The DripAssist Plus is a device intended to be used with gravity infusions as a supplementary monitor the flow of fluid through a compatible drip chamber. The device is intended to be used with single-use intravascular administration sets uniquely identified as "compatible with DripAssist Plus." 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 set infusion rate setting controlled through the IV administration set.

Device Description

The DripAssist Plus device is intended to be used as a supplementary monitoring system for monitoring the flow rate of intravenous fluids. DripAssist Plus 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 compatible single-use intravascular administration set that is inserted into a mechanical attachment mechanism on the DripAssist Plus. 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 a fixed percentage from the "set point." The device can be used with compatible drip sets of 10, 15, 20, or 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.

AI/ML Overview

The provided document describes the DripAssist Plus, a device intended to be a supplementary monitor for gravity infusions, and its substantial equivalence to the predicate device, DripAssist (K150687). The document primarily focuses on demonstrating that the DripAssist Plus meets its specifications and is substantially equivalent to the predicate device.

Here's an analysis of the acceptance criteria and the study performance based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly provide a "table of acceptance criteria" with specific pass/fail thresholds for each test, nor does it present the "reported device performance" in a granular, quantitative manner for all parameters. Instead, it describes general performance characteristics and states that "Predefined acceptance criteria were met" and "results were acceptable for all testing."

However, we can infer some performance characteristics and the device's claimed adherence to them:

Inferred Acceptance Criteria and Reported Performance for DripAssist Plus (compared to DripAssist Predicate)

Characteristic / Acceptance Criteria	Reported Device Performance (DripAssist Plus)	Notes/Comparison to Predicate
Indications for Use	Used with gravity infusions as a supplementary monitor, measures flow of fluid through compatible drip chamber, used with single-use intravascular administration sets uniquely identified as "compatible with DripAssist Plus." Sensors measure flow rate, convert drip rate to mL/hr, and display total volume. Alarm alerts if drip rate deviates from set infusion rate.	Change: Predicate used "standard IV administration set," subject device uses specifically "compatible" sets. This change led to additional mechanical testing.
Measurement Method	Infrared emitter and detector positioned on opposite sides of a well where drip chamber is situated to track drops.	No Change from Predicate
Control of Flow Rate	Passive device; does not control flow rate.	No Change from Predicate
Compatible Drip Sets	Can be used with compatible drip sets of 10, 15, 20, or 60 gtt/mL.	This is implied as an operational parameter, not explicitly stated as an acceptance criterion being "met" through testing in this section. Predicate also supports this.
Display Capabilities	Displays flow rate in drops per minute or mL per hour. Can display total volume dispensed.	No Change from Predicate
Flow Rate Range	4-400 drops/min	No Change from Predicate
Drip Rate Measurement Accuracy	1%	No Change from Predicate. This is a key performance metric and implies an acceptance criterion of <=1% deviation.
Alarm Functionality	Audio alarm activated when desired flow rate ("set point") is reached. Alarm sounds when flow rate deviates a fixed percentage from the "set point."	No Change from Predicate.
Rate Change to Trigger Alarm	Set Rate +/- 13%	No Change from Predicate. Implies an acceptance criterion of +/-13% deviation.
Power Source	1 AA battery	No Change from Predicate
Operation Environment	Room temperature, 65-85 degrees Fahrenheit at 30-70% humidity, non-condensing, at altitude less than 3000 meters.	No Change from Predicate
Sterility	N/A (Not applicable)	No Change from Predicate
Mechanical Durability	Additional testing for device wear and attachment, drop testing.	Improved/Additional Testing: Compared to predicate, due to mechanical design changes (snap-in attachment vs. cam and bumpers). Results "acceptable."
Firmware Accuracy	Device firmware verification/accuracy testing.	Improved/Additional Testing: Due to microprocessor chip change. Results "acceptable."
Electrical Safety (EMC/EMI)	EMC Test Report, IEC 60601-1-2:2007. Conforms to specifications.	No Change: Circuit design, MCU, shielding, emissions are identical/not affected by minor electrical change. Tested again.
Cleaning	Device cleaning tests performed.	Additional Testing: Implied due to new cleaning protocol or verification. Results "acceptable."
Basic Safety & Essential Performance	Testing for general requirements per IEC 60601-1:2012. Conforms to specifications.	Comprehensive Testing: Ensures overall safety. Results "acceptable."

