HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM by HOMMED LLC.

The HomMed Sentry IIIB-F Patient Monitor System is designed to measure Patient Vital Signs in the home by patients or in clinical environments by health care providers. The HomMed Sentry IIIB-F Patient Monitor System is available with physicians' orders only.

The HomMed Sentry IIIB-F Patient Monitor System measures the following parameters: Non-Invasive Blood Pressures (Systolic and Mean Arterial Pressure), Functional Oxygen Saturation (%SpO₂), Peripheral Pulse Rate (PPR), Pulse Strength, Oral Temperature and Patient Weight via an external scale. The HomMed Sentry IIIB-F Patient Monitor System's optional, compatible devices extend those measurements to glucometer, spirometer, electrocardiogram (ECG) and prothrombin time (PT/INR) monitoring and digital image acquisition. The patient parameter data is collected and displayed by the HornMed Sentry IIIB-F Patient Monitor System. Data can be transmitted via the communication module to a central station where the patient data can be viewed and analyzed.

Device Description

The HomMed Sentry IIIB-F Patient Monitor System (Sentry IIIB-F) is a portable patient vital signs monitoring system. The system measures noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. In addition, the system has optional glucometer, spirometer, electrocardiogram (ECG) and prothrombin time (PT/INR) measuring, and digital image acquisition capabilities. The Sentry IIIB-F acquires the patient vital signs data and displays it. The data can also be transmitted via the communication system through the Skytel or PageNet Pager Network to a central station for storage with retrospective display and analysis.

Sentry IIIB-F provides a noninvasive blood pressure (NIBP) monitor for measurements of a patient's systolic, diastolic, and mean arterial (MAP) blood pressures; pulse oximeter, acquires a pulse rate using an oximeter; oral temperature via an electronic thermometer; weight from an electronic scale. All data collected from these functions as well as optional glucometry, ECG devices, PT/INR monitor and acquired digital images are sent through an internal communication module.

AI/ML Overview

The provided 510(k) summary for the HomMed Sentry IIIB-F Patient Monitor System states that the device's performance has been confirmed to be equivalent to its predicate device (HomMed Sentry III Patient Monitor System with Card Reader, K014025). The summary also mentions compliance with various national and international standards. However, it does not provide a detailed list of specific acceptance criteria or the reported device performance in a numerical or quantitative format. Instead, it offers a general statement regarding compliance and consistency with guidelines.

Therefore, the requested table of acceptance criteria and reported device performance, as well as several other detailed study parameters, cannot be fully extracted from the provided text. The document focuses on regulatory compliance and equivalence to a predicate device rather than presenting a standalone clinical or performance study with detailed statistical results.

Here's a breakdown of what can and cannot be extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Device Parameter / Test	Acceptance Criteria	Reported Device Performance
All Functions (General Performance)	Consistent with guidelines and standards found in the FDA reviewer's guides for respiratory devices and electronic thermometers.	"Performed within its specifications and functional requirements." "Performance is consistent with the HomMed Sentry III with Card Reader performance." "Performs as well as the legally marketed predicate device."
Noninvasive Blood Pressure (NIBP)	(Not specified quantitatively)	"Provides fast, reliable measurements on patients when using the appropriate blood pressure cuff."
Pulse Oximetry (SpO2 & Pulse Rate)	(Not specified quantitatively)	"Works with the Sentry pulse oximetry probes provided by HomMed, providing SpO2 and pulse rate on all patients."
Oral Temperature	(Not specified quantitatively)	"Requires use of the Welch Allyn oral thermometry probe and probe covers. It provides only oral temperature information."
Weight	(Not specified quantitatively)	"Uncomplicated measurement and remote monitoring of patient vital signs including weight."
EMC	IEC 601-1-2	"Completed demonstrating compliance with applicable standards." "Test results demonstrated that the Sentry IIIB-F is in compliance."
Electrical Safety	EN 60601-1	"Completed demonstrating compliance with applicable standards." "Test results demonstrated that the Sentry IIIB-F is in compliance."
Mechanical Durability	(Not specified)	"Completed demonstrating compliance with applicable standards." "Test results demonstrated that the Sentry IIIB-F is in compliance."
Safety (Operator & Patient)	EN 60601-1, ISO 10993-5, 10-11 (Biocompatibility)	"Completed demonstrating compliance with applicable standards." "Test results demonstrated that the Sentry IIIB-F is in compliance."
Temperature/Humidity	(Not specified)	"Completed demonstrating compliance with applicable standards." "Test results demonstrated that the Sentry IIIB-F is in compliance."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not specified. The document mentions "testing done on the Sentry III IIIB-F" but does not provide details on sample size (e.g., number of patients, number of measurements), data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not specified. The nature of the device (vital signs monitor) suggests that ground truth would typically be established by validated reference devices rather than human experts interpreting complex data. The document does not mention any expert involvement in establishing ground truth for testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. This type of adjudication is typically used for subjective interpretations by multiple human readers (e.g., in imaging studies). For a vital signs monitor, performance is usually assessed against a known standard or reference device, not via subjective adjudication.

