(393 days)
Not Found
No
The document describes a standard blood glucose monitoring system that measures glucose levels and transmits the data. There is no mention of AI or ML in the intended use, device description, or performance studies. The studies focus on analytical accuracy and user performance, not on algorithmic learning or prediction.
No
The device is a diagnostic tool for measuring blood glucose, not a therapeutic device that directly treats a condition.
No
The "Intended Use / Indications for Use" section explicitly states, "The CONTOUR® LINK Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus." It is used for measurement of glucose in whole blood for persons with diabetes, which is for monitoring, not diagnosis.
No
The device description explicitly states that the system features a "CONTOUR LINK Wireless Blood Glucose Monitor" and "CONTOUR Blood Glucose Test Strips," which are hardware components. The software is part of a larger system that includes physical hardware for measuring glucose.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is "for the measurement of glucose in whole blood". This is a diagnostic measurement performed in vitro (outside the body) on a biological sample (whole blood).
- Sample Type: It uses "fresh capillary whole blood samples drawn from the fingertip". This is a biological specimen.
- Measurement: It performs a "quantitative measurement of glucose". This is a diagnostic test.
- Device Description: It is a "Blood Glucose Monitoring System" which includes a meter and test strips, components specifically designed for in vitro diagnostic testing of blood glucose.
While it's not intended for diagnosis or screening of diabetes, the act of measuring glucose in a blood sample for monitoring purposes in individuals with diabetes falls squarely under the definition of an In Vitro Diagnostic device. The fact that it transmits data to an insulin pump doesn't change its fundamental function as a blood glucose measurement device.
N/A
Intended Use / Indications for Use
The CONTOUR® 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® LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip only. CONTOUR® 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® 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 through use of radio frequency communication.
The CONTOUR® 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
Device Description
The CONTOUR LINK Wireless Blood Glucose Monitoring System features the CONTOUR LINK Wireless Blood Glucose Monitor and the currently marketed CONTOUR Blood Glucose Test Strips, among other components (e.g., lancing device, lancets and control solution)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
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
Precision
Protocol: Venous blood was tested at five glucose concentration ranges: 30 - 50, 51 - 110, 111 - 150, 151 - 250 and 251 - 400mg/dL. One lot of test strips was tested on 10 meters with 10 replicates per meter (n=100).
Intermediate Precision
Protocol: Three levels of control solutions (Low, Normal and High) were tested on 10 meters over the course of 10 days. One measurement was taken per meter per lot per control solution per day.
Accuracy
Protocol: Fresh capillary blood was collected in the glucose range distribution specified by ISO 15197 Section 7.3. One hundred blood samples were tested using each of two CONTOUR test strip lots on two CONTOUR LINK meters for a total of 400 readings. Samples were also tested in parallel on a YSI 2300 STAT PLUS glucose analyzer.
Linearity/assay reportable range
Two studies were conducted to establish the linearity of the CONTOUR system throughout the entire reportable range of 10 to 600 mg/dL. In one study, blood with a hematocrit level of 40% was adjusted to plasma glucose concentrations of 20, 30, 40, 50, and 60 mg/dL and tested with three CONTOUR lots, 24 sensors per lot.
Eight meters were used, with three sensors per lot tested on each.
Detection limit
The low glucose concentration testing conducted as part of the Linearity/Assay Reportable Range above confirmed detection limit. In addition, three production lots of CONTOUR sensors were tested with whole blood samples manipulated to have glucose concentrations of 5, 900, 1200, 1500 and 1800 mg/dL, 24 sensors per samples.
Method comparison with predicate device (K062058)
Protocol: The CONTOUR and CONTOUR LINK meters were tested in a comprehensive fingerstick study using fresh capillary blood samples. In this study, the RF function of the CONTOUR LINK was left on to simulate real-world usage.
Materials and Method: Samples from 111 subjects were collected by fingerstick and tested using two lots of CONTOUR sensors. Four CONTOUR meters were used, with disinfection between each subject. Plasma samples were tested in duplicate on the YSI reference method, with the average value used for the comparison. Hematocrit values also were measured. All measurements were performed at 23°C + 5°C. In most cases, samples were tested fresh from the finger without any modification. However, samples at very low and very high glucose concentrations were created by either glycolyzing a specimen to lower the glucose concentration or supplementing a specimen with a concentrated glucose solution to increase the glucose level.
Clinical study (subject device)
Protocol: The subject pool included 77 adults aged 20 through 85, for use for self-testing, and the resulting accuracy of results, were assessed.
