CONTOUR NEXT BLOOD GLUCOSE METER by BAYER HEALTHCARE LLC

The CONTOUR®NEXT Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR®NEXT Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only.

CONTOUR®NEXT Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.

The CONTOUR®NEXT Control Solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check.

The CONTOUR®NEXT Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

Device Description

The CONTOUR® NEXT Blood Glucose Monitoring System consists of a small handheld blood glucose meter that utilizes dry reagent test strips and liquid controls for the measurement of glucose in capillary whole blood by persons with diabetes. The meter together with the test strips and control solutions is referred to as the CONTOUR® NEXT Blood Glucose Monitoring System.

AI/ML Overview

The CONTOUR® NEXT Blood Glucose Monitoring System underwent various verification and validation activities to demonstrate its substantial equivalence to the predicate device. Details regarding acceptance criteria and study results are provided below based on the information extracted:

Acceptance Criteria and Device Performance

Risk	Acceptance Criteria	Reported Device Performance (Results)
User injury from electric shock	- Meter shall not allow a test to initiate when connected to an external device (e.g., computer).- Meter shall not experience permanent damage or present hazard such as excessive temperature or heat due to overvoltage.	- All blood glucose tests attempted while connected to PC generated "Do not Test, Connected" error screen.- All results maintained correct voltage regulation within limits and did not present temperature hazard near or above the specified limit.
Biocontamination – exposure to blood-borne pathogens via device	- Must meet requirements set forth in IEC 61010-1:2001 (2nd Edition).- No residual blood or control solution to be observed on any of the meters after cleaning.- No virus must be detected on any surface after 60s of cleaning with specified wipes.	- Compliance with IEC 61010-1:2001 requirements confirmed via testing by an external lab.- There was no residual blood or control solution observed on any of the meters after soiling and cleaning.- The specified disinfectant passed the virus elimination effectiveness test for all tested meter device surfaces.
Material degradation due to cleaning and disinfection	- Plastic parts were not to exhibit any cracking, glazing, discoloration or expansion after being exposed to cleaning agents.- Metallic parts were to exhibit little or no corrosion (evaluated as low, medium, or high).	- All results for plastic and metallic parts met the specified criteria for each solution tested.
Choking/toxicity dangers from small parts (batteries)	- Reagent insert shall warn users of accidental swallowing of test strip.- User Guide shall warn users of accidental swallowing of assembly components.- Assembly components are not required to be unscrewed for any reason.- Design will utilize a non-ordinary screw and require uncommon tools to remove.	- Test strip insert already warns against swallowing test strips.- System User Guide warns: "Keep out of reach of children. This kit contains small parts which could cause suffocation if accidentally swallowed." and "Keep batteries away from children. Lithium batteries are poisonous. If swallowed, immediately contact your poison..."- Device designed so that no hazardous assembly parts are easily accessible to user.
Meter malfunction - incorrect reading or does not function properly	- The accuracy of the test strip driving voltage of the Analog Front End at operating temperature range shall be assessed under various test temperatures.- The CONTOUR®NEXT meter data port shall withstand multiple cycles (insertions/removals).- The meter shall perform an electronics self test to verify proper function of the meter electronics.	- All results for each test temperature were within the required mV range set forth in the testing.- All results for the meter data port were within the specified limits after multiple test strip insertion/removal cycles.- All software test conditions in validation testing passed acceptance criteria.
Erroneous data transfer from meter to PC	- The CONTOUR®NEXT meter's computer interface shall detect and correct communication errors.	- All software test conditions in validation testing passed acceptance criteria.
User unable to properly use meter or follow its instructions for use	- Product labeling for proper instrument operation shall be validated through customer focus study (summative usability study) for 2 critical tasks: 1) completing initial setup and 2) running a mock blood glucose test and marking the result.	- Completing initial setup task was successful.- Study subjects successfully completed a mock blood glucose test and marked the reading.
User misinterprets meter readings	- Product labeling for proper instrument operation shall be validated through customer focus study (summative usability study) for 2 critical tasks: 1) completing initial setup and 2) running a mock blood glucose test and marking the result.	- Completing initial setup task was successful.- Study subjects successfully completed a mock blood glucose test and marked the reading.
User mishandles meter (i.e., drops meter, spills liquid on meter)	- Meter must be designed to withstand drop and show no signs of damage to any components.- Meter must also be designed to withstand Spill Test after exposure to various test solutions.	- All results withstood the stated Drop test and Spill challenges.

