(83 days)
Not Found
No
The description focuses on basic measurement and calculation using a processor and flow meter, with no mention of AI/ML terms or concepts like training/test sets.
No.
The device is a monitor that detects deviations in IV drip rates and sounds an alarm; it does not directly treat or prevent a disease or condition.
No.
The device monitors the drip rate of an IV administration set and sounds an alarm when the drip rate falls outside a preselected range. It does not diagnose medical conditions.
No
The device description explicitly states it uses a processor, a flow meter, and is powered by batteries, indicating it includes hardware components beyond just software.
Based on the provided information, the Drip Alert device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The Drip Alert device monitors the flow of intravenous fluid within an administration set, which is external to the patient's body and not a biological specimen.
- The intended use and device description clearly state its function is to monitor the drip rate of an IV line. This is a physical measurement related to the delivery of medication or fluids, not a diagnostic test performed on a biological sample.
- The device description mentions a flow meter and processor, not components typically associated with IVD testing.
The Drip Alert device is a medical device used to monitor the delivery of IV fluids, falling under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
FLN
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.
Feature: Passive device, no fluid control - Yes
Feature: Used for monitoring the rate of infusion - Yes
Feature: Accommodates most typical infusion administration sets - Yes
Feature: Sounds and alarm when infusion is low or complete - Yes
Feature: Uses a processor to perform calculations and measurements - Yes
Feature: Has a flow meter - Yes
Feature: Sounds an alarm when there is a deviation in flow rate - Yes
Feature: Sounds a low battery alarm - Yes
Feature: Power Source - 2-AAA batteries, typical 30 day life
Feature: Class II Device - Yes
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
Not Found
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)
Not Found
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).
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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
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.
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.
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.
Patrice Lucenti
eneral Hospital,
510(k) Number: K030136