(148 days)
No
The description focuses on data communication and conversion, with no mention of AI/ML terms or functionalities like learning, prediction, or complex data analysis beyond simple protocol conversion.
No
The device is described as a system for data collection and clinical information management, specifically for transmitting patient data, and is explicitly stated as "not intended for monitoring purposes," "not intended to control any of the clinical devices." This indicates it does not directly treat, diagnose, or mitigate a disease or condition, which are characteristics of a therapeutic device.
No
Explanation: The device is indicated for data collection and clinical information management and is not intended for monitoring purposes. It acquires and transmits patient data but does not interpret or analyze it to provide diagnostic information.
No
The device description explicitly states that the Unity Network ID acquires digital data from eight serial ports, converts the data, and transmits it. This indicates the presence of hardware components (serial ports, data conversion hardware) beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "data collection and clinical information management through networks with independent bedside devices." This describes a system for managing and transmitting patient data, not for performing tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The device description focuses on acquiring digital data from other devices, converting it to a specific protocol, and transmitting it. It does not mention any interaction with biological specimens (blood, urine, tissue, etc.) or performing any analytical tests.
- Lack of IVD Characteristics: The description lacks any mention of typical IVD activities such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on biological sample analysis.
The device functions as a data communication and management system within a clinical network, which is distinct from the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indicated for use in data collection and clinical information management through networks with independent bedside devices.
The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices (independent bedside devices/ information systems) it is connected to.
Product codes
MWI
Device Description
The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies patient monitors.
The Unity Network ID acquires digital data from eight serial ports, converts the data to Unity Network protocols, and transmits the data over the monitoring network to a Unity Network device such as a patient monitor, clinical information system or central station.
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
Not Found
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 Unity Network ID and its host patient monitoring system comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Unity Network ID:
- . Risk Analysis
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) .
- . Integration testing (System verification)
- Final acceptance testing (Validation) .
- Performance testing ●
- Safety testing ●
- . Environmental testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
OCT 01 2002
Section 2 Summary and Certification
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Date: | May 2, 2002 |
| Submitter: | GE Medical Systems Information Technologies |
| 8200 West Tower Avenue | |
| Milwaukee, WI 53223 USA | |
| Contact Person: | Joelle Neider |
| Regulatory Affairs Specialist | |
| GE Medical Systems Information Technologies | |
| Phone: (203) 949-8232 | |
| Fax: (414) 918-8113 | |
| Email: joelle.neider@med.ge.com | |
| Device: Trade Name: | Unity Network ID |
| Common/Usual Name: | Monitor, Physiological, Patient (without arrhythmia detection or alarms) |
| Classification Names: | 21 CFR 870.2300 |
Classification for the externally connected devices are as follows:
| Regulation Number | Classification Name | Panel | Procode |
|---|---|---|---|
| 870.1110 | Computer, blood pressure | Cardiovascular | 74 DSK |
| 870.1130 | System, measurement, blood pressure, | ||
| noninvasive | Cardiovascular | 74 DXN | |
| 870.2300 | Monitor, cardiac | Cardiovascular | 74 DRT |
| 876.1800 | Urinometer | Gastro-urology | 78 EXS |
| 880.5725 | Pump, infusion | General hospital | 80 FRN |
| 870.3535 | System, balloon, intra-aortic and control | Cardiovascular | 74 DSP |
| 868.5895 | Continuous ventilator | Anesthesiology | 73 CBK |
| 868.1730 | Computer, oxygen uptake | Anesthesiology | 73 BZL |
| 870.2700 | Oximeter | Cardiovascular | 74 DQA |
| 868.1400 | Carbon Dioxide Gas Analyzer | Anesthesiology | 73 CCK |
| 870.1915 | Thermodilution probe | Cardiovascular | 74 QGL |
| 868.2375 | Breathing Frequency Monitor | Anesthesiology | 73 BZQ |
| 868.2480 | Monitor, Carbon Dioxide, Cutaneous | Anesthesiology | 74 LKD |
Predicate Devices:
Phillips Medical Systems, Inc., M2376A Device Link System – K012094
1
K021454
p. 2/2
Device Description: The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies patient monitors.
The Unity Network ID acquires digital data from eight serial ports, converts the data to Unity Network protocols, and transmits the data over the monitoring network to a Unity Network device such as a patient monitor, clinical information system or central station.
Intended Use:
Indicated for use in data collection and clinical information management through networks with independent bedside devices.
The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices (independent bedside devices/ information systems) it is connected to.
Technology:
The Unity Network ID employs the same functional scientific technology as its predicate device.
Test Summary:
The Unity Network ID and its host patient monitoring system comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Unity Network ID:
- . Risk Analysis
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) .
- . Integration testing (System verification)
- Final acceptance testing (Validation) .
- Performance testing ●
- Safety testing ●
- . Environmental testing
Conclusion:
The results of these measurements demonstrated that the Unity Network ID is as safe, as effective, and perform as well as the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 01 2002
GE Medical Systems Information Technologies c/o Ms. Joelle Neider Regulatory Affairs Specialist 8200 W. Tower Ave. Milwaukee, WI 53223
Re: K021454
Trade Name: Unity Network ID module Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: August 15, 2002 Received: August 16, 2002
Dear Ms. Neider:
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 cither 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.
3
Page 2 – Ms. Joelle Neider
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Kalkman
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known):
K021454 Unknown; 510(k) filed on May 2, 2002
Device Name: Unity Network ID
Indications for Use:
Indicated for use in data collection and clinical information management through networks with independent bedside devices.
The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices (independent bedside devices/ information systems) it is connected to.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Oak Tun
Division of Cardiovascular & Respiratory Devices
510(k) Number K021454