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

No. This is not an AI-assisted device, nor is it a device that involves human readers interpreting complex cases in the way that an MRMC study would apply. Therefore, no such study was conducted or reported.

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

Yes, implicitly. The "Performance Data" section describes "testing done on the Sentry III IIIB-F" to assure compliance with standards and to demonstrate it "performed within its specifications and functional requirements." This refers to the device's inherent performance. Since this is a direct vital signs measurement device, its "standalone" performance is its primary mode of operation. There is no "algorithm only" in the sense of an AI model being evaluated separately from the device's physical sensors and processing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Implicitly, reference standards or validated measurement methods. For vital signs, ground truth would be established by highly accurate, often invasive or gold-standard, reference devices (e.g., intra-arterial blood pressure for NIBP, co-oximetry for SpO2, calibrated scales for weight, etc.). The document does not explicitly state the specific reference devices used but implies comparison to established and validated measurement techniques.

8. The sample size for the training set

Not applicable/Not specified. This device is not an AI/machine learning device that requires a training set in the conventional sense. Its performance is based on traditional signal processing and sensor technology, not a learned model.

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

Not applicable/Not specified. As mentioned above, there is no "training set" for this type of device.

Summary

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510(k) Summary

HomMed Sentry IIIB-F Patient Monitor System

Consultant Contact: Tommie J. Morgan, Ph.D., President Morgan Consultants Inc. 2018 North Durham Drive Houston, TX 77008 713 880-5111 Voice or 713 880-3494 Fax
Company: HomMed. LLC 19275 West Capitol Dr., Suite 200 Brookfield , WI 53045 262 783-5440 Voice or 262 783-5441 Fax

HomMed Sentry IIIB-F Patient Monitor System Trade Name:

Patient Vital Signs Monitor with Options Common Name:
Classification Name: Cardiovascular and Respiratory Devices, Class II
Substantial Equivalence Claimed to:

HomMed Sentry III Patient Monitor System with Card Reader K014025

The HomMed Sentry IIIB-F Patient Monitor System (Sentry IIIB-F) is a portable Device Description: patient vital signs monitoring system. The system measures noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. In addition, the system has optional glucometer, spirometer, electrocardiogram (ECG) and prothrombin time (PT/INR) measuring, and digital image acquisition capabilities. The Sentry IIIB-F acquires the patient vital signs data and displays it. The data can also be transmitted via the communication system through the Skytel or PageNet Pager Network to a central station for storage with retrospective display and analysis.
The HomMed Sentry IIIB-F is intended for in home and/or healthcare facility Indications for Use: applications under physician orders. The use of the system is to allow retrospective review of certain patient physiological functions. The HomMed Sentry IIIB-F can measure and display patient data including noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. Additionally, the patient vital signs data can be communicated to a central review station via a pager network with a backup landline telephone modem for telephone communication with the central pager network if necessary.

