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."

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the DripAssist device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criterion (Test)	Reported Device Performance & Compliance
Drip Rate Accuracy Test	The results of this test contributed to the conclusion that the device performs as well as the legally marketed predicate device (Drip Alert) and is substantially equivalent. (Specific quantitative accuracy not detailed in this summary, but the +/- 5% accuracy variability mentioned for alarm range implies a target accuracy.)
Alarm Accuracy Test	The results of this test contributed to the conclusion that the device performs as well as the legally marketed predicate device (Drip Alert) and is substantially equivalent. (Alarm triggers for +/- 13% deviation from set point, excluding 5% accuracy variability.)
Electromagnetic Compatibility (EMC) (IEC 60601-1-2:2007 Ed: 3)	The device met the requirements of IEC 60601-1-2:2007 (Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Test).
Design Verification and Validation	The completion of this test indicates that the design was verified and validated, concluding that the device performs as well as the legally marketed predicate device and is substantially equivalent. (Specific details of validation criteria not provided.)

Study Information

Sample Size used for the test set and the data provenance:
- The provided text does not specify the exact sample size for each performance test (Drip Rate Accuracy, Alarm Accuracy, EMC, Design Verification and Validation).
- The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). These are non-clinical performance tests conducted on the device itself, rather than clinical studies on patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Given these are performance tests of a physical device measuring flow rates, the "ground truth" would likely be established through highly calibrated measurement equipment or standard reference methods, rather than expert human interpretation.
Adjudication method for the test set:
- This is not applicable as the studies described are performance tests of a physical device against predefined metrics, not human-interpreted data requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The DripAssist is an IV flow rate monitor, not an AI-powered diagnostic device. The studies were focused on the device's accuracy and performance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the described studies (Drip Rate Accuracy Test, Alarm Accuracy Test, EMC, Design Verification and Validation) are standalone performance tests of the device itself (algorithm and hardware combined) without human-in-the-loop performance being evaluated as a primary outcome. The device's function is to monitor and alert, it does not involve human interpretation of complex data.
The type of ground truth used:
- For the Drip Rate Accuracy Test, the ground truth would typically be established by a highly accurate, calibrated flow meter or precise measurement of dispensed volume over time.
- For the Alarm Accuracy Test, the ground truth would be the actual flow rate deviation measured by calibrated equipment.
- For EMC, the ground truth is adherence to the specified IEC standard.
- For Design Verification and Validation, the ground truth would be the pre-defined design specifications and user requirements.
The sample size for the training set:
- This information is not applicable. The DripAssist is not an AI/machine learning device that requires a "training set" in the conventional sense for developing a predictive algorithm. It operates based on pre-programmed logic for infrared detection, calculations, and alarm triggers.
How the ground truth for the training set was established:
- This information is not applicable, as there is no "training set" for this type of device.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K150687

Device Name

DripAssist

Indications for Use (Describe)

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)

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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 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.""

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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 Assist	Drip 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

Drip Assist

Drip 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

	DripAssist	Drip Alert
Passive monitor; does not control flow rate	Yes	Yes
Device status information to user	LCD screen includes status information and audio alarm signals	Unique audio signals for four different conditions: power on; calculating drip rate; drip rate deviation; low battery
Microprocessor and algorithms used for measurements and calculations	Yes	Yes

Technological characteristics

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Drip rate setting method	Three drops; monitored byuser to determineaccuracy before activatingsetting	Nine drops used bymicroprocessor tocalculate drip rate
Used with standard IVadministration sets	Yes (10, 15, 20, and 60 gtt/mL)	Yes
Infrared sensor detection offlow rate	One emitter, one receiver	One emitter, two receivers
Audio alarm when flow rateis outside preset range	Yes	Yes
Drip rate range	0.15 - 30 seconds	0.5 - 12 seconds
Range variability to triggeralarm	+/- 13% (not including5% accuracy variability)	Two thresholds set byuser: +/- 12.5% or+/- 18.75%
Materials	Plastic Housing: ABSBlue Parts (Cam,bumpers): SiliconeFront 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.

Regulation Number and Section

§ 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).