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.

Device Description

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.

AI/ML Overview

The Hoana Medical L1 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 also monitors bed exit.

Here's a breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a table format. Instead, it makes a general statement about the device meeting "performance requirements." However, based on the conclusion, the implied performance criteria are that the device 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."

Implied Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Heart Rate Measurement Accuracy	(Comparable to predicate devices: Escort 100/300 Series B Patient Monitor)	"The results of the clinical testing demonstrate that the [G1 Intelligent Medical Vigilance System meets the performance requirements." and is "safe, effective and performs as well as the predicate devices..."
Respiratory Rate Measurement Accuracy	(Comparable to predicate devices: Escort 100/300 Series B Patient Monitor)	"The results of the clinical testing demonstrate that the [G1 Intelligent Medical Vigilance System meets the performance requirements." and is "safe, effective and performs as well as the predicate devices..."
Bed Exit Monitoring Accuracy	(Comparable to predicate devices: Hill-Rom Advanta-Bed Patient Position Monitor)	"The results of the clinical testing demonstrate that the [G1 Intelligent Medical Vigilance System meets the performance requirements." and is "safe, effective and performs as well as the predicate devices..."
Safety	Meets electrical, mechanical, EMC (IEC 60601) and biocompatibility (ISO 10993) standards.	"Electrical, Mechanical and EMC Testing per IEC 60601 was performed and the [G1 Intelligent Medical Vigilance System passed all tests." and "Biocompatibility testing was conducted according to the requirements of ISO 10993... All test article materials passed."
Effectiveness	Monitors heart rate, respiratory rate, and bed exit, and provides alarms when limits are exceeded, comparable to predicate devices.	"The results of the clinical testing demonstrate that the [G1 Intelligent Medical Vigilance System meets the performance requirements." and is "safe, effective and performs as well as the predicate devices..."

2. Sample Size Used for the Test Set and Data Provenance

The provided document mentions "Clinical Testing" but does not specify the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance. The testing described is focused on the device's performance against predicate devices, not on human-AI collaboration.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

The clinical testing described appears to be a standalone performance evaluation of the device's algorithms for measuring heart rate, respiratory rate, and bed exit. The system is designed to passively extract patient information and display data, with alarm logic built into the Bedside Unit. This suggests the evaluation was of the algorithm's performance without direct human intervention in the real-time measurement process.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, given the nature of measuring heart rate, respiratory rate, and bed exit, it is highly probable that the ground truth would have been established by:

Reference medical devices/sensors: Using established, highly accurate medical monitors as a gold standard for heart rate and respiratory rate.
Direct observation: For bed exit, direct observation or dedicated sensors not part of the study device would likely be used to confirm bed exit events.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set. It refers to "proprietary signal processing algorithms" but provides no details on their development or training data.

9. How the Ground Truth for the Training Set Was Established

The document does not provide any information on how the ground truth for the training set was established.

Summary

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KOSZ446

SECTION 5 - 510(k) Summary
Submitted By:	Hoana Medical Inc.1001 Bishop StreetASB Tower Suite 2828Honolulu, HI 96813Phone: (808) 523-5483Fax: (808) 523-5480
Contact:	Matt GleiVice President of Research andDevelopment and Regulatory Affairs
Date Summary Prepared:	September 2, 2005
Trade Name:	L1 Intelligent Medical Vigilance System
Common/Classification Name:	Monitor, Cardiac74DRT, 870.2300
Substantially Equivalent Devices:	Escort 100/300 Series B Patient Monitor(K992413)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.

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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.

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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.

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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 (240) 276-0210. 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 (800) 638-2041 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

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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)

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).