DRIP ALERT

K030136 · Drip Alert, Inc. · FLN · Apr 7, 2003 · General Hospital

Device Facts

• Record ID: K030136
• Device Name: DRIP ALERT
• Applicant: Drip Alert, Inc.
• Product Code: FLN · General Hospital
• Decision Date: Apr 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2420
• Device Class: Class 2

Intended Use

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 Story

Drip Alert is a passive, battery-powered monitor for gravity-fed IV administration sets. Device attaches to IV drip chamber; uses internal processor to measure time intervals between drops. When measured interval falls outside preselected range—indicating air in line, occlusion, empty fluid bag, or flow rate deviation—device triggers audible alarm. Used in clinical settings to supplement standard IV monitoring; provides real-time feedback to healthcare providers regarding infusion status. Does not control fluid flow or clamp tubing; serves solely as monitoring/alerting tool to improve patient safety during gravity infusion.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Passive electronic monitor for gravity flow infusion. Powered by 2-AAA batteries. Features internal processor for drip interval calculation and flow monitoring. Compatible with standard IV administration sets. Class II device per 21 CFR 880.2420.

Indications for Use

Indicated for patients receiving intravenous therapy via gravity flow infusion systems. Used to monitor drip rate and alert clinicians to deviations caused by air in line, occlusion, fluid depletion, or flow rate changes.

Regulatory Classification

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.

Predicate Devices

• MT Alert Infusion Monitor (K022248)
• Gemini Infusion System (K012383)
• Sigma programmable infusion pump (K950766)

Submission Summary (Full Text)

{0}------------------------------------------------

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.<br>Miami, Florida 9212 |

- C. Company Phone: [phone] 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.

{1}------------------------------------------------

# 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 |

:

{2}------------------------------------------------

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.

{3}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

#### 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