Study Details

Sample size used for the test set and the data provenance:
- Biocontamination: "One set of meters were soiled with CONTOUR®NEXT liquid control and another set of meters were soiled with 5 uL of venous blood." "Test meters received contact with an EPA-approved surrogate for a human virus for 24 hours on various test surfaces." The exact number of meters in each set is not specified.
- Usability Study: The document refers to a "customer focus study (summative usability study)" but does not specify the number of participants.
- Other tests: For other technical performance tests (e.g., electrical safety, material degradation, meter malfunction, data transfer, drop/spill), the sample size of meters or components tested is not explicitly stated, but the results indicate "All results" for the tested items met criteria.
- Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." The studies appear to be internal verification and validation tests conducted by the manufacturer as part of the device development and submission process.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies described are engineering and usability focused, not involving expert interpretation of medical images or diagnostic results. The "ground truth" for these tests are objective engineering specifications or direct observation of user behavior (for usability).
Adjudication method for the test set: Not applicable. The tests performed are objective, involving mechanical stress, electrical measurement, or direct observation of adherence to instructions. There is no mention of a need for adjudication.
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: Not applicable. This device is a blood glucose monitoring system, not an AI-based diagnostic imaging tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is standalone in terms of its glucose measurement algorithm. The various tests described assess the device's standalone performance across different parameters (electrical, mechanical, software, etc.). The usability studies indirectly evaluate human-in-the-loop performance in terms of whether users can operate the device correctly.
The type of ground truth used:
- Objective Engineering Specifications: For risks like electric shock, material degradation, meter malfunction, erroneous data transfer, and user mishandling, "ground truth" is defined by established engineering standards (e.g., IEC 61010-1:2001, specified mV ranges, withstand limits for drop/spill).
- Direct Observation/Absence of Failure: For biocontamination, the ground truth is the absence of observed residual blood/control solution or detected virus.
- Successful Task Completion: For user inability to use the meter or misinterpreting readings, the ground truth is the successful completion of specific tasks by study participants as observed in the usability study.
The sample size for the training set: Not applicable based on the provided document. The document describes validation and verification studies for a medical device (blood glucose meter), not an AI algorithm requiring a training set. The device utilizes a "blood glucose measurement algorithm and automatic calibration," but details about the development or training of this algorithm are not provided in this 510(k) summary.
How the ground truth for the training set was established: Not applicable, as no training set for an AI algorithm is described.

Summary

{0}------------------------------------------------

K121190.

Image /page/0/Picture/2 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" written twice, once horizontally and once vertically, intersecting at the letter "Y". The text is enclosed in a circle. The logo is black and white.

510(k) Summary

Date prepared: July 24, 2012

JUL 26 2012

According to the requirements of 21 CFR 807.92, the following information is being submitted in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.

1) Submitter	Charles RyanSenior Manager, Regulatory AffairsBayer Healthcare LLC555 White Plains RoadTarrytown, New York 10951Telephone: (914) 333-6122
2) Device name:	Trade name: CONTOUR ® NEXT Blood Glucose MonitoringSystemFDA Product Code: NBWClassification name: Blood Glucose Test System, Over-the-Counter (21 CFR § 862.1345)
3) Predicate device:	CONTOUR ® NEXT LINK Wireless Blood Glucose Meter(Reference: CONTOUR ® NEXT LINK WirelessBlood Glucose Monitoring System (K110894))
4) Device description:	The CONTOUR ® NEXT Blood Glucose Monitoring Systemconsists of a small handheld blood glucose meter thatutilizes dry reagent test strips and liquid controls for themeasurement of glucose in capillary whole blood bypersons with diabetes. The meter together with the teststrips and control solutions is referred to as theCONTOUR ® NEXT Blood Glucose Monitoring System.
5) Intended Use:	The CONTOUR ® NEXT Blood Glucose Monitoring Systemis an over the counter (OTC) device utilized by personswith diabetes in home settings for the measurement ofglucose in whole blood, and is for single-patient use onlyand should not be shared. The CONTOUR ® NEXT BloodGlucose Monitoring System is indicated for use with freshcapillary whole blood samples drawn from the fingertip andpalm only.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the Bayer company logo, which consists of the word "BAYER" arranged in a cross shape within a circle. The letters are capitalized and have a bold, outlined appearance. The circle is also outlined, giving the logo a clean and recognizable design.

