CENTRAL STATION, VERSION 3.3H

K040032 · Hommed, LLC · DXN · Feb 27, 2004 · Cardiovascular

Device Facts

• Record ID: K040032
• Device Name: CENTRAL STATION, VERSION 3.3H
• Applicant: Hommed, LLC
• Product Code: DXN · Cardiovascular
• Decision Date: Feb 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

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 Story

Software-based system operating on standard PC hardware; receives physiological data from HomMed Sentry Patient Monitors and optional stand-alone devices (glucometers, spirometers, ECG, etc.). Functions as retrospective data management station; displays patient parameters and system alerts for review by physician-supervised nurses. Includes HL7 interface for data transfer to external vendor systems/storage. Not intended for real-time monitoring or emergency use. Benefits include centralized retrospective evaluation of patient health trends in home or clinical environments.

Clinical Evidence

Bench testing only. Software validation demonstrated compliance with FDA guidelines and functional requirements for a retrospective patient monitoring system.

Technological Characteristics

Software system operating on commercial PC hardware. Features HL7 interface for data interoperability. Supports retrospective data management of NIBP, pulse, SpO2, temperature, weight, and auxiliary device inputs (ECG, glucometry, etc.).

Indications for Use

Indicated for adult and pediatric patients (>12 years) in healthcare or home settings for retrospective display and storage of physiological parameters (NIBP, pulse, SpO2, temp, weight) and data from optional devices (glucometry, spirometry, prothrombin time, ECG, images). Not for emergency 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 Central Station

Submission Summary (Full Text)

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## 510(k) Summary for HomMed Central Station

| Submitter:<br>Address: | HomMed, LLC<br>19275 West Capital Drive, Suite 200<br>Brookfield, Wisconsin 53045 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Corporate Contact:<br>Telephone: | Herschel Peddicord, President, HomMed, LLC<br>Ph: [phone]<br>Fax: [phone] |
| Establishment Registration #: | 3004183721 |
| Submission Contact: | Tommie J. Morgan Ph.D., President<br>Morgan Consultants, Inc.<br>2018 North Durham<br>Houston, Texas 77008<br>Ph: [phone]<br>Fax: [phone] |
| 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 System<br>Product 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines.

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

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.

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