(129 days)
Not Found
No
The device description focuses on the electrochemical measurement of glucose and data transmission, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is for the quantitative measurement of glucose in whole blood to aid in monitoring the effectiveness of diabetes control, not for treating the condition.
No
The "Intended Use / Indications for Use" section explicitly states "The Contour Next blood glucose monitoring system is not intended for the diagnosis or screening for diabetes mellitus..." and "...is not intended for the diagnosis of or screening for diabetes mellitus..." for both systems described. It is intended as "an aid to monitor the effectiveness of diabetes control," which is a monitoring function, not a diagnostic one.
No
The device description explicitly states that the system consists of a physical blood glucose meter, test strips, and control solutions, in addition to software components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The system is intended for self-testing outside the body (in vitro diagnostic use)".
- Nature of the Test: The device measures glucose in a sample of whole blood, which is a biological specimen taken from the body. This is the definition of an in vitro diagnostic test.
- Purpose: The purpose is to provide quantitative measurement of glucose to aid in monitoring the effectiveness of diabetes control, which is a diagnostic purpose related to a medical condition.
N/A
Intended Use / 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 quantitative measurement of glucose in whole blood, and is for single-patient use only, and should not be shared. The system is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control.
The Contour Next blood glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The system consists of a Contour Next blood glucose meter. Contour Next control solutions.
Contour Next test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples.
The Contour Next blood glucose monitoring system is not intended for the diagnosis or screening for diabetes mellitus and is not intended for use on neonates.
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 quantitative measurement of glucose in whole blood, and is for singlepatient use only and should not be shared. The System is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control.
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. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
Contour Next Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples.
The Contour Next Link Wireless Blood Glucose Monitoring System is intended to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps 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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR
Device Description
Contour Next Link Wireless Blood Glucose Meter: The Contour Next Link Wireless Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next Link Wireless Blood Glucose Monitoring System.
The System also contains radio frequency (RF) functions for sending blood glucose 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 manaqement software.
The chemical principle utilized for both the predicate and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD qlucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.
Contour Next Blood Glucose Meter: The Contour Next Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next Blood Glucose Monitoring System.
The chemical principle utilized for both the predicate and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD qlucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip and palm
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
persons with diabetes in home settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to ensure that the error checks acted as intended and gave error messages for:
- Test strips that had been exposed to a reducing agent
- Un-mixed control test solution
- Samples that had been disturbed during the test countdown
Software verification testing was conducted to ensure that no good results were classified as errors as a result of the modifications.
Equivalency testing was conducted to ensure the performance of the modified and predicate meters was not statistically different.
An internal user study was conducted to ensure the modifications did not impact the blood glucose result accuracy of the Contour Next Link Wireless system.
The Contour Next Link Wireless Blood Glucose Meter is substantially equivalent in its intended use, performance, safety and effectiveness to the predicate Contour Next Link Wireless Blood Glucose Meter (K122370) based on the performance of the Contour Next Link Wireless Blood Glucose Monitoring System.
The Contour Next Blood Glucose Meter is substantially equivalent in its intended use, performance, safety and effectiveness to the predicate Contour Next Blood Glucose Meter (K121190) based on the performance of the Contour Next Blood Glucose Monitoring System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. In the center of the circle is an abstract symbol consisting of three stylized human profiles facing to the right, with flowing lines above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 24, 2016
ASCENSIA DIABETES CARE US INC. JENNIFER GREGORY PRINCIPAL REGULATORY AFFAIRS SPECIALIST 430 SOUTH BEIGER STREET MISHAWAKA IN 46544
Re: K160430
Trade/Device Name: Contour Next Link Wireless Blood Glucose Monitoring System Contour Next Blood Glucose Monitoring System Regulation Number: 21 CFR § 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: May 26, 2016 Received: May 27, 2016
Dear Ms. Gregory:
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 (see 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/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 Industry and Consumer Education 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,
Katherine Serrano -S
For :
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
2
Indications for Use
510(k) Number (if known) K160430
Device Name
Contour Next Blood Glucose Monitoring System
Indications for Use (Describe)
The Contour Next blood glucose monitoring system is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only, and should not be shared. The system is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control.
