The ACCU-CHEK Aviva Plus 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, forearm, upper arm, or palm. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ACCU-CHEK Aviva Plus 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 Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

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

The ACCU-CHEK Combo System is indicated for the treatment of insulin requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.

The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK 360° Insulin Pump Configuration software facilitates the monitoring and programming of the pump settings.

The ACCU-CHEK Aviva Combo blood glucose system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control. The ACCU-CHEK Aviva Combo blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Combo blood glucose monitoring system.

The ACCU-CHEK Aviva Plus test strips are for use with the ACCU-CHEK Aviva Combo blood glucose meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The ACCU-CHEK Aviva Combo meter can also be used to interface with, and remotely control the ACCU-CHEK Spirit Combo insulin infusion pumps via radio frequency communication. The ACCU-CHEK Aviva Combo meter is also indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data.

For in vitro diagnostic use

The ACCU-CHEK Aviva Combo system is intended for single patient use and should not be shared.

Device Description

The modified Black Code Key used in conjunction with the ACCU-CHEK® Aviva meter and the ACCU-CHEK® Aviva Combo meter.

The Black Code Key contains a universal code and can be used on all released ACCU-CHEK Aviva Plus test strip lots.

The single-patient use ACCU-CHEK Aviva Blood Glucose Monitoring System will consist of:
Meter: ACCU-CHEK Aviva Meter
Test Strip: ACCU-CHEK Aviva Plus Test Strip
Controls: ACCU-CHEK Aviva Control Solutions

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ACCU-CHEK® Aviva Plus Blood Glucose Monitoring System and ACCU-CHEK® Aviva Combo System.

It's important to note that the provided 510(k) summary is quite brief on the specific details of the performance study. While it states that "Performance testing... demonstrated that the device meets the performance requirements for its intended use," it does not explicitly list the acceptance criteria or show a detailed comparison table with reported device performance metrics. It also lacks detailed information about the study design that would address many of your specific questions.

Based on the provided text, here's what can be extracted and what remains unknown:

Description of the Acceptance Criteria and Study

The document, a 510(k) summary for the ACCU-CHEK® Aviva Plus and ACCU-CHEK® Aviva Combo Systems, states that performance testing was conducted to demonstrate substantial equivalence to predicate devices (K101299 and K111353, respectively). The key modification described is the use of a "Black Code Key" with a universal code, implying that the core testing mechanism (test strip and meter) remains largely the same as the predicate devices, but the coding simplification was evaluated.

The summary asserts that the device meets the performance requirements for its intended use and that the test strip is substantially equivalent to the predicate device. However, the specific quantitative acceptance criteria (e.g., accuracy percentages within certain glucose ranges, precision limits) and the detailed results of the study are not included in this document. Such details are typically found in the full 510(k) submission, which is more extensive than this summary.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided 510(k) summary does not explicitly state the specific quantitative acceptance criteria or report detailed device performance metrics in a table format. It only makes a general statement that the device meets performance requirements. For typical blood glucose meters, acceptance criteria would generally refer to standards like ISO 15197 (e.g., N% of results within ±15 mg/dL or ±15% of the reference value). Without this information in the provided text, a table cannot be constructed.

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

The provided text does not specify the sample size used for the test set.

Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, though performance evaluation studies for new medical devices are almost always prospective.

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

The provided text does not specify the number or qualifications of experts used to establish ground truth. For blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., YSI analyzer), not necessarily human experts in adjudication.

4. Adjudication Method for the Test Set

The provided text does not specify any adjudication method. This is typically not relevant for blood glucose meter performance studies, where each sample is measured against a definitive laboratory reference method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are primarily relevant for imaging diagnostics or other subjective interpretation tasks where multiple human readers interpret cases. For blood glucose meters, the performance is measured objectively against a reference method.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance study performed for the ACCU-CHEK® Aviva Plus and ACCU-CHEK® Aviva Combo Systems is inherently a standalone (algorithm only) performance evaluation. Blood glucose meters do not involve "human-in-the-loop" interpretation in the same way imaging AI does. The device (meter + test strip) directly provides a quantitative glucose measurement. The study assesses the accuracy of this quantitative result compared to a reference method, independent of human interpretation.

7. The Type of Ground Truth Used

The provided text does not explicitly state the type of ground truth used. However, for blood glucose monitoring systems, the standard ground truth for accuracy studies is typically a laboratory reference method (e.g., a YSI STAT PLUS glucose and L-lactate analyzer) that provides highly accurate glucose measurements from venous blood samples. This is considered the gold standard for comparison. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The provided text does not specify any training set size. Blood glucose monitoring systems like ACCU-CHEK Aviva are typically developed and calibrated based on extensive laboratory testing and chemical engineering principles, rather than machine learning models that require a "training set" in the common sense of AI/ML. If there were any machine learning components, no details are provided here.

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

As no "training set" in the context of machine learning is indicated, the document does not describe how ground truth for such a set was established. Device calibration and development would be based on established chemical analysis methods and numerous internal studies.

