CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR

K122370 · Bayer Healthcare · NBW · Sep 26, 2013 · Clinical Chemistry

Device Facts

• Record ID: K122370
• Device Name: CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
• Applicant: Bayer Healthcare
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Contour NEXT LINK Wireless 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 LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. The system consists of a Contour NEXT LINK Wireless Blood Glucose Meter and Contour NEXT Test Strips. 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 LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed Paradigm REAL-TIME Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps or Guardian REAL-TIME Monitor and facilitate transfer of information to Medtronic MiniMed Carelink Therapy Management Software through use of radio frequency communication. The Contour NEXT LINK Wireless 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 Story

System measures glucose in capillary whole blood via amperometric method using FAD-glucose dehydrogenase; blood drawn into test strip via capillary action; reaction generates current proportional to glucose concentration. Meter displays results; stores data; transmits glucose values via radio frequency (RF) to compatible Medtronic MiniMed insulin pumps and Guardian REAL-TIME Monitor; acts as pass-through for data transfer to Medtronic Carelink Therapy Management Software. Used in home settings by patients with diabetes. Output allows patients and clinicians to monitor glucose levels for therapy management. Device is identical to predicate (k110894) with added compatibility for Medtronic MiniMed 530G Insulin Pump.

Clinical Evidence

No new clinical data provided. Performance characteristics, including precision, linearity, analytical specificity, and user performance, were established in predicate k110894. User interaction with the MiniMed 530G system was previously approved under P120010.

Technological Characteristics

Blood glucose meter using multi-pulse algorithm; OLED graphical display; 4-button interface. Connectivity via RF for data transmission to Medtronic insulin pumps/monitors. Uses Contour NEXT test strips and liquid controls.

Indications for Use

Indicated for persons with diabetes for self-testing of glucose in fresh capillary whole blood from fingertip and palm. Not for neonates, screening, or diagnosis of diabetes. Not for critically ill patients (e.g., severe hypotension, shock, DKA).

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 Meter (K110894)

Submission Summary (Full Text)

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K12370

## 510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements
of 21 CFR 807.92

| Submitter Information | |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Bayer Healthcare, Diabetes Care |
| Address | 430 S Beiger St<br>Mishawaka IN 46544 |
| Phone number | 574-256-3441 |
| Fax number | 547-256-3519 |
| Establishment<br>Registration<br>Number | 1826988<br>SEP 2 6 2013 |
| Name of<br>contact person | Roger Sonnenburg |
| Date prepared | 08/03/2012 |
| Name of device | |
| Trade or<br>proprietary<br>name | Contour® NEXT LINK Wireless Blood Glucose Meter |
| Common or<br>usual name | Blood Glucose Meter |
| Classification<br>name | 75 LFR Glucose Dehydrogenase, Glucose |
| Classification panel | Clinical Chemistry and Toxicology |
| Regulation | 21 CFR 862.1345 |
| Product code(s) | LFR (Glucose Dehyrogenase, Glucose), NBW (System, Test, Blood Glucose,<br>Over The Counter) |
| Legally marketed<br>device(s) to which<br>equivalence is<br>claimed | K110894 Contour® NEXT LINK Wireless Blood Glucose Meter |
| Reason for 510(k)<br>submission | This submission is to add a Medtronic MiniMed pump, the 530G, to the list of<br>Medtronic devices listed in the Indications for Use |
| Device description | The Contour® NEXT LINK Wireless Blood Glucose Monitoring System consists<br>of a blood glucose meter, dry test strips and liquid controls to be used for the<br>measurement of glucose in capillary whole blood by persons with diabetes.<br>The System has the same automatic calibration as the predicate device. Blood<br>glucose results are displayed on the meter window and stored in the meter's<br>memory. The System also contains radio frequency (RF) functions for sending<br>BGM results to compatible Medtronic MiniMed insulin pumps. The RF function<br>can also serve as a pass through for data being transmitted from Medtronic<br>MiniMed insulin pumps to Medtronic's MiniMed PC-based data management<br>software. |
| Intended use of the<br>device | See indications for use below |
| Indications for use | The Contour NEXT LINK Wireless Blood Glucose Monitoring System<br>is an over the counter (OTC) device utilized by persons with diabetes<br>in home settings for the measurement of glucose in whole blood, and<br>is for single-patient use only and should not be shared. The Contour<br>NEXT LINK Wireless Blood Glucose Monitoring System is indicated<br>for use with fresh capillary whole blood samples drawn from the<br>fingertip and palm only.<br><br>Contour NEXT Test Strips are intended for self-testing by persons with<br>diabetes for the quantitative measurement of glucose in whole blood<br>samples from 20 to 600 mg/dL.<br><br>The Contour NEXT LINK Wireless Blood Glucose Monitoring System<br>is intended to be used to transmit glucose values to Medtronic<br>MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm<br>REAL-Time Revel Insulin Pumps or Medtronic MiniMed Paradigm<br>REAL-TIME Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps<br>or Guardian REAL-TIME Monitor and facilitate transfer of information<br>to Medtronic MiniMed Carelink Therapy Management Software<br>through use of radio frequency communication.<br><br>The Contour NEXT LINK Wireless Blood Glucose Monitoring System<br>is not intended for the diagnosis of or screening for diabetes mellitus<br>and is not intended for use on neonates. |

