(27 days)
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Not Found
No
The device description and lack of mentions of AI/ML terms or data sets indicate a simple weighing mechanism with user-set alarms, not AI/ML technology.
No
The device is described as a passive weighing device that monitors fluid infusions and alarms when bags are near-empty or a prescribed bolus is administered. It does not actively treat or diagnose a medical condition.
No
The device monitors the volume of fluid in an infusion bag and alarms when it's near-empty or a bolus has been administered. It does not diagnose any medical condition or disease.
No
The device description explicitly states it is a "passive weighing device" that "operates from common alkaline batteries and mounts on common poles and rods," indicating it includes physical hardware components beyond just software.
Based on the provided information, the MT Alert Infusion Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor gravity-flow infusions in a healthcare setting. This involves monitoring the physical process of fluid delivery to a patient, not analyzing biological samples in vitro (outside the body).
- Device Description: The device is described as a "passive weighing device" that monitors the weight of an infusion bag. This is a physical measurement, not a diagnostic test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention any analysis of blood, urine, tissue, or any other biological material. It doesn't perform any tests to diagnose a disease or condition.
IVD devices are specifically designed to perform tests on biological samples to provide information for diagnosis, monitoring, or treatment decisions. The MT Alert Infusion Monitor's function is purely related to the delivery of fluids to a patient.
N/A
Intended Use / 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.
Product codes
FLN
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
any healthcare setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The validation procedures performed on the system indicate that the new device is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
0
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
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.
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.
1
Substantial Equivalence Chart
| Feature | MT AlertTM | LeveLert |
|---|---|---|
| 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 |
Marlon Lattimore
Richard Citrenbaum, MD, President
$\k01312/$
(Premarket Notification [510(k)] Number)
(Premarket Notification [510(k)] Number)
2
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.
3
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
4
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