CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR by BAYER HEALTHCARE

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.

Device Description

The Contour® NEXT LINK Wireless Blood Glucose Monitoring System consists of a blood glucose meter, dry test strips and liquid controls to be used for the measurement of glucose in capillary whole blood by persons with diabetes. The System has the same automatic calibration as the predicate device. Blood glucose results are displayed on the meter window and stored in the meter's memory. The System also contains radio frequency (RF) functions for sending BGM results to compatible Medtronic MiniMed insulin pumps. The RF function can also serve as a pass through for data being transmitted from Medtronic MiniMed insulin pumps to Medtronic's MiniMed PC-based data management software.

AI/ML Overview

This 510(k) summary (K122370) describes Bayer Healthcare's Contour® NEXT LINK Wireless Blood Glucose Monitoring System. The submission is to add the Medtronic MiniMed 530G insulin pump to the list of compatible devices in the Indications for Use, meaning the device itself (the blood glucose meter) remains essentially the same as the predicate (K110894).

Therefore, the performance of the updated device is considered substantially equivalent to the predicate device. The submission explicitly states: "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)." This implies that the acceptance criteria and performance data for the predicate device are referenced.

Acceptance Criteria and Reported Device Performance:

The document refers to a 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. Without access to P120010, the specific acceptance criteria and detailed performance of the device cannot be explicitly extracted from this 510(k) summary. However, for blood glucose meters, typical acceptance criteria would involve accuracy standards (e.g., ISO 15197 for clinical accuracy) which define the permissible deviation of meter readings from laboratory reference values within certain error grids (e.g., Consensus Error Grid or Clarke Error Grid).

Given the statement of substantial equivalence, the device is expected to meet the same performance criteria as the predicate device (K110894).

Acceptance Criteria (Typical for BGM)	Reported Device Performance (Implied from K110894 & Substantial Equivalence)
Accuracy based on a recognized standard (e.g., ISO 15197:2003 or later) for blood glucose measurement	Expected to meet or exceed the accuracy standards defined for K110894
Measurement range (e.g., 20 to 600 mg/dL)	20 to 600 mg/dL (as stated in Indications for Use)
Precision (repeatability/reproducibility)	Expected to be substantially equivalent to K110894
Interference studies (various substances)	Expected to be substantially equivalent to K110894
Hematocrit range	Expected to be substantially equivalent to K110894
Temperature/humidity effects	Expected to be substantially equivalent to K110894
Usability (human factors)	Expected to be substantially equivalent to K110894
Compatibility with Medtronic MiniMed 530G Insulin Pump (new to this submission)	Verified as part of PMA P120010

Study Information (Based on the provided 510(k) summary and inferring from BGM regulatory practices):

Sample size used for the test set and the data provenance:
- The 510(k) summary does not explicitly state the sample size for the test set. It refers to "VERIFICATION AND VALIDATION DATA" in PMA submission P120010.
- Data provenance: Not specified in this 510(k) document. Typically, accuracy studies for blood glucose meters involve prospective clinical studies with human subjects.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the conventional sense for a blood glucose meter accuracy study. The "ground truth" for blood glucose measurements is established by a laboratory reference method (e.g., YSI 2300 STAT PLUS Glucose & Lactate Analyzer), not by expert consensus. This method is operated by trained laboratory personnel, not "experts" in the context of medical imaging or diagnosis.
Adjudication method for the test set:
- Not applicable. Blood glucose meter accuracy studies compare meter readings directly against a highly accurate laboratory reference method, not against an adjudicated ground truth from multiple observers.
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, a MRMC study was not done. This is a blood glucose meter, an in-vitro diagnostic device, not an AI-assisted diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the accuracy studies for blood glucose meters fundamentally assess the standalone performance of the device (meter + test strip) against a laboratory reference. The user interaction is typically part of human factors validation, ensuring correct operation, but the core accuracy is an "algorithm only" measurement.
The type of ground truth used:
- Laboratory Reference Method: For blood glucose meters, the ground truth is established by a highly accurate and precise laboratory reference instrument, such as a YSI glucose analyzer, which measures glucose concentrations in blood samples.
The sample size for the training set:
- This is not relevant for a blood glucose meter in the context of this 510(k). The device uses a "Multi-pulse algorithm" which is established during the device's original development (likely for K110894) and does not typically involve additional "training sets" in the AI/machine learning sense for each submission unless the algorithm itself is being changed, which it isn't here. This submission is for compatibility with a new insulin pump, not a new algorithm.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a "training set" in the context of this 510(k) for the reasons mentioned above. The algorithm's parameters would have been set based on extensive testing and calibration during its initial development, using blood samples with known glucose concentrations verified by a laboratory reference.

