(132 days)
The ACCU-CHEK® Aviva system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring blood glucose in the home or health care facility. The device is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.
The ACCU-CHEK Aviva system utilizes reagent test strips stored within a desiccated vial. A test strip is removed from the vial and inserted into the meter. Upon insertion, the meter is activated. Blood is applied to the end of the test strip, and a glucose result is reported. The test principle is: Blood from the test site works with the chemicals in the test strip to make a small electrical current in the test strip. The