(37 days)
The Ascensia BRIO™ Blood Glucose Monitoring System is for the Self-Monitoring of Blood Glucose as an adjunct to the care of person with diabetes.
The Ascensia BRIO™ Blood Glucose Meter is used with Ascensia® EASYFILL™ Blood Glucose Test Strips and ASCENSIA® EASYFILL™ CONTROL SOLUTIONS (Low, Normal, and High) for the measurement of glucose in whole blood. The Ascensia BRIO™ 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® Brio™ Blood Glucose Monitoring System is indicated for use with fingertip capillary whole blood specimens.
The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
The Ascensia BRIO™ Blood Glucose Monitoring System consists of an electrochemical method-based meter and reagent sensor (test strips) designed for testing glucose by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
The Ascensia BRIOTM Blood Glucose Monitoring System test is based on the measurement of electrical current caused by the reaction of glucose with the reagents (glucose oxidase) on the electrode of the test strip. It is conceptually the same as other blood glucose monitoring products available for blood glucose testing. There are 50 test strips in a plastic bottle. The system is specific for glucose and has been referenced to plasma glucose values from fingerstick capillary samples. The System has a linear response to glucose from 30-550 mg/dL.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Ascensia BRIO™ Blood Glucose Monitoring System:
The provided documents are a 510(k) Safety and Effectiveness Summary and the FDA clearance letter for the Ascensia BRIO™ Blood Glucose Monitoring System. These documents are primarily focused on demonstrating substantial equivalence to a predicate device for market clearance, rather than detailing specific, quantified acceptance criteria and study results in the manner typically found in comprehensive medical device validation reports or peer-reviewed publications. As such, some of the requested information (like specific effect sizes for MRMC studies, training set details, or highly granular expert qualifications) is not present in these specific documents.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The provided documents do not explicitly state numerical acceptance criteria in a detailed table format. Instead, the assessment of performance relies on demonstrating "substantial equivalence" to predicate devices. The key performance indicator mentioned is the system's ability to measure glucose within a specified linear range.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Substantial equivalence to current methods for blood glucose monitoring. | "The studies demonstrated that users can obtain blood glucose results that are substantially equivalent to current methods for blood glucose.""The results of clinical evaluations... demonstrate that the device is equivalent in performance to the predicate devices and suitable for its intended use." |
| Specificity for glucose. | "The system is specific for glucose." |
| Linear response for glucose. | "The System has a linear response to glucose from 30-550 mg/dL." |
| Use by persons with diabetes or healthcare professionals. | "studied both internally and externally in a clinical setting by persons with diabetes." |
| Referenced to plasma glucose values. | "The system... has been referenced to plasma glucose values from fingerstick capillary samples." |
Note: For blood glucose meters, typical acceptance criteria often refer to accuracy within specific ranges (e.g., ±15% or ±20% of a reference method for certain glucose concentrations, or error grid analysis like Clarke Error Grid). These specific numerical targets are not provided in this summary.
Study Details
2. Sample size for the test set and data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "An evaluation... was studied both internally and externally in a clinical setting by persons with diabetes." However, the exact number of participants or samples is not specified.
- Data Provenance: The studies were conducted "internally and externally in a clinical setting." The country of origin for the data is not explicitly stated, but given the submitter's address (Elkhart, IN, USA) and FDA regulatory submission, it is highly likely that at least a significant portion, if not all, of the clinical data was generated in the United States. The studies were likely prospective given they involved clinical settings and persons with diabetes using the device.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. However, the ground truth for blood glucose meters typically involves a laboratory reference method performed by trained laboratory personnel.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable/not specified. For blood glucose meters, the "ground truth" is typically established by comparing the device's reading to a laboratory reference method, not by expert adjudication of human interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging or interpretation tasks where multiple human readers assess cases. Blood glucose monitoring systems primarily measure a physiological value, and their performance is assessed against a reference measurement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the fundamental performance of the device itself (the meter and test strip system) represents "standalone" performance. The clinical studies evaluated how users operate the device and how accurately the device measures glucose. The "algorithm" in this context is the electrochemical measurement process and the meter's internal calculations. The statement "The studies demonstrated that users can obtain blood glucose results..." confirms evaluation of the device's final output.
7. The type of ground truth used:
- Ground Truth Type: The ground truth for the test set was based on plasma glucose values from fingerstick capillary samples as measured by current reference methods. The document states, "The system is specific for glucose and has been referenced to plasma glucose values from fingerstick capillary samples."
