The ACCU-CHEK Nano SmartView 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 or palm. The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ACCU-CHEK Nano SmartView 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 Nano Smartview 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* SmartView Test Strips are for use with the ACCU-CHEK Nano Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.

Device Description

The ACCU-CHEK® Nano meter was developed to utilize the ACCU-CHEK® Aviva Plus test system's technology and performance characteristics. The ACCU-CHEK® Nano meter designers took the measurement components of the ACCU-CHEK® Aviva Plus system, slightly changed the firmware and hardware supporting the new user interface and housing and embedded/programmed the strip lot code information within the meter so a physical code key or code key port are no longer used.

The ACCU-CHEK ® SmartView test strip is a No Code Freedom 2 Chemistry test strip which shares the same scientific technology as the predicate device, the ACCU-CHEK® Aviva Plus test strips. The instrument's measurement method is not modified as a part of this test strip modification project.

When an ACCU-CHEK® SmartView test strip is inserted into the ACCU-CHEK® Nano meter, a small alternating current (AC) is applied until the application of blood causes a spike in the conductivity to be observed at the measurement and sample-sufficiency electrodes – both are used to assure an adequate sample has been applied.

The instrument then applies a series of AC voltages at four frequencies and reads the AC responses. These carry information about the sample type and environmental temperature; they also allow the system to perform various internal quality checks.

After the AC measures are completed, a small (DC) voltage is applied and current is observed which is proportionate to the glucose. The AC and DC information are then combined to provide a hematocrit and temperature compensated glucose result.

The single-patient use ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System will consist of:

Meter: ACCU-CHEK® Nano Meter Test Strip: ACCU-CHEK® SmartView Test Strip Controls: ACCU-CHEK® SmartView Control Solutions

AI/ML Overview

The provided text describes the ACCU-CHEK Nano SmartView Blood Glucose Monitoring System and its substantial equivalence to a predicate device. However, it does not explicitly detail the acceptance criteria for performance, nor does it present the results of a specific study in the format requested. The document primarily focuses on the device's description, intended use, and a statement of substantial equivalence based on "performance testing."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, information on sample sizes for a test set, ground truth establishment methods, expert qualifications, adjudication methods, or details about MRMC or standalone studies with specific effect sizes from the provided text.

The text does state: "Performance testing on the ACCU-CHEK® Nano SmartView Blood Glucose Monitoring 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." This indicates that such testing was conducted and met predefined criteria, but the specific details are not included in this summary.

Based on the provided input, the following information can be extracted:

A table of acceptance criteria and the reported device performance:
- Not explicitly provided in the text. The document states that performance testing demonstrated that the device meets the performance requirements for its intended use and that the test strip is substantially equivalent to the predicate device. Specific numerical acceptance criteria and reported performance values are not given.
Sample sized used for the test set and the data provenance:
- Not explicitly provided in the text. The document mentions "Performance testing," but does not specify the sample size or data provenance (e.g., country of origin, retrospective/prospective nature).
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):
- Not applicable/provided in the text. For a blood glucose monitoring system, the "ground truth" is typically established by comparative measurements against a well-established laboratory reference method, not through expert consensus in the way it would be for image interpretation by clinicians. The text does not detail the specific ground truth method used for performance testing or the involvement of human "experts" in establishing it beyond the use of a reference method.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/provided in the text. Adjudication methods are typically used when multiple human readers interpret data, and their findings need to be reconciled to establish a ground truth or resolve discrepancies. This is not directly relevant to the performance testing of a blood glucose monitoring system, which typically involves comparison to a reference method.
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:
- No, an MRMC study was not done (and is not applicable). This device is a blood glucose monitoring system, not an AI-assisted diagnostic tool for human readers. Its purpose is direct measurement.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, effectively. The performance testing described (though details are absent) would inherently be a standalone evaluation of the device's accuracy in measuring glucose levels against a reference. The device itself is an "algorithm only" type of system in that it measures and reports a value without human interpretation in the loop of the measurement process.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Implied to be a laboratory reference method. For blood glucose monitoring systems, ground truth is typically established by comparing the device's readings against results from a highly accurate laboratory analyzer (e.g., YSI analyzer) measuring the same blood samples. This is not explicitly stated but is the standard practice for such devices.
The sample size for the training set:
- Not explicitly provided in the text. This document describes a 510(k) submission, which focuses on performance data for substantial equivalence, not the development or training of an algorithm in the machine learning sense. While the device utilizes embedded firmware and hardware, the concept of a "training set" in the context of AI or machine learning is not discussed for this type of device.
How the ground truth for the training set was established:
- Not applicable/provided in the text. As mentioned above, a "training set" in the context of algorithm development for machine learning is not discussed for this device.

Summary

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K 113/37

JAN - 6 2012

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.
1) Submitter name, address, contact	Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 521-7593Contact Person: Khone SaysanaDate Prepared: October 18, 2011
2) Device name	Proprietary name:ACCU-CHEK® Nano SmartView Blood Glucose Monitoring SystemMeter: ACCU-CHEK® Nano MeterTest Strip: ACCU-CHEK® SmartView Test StripControls: ACCU-CHEK® SmartView 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)

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510(k) Summary, Continued

4) Device Description

・・・・

Continued on next page

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510(k) Summary, Continued

The ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System is 5) Intended use intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ACCU-CHEK® Nano SmartView 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® Nano SmartView 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® SmartView Test Strips are for use with the ACCU-CHEK® Nano Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.

The single-patient use ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System will consist of:

Meter: ACCU-CHEK® Nano Meter Test Strip: ACCU-CHEK® SmartView Test Strip Controls: ACCU-CHEK® SmartView Control Solutions

6) Substantialequivalence	The modified ACCU-CHEK® Nano SmartView Blood Glucose MonitoringSystem is substantially equivalent to the ACCU-CHEK® Aviva Plus System(K101299).
7) Datademonstratingsubstantialequivalence	Performance testing on the ACCU-CHEK® Nano SmartView Blood GlucoseMonitoring System demonstrated that the device meets the performancerequirements for its intended use. The data demonstrates that the test strip issubstantially equivalent to the predicate device.

0012

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized design of a human figure, with three overlapping profiles facing to the right. The design is simple and modern, with bold lines and a sense of movement.

10903 New Hampshire Avenue Silver Spring, MD 20993

Roche Diagnostics c/o Khonesavanh Saysana 9115 Hague Road Indianapolis, Indiana 46250-0416

JAN - 6 2012

Re: K113137 Trade Name: Roche ACCU-CHEK Nano SmartView Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW. LFR Dated: December 7, 2011 Received: December 8, 2011

Dear Mr. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

signature

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

Enclosure

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Indications for Use Statement

从113137 Device Name: ACCU-CHEK Nano SmartView Blood Glucose Monitoring System

Indications for Use:

Prescription Use _ (Part 21 CFR 801 Subpart D) AND

Over-The-Counter Use __ XX (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 Diagnostic Devices (OIVD)

Division Sign Off

ision Sian-

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k"313

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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.