The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

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

The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Connect Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

For in vitro diagnostic use

Device Description

The ACCU-CHEK Aviva Connect blood glucose monitoring system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Connect meter, the ACCU-CHEK Aviva Plus test strips (K101299), and the ACCU-CHEK Aviva control solutions (K101299). The ACCU-CHEK Aviva Connect meter is a modification of the ACCU-CHEK Aviva meter (K133862) with an improved design and the addition of a USB port and the BLE communication capability.

AI/ML Overview

The provided text describes the ACCU-CHEK Aviva Connect Blood Glucose Monitoring System and its substantial equivalence to a predicate device. However, it does not contain a detailed study report with all the requested information for acceptance criteria and device performance.

Based on the available information, here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document mentions "Precision: For response targets < 75 mg/dL, the SD is ≤ 5.0 mg/dL, and for response targets ≥ 75 mg/dL, the CV is ≤ 5.0%." This is an acceptance criterion for precision.

The document claims that "Performance testing on the ACCU-CHEK Aviva Connect System demonstrated that the device meets the performance requirements for its intended use" and "The data demonstrates that the ACCU-CHEK Aviva Connect System is substantially equivalent to the predicate device." However, the actual reported device performance data that proves it meets these criteria is not provided in the excerpt.

Acceptance Criteria (Example from document)	Reported Device Performance
For response targets < 75 mg/dL, SD ≤ 5.0 mg/dL	(Not explicitly provided in the text)
For response targets ≥ 75 mg/dL, CV ≤ 5.0%	(Not explicitly provided in the text)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the excerpt. The document only states "Performance testing on the ACCU-CHEK Aviva Connect System demonstrated that the device meets the performance requirements". It does not specify the sample size, type of study (retrospective/prospective), or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the excerpt. The document refers to a "Blood Glucose Monitoring System," which typically compares device readings against a laboratory reference method, not necessarily expert consensus in the same way an imaging diagnostic device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the excerpt.

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

This is not applicable as the device is a Blood Glucose Monitoring System, not an AI-assisted diagnostic tool that involves human readers interpreting cases.

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

The device is a standalone blood glucose monitoring system. The performance testing would inherently be standalone algorithm/device performance, as it quantifies glucose levels directly. The document states it is "intended for self testing outside the body... by people with diabetes at home as an aid to monitor the effectiveness of diabetes control." This implies standalone use.

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

While not explicitly stated, for a Blood Glucose Monitoring System, the "ground truth" (or reference method) for glucose measurements is typically established by laboratory reference methods (e.g., YSI analyzer) which are considered highly accurate.

8. The sample size for the training set

This information is not provided in the excerpt. The document does not mention a "training set" in the context of machine learning. For traditional medical devices like blood glucose meters, "training sets" are not typically discussed in the same way as for AI/ML models. Performance is usually evaluated through analytical and clinical studies.

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

As there is no mention of a "training set" in the context of AI/ML, this information is not provided and likely not relevant to the device as described. If "training set" refers to samples used for initial development or calibration, the ground truth would also be established via laboratory reference methods.

In summary, the provided document focuses on the regulatory submission and claims substantial equivalence based on performance testing but does not provide the detailed study results or methodology that would fully address all the requested points.

Summary

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

March 3, 2015

ROCHE DIAGNOSTICS KHONE SAYSANA PRINCIPLE REGULATORY AFFAIRS, DIABETES CARE 9115 HAGUE ROAD INDIANAPOLIS IN 46250

Re: K141867

Trade/Device Name: ACCU-CHEK® Aviva Connect Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. LFR Dated: February 2, 2015 Received: February 3, 2015

Dear Khone Saysana:

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 (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.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), 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" (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.

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,

Stayce Beck -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

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Indications for Use

510(k) Number (if known) K141867

Device Name

ACCU-CHEK Aviva Connect Blood Glucose Monitoring System

Indications for Use (Describe)

For in vitro diagnostic use

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
SubmitterName, Address,Contact	Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 521-7593Contact Person: Khone SaysanaDate Prepared: February 6, 2015
Device Name	Proprietary name:ACCU-CHEK® Aviva Connect Blood Glucose Monitoring SystemMeter: ACCU-CHEK Aviva Connect MeterTest Strip: ACCU-CHEK Aviva Plus Test StripControls: ACCU-CHEK Aviva Control Solutions
	Classification name: Glucose dehydrogenase, glucose test system(21 C.F.R. § 862.1345); Class IINBW, Blood Glucose Test System, Over-the-CounterLFR, Glucose Dehydrogenase
PredicateDevice	ACCU-CHEK Aviva Plus System (K133862), concurrence received on 30 April 2014.
DeviceDescription	The ACCU-CHEK Aviva Connect blood glucose monitoring system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Connect meter, the ACCU-CHEK Aviva Plus test strips (K101299), and the ACCU-CHEK Aviva control solutions (K101299). The ACCU-CHEK Aviva Connect meter is a modification of the ACCU-CHEK Aviva meter (K133862) with an improved design and the addition of a USB port and the BLE communication capability.

