The Drip Alert device is intended to be used as a supplementary monitor with a standard IV administration set such that an alarm sounds when the drip rate in the drip chamber of the administration set falls outside a preselected range of acceptable drip rate deviation. The deviation in the drip rate may be due to air in the IV line, occlusion, excessive movement by the patient or displacement of the IV catheter.

Device Description

The Drip Alert device is a passive device that measures time between intravenous drops and sounds an alarm when the time between drops falls outside an acceptable range due to air in the line, occlusion, low or empty fluid in the solution bag, high or low flow rate, and low battery. The Drip Alert device does not have a pump or clamping mechanism. It uses a processor to perform calculations and measurements and has a flow meter. It is powered by 2-AAA batteries with a typical 30 day life. It is a Class II Device.

AI/ML Overview

This document, a 510(k) summary for the Drip Alert intravenous drip monitor, provides limited information about specific acceptance criteria and performance studies. The focus of this submission is to demonstrate substantial equivalence to predicate devices rather than necessarily reporting on extensive performance studies with defined acceptance criteria.

Based on the provided text, here's what can be extracted and what remains unknown:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or specific performance metrics as they would typically be presented from a defined study. Instead, it provides a comparative chart showing features and capabilities against predicate devices. The "performance" is implicitly defined by its functionality as described in the "Indication for Use" and the features listed in the "Substantial Equivalence Chart."

Acceptance Criteria (Implied Functionality)	Reported Device Performance (as listed in Substantial Equivalence Chart)
Passive device, no fluid control	Yes (Drip Alert™)
Used for monitoring the rate of infusion	Yes (Drip Alert™)
Accommodates most typical infusion administration sets	Yes (Drip Alert™)
Sounds an alarm when infusion is low or complete	Yes (Drip Alert™)
Uses a processor to perform calculations and measurements	Yes (Drip Alert™)
Has a flow meter	Yes (Drip Alert™)
Sounds an alarm when there is a deviation in flow rate	Yes (Drip Alert™)
Sounds a low battery alarm	Yes (Drip Alert™)
Power Source (typical life)	2-AAA batteries, typical 30 day life
Regulation: Class II Device	Yes (Drip Alert™)
Additional Functionality from Indication for Use: Sounds an alarm when time between drops falls outside acceptable range due to air in the line, occlusion, low/empty fluid, high/low flow rate, and low battery.	(Implied by stating "Indication for Use")

2. Sample size 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 510(k) summary focuses on equivalence to predicate devices rather than detailed performance study results from a test set.

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 specific performance study with a test set and ground truth is described, there's no mention of experts for establishing ground truth.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable here. The Drip Alert is a device (monitoring system), not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The Drip Alert is a standalone device in the sense that it performs its monitoring function automatically and signals an alarm when a deviation occurs. It is not an "algorithm only" in the context of AI/ML, but rather an electronic device with a processor that performs calculations and measurements. The document does not describe what would typically be considered a 'standalone performance study' in the context of recent medical device submissions, which often entail detailed metrics like sensitivity, specificity, etc. However, its core function is designed to operate without constant human intervention for its primary task of monitoring.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided.

8. The sample size for the training set

This information is not provided. The Drip Alert is described as having a processor to perform calculations; however, the document does not suggest it utilizes complex machine learning algorithms that would require a "training set" in the modern sense. It appears to be a rule-based or threshold-based system.

9. How the ground truth for the training set was established

This information is not provided and is likely not applicable given the apparent nature of the device (not a machine learning model requiring a training set with ground truth).

Summary

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K030136

PREMARKET NOTIFICATION 510K SUMMARY VIII.

SUBMITTER INFORMATION

APR 0 7 2003

A.	Company Name:	Drip Alert, Inc.
B.	Company Address:	13882 N. Kendall Dr.Miami, Florida 9212

C. Company Phone: 305-385-8000 305-388-3965 Company Fax:
D. Contact Person: Dr. Barry Goldberg
E. Date Summary Prepared: January 9, 2003

DEVICE IDENTIFICATION

A. Generic Device Name:	I.V. drip monitor
-------------------------	-------------------

B. Trade/Proprietary Name: Drip Alert
Monitor, Electric for Gravity Flow Infusion Systems C. Classification: 21 CFR 880.2420, Class II, General Hospital Product Code FLN

INDICATION FOR USE

SUBSTANTIAL EQUIVALENCE

The Drip Alert intravenous drip monitor and alarm is of a comparable type and is substantially equivalent to the predicate devices, MT Alert Infusion Monitor made by Seirra BioSearch, Inc. K022248 and the drop counter and alarm profiles which are components of the Gemini Infusion System made by Alaris Medical Systems, Inc. K012383 and the Sigma programmable infusion pump with optional flow sensor manufactured by Sigma K950766. The Drip Alert device does not have a pump or clamping mechanism.

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SUBSTANTIAL EQUIVALENCE CHART

Feature	Drip Alert™	MT Alert™	Gemini® Infusion Pump	Sigma with optional flow sensor
Passive device, no fluid control	Yes	Yes	No	No
Used for monitoring the rate of infusion	Yes	No	Yes	Yes
Accommodates most typical infusion administration sets	Yes	Yes	Yes	Yes
Sounds and alarm when infusion is low or complete	Yes	Yes	Yes	Yes
Uses a processor to perform calculations and measurements	Yes	Yes	Yes	Yes
Has a flow meter	Yes	No	Yes	Yes
Sounds an alarm when there is a deviation in flow rate	Yes	No	Yes	Yes
Sounds a low battery alarm	Yes	Yes	Yes	Yes
Power Source	2-AAA batteries, typical 30 day life	2-AA batteries, typical 180 day life	Sealed lead battery 5 hours on fully charged battery or external source	Rechargeable battery 4 hour to low battery alarm
Class II Device	Yes	Yes	Yes	Yes

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing right, stacked on top of each other, with a curved line underneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 0 7 2003

Drip Alert, Incorporated C/O Ms. Polly D. Heseman Gunster, Yoakley & Stewart P.A. 500 E. Broward Boulevard, Suite 1400 Ft. Lauderdale, Florida 33394

Re: K030136

Trade/Device Name: Drip Alert Regulation Number: 880.2420 Regulation Name: Electronic Monitor for Gravity Flow Infusion Systems Regulatory Class: II Product Code: FLN Dated: January 10, 2003 Received: January 14, 2003

Dear Ms. Heseman:

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 - Ms. Heseman

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 Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation 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 Division 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,

Susan Runne

Susan Runner, DDS, MA Interim 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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STATEMENT OF INDICATION OF USE IV.

Patrice Lucenti

eneral Hospital,

510(k) Number: K030136

Regulation Number and Section

§ 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).