The HomMed Central Station is intended to be used to retrospectively receive, display, evaluate, analyze and store certain monitored physiological parameters of patients within healthcare and home environments. The physiologic patient parameters available for retrospective display and evaluation include NIBP, pulse rate, SpO2, temperature and weight. The Central Station will be the device used by the healthcare professional to display and evaluate the monitored patient data, and the healthcare professional is responsible for the interpretation of the monitored data made available by the Observer. The Central Station data will be a utilized by the healthcare professional health including physicians and/or physician supervised nurses. Physiological data, system alerts and patient data analysis will be available to the health care provider from Central Station that may be considered as a retrospective data monitor system.

Device Description

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the HomMed Central Station, based on the provided text:

Summary of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Requirement	Reported Device Performance
Functional Requirements	Intended use as defined: retrospectively receive, display, evaluate, analyze, and store certain monitored physiological parameters (NIBP, pulse rate, SpO2, temperature, weight). Not for emergency use or real-time monitoring.	"Software validation results demonstrated that the HomMed Central Station System... performed within its specifications and functional requirements."
Performance Specifications	Operation on commercially available PC systems with minimum performance specifications consistent with typical PC hardware.	"Software validation results demonstrated that the HomMed Central Station System... performed within its specifications and functional requirements." (Implies it met the PC requirements and overall performance).
Regulatory Compliance	Compliance with relevant guidelines and standards referenced in FDA reviewer's guides. Specifically mentioned: - Medical Software Validation Standards - EN 60601-1 Medical Electrical Safety - EMC Compliance IEC 601-1-2 - ISO 10993-5, 10-11 Biocompatibility (Though Biocompatibility might be for associated hardware, not directly the software, it's listed under compliance).	"Software validation results demonstrated that the HomMed Central Station System was in compliance with the guidelines and standards referenced in the FDA reviewer's guides..."
Safety	General safety requirements for medical electrical systems.	"Software validation results demonstrated that the HomMed Central Station System was in compliance with the guidelines and standards referenced in the FDA reviewer's guides..." (Likely covers safety implicitly).

Study Information

Based on the provided text, the submission is a 510(k) Premarket Notification for the HomMed Central Station. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting extensive clinical efficacy trials typically seen for PMA applications.

Here's what can be inferred about the "study" mentioned for this device:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states: "The software validation results demonstrated that the HomMed Central Station 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 indicates a software validation study was performed. However, no specific sample size for a "test set" of patient data is provided. The validation would likely involve testing various scenarios and inputs to ensure the software (Central Station) accurately receives, displays, evaluates, analyzes, and stores the physiological parameters from the HomMed Sentry Patient Monitors.
- Data provenance is not specified. Given the nature of a software validation, it would likely involve simulated or representative data, potentially from a variety of sources but not explicitly stated. The intent is to process data acquired "within healthcare and home environments."
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):
- The document does not mention the use of experts to establish ground truth for a test set in the context of validating algorithmic performance. The validation appears to be centered on the software's functional correctness and adherence to technical specifications. The "healthcare professional is responsible for the interpretation of the monitored data."
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. The study described is a software validation, not a clinical study involving adjudication of interpretations.
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, an MRMC comparative effectiveness study was not done. The HomMed Central Station is described as "a retrospective data view and analysis system" and an "accessory device used by the healthcare professional to display and evaluate the monitored patient data." It does not claim to incorporate AI or provide interpretations that would necessitate an MRMC study comparing human performance with and without AI assistance. The healthcare professional is explicitly stated to be "responsible for the interpretation of the monitored data."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, the "software validation" serves as a standalone performance assessment of the algorithm/software's functionality. The validation assesses if the software, in isolation, correctly receives, processes, stores, and displays data according to its specifications. However, it's crucial to note that this "standalone" performance is within the context of a retrospective display and analysis system, where final interpretation remains with the human professional. The device is not making diagnostic decisions on its own.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a software validation of this nature, the "ground truth" would likely be derived from:
  - Expected system behavior: Comparison of the software's output against predefined functional and performance requirements.
  - Input data accuracy: Ensuring that known input physiological data is accurately processed and displayed by the system.
  - Compliance with standards: Verifying that the software adheres to established software development and medical device standards.
- There is no mention of pathology, expert consensus on patient conditions, or outcomes data being used as ground truth for this software validation.
The sample size for the training set:
- Not applicable/Not mentioned. This device is not described as an "AI" or machine learning device that requires a training set in the typical sense. It is a data management and display software system.
How the ground truth for the training set was established:
- Not applicable, as there is no indication of a "training set" for AI/ML processes.