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Summary ofTechnologicalCharacteristicsCompared tothe PredicateDevice	System Feature	ACCU-CHEK Aviva Plus System(K133862, predicate)	ACCU-CHEK AvivaConnect System(new device)
	Indications forUse	The ACCU-CHEK Aviva Plus Blood GlucoseMonitoring System is intended to be used forthe quantitative measurement of glucose(sugar) in fresh capillary whole blood samplesdrawn from the fingertips. The ACCU-CHEKAviva Plus Blood Glucose Monitoring Systemis intended to be used by a single person andshould not be shared.	Same
		The ACCU-CHEK Aviva Plus Blood GlucoseMonitoring System is intended for self testingoutside the body (in vitro diagnostic use) bypeople with diabetes at home as an aid tomonitor the effectiveness of diabetescontrol. The ACCU-CHEK Aviva Plus BloodGlucose Monitoring System should not be usedfor the diagnosis of or screening of diabetes orfor neonatal use.
		The ACCU-CHEK Aviva Plus Test Strips arefor use with the ACCU-CHEK Aviva PlusBlood Glucose Meter to quantitatively measureglucose (sugar) in fresh capillary whole bloodsamples drawn from the fingertips.
	MeterCommunication	Infrared Communication viadongle	USB (Universal SerialBus) andBLE (Blue Tooth LowEnergy)Communications
	AST Claims	Palm, Upper Arm and Forearm	None
	Meter Buttons	Arrow buttons on the front areused to toggle through memory	Button functionalityhas changed
	Embedded PCReports	No	Embedded Reportsavailable fortransmission to aPersonalComputer
	Meter Housing	Black housing	Modified black housing
	Test Strip	Utilizes the ACCU-CHEK Aviva Plus test strip	Same
	Meter Coding	Universal code or blood glucose measurementparameters are programmed into an internalEEPROM	Same
System Feature	ACCU-CHEK Aviva Plus System(K133862, predicate)	ACCU-CHEK AvivaConnect System(new device)
Test Principle	Amperometric Detection	Same
Enzyme	Mut. Q-GDH	Same
SampleHematocrit	10 to 65%	Same
MaximumAltitude	10,000 feet	Same
MeasuringRange	20 - 600 mg/dL	Same
Sample Volume	0.6 µL	Same
Test Time	5 seconds	Same
OperatingTemperatureand RelativeHumidity	(57 to 100°F)10 to 80% r.h.	Same
Precision	For response targets < 75 mg/dL, the SD is ≤5.0 mg/dL, and for response targets ≥ 75mg/dL, the CV is ≤ 5.0%.	Same
Closed andOpen Vial ShelfLife Stability	18 months	Same
Double Dosing	No	Same
ControlSolutions	Aqueous, 2 levels, uses ACCU-CHEK AvivaControl Solutions	Same
PrimaryPackaging	Standard flip top vial	Same
Limitations ofProcedure	Galactose >15 mg/dL will cause overestimationof blood glucose results.	Same
	Lipemic Samples >1800 mg/dL	Same
	Intravenous administration of ascorbic acidwhich results in blood concentrations ofascorbic acid >3 mg/dL will causeoverestimation of blood glucose results.	Same
	If peripheral circulation is impaired, collectionof fresh capillary whole blood from theapproved sample sites is not advised as theresults might not be a true reflection of thephysiological blood glucose level. This mayapply in the following circumstances: severedehydration as a result of diabetic ketoacidosisor due to hyperglycemic hypersmolar non-ketotic syndrome, hypotension, shock,decompensated heart failure, NYHA Class IV,or peripheral arterial occlusive disease	Same

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Summary of Technological Characteristics Compared to the Predicate

Device

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Intended Use	The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
	The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
	The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Connect Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
	The single-patient use ACCU-CHEK Aviva Connect Blood Glucose Monitoring System will consist of:
	Meter: ACCU-CHEK Aviva Connect Meter Test Strip: ACCU-CHEK Aviva Plus Test Strip Controls: ACCU-CHEK Aviva Control Solutions
Substantial Equivalence	The ACCU-CHEK Aviva Connect system is substantially equivalent to the ACCU-CHEK Aviva Plus System (K133862).
Data demonstrating substantial equivalence	Performance testing on the ACCU-CHEK Aviva Connect System demonstrated that the device meets the performance requirements for its intended use. The data demonstrates that the ACCU-CHEK Aviva Connect System is substantially equivalent to the predicate device.

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.