The document repeatedly states, "Predefined acceptance criteria were met" and "results were acceptable for all testing." This is a high-level confirmation that the device passed its internal validation studies but lacks the specific quantitative data that a typical medical device study report would provide for each specified criterion (e.g., "The accuracy was measured to be 0.8%, meeting the acceptance criterion of <=1%").

2. Sample size used for the test set and the data provenance

The document states "bench tested to verify drip rate flow measurements are accurate and the alarm functions as intended. DripAssist Plus repeated all those tests; results were acceptable for all testing."

Sample Size: The document does not specify the sample sizes (e.g., number of devices, number of tests run, duration of tests) used for any of the non-clinical tests. This information is critical for assessing the statistical power and reliability of the test results.
Data Provenance: The testing appears to be entirely prospective bench testing conducted by the manufacturer, Shift Labs, Inc. There is no indication of patient data being used (as this is a monitoring device, not a diagnostic one that processes patient data/images). The location of the testing is not explicitly stated, but given the company's address in Seattle, Washington, USA, it is likely that the testing was conducted domestically within the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a flow rate monitor, not a diagnostic imaging device requiring expert interpretation of medical data (like a radiologist reading an X-ray). The "ground truth" for its performance (e.g., exact flow rate, alarm thresholds) would be established by engineered specifications and precise measurement instruments, not by human experts interpreting clinical data.

4. Adjudication method for the test set

Not applicable for the same reasons as #3. Ground truth is established by physical measurement against engineering standards, not through human consensus or adjudication.

5. 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

Not applicable. This device is not an AI-assisted diagnostic tool that aids human readers. It is a standalone monitoring device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in essence, all the non-clinical testing described (e.g., accuracy, alarm functionality, mechanical durability, EMC/EMI) represents standalone performance testing of the device's inherent mechanisms and algorithms, without a human operator's variable input being the primary focus of the test itself (though a human activates and observes the device during testing). The accuracy of the drip rate measurement (1%) and the alarm trigger accuracy (Set Rate +/- 13%) are examples of standalone algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for these tests would be:

Physical Measurements/Engineering Standards: For flow rate accuracy, this would involve precise measurement of fluid volume over time using highly accurate pumps or calibrated measurement systems.
Predefined Specifications: For alarm thresholds, mechanical durability (e.g., insertion force, drop test impacts), and electrical characteristics, the device's performance would be compared against predefined engineering specifications.
International Standards: Compliance with standards like IEC 60601-1 (general safety) and IEC 60601-1-2 (EMC/EMI) serves as a form of "ground truth" for safety and essential performance.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning device that requires a "training set" in the conventional sense. Its functionality is based on sensors and deterministic algorithms, not learned patterns from data.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 25, 2018

Shift Labs, Inc. Camelia Kouki Director, QA/RA 1600 Dexter Ave N, Suite A Seattle, Washington 98109

Re: K172242

Trade/Device Name: DripAssist Plus Regulation Number: 21 CFR 880.2420 Regulation Name: Electronic Monitor for Gravity Flow Infusion Systems Regulatory Class: Class II Product Code: FLN Dated: April 21, 2018 Received: April 25, 2018

Dear Ms. Camelia Kouki:

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 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.

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tina Kiang
-s

Tina Kiang, Ph.D. Acting 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) K172242

Device Name DripAssist Plus

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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Image /page/3/Picture/0 description: The image shows the logo for Shift Labs. The logo consists of a rounded square shape on the left and the text "SHIFT LABS" on the right. The square shape is white with a black border. The text is in a bold, sans-serif font, with "SHIFT" stacked above "LABS".

510(k) Premarket Notification

Shift Labs DripAssist Plus

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

Date prepared: April 16, 2018

Submitter:

Shift Labs Inc. 9200 Holman Road NW Seattle, WA 98117

Contact Person:

Camelia Kouki Ph: 206-369-1216 Email: camelia@shiftlabs.com

Proprietary name:

DripAssist Plus

Common name:

IV flow rate monitor

Classified name:

Electronic monitor for gravity flow infusion systems CFR 880.2420 Product code: FLN

Classification: Class II Medical Device

Predicate Device: DripAssist K150687

Indications for use

The DripAssist Plus is a device intended to be used with gravity infusions as a supplementary monitor that measures the flow of fluid through a compatible drip chamber. The device is intended to be used with single-use intravascular administration sets uniquely identified as "compatible with DripAssist Plus." 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 set infusion rate setting controlled through the IV administration set.

