(125 days)
Not Found
No
The description focuses on passive sensing and preset conditions for alarming, with no mention of learning, adaptation, or complex data analysis typically associated with AI/ML.
No
The device is a passive sensing device that monitors fluid levels and provides alarms. It does not directly treat or diagnose any medical condition, it merely monitors a situation to improve efficiency in a medical setting.
No
The device is described as a "passive sensing device that alarms when the infusion fluid is low." Its purpose is to monitor fluid levels during infusion and alert healthcare personnel, rather than to diagnose a medical condition or disease.
No
The device description explicitly states that the Fluid Level Monitor includes both a main control unit and an external sensor, indicating hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Fluid Level Monitor is a passive sensing device that monitors the fluid level in an infusion system. It provides an alarm when the fluid level is low.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from a patient. It interacts with the infusion tubing and the fluid within it, but not with the patient's body or any samples taken from it.
- Intended Use: The intended use is to monitor fluid levels in gravity flow infusions to improve efficiency in a healthcare setting by alerting personnel to low fluid levels. This is a monitoring function related to the delivery of a substance, not a diagnostic test on a patient sample.
Therefore, the Fluid Level Monitor falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Fluid Level Monitor is a passive sensing device that alarms when the infysion fluid level is low. The device provides both visual and audible alarms when preset condition is met.
The Fluid Level Monitor is intended for low-fluid-level alarm use in any healthcare setting where gravity flow infusion is utilized. The use of the device improves efficiency within a busy medical setting by providing healthcare personnel of timely notification of the low-fluid-level status. The available models are:
LM771: 1-channel, DC battery power LM781 1-channel, DC plug-in power
Product codes (comma separated list FDA assigned to the subject device)
FLN
Device Description
Fluid Level Monitor is a passive sensing device that alarms when the infusion fluid level is low. Fluid Level Monitor provides both visual and audible alarms when preset condition is met. Fluid Level Monitor operates on DC power source.
Fluid Level Monitor includes both main control unit and external sensor. There are status LEDs on the main control unit to display run, alarm and battery-low status. There is a buzzer on the main control unit to provide audible alarm.
The external sensor is connected to the main control unit via shielded signal cable. The sensor can be clipped on the tubing to monitor fluid level.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
any healthcare setting where gravity flow infusion is utilized.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on the risk analysis, the verification and validation tests that were performed and the acceptance criteria applied for each are listed in Section 18. Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed.
The performance test data demonstrated that the system power consumption remains same when using:
- a) DC battery or DC plug-in power
- b) 1-channel or 5-channel sensing
We concluded that the design difference on number of monitoring points does not raise safety or effectiveness concerns.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
5. 510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for Coleman Laboratories' Fluid Level Monitor 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
1) Submitter Information
| Company Name: | Coleman Laboratories |
|---|---|
| Company Address: | 1150 First Avenue, Suite 501 |
| King of Prussia, PA 19406, USA | |
| Contact: | Le-Jun Yin, Vice President, Product Management |
| Email: | lejun.yin@colemanlabs.com |
| Phone: | (484) 727-8812 |
| Fax: | (484) 727-8828 |
| Date Summary Prepared: | December 18th, 2013 |
2) Device Identification
| Generic Device Name: | Electronic I.V. Monitor |
|---|---|
| Trade/Proprietary Name: | Fluid Level Monitor Model |
| Numbers: | LM771, LM781, LM785 |
| Classification: | Class II |
| Panel: | General Hospital (80) |
| Regulation Number: | 21 CFR 880.2420 |
| Regulation Name: | Electronic monitor for gravity flow infusion systems |
| Product Code: | FLN |
| 510(k) Number: | K133870 |
3) Predicate Device
| 510(k) Number: | K030136, K903193 |
|---|---|
| Trade Name: | Drip Alert, Levelert |
| Product Code: | FLN |
4) Description of Device
Fluid Level Monitor is a passive sensing device that alarms when the infusion fluid level is low. Fluid Level Monitor provides both visual and audible alarms when preset condition is met. Fluid Level Monitor operates on DC power source.
