The Dario Blood Glucose Monitoring System consists of the Dario Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario App as the display component of the Dario Blood Glucose Monitoring System. The Dario Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The Dario Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. The Dario Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

Device Description

The Dario Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario meter is connected to a SMD through a standard 3.5mm audio plug in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform.

AI/ML Overview

The provided text describes the Dario Blood Glucose Monitoring System and its substantial equivalence determination. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that the device "meets all of its associated specifications" and that performance and safety testing "confirmed the proposed device to be substantially equivalent to the predicate device." However, specific numerical acceptance criteria (e.g., accuracy percentages) are not explicitly stated in this summary. The categories of performance assessed include:

Acceptance Criteria Category	Reported Device Performance
In Vitro Performance	Meets all associated specifications
Software	Documentation prepared and submitted for a moderate level of concern device in accordance with FDA guidance
Electrical Safety	Successfully passed all relevant sections of IEC 60601-1 Medical electrical equipment, General requirements for Safety
Electromagnetic Interference	Successfully met all relevant sections (Radiated emissions, Electrostatic discharge immunity test, radiated radio frequency, electromagnetic field immunity, and power frequency magnetic field immunity test) to satisfy compliance
Repeatability Precision	Confirmed to be substantially equivalent to the predicate device
Intermediate Precision	Confirmed to be substantially equivalent to the predicate device
Linearity	Confirmed to be substantially equivalent to the predicate device
Operating Conditions	Confirmed to be substantially equivalent to the predicate device
Altitude	Confirmed to be substantially equivalent to the predicate device
Accuracy	Confirmed to be substantially equivalent to the predicate device

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document mentions a "User Performance study" for the expanded indications. However, the specific sample size used for this study is not provided in the given text.
Data Provenance: The document does not specify the country of origin for the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Given that this is a Blood Glucose Monitoring System, a "Multi-Reader Multi-Case (MRMC) comparative effectiveness study" as typically understood in imaging diagnostics (human readers reviewing cases) is not applicable. The "User Performance study" mentioned would likely involve human users operating the device, but not in the context of interpreting results in a comparative effectiveness study with AI assistance. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The Dario Blood Glucose Monitoring System comprises "the Dario Blood Glucose Meter, Dario Glucose Test Strips, Dario Glucose Control Solutions and the Dario App as the display component." The description states, "The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function." This implies that the core glucose measurement performance is inherent in the meter and test strips, which would have been tested in a standalone manner (in vitro performance). The app primarily acts as a display. The "User Performance study" would involve human users operating the system, incorporating a "human-in-the-loop" aspect for usability and performance in real-world scenarios.

7. The Type of Ground Truth Used

For a blood glucose monitoring system, the ground truth for accuracy and precision studies is typically established using:

Reference laboratory methods: Such as a YSI glucose analyzer, which is considered highly accurate for blood glucose measurements.
Clinical laboratory results: From comparative devices.

While not explicitly stated as "ground truth" in the provided text, the "In Vitro" performance and "Accuracy" assessments would rely on comparison to these established reference methods.

8. The Sample Size for the Training Set

This information is not provided in the given text, as the device is not described as having an AI algorithm that requires a training set in the conventional sense (e.g., for image recognition). The "Software" section refers to documentation for a moderate level of concern device, which typically relates to software validation and verification, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of an AI algorithm or a training set in the conventional sense, this information is not applicable and therefore not provided in the document.

Summary

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

July 19, 2017

LABSTYLE INNOVATIONS, LTD. C/O TRACEY WIELINSKI, PRESIDENT QUALTRA CONSULTING, INC. 5 CASIE LANE PEPPERELL, MA 01463

Re: K163159

Trade/Device Name: Dario Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: June 15, 2017 Received: June 19, 2017

Dear Tracey Wielinski:

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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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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/ResourcesforYou/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.