Substantial equivalence

The DripAssist Plus is substantially equivalent to the DripAssist (K150687).

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Image /page/4/Picture/0 description: The image shows the logo for Shift Labs. The logo consists of two parts: a geometric shape on the left and the text "SHIFT LABS" on the right. The geometric shape is a circle with a square inside it. The text "SHIFT LABS" is written in a bold, sans-serif font, with "SHIFT" on top of "LABS".

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 a fixed percentage from the "set point."

The device can be used with compatible drip sets of 10, 15, 20, or 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 compared to predicate devices

Both the DripAssist Plus and the DripAssist have the same technological characteristics and both are intended to be used 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 each uses sensors and microprocessors to measure and calculate the flow rate. Both devices include audio alarms for when the flow rate deviates from a pre-set range. Both devices are powered by disposable batteries. Both devices have the same internal electrical layout and components except for (1) a swap to a microprocessor chip with identical architecture but more memory, and (2) the removal of a capacitor. Both devices attach to the outside of a drip chamber on a drip set; the predicate device uses a cam and bumpers to attach whereas the subject device uses a snap-in attachment.

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Image /page/5/Picture/0 description: The image shows the logo for Shift Labs. The logo consists of two parts: a circular icon on the left and the text "SHIFT LABS" on the right. The circular icon contains a rounded square shape inside. The text "SHIFT LABS" is stacked vertically, with "SHIFT" on top of "LABS".

	DripAssist Plus	DripAssist (K150687)	Change Analysis
Device class	Class II	Class II	No Change
Indicationsfor Use	The DripAssist Plus is a deviceintended to be used withgravity infusions as asupplementary monitor thatmeasures the flow of fluidthrough a compatible dripchamber. The device isintended to be used withsingle- use intravascularadministration sets uniquelyidentified as "compatiblewith DripAssist Plus."Sensors measure the flowrate and calculations areperformed to convert thedrip rate to mL/hrmeasurement and totalvolume. An alarm is availableto alert the user if the driprate deviates from the setinfusion rate settingcontrolled through the IVadministration set.	The DripAssist is adevice intended to beused as asupplementarymonitor thatmeasures the flow offluid through the dripchamber of astandard IVadministration set.Sensors measure theflow rate andcalculations areperformed to convertthe drip rate to mL/hrmeasurement andtotal volume. Analarm is available toalert the user if thedrip rate deviatesfrom the infusion ratesetting controlledthrough the IVadministration set.	The difference in indicationfor use is that the predicatestates: "measures the flowof fluid through the dripchamber of a standard IVadministration set." For theDripAssist Plus, theindication for use states:"measures the flow of fluidthrough a compatible dripchamber. The device isintended to be used withsingle-use intravascularadministration sets uniquelyidentified as "compatiblewith DripAssist Plus."DripAssist Plus is amechanical variant of theDripAssist infusion ratemonitor. The mechanicaldesign has been changed toprovide a solution for usesolely with compatibleadministration sets, asopposed to all standardinfusion sets.
ProductConfiguration	Single SKU for all markets -One device, user manual,shipping materials	Single SKU for allmarkets - One device,user manual, shippingmaterials	No Change
Components	One-piece device plussupplied AA battery	One-piece device plussupplied AA battery	No Change
Image: SHIFT LABS logo
PerformanceTesting	DripAssist Plus ChamberWear Test Plan, DripAssistPlus Chamber Wear TestResults, DripAssist PlusInsertion Force for CollarAttachment Test Results,DripAssist Plus InsertionForce for Collar AttachmentTest Plan,DripAssist AVR -Firmware DVT Test ReportFW2.5.5.37, DripAssist GenoaSystem DVT Test Plan,DripAssist Genoa System DvTReport, Genoa CleaningChemical Tests, Genoa DropTest Plans and Results	Device VerificationTesting , DVT TestReport, Infusion TimeStudy, DripAssistBabylon - EMC TestReport, DripAssistBabylon - System DVTPlan, DripAssistBabylon - System DVTReport	Additional testing for thesubject device has beenadded. These tests can begrouped into threecategories: (1) performancetesting for device wear andattachment , (2)performance testing fordevice firmware, (3)performance testing fordevice durability.

