(104 days)
The Ascensia BREEZE®2 Blood Glucose Monitoring System consisting of the Ascensia "BREEZE"2 Blood Glucose Meter, Ascensia" BREEZE® Reagent Strips and Ascensia BREEZE®2 Control Solution is for the measurement of glucose in whole blood. The Ascensia BREEZE® 2 Gonton Solution in of the measurement of glucose in whole blood. The Ascensia® BREEZE® 2 Blood Glucose Monitoring System allows the user an option to use the palm and forearm in addition to the fingertip (testing) to collect capillary blood for self-monitoring of blood glucose within certain conditions as explained in the labeling. Ascensia BREEZE®2 Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes. Ascensia BREEZE 2 Blood Glucose Monitoring System is not for use with neonatal blood specimens. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
The Ascensia® BREEZE®2 Blood Glucose Monitoring System consists of:
- Ascensia® BREEZE®2 Blood Glucose Monitor
- Ascensia BREEZE®2 Blood Glucose Test Strips
- Ascensia BREEZE®2 Control Solution
The provided text describes the Ascensia® BREEZE®2 Blood Glucose Monitoring System. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria in a table format with specific performance metrics (e.g., accuracy percentages, limits of agreement). Instead, it makes a general statement about performance.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | "The results of the clinical evaluations of The Ascensia® BREEZE®2 Blood Glucose Monitoring System demonstrated that the device can produce blood glucose results that are substantially equivalent to results obtained on the predicate device." |
| Improved Performance over Original Ascensia® BREEZE® | "The studies showed improved performance compared with past clinical studies of the original Ascensia® BREEZE® Blood Glucose Monitoring System." |
| Linearity Range | "The system has a linearity response to glucose from 20-600 mg/dL." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "subject meter results for capillary blood samples" and "a validation... performed in a clinical setting by persons with diabetes." However, the exact number of participants or samples is not provided.
- Data Provenance: Prospective and clinical. The study was "performed in a clinical setting by persons with diabetes," suggesting a prospective clinical trial. The country of origin is not specified but given the submitter's address (Mishawaka, IN, USA) and FDA submission, it likely involved data from the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The ground truth was established by "results of a laboratory glucose analyzer" and "BREEZE®2 results obtained by a healthcare professional." The specific qualifications of the healthcare professional are not detailed, nor are the specific details of the laboratory glucose analyzer.
4. Adjudication Method for the Test Set
Not specified. The document states that "subject meter results for capillary blood samples were compared with BREEZE®2 results obtained by a healthcare professional and results of a laboratory glucose analyzer." This implies a comparison against these two reference methods, but no adjudication process for discrepancies is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This device is a blood glucose monitoring system, not an imaging device that would typically involve multiple human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance assessment was effectively done. The device's results (from the Ascensia® BREEZE®2 Blood Glucose Monitor used by subjects) were compared directly against reference methods ("BREEZE®2 results obtained by a healthcare professional and results of a laboratory glucose analyzer"). This evaluates the device's performance independently.
7. The Type of Ground Truth Used
The ground truth for the test set was established by:
- Comparison with laboratory glucose analyzer results. This is considered a high-fidelity reference standard for blood glucose measurement.
- Comparison with BREEZE®2 results obtained by a healthcare professional. This serves as another point of comparison, likely using the device itself but operated by a trained professional.
8. The Sample Size for the Training Set
Not applicable/Not provided. The text describes a validation study, but there is no mention of a separate "training set" in the context of an AI/ML algorithm development, as this device predates widespread regulatory submissions for such technologies in medical devices. This is a traditional medical device submission for a blood glucose monitor.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this device predates the typical AI/ML development paradigms involving distinct training sets requiring ground truth establishment in that context.
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Bayer HealthCare Diabetes Care
Image /page/0/Picture/1 description: The image shows the Bayer company logo. The logo is a circle with the word "BAYER" written vertically in the center. The letters are arranged in a cross shape, with the "Y" in the middle. The logo is simple and recognizable, and it is often used on Bayer products and advertising materials.
