(364 days)
Not Found
No
The summary describes a standard blood glucose monitoring system that measures glucose levels using test strips and transmits the data. There is no mention of AI or ML being used for analysis, interpretation, or prediction. The performance studies focus on analytical accuracy and precision, not on the performance of an AI/ML algorithm.
No
The device is a diagnostic tool used for measuring glucose levels in blood, not for treating or preventing disease. While the results can inform therapeutic decisions (e.g., insulin dosage via linked pumps), the device itself does not provide therapy.
No
The device is explicitly stated as "not intended for the diagnosis of or screening for diabetes mellitus." It is used for measurement of glucose in persons already diagnosed with diabetes.
No
The device description explicitly states the system consists of a "small handheld electronic device" (the meter), test strips, and control solutions, all of which are hardware components. While it includes software for data transmission and management, it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is for the "measurement of glucose in whole blood" and the test strips are for the "quantitative measurement of glucose in whole blood samples." This is a classic definition of an in vitro diagnostic test, as it involves analyzing a biological sample (whole blood) outside of the body to obtain diagnostic information (glucose levels).
- Device Description: The description mentions the use of "dry reagent strips and liquid controls to be used for the measurement of glucose in capillary whole blood." Reagent strips and control solutions are common components of IVD devices used for chemical analysis of biological samples.
- Performance Studies: The document details extensive non-clinical and clinical studies evaluating the accuracy, precision, linearity, and analytical specificity of the system in measuring glucose in blood samples. These types of performance studies are standard requirements for demonstrating the reliability and validity of IVD devices.
The fact that it's an "over the counter (OTC) device utilized by persons with diabetes in home settings" and "for single-patient use only" describes the intended user and use environment, but it doesn't change its fundamental classification as an IVD based on its function of measuring a substance in a biological sample outside the body for medical purposes.
N/A
Intended Use / 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. The system consists of a Contour NEXT LINK Wireless 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 from 20 to 600 mg/dL.
The CONTOUR® NEXT Control Solutions are aqueous glucose solutions intended for use in selftesting by people with diabetes as a quality control check.
The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit dlucose 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LFR, NBW, JJX
Device Description
The Contour® NEXT LINK Wireless Blood Glucose Monitoring System consists of a small handheld electronic device is substantially equivalent in look and feel to the Contour® USB predicate system (K091820). The System also contains dry reagent 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 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.
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. (Implies all other ages)
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)
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary-New Device
Precision
- Repeatability (ISO 15197 Section 7.2.2)
- Protocol: The repeatability of the CONTOUR NEXT LINK wireless blood glucose monitoring system was tested at glucose levels of 38, 78, 122, 204 and 326 mg/dL. Three lots of Contour Next reagent strips were tested across 10 Contour NEXT LINK wireless meters.
- Acceptance Criteria: Internal acceptance criteria are Cpk > 0.65 at all levels.
- Results: Pass, All Cpk's greater than 0.65.
- Intermediate Precision (ISO 15197 Section 7.2.3)
- Protocol: The intermediate precision of the CONTOUR® NEXT LINK wireless blood glucose monitoring system was determined using three levels of Contour NEXT control on three Contour NEXT strip lots on 10 Contour NEXT LINK wireless meters over the course of 10 days.
- Acceptance Criteria for Contour reagent strips: Internal acceptance criteria are Cp > 1.0 at all levels.
- Acceptance Criteria for Contour NEXT reagent strips: Internal acceptance criteria are Cp > 1.0 at all levels.
- Results: Pass. All Cp’s above 1.0
Accuracy
- System Accuracy Evaluation (ISO 15197 Section 7.3)
- Protocol: The accuracy of the CONTOUR®NEXT LINK wireless blood glucose monitoring system was assessed using 100 fresh capillary blood specimens that were collected during a fingerstick study at the Mishawaka site. The blood samples were tested using three CONTOUR® NEXT reagent lots, 10 vials per lot to yield 300 results. The reference measurement was done on a YSI™ glucose analyzer.
- Acceptance Criteria: 95% ± 15 mg/dL
§ 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.
