CONTOUR NEXT BLOOD GLUCOSE METER

K121190 · Bayer Healthcare, LLC · LFR · Jul 26, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121190
• Device Name: CONTOUR NEXT BLOOD GLUCOSE METER
• Applicant: Bayer Healthcare, LLC
• Product Code: LFR · Clinical Chemistry
• Decision Date: Jul 26, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device system is intended for single-patient use only.

Device Story

Handheld blood glucose meter; uses dry reagent test strips and liquid controls; measures glucose in capillary whole blood. Operated by persons with diabetes in home settings. Device performs electronics self-test before measurement; uses blood glucose measurement algorithm and automatic calibration. Output displayed on meter screen; informs patient of glucose levels for self-management. Differences from predicate include removal of wireless transmission to Medtronic devices, use of replaceable batteries, and physical form factor changes. Benefits include accurate, convenient home glucose monitoring.

Clinical Evidence

Bench testing only. Verification and validation activities included electrical safety (IEC 61010-1:2001), cleaning/disinfection robustness, drop/spill testing, and summative usability study for initial setup and mock blood glucose testing.

Technological Characteristics

Handheld meter; dry reagent test strip sensing; replaceable battery power; data port for PC interface. Complies with IEC 61010-1:2001. Software-based electronics self-test and automatic calibration.

Indications for Use

Indicated for single-patient use for blood glucose monitoring.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System (K110894)

Submission Summary (Full Text)

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K121190.

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## 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 Ryan<br>Senior Manager, Regulatory Affairs<br>Bayer Healthcare LLC<br>555 White Plains Road<br>Tarrytown, New York 10951<br>Telephone: [phone] |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name: | Trade name: CONTOUR ^® NEXT Blood Glucose Monitoring<br>System<br>FDA Product Code: NBW<br>Classification name: Blood Glucose Test System, Over-<br>the-Counter (21 CFR § 862.1345) |
| 3) Predicate device: | CONTOUR ^® NEXT LINK Wireless Blood Glucose Meter<br>(Reference: CONTOUR ^® NEXT LINK Wireless<br>Blood Glucose Monitoring System (K110894)) |
| 4) Device description: | The CONTOUR ^® NEXT Blood Glucose Monitoring System<br>consists of a small handheld blood glucose meter that<br>utilizes dry reagent test strips and liquid controls for the<br>measurement of glucose in capillary whole blood by<br>persons with diabetes. The meter together with the test<br>strips and control solutions is referred to as the<br>CONTOUR ^® NEXT Blood Glucose Monitoring System. |
| 5) Intended Use: | The CONTOUR ^® NEXT Blood Glucose Monitoring System<br>is an over the counter (OTC) device utilized by persons<br>with diabetes in home settings for the measurement of<br>glucose in whole blood, and is for single-patient use only<br>and should not be shared. The CONTOUR ^® NEXT Blood<br>Glucose Monitoring System is indicated for use with fresh<br>capillary whole blood samples drawn from the fingertip and<br>palm only. |