The Contour Next blood glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The system consists of a Contour Next blood glucose meter. Contour Next control solutions.
Contour Next test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples.
The Contour Next blood glucose monitoring system is not intended for the diagnosis or screening for diabetes mellitus and is not intended for use on neonates.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | X |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K160430
Device Name
Contour Next Link Wireless Blood Glucose Monitoring System
Indications for Use (Describe)
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 quantitative measurement of glucose in whole blood, and is for singlepatient use only and should not be shared. The System is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control.
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. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
Contour Next Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples.
The Contour Next Link Wireless Blood Glucose Monitoring System is intended to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" in purple, with a blue teardrop shape next to it. Below the symbol, the word "ASCENSIA" is written in a dark purple sans-serif font, and below that, the words "Diabetes Care" are written in a lighter purple font.
510(k) Summary
Date prepared: June 21, 2016
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 | Jennifer Gregory
Principal Regulatory Affairs Specialist
Ascensia Diabetes Care US Inc.
430 South Beiger Street
Mishawaka, IN 46544
Telephone: (574) 256-3447
Fax: (574) 256-3519 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device names: | Trade name: Contour® Next Link Wireless Blood Glucose
Monitoring System
Trade name: Contour® Next Blood Glucose Monitoring
System
Common name: Blood Glucose Test System
Classification name:
Blood Glucose Test System, Over-the-Counter, 75 NBW
Glucose Dehydrogenase, 75 LFR (21 CFR § 862.1345) |
| 3) Predicate
devices: | Contour Next Link Wireless Blood Glucose Monitoring
System:
Contour Next Link Wireless Blood Glucose Monitoring
System K122370
Contour Next Blood Glucose Monitoring System:
Contour Next Blood Glucose Monitoring System K121190 |
5
Image /page/5/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" formed by a purple triangle on the left and a blue teardrop shape on the right. Below the symbol, the word "ASCENSIA" is written in a sans-serif font, with the words "Diabetes Care" in a smaller font size underneath.
- Device descriptions:
Contour Next Link Wireless Blood Glucose Meter:
The Contour Next Link Wireless Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next Link Wireless Blood Glucose Monitoring System.
The System also contains radio frequency (RF) functions for sending blood glucose 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 manaqement software.
The chemical principle utilized for both the predicate and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD qlucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.
Contour Next Blood Glucose Meter:
The Contour Next Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next Blood Glucose Monitoring System.
The chemical principle utilized for both the predicate
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Image /page/6/Picture/0 description: The image is a logo for Ascensia Diabetes Care. The logo features a stylized letter "A" with a purple left side and a blue teardrop shape on the right. Below the symbol, the word "ASCENSIA" is written in a bold, purple font. Underneath "ASCENSIA", the words "Diabetes Care" are written in a smaller, less bold font.
and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD qlucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.
5) Intended Use: Contour Next Link Wireless Blood Glucose Monitoring System:
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 quantitative measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The System is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control.
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. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
Contour Next Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples.
The Contour Next Link Wireless Blood Glucose Monitoring System is intended to be used to transmit qlucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps and facilitate transfer of information to Medtronic MiniMed Carelink Therapy Management Software through use of radio frequency communication.
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Image /page/7/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" formed by a purple triangle on the left and a light blue teardrop shape on the right. Below the symbol, the word "ASCENSIA" is written in a purple sans-serif font, with the words "Diabetes Care" in a smaller font size underneath.
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.
Contour Next Blood Glucose Monitoring System:
The Contour Next blood glucose monitoring system is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for singlepatient use only, and should not be shared. The system is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control.
The Contour Next blood glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The system consists of a Contour Next blood glucose meter, Contour Next test strips and Contour Next control solutions.