8. The sample size for the training set:
- Training Set Sample Size: Not specified. For this type of device (electrochemical sensor), there isn't typically a "training set" in the machine learning sense. The device's calibration and algorithm development would be based on internal development data, not necessarily a distinct "training set" as defined in AI studies.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set (if applicable): Not explicitly detailed in the provided documents. The calibration and development of such systems usually involve controlled laboratory experiments comparing the device's readings to highly accurate laboratory reference instruments using known glucose concentrations or patient samples tested by those reference methods.
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DEC 2 2 2004
Bayer HealthCare LLC ASCENSIA BRIO™ Blood Glucose Monitoring System S&E Summary Page 1 of 2
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | November 8, 2004 |
|---|---|
| Submitter: | Bayer HealthCare LLC |
| Address: | 1884 Miles Avenue, P.O. Box 70Elkhart, IN 46515574.262.6928 |
| Contact: | George M. TancosManager, Regulatory Affairs |
| Device: | Trade/Proprietary Name: Ascensia BRIO™ Blood GlucoseMonitoring System |
| Common/Usual Name: Blood Glucose Meter | |
| Document Control Number: K04 3/58 | |
| Classification: | Division of Clinical Laboratory DevicesPanel - Clinical Chemistry and ToxicologyClassification Code – 75 CGA (Glucose Oxidase, Glucose) |
| Predicate Devices: | ASCENSIA ELITE™ Diabetes Care System |
| Device Description: | The Ascensia BRIO™ Blood Glucose Monitoring System consistsof an electrochemical method-based meter and reagent sensor (teststrips) designed for testing glucose by persons with diabetes or byhealthcare professionals in the home or in healthcare facilities. |
| Intended Use: | The Ascensia BRIO™ Blood Glucose Monitoring System is for theSelf-Monitoring of Blood Glucose as an adjunct to the care ofperson with diabetes. 1 |
1 "Consensus Statement on Self-Monitoring of Blood Glucose, " Diabetes Care, Vol. 10, No. 1, January-February 1987, pp. 95.99
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| TechnologicalCharacteristics: | The Ascensia BRIOTM Blood Glucose Monitoring System test is based on the measurement of electrical current caused by the reaction of glucose with the reagents (glucose oxidase) on the electrode of the test strip. It is conceptually the same as other blood glucose monitoring products available for blood glucose testing. There are 50 test strips in a plastic bottle. The system is specific for glucose and has been referenced to plasma glucose values from fingerstick capillary samples. The System has a linear response to glucose from 30-550 mg/dL. |
|---|---|
| Assessment ofPerformance: | An evaluation of the Ascensia BRIOTM Blood Glucose Monitoring System was studied both internally and externally in a clinical setting by persons with diabetes. The studies demonstrated that users can obtain blood glucose results that are substantially equivalent to current methods for blood glucose. |
| Conclusion: | The results of clinical evaluations of the Ascensia BRIOTM Blood Glucose Monitoring System demonstrate that the device is equivalent in performance to the predicate devices and suitable for its intended use. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three horizontal lines above it, resembling an abstract representation of a person and their spirit or well-being.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 2 2004
Mr. George M. Tancos Manager, Regulatory Affairs Bayer HealthCare LLC. 1884 Miles Avenue, P.O. Box 70 Elkhart, IN 46514-0070
Re: K043158
Trade/Device Name: Ascensia BRIOTM Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: November 12, 2004 Received: November 15, 2004
Dear Mr. Tancos:
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Sincerely yours,
Cornelia B. Lorkis
Cornelia B. Rooks, MA Acting 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): ____________________________________________________________________________________________________________________________________________________
(If known). (86-2151)
Device Name: Ascensia BRIO™ Blood Glucose Monitoring System
Indications For Use:
The Ascensia BRIO™ Blood Glucose Meter is used with Ascensia® EASYFILL™ Blood Glucose Test Strips and ASCENSIA® EASYFILL™ CONTROL SOLUTIONS (Low, Normal, and High) for the measurement of glucose in whole blood. The Ascensia BRIO™ 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® Brio™ Blood Glucose Monitoring System is indicated for use with fingertip capillary whole blood specimens.
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 -XX-(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
| Carol C. Benson |
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Division Sign-Off
5100k
Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of 1
§ 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.