NOV 2 1 2006
510(k) SUMMARY
Ascensia® BREEZE®2 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 K062347
| Prepared: | August 9, 2006 |
|---|---|
| Submitter: | Bayer HealthCare, Diabetes Care |
| Address: | Bayer HealthCare, Diabetes Care430 South Beiger StreetMishawaka, IN 46544Phone (574) 256-7719; FAX (574) 256-3519 |
| Contact: | Marc A. Henn, Regulatory Affairs Specialist |
| Device: | Trade/Proprietary Name: Ascensia® BREEZE®2 BloodGlucose Monitoring System |
| Common/Usual Name: | Blood Glucose Meter |
| Classification: | Division of Clinical Laboratory DevicesPanel - Clinical Chemistry and ToxicologyClassification Code - 75 CGA, (Glucose Oxidase, Glucose) |
| Predicate Device: | Ascensia BREEZE® Diabetes Care System, K024062 |
| Device Description: | The Ascensia® BREEZE®2 Blood Glucose Monitoring Systemconsists of:1. Ascensia® BREEZE®2 Blood Glucose Monitor2. Ascensia BREEZE®2 Blood Glucose Test Strips3. Ascensia BREEZE®2 Control Solution |
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| Intended Use: | The Ascensia® BREEZE®2 Blood Glucose MonitoringSystem consisting of the Ascensia® BREEZE®2 BloodGlucose Meter, Ascensia® BREEZE®2 Reagent Strips andAscensia® BREEZE®2 Control Solution is for themeasurement of glucose in whole blood. The Ascensia®BREEZE®2 Blood Glucose Monitoring System allows theuser an option to use the palm and forearm in addition to thefingertip (testing) to collect capillary blood for self-monitoringof blood glucose within certain conditions as explained in thelabeling. Ascensia® BREEZE®2 Blood Glucose MonitoringSystem is an over-the-counter (OTC) device used bypersons with diabetes. Ascensia® Breeze®2 Blood GlucoseMonitoring System is not for use with neonatal bloodspecimens. The frequent monitoring of blood glucose is anadjunct to the care of persons with diabetes. |
|---|---|
| TechnologicalCharacteristics: | The Ascensia® BREEZE®2 Blood Glucose MonitoringSystem employs an amperometric glucose oxidase methodto measure glucose in blood. It is conceptually the same asother blood glucose monitoring products available for bloodglucose testing. Blood glucose results are referenced toplasma glucose. The system has a linearity response toglucose from 20-600 mg/dL. |
| Assessment ofPerformance: | A validation of the Ascensia® BREEZE®2 Blood GlucoseMonitoring System was performed in a clinical setting bypersons with diabetes. The subject meter results forcapillary blood samples were compared with BREEZE®2results obtained by a healthcare professional and results ofa laboratory glucose analyzer. The studies showedimproved performance compared with past clinical studies ofthe original Ascensia® BREEZE® Blood Glucose MonitoringSystem. |
| Conclusion: | The results of the clinical evaluations of The Ascensia®BREEZE®2 Blood Glucose Monitoring System demonstratedthat the device can produce blood glucose results that aresubstantially equivalent to results obtained on the predicatedevice. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion. The logo is rendered in black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Roger Sonnenburg Manager, Regulatory Affairs Bayer HealthCare, LLC 430 South Beiger St. Mishawaka, IN 46544
NOV 2 1 2006
Re: K062347
Trade/Device Name: Ascensia® BREEZE®2 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: November 15, 2006 Received: November 16, 2006
Dear Mr. 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 vours.
Alberto Gutierrez
Alberto Gutierrez, Ph.D.
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): K062347
Device Name: Ascensia® BREEZE®2 Blood Glucose Monitoring System
Indications For Use: The Ascensia BREEZE®2 Blood Glucose Monitoring System consisting of the Ascensia "BREEZE"2 Blood Glucose Meter, Ascensia" BREEZE® Reagent Strips and Ascensia BREEZE®2 Control Solution is for the measurement of glucose in whole blood. The Ascensia BREEZE® 2 Gonton Solution in of the measurement of
glucose in whole blood. The Ascensia® BREEZE® 2 Blood Glucose Monitoring System allows the user an option to use the palm and forearm in addition to the fingertip (testing) to collect capillary blood for self-monitoring of blood glucose within certain conditions as explained in the labeling. Ascensia BREEZE®2 Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes. Ascensia BREEZE 2 Blood Glucose Monitoring System is not for use with neonatal 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 (21 CFR 801 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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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L062347
§ 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.