CONTOUR®NEXT Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.

The CONTOUR®NEXT Control Solutions are aqueous alucose solutions intended for use in self-testing by people with diabetes as a quality control check.

The CONTOUR®NEXT Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

Data demonstrating substantial equivalence

The CONTOUR®NEXT Blood Glucose Monitoring System features a small handheld blood glucose meter that is substantially equivalent in its intended use and fundamental scientific technology to the predicate, CONTOUR®NEXT LINK Wireless Blood Glucose Meter featured with the CONTOUR®NEXT LINK Wireless Blood Glucose Monitoring System (K110894). Both devices utilize the same CONTOUR®NEXT dry reagent strips and liquid controls for the measurement of glucose in capillary whole blood by persons with diabetes. Additionally, both devices utilize the same blood glucose measurement algorithm and automatic calibration. The chief differences between the devices is the removal of the ability to wirelessly transmit glucose results to an associated Medtronic device, the use of replaceable batteries as a power supply, and a different look and size for the meter.

The risk analysis methods used to assess the design of the subject device were a Hazard Analysis and Failure Modes and Effects Analyses (FMEA).

In brief summary, the risks identified as applicable to the CONTOUR®NEXT Blood Glucose Monitoring System are listed in the table below along with their corresponding Verification and Validation Activities' acceptance criteria and results.

Risk	Acceptance Criteria	Results
User injury fromelectric shock	The meter shall not allow a testto initiate when the meter isconnected to an external device(e.g. computer). The meter shall not experiencepermanent damage or presenthazard such as excessivetemperature or heat due toovervoltage.	Pass All blood glucose tests attemptedwhile connected to PC generated"Do not Test, Connected" errorscreen. All results maintained correctvoltage regulation within limitsand did not present temperaturehazard near or above the
Risk	Acceptance Criteria	Results
Biocontamination –exposure to blood-borne pathogens viadevice	Must meet requirements setforth in IEC 61010-1:2001 (2nd Edition) One set of meters were soiledwith CONTOUR®NEXT liquidcontrol and another set ofmeters were soiled with 5 uL ofvenous blood. All meters wereallowed to dry for 24hrs. Thesoil locations were the meterbutton and display. All meterswere then cleaned with Cloroxgermicidal wipes. No residualblood or control solution was tobe observed on any of themeters. Test meters received contactwith an EPA-approvedsurrogate for a human virus for24 hours on various testsurfaces. All instruments mustbe cleaned with wipescontaining 0.55% sodiumhypochlorite and no virus mustbe detected on any surfaceafter 60s.	Pass specified limit. Compliance with IEC 61010-1:2001 requirements confirmedvia testing by an external lab. There was no residual blood orcontrol solution observed on anyof the meters. The specified disinfectant passedthe virus eliminationeffectiveness test for all testedmeter device surfaces.
Material degradationdue to cleaning anddisinfection	Interior meter case parts andexterior meter case parts wereexposed to several differentcleaning agents (such as bleachsolutions, isopropyl alcohol, andsoap and water) that might beapplied by a user.The plastic parts were not to exhibitany cracking, glazing, discolorationor expansion after being exposed.The metallic parts were to exhibitlittle or no corrosion and were to beevaluated based on a low, mediumor high corrosion level.	Pass All results for plastic and metallicparts met the specified criteria foreach solution tested.
Choking/toxicitydangers from smallparts (batteries)	Reagent insert shall warn usersof accidental swallowing of teststrip. User Guide shall warn users ofaccidental swallowing ofassembly components (such asbatteries, battery cover etc. Assembly components (such as	Pass Test strip insert already warnsagainst swallowing test strips System User Guide warns:"Keep out of reach of children.This kit contains small partswhich could cause suffocation ifaccidentally swallowed."and
Risk	Acceptance Criteria	Results
	screws) are not required to beunscrewed for any reason.Design will utilize a non-ordinary screw and requireuncommon tools to remove.	"Keep batteries away fromchildren. Lithium batteries arepoisonous. If swallowed,immediately contact your poison• Device designed so that nohazardous assembly parts areeasily accessible to user.
Meter malfunction -incorrect reading ordoes not functionproperly	The accuracy of the test stripdriving voltage of the Analog FrontEnd at operating temperature rangeshall be assessed under varioustest temperatures.The CONTOUR®NEXT meter dataport shall withstand multiple cycles(insertions/removals).When preparing to perform a bloodglucose measurement, the metershall perform an electronics self testto verify proper function of themeter electronics.	Pass• All results for each testtemperature were within therequired mV range set forth in thetesting.• All results for the meter data portwere within the specified limitsafter multiple test stripinsertion/removal cycles.• All software test conditions invalidation testing passedacceptance criteria
Erroneous datatransfer from meterto PC	The CONTOUR®NEXT meter'scomputer interface shall detect andcorrect communication errors,reducing the chance of data errorsover the interface.	Pass• All software test conditions invalidation testing passedacceptance criteria
User unable toproperly use meteror follow itsinstructions for use	Product labeling for properinstrument operation shall bevalidated through customer focusstudy (summative usability study)for 2 critical tasks: 1) completinginitial setup and 2) running a mockblood glucose test and marking theresult using the meter andinstructions for use.	Pass• Completing initial setup task wassuccessful. Study subjectssuccessfully completed a mockblood glucose test and markedthe reading.
User misinterpretsmeter readings	Product labeling for properinstrument operation shall bevalidated through customer focusstudy (summative usability study)for 2 critical tasks: 1) completinginitial setup and 2) running a mockblood glucose test and marking theresult using the meter andinstructions for use.	Pass• Completing initial setup task wassuccessful. Study subjectssuccessfully completed a mockblood glucose test and markedthe reading.
User mishandlesmeter (i.e., dropsmeter, spills liquidon meter)	Meter must be designed towithstand drop and show no signsof damage to any components.Meter must also be designed towithstand	Pass• All results withstood the statedDrop test and Spill challenges.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged vertically within a circle. The letters are in a bold, outlined font, and the circle is also outlined.

