(93 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 the Unity Network ID, a device designed for data collection and clinical information management. The information mainly focuses on its regulatory submission and general testing, rather than a specific study proving its performance against acceptance criteria in the context of an AI/human reader evaluation.
Therefore, many of the requested categories regarding acceptance criteria and a specific study cannot be fully answered from the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance/Safety/Effectiveness | "The results of these measurements demonstrated that the Unity Network ID is as safe, as effective, and performs as well as the predicate devices." |
| Compliance with Voluntary Standards | "The Unity Network ID complies with the voluntary standards as detailed in Section 9 of this submission." |
| Quality Assurance Measures | - 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 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated for a specific "test set" related to performance metrics. The document describes general "testing on unit level," "integration testing," and "final acceptance testing," but no details on sample size or data provenance for these tests are provided.
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)
- Not applicable. The device is a "physiological patient monitor" communication system, not one that requires expert interpretation for a "ground truth" like medical imaging or diagnostics. The validation seems to be against engineering and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is mentioned as there's no indication of interpretation by multiple experts.
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
- No. This is not an AI-based device, nor is there any mention of a human-reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially. The device itself is "standalone" in its function as a data communication system. Its performance evaluation would be based on its ability to accurately acquire, convert, and transmit data, rather than an "algorithm only" performance in the context of diagnostics or interpretation. The document mentions unit-level, integration, and final acceptance testing, which imply standalone functional evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated in terms of a "ground truth" for diagnostic purposes. For this type of device, "ground truth" would likely refer to the correct functioning of data communication protocols and accurate data transfer, which would be measured against engineering specifications and validated data streams, rather than medical ground truth like pathology.
8. The sample size for the training set
- Not applicable. This device does not appear to use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. This device does not appear to use a "training set" in the context of machine learning.
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K04-0559
JUN - 4 2004
| Section 2 Summary510(k) Summary of Safety and Effectiveness | |
|---|---|
| Date: | March 1, 2004 |
| 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 |
| Trade Name: | |
| 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: | K033672 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 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 2004
Mr. Andrew Kluessendorf Regulatory Affairs Specialist GE Medical Systems Information Technologies 8200 West Tower Avenue Milwaukee, WI 53223
Re: K040559
Trade/Device Name: Unity Network ID Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI Dated: April 21, 2004 Received: May 11, 2004
Dear Mr. Kluessendorf:
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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to de roses was a cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions or an 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 If your device is clabories (so as additional controls. Existing major regulations affecting (I MA), it may of subject to same and of Federal Regulations, Title 21, Parts 800 to 898. In your device ean or round in further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not I icase that FDA has made a determination that your device complies with other requirements moan that I Dr. Inde made statutes and regulations administered by other Federal agencies. of the Act of ally rederal and of the requirements, including, but not limited to: registration
{3}------------------------------------------------
Page 2 -- Mr. Andrew Kluessendorf
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practices and listing (21 CFR 1 art 807), laceming (21 cegulation (21 CFR Part 820); and if requirents as set form in the quality of economic (Sections 531-542 of the Act); 21 CFR 1000-1050.
21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with anow you to objamiations.
The First with anow you to of substantial equivalence of your device to a premiarket notification. The PDF milling of succem.
Iegally 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), If you desire specific ad not for your as at (301) 594-4646. Also, please note the regulation in prease contact the Office or Ochiphan promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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,
Ken Muluy
for Chiu Lin, Ph.D.
Chiu Lin. Ph.D Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
510(k) filed on March 1, 2004
.
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 (D is management ufrough networks with macpondont boutle vork ID intended to control any of not miended for monitoring purposes, from to the Unity reation systems) it is connected to.
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
and the same of the same of the same of the same of the same of the same of the same of the same of the same of the same of the same of the secure of the second of the states
Auybulion
(Division Sign-Off) Division of Anesthesiol - General Hospital, Infection Control, Dental Devices
204055 510(k) Number:
Page 1 of 1
§ 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).