Summary

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APR 2 2 2002

510(k) Summary for HomMed Central Station

Submitter:	Ho
Address:	19Bro
Corporate Contact:	He
Telephone:	PhFax
Submission Contact:	ToM20Ho

mMed. LLC 275 West Capital Drive, Suite 200 ookfield, Wisconsin 53045 rschel Peddicord, President, HomMed, LLC : (262) 783-5440 x: (262) 783-5441

mmie J. Morgan Ph.D., President organ Consultants, Inc. 18 North Durham uston, Texas 77008 Ph: (713) 880-5111 Fax: (713) 880-3494

December 15, 2001

HomMed Central Station

HomMed Observer, Model I

Prepared:

Proprietary Name:

Common/Classification Name: Cardiovascular

Predicate Device:

HomMed Central Station New Device Description:

Intended Use:

The HomMed Central Station intended use is to retrospectively receive, display, evaluate, analyze and store certain monitored physiological parameters of patients when this data is acquired within healthcare and home environments. The Central Station is the accessory device used by the healthcare professional to display and evaluate the monitored patient data from the HomMed Sentry, Patient Monitor Systems and the healthcare professional is responsible for the interpretation of the monitored data made available by the Central Station. The data received from the Sentry and displayed by the Central Station will be utilized by healthcare professionals, (including physician and/or physician supervised nurses), to retrospectively view patient physiological data. Physiological data, system alerts and patient data analysis will be available to the health care provider from Observer. The Central Station, a retrospective data view and analysis system is not intended for emergency use or real-time monitoring of data received from the HomMed Sentry Patient Monitors.

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 is an accessory to the HomMed Sentry Patient Monitors. The software validation results demonstrated that the HomMed Central Station 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.

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

Compliance to Standards and Regulations:

Safety

Medical Software Validation Standards

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

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of an eagle. The eagle is composed of three curved lines that suggest its wings and body. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2002

HomMed. LLC c/o Tommie J. Morgan, Ph.D. President Morgan Consultants, Inc. 2018 North Durham Houston, TX 22008

Re: K020184

Trade Name: HomMed Central Station Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: April 2, 2002 Received: April 3, 2002

Dear Dr. Morgan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becaren or (2) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sualed in the encreated 776, the enactment date of the Medical Device Amendments, or to conniner of they 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de noos that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, arores, missions of the Act include requirements for annual registration, listing of general volurols provisions of tactice, 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to back additions, 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 I loase of actived a determination that your device complies with other requirements of the Act that I DT has made a aown regulations administered by other Federal agencies. You must or uny I valuated and states requirements, including, but not limited to: registration and listing (21 CER Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in alle qualion 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) I mis loter will and w your to organization of substantial equivalence of your device to a legally prematicate 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF F F ar 8646. Additionally, for questions on the promotion and advertising of Compinatee at (301) 59 - 1 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). I og all information on your responsibilities under the Act may be obtained from the Oinor general mironmances, 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-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: HomMed Central Station

Indications for Use

The HomMed Central Station is intended to be used to retrospectively receive, , display, evaluate, analyze and store certain monitored physiological parameters of patients within healthcare and home environments. The physiologic patient parameters available for retrospective display and evaluation include NIBP, pulse rate, SpO2, temperature and weight. The Central Station will be the device used by the healthcare professional to display and evaluate the monitored patient data, and the healthcare professional is responsible for the interpretation of the monitored data made available by the Observer. The Central Station data will be a utilized by the healthcare professional health including physicians and/or physician supervised nurses. Physiological data, system alerts and patient data analysis will be available to the health care provider from Central Station that may be considered as a retrospective data monitor system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Only (Per 21 CFR 801.109)

Over-the-Counter Use

Division of Cardiovascular & Respiratory Devices
510(k) Number K020184

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).