Fluid Level Monitor includes both main control unit and external sensor. There are status LEDs on the main control unit to display run, alarm and battery-low status. There is a buzzer on the main control unit to provide audible alarm.
The external sensor is connected to the main control unit via shielded signal cable. The sensor can be clipped on the tubing to monitor fluid level.
5) Intended Use
The Fluid Level Monitor is a passive sensing device that alarms when the infysion fluid level is low. The device provides both visual and audible alarms when preset condition is met.
The Fluid Level Monitor is intended for low-fluid-level alarm use in any healthcare setting where gravity flow infusion is utilized. The use of the device improves efficiency within a busy medical setting by providing healthcare personnel of timely notification of the low-fluid-level status. The available models are:
LM771: 1-channel, DC battery power LM781 1-channel, DC plug-in power
1
LM785 - 5-channel, DC plug-in power
Coleman Laboratories' Fluid Level Monitors (3 Models) are substantially equivalent to the predicate devices:
K030136 - Drip Alert, Drip Alert, Inc. K903193 - Smith & Nephew, Inc.
They have the same design principles, material, indications for use, and intended use.
| Device Name | Fluid Level Monitor | Drip Alert | Levelert | ||
|---|---|---|---|---|---|
| Device Model | LM771 | LM781 | LM785 | - | - |
| 510(K) Number | K133870 | K030136 | K903193 | ||
| Passive device | Yes | Yes | Yes | Yes | Yes |
| Uses a processor to | |||||
| perform | |||||
| measurements | Yes | Yes | Yes | Yes | Yes |
| Use sensor to detect | |||||
| fluid-level-low status | Yes | Yes | Yes | Yes | Yes |
| Visual and audible | |||||
| alarm on fluid-level- | |||||
| low status | Yes | Yes | Yes | Yes | Yes |
| Patient has no contact | |||||
| with device | Yes | Yes | Yes | Yes | Yes |
| Class II device | Yes | Yes | Yes | Yes | Yes |
| Power source | DC | ||||
| battery | DC | ||||
| plugin | DC | ||||
| plugin | DC | ||||
| battery | DC | ||||
| plugin | |||||
| Monitoring Point | 1 | 1 | 5 | 1 | 1 |
7) Summary Performance Data
Based on the risk analysis, the verification and validation tests that were performed and the acceptance criteria applied for each are listed in Section 18. Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed.
2
The performance test data demonstrated that the system power consumption remains same when using:
- a) DC battery or DC plug-in power
- b) 1-channel or 5-channel sensing
We concluded that the design difference on number of monitoring points does not raise safety or effectiveness concerns.
8) Conclusion
Based on the analysis on nonclinical test data, and comparison on design principle, operation procedure and indications for use, we demonstrated that the device is as safe, as effective, and performs as well as the predicate devices. The design difference does not raise questions on safety or effectiveness.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2014
Coleman Laboratories Le-Jun Yin Vice President, Product Management 1150 First Avenue, Suite 501 King of Prussia, PA 19406, USA
Re: K133870
Trade/Device Name: Fluid Level Monitor, Models LM771, LM781, and LM785 Regulation Number: 21 CFR 880.2420 Regulation Name: Electronic monitor for gravity flow infusion systems Regulatory Class: II Dated: March 13, 2014 Received: March 28, 2014
Dear Mr. Yin:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2 - Mr. Yin
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Susan R. DODDS, MA
Erin I. Keith, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133870
Device Name
Fluid Level Monitor, Models LM771, LM781, and LM785
Indications for Use (Describe)
The Fluid Level Monitor is a passive sensing device that alarms when the infusion fluid is low. The device provides both visual and audible alarms when preset condition is met.
The Fluid Level Monitor is intended for low-fluid-level alarm use in any healthcare setting where gravity flow infirsed. The use of the device improves efficiency within a busy medical setting by providing healthcare personnel of the low-fluid-level status.
LM771: 1-channel, DC battery power LM781: 1-channel, DC plug-in power LM785: 5-channel DC plug-in power
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)