The MT Alert Infusion Monitor is a passive weighing device that alarms when the infusion bag is near-empty. The alarm point can be set by the user. In addition, MT Alert may also assist in monitoring fluid bolus administration. MT Alert will alarm when a prescribed bolus of fluid has been taken from the infusion bag. MT Alert provides various audio and visual alarms. MT Alert operates from common alkaline batteries and mounts on common poles and rods.

AI/ML Overview

Here's the breakdown of the acceptance criteria and the study information for the MT Alert Infusion Monitor based on the provided document:

Acceptance Criteria and Device Performance

The provided document does not explicitly state quantitative acceptance criteria with specific performance metrics (e.g., accuracy percentages, alarm thresholds). Instead, the "Safety and Effectiveness in Comparison to Predicate Devices" section states: "The validation procedures performed on the system indicate that the new device is as safe and effective as the predicate devices."

The Substantial Equivalence Chart serves as an implicit set of functional acceptance criteria, demonstrating that the MT Alert Infusion Monitor meets or exceeds the capabilities of the predicate device (Smith & Nephew Dyonics LeveLert System).

Feature / Acceptance Criteria	Reported Device Performance (MT Alert™)	Predicate Device (LeveLert) Performance
Used for monitoring the fluid level of an infusion bag.	Yes	Yes
Automatic alarm when the fluid level has reached a pre-determined weight with audio and visual alarms.	Yes	Yes
Adjustable near-empty alarm point.	Yes - Easily programmed by hanging the desired weight.	Yes.
Accommodates most typical infusion bag sizes.	Yes (up to 3 liter size)	Yes (up to 3 liter size)
Bolus monitoring feature.	Yes (1 liter mode only)	No.
Passive device, no fluid control functions.	Yes	Yes
Infusion Container hangar.	Yes	Yes
Pole Mounting.	Yes	Yes
Power	2- AA batteries, typical 180 day life	Powered externally
Device Class.	Class II	Class II

Study Details

The provided 510(k) summary is very limited in its description of the underlying studies that demonstrate safety and effectiveness. It primarily relies on demonstrating substantial equivalence to a predicate device. Therefore, many of the requested details cannot be extracted directly from this document.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified. It's likely that internal bench testing or validation was performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe the establishment of a ground truth in a clinical or expert review setting for the validation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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:
- Not applicable. This device is an infusion monitor, not an AI-assisted diagnostic tool for "human readers." The document states it "can improve existing practice by notifying healthcare personnel of gravity infusion end-points." However, no formal MRMC study or effect size is mentioned for human improvement with the device vs. without.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device functions as a "standalone" monitor in that it operates independently to detect fluid levels and alarm. However, the term "standalone" in the context of performance studies usually refers to the performance of an algorithm without human intervention in a diagnostic sense. The device's primary function is to alert human personnel; it doesn't make diagnostic decisions. The document implies performance of the device itself was validated to ensure it functions as intended (e.g., alarming at the correct weight), but specific "standalone performance" metrics are not detailed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the functional aspects (e.g., alarming at a specific weight), the ground truth would likely be based on measured weight or volume (physical truth) rather than expert consensus or pathology. The document doesn't detail the specific methods for establishing ground truth during its internal validation.
The sample size for the training set:
- Not applicable. This is a physical device with embedded logic, not a machine learning model that undergoes a "training" phase with a dataset.
How the ground truth for the training set was established:
- Not applicable, as it's not a machine learning model.

Summary

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OCT 1 5 2001

1.2 510(k) Summary

Sierra BioSearch, Inc. 395 Mt. Tom Road Bishop, California 93514

510(k) Summary of Safety and Effectiveness

Identification of the Device

Proprietary-Trade Name:	MT Alert Infusion Monitor
Classification Name:	Monitor, Electric for Gravity Flow Infusion Systems
Device Class:	II
Product Code:	FLN
Common/Generic Name:	Gravity Infusion Monitor

Equivalent Predicate Devices

The MT Alert Infusion Monitor is substantially equivalent in design and function to the Smith & Nephew Dyonics LeveLert System.

Indications for Use

MT Alert Infusion Monitor is intended for use in any healthcare setting where gravityflow infusions are utilized.

Description of the Device

Safety and Effectiveness in Comparison to Predicate Devices.

The validation procedures performed on the system indicate that the new device is as safe and effective as the predicate devices.

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Substantial Equivalence Chart

Feature	MT AlertTM	LeveLert
Used for monitoring the fluid level of aninfusion bag.	Yes	Yes
Automatic alarm when the fluid levelhas reached a pre-determined weightwith audio and visual alarms.	Yes	Yes
Adjustable near-empty alarm point.	Yes- Easily programmed byhanging the desired weight.	Yes.
Accommodates most typical infusionbag sizes.	Yes (up to 3 liter size)	Yes (up to 3 liter size)
Bolus monitoring feature.	Yes (1 liter mode only)	No.
Passive device, no fluid controlfunctions.	Yes	Yes
Infusion Container hangar.	Yes	Yes
Pole Mounting.	Yes	Yes
Power	2- AA batteries, typical 180day life	Powered externally
Device Class.	Class II	Class II

Marlon Lattimore

Richard Citrenbaum, MD, President

$\k01312/$
(Premarket Notification [510(k)] Number)

(Premarket Notification [510(k)] Number)

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2001

Dr. Richard Citrenbaum President Sierra BioSearch, Incorporated 395 Mount Tom Road Bishop, California 93514

Re: K013121

Trade/Device Name: MT Alert Infusion Monitor Regulation Number: 880.2420 Regulation Name: Monitor, Electric for Gravity Flow Infusion Systems Regulatory Class: II Product Code: FLN Dated: September 14, 2001 Received: September 18, 2001

Dear Dr. Citrenaum:

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.

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.

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Page 2 - Dr. Citrenaum

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 (QS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 Penno

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K0/3/21

1.3 Statement of Indications for Use

Sierra BioSearch, Inc. 395 Mt. Tom Road Bishop, California 93514

Statement of Indications for Use

MT Alert Infusion Monitor is intended for use in any healthcare setting where gravity-flow infusions are utilized.

The device monitors the weight of the infusion bag and sounds an audible alarm to alert I he device monitors the worked on end-points. These end-points include (1) near-empty condition and (2) fluid bolus completion ..

Current practice typically involves visual monitoring of infusion bags by healthcare Current practice typically involves visual bolus completion. Although the MT persomici for near-emply condition the safe use of a gravity IV, it can improve Arelt Information Morney in no way atting by notifying healthcare personnel of gravity infusion end-points. This alert system allows for timely replacement of intravenous or infusion bags and prompts healthcare providers to reevaluate the infusion rate at the completion of a 250 or 500ml fluid bolus.

B. Bollen

(Division Sign-Off Division of Dental, Infection Control, and General Hospital Devic 510(k) Number

MT Alert Infusion Monitor 510(k)- Page

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).