Clinical study (predicate device K062058)
Protocol: The subject device is equivalent to the predicate CONTOUR® device with RF transmission capability added. The subject pool included 109 adults aged 20 through 75, each diagnosed with diabetes. The ability to follow instructions for use for self-testing, and the resulting accuracy of results, were assessed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision
Study Type: Repeatability
Sample Size: 100 (10 meters, 10 replicates each)
Key Results: Cpk values are greater than 1.0 when compared to established accuracy requirements of ± 20% or ± 15mg/dL. Mean, SD and %CV results were provided.
Intermediate Precision
Study Type: Intermediate Precision
Sample Size: Not explicitly stated, but involved 10 meters over 10 days with three control levels.
Key Results: Cp values are over 1.0 when compared to established limits of + 11% or + 5mg/dL. Mean, SD and %CV results were provided for each control level.
Accuracy
Study Type: System Accuracy Evaluation
Sample Size: 400 readings (100 blood samples, 2 test strip lots, 2 meters)
Key Results: 98.7 % of the individual glucose results fell within ± 15 mg/dL of the results obtained on the YSI analyzer at glucose concentrations 75 mg/dL). All control solution test performed by subjects (77) generated in-range glucose values, and all were marked as controls by the meters.
Clinical study (predicate device K062058)
Study Type: Clinical Accuracy (self-testing)
Sample Size: 109 adults
Key Results: Ninety-nine percent of the subjects either did not require any assistance or required answers to questions in an interaction that was comparable to a Customer Service call. Analytical accuracy of the subjects' self-testing was statistically indistinguishable from the laboratory glucose method. More than 96% were within the limits of ±15 mg/dL or ±20% of the laboratory glucose method, thus meeting the established performance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
98.7 % of the individual glucose results fell within ± 15 mg/dL of the results obtained on the YSI analyzer at glucose concentrations 75 mg/dL).
Clinical Study (Predicate Device):
More than 96% were within the limits of ±15 mg/dL or ±20% of the laboratory glucose method.
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.
CONTOUR Blood Glucose Meter (K062058), OneTouch UltraLink Blood Glucose Meter (K073231)
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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510(k) SUMMARY
Summary of 510(k) safety and effectiveness in accordance with the requirements of 21 . CFR 807.92.
Submitter Information | ||
---|---|---|
Name | Bayer Healthcare | |
Address | 555 White Plains Road | |
Tarrytown, NY 10591 | ||
Phone number | (914) 366-1800 | |
Fax number | (914) 366-1899 | |
Establishment | ||
Registration | ||
Number | 3003962513 | |
Name of contact | ||
person | Chuck Ryan | |
Date prepared | March 27, 2012 | |
Name of device | ||
Trade or proprietary | ||
name | CONTOUR® LINK | |
Common or usual | ||
name | Wireless Blood Glucose Monitoring System | |
Classification name | Glucose Test System | |
Classification panel | Clinical Chemistry and Clinical Toxicology | |
Regulation | 21 CFR 862.1345 | |
Product Code(s) | LFR (Glucose Dehydrogenase, Glucose), NBW (System, Test, Blood Glucose, Over The Counter) | |
Legally marketed | ||
device(s) to which | ||
equivalence is claimed | CONTOUR Blood Glucose Meter (K062058) | |
OneTouch UltraLink Blood Glucose Meter (K073231) | ||
Reason for 510(k) | ||
submission | Addition of RF wireless transmission capability | |
Device description | The CONTOUR LINK Wireless Blood Glucose | |
Monitoring System features the CONTOUR LINK | ||
Wireless Blood Glucose Monitor and the currently | ||
marketed CONTOUR Blood Glucose Test Strips, among | ||
other components (e.g., lancing device, lancets and | ||
control solution) | ||
Intended use of the device | See Indications for Use below | |
Indications for use | The CONTOUR® 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® LINK Wireless Blood Glucose Monitoring | ||
System is indicated for use with fresh capillary whole | ||
blood samples drawn from the fingertip only. | ||
CONTOUR® 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® 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 through use of radio frequency | ||
communication. | ||
The CONTOUR® 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. | ||
Summary of the Technological Characteristics of the New Device Compared to | ||
Predicate 1 | ||
SIMILARITIES to Predicate 1 | ||
Characteristic | New Device | |
Bayer's CONTOUR LINK | ||
meter | Predicate 1 | |
Bayer's CONTOUR meter | ||
K062058 | ||
Detection | ||
Technology | Amperometric measurement of | |
blood glucose | same | |
Reference method | Plasma equivalent | same |
Test strip | CONTOUR test strip | same |
Test Strip enzyme | Glucose Dehydrogenase FAD | same |
Calibration/Coding | No coding needed | same |
Accuracy | Meets ISO 15197 requirements | same |
Reaction time | 5 seconds | same |
