(50 days)
HomMed Central Station
HomMed Central Station
No
The document describes a software system for receiving, displaying, and storing physiological data. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The system is described as a retrospective data monitor, not involving complex analysis or predictive capabilities typically associated with AI/ML in medical devices.
No.
The device is a retrospective data monitor system that receives, displays, and stores physiological parameters and other monitoring device data, but it is not intended for therapy or emergency use.
No
A diagnostic device is used to identify a disease, condition, or injury. This device is described as a "retrospective data monitor system" that receives, displays, and stores physiological parameters and other monitoring device data for "review and interpretation by physicians and/or physician supervised nurses." It explicitly states it "is not intended for emergency use or real-time monitoring," which further indicates it's for data management and display rather than direct diagnostic determination.
Yes
The device description explicitly states that the HomMed Central Station is a "software system that operates on a commercially available PC system" and "accepts data from the HomMed Sentry Patient Monitors." This indicates it is a software component that processes data from separate hardware devices, not a hardware device 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.
- HomMed Central Station Function: The HomMed Central Station receives, displays, and stores physiological parameters (NIBP, pulse rate, SpO2, temperature, weight) and data from other monitoring devices (glucometry, spirometry, prothrombin time, ECG, digital camera images). These are primarily in vivo measurements (taken from within the living body) or data from devices that perform in vitro tests (like glucometry or prothrombin time), but the Central Station itself is not performing the in vitro test.
- Intended Use: The intended use is to retrospectively review and interpret data from monitoring devices, not to perform diagnostic tests on patient samples.
The HomMed Central Station is a data management and display system for physiological and other monitoring data, not a device that performs in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
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 accepts data from the HomMed Sentry Patient Monitors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital camera images
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric (over 12 years of age)
Intended User / Care Setting
physician-supervised nurses, physicians and/or physician supervised nurses / health care 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
HomMed Central Station
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary for HomMed Central Station
| Submitter:
Address: | HomMed, LLC
19275 West Capital Drive, Suite 200
Brookfield, Wisconsin 53045 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Corporate Contact:
Telephone: | Herschel Peddicord, President, HomMed, LLC
Ph: (262) 783-5440
Fax: (262) 783-5441 |
| Establishment Registration #: | 3004183721 |
| Submission Contact: | Tommie J. Morgan Ph.D., President
Morgan Consultants, Inc.
2018 North Durham
Houston, Texas 77008
Ph: (713) 880-5111
Fax: (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 System
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.
000001
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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
3
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