0
MAR 2 8 2012
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements
of 21
Submitter Information | |
---|---|
Name | Bayer Healthcare, Diabetes Care |
Address | 430 S Beiger St |
Mishawaka IN 46544 | |
Phone number | 574-256-3441 |
Fax number | 547-256-3519 |
Establishment Registration Number | 1826988 |
Name of contact person | Roger Sonnenburg |
Date prepared | 3/26/2012 |
Trade or proprietary name | Contour® NEXT LINK Wireless Blood Glucose Meter |
Common or usual name | Blood Glucose Meter |
Classification 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, Over The Counter) |
Legally marketed device(s) to which equivalence is claimed | Predicate 1 Contour USB (K091820), Predicate 2 One Touch Ultralink (K073231), Predicate 3 Care Link USB (K070438) |
Reason for 510(k) submission | This submission reports a modification of the Contour USB meter (K091820). This modification includes the ability to read a new reagent strip and wireless transmission capabilities with compatible Medtronic Minimed devices |
Device description | The Contour® NEXT LINK Wireless Blood Glucose Monitoring System consists of a small handheld electronic device is substantially equivalent in look and feel to the Contour® USB predicate system (K091820). The System also contains dry reagent 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 |
1
| | software. | 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 | |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Intended use of the
device | See indications for use below | | |
| 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. The system consists of a Contour NEXT LINK wireless 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 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. | | |
| | use of radio frequency communication. | 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 Guardian REAL-TIME and facilitate transfer
of information to Medtronic MiniMed Carelink Therapy Management Software through | |
| | neonates. | 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 | |
| | 1. 13. 2. 13. 1 | nological Characteristics of the New Device Compared to Pre | |
| | Similarities to Predicate 1 | | |
| Characteristic | Predicate 1 | New Device | |
| | Contour USB K091820 | Contour NEXT LINK Wireless | |
| Blood sample volume
Meal markers | 0.6ul | Same as predicate | |
| Automatic calibration | Yes
Yes | Same as predicate
Same as predicate | |
| Communication port | USB | Same as predicate | |
| User interface | Alphanumeric, Iconic, Native
Language | Same as predicate | |
| Display (technology) | Graphical (OLED) | Same as predicate | |
| Display visibility | Day & Night | 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 | |
| | | | |
| Communication Link to
Computer
Displayed countdown | Direct USB Connection or
optional USB Cable
5 seconds | Same as predicate
Same as predicate | |
| Characteristic | Predicate 1
Contour USB K091820 | New Device
Contour NEXT LINK Wireless | |
| Control solution ranges | Low/Normal/High | Level 1/Level 2 | |
| Control solution buffer
concentration | 50-100 mM | 22 mM | |
| Reagent strip
compatibility | Only compatible with Contour
reagent strip | Only compatible with Contour NEXT
reagent strip | |
| Total test time Contour
NEXT reagent strip | N/A | 7 Seconds | |
| Software system
requirements | Windows:XP,SP3,Vista SP2, 7;
MAC OS 10.6.3,10.5.8;
Java 1.6.0_07 or higher, High
power USB port | High power USB port | |
| Double dip function
Contour NEXT reagent
strip | N/A | Yes | |
| Indications for Use | Cleared for home and
professional use and fingertip,
palm and forearm sampling. | Intended for home use, single patient use
only fingertip and palm sampling only.