The device will provide fast, reliable measurements on patients when using the appropriate blood pressure cuff. Sentry IIIB-F's pulse oximetry works with the

3/8/04

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Sentry pulse oximetry probes provided by HomMed, providing Sp02 anc pulse rate on all patients. The electronic thermometry requires use of the Welch Allyn oral thermometry probe and probe covers. It provides only cral temperature information.

Comparison with Predicate Devices:

This HomMed Sentry IIIB-F allows uncomplicated measurement and remote monitoring of patient vital signs including weight utilizing the existing technologies of the predicate device, HomMed Sentry III Patient Monitor System with Card Reader.

Determination of Substantial Equivalence:

The performance of each component of the HomMed Sentry IIIB-F has been confirmed to be equivalent to the predicate device HomMed Sentry III Patient Monitor System with Card Reader.

Compliance to Standards and Regulations:

The HomMed Model Sentry 111B-F complies with the following national and international standards:

Safety		EN 60601-1	Medical Electrical Safety
		IEC 601-1-2	EMC Compliance
		ISO 10993-5,10-11	Biocompatibility

Performance Data:

The HomMed Sentry IIIB-F is utilized within the environments for which it and Sentry III with Card Reader are marketed. The Sentry IIIB-F performs consistent with guidelines and standards found in the FDA reviewer's guides for respiratory devices and electronic thermometers. EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing has been completed demonstrating compliance with applicable standards. The test results demonstrated that the Sentry IIIB-F is in compliance with the guidelines and standards referenced in the FDA reviewer's quides and that it performed within its specifications and functional requirements.

The HomMed Sentry IIIB-F performance is consistent with the HomMed Sentry III with Card Reader performance. Testing done on the Sentry III IIIB-F assures compliance with applicable electrical, safety and healthcare standards. Thus it is the HomMed position that the HomMed Sentry IIIB-F performs as well as the legally marketed predicate device.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of FDA regarding patient monitors.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract shapes, possibly representing human figures or abstract forms. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 2004

HomMed, LLC c/o Tommie J. Morgan, Ph.D. President Morgan Consultants Inc. 2018 North Durham Drive Houston, TX 77008

Re: K040651

Ro40031
Trade Name: HomMed Sentry IIIB-F Patient Monitor System Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: II (two) Product Code: DXH Dated: July 29, 2004 Received: July 30, 2004

Dear Dr. Morgan:

We have reviewed your Section 510(k) premarket notification of intent to market the device t We have reviewed your Section 9 ro(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manat date of the Medical Device Amendments, or to commerce prior to May 26, 1970, the characters and other of the Federal Food, Drug, devices that have been recalssinod in accessful of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval post of and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The I ou may, merciole, manel the act include requirements for annual registration, listing of general controls provisions of the rise 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 II your device is classified (see above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations ED t may be subject to suen additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I casa announceming your device in the Federal Register.

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Page 2 - Tommie J. Morgan, Ph.D.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuation of a basean. In other requirements of the Act that FDA has made a decommation administered by other Federal agencies. You must of any I edital statutes and regalations and admited to: registration and listing (21 compry with an the Act 3 requirements, news 801); good manufacturing practice requirements as set CFK Fatt 807), fabeing (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Seting your device as described in your Section 510(k) This letter witi anow you to ogen manies. By
premarket notification. The FDA finding of substantial equivalence of your device to a legally prematics notheation: The PDF Intentigation 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 11 you ucate specific advice for your act (301) 594-4646. Also, please note the regulation entitled, Contact the Office of Come of Come are to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Oiller general information on your respational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil R.P. Ogden

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

Enclosure

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510(k) Number (if known):	K04065
---------------------------	--------

Device Name: HomMed Sentry IIIB-F Patient Monitor System

Indications for Use

Prescription Use X (21 CFR 807 Subpart D)

Over-th
(21 CE

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - - CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K040651

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Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).