(357 days)
Not Found
No
The description focuses on data transfer and storage, with no mention of AI/ML algorithms for analysis or interpretation.
No
The device is described as a "Monitoring System" used to "transfer patient physiological data" for review by a healthcare professional, not to treat or directly manage a condition. Its function is data transfer and collection, not therapeutic action.
No
Explanation: The device is intended to transfer physiological data for review by a healthcare professional, not to perform any diagnostic analysis itself. It acts as a data relay system.
No
The device description explicitly details hardware components like the MedStar Unit (portable, battery-operated unit with LCD screen, buttons, serial ports, phone jacks) and the Collection Server (Personal Computer-type Processor Unit with an additional electronics board). This indicates it is not a software-only device.
Based on the provided information, the MedStar System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- MedStar System Function: The MedStar System's primary function is to transfer patient physiological data from existing patient monitors (Blood/Glucose Monitors, Weight Scales, NIBP Monitors, EKG Monitors) to a remote location for review by a healthcare professional. It does not directly analyze or test biological specimens.
- Data Source: The data it handles comes from other medical devices that are measuring physiological parameters, not from in vitro analysis of patient samples.
Therefore, the MedStar System falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MedStar System is intended to transfer patient physiological data from a range of patient monitors to a remote station, such as a Disease Management Center, for subsequent transfer by a Hospital Information System for review by a healthcare professional. The MedStar System is intended for use with any patient requiring Out-of-Hospital monitoring. The MedStar System is not used directly with a patient.
The MedStar Unit is intended for Out-of-Hospital Use. The associated Collection Server is intended for use in a Disease Management Center, Hospital or Hospital-Type facility, Medical Clinic or Physician's Office. The MedStar System is intended for sale by or on the order of a physician only.
Product codes (comma separated list FDA assigned to the subject device)
DXH
Device Description
The MedStar Monitoring System comprises the MedStar Unit and the associated Collection Server. The MedStar Unit is a portable, battery-operated unit for controlling the transmission of data from a range of compatible patient monitors or measurement devices to a remote monitoring center. Data is transmitted via telephone lines to the associated data collection server at the remote site.
The MedStar Unit is contained in a small plastic enclosure with an LCD screen mounted into the top of the case. The case is made of a strong impact resistant plastic material. A User push button control is located adjacent to the display. Four serial communication ports are located at the side of the unit for connection to the serial data ports of specific patient monitors. Two standard phone jacks are also located at the side of the unit for connection to standard phone outlets. Two recessed programming buttons are included on the opposite side of the enclosure to the phone jacks.
Collection Server comprises a Personal Computer-type Processor Unit The incorporating an additional electronics board to control phone line transmission to and from the MedStar Unit.
The MedStar System accepts serial data from the following patient monitors or measurement devices: Blood/Glucose Monitor Lifescan SureStep, Weight Scale - A&D Medical UC-300, Weight Scale - A&D Medical UC-321, NIBP Monitor - A&D Medical UA-767PC.
Monitored/measured data is transferred from a patient monitor/measurement device, e.g. a Blood/Glucose Monitor or Weight Scale, via that unit's serial data port under the control of a serial port protocol. The data is then stored in the MedStar Unit prior to undergoing Dual Tone Multiple Frequency, DTMF, encoding to facilitate phone line transmission to a remote site, such as a Disease Management Center.
A Collection Server comprising a Personal Computer with an additional communications board, receives and decodes the transmitted data and stores the data locally for subsequent transfer by a Hospital Information System for review by a healthcare professional.
In addition to transferring encoded data from the three measurement devices described above, EKG data may also be transferred directly from an EKG Monitor to the Collection Server, via phone line, using an EKG Monitor's standard audio data output.
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
Intended User: Healthcare professional (for review), physician (for sale by or on order of)
Care Setting: Out-of-Hospital, Disease Management Center, Hospital or Hospital-Type facility, Medical Clinic, Physician's Office.
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)
Bench testing was conducted to establish the MedStar System's accuracy and performance to specification.
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.
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
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
0
Section 16. SECTION 16. 510(k) SUMMARY.
Section 16.a Date Summary Prepared February 15, 2002
Section 16.b Company Information
Establishment:
Official Correspondent:
FEB 1 1 2003
Cybernet Medical. 727 Airport Blvd. Ann Arbor MI 48108
David A. C. Green Regulatory Affairs Consultant for Cybernet Medical. 1460 Golfcrest Place Vista, CA 92083 (760) 599 9661 (760) 599-9661 (fax)
Section 16.c Name of Device
Proprietary:
Common/Usual:
Classification:
MedStar System
MedStar
Telephone Electrocardiograph transmitter and receiver (§870.2920/74DXH)
Section 16.d Equivalent Devices
Substantial equivalence to the following legally marketed predicate devices with the same or similar indications for use has been demonstrated by a comparison of product features as described in the labeling and promotional literature for predicate devices and for the MedStar System, as well as testing to accepted industry standards. In addition. bench testing was conducted to establish the MedStar System's accuracy and performance to specification. The predicate devices are as follows:
- Home Care Monitoring System, AvidCare Corp., K010029 ●
- Model EHC 400 Desktop Patient Station, Cybercare Technologies Inc., K003257 ●
- PaceArt Central Station CPTS 86-12, PaceArt Inc., K915632 ●
Section 16.e Device Description & Technological Characteristics
The MedStar Monitoring System comprises the MedStar Unit and the associated Collection Server. The MedStar Unit is a portable, battery-operated unit for controlling the transmission of data from a range of compatible patient monitors or measurement devices to a remote monitoring center.
