(27 days)
The FlexView™ Clinical Monitoring System is intended for use as a secondary annunciation of compatible primary medical device alarms.
The FlexView™ Clinical Monitoring System is for use as an accessory to primary medical devices and is currently compatible with puise oximeters, infusion pumps and ventilators. The FlexView™ Clinical Monitoring System is to supplement and not replace any part of the current primary medical device monitoring procedure.
The FlexView™ Clinical Monitoring System is for use by healthcare professionals trained in the primary medical devices that are being monitored. The FlexView™ Clinical Monitoring System is not considered to be diagnostic without skilled interpretation and does not replace physician's care.
The Flex\lew™ Clinical Monitoring System is for use with patient populations being monitored by healthcare professionals utilizing compatible pulse oximeters, infusion pumps and ventilators.
The FlexView™ Clinical Monitoring System is for use in healthcare facilities such as hospitals, or free standing surgical centers.
The FlexView™ Clinical Monitoring System is a PC based central monitoring station used to acquire information from primary medical devices (pulse oximeters, infusion pumps and redisplay it on a single monitor in a central location. It allows the remote monitoring of multiple medical devices simultaneously and provides secondary annunciation of the alarms from the primary medical devices.
This device, the FlexView™ Clinical Monitoring System, is a Class II medical device (System, Network and Communication, Physiological Monitors). The 510(k) summary indicates that its safety and effectiveness were demonstrated through risk, verification, and validation testing, concluding that its performance, functionality, and safety characteristics are substantially equivalent to the predicate device (FlexView™ Clinical Monitoring System, K003998).
However, the provided text does not contain the specific details necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device performance in the way you've outlined. The submission focuses on substantial equivalence to a predicate device rather than presenting a novel clinical study with explicit acceptance criteria for performance metrics like accuracy, sensitivity, or specificity.
Here's a breakdown of what information can and cannot be extracted from the provided document, based on your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity values) for its performance, nor does it present specific numerical performance results (like sensitivity or specificity) for the device. Instead, it states:
"Test results demonstrated that the modified FlexView™ Clinical Monitoring System performance, functionality and safety characteristics are substantially equivalent to the predicate device."
This implies the acceptance criterion was likely substantial equivalence in performance, functionality, and safety to the predicate device (K003998) through a series of internal verification and validation tests, rather than meeting predefined clinical performance thresholds.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission references "risk and verification and validation testing," but does not detail the methodology, sample sizes, or data provenance (e.g., patient data, simulated data).
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 information is not provided. As no clinical study with a "test set" and "ground truth" derived from expert review is described, these details are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 MRMC study was conducted or described. This device is a monitoring system for secondary annunciation of alarms from other medical devices, not an AI-powered diagnostic tool requiring human interpretation or assistance for analysis. Therefore, the concept of "human readers improving with AI assistance" does not apply in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device's function is the "secondary annunciation of compatible primary medical device alarms" and it's stated to "supplement and not replace any part of the current primary medical device monitoring procedure." It is intended for "use by healthcare professionals." Therefore, it is not a standalone algorithm without human involvement. Its primary function is to relay information to human healthcare professionals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. Given the nature of the device (a monitoring system for alarm annunciation), ground truth might pertain to the accuracy and timeliness of alarm relay, rather than diagnostic accuracy. It's plausible that internal engineering validation and verification tests, potentially using simulated or recorded physiological data, were used to confirm alarm processing and display accuracy, but the specifics are not detailed.
8. The sample size for the training set
This information is not provided. The device is described as a "PC based central monitoring station," and while it likely involves software, there's no mention of machine learning or AI that would require a "training set" in the context of supervised learning.
9. How the ground truth for the training set was established
This information is not provided, as there is no indication of a "training set" being used for a machine learning model.
