(331 days)
The ISSYS Drug Flow Monitor is a passive monitoring device for gravity infusion. The unit uses a flow sensor to measure the amount of liquid through the infusion line and displays the flow rate and total volume administered to the patient. Flow rates and volumes are recorded, and if the flow rate or volume falls outside the preset range, both a visible and audible alarm is triggered. This monitor is indicated for use in where the flow rates are between 5 and 200 mL/hr. The accuracy of the monitor is +/- 20% at 5 mL/hr and +/- 5% at 200 mL/hr. For use with IV drug solutions administered by gravity. WARNING: DO NOT USE WITH BLOOD OR BLOOD PRODUCTS.
The ISSYS Drug Flow Monitor is a passive monitoring device for gravity infusion. The unit uses a flow sensor to measure the amount of liquid through the infusion line and displays the flow rate and total volume administered to the patient. Flow rates and volumes are recorded, and if the flow rate or volume falls outside the preset range, both a visible and audible alarm is triggered.
The provided text describes a 510(k) premarket notification for the ISSYS Drug Flow Monitor®. It includes information on the device's intended use and performance specifications, which can be interpreted as acceptance criteria. However, it does not detail a specific study proving the device meets these criteria in the comprehensive manner requested (e.g., sample size, expert ground truth, MRMC study, training set details).
Here's a breakdown of the information that can be extracted or inferred, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the "Indications For Use" section, the following can be constructed:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Flow Rate Range | 5 to 200 mL/hr |
| Accuracy at 5 mL/hr | +/- 20% |
| Accuracy at 200 mL/hr | +/- 5% |
| Alarm Trigger | Visible and audible if flow rate or volume falls outside preset range |
Missing Information:
The document does not provide details of a specific study that proves these performance metrics. It merely states them as characteristics of the device and its intended use. There is no mention of study design, methodology, or results from an independent study to validate these claims.
2. Sample Size Used for the Test Set and Data Provenance
Missing Information:
The document does not describe a test set, its sample size, or its data provenance (e.g., country of origin, retrospective/prospective). The provided text is a regulatory clearance letter, not a scientific study report.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Missing Information:
No information is provided regarding experts, ground truth establishment, or their qualifications. This is not a study involving human interpretation of medical images or data.
4. Adjudication Method
Missing Information:
No information is provided about an adjudication method. This is not relevant for a device that directly measures flow rates.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Missing Information:
An MRMC study is not relevant for this device. The ISSYS Drug Flow Monitor® is a "passive monitoring device" that "uses a flow sensor to measure the amount of liquid." It's an automated measurement device, not one that assists human readers in interpreting clinical data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
While the device operates "standalone" in the sense that it automatically measures and alarms, the document does not describe a study to test its standalone performance against a gold standard or reference. It only states the device's claimed accuracy specifications.
7. Type of Ground Truth Used
Missing Information:
No information is provided regarding the type of ground truth used for performance validation. For a device measuring flow, the ground truth would typically be highly accurate reference flow meters, but the document does not describe how these specific accuracy figures were derived or verified in a formal study for regulatory submission.
8. Sample Size for the Training Set
Missing Information:
There is no mention of a "training set." This type of device is likely based on physical principles of fluid dynamics and sensor calibration, not on machine learning or algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
Missing Information:
As there's no mention of a training set, there's no information on how its ground truth was established.
Summary of Document's Relevance to the Request:
The provided FDA letter serves as regulatory clearance based on the manufacturer's claims and submissions, not as a detailed scientific study report. It states the device's intended use and performance specifications (which can be interpreted as acceptance criteria), but it does not describe the specific studies that validated these claims according to the detailed scientific rigor outlined in your request. The format of the request (e.g., MRMC studies, expert ground truth) is more applicable to diagnostic imaging AI devices, whereas the ISSYS Drug Flow Monitor is a measurement and alarm device for gravity infusion systems.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2006
Mr. Stephen Goldner, JD, RAC Vice President, Regulatory Affairs Integrated Sensing Systems, Incorporated 391 Airport Industrial Drive Ypsilanti, Michigan 48198
Re: K050783
Trade/Device Name: ISSYS Drug Flow Monitor® Regulation Number: 21 CFR 880.2420 Regulation Name: Electronic monitor for gravity flow infusion systems Regulatory Class: Class II Product Code: FLN Dated: Februrary 13, 2006 Received: February 16, 2006
Dear Mr. Goldner:
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 – Mr. Stephen Goldner, JD, RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvisod that 1 DX 3 issualled of a bases and issues complies with other requirements mean that ITDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal states and systements, including, but not limited to: registration 1 ou must comply with an the Piebeling (21 CFR Part 801); good manufacturing practice allo fishing (21 CFR Part 007), labeling (21 cm (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality by seems (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 This letter will anow you to ough himsing of substantial equivalence of your device 510(K) predicate notification: "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 advice for your do recolor of the 311-5. Also, please note the regulation in entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general meethallers, 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/industry/support/index.html.
Sincerely yours,
Clues
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): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use: The ISSYS Drug Flow Monitor is a passive monitoring device for rravity infusion. The unit uses a flow sensor to measure the amount of liquid through the infusion line and displays the flow rate and total volume administered to the patient. Flow rates and volumes are recorded, and if the flow rate or volume falls outside the preset range, both a visible and audible alarm is triggered. This monitor is indicated for use in range, both a the flow rates are between 5 and 200 mL/hr. The accuracy of the monitor is +/- 20% at 5 mL/hr and +/- 5% at 200 mL/hr. For use with IV drug solutions administered by gravity. WARNING: DO NOT USE WITH BLOOD OR BLOOD PRODUCTS.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Case D.m.
- Perfection Circus (Peneral Hospical, Tophol Dunlal Davices
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§ 880.2420 Electronic monitor for gravity flow infusion systems.
(a)
Identification. An electronic monitor for gravity flow infusion systems is a device used to monitor the amount of fluid being infused into a patient. The device consists of an electronic transducer and equipment for signal amplification, conditioning, and display.(b)
Classification. Class II (performance standards).