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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 from<br>electric shock | The meter shall not allow a test<br>to initiate when the meter is<br>connected to an external device<br>(e.g. computer). The meter shall not experience<br>permanent damage or present<br>hazard such as excessive<br>temperature or heat due to<br>overvoltage. | Pass All blood glucose tests attempted<br>while connected to PC generated<br>"Do not Test, Connected" error<br>screen. All results maintained correct<br>voltage regulation within limits<br>and did not present temperature<br>hazard near or above the |
| Risk | Acceptance Criteria | Results |
| Biocontamination –<br>exposure to blood-<br>borne pathogens via<br>device | Must meet requirements set<br>forth in IEC 61010-1:2001 (2nd Edition) One set of meters were soiled<br>with CONTOUR®NEXT liquid<br>control and another set of<br>meters were soiled with 5 uL of<br>venous blood. All meters were<br>allowed to dry for 24hrs. The<br>soil locations were the meter<br>button and display. All meters<br>were then cleaned with Clorox<br>germicidal wipes. No residual<br>blood or control solution was to<br>be observed on any of the<br>meters. Test meters received contact<br>with an EPA-approved<br>surrogate for a human virus for<br>24 hours on various test<br>surfaces. All instruments must<br>be cleaned with wipes<br>containing 0.55% sodium<br>hypochlorite and no virus must<br>be detected on any surface<br>after 60s. | Pass specified limit. Compliance with IEC 61010-<br>1:2001 requirements confirmed<br>via testing by an external lab. There was no residual blood or<br>control solution observed on any<br>of the meters. The specified disinfectant passed<br>the virus elimination<br>effectiveness test for all tested<br>meter device surfaces. |
| Material degradation<br>due to cleaning and<br>disinfection | Interior meter case parts and<br>exterior meter case parts were<br>exposed to several different<br>cleaning agents (such as bleach<br>solutions, isopropyl alcohol, and<br>soap and water) that might be<br>applied by a user.<br><br>The plastic parts were not to exhibit<br>any cracking, glazing, discoloration<br>or expansion after being exposed.<br>The metallic parts were to exhibit<br>little or no corrosion and were to be<br>evaluated based on a low, medium<br>or high corrosion level. | Pass All results for plastic and metallic<br>parts met the specified criteria for<br>each solution tested. |
| Choking/toxicity<br>dangers from small<br>parts (batteries) | Reagent insert shall warn users<br>of accidental swallowing of test<br>strip. User Guide shall warn users of<br>accidental swallowing of<br>assembly components (such as<br>batteries, battery cover etc. Assembly components (such as | Pass Test strip insert already warns<br>against swallowing test strips System User Guide warns:<br>"Keep out of reach of children.<br>This kit contains small parts<br>which could cause suffocation if<br>accidentally swallowed."<br>and |
| Risk | Acceptance Criteria | Results |
| | screws) are not required to be<br>unscrewed for any reason.<br>Design will utilize a non-<br>ordinary screw and require<br>uncommon tools to remove. | "Keep batteries away from<br>children. Lithium batteries are<br>poisonous. If swallowed,<br>immediately contact your poison• Device designed so that no<br>hazardous assembly parts are<br>easily accessible to user. |
| Meter malfunction -<br>incorrect reading or<br>does not function<br>properly | The accuracy of the test strip<br>driving voltage of the Analog Front<br>End at operating temperature range<br>shall be assessed under various<br>test temperatures.<br>The CONTOUR®NEXT meter data<br>port shall withstand multiple cycles<br>(insertions/removals).<br>When preparing to perform a blood<br>glucose measurement, the meter<br>shall perform an electronics self test<br>to verify proper function of the<br>meter electronics. | Pass<br>• All results for each test<br>temperature were within the<br>required mV range set forth in the<br>testing.<br>• All results for the meter data port<br>were within the specified limits<br>after multiple test strip<br>insertion/removal cycles.<br>• All software test conditions in<br>validation testing passed<br>acceptance criteria |
| Erroneous data<br>transfer from meter<br>to PC | The CONTOUR®NEXT meter's<br>computer interface shall detect and<br>correct communication errors,<br>reducing the chance of data errors<br>over the interface. | Pass<br>• All software test conditions in<br>validation testing passed<br>acceptance criteria |
| User unable to<br>properly use meter<br>or follow its<br>instructions for use | Product labeling for proper<br>instrument operation shall be<br>validated through customer focus<br>study (summative usability study)<br>for 2 critical tasks: 1) completing<br>initial setup and 2) running a mock<br>blood glucose test and marking the<br>result using the meter and<br>instructions for use. | Pass<br>• Completing initial setup task was<br>successful. Study subjects<br>successfully completed a mock<br>blood glucose test and marked<br>the reading. |
| User misinterprets<br>meter readings | Product labeling for proper<br>instrument operation shall be<br>validated through customer focus<br>study (summative usability study)<br>for 2 critical tasks: 1) completing<br>initial setup and 2) running a mock<br>blood glucose test and marking the<br>result using the meter and<br>instructions for use. | Pass<br>• Completing initial setup task was<br>successful. Study subjects<br>successfully completed a mock<br>blood glucose test and marked<br>the reading. |
| User mishandles<br>meter (i.e., drops<br>meter, spills liquid<br>on meter) | Meter must be designed to<br>withstand drop and show no signs<br>of damage to any components.<br>Meter must also be designed to<br>withstand | Pass<br>• All results withstood the stated<br>Drop test and Spill challenges. |

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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.

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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.

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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 exposure<br>to 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.

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### 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).

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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 [phone]. 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

N

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

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## Indications for Use

510(k) Number (if known):

Device Name: CONTOUR® NEXT Blood Glucose Monitoring System

Indications for Use:

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.

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