K Number

Device Name

DripAssist Plus

Manufacturer

Shift Labs, Inc.

Date Cleared

2018-05-25

(303 days)

Product Code

FLN

Regulation Number

880.2420

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K150687

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on basic sensor technology (infrared emitter/detector) and simple calculations (converting drip rate to mL/hr, tracking intervals). There is no mention of AI, ML, or complex algorithms that would suggest learning or adaptive capabilities.

Therapeutic

No.
The device functions as a supplementary monitor for fluid flow and does not control or administer any therapeutic substance.

Diagnostic

The device is described as a supplementary monitor for the flow rate of intravenous fluids. Its function is to measure and display the drip rate and total volume, and to alert the user if the drip rate deviates from a set point. It does not diagnose any medical condition or disease.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "passive device" that operates by "monitoring the drops through the drip chamber" using an "infrared emitter and detector positioned on opposite sides of a well wherein the drip chamber is situated." It also mentions a "mechanical attachment mechanism" and being "powered by one AA battery." These are all physical hardware components, indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the device is a "supplementary monitor the flow of fluid through a compatible drip chamber" for "gravity infusions." It measures the flow rate of fluids being administered to a patient.
Device Description: The description details how the device works by monitoring drops in a drip chamber using infrared technology. It calculates flow rate and volume.
Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The DripAssist Plus does not interact with or analyze any biological specimens. It monitors the physical flow of fluids being delivered to the patient.

Therefore, the DripAssist Plus falls under the category of a medical device used for monitoring during patient treatment, not an IVD device used for analyzing biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

FLN

Device Description

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.

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)

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.

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)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Drip rate measurement accuracy: 1%
Rate change to trigger alarm: Set Rate +/- 13%

Predicate Device(s)

K150687

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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.

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

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).

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.

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.

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
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 user if the drip
rate deviates from the set
infusion rate setting
controlled through the IV
administration set.	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 difference in indication
for use is that the predicate
states: "measures the flow
of fluid through the drip
chamber of a standard IV
administration set." For the
DripAssist Plus, the
indication for use states:
"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."
DripAssist Plus is a
mechanical variant of the
DripAssist infusion rate
monitor. The mechanical
design has been changed to
provide a solution for use
solely with compatible
administration sets, as
opposed to all standard
infusion sets.
Product
Configuration	Single SKU for all markets -
One device, user manual,
shipping materials	Single SKU for all
markets - One device,
user manual, shipping
materials	No Change
Components	One-piece device plus
supplied AA battery	One-piece device plus
supplied AA battery	No Change
Image: SHIFT LABS logo
Performance
Testing	DripAssist Plus Chamber
Wear Test Plan, DripAssist
Plus Chamber Wear Test
Results, DripAssist Plus
Insertion Force for Collar
Attachment Test Results,
DripAssist Plus Insertion
Force for Collar Attachment
Test Plan,DripAssist AVR -
Firmware DVT Test Report
FW2.5.5.37, DripAssist Genoa
System DVT Test Plan,
DripAssist Genoa System DvT
Report, Genoa Cleaning
Chemical Tests, Genoa Drop
Test Plans and Results	Device Verification
Testing , DVT Test
Report, Infusion Time
Study, DripAssist
Babylon - EMC Test
Report, DripAssist
Babylon - System DVT
Plan, DripAssist
Babylon - System DVT
Report	Additional testing for the
subject device has been
added. These tests can be
grouped into three
categories: (1) performance
testing for device wear and
attachment , (2)
performance testing for
device firmware, (3)
performance testing for
device durability.

cure

Performance/Technical Specifications
	DripAssist Plus	DripAssist
(K150687)	Change Analysis
Infrared sensor
detection of flow rate	One emitter, one
receiver	One emitter, one
receiver	No change
Audio alarm when flow
rate is outside preset
range	Yes	Yes	No change
Drip rate range	4-400 drops/min	4-400 drops/min	No change
Drip rate measurement
accuracy	1%	1%	No change
Rate change to trigger
alarm	Set Rate +/- 13%	Set Rate +/- 13%	No change
Power source	1 AA battery	1 AA battery	No change
Operation environment	Room temperature.
65-85 degrees
Fahrenheit at 30-
70% humidity,
non- condensing, at
altitude less than
3000 meters.	Room temperature.
65-85 degrees
Fahrenheit at 30-
70% humidity, non-
condensing, at
altitude less than
3000 meters.	No change
Sterility	N/A	N/A	No change
Dimensional
Characteristics	133.4 x 67.6 x 30.5
mm	128 x 62 x 30 mm	Subject device is slightly
larger.

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.

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".

Summary of non-clinical testing

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.