Contour Next test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples.
The Contour Next blood glucose monitoring system is not intended for the diagnosis or screening for diabetes mellitus and is not intended for use on neonates.
Data demonstrating substantial equivalence
Contour Next Link Wireless meter:
The Contour Next Link Wireless Blood Glucose Meter consists of a small handheld blood glucose meter that is substantially equivalent to the predicate device, the Contour Next Link Wireless Blood Glucose Meter (K122370). The modified and
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Image /page/8/Picture/0 description: The image is a logo for Ascensia Diabetes Care. The logo features a stylized letter "A" in purple, with a blue teardrop shape to the right of the "A". Below the graphic is the word "ASCENSIA" in purple, with the words "Diabetes Care" in a smaller font size below the word "ASCENSIA".
predicate devices use the same glucose calculation algorithm. Both devices also use dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes and liquid controls to check the performance of the system. The same Contour Next test strips and Contour Next control solutions are used by both the modified and predicate devices.
A detailed comparison of the characteristics featured between the modified and predicate devices is provided in the tables on the following pages:
Image /page/8/Picture/3 description: The image shows two devices labeled "Modified Device" and "Predicate Device", both identified as "Contour Next Link Wireless meter". Both devices display a screen showing "01:33PM/11/10" and a blood sugar reading of "93". The screen also shows the words "Before Meal", "Reminder", and "Notes".
| Summary of the Technological Characteristics of the Modified Device Compared to
| Predicate | ||
|---|---|---|
| SIMILARITIES to Predicate | ||
| Predicate | Contour Next Link Wireless | |
| Characteristic | Contour Next Link | |
| Wireless (K122370) | (Modified Device) | |
| Test Strip | Contour Next Test Strips | Same as Predicate |
| Control Solution | Contour Next Control Solution | |
| (Level 1 and 2) | Same as Predicate | |
| Detection Method | Amperometric | Same as Predicate |
| Measuring Range | 20-600 mg/dL | Same as Predicate |
| Sample Volume | 0.6 µL | Same as Predicate |
| Countdown time displayed | 5 Seconds | Same as Predicate |
| Illuminated Strip Port | Yes | Same as Predicate |
| Operational Buttons | 4 | Same as Predicate |
| Battery Type | Rechargeable (3.4-4.2V) | Same as Predicate |
| Operating Temperature | ||
| Range | 41°-113° F | Same as Predicate |
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Image /page/9/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo consists of a purple triangle on the left and a blue teardrop shape on the right. Below the shapes, the word "ASCENSIA" is written in purple, followed by the words "Diabetes Care" in a smaller font.
| Summary of the Technological Characteristics of the Modified Device Compared to
| Predicate | ||
|---|---|---|
| SIMILARITIES to Predicate | ||
| Characteristic | Predicate | |
| Contour Next Link | ||
| Wireless (K122370) | Contour Next Link Wireless | |
| (Modified Device) | ||
| Operating Humidity Range | 10-93% RH | Same as Predicate |
| Hematocrit Range | 15%-65% | Same as Predicate |
| Meter life | 5 Years | Same as Predicate |
| Validated Product Used for | ||
| Cleaning and Disinfection | Clorox Germicidal wipes | Same as Predicate |
| Meal Markers | Yes | Same as Predicate |
| Calibration/Coding | Autocoding (no coding for | |
| users) | Same as Predicate | |
| User Interface | Alphanumeric, Iconic, Native | |
| Language | Same as Predicate | |
| Display (technology) | Graphical (OLED) | Same as Predicate |
| Display Visibility | Day and night | Same as Predicate |
| Communication Port | USB Interface | Same as Predicate |
| Communication Link to | ||
| Computer | Direct USB connection or | |
| optional USB cable | Same as Predicate | |
| Test Results in Memory | 1000 Results | Same as Predicate |
| User Contact | ||
| Materials/Surface Finish | Display/buttons: AS | |
| Top/bottom case and USB | ||
| cap: PC/ABS | Same as Predicate |
10
Image /page/10/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a purple triangle shape with a light blue teardrop shape inside. Below the shape, the word "ASCENSIA" is written in a bold, sans-serif font, and below that, the words "Diabetes Care" are written in a smaller, lighter font.
