(94 days)
HomMed Central Station
No
The summary describes a software system for receiving, displaying, evaluating, analyzing, and storing physiological parameters. It explicitly states that the healthcare professional is responsible for the interpretation of the data and analysis. There is no mention of AI, ML, or any related terms, nor is there any description of training or test sets typically associated with AI/ML development.
No
The device is described as a software system that retrospectively displays, evaluates, analyzes, and stores monitored physiological parameters. It assists healthcare professionals in interpreting data but does not directly provide therapy or affect the patient's physiological state.
No
The device is described as a system for retrospectively receiving, displaying, evaluating, analyzing, and storing monitored physiological parameters. It assists healthcare professionals in interpreting data but does not explicitly state it makes a diagnosis itself. The responsibility for interpretation lies with the healthcare professional.
Yes
The device description explicitly states that the HomMed Central Station is a "software system that operates on a commercially available PC system" and is an "accessory to the HomMed Sentry Patient Monitors." This indicates it is a software component that processes data from separate hardware monitors, making it a software-only medical device in itself.
Based on the provided information, the HomMed Central Station is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- HomMed Central Station Function: The description clearly states that the HomMed Central Station receives, displays, evaluates, analyzes, and stores physiological parameters of patients. These parameters (NIBP, pulse rate, SpO2, temperature, weight) are measured directly from the patient's body by the HomMed Sentry Patient Monitors.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens or samples taken from the patient.
The HomMed Central Station is a system for managing and displaying data collected from patient monitoring devices, which are used in vivo (within the living body).
N/A
Intended Use / Indications for 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.
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.
Product codes
DXN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional (including physician and/or physician supervised nurses) / healthcare and home environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
HomMed Central Station
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
APR 2 2 2002
510(k) Summary for HomMed Central Station
| Submitter: | Ho |
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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.
1
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
2
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.
3
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
4
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)
OR
Prescription Use Only (Per 21 CFR 801.109)
Over-the-Counter Use
Division of Cardiovascular & Respiratory Devices
510(k) Number K020184