{3}------------------------------------------------

Image /page/3/Figure/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" written vertically, with the letters stacked on top of each other. The entire word is enclosed within a circle. The logo is black and white.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged in a cross shape, with each letter of the word appearing once in the cross. The logo is enclosed in a circle.

Risk	Acceptance Criteria	Results
	withstand Spill Test after exposureto various test solutions.

Conclusion

The CONTOUR®NEXT Blood Glucose Monitoring System is substantially equivalent in its intended use, performance, safety and effectiveness to the predicate CONTOUR®NEXT LINK Wireless Blood Glucose Monitoring System.

ਾਂ

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around the perimeter. In the center is a stylized image of an eagle with three human profiles incorporated into its design, symbolizing health and human services.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Bayer Healthcare LLC c/o Charles Ryan Senior Manager Regulatory Affairs 555 White Plains Road Tarrytown, NY 10591

JUL 26 2012

K121190 Re:

K121190
Trade Name: CONTOUR NEXT Blood Glucose Monitoring System Regulation Number: 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, LFR, JJX Dated: June 28, 2012 Received: June 29, 2012

Dear Charles Ryan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaler or see ????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? reletenced above and have determined the to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Intelstate conmisted prior to May 20, 1978, and and in accordance with the provisions of Amelianients, or to devices that nave ooon (Act) that do not require approval of a premarket the Federal Pood, Drug, and Cosmene i to crefere, market the device, subject to the general approval application (1 Miry). 1 Sa . The general controls provisions of the Act include controls provisions of the Fet. - The 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 If your device is Classified ($60 above) into exactives. Existing major regulations affecting (PMA), If may be subject to sach ademond. Founders (CFR), Parts 800 to 895.
Forderice can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. your device can be found in This 21, Code of Possible of Personal Prour device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA Stissualled of a substantial vita complies with other requirements mean that FDA has made a decemination administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other todates and interest of the Act of ally rederal statutes and regirements, including, but not limited to: registration in rou must comply with an the Pro. Biog 2017 CFR Parts 801 and 809); medical device and co and listing (21 CFR Fall 607), labeling (21 OFR 803); and good reporting (reporting of medical device-related adverse of this) (
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{6}------------------------------------------------

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/Resourcesfor You/Industry/default.htm

Sincerely yours,

Counney 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

{7}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: CONTOUR® NEXT Blood Glucose Monitoring System

Indications for Use:

CONTOUR®NEXT Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.

The CONTOUR®NEXT Control Solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check.

The CONTOUR®NEXT Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

CWS

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) ie 12 119D

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.