K Number
K150687
Device Name
DripAssist
Manufacturer
Date Cleared
2015-10-13

(210 days)

Product Code
Regulation Number
880.2420
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DripAssist is a device intended to be used as a supplementary monitor that measures the flow of fluid through the drip chamber of a standard IV administration set. Sensors measure the flow rate and calculations are performed to convert the drip rate to ml/hr measurement and total volume. An alarm is available to alert the drip rate deviates from the infusion rate setting controlled through the IV administration set.
Device Description
The DripAssist device is intended to be used as a supplementary monitoring system for monitoring the flow rate of intravenous fluids. The DripAssist is a passive device. It does not control the flow rate of fluids passing through a drip chamber. The device operates by monitoring the drops through the drip chamber of a standard IV administration set. By tracking the intervals between drops, the device calculates the flow rate through the chamber and displays the flow rate on an LCD screen. The device operates by tracking drops using an infrared emitter and detector positioned on opposite sides of a well wherein the drip chamber is situated. There is an alarm functionality that can be activated once a desired flow rate, or "set point," is reached. The alarm, when activated, will sound when the flow rate deviates from a fixed percentage from the "set point."
More Information

No
The description details basic sensor-based measurement and calculation of flow rate, with no mention of AI or ML algorithms for analysis or prediction.

No
The device is described as a supplementary monitor for IV fluid flow and does not control the flow rate or directly treat a condition.

No

The device is described as a supplementary monitor that measures the flow of fluid and triggers an alarm if the flow rate deviates from a set point. It does not provide any diagnosis of a medical condition.

No

The device description explicitly states it uses an infrared emitter and detector positioned on opposite sides of a well to track drops, indicating the presence of hardware components beyond just software.

Based on the provided text, the DripAssist device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device "measures the flow of fluid through the drip chamber of a standard IV administration set." This is a measurement of a physical process happening in vivo (within the patient's body, as the IV fluid is being administered), not a test performed in vitro (outside the body) on biological samples.
  • Device Description: The description reinforces this by explaining how it monitors "drops through the drip chamber" and calculates flow rate. This is a monitoring function related to the delivery of a substance to the patient.
  • Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring analytes (substances in biological samples)
    • Providing information for diagnosis, monitoring, or screening of diseases or conditions based on analysis of biological samples.

The DripAssist is a device used to monitor the delivery of fluids to a patient, which falls under the category of medical devices used for patient care, but not specifically IVDs.

N/A

Intended Use / Indications for Use

The DripAssist is a device intended to be used as a supplementary monitor that measures the flow of fluid through the drip chamber of a standard IV administration set. Sensors measure the flow rate and calculations are performed to convert the drip rate to mL/hr measurement and total volume. An alarm is available to alert the user if the drip rate deviates from the infusion rate setting controlled through the IV administration set.

Product codes

FLN

Device Description

The DripAssist device is intended to be used as a supplementary monitoring system for monitoring the flow rate of intravenous fluids. The DripAssist is a passive device. It does not control the flow rate of fluids passing through a drip chamber. The device operates by monitoring the drops through the drip chamber of a standard IV administration set. By tracking the intervals between drops, the device calculates the flow rate through the chamber and displays the flow rate on an LCD screen.

The device operates by tracking drops using an infrared emitter and detector positioned on opposite sides of a well wherein the drip chamber is situated.

There is an alarm functionality that can be activated once a desired flow rate, or "set point," is reached. The alarm, when activated, will sound when the flow rate deviates from a fixed percentage from the "set point."

The device can be used with drip sets of 10, 15, 20, and 60 gtt/mL. The device is powered by one AA battery. The device can display the flow rate in drops per minute or mL per hour. The unit of measurement being displayed can be changed while the device operates. The device can also display the total volume that has dispensed through the drip chamber. The device is designed to be used with drip rates slow enough to be calculated by the human eye; a steady stream of fluid is outside the operating parameters.

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

Non-Clinical Testing:

  • Drip Rate Accuracy Test
  • Alarm Accuracy Test .
  • IEC 60601-1-2:2007 Ed: 3 Medical Electrical Equipment Part 1-2: General Requirements . for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Test
  • Design Verification and Validation test .

Conclusion:
The conclusions drawn from the performance tests demonstrate that the subject device performs as well as the legally marketed device and the DripAssist is substantially equivalent to the Drip Alert.

Key Metrics

Not Found

Predicate Device(s)

Drip Alert K030136

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are connected to form a single, flowing shape. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 13,2015

Shift Labs C/O Mr. Steven Chernoff Vice President Drug & Device Development Co. P.O. Box 3515 Seattle, Washington 98073

Re: K150687

Trade/Device Name: DripAssist Regulation Number: 21 CFR 880.2420 Regulation Name: Electronic Monitor for Gravity Flow Infusion Systems Regulatory Class: II Product Code: FLN Dated: September 8, 2015 Received: September 11, 2015

Dear Mr. Steven Chernoff:

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.

