The HomMed Model Sentry patient monitor system is for spot checking of adult or pediatric patient's systolic, diastolic and mean arterial (MAP) blood pressures, pulse rate, SpO2 oximetry and oral temperature. The device will provide fast, reliable NIBP measurements on patients when using the appropriate blood pressure cuff. The oximetry function operates with all OEM (BCI) oximetry sensors, providing SpO2 and pulse rate on all patients from pediatric to adult patients. The electronic thermometry is intended for oral temperature measurements and is only compatible with the Welch Allyn thermometry probes and probe covers. The device is intended for use in clinical environments by health care providers and for home use by patients with retrospective review by health care providers.

Device Description

HomMed Model Sentry patient monitor provides a manually initiated sequence of automatic patient measurements. The Sentry patient monitor consists of a small tabletop NIBP monitor with a desktop Features include an NIBP cuff hose connection, an SpO2 sensor interface, a oral charger. temperature probe interface and holder, display of patient systolic, diastolic, and mean arterial pressure, interval timer, SpO2, pulse rate, pulse strength, temperature via an LED display.

The HomMed Model Sentry is the existing presently marketed BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with oximeter and electronic thermometer options with certain defeatures implemented via software toggle off/on function controls. The BCI Mini-Torr Plus monitor has a FDA 510(k) approval, Number K983796.

AI/ML Overview

The provided text describes a 510(k) submission for the HomMed Model Sentry patient monitor. However, the document explicitly states that no additional performance testing was conducted for the HomMed Model Sentry. Instead, its performance is considered equivalent to its predicate device, the BCI Model 6004, which had already met applicable FDA requirements.

Therefore, the HomMed Model Sentry itself did not undergo a study to prove it meets specific acceptance criteria. Its acceptance is based on the substantial equivalence principle, drawing upon the pre-existing performance data of the BCI Model 6004.

Given this, I cannot provide an answer that fully addresses all points of your request as the specific performance study for the HomMed Model Sentry, and thus its unique acceptance criteria and study details, are not present in the provided text.

However, I can extract the relevant information regarding the basis for its acceptance:

1. A table of acceptance criteria and the reported device performance

Since no new performance testing was conducted for the HomMed Model Sentry, there are no specific new acceptance criteria or reported device performance metrics unique to this device in the provided text. The device's acceptance is based on the performance of its predicate device, the BCI Model 6004. The HomMed Model Sentry is stated to perform "within its specifications and functional requirements," which are implicitly those of the BCI 6004.

Acceptance Criteria (Implicit, based on predicate): Compliance with guidelines and standards referenced in FDA reviewer's guides for respiratory devices and electronic EMC, electrical, mechanical durability, safety (operator and patient), and thermometers.
Reported Device Performance (Implicit, based on predicate): The Sentry "performed within its specifications and functional requirements" and its performance "remains unchanged" from the BCI 6004.

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

Not applicable, as no new testing was performed for the HomMed Model Sentry. The predicate device's testing details are not provided.

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, as no new testing was performed for the HomMed Model Sentry.

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

Not applicable, as no new testing was performed for the HomMed Model Sentry.

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

Not applicable. The device is a patient monitor, not an AI-assisted diagnostic tool.

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

Not applicable, as no new testing was performed for the HomMed Model Sentry. The device is an integrated patient monitor with hardware and software elements, not a standalone algorithm.

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

Not applicable, as no new testing was performed for the HomMed Model Sentry. The predicate device's testing would have used established reference methods for vital sign measurements (e.g., direct arterial line for NIBP, calibrated temperature probes for temperature).

8. The sample size for the training set

Not applicable, as no new testing was performed for the HomMed Model Sentry, and the device is not described as having an AI component that would require a "training set" in the typical machine learning sense.

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

Not applicable, as no new testing was performed for the HomMed Model Sentry, and the concept of a "training set" is not relevant to the described device.

Summary

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MAR 1 5 2000

K 99 39 38

HomMed LLC

February 15, 2000

510(k) Summary for HomMed Model Sentry

Submitter:Address:	HomMed LLC19275 West Capital Drive, Suite 200Brookfield, Wisconsin 53045
Telephone:	(414) 783-5440
Contact:	Herschel Peddicord, President
Prepared:	February 15, 2000
Proprietary Name:	HomMed Model Sentry
Common/Classification Name:	Noninvasive blood pressure measurement system
Predicate Devices:	BCI Mini-Torr Plus (model 6004) with newelectronic thermometer option; and, BCI 6004 NIBP monitorWelch Allyn 678 SureTemp Thermometer

New Device Description:

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Intended Use:

The HomMed Model Sentry monitor is a portable noninvasive blood pressure (NIBP) monitor for spot checking of a patient's systolic, diastolic, and mean arterial (MAP) blood pressures, pulse rate using an oximeter and oral temperature via an electronic thermometer. The device will provide fast, reliable NIBP measurements on patients ranging from children (pediatrics) to adults when using the appropriate blood pressure cuff provided. The oximetry works with Model Sentry oximetry probes provided by HomMed, providing Sp02 and pulse rate on all patients from pediatric to adult. The electronic thermometry requires use of the Welch Allyn oral thermometry probe and probe covers. It will provide oral temperature information only. The device is intended for use in clinical environments by health care professionals and in home use by patients as prescribed by or on orders by a physician.

Performance Data:

The HomMed Model Sentry utilizes the technology in the BCI 6004 monitor and performs within the environments for which Sentry is marketed. BCI has performed in accordance with the guidelines and standards found in the FDA reviewer's guides for respiratory devices and electronic EMC, electrical, mechanical durability, safety (operator and patient), and thermometers. temperature/humidity testing has been completed. The results demonstrated that the Sentry was in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements.

Since the HomMed Model Sentry is the BC1 6004, which has met and continues to meet the applicable FDA requirements, it was not necessary to do additional performance testing. The performance of the Sentry and the BCI Model 6004 remains unchanged.

The HomMed Model Sentry performance is the BCI 6004 performance and no additional or different testing has been done on the HomMed Model Sentry patient monitor. Thus it is the HomMed position that the Sentry performs as well as the legally marketed predicate device, BCI Model 6004.

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

Page 2

Sincerely,

Tommie J. Morgan, Ph.D.

Morgan Consyllants, Ine.

On Behalf of: Herschel Peddicord, President HomMed LLC

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2000

Ms. Herschel Peddicord Hommed LLC 19275 West Capitol Drive, Suite 200 Brookfield, WI 53045

K993938 Re: The Hommed Sentry, Model 1 Sentry Regulatory Class: II (two) Product Code: DXN Dated: January 20, 2000 Received: January 21, 2000

Dear Ms. Peddicord:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Herschel Peddicord

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Celia M. Witten, Ph.D., M.D.

Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K993938

Device Name: HomMed Model Sentry

Indications for Use:

Federal law restricts this device to sale by or on the order of a physician.

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K993938
werle

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use i (Per 21 CFR 801.109)

Over-the Counter Use

(Optional Format 1-26-96)

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).