(53 days)
The Ascensia® CONTOUR®Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Ascensia CONTOUR® Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.
The Ascensia CONTOUR® Blood Glucose Monitoring System is indicated for use with capillary, venous, and arterial whole blood samples and neonatal blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, and in the case of neonates, the heel.
The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
The Ascensia® CONTOUR® Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The system contains a blood glucose meter, a bottle of strips, a bottle of normal control solution, a lancing device and lancets and instructions for use.
Here's a breakdown of the acceptance criteria and study information for the Ascensia CONTOUR® Blood Glucose Monitoring System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria in a table format for accuracy. Instead, it focuses on demonstrating "equivalent performance" to a predicate device. The performance assessment section describes the studies conducted.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent performance to predicate device | Studies showed equivalent performance with the original Ascensia® CONTOUR® Blood Glucose Monitoring System |
| Substantially equivalent to predicate device | Demonstrated that the device produces blood glucose results that are substantially equivalent to results obtained on the predicate device. |
| (Specific accuracy criteria - e.g., % within +/- threshold) | Not specified in the provided text. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions that the device was "studied in the laboratory and in a clinical setting by persons with diabetes." However, it does not specify the sample size for the test set or the country of origin. It indicates that the clinical setting involved "persons with diabetes," suggesting a prospective clinical study component.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth specifically for the test set. It mentions comparison to "a laboratory method," which implies a reference method, but details about the personnel executing this reference method are absent.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. There is no information about human readers or the effect size of AI assistance. This type of study is typically relevant for interpretative devices (e.g., imaging) where expert readers provide interpretations. For a blood glucose meter, the primary comparison would be against a reference method rather than different human interpretations.
6. Standalone (Algorithm Only) Performance
The device itself is a standalone algorithm (blood glucose meter and its internal software). Its performance against the predicate and laboratory method is its standalone performance. There isn't a separate "algorithm only" study distinct from the device's overall performance.
7. Type of Ground Truth Used
The ground truth for evaluating the device's performance was established by:
- Comparison to the original Ascensia® CONTOUR® Blood Glucose Monitoring System (predicate device).
- Comparison to a "laboratory method." The specific type of laboratory method (e.g., YSI analyzer, enzymatic assay) is not detailed, but it serves as the reference standard.
8. Sample Size for the Training Set
The document does not provide information on the sample size for the training set. Blood glucose meters are typically calibrated during manufacturing and would have undergone extensive internal testing, but the specifics of a "training set" for algorithm development are not disclosed here.
9. How Ground Truth for the Training Set Was Established
The document does not describe how ground truth for any potential "training set" was established. Given the nature of a blood glucose meter, the "training" would likely involve robust manufacturing calibration and quality control procedures using known glucose concentrations.
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Bayer HealthCare Diabetes Care Division
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SEP 1 1 2006
510(k) SUMMARY
Ascensia Contovr® Blood Glucose Monitoring System
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is K062058.
| Prepared: | August 4, 2006 |
|---|---|
| Submitter: | Bayer HealthCare, Diabetes Care Division |
| Address: | 430 South Beiger StreetMishawaka, IN 46544Phone (574) 262-7152; FAX (574) 262 6945 |
| Contact: | Roger Sonnenburg, Regulatory Affairs Manager |
| Device: | Trade/Proprietary Name: Ascensia® CONTOUR® BloodGlucose Monitoring System |
| Common/Usual Name: | Blood Glucose Meter |
| Classification: | Division of Clinical Laboratory DevicesPanel - Clinical Chemistry and ToxicologyClassification Code – 75 LFR, Glucose Dehydrogenase,Glucose |
| Predicate Device: | Ascensia® CONTOUR® Diabetes Care System, K023657 |
| Device Description: | The Ascensia® CONTOUR® Blood Glucose Monitoring Systemis used for the measurement of glucose in whole blood. Thesystem contains a blood glucose meter, a bottle of strips, abottle of normal control solution, a lancing device and lancetsand instructions for use. |
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Ascensia Page 2 of 2
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| Intended Use: | The Shogun Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Shogun Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The Shogun Blood Glucose Monitoring System is indicated for use with capillary, venous, and arterial whole blood samples and neonatal blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, and in the case of neonates, the heel. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes. |
|---|---|
| Technological Characteristics: | There were no changes to the fundamental scientific technology. |
| Comparison to Predicate device: | The modifications to the device encompass meter design changes, software changes, and labeling changes. There has been no change to the intended use, operating principle, or functionality of the device. |
| Assessment of Performance: | An evaluation of the Ascensia ® CONTOUR ® Blood Glucose Monitoring System was studied in the laboratory and in a clinical setting by persons with diabetes. The results were compared to results from the original Ascensia ® CONTOUR ® Blood Glucose Monitoring System and to a laboratory method. The studies showed equivalent performance with the original Ascensia ® CONTOUR ® Blood Glucose Monitoring System. |
| Conclusion: | The results of the laboratory and clinical evaluations of the Shogun Blood Glucose Monitoring System demonstrated that the device produces blood glucose results that are substantially equivalent to results obtained on the predicate device. Therefore, the system with the modified meter is as safe and effective as the original system. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 1 2006
Mr. Roger Sonnenburg Bayer Healthcare LLC Diabetes Care Division 430 South Beiger Street Mishawaka, IN 46544
Re: K062058
Trade/Device Name: Ascensia® CONTOUR ® Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR Dated: July 19, 2006 Received: July 20, 2006
Dear Mr. Roger 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.
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gu
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology 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 (if known): K062058
Device Name: Ascensia CONTOUR® Blood Glucose Monitoring System
Indications For Use: The Ascensia® CONTOUR®Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Ascensia CONTOUR® Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.
The Ascensia CONTOUR® Blood Glucose Monitoring System is indicated for use with capillary, venous, and arterial whole blood samples and neonatal blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, and in the case of neonates, the heel.
The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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§ 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.