| DIFFERENCES from Predicate | |||
|---|---|---|---|
| Characteristic | Predicate | ||
| Contour Next Link | |||
| Wireless (K122370) | Contour Next Link | ||
| Wireless | |||
| (Modified Device) | Risk Assessment Summary | ||
| Improved detection of test strips that may | |||
| have been exposed to a chemical that can | |||
| degrade the mediator. | No | Yes | The error check improves the ability of the |
| modified meter to detect exposed test strips and | |||
| provide an error message instead of a high biased | |||
| result. | |||
| Improved detection of un-mixed control | |||
| solution. | No | Yes | The error check improves the ability of the |
| modified meter to detect un-mixed control test | |||
| solutions and provide an error message instead of a | |||
| high biased result. | |||
| Improved detection of sample | |||
| 'perturbation' during a test. | No | Yes | The error check improves the ability of the |
| modified meter to detect a sample that is disturbed | |||
| during the countdown period and provide an error | |||
| message instead of a biased result. |
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Image /page/11/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized "A" shape in purple, with a blue teardrop shape positioned to its right, creating a sense of balance and visual interest. Below the graphic, the word "ASCENSIA" is written in a bold, sans-serif font, followed by the words "Diabetes Care" in a smaller font size.
Contour Next meter:
The Contour Next Blood Glucose Meter consists of a small handheld blood glucose meter that is substantially equivalent to the predicate device, the Contour Next Blood Glucose Meter (K121190). The modified and predicate devices use the same glucose calculation algorithm. Both devices also use dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes and liquid controls to check the performance of the system. The same Contour Next test strips and Contour Next control solutions are used by both the modified and predicate devices.
A detailed comparison of the characteristics featured between the modified and predicate devices is provided in the tables below and on the following pages:
Modified Device (Contour Next meter)
Image /page/11/Picture/5 description: The image shows a Bayer Contour Next One blood glucose meter. The meter has a black casing with a screen displaying a blood sugar reading of 163. Below the screen are buttons for navigation and confirmation. The device is compact and designed for personal use in monitoring blood glucose levels.
Predicate Device (Contour Next meter)
Image /page/11/Picture/7 description: The image shows a Bayer Contour Next One blood glucose meter. The meter has a black casing and a screen displaying a blood sugar reading of 163. Below the screen are several buttons, including an 'OK' button and directional arrows for navigation. The device is designed for monitoring blood glucose levels.
| Summary of the Technological Characteristics of the Modified Device Compared to
| Predicate | |||||
|---|---|---|---|---|---|
| SIMILARITIES to Predicate | |||||
| Characteristic | Predicate | Contour Next | |||
| Contour Next (K121190) | (Modified Device) | ||||
| Test Strip | Contour Next Test Strips | Same as Predicate | |||
| Control Solution | Contour Next Control Solution | ||||
| (Level 1 and 2) | Same as Predicate | ||||
| Detection Method | Amperometric | Same as Predicate | |||
| Measuring Range | 20-600 mg/dL | Same as Predicate | |||
| Sample Volume | 0.6 µL | Same as Predicate |
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Image /page/12/Picture/0 description: The image contains the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" formed by a purple triangle on the left and a blue teardrop shape on the right. Below the logo, the words "ASCENSIA" and "Diabetes Care" are written in a simple, sans-serif font, with "ASCENSIA" in a larger font size than "Diabetes Care".