{0}------------------------------------------------
<011999
510(k) SUMMARY
This 510(k) summary is submitted in accordance with 21 CFR 807.92.
| Submitter's Name: | Data Critical Corporation |
|---|---|
| Submitter's Address: | 19820 North Creek Parkway |
| Bothell, WA 98011 | |
| Telephone: | 425-482-7000 |
| Fax: | 425-482-7010 |
| Contact Person: | Teresa M. Davidson |
| Date Prepared: | June 26, 2001 |
| Device Trade Name: | FlexView™ Clinical Monitoring System |
| Device ClassificationName: | System, Network and Communication, Physiological Monitors |
| Device Classification: | Class II |
| Predicate Device(s): | FlexView™ Clinical Monitoring System (K003998) |
Device Description
The FlexView™ Clinical Monitoring System is a PC based central monitoring station used to acquire information from primary medical devices (pulse oximeters, infusion pumps and redisplay it on a single monitor in a central location. It allows the remote monitoring of multiple medical devices simultaneously and provides secondary annunciation of the alarms from the primary medical devices.
Intended Use
The FlexView™ Clinical Monitoring System is intended for use as a secondary annunciation of compatible primary medical device alarms.
Indications For Use
The FlexView™ Clinical Monitoring System is intended for use as a secondary annunciation of compatible primary medical device alarms.
The FlexView™ Clinical Monitoring System is for use as an accessory to primary medical devices and is currently compatible with puise oximeters, infusion pumps and ventilators. The FlexView™ Clinical Monitoring System is to supplement and not replace any part of the current primary medical device monitoring procedure.
The FlexView™ Clinical Monitoring System is for use by healthcare professionals trained in the primary medical devices that are being monitored. The FlexView™ Clinical Monitoring System is not considered to be diagnostic without skilled interpretation and does not replace physician's care.
The Flex\lew™ Clinical Monitoring System is for use with patient populations being monitored by healthcare professionals utilizing compatible pulse oximeters, infusion pumps and ventilators.
The FlexView™ Clinical Monitoring System is for use in healthcare facilities such as hospitals, or free standing surgical centers.
Performance Data
The safety and effectiveness of the modified FlexView™ Clinical Monitoring System described in this submission has been demonstrated through risk and verfication and validation testing. Test results demonstrated that the modified FlexView™ Clinical Monitoring System performance, functionality and safety characteristics are substantially equivalent to the predicate device.
Conclusions
Based on the information provided in this submission, the modified FlexView™ Clinical Monitoring System is substantially equivalent to the predicate device and does not raise new issues of safety and effectiveness.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing its wings.
JUL 2 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Teresa M. Davidson Director of Regulatory Affairs and Quality Assurance Data Critical Corporation 19820 North Creek Parkway Bothell, WA 98011
Re: K011999
Trade Name: FlexViewTM Clinical Monitoring System Regulation Number: 21 CFR 870.2300 Regulatory Class: II (two) Product Code: 74 MSX Dated: June 26, 2001 Received: June 27, 2001
Dear Ms. Davidson:
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 control provisions of the Act. The general control 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 I substantially of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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
{2}------------------------------------------------
Page 2 - Ms. Teresa M. Davidson
Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4645. 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,
V. O. K. Teller
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Page | _ of __
INDICATIONS FOR USE STATEMENT
510(k) Number: Koll1999 --------
Device Name: FlexView™ Clinical Monitoring System
Indications For Use:
The FlexView™ Clinical Monitoring System is intended for use as a secondary annunciation of compatible primary medical device alarms.
The FlexView™ Clinical Monitoring System is for use as an accessory to primary medical devices and is The FlexYlew - Olinour mornitoring oyears, infusion pumps and ventilators. The FlexView™ Clinical Monitoring System is to supplement and not replace any part of the current primary medical device monitoring procedure.
The FlexView™ Clinical Monitoring System is for use by healthcare professionals trained in the use of the rries lox in on onlined monitored. The FlexView™ Clinical Monitoring System is not primally modiour de noce that the ut skilled interpretation and does not replace physician's care.
The FlexView™ Clinical Monitoring System is for use with patient populations being monitored by healthcare professionals utilizing compatible pulse oximeters, infusion pumps and ventilators.
The FlexView™ Clinical Monitoring System is for use in healthcare facilities such as hospitals, outpatient clinics or free standing surgical centers.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K011999
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
0000000
OR
§ 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).