CENTRAL STATION, VERSION 3.3H by HOMMED LLC.

The HomMed Central Station intended use is to retrospectively receive, display, and store certain monitored physiological parameters received from adult and pediatric (over 12 years of age) patients within healthcare and home environments. Central Station, Version 3.3H includes a HL7 interface to transfer data from HomMed Central Station to vendor systems and storage media. The physiologic patient parameters available for retrospective display and evaluation include NIBP, pulse rate, SpO2, temperature, and weight. Additionally monitoring device data from optional commercial stand-alone products including glucometry, spirometry, prothrombin time, ECG and digital camera images can also be received, displayed and stored. The Central Station displays patient data and system alerts for review and interpretation by physicians and/or physician supervised nurses. Central Station is a retrospective data monitor system and is not intended for emergency use or real-time monitoring.

Device Description

AI/ML Overview

The provided text describes the HomMed Central Station, Version 3.3H, a device intended to retrospectively receive, display, and store physiological parameters. However, the document does not contain information regarding specific acceptance criteria, a detailed study proving performance, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or how ground truth was established beyond a general statement of "software validation results."

The "Performance Data" section states that "The software validation results demonstrated that the HomMed Central Station 3.3H System 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." This is a high-level summary and does not provide the specific details requested in the prompt.

Therefore, I can only provide limited information based on the text.

Here's a breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria. The performance is stated generally:

Acceptance Criteria	Reported Device Performance
(Not specified)	Complied with guidelines and standards referenced in FDA reviewer's guides.
(Not specified)	Performed within its specifications and functional requirements.

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

Sample size for the test set: Not specified in the provided document.
Data provenance: Not specified in the provided document. The device itself retrospectively receives data, but the provenance of data used for validation is not mentioned.

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 specified in the provided document.

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

Not specified in the provided 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

No MRMC comparative effectiveness study is mentioned or implied. The device is a data display and storage system, not an AI-powered diagnostic tool for human reader improvement.

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

The document implies a standalone software validation was performed ("The HomMed Central Station is a software system... The software validation results demonstrated..."), but specific details on the methodology (e.g., comparison to a reference standard without human involvement) are not provided. The phrase "algorithm only" might not be fully applicable as it's a data management system, not a diagnostic algorithm.

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

Not specified. The statement "performed within its specifications and functional requirements" suggests validation against predetermined software requirements and potentially functional testing, but the nature of the "ground truth" for the physiological parameters themselves is not detailed.

8. The sample size for the training set

Not specified in the provided document.

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

Not specified in the provided document.

Summary

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510(k) Summary for HomMed Central Station

Submitter:Address:	HomMed, LLC19275 West Capital Drive, Suite 200Brookfield, Wisconsin 53045
Corporate Contact:Telephone:	Herschel Peddicord, President, HomMed, LLCPh: (262) 783-5440Fax: (262) 783-5441
Establishment Registration #:	3004183721
Submission Contact:	Tommie J. Morgan Ph.D., PresidentMorgan Consultants, Inc.2018 North DurhamHouston, Texas 77008Ph: (713) 880-5111Fax: (713) 880-3494
Trade Name:	HomMed Central Station, Version 3.3H
Predicate Device:	HomMed Central Station
Common Name:	Patient Vital Signs Monitor Viewing Station
Classification Name:	Non-Invasive Blood Pressure Measurement SystemProduct Code: DXN

Intended Use:

Central Station's intended use is to retrospectively receive, display and store certain monitored physiological parameters received from adult and pediatric (over 12 years of age) patients within health care and home environments. Central Station, Version 3.3H includes a HL7 interface to transfer data from HomMed Central Station to vendor systems and storage media. The physiologic patient parameters available for retrospective display and evaluation include NIBP, pulse rate, Sp02, temperature and weight. Additionally monitoring device data from optional commercial stand-alone products including glucometry, prothrombin time, ECG and digital camera images can also be received, displayed and stored. The Central Station displays patient data and system alerts for review and interpretation by physician-supervised nurses. Central Station is a retrospective data monitor system and is not intended for emergency use or real-time monitoring.

Performance Data:

The HomMed Central Station is a software system that operates on a commercially available PC system with the minimum performance specifications consistent with typical PC hardware and equipment specifications. The HomMed Central Station is a software system that accepts data from the HomMed Sentry Patient Monitors. The software validation results demonstrated that the HomMed Central Station 3.3H System 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.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2004

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

Re: K040032

Trade Name: Central Station, Version 3.3 H Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: January 07, 2004 Received: January 08, 2004

Dear Dr. Morgan:

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 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 - Tommie J. Morgan, Ph.D.

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): 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Donna R. Kirchner

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): K040032

Device Name: Central Station, Version 3.3H

Indications For Use:

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muna R. Sochner
(Division Sign-Off)

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Division of Cardiovascular Devices = 10/2/ Nimhor K04003

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).