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K163159

Device Name Dario Blood Glucose Monitoring System

Indications for Use (Describe)

The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

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

Submitter:	LabStyle Innovations9 Halamish StreetNorth Industrial ParkCaesarea 3890000Israel
Contact Person:	Tara N. TurneyRegulatory ConsultantQualtra Consulting, IncTelephone: +852-5964-8211E-mail: tara@mydario.com
Date Prepared:	July 18, 2017
Trade Name:	Dario® Blood Glucose Monitoring System
Common Name:	Glucose Test System
Regulation:	21 § 862.1345
Product Code:	NBW
ClassificationName:	System, Test, Blood Glucose, Over The Counter
Predicate Device:	Dario Blood Glucose Monitoring SystemK150817
DeviceDescription:	The Dario Blood Glucose Monitoring System is a compact,all-in-one blood glucose meter that is used in conjunction witha smart mobile device (SMD). The Dario meter is connectedto a SMD through a standard 3.5mm audio plug in order toprovide the glucose meter with power. The SMD alsoprovides an external display for the user to review bloodglucose testing results via a mobile application downloaded tothe SMD. The full process of blood glucose measurement isdone on the glucose meter; the SMD does not provide anydiagnostic or clinical analysis function. When connected to aSMD, the Dario glucose meter is agnostic both to the platformof the smart mobile device and to the model of the individualSMD within a platform.
Statement ofIntended Use:	The Dario Blood Glucose Monitoring System is intended forthe quantitative measurement of glucose (sugar) in fresh
	capillary whole blood. The Dario is intended for self-testingoutside the body (in vitro diagnostic use) by people withdiabetes at home to monitor the effectiveness of their diabetescontrol.
Statement ofIndications for Use:	The Dario Blood Glucose Monitoring System consists of theDario Blood Glucose Meter, Dario Glucose Test Strips, DarioGlucose Control Solutions and the Dario App as the displaycomponent of the Dario Blood Glucose Monitoring System.The Dario Blood Glucose Monitoring System is intended forthe quantitative measurement of glucose (sugar) in freshcapillary whole blood samples drawn from the fingertips. TheDario Blood Glucose Monitoring System is intended to beused by a single person and should not be shared.
	The Dario Blood Glucose Monitoring System is intended forself-testing outside the body (in vitro diagnostic use) bypeople with diabetes at home to monitor the effectiveness ofdiabetes control. The Dario Blood Glucose MonitoringSystem should not be used for the diagnosis of or screening ofdiabetes or for neonatal use.
	The Dario Blood Glucose Test Strips are for use with theDario Blood Glucose Meter to quantitatively measure glucose(sugar) in fresh capillary whole blood samples drawn from thefingertip.
Summary ofTechnologicalCharacteristics:	The proposed device has the same technologicalcharacteristics and is identical in design and configuration ascompared to the predicate device.
Summary of Non-Clinical Data:	The following performance and safety testing has confirmedthe proposed device to be substantially equivalent to thepredicate device:
	• In Vitro: the proposed Dario Blood GlucoseMonitoring System has been tested for in vitroperformance and meets all of its associatedspecifications;
	• Software: documentation was prepared and submittedfor a moderate level of concern device in accordancewith FDA's Guidance for the Content of PremarketSubmissions for Software Contained in MedicalDevices;
	• Electrical Safety: the proposed Dario Blood GlucoseMonitoring System has been tested and successfully
Summary ofClinical Data:	A User Performance study was completed for the expandedindications of the Dario Blood Glucose Monitoring System.This evaluation confirmed the proposed device to besubstantially equivalent to the predicate device.
Conclusion fromData:	LabStyle Innovations has demonstrated that the proposedDario Blood Glucose Monitoring System is substantiallyequivalent to the predicate device based upon indications foruse, design, test results and the same fundamental scientifictechnology.

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passed all of the relevant sections of IEC 60601-1 Medical electrical equipment, General requirements for Safety;

. Electromagnetic Interference: the proposed Dario Blood Glucose Monitoring System has been tested and successfully met all of the relevant sections (Radiated emissions, Electrostatic discharge immunity test, radiated radio frequency, electromagnetic field immunity, and power frequency magnetic field immunity test) to satisfy compliance;
The following categories of performance were assessed and have confirmed the proposed device to be substantially equivalent to the predicate device:
Repeatability Precision
. Intermediate Precision
Linearity
Operating Conditions .
. Altitude
Accuracy ●

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.