DIFFERENCES from Predicate 1 | ||
RF | ||
Communication | ||
Protocol | Transmits glucose values to | |
compatible MiniMed Paradigm | ||
and Guardian REAL Time | ||
devices. | No RF capability | |
Alternative site | ||
testing | Fingertip only | Fingertip, palm or forearm |
Measurement | ||
range | 20-600 mg/dL | 10-600 mg/dL |
Sample type | Capillary whole blood samples | |
only. Not for use on neonates. | Capillary, venous, and | |
arterial whole blood | ||
samples and neonatal blood | ||
samples | ||
Hct range | 20-65% | 0-70% |
Summary of the Technological Characteristics of the New Device Compared to Predicate 2 | ||
SIMILARITIES to Predicate 2 | ||
Characteristic | New Device | |
Bayer's CONTOUR LINK | ||
meter | Predicate 2 | |
LifeScan OneTouch | ||
UltraLink meter | ||
K073231 | ||
Detection | ||
Technology | Amperometric measurement of | |
blood glucose | same | |
Reference method | Plasma equivalent | same |
Accuracy | Meets ISO 15197 requirements | same |
Sample type | Capillary whole blood samples only. Not for use on neonates. | same |
Reaction time | 5 seconds | same |
Measurement range | 20-600 mg/dL | same |
RF Communication Protocol | Transmits glucose values to compatible Medtronic MiniMed devices. | same |
DIFFERENCES from Predicate 2 | ||
Test Strip | CONTOUR test strip | OneTouch Ultra test strip |
Test Strip enzyme | Glucose Dehydrogenase FAD | Glucose Oxidase |
Alternative site testing | Fingertip only | Fingertip, palm or forearm |
Calibration/Coding | No coding needed | Manual coding required |
Hct range | 20-65% | 30-55% |
PERFORMANCE DATA | ||
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR | ||
DETERMINATION OF SUBSTANTIAL EQUIVALENCE |
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Performance Test Summary-New Device
Characteristic
Results Summary
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Precision | Repeatability (ISO 15197 Section 7.2.2) | |||
---|---|---|---|---|
Reference: 510(k) submission, Section 018-4 | ||||
Protocol: Venous blood was tested at five glucose | ||||
concentration ranges: 30 - 50, 51 - 110, 111 - 150, 151 - 250 and | ||||
251 - 400mg/dL. One lot of test strips was tested on 10 meters with | ||||
10 replicates per meter (n=100). | ||||
Acceptance criteria: No ISO acceptance criteria stated. Internal | ||||
acceptance criteria: Repeatability test must perform within the | ||||
established accuracy requirements. | ||||
(Cpk values > 1.0 when compared to established accuracy | ||||
requirements of ± 20% or ± 15mg/dL.). | ||||
Results: Cpk values are greater than 1.0 when compared to | ||||
established accuracy requirements of ± 20% or ± 15mg/dL. | ||||
Mean, SD and %CV were as follows: | ||||
Mean, mg/dL | SD,mg/dL | CV% | ||
41.8 | 1.26 | |||
78.1 | 1.99 | 3.02% | ||
125.7 | 2.55% | |||
198.0 | 2.67 | 2.12% | ||
312.3 | 4.32 | 2.18% | ||
5.01 | 1.60% | |||
Intermediate Precision (ISO 15197 Section 7.2.3) | ||||
Reference: 510(k) submission, Section 018-4 | ||||
Protocol: Three levels of control solutions (Low, Normal and High) | ||||
were tested on 10 meters over the course of 10 days. One | ||||
measurement was taken per meter per lot per control solution per | ||||
day. | ||||
Acceptance criteria: Cp value for 10 days> 1.0 when compared to | ||||
established limits of + 11% or +5mg/dL. | ||||
Results: Cp values are over 1.0 when compared to established limits | ||||
of + 11% or + 5mg/dL. | ||||
Mean, SD and %CV were as follows: | ||||
Control | Mean, | SD,mg/dL | CV% | |
Level | mg/dL | |||
Low | 38.9 | 0.55 | 1.41 | |
Normal | 121.7 | 1.26 | 1.04 | |
High | 354.9 | 4.49 | 1.26 |
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| Accuracy | System Accuracy Evaluation (ISO 15197 Section 7.3)
Reference: 510(k) submission, Section 018-5 | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|----------------|-------|
| | Protocol: Fresh capillary blood was collected in the glucose
range distribution specified by ISO 15197 Section 7.3. One
hundred blood samples were tested using each of two CONTOUR
test strip lots on two CONTOUR LINK meters for a total of 400
readings. Samples were also tested in parallel on a YSI 2300
STAT PLUS glucose analyzer. | | | |
| | Acceptance Criteria: A minimum of 95 % of the individual
glucose results shall fall within ± 15 mg/dL of the results
obtained on the YSI analyzer at glucose concentrations 20 mg/dL | ≤10% | Passed |
| | Acetaminophen | >22 mg/dL | ≤10% | Passed |
| | Uric Acid | >18 mg/dL | ≤10% | Passed |
| | Ascorbic Acid | >30 mg/dL | ≤10% | Passed |
| | Maltose | >200
mg/dL | ≤7% | Passed |
| | Galactose | >200
mg/dL | ≤7% | Passed |
| | Xylose | Interferes with test | | |
| Assay cut-off | Not applicable | | | |
| COMPARATIVE PERFORMANCE INFORMATION SUMMARY | | | | |
| Method
comparison with
predicate device
(K062058) | Reference: 510(k) submission, Section 018-3
Protocol: The CONTOUR and CONTOUR LINK meters were
tested in a comprehensive fingerstick study using fresh capillary
blood samples. In this study, the RF function of the CONTOUR
LINK was left on to simulate real-world usage.