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| Similarities to Predicate Device | | |
|----------------------------------|-----------------------------------------------------------|------------------------------------------|
| Characteristic | Predicate Device<br>Contour NEXT LINK Wireless<br>K110894 | New Device<br>Contour NEXT Link Wireless |
| Test Strip | Contour NEXT Test Strip | Same as predicate |
| Algorithm | Multi-pulse algorithm | Same as predicate |
| User interface | Alphanumeric, Iconic, Native<br>Language | Same as predicate |
| Number of buttons | 4 | Same as predicate |
| Display (technology) | Graphical (OLED) | Same as predicate |
| Radio-frequency<br>communication | Yes | Same as predicate |

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| Differences from Predicate Device | | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Characteristic | Predicate Device<br>Contour NEXT Link Wireless<br>K110894 | New Device<br>Contour NEXT Link Wireless |
| Indications for Use | Includes the following Medtronic<br>devices: Medtronic MiniMed<br>Paradigm Insulin Pumps or<br>Medtronic MiniMed Paradigm<br>REAL-Time Revel Insulin Pumps<br>or Medtronic MiniMed<br>Paradigm® REAL-TIME Insulin<br>Pumps or Guardian REAL-TIME<br>Monitor. | Adds Medtronic MiniMed 530G Insulin<br>Pump to the Indications for Use |

## VERIFICATION AND VALIDATION DATA

Please refer to PMA submission P120010 for verification reports on the performance of the Contour NEXT Link Wireless Blood Glucose Meter with the Medtronic MiniMed 530G Insulin Pump.

## CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The performance of the Contour NEXT LINK Wireless Blood Glucose Monitoring System is substantially equivalent to the performance of the previously cleared Contour NEXT LINK Wireless Blood Glucose Monitoring System (K110894).

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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Commol Center - WO66-G609 Silver Spring, MD 20993-0002

September 26, 2013

Bayer Healthcare c/o Mr. Roger Sonnenburg 430 Sourth Beiger St. MISHAWAKA IN 46544

Re: K122370

Trade/Device Name: Contour Next Link Wireless Blood Glucose Monitor Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: September 20, 2013 Received: September 23, 2013

Dear Mr. Sonnenburg:

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. 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 (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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 that FDA has made a determination that your device complics 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.

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Page 2—Mr. Sonnenburg

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/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/McdicalDevices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias, Ph.D.

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

510(k) Number (if known): K122370

Contour® NEXT LINK Wireless Blood Glucose Monitoring System Device Name:

Indications For Use:

The Contour NEXT LINK Wireless 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 LINK Wireless 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 LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed Paradigm REAL-TIME Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps or Guardian REAL-TIME Monitor and facilitate transfer of information to Medtronic MiniMed Carelink Therapy Management Software through use of radio frequency communication.

The Contour NEXT LINK Wireless 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 i x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use ___x (21 CFR 807 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)

Stayce Beck 2013.09.24 12:23:06 -04'00' ----------------------------------------------------------------------------------------------

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