(24 days)
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.
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.
The provided text describes a medical device called "Unity Network ID," which is a device for data collection and clinical information management through networks with independent bedside devices. It is not a device that involves AI (Artificial Intelligence) or machine learning algorithms for diagnostic or prognostic purposes, and therefore, many of the requested categories related to algorithm performance, training data, ground truth, and expert evaluation are not applicable.
The document discusses compliance with voluntary standards and quality assurance measures for the development of the system. The "Test Summary" indicates that the Unity Network ID was subjected to various testing phases to ensure its safety and effectiveness.
Here's an attempt to answer the questions based on the available information, noting when information is not present or not applicable to this type of device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| System Reliability/Safety | Compliance with voluntary standards detailed in Section 9 of the submission (not explicitly detailed in provided text). | "The Unity Network ID complies with the voluntary standards as detailed in Section 9 of this submission." | The specific standards and their detailed requirements are not provided in the extracted text. |
| Design & Development Quality | - Risk Analysis conducted- Requirements Reviews conducted- Design Reviews conducted- Unit level testing (Module verification)- Integration testing (System verification)- Final acceptance testing (Validation)- Performance testing conducted- Safety testing conducted- Environmental testing conducted | All listed quality assurance measures were "applied to the development of the system." | This indicates process adherence rather than specific quantitative performance metrics. The results of these measures "demonstrated that the Unity Network ID is as safe, as effective, and performs as well as the predicate devices." |
| Functional Equivalence | As safe, as effective, and performs as well as the predicate device (K021524 Unity Network ID). | "The results of these measurements demonstrated that the Unity Network ID is as safe, as effective, and performs as well as the predicate devices." | No specific performance metrics (e.g., data transfer rates, error rates) are provided to quantify "as well as." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes testing phases (unit, integration, final acceptance, performance, safety, environmental testing) for the device's functionality and safety, not for an AI algorithm's diagnostic or predictive performance on a patient data set. Therefore, there is no mention of a "test set" in the context of patient data, sample size, or data provenance (country, retrospective/prospective) for evaluating an AI's performance. The testing would have involved the device itself and its interaction with other systems.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the device is a data collection and management system, not an AI diagnostic tool that requires ground truth established by medical experts on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set) for the test set
This is not applicable for the same reason as point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not applicable because the Unity Network ID is a data infrastructure device, not an AI system that assists human readers in interpreting medical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as there is no AI algorithm being evaluated for standalone performance. The device itself is a standalone hardware/software system designed for data management.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This is not applicable. The "ground truth" for this device would relate to its ability to correctly acquire, convert, and transmit digital data as per its specifications, rather than clinical outcomes or expert consensus on medical conditions. The "ground truth" would be defined by the expected behavior and data integrity within the network.
8. The sample size for the training set
This is not applicable. The device does not involve machine learning; therefore, there is no "training set" in the context of AI model development.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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DEC 1 8 2003
| Section 2 Summary | |
|---|---|
| 510(k) Summary of Safety and Effectiveness | |
| Date: | November 21, 2003 |
| Submitter: | GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA |
| Contact Person: | Diana M. ThorsonRegulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: 714-247-4135Fax: 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 sourcesother than GE Medical Systems Information Technologies equipment toa clinical information system, central station, and/or GE MedicalSystems 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 dataover the monitoring network to a Unity Network device such as a patientmonitor, clinical information system or central station. |
| Intended Use: | The Unity Network ID is indicated for use in data collection and clinicalinformation management through networks with independent bedsidedevices.The Unity Network ID is not intended for monitoring purposes, nor is theUnity 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 thepredicate device. |
:
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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.
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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.
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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
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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
§ 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).