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.

Device Description

The modified ACCU-CHEK Aviva meter used in conjunction with the ACCU-CHEK® Aviva Plus test strips. The new ACCU-CHEK Aviva meter no longer uses a code key.

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 ACCU-CHEK Aviva Plus Blood Glucose Monitoring System, focusing on acceptance criteria and study details.

Based only on the provided text, the specific details regarding the acceptance criteria and a detailed study proving the device meets them are very limited. The document is primarily a 510(k) summary for a modified device, emphasizing its substantial equivalence to a predicate device.

Here's what can be extracted and what is explicitly not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for performance metrics. Instead, it makes a general statement about meeting performance requirements and being substantially equivalent to the predicate device.

Performance Metric	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (General Statement)
Accuracy of glucose measurement	(Not explicitly stated, but implied to be comparable to predicate)	"Performance testing on the ACCU-CHEK Aviva System demonstrated that the device meets the performance requirements for its intended use."
Precision/Reproducibility	(Not explicitly stated)	Implied to be acceptable as part of meeting "performance requirements for its intended use."
Usability for self-testing	(Not explicitly stated)	Implied to be acceptable for "self testing outside the body (in vitro diagnostic use) by people with diabetes at home."
Performance across various blood draw sites (fingertips, forearm, upper arm, palm)	(Not explicitly stated)	The device 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."

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

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). The document only states "Performance testing on the ACCU-CHEK Aviva System demonstrated..."

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

This information is not provided in the given text. For blood glucose monitoring systems, ground truth is typically established using a high-precision laboratory reference method, not necessarily by human experts in the same way it would be for imaging diagnostics. The text does not elaborate on the method used to establish reference glucose values.

4. Adjudication method

This information is not provided in the given text.

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

MRMC Study: Not applicable/not mentioned. This device is a blood glucose monitoring system, which typically does not involve human "readers" interpreting results in the same way an imaging AI system would. Its primary function is to provide a quantitative measurement.
AI Improvement Effect Size: Not applicable. There is no mention of AI integration in this blood glucose monitoring system.

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

The device itself is a standalone system in the sense that the meter provides the glucose reading without requiring human interpretation or intervention beyond performing the test procedure. However, the document does not distinguish between "standalone algorithm performance" and "system performance" as it might for an AI-driven diagnostic. The "performance testing" referred to would inherently be of the "algorithm only" (i.e., the device's measurement capability) without a human interpreting the result to determine the glucose level.

7. The type of ground truth used

The type of ground truth is not explicitly stated beyond the implication that it's a quantitative measurement of glucose. For blood glucose meters, the ground truth is typically established by comparative measurements against a laboratory reference method (e.g., YSI analyzer) known for its high accuracy. The text only mentions "quantitative measurement of glucose (sugar)."

8. The sample size for the training set

This information is not provided in the given text. Blood glucose meters are not typically "trained" in the same way a machine learning algorithm would be. Their performance is based on the chemical and electrical design of the test strip and meter. If any statistical models or calibrations were involved, the training set details are omitted.

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

This information is not provided in the given text. (See point 8 regarding "training set.")

Summary of Limitations due to Document Scope:

The provided document, a 510(k) Summary, primarily focuses on demonstrating substantial equivalence to a predicate device for a modified blood glucose monitoring system (specifically, a meter that no longer uses a code key). It states that performance testing was done and that the device "meets the performance requirements for its intended use" and is "substantially equivalent to the predicate device." However, it does not provide detailed technical specifications, exact acceptance criteria, or granular study results (like sample sizes for performance studies, specific ground truth methods, or any statistical analysis) that would be found in a full submission or a detailed study report. These details are often proprietary or contained in other sections of a 510(k) submission not included here.

Summary

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K133862

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510(k) Summary

APR 2 9 2014

Roche)

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.
1) Submitter name, address, contact	Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 521-7593Contact Person: Khone SaysanaDate Prepared: December 17, 2013
2) Device name	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
3) Predicate device	ACCU-CHEK Aviva Plus System (K101299)
4) DeviceDescription	The modified ACCU-CHEK Aviva meter used in conjunction with theACCU-CHEK® Aviva Plus test strips. The new ACCU-CHEK Aviva meterno longer uses a code key.
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
6) Substantialequivalence	The modified ACCU-CHEK Aviva meter is substantially equivalent to theACCU-CHEK Aviva Plus System (K101299).
7) Datademonstratingsubstantialequivalence	Performance testing on the ACCU-CHEK Aviva System demonstrated thatthe device meets the performance requirements for its intended use. The datademonstrates that the test strip is substantially equivalent to the predicatedevice.

Continued on next page

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510(k) Summary, Continued

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20093-0002

April 29,2014

ROCHE DIAGNOSTICS CORPORATION KHONE SAYSANA REGULATORY AFFAIRS PRINCIPAL 9115 HAGUE ROAD INDIANAPOLIS IN 46250

Re: K133862

Trade/Device Name: ACCU-CHEK Aviva Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: 11 Product Code: NBW Dated: March 28. 2014 Received: March 31. 2014

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 (o 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. Iisting 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 requlations 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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Page 2-Khone Saysana

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" (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/ReportalProblem/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.

Katherine Serrano -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133862

Device Name

ACCU-CHEK Aviva Plus Blood Glucose Monitoring System

Indications for Use (Describe)

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, 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.

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

J Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Stayce Beck -S

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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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.