Data is transmitted via telephone lines to the associated data collection server at the remote site.
1
Data is transmitted via telephone lines to the associated data collection server at the remote site.
The MedStar Unit is contained in a small plastic enclosure with an LCD screen mounted into the top of the case. The case is made of a strong impact resistant plastic material. A User push button control is located adjacent to the display.
Four serial communication ports are located at the side of the unit for connection to the serial data ports of specific patient monitors.
Two standard phone jacks are also located at the side of the unit for connection to standard phone outlets.
Two recessed programming buttons are included on the opposite side of the enclosure to the phone jacks.
Collection Server comprises a Personal Computer-type Processor Unit The incorporating an additional electronics board to control phone line transmission to and from the MedStar Unit.
The MedStar System accepts serial data from the following patient monitors or measurement devices:
Device | Communication Protocol |
---|---|
Blood/Glucose Monitor | |
Lifescan SureStep | Available |
Weight Scale - A&D Medical UC-300 | Available |
Weight Scale - A&D Medical UC-321 | Available |
NIBP Monitor - | |
A&D Medical UA-767PC | Available |
Monitored/measured data is transferred from a patient monitor/measurement device, e.g. a Blood/Glucose Monitor or Weight Scale, via that unit's serial data port under the control of a serial port protocol. The data is then stored in the MedStar Unit prior to undergoing Dual Tone Multiple Frequency, DTMF, encoding to facilitate phone line transmission to a remote site, such as a Disease Management Center.
A Collection Server comprising a Personal Computer with an additional communications board, receives and decodes the transmitted data and stores the data locally for subsequent transfer by a Hospital Information System for review by a healthcare professional.
In addition to transferring encoded data from the three measurement devices described above, EKG data may also be transferred directly from an EKG Monitor to the Collection Server, via phone line, using an EKG Monitor's standard audio data output.
2
Section 16.f Intended Use
The MedStar System is intended to transfer patient physiological data from a range of patient monitors to a remote station, such as a Disease Management Center, for subsequent transfer by a Hospital Information System for review by a healthcare professional. The MedStar System is intended for use with any patient requiring Out-of-Hospital monitoring. The MedStar System is not used directly with a patient.
The MedStar Unit is intended for Out-of-Hospital Use. The associated Collection Server is intended for use in a Disease Management Center, Hospital or Hospital-Type facility, Medical Clinic or Physician's Office. The MedStar System is intended for sale by or on the order of a physician only.
The intended use, patient population and environment of use are the same or similar to the predicate devices, the Avid Care Corporation Home Care Monitoring System, K010029, the Cybercare Technologies Model EHC 400 Desktop Patient Station, K003257 and the PaceArt Central Station CPTS 86-12, K915632.
Section 16.g Certification Statement
In accordance with the requirements of 21 CFR 807.87(j), the following certification is provided:
Cybernet Medical believes that all data and information submitted in this premarket notification are truthful and accurate and no material fact has been omitted.
Eric D. Lichtenstein Product Development Manager Cybernet Medical.
David A. C. Queen
David A. C. Green Regulatory Affairs Consultant for Cybernet Medical.
3
Public Health Service
Image /page/3/Picture/2 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 a stylized image of a human figure, represented by three curved lines forming a profile of a head and shoulders.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2003
Cybernet Medical c/o Mr. David A.C. Green Regulatory Consultant BBP Consultants Inc. 1460 Golfcrest Place Vista, CA 92083
Re: K020534
Trade Name: MedStar System Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: November 29, 2002 Received: December 2, 2002
Dear Mr. Green:
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.
4
Page 2 – Mr. David A.C. Green
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) 594-4646. 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 may be obtained 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.
K. Bruce D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT 2.g
Applicant: | Cybernet Medical. |
---|---|
510(k) Number: | K020534 |
Device Name: | MedStar System |
Indications for Use: | The MedStar System is indicated for Out-of-Hospital Use with any patient |
requiring Out-of-Hospital monitoring | |
The associated Collection Server is intended for use in a Disease | |
Management Center, Hospital or Hospital -Type facility, Medical Clinic or | |
Physician's Office. |
Yes (Per 21 CFR 801.109). Prescription Use:
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)
NCATTM
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K020534
Prescription Use _____________________________________________________________________________________________________________________________________________________________
or
OTC Use ______________________________________________________________________________________________________________________________________________________________________