Materials and Method
Samples from 111 subjects were collected by fingerstick and
tested using two lots of CONTOUR sensors. Four CONTOUR
meters were used, with disinfection between each subject.
Plasma samples were tested in duplicate on the YSI reference
method, with the average value used for the comparison.
Hematocrit values also were measured. All measurements were
performed at 23°C + 5°C.
In most cases, samples were tested fresh from the finger without
any modification. However, samples at very low and very high
glucose concentrations were created by either glycolyzing a
specimen to lower the glucose concentration or supplementing a
specimen with a concentrated glucose solution to increase the
glucose level.
Acceptance Criteria: | | | |
.
:
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Image: Bayer logo | ||
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Linearity/assay reportable range - comparison with predicate device (K062058) | A proportionally weighted Deming regression of the CONTOUR sensor data was used to calculate slope, intercept, and the 95% confidence interval around the slope and intercept estimates shall include a 1.0 and 0.0, respectively. |
Results:
A total of 444 paired readings were collected. The plasma glucose range was 23 to 468 mg/dL, and the hematocrit range was 25% to 51.5%. A proportionally weighted Deming regression model was used to calculate slope and intercept estimates. The system performance meets the acceptance criteria.
Slope: 0.989, confidence interval = 0.989 to 1.008
Intercept: 0.49, confidence interval = -0.4 to 1.38 mg/dL
Reference: 510(k) submission, Section 018-2
Protocol: Pooled fresh venous blood at plasma glucose concentrations of approximately 10, 45, 67, 134, 336, and 600 mg/dL were tested on eight CONTOUR LINK meters and eight CONTOUR meters with one lot of test strips. Each sample was tested three times on each meter, and a total of 24 readings were collected per system.
Acceptance criteria:
95% confidence interval width for the percent difference between CONTOUR LINK mean and CONTOUR mean is within ± 4% (± 3 mg/dL if glucose 75 mg/dL). All control solution test performed by subjects (77) generated inrange glucose values, and all were marked as controls by the meters.
Reference: Predicate 510(k) K062058
Protocol: The subject device is equivalent to the predicate CONTOUR® device with RF transmission capability added. The subject pool included 109 adults aged 20 through 75, each diagnosed with diabetes. The ability to follow instructions for use for self-testing, and the resulting accuracy of results, were assessed.
Results:
Ninety-nine percent of the subjects either did not require any assistance or required answers to questions in an interaction that was comparable to a Customer Service call.
Analytical accuracy of the subjects' self-testing was statistically indistinguishable from the laboratory glucose method. More than 96% were within the limits of ±15 mg/dL or ±20% of the laboratory glucose method, thus meeting the established performance criteria.
CONCLUSIONS/DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The performance of the CONTOUR® LINK Blood Glucose Monitoring System is equivalent to the performance of the previously cleared CONTOUR® Blood Glucose Monitoring System (K062058).
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Image /page/10/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three heads, suggesting a focus on multiple aspects of health and human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Bayer HealthCare LLC, Diabetes Care c/o Charles Ryan 777 Old Saw Mill River Road Tarrytown, NY 10591
MAR 2 8 2012
Re: K110587
Trade Name: CONTOUR® Link Wireless Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: LFR, NBW Dated: March 27, 2012 Received: March 28, 2012
Dear Mr. Ryan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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): and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number K110587:
Device Name: CONTOUR® LINK Wireless Blood Glucose Monitoring System
Indications for Use:
The CONTOUR® 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® LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip only.
CONTOUR® 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® 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 through use of radio frequency communication.
The CONTOUR® 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 X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
ARS
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k1101587