Summary

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Roche > 长13)029

510(k) Summary

Introduction	According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence.
1) Submittername,address,contact	Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 521-2110Contact Person: Khone SaysanaDate Prepared: April 10, 2013	AUG 09 2013
2) Devicename	Proprietary name:ACCU-CHEK® Aviva Plus Blood Glucose Monitoring SystemMeter: ACCU-CHEK Aviva MeterTest Strip: ACCU-CHEK Aviva Plus Test StripControls: ACCU-CHEK Aviva Control SolutionsClassification name: Glucose dehydrogenase, glucose test system(21 C.F.R. § 862.1345)NBW, Blood Glucose Test System, Over-the-CounterLFR, Glucose Dehydrogenase
	Proprietary name: ACCU-CHEK® Aviva Combo SystemCommon Name: Insulin infusion pump, glucose test system, and accessoriesClassification name:Pump, infusion, insulin (21 CFR 880.5725); Class II; Product Code: LZG Glucose test system (21 CFR 862.1345); Class II; Product Code: NBW Drug dosing calculator (21 CFR 868.1890); Class II; Product Code: NDC
3) Predicatedevice	ACCU-CHEK Aviva Plus System (K101299)ACCU-CHEK Aviva Combo System (K111353)

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4) DeviceDescription	The modified Black Code Key used in conjunction with the ACCU-CHEK®Aviva meter and the ACCU-CHEK® Aviva Combo meter.The Black Code Key contains a universal code and can be used on allreleased ACCU-CHEK Aviva Plus test strip lots.
5) Intendeduse	The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intendedto be used for the quantitative measurement of glucose (sugar) in freshcapillary whole blood samples drawn from the fingertips, forearm, upper arm,or palm. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System isintended to be used by a single person and should not be shared.
	The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intendedfor self testing outside the body (in vitro diagnostic use) by people withdiabetes at home as an aid to monitor the effectiveness of diabetes control.The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System should notbe used for the diagnosis of or screening of diabetes or for neonatal use.Alternative site testing should be done only during steady - state times (whenglucose is not changing rapidly).
	The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEKAviva Blood Glucose Meter to quantitatively measure glucose (sugar) in freshcapillary whole blood samples drawn from the fingertips, forearm, upper arm,or palm.
	The single-patient use ACCU-CHEK Aviva Blood Glucose MonitoringSystem will consist of:
	Meter: ACCU-CHEK Aviva MeterTest Strip: ACCU-CHEK Aviva Plus Test StripControls: ACCU-CHEK Aviva Control Solutions

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The ACCU-CHEK Combo System is indicated for the treatment of insulin 5) Intended requiring diabetes and for the quantitative measurement of glucose in fresh use continued capillary whole blood from the finger.

The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK 360° Insulin Pump Configuration software facilitates the monitoring and programming of the pump settings.

The ACCU-CHEK Aviva Combo blood glucose system is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control. The ACCU-CHEK Aviva Combo blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Combo blood glucose monitoring system.

For in vitro diagnostic use The ACCU-CHEK Aviva Combo system is intended for single patient use and should not be shared.

The modified ACCU-CHEK Aviva Plus System with Black 6) Substantial Code Key is substantially equivalent to the ACCU-CHEK Aviva Plus System equivalence (K101299).

The modified ACCU-CHEK Aviva Combo System with black code key is substantially equivalent to the ACCU-CHEK Aviva Combo System (K11353).

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7) Data demonstrating substantial equivalence

Performance testing on the ACCU-CHEK Aviva Plus System demonstrated that the device meets the performance requirements for its intended use. The data demonstrates that the test strip is substantially equivalent to the predicate device.

Performance testing on the ACCU-CHEK Aviva Combo System demonstrated that the device meets the performance requirements for its intended use. The data demonstrates that the test strip is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0(8)2

August 9, 2013

Roche Diagnostics Corporation c/o Khone Saysana 9115 Hague Rd.. INDIANAPOLIS IN 46250

Re: K131029

Trade/Device Name: ACCU-CHEK® Aviva Combo System; ACCU-CHEK® Aviva Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, LZG, NDC Dated: July 8, 2013 Received: July 10, 2013

Dear Mr. Saysana:

We have reviewed your Section 510(k) premarket notification of intent to market the device we ferenced 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). and Cosmetic Herefore, market the device. subject to the general controls provisions of the Act. The r ou may, therefore, manier the as act include requirements for annual registration, listing of general controls proficions gractice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Teass note: Obter assess 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), If your device is classified (500 above) ... 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 I least be advised that I Dr. 3 issuance orour device complies with other requirements of the Act that I DA has made a are regulations administered by other Federal agencies. You must or any i ederal stiller and regimanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (2) CFR Parts 801 and 809); medical device reporting (reporting of CrK Fall 607), ademig (21 CFR Paris 607), good manufacturing practice requirements mental device-related adverse orches) regulation (21 CFR Part 820); and if applicable, the as set form in the quality of stone (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Saysana

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Carol C. Benson -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

Enclosure

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Indications for Use Form

510(k) Number: K131029 Device Name: ACCU-CHEK Aviva Plus Test System

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________	AND	Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)		(Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Katherine Serrano -S

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k): K131029

Page 1 of 1

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Indications for Use Form

510(k) Number: K131029 Device Name: ACCU-CHEK Aviva Combo System

Indications for Use:

The ACCU-CHEK Combo System is indicated for the treatment of insulin requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.

Page 1 of 2

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For in vitro diagnostic use

The ACCU-CHEK Aviva Combo system is intended for single patient use and should not be shared.

Prescription Use __ XX___ (Part 21 CFR 801 Subpart D) AND

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Katherine Serrano -S

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k): K131029

Page 2 of 2

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.