HOMMED CENTRAL STATION

K020184 · Hommed, LLC · DXN · Apr 22, 2002 · Cardiovascular

Device Facts

• Record ID: K020184
• Device Name: HOMMED CENTRAL STATION
• Applicant: Hommed, LLC
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

HomMed Central Station is a software-based accessory for HomMed Sentry Patient Monitors; operates on standard PC hardware. Receives, stores, and displays retrospective physiological data (NIBP, pulse, SpO2, temperature, weight) and system alerts. Used by healthcare professionals (physicians/nurses) in clinical or home-care environments to review patient data and perform analysis. Does not provide real-time monitoring or emergency alerts. Enables clinicians to evaluate patient status over time to support clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Software validation demonstrated compliance with FDA guidelines and standards, confirming the system performs within specified functional requirements.

Technological Characteristics

Software system operating on standard PC hardware. Functions as an accessory to HomMed Sentry Patient Monitors. Connectivity via data transfer from Sentry monitors. Complies with EN 60601-1 (electrical safety), IEC 601-1-2 (EMC), and ISO 10993-5, 10-11 (biocompatibility).

Indications for Use

Indicated for retrospective display, evaluation, analysis, and storage of physiological parameters (NIBP, pulse rate, SpO2, temperature, weight) for patients in healthcare and home settings. Intended for use by physicians and physician-supervised nurses. Not for emergency use or real-time monitoring.

Regulatory Classification

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.

Predicate Devices

• HomMed Observer, Model I

Submission Summary (Full Text)

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# APR 2 2 2002

# 510(k) Summary for HomMed Central Station

| Submitter: | Ho |
|---------------------|---------------------|
| Address: | 19<br>Bro |
| Corporate Contact: | He |
| Telephone: | Ph<br>Fax |
| Submission Contact: | To<br>M<br>20<br>Ho |

mMed. LLC 275 West Capital Drive, Suite 200 ookfield, Wisconsin 53045 rschel Peddicord, President, HomMed, LLC : [phone] x: [phone]

mmie J. Morgan Ph.D., President organ Consultants, Inc. 18 North Durham uston, Texas 77008 Ph: [phone] Fax: [phone]

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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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 [phone]. 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 [phone] or [phone] 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use Only (Per 21 CFR 801.109)

#### Over-the-Counter Use

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