(19 days)
For central monitoring of multiple adult, pediatric and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
The modification is a software-based change that provides database server access via the hospital intra/internet system.
This document is a 510(k) Pre-Market Notification for a software device, the Viridia Information Software for Model M3154A Database Server, Release B.02. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical studies with detailed acceptance criteria and performance metrics typically found in AI/ML device submissions.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way modern AI/ML devices do (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device.
Acceptance Criteria (Implied from the document):
| Criterion | Reported Device Performance |
|---|---|
| Performance, functionality, and reliability characteristics relative to the predicate | Meets all reliability requirements and performance claims. |
| Specifications cleared for the predicate device | Test results showed substantial equivalence. |
| Web software interface functionality | Meets all reliability requirements and performance claims. |
| Substantial Equivalence to legally marketed predicate devices | Verified via system level tests, integration tests, environmental tests, and safety testing from hazard analysis. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "system level tests, integration tests, environmental tests, and safety testing from hazard analysis," but does not provide specific data sample sizes or details about patient data used in testing.
- Data Provenance: Not specified. As this is a software update primarily focused on database access via intra/internet, details about patient data origin are not a focus of this submission.
- Retrospective or Prospective: Not specified. The device is used for "read-only viewing of patient physiologic data, including retrospective review applications." The testing methodology does not detail whether new prospective data was used for validation.
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. This device is a database server software for viewing patient physiological data, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As above, this is not a diagnostic device requiring adjudicated ground truth for performance evaluation. The testing involved verifying software functionality and equivalence to a predicate.
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-assisted diagnostic device. The study described focuses on software functionality, reliability, and substantial equivalence to a predicate device for displaying patient data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in a sense. The "device" itself is the software, which performs its functions (database access, data display) without human intervention in its core operation. However, its purpose is to present data for human interpretation, so it's inherently part of a human-in-the-loop clinical workflow for data review. The described testing verifies the software's stand-alone functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the typical sense for medical diagnostic devices. The "ground truth" for this device's performance would be the successful and accurate display of patient physiological data as recorded by monitoring devices, consistent with the predicate device's functionality. The testing confirmed that the software correctly accessed, displayed, and allowed review of this data according to its specifications.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML model that undergoes a "training" phase with data. It's conventional software for data management and display.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" for this type of software.
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DEC - 6 1999
9.0 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.
- The submitter of this premarket notification is: Dave Osborn Regulatory Affairs Engineer Healthcare Solutions Group Agilent Technologies 3000 Minuteman Road Andover, MA 01810-1085
978 659 3178 Tel: Fax: 978 685 5624 Email:dosborn@agilent.com
This summary was prepared on 10 November, 1999
-
- The name of this device is the Viridia Information Software for Model M3154A Database Server, Release B.02. Classification names are as follows:
870.2800, II 74 DSH Recorder, Magnetic Tape, Medical
- The name of this device is the Viridia Information Software for Model M3154A Database Server, Release B.02. Classification names are as follows:
-
- The modification is a software-based change that provides database server access via the hospital intra/internet system.
-
- The new device has the same intended use as the legally marketed predicate device. It is used for the read-only viewing of patient physiologic data, including retrospective review applications of Alarm, Event, Wave, Trend, and ST segment (adults) Review to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of The difference is that the modified device extends symptoms. the review of retrospective patient data from the central monitor in the care unit to remote locations via the hospital's HIS LAN web access (hospital intra/internet).
-
- The new device has the same technological characteristics as the legally marketed predicate device.
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- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that web software interface functionality meets all reliability requirements and performance claims.
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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 stylized eagle or bird-like symbol with three curved lines forming its body and wings. Encircling the symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 6 1999
Mr. Dave Osborn Regulatory Affairs Aqilent Technologies, Inc. 3000 Minuteman Rd. Andover, MA 01810-1099
Re : K993907 Viridia Information Center (VIC) Software for Model M3154A Database Server (DBS), Release B.02 Requlatory Class: III (three) MHX, DSI, MLD Product Code: November 16, 1999 Dated: November 17, 1999 Received:
Dear Mr. Osborn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Dave Osborn
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Dan R. Teth
2n Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: Viridia Information Center (VIC) Software for Model M3154A Database Server (DBS), Release B.02
For central monitoring of multiple adult, pediatric and Indications For Use: neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K993907 |
| Prescription Use X(Per 21 CFR 801.109) | OR | Over-The-Counter Use ______ |
|---|---|---|
| -------------------------------------------- | ---- | ----------------------------- |
(Optional Format 1-2-96)
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).