RF Capability to communicate with
compatible insulin pumps and act as a
data pass through between insulin pumps
and data management software (see
Indications for Use section). | |
| Test memory | 2000 results | 1000 results | |
| User accessible data
storage | Yes (500MB) | No | |
| Data management
software application on- | Yes | No | |
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Summary of the Technological Characteristics of the New Device Compared to Predicate 2 (One Touch Ultralink K073231) - - - - - - -Similarities to Predicate 2 Predicate 2 New Device
Characteristic | One Touch Ultralink | Contour NEXT LINK Wireless |
---|---|---|
Communication | Ability to communicate with | |
compatible insulin pump via RF | Same as predicate | |
Frequency | 916.5 MHz | Same as predicate |
Differences from Predicate 2 | ||
Characteristic | Predicate 2 | |
One Touch Ultralink | New Device | |
Contour NEXT LINK Wireless | ||
User | ||
confirmation | ||
regarding | ||
sending via RF | ||
of BGM result | RF on, RF off | RF on, RF off and RF prompt |
Summary of the Technological Characteristics of the New Device Compared to Predicate 3 (Care Link USB K070438) - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1
| Characteristic | Predicate 3
Care Link USB | New Device
Contour NEXT LINK Wireless |
|--------------------------|------------------------------|------------------------------------------|
| Pass through
function | Yes | Same as predicate |
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary-New Device
Performance Test Summary-New Device | |
---|---|
Characteristic | Results Summary |
Precision | Repeatability (ISO 15197 Section 7.2.2) |
Reference: 510(k) submission, Section Labeled Performance Testing Bench | |
Protocol: The repeatability of the CONTOUR NEXT LINK wireless blood glucose monitoring | |
system was tested at glucose levels of 38, 78, 122, 204 and 326 mg/dL. Three lots of Contour | |
Next reagent strips were tested across 10 Contour NEXT LINK wireless meters. | |
Acceptance Criteria: No ISO criteria stated. Internal acceptance criteria are $Cpk > 0.65$ at all | |
levels. (Cpk is difference between the mean result and the nearest limit, divided by 3 standard | |
deviations.) | |
Results: Pass, All Cpk's greater than 0.65. | |
Intermediate Precision (ISO 15197 Section 7.2.3) | |
Reference: 510(k) submission, Section Labeled Performance Testing Bench | |
Protocol: The intermediate precision of the CONTOUR® NEXT LINK wireless blood glucose | |
monitoring system was determined using three levels of Contour NEXT control on three | |
Contour NEXT strip lots on 10 Contour NEXT LINK wireless meters over the course of 10 | |
days. | |
Acceptance Criteria for Contour reagent strips: No ISO criteria stated. Internal acceptance | |
criteria are $Cp > 1.0$ at all levels. (Cp is the tolerance range divided by 6 standard deviations.) | |
Acceptance Criteria for Contour NEXT reagent strips: Internal acceptance criteria are $Cp > $ | |
1.0 at all levels | |
Results: Pass. All Cp’s above 1.0 |
4
| Accuracy | System Accuracy Evaluation (ISO 15197 Section 7.3)
Reference: 510(k) submission, Section Labeled Performance Testing Bench
Protocol: The accuracy of the CONTOUR®NEXT LINK wireless blood glucose monitoring
system was assessed using 100 fresh capillary blood specimens that were collected during a
fingerstick study at the Mishawaka site. The blood samples were tested using three
CONTOUR® NEXT reagent lots, 10 vials per lot to yield 300 results. The reference
measurement was done on a YSI™ glucose analyzer.
Acceptance Criteria: 95% ± 15 mg/dL . . . . . . . . . -
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| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL
EQUIVALENCE AND/OR OF CLINICAL INFORMATION | |||||
---|---|---|---|---|---|
Clinical | |||||
Performance | |||||
Data/Information | Reference: 510(k) submission, Section Labeled Clinical Trials | ||||
Protocol for Contour NEXT LINK wireless meters using Contour NEXT reagent strips: | |||||
The Contour NEXT wireless blood glucose monitoring system clinical trial included 110 adults | |||||
aged 19-86. 88% of the subjects managed their diabetes at home with insulin. | |||||
Three lots of reagent were tested in the study with each subject randomized to one lot. Each | |||||
subject performed one fingerstick self test, followed by testing of the subject's blood by the study | |||||
staff. Subjects also performed AST self tests on the palm. All meter results were compared to | |||||
the YSI reference results. | |||||
Acceptance Criteria for Contour NEXT LINK wireless meter using Contour NEXT reagent | |||||
strips: | |||||
95% of results within ±20% (≥ 75 mg/dL) or within ±15 mg/dL ( |