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Performance/Technical Specifications
	DripAssist Plus	DripAssist(K150687)	Change Analysis
Infrared sensordetection of flow rate	One emitter, onereceiver	One emitter, onereceiver	No change
Audio alarm when flowrate is outside presetrange	Yes	Yes	No change
Drip rate range	4-400 drops/min	4-400 drops/min	No change
Drip rate measurementaccuracy	1%	1%	No change
Rate change to triggeralarm	Set Rate +/- 13%	Set Rate +/- 13%	No change
Power source	1 AA battery	1 AA battery	No change
Operation environment	Room temperature.65-85 degreesFahrenheit at 30-70% humidity,non- condensing, ataltitude less than3000 meters.	Room temperature.65-85 degreesFahrenheit at 30-70% humidity, non-condensing, ataltitude less than3000 meters.	No change
Sterility	N/A	N/A	No change
DimensionalCharacteristics	133.4 x 67.6 x 30.5mm	128 x 62 x 30 mm	Subject device is slightlylarger.

Materials	ABS, PET	ABS, PET, Silicone	The subject device materials do not contain anything different than the materials on the predicate device. The only difference is that silicone components (cam and bumpers) on the predicate device have been removed from the subject device
Major Components	LCD Display, four touch buttons, Battery cover, audio alarm, administration set attachment point	LCD Display, four touch buttons, Battery cover, audio alarm, cam securing mechanism	The differences between the subject device and the predicate device are the predicate device uses a cam securing mechanism to attach to drip sets. The subject device has an integrated "administration set attachment point." In other words, the silicone cam used to "grip" most standard tubing sets in the predicate device has been removed. Compatible tubing sets now use a friction fit into a slot on the top of the device.
Electrical Safety	EMC Test Report	EMC Test Report	Circuit design is identical. MCU is same, but with more memory. Capacitor has been depopulated, change is mechanical not electrical. No change in shielding. No changes are made that affect emissions.

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Image /page/7/Picture/0 description: The image shows the logo for Shift Labs. The logo consists of two parts: a geometric shape on the left and the text "SHIFT LABS" on the right. The geometric shape is a rounded square with a white square inside. The text "SHIFT LABS" is in a bold, sans-serif font, with "SHIFT" stacked above "LABS".

The initial DripAssist was bench tested to verify drip rate flow measurements are accurate and the alarm functions as intended. DripAssist Plus repeated all those tests; results were acceptable for all testing.

Although most aspects of the DripAssist Plus remain the same as the predicate (DripAssist), for the aspects of the subject device that are new or modified, additional testing was done. Testing needs were determined based on the device specifications to fulfill verification and validation of the product, as well as potential risks identified during the risk assessment process.

Summary of non-clinical testing

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Image /page/8/Picture/0 description: The image shows the logo for Shift Labs. The logo consists of a circle with a square inside of it on the left, and the words "SHIFT LABS" on the right. The word "SHIFT" is above the word "LABS".

Below outlines the non-clinical testing conducted. These non-clinical test results have demonstrated that the device conforms to its specifications. Predefined acceptance criteria were met. These test results demonstrate equivalence to the predicate device.

Areas Tested:

· Mechanical durability of the DripAssist Plus attachment mechanism
· Mechanical insertion and removal force testing for adherence to specifications
· Device firmware verification/accuracy testing
· Device cleaning
· Mechanical durability (drop testing)
· Operational temperature testing Testing for general requirements for basic safety and essential performance, IEC 60601-1:2012
· Alarm testing
· EMC/EMI testing for medical device compliance EMC Test, IEC 60601-1-2:2007
· Tracing design requirements to verification methods to verify performance standards (V&V)

Conclusion

Based on the review of intended use, functional application, and design, the DripAssist Plus is substantially equivalent to the predicate device K150687.

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).