(99 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, Inc. equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies Inc. 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 document is a 510(k) summary for the GE Healthcare Unity Network ID V7. It describes a data collection and clinical information management system.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity) for the Unity Network ID V7, nor does it present device performance against such. Instead, it focuses on demonstrating that the device meets design specifications and complies with applicable voluntary standards.
The "Determination of Substantial Equivalence: Summary of Non-Clinical Tests" section indicates: "The Unity Network ID V7 and its applications were tested to, and comply with, applicable voluntary standards. The Unity Network ID V7 was tested to assure that the device meets its design specifications."
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Standards Compliance | Compliance with applicable voluntary standards | "The Unity Network ID V7 and its applications were tested to, and comply with, applicable voluntary standards." |
| Design Specifications | Device meets its design specifications | "The Unity Network ID V7 was tested to assure that the device meets its design specifications." |
| Quality Assurance Measures | Adherence to specified QA processes | "The following quality assurance measures were applied to the development and testing of the system: • Risk Analysis • Requirements Reviews • Design Reviews • Testing on unit level (Module verification) • Integration testing (System verification) • Performance testing (Verification) • Safety testing (Verification) • Simulated use testing (Validation)" |
| Clinical Equivalence | Not stated as a performance criterion, but the overall conclusion is related to safety, effectiveness, and substantial equivalence to the predicate. | "GE Healthcare considers the Unity Network ID V7 to be as safe, as effective, and its performance is substantially equivalent to the predicate device(s)." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical or performance data from a specific dataset of patients or cases. The testing described is primarily software and hardware verification and validation, rather than an evaluation against a clinical dataset. Therefore, there is no mention of sample size or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Since there is no "test set" based on patient data, there is no mention of experts needed to establish ground truth or their qualifications. The "ground truth" in this context refers to the successful functionality and compliance of the device against its specifications and standards.
4. Adjudication Method for the Test Set
Not applicable, as there is no mention of a test set requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The device is a data collection and management system, not an interpretive diagnostic tool that involves human readers interpreting clinical output. The document explicitly states: "The subject of this premarket submission, Unity Network ID V7, did not require clinical studies to support substantial equivalence."
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
The "testing included all new or modified features" and involved various quality assurance measures like unit-level testing, integration testing, performance testing, and safety testing. These tests would evaluate the algorithm's functionality and accuracy in its intended role of data conversion and transmission. So, in essence, the "standalone" performance of the data conversion and routing algorithms was assessed as part of these non-clinical tests. However, it's not a "standalone performance study" in the typical sense of evaluating diagnostic accuracy.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests appears to be:
- Design specifications: The device's output and functionality were compared against predefined technical and functional specifications.
- Voluntary standards: Compliance with relevant engineering and medical device standards (though specific standards are not listed in this summary, they are implied).
- Expected behavior: For simulated use testing and verification, the "ground truth" would be the expected correct data conversion and transmission as per the device's design and independent bedside device protocols.
8. The Sample Size for the Training Set
Not applicable. This device is a data integration and conversion system, not an AI/ML model that requires a "training set" in the typical sense of machine learning for image analysis or diagnostics. Its functionality is based on established communication protocols and data mapping.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 7, 2015
GE Healthcare Robert Casarsa Regulatory Affairs Leader 8200 West Tower Ave. Milwaukee, Wisconsin 53223
Re: K142840
Trade/Device Name: Unity Network ID V7 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: December 5, 2014 Received: December 8, 2014
Dear Robert Casarsa.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melissa A. Torres -S
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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Indications for Use Statement
510(k) Number (if known): n/a Device Name: Unity Network ID V7 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.
Prescription Use X (Part 21 CFR 801 Sub part D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | September 26, 2014 |
|---|---|
| Submitter: | GE Healthcare8200 W. Tower Ave.Milwaukee, WI 53223 |
| Primary Contact Person: | Robert CasarsaRegulatory Affairs LeaderGE Medical Systems Information Technologies, Inc.Email: robert.casarsa@ge.comPh: (414) 362-3063Fax: (414) 262-2585 |
| Secondary ContactPerson: | Douglas KentzRegulatory Affairs DirectorGE Medical Systems Information Technologies, Inc.Ph: (414) 362-2038 |
| Device Trade Name: | Unity Network ID |
| Common/Usual Name: | Physiological Patient Monitor |
| Classification Names:Product Code: | 21 CFR 870.2300 Monitor, Physiological, Patient (withoutarrhythmia detection or alarms)MWI |
| Predicate Device(s): | Unity Network ID V6 K103432 |
| Device Description: | The Unity Network ID system communicates patient data fromsources other than GE Medical Systems InformationTechnologies, Inc. equipment to a clinical information system,central station, and/or GE Medical Systems InformationTechnologies Inc. patient monitors.The Unity Network ID acquires digital data from eight serialports, converts the data to Unity Network protocols, andtransmits the data over the monitoring network to a UnityNetwork device such as a patient monitor, clinical informationsystem or central station. |
| Intended Use: | The Unity Network ID is indicated for use in data collection andclinical information management through networks with |
| independent bedside devices. The Unity Network ID is notintended for monitoring purposes, nor is the Unity Network IDintended to control any of the clinical devices (independentbedside devices/ information systems) it is connected to. | |
| Technology: | The device converts the output from independent bedsidedevice's RS-232 protocol into the Unity Network protocol |
| Determination ofSubstantial Equivalence: | Summary of Non-Clinical Tests: |
| The Unity Network ID V7 and its applications were tested to, andcomply with, applicable voluntary standards. The Unity NetworkID V7 was tested to assure that the device meets its designspecifications. Testing included all new or modified features. | |
| The following quality assurance measures were applied to thedevelopment and testing of the of the system: | |
| • Risk Analysis | |
| • Requirements Reviews | |
| • Design Reviews | |
| • Testing on unit level (Module verification) | |
| • Integration testing (System verification) | |
| • Performance testing (Verification) | |
| • Safety testing (Verification) | |
| • Simulated use testing (Validation) | |
| Summary of Clinical Tests: | |
| The subject of this premarket submission, Unity Network ID V7,did not require clinical studies to support substantialequivalence. | |
| Comparison: | Hardware: |
| 1) No change to the Unity Network ID hardware | |
| 2) Create interface cables for the newly supported devices | |
| Software: | |
| 1) Add interface support for the following third partydevices: | |
| (a) Drager Evita infinity V500 (K093633) | |
| (b) Radiometer TCM4 (K043003) | |
| (c) Radiometer TCM40 (K043003) | |
| (d) Radiometer TCM CombiM (K093154) | |
| (e) Radiometer TCM Tosca (K093154) | |
| 2) Add interface support for the following GEHealthcare devices:(a) Carescape R860 (not sold in USA)(b) Carestation 600 (not sold in USA) | |
| 3) Support of additional parameteres from currentlysupported devices:Pulsion PiCCO plus (K060898): Cardiac Index (CI),Continuous Cardiac Index (CCI) and System VascularResistance Index (SVRI)Pulsion PiCCO2 (K072735): Cardiac Index (CI), ContinuousCardiac Index (CCI) and System Vascular ResistanceIndex (SVRI)GE Datex-Ohmeda Aisys (K061609): volume waveformGE Datex-Ohmeda Avance (K040743): volume waveformGE Datex-Ohmeda Engstrom (K062710): volumewaveform | |
| Conclusion: GE Healthcare considers the Unity Network ID V7 to be as safe,as effective, and its performance is substantially equivalent tothe predicate device(s). |
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§ 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).