

# KOSZ446

| SECTION 5 - 510(k) Summary | |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Hoana Medical Inc.<br>1001 Bishop Street<br>ASB Tower Suite 2828<br>Honolulu, HI 96813<br>Phone: [phone]<br>Fax: [phone] |
| Contact: | Matt Glei<br>Vice President of Research and<br>Development and Regulatory Affairs |
| Date Summary Prepared: | September 2, 2005 |
| Trade Name: | L1 Intelligent Medical Vigilance System |
| Common/Classification Name: | Monitor, Cardiac<br>74DRT, 870.2300 |
| Substantially Equivalent Devices: | Escort 100/300 Series B Patient Monitor<br>(K992413)<br>Hill-Rom Advanta-Bed, Class I Exempt |

# Description of the ¿G¹ Intelligent Medical Vigilance System:

The ¿G¹™ technology analyzes basic heart and respiratory rates without direct patient contact, eliminating the use of electrodes, wires and leads. The technology integrates proprietary signal processing algorithms with patented data collection devices that produce an electrical signal in response to physiological stimuli. The Bedside Unit passively extracts patient information as the patient lies upon this "sensor array." providing accurate measurements even through clothing, gowns or sheets.

The [G] system consists of two main components: the Bedside Unit, and the Passive Sensor Array™ (PSA™). The Bedside Unit houses the digital signal processing algorithms ([G1 algorithms, version 1.0.0.36) that calculate heart and respiratory rates and bed exit status (in-bed sensor) in real time, and displays the data as part of the integrated graphical user interface. The Bedside Unibilary houses the alarm logic, and interfaces to the existing nurse call system found in the hospital. The PSA is comprised of a mattress ticking ("coverlet" that zips over the entire mattress) that houses an array of sensors, which connect to the Bedside Unit via a cable with an integrated "quick disconnect" safety feature.

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

## Intended Use

The LG1™ Intelligent Medical Vigilance System is intended to measure heart rate and respiratory rate in adult patients, in bed, in a general care nospital environment. The system will also monitor bed exit.

# Principles of Operation

The [G1 Intelligent Medical Vigilance System operates in the following manner, The bed on a general care floor is fitted with the sensor array built into a sleep surface coverlet. Each bed is then fitted with a normal sheet and bedding above the coverlet.

The device measures heart rate and respiration rate and monitors those against preset limits. If the bedside unit senses the heart rate or respiration rate is outside the desired limits for a period of time, it will signal the nurse with an alarm indicator using the existing nurse call system. If the patient has been evaluated as at risk to fall, the bed exit alarm can also be enabled. When the unit senses the patient is attempting to get out of bed, it will use the nurse call system to signal the nurse.

The system will trend and display graphics or a table of heart rate and respiration rate in 10 minute, 2, 4, 8, and 12 hour views of the data.

## Electrical, Mechanical and EMC Testing

Electrical, Mechanical and EMC Testing per IEC 60601 was performed and the [G1 Intelligent Medical Vigilance System passed all tests.

## Biocompatibility Testing

Biocompatibility testing was conducted according to the requirements of ISO 10993, Biological Evaluation of Medical Devices, Table 1 -- Initial Evaluation Tests for Consideration for a surface device in contact with skin for less than 24 hrs. All test article materials passed.

## Clinical Testing

The results of the clinical testing demonstrate that the ‫(G1 Intelligent Medical Vigilance System meets the performance requirements.

## Conclusion

All test results demonstrate that the ‫(G1 Intelligent Medical Vigilance System is safe, effective and performs as well as the predicate devices, the Escort 100/300 Series B Patient Monitor and the Hill-Rom Advanta-Bed Patient Position Monitor.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA". The logo is simple and recognizable, conveying the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EEB

Hoana Medical, Inc. c/o Mr. Matthew S. Glei Vice President, Research and Development and Regulatory Affairs 1001 Bishop Street American Savings Bank Tower, Suite 228 Honolulu, HI 96813

Re: K052446

Trade Name: ¿G'TM Intelligent Vigilanc e System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: DRT Dated: January 3, 2006 Received: January 5, 2006

Dear Mr. Glei:

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 cither 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 may publish further announcements concerning your device in the Federal Register.

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

Page 2 – Mr. Matthew S. Glei

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 lease be advised that I Dr. Bressantly own device complies with other requirements of the Act that I Dri has made a actuations administered by other Federal agencies. You must of any I cuchares and roganizents, including, but not limited to: registration and listing Comply with an the Fee Frequirements of and 801); good manufacturing practice requirements as set (21 CFR Part 807), laoomig (21 CFR Part 820); and if applicable, the electronic form in alle quart of by oversions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro risens ( veting your device as described in your Section 510(k) I mis letter will anow you to organization of substantial equivalence of your device to a legally promatics notification: "The Pro 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 If you desire specific arrivaliance at [phone]. Also, please note the regulation entitled, Comaci the Office of Compullion and (21 ) == (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Octess http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimmar for

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

Enclosure

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

HOANA MEDICAL

# Indications for Use

510(k) Number (if known): _ K052446

Device Name: LG TM INTELLIGENT MEDICAL VIGILANCE SYSTEM

Indications for Use:

The LG TM Intelligent Medical Vigilance System is intended to measure heart rate and respiratory rate in adult patients, in a general care hospital environment. The system will also monitor bed exit.

Prescription Use _ X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rhummer
5/21/2003

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

(Posted November 13, 2003)