Summary

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

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 StMishawaka IN 46544
Phone number	574-256-3441
Fax number	547-256-3519
EstablishmentRegistrationNumber	1826988SEP 2 6 2013
Name ofcontact person	Roger Sonnenburg
Date prepared	08/03/2012
Name of device
Trade orproprietaryname	Contour® NEXT LINK Wireless Blood Glucose Meter
Common orusual name	Blood Glucose Meter
Classificationname	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,Over The Counter)
Legally marketeddevice(s) to whichequivalence isclaimed	K110894 Contour® NEXT LINK Wireless Blood Glucose Meter
Reason for 510(k)submission	This submission is to add a Medtronic MiniMed pump, the 530G, to the list ofMedtronic devices listed in the Indications for Use
Device description	The Contour® NEXT LINK Wireless Blood Glucose Monitoring System consistsof a blood glucose meter, dry test strips and liquid controls to be used for themeasurement of glucose in capillary whole blood by persons with diabetes.The System has the same automatic calibration as the predicate device. Bloodglucose results are displayed on the meter window and stored in the meter'smemory. The System also contains radio frequency (RF) functions for sendingBGM results to compatible Medtronic MiniMed insulin pumps. The RF functioncan also serve as a pass through for data being transmitted from MedtronicMiniMed insulin pumps to Medtronic's MiniMed PC-based data managementsoftware.
Intended use of thedevice	See indications for use below
Indications for use	The Contour NEXT LINK Wireless Blood Glucose Monitoring Systemis an over the counter (OTC) device utilized by persons with diabetesin home settings for the measurement of glucose in whole blood, andis for single-patient use only and should not be shared. The ContourNEXT LINK Wireless Blood Glucose Monitoring System is indicatedfor use with fresh capillary whole blood samples drawn from thefingertip and palm only.Contour NEXT Test Strips are intended for self-testing by persons withdiabetes for the quantitative measurement of glucose in whole bloodsamples from 20 to 600 mg/dL.The Contour NEXT LINK Wireless Blood Glucose Monitoring Systemis intended to be used to transmit glucose values to MedtronicMiniMed Paradigm Insulin Pumps or Medtronic MiniMed ParadigmREAL-Time Revel Insulin Pumps or Medtronic MiniMed ParadigmREAL-TIME Insulin Pumps or Medtronic MiniMed 530G Insulin Pumpsor Guardian REAL-TIME Monitor and facilitate transfer of informationto Medtronic MiniMed Carelink Therapy Management Softwarethrough use of radio frequency communication.The Contour NEXT LINK Wireless Blood Glucose Monitoring Systemis not intended for the diagnosis of or screening for diabetes mellitusand is not intended for use on neonates.

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

Similarities to Predicate Device
Characteristic	Predicate DeviceContour NEXT LINK WirelessK110894	New DeviceContour NEXT Link Wireless
Test Strip	Contour NEXT Test Strip	Same as predicate
Algorithm	Multi-pulse algorithm	Same as predicate
User interface	Alphanumeric, Iconic, NativeLanguage	Same as predicate
Number of buttons	4	Same as predicate
Display (technology)	Graphical (OLED)	Same as predicate
Radio-frequencycommunication	Yes	Same as predicate

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

Differences from Predicate Device
Characteristic	Predicate DeviceContour NEXT Link WirelessK110894	New DeviceContour NEXT Link Wireless
Indications for Use	Includes the following Medtronicdevices: Medtronic MiniMedParadigm Insulin Pumps orMedtronic MiniMed ParadigmREAL-Time Revel Insulin Pumpsor Medtronic MiniMedParadigm® REAL-TIME InsulinPumps or Guardian REAL-TIMEMonitor.	Adds Medtronic MiniMed 530G InsulinPump 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).

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

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.

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

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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

Indications for Use

510(k) Number (if known): K122370

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

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 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' ----------------------------------------------------------------------------------------------

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.