1

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/Resourcesfor You/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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K150687

Device Name

DripAssist

Indications for Use (Describe)

The DripAssist is a device intended to be used as a supplementary monitor that measures the flow of fluid through the drip chamber of a standard IV administration set. Sensors measure the flow rate and calculations are performed to convert the drip rate to ml/hr measurement and total volume. An alarm is available to alert the drip rate deviates from the infusion rate setting controlled through the IV administration set.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(k) Summary (21 CFR 807.92) Section 5.

Date prepared: October 8, 2015

Submitter:

Shift Labs 1752 NW Market St. #211 Seattle, WA 98107

Contact Person:

Beth Kolko Ph: 206-650-0120 Email: beth@shiftlabs.com

Proprietary name:

DripAssist

Common name:

IV flow rate monitor

Classified name:

Electronic monitor for gravity flow infusion systems CFR 880.2420 Product code: FLN Regulatory Class: II Predicate Device: Drip Alert K030136

Intended use:

The DripAssist is a device intended to be used as a supplementary monitor that measures the flow of fluid through the drip chamber of a standard IV administration set. Sensors measure the flow rate and calculations are performed to convert the drip rate to mL/hr measurement and total volume. An alarm is available to alert the user if the drip rate deviates from the infusion rate setting controlled through the IV administration set.

Substantial equivalence:

The DripAssist is substantially equivalent to the Drip Alert (K030136).

Description of device:

The DripAssist device is intended to be used as a supplementary monitoring system for monitoring the flow rate of intravenous fluids. The DripAssist is a passive device. It does not control the flow rate of fluids passing through a drip chamber. The device operates by monitoring the drops through the drip chamber of a standard IV administration set. By tracking the intervals between drops, the device calculates the flow rate through the chamber and displays the flow rate on an LCD screen.

The device operates by tracking drops using an infrared emitter and detector positioned on opposite sides of a well wherein the drip chamber is situated.

There is an alarm functionality that can be activated once a desired flow rate, or "set point," is reached. The alarm, when activated, will sound when the flow rate deviates from a fixed percentage from the "set point.""

4

The device can be used with drip sets of 10, 15, 20, and 60 gtt/mL. The device is powered by one AA battery. The device can display the flow rate in drops per minute or mL per hour. The unit of measurement being displayed can be changed while the device operates. The device can also display the total volume that has dispensed through the drip chamber. The device is designed to be used with drip rates slow enough to be calculated by the human eye; a steady stream of fluid is outside the operating parameters.

Summary of technological characteristics and indication for use compared to predicate device:

Both the DripAssist and the Drip Alert are intended to be used with standard size gravity feed IV administration sets as a monitor to inform the user of the rate of flow, which is controlled by the IV administration set. Neither device controls the flow rate, but uses sensors and microprocessors to measure and calculate the flow rate. Both devices include audio alarms when the flow rate deviates from a pre-set range. Both devices are powered by disposable batteries.

Indication for Use
Drip AssistDrip Alert
The DripAssist is a device intended to be used as a supplementary monitor that measures the flow of fluid through the drip chamber of a standard IV administration set. Sensors measure the flow rate and calculations are performed to convert the drip rate to mL/hr measurement and total volume. An alarm is available to alert the user if the drip rate deviates from the infusion rate setting controlled through the IV administration set.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.

Indication for Use

DripAssistDrip Alert
Passive monitor; does not control flow rateYesYes
Device status information to userLCD screen includes status information and audio alarm signalsUnique audio signals for four different conditions: power on; calculating drip rate; drip rate deviation; low battery
Microprocessor and algorithms used for measurements and calculationsYesYes

Technological characteristics

5

| Drip rate setting method | Three drops; monitored by
user to determine
accuracy before activating
setting | Nine drops used by
microprocessor to
calculate drip rate |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Used with standard IV
administration sets | Yes (10, 15, 20, and 60 gtt/mL) | Yes |
| Infrared sensor detection of
flow rate | One emitter, one receiver | One emitter, two receivers |
| Audio alarm when flow rate
is outside preset range | Yes | Yes |
| Drip rate range | 0.15 - 30 seconds | 0.5 - 12 seconds |
| Range variability to trigger
alarm | +/- 13% (not including
5% accuracy variability) | Two thresholds set by
user: +/- 12.5% or
+/- 18.75% |
| Materials | Plastic Housing: ABS
Blue Parts (Cam,
bumpers): Silicone
Front overlays: PET | Not publically available |
| Power source | 1 AA battery | 2 AAA batteries |

Non-Clinical Testing:

The following performance tests were completed on the subject device for determination of substantial equivalence to the predicate device.

  • Drip Rate Accuracy Test
  • Alarm Accuracy Test .
  • IEC 60601-1-2:2007 Ed: 3 Medical Electrical Equipment Part 1-2: General Requirements . for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Test
  • Design Verification and Validation test .

Conclusion:

The conclusions drawn from the performance tests demonstrate that the subject device performs as well as the legally marketed device and the DripAssist is substantially equivalent to the Drip Alert.