(84 days)
The ASCENSIA BREEZE Blood Glucose Meter is used with the ASCENSIA™ AUTODISC™ Blood Glucose Test Strips and ASCENSIA™ AUTODISCTM CONTROLS for the measurement of glucose in whole blood. The ASCENSIA BREEZE Blood Glucose Meter is an Over-the-Counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings.
The ASCENSIA BREEZE Blood Glucose System is indicated for use with venous, and capillary whole blood samples drawn from the fingertip, palm, forearm, abdomen and thigh.
The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
The ASCENSIA™ BREEZE™ consists of an electrochemical method- based meter and dry reagent sensors (test strips) designed for testing glucose by persons with diabetes.
Here's a breakdown of the acceptance criteria and study information for the Ascensia BREEZE™ Blood Glucose Meter, extracted from 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. Instead, it describes equivalence to a predicate device. The performance is assessed against the performance of the predicate device, ASCENSIA™ DEX® 2.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence in performance to the predicate device, ASCENSIA™ DEX® 2 | The results of the evaluation demonstrated that the ASCENSIA™ BREEZE™ Blood Glucose Meter is equivalent in performance to the predicate device. |
| Suitable for its intended use | The device is suitable for its intended use (Self-Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes). |
| Linear response to glucose within a specified range | The ASCENSIA™ BREEZE™ Blood Glucose Meter has a linear response to glucose from 10-600 mg/dL. |
Note: The FDA's 510(k) clearance is based on a determination of "substantial equivalence" to a legally marketed predicate device, rather than meeting pre-defined numerical performance targets in the same way a PMA (Premarket Approval) might require. The "acceptance criteria" here are implicitly tied to demonstrating this substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document states an "evaluation of the ASCENSIA™ BREEZE™ Blood Glucose Meter was conducted at five clinical sites." However, it does not specify the sample size (number of participants or tests) used in this evaluation.
- Data Provenance: Clinical sites. The specific country of origin is not mentioned, but the submitter is Bayer Corporation, Elkhart, IN, USA, implying the study was likely conducted in the USA.
- Retrospective or Prospective: Not explicitly stated, but clinical evaluations for device clearance are typically prospective in nature, collecting new data specifically for the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
This is not applicable to a blood glucose meter study. MRMC studies are typically for image interpretation tasks performed by multiple human readers (e.g., radiologists). This device is a direct measurement tool. The study did, however, evaluate the device "in the hands of diabetics," suggesting real-world user performance was considered.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the primary evaluation described is of the device itself (algorithm only, in the sense of the chemical and electronic measurement process) as performed by users. The "Assessment of Performance" section focuses on the meter's equivalence. While users operate the device, the performance being assessed is the meter's ability to accurately measure glucose, not human interpretation skills.
7. The Type of Ground Truth Used
The document states that "Blood glucose results are reference to plasma glucose." This strongly implies that the ground truth was established by a laboratory reference method for plasma glucose.
8. The Sample Size for the Training Set
The document does not provide information on a training set size. For a blood glucose meter, the "training" (calibration) is typically part of the device's design and manufacturing process, not a separate data-driven machine learning training set as might be seen for AI algorithms. The "linear response to glucose from 10-600 mg/dL" implies intrinsic calibration.
9. How the Ground Truth for the Training Set was Established
As no training set is explicitly discussed in the context of a machine learning-style model, this question is not directly applicable. However, the inherent calibration and accuracy of the device (its "training" in a broad sense) would be based on precise chemical standards and reference methods for glucose measurement, ensuring its linear response from 10-600 mg/dL, with plasma glucose as the reference.
{0}------------------------------------------------
Bayer Corporation, Business Group Diagnostics Ascensia TM Breeze™ Blood Glucose Meter Page 1 of 2
MAR 0 3 2003
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | December 2, 2002 |
|---|---|
| Submitter: | Bayer Corporation, Business Group Diagnostics |
| Address: | 1884 Miles AvenueP.O. Box 70Elkhart, IN 46515574.262.6928 |
| Contact: | George M. Tancos RACManager, Regulatory Affairs |
| Device: | |
| Trade/Proprietary Name: Ascensia ™ BREEZE™ Blood Glucose Meter | |
| Common/Usual Name: Test for glucose in whole blood -- Blood Glucose Meter | |
| Document Control Number: K024062 | |
| Classification Name: | Division of Clinical laboratory DevicesPanel -- Clinical Chemistry and ToxicologyClassification Code -- 75 CGA (Glucose Oxidase, Glucose) |
| In 21 CFR 862.1345, a glucose test system is classified as a Class II medical device. | |
| Predicate Devices: | ASCENSIA™ DEX® 2Manufactured by: Bayer Diagnostics, Mishawaka, IN |
| Device Description: | The ASCENSIA™ BREEZE™ consists of an electrochemical method- based meter and dry reagent sensors (test strips) designed for testing glucose by persons with diabetes. |
| Intended Use: | The ASCENSIA™ BREEZE™ Blood glucose Meter is for the Self- Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes. 1 |
1 "Consensus Statement on Self-Monitoring of Blood glucose," Diabetes Care, vol. 10, No. 1, January-February 1987, pages 95-99.
{1}------------------------------------------------
| Technological Characteristics: | The electronics of the ASCENSIA™ BREEZE™ BloodGlucose Meter employs an amperometric glucose oxidasemethod to measure glucose in blood. It is conceptuallysimilar as other blood glucose testing monitoring systemsavailable for blood glucose testing. The Reagent TestSensors are individually sealed in cartridges of tensensors. Blood glucose results are reference to plasmaglucose. The ASCENSIA™ BREEZE™ Blood GlucoseMeter has a linear response to glucose from 10-600mg/dL. |
|---|---|
| Assessment of Performance: | An evaluation of the ASCENSIA™ BREEZE™ BloodGlucose Meter was conducted at five clinical sites todemonstrate the equivalence of the ASCENSIA™BREEZE™ Blood glucose meter to the Ascensia DEX 2Blood Glucose Meter, the predicate device, in the handsof diabetics. |
| Conclusion: | The results of the evaluation of the ASCENSIA™BREEZE™ Blood Glucose Meter demonstrate that themeter is equivalent in performance to the predicate deviceand suitable for its intended use. |
{2}------------------------------------------------
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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three horizontal lines representing its wings and wavy lines representing its tail feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 0 3 2003
Mr. George M. Tancos Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 1884 Miles Avenue P.O. Box 70 Elkhart, IN 46515-0070
Re: K024062
Trade/Device Name: ASCENSIA" BREEZE™ Blood Glucose Meter Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW: CGA Dated: February 18, 2003 Received: February 24, 2003
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 ger.eral controls provisions of the Act include requirements for annual registration. Iisting 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).
{3}------------------------------------------------
Page 2 -
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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Number (if known): K024062
Device Name:
Indications for Use:
ASCENSIA™ BREEZE™ Blood Glucose Meter
The ASCENSIA BREEZE Blood Glucose Meter is used with the ASCENSIA™ AUTODISC™ Blood Glucose Test Strips and ASCENSIA™ AUTODISCTM CONTROLS for the measurement of glucose in whole blood. The ASCENSIA BREEZE Blood Glucose Meter is an Over-the-Counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings.
The ASCENSIA BREEZE Blood Glucose System is indicated for use with venous, and capillary whole blood samples drawn from the fingertip, palm, forearm, abdomen and thigh.
The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
Sean Conroy
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number KE24062
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
$\varnothing R$
and
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.