(24 days)
Not Found
No
The summary describes a data networking and conversion device. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on data transmission and protocol conversion.
No
The device is described as a system for data collection and clinical information management, specifically for communicating patient data among various medical devices and information systems. It is explicitly stated that it is "not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices," which indicates it does not directly treat or diagnose patients.
No
Explanation: The device is described as a data collection and management system that communicates patient data. It is explicitly stated that it is "not intended for monitoring purposes" and "not intended to control any of the clinical devices." This indicates it processes existing data rather than generating new diagnostic information.
No
The device description explicitly states that the Unity Network ID acquires digital data from eight serial ports and converts it, indicating the presence of hardware components (serial ports and conversion circuitry) in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "data collection and clinical information management through networks with independent bedside devices." It explicitly states it's "not intended for monitoring purposes." IVDs are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or treatment. This device does not perform such examinations.
- Device Description: The description focuses on acquiring and transmitting digital data from other devices. It doesn't mention analyzing biological specimens.
- Lack of IVD-related information: There is no mention of analyzing samples, reagents, or any other elements typically associated with in vitro diagnostics.
The device appears to be a data networking and management system for clinical information, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Unity Network ID is 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 (comma separated list FDA assigned to the subject device)
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 complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system:
- 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.
The results of these measurements demonstrated that the Unity Network ID is as safe, as effective, and performs as well as the predicate devices.
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.
K021524 Unity Network ID
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
§ 870.2300 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
DEC 1 8 2003
| Section 2 Summary | |
|---|---|
| 510(k) Summary of Safety and Effectiveness | |
| Date: | November 21, 2003 |
| Submitter: | GE Medical Systems Information Technologies |
| 8200 West Tower Avenue | |
| Milwaukee, WI 53223 USA | |
| Contact Person: | Diana M. Thorson |
| Regulatory Affairs Specialist | |
| GE Medical Systems Information Technologies | |
| Phone: 714-247-4135 | |
| Fax: 714-247-4155 | |
| Device: | Unity Network ID |
| Common/Usual Name: | 21 CFR 870.2300 Monitor, Physiological, Patient |
| Classification Name: | 21 CFR 870.2300 Monitor, Physiological, Patient (without arrhythmia detection or alarms) |
| Predicate Device: | K021524 Unity Network ID |
| 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: | The Unity Network ID is 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 technology as the |
| predicate device. |
:
·
1
Test Summary:
The Unity Network ID complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system:
- 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 .
- The results of these measurements demonstrated that the Unity Conclusion: Network ID is as safe, as effective, and performs as well as the predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2003
GE Medical Systems Information Technology c/o Ms. Diana M. Thorson Regulatory Affairs Specialist 8200 West Tower Ave. Milwaukee, WI 53223
Re: K033672
Trade Name: Unity Network ID Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: November 21, 2003 Received: November 24, 2003
Dear Ms. Thorson:
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.
3
Page 2 - Ms. Diana Thorson
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 vours.
Ova Deenhu for
Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K033672 510(k) Number (if known):
510(k) filed on November 21, 2003
Device Name: Unity Network ID
Indications For Use:
The Unity Network ID is 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)
Dma Deenlu
510