| Summary of the Technological Characteristics of the Modified Device Compared to
| Predicate | |||
|---|---|---|---|
| SIMILARITIES to Predicate | |||
| Predicate | Contour Next | ||
| Characteristic | Contour Next (K121190) | (Modified Device) | |
| Countdown time displayed | 5 Seconds | Same as Predicate | |
| Operational Buttons | 2 button choice selection and | ||
| menu/power button | Same as Predicate | ||
| Battery Type | Two 3-volt lithium batteries | ||
| (DL2032 or CR2032) | Same as Predicate | ||
| Operating Temperature | |||
| Range | 41°-113° F | Same as Predicate | |
| Operating Humidity Range | 10-93% RH | Same as Predicate | |
| Hematocrit Range | 15%-65% | Same as Predicate | |
| Meter life | 5 Years | Same as Predicate | |
| Validated Product Used for | |||
| Cleaning and Disinfection | Clorox Germicidal wipes | Same as Predicate | |
| Meal Markers | Yes | Same as Predicate | |
| Calibration/Coding | Autocoding (no coding for | ||
| users) | Same as Predicate | ||
| Display (technology) | Graphical (LCD), Alphanumeric | ||
| characters, icons and native | |||
| language | Same as Predicate | ||
| Display Visibility | Day and night | Same as Predicate | |
| Communication Link to | |||
| Computer | Via micro-USB to USB cable | Same as Predicate | |
| Test Results in Memory | 800 Test Results | Same as Predicate | |
| User Contact | |||
| Materials/Surface Finish | Case Top/Bottom: PC and ABS | ||
| Buttons: Silicone Rubber | Same as Predicate | ||
| DIFFERENCES from Predicate | |||
| Characteristic | Predicate | ||
| Contour Next | |||
| (K121190) | Contour Next | ||
| (Modified Device) | Risk Assessment Summary | ||
| Improved detection of test strips | |||
| that may have been exposed to a | |||
| chemical that can degrade the | |||
| mediator | No | Yes | The error check improves the ability of the |
| modified meter to detect exposed test | |||
| strips and provide an error message instead | |||
| of a high biased result. | |||
| Improved detection of un-mixed | |||
| control solution | No | Yes | The error check improves the ability of the |
| modified meter to detect un-mixed control | |||
| test solutions and provide an error message | |||
| instead of a high biased result. | |||
| Improved detection of sample | |||
| perturbation' during a test | No | Yes | The error check improves the ability of the |
| modified meter to detect a sample that is | |||
| disturbed during the countdown period and | |||
| provide an error message instead of a | |||
| biased result. |
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Image /page/13/Picture/0 description: The image features the logo for Ascensia Diabetes Care. The logo consists of a purple triangle shape next to a light blue water droplet. Below the shapes, the text "ASCENSIA" is written in a sans-serif font, with the words "Diabetes Care" written in a smaller font size below it.
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Image /page/14/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo consists of two shapes: a purple triangle and a blue teardrop. The word "ASCENSIA" is written in purple below the shapes, and the words "Diabetes Care" are written in red below the word "ASCENSIA".
Summary of Performance testing for the Contour Next Link Wireless and Contour Next meters
Bench testing was conducted to ensure that the error checks acted as intended and gave error messages for:
- Test strips that had been exposed to a reducing agent
- · Un-mixed control test solution
- Samples that had been disturbed during the test countdown
Software verification testing was conducted to ensure that no good results were classified as errors as a result of the modifications.
Equivalency testing was conducted to ensure the performance of the modified and predicate meters was not statistically different.
An internal user study was conducted to ensure the modifications did not impact the blood glucose result accuracy of the Contour Next Link Wireless system.
Conclusions from Performance Evaluations
The Contour Next Link Wireless Blood Glucose Meter is substantially equivalent in its intended use, performance, safety and effectiveness to the predicate Contour Next Link Wireless Blood Glucose Meter (K122370) based on the performance of the Contour Next Link Wireless Blood Glucose Monitoring System.
The Contour Next Blood Glucose Meter is substantially equivalent in its intended use, performance, safety and effectiveness to the predicate Contour Next Blood Glucose Meter (K121190) based on the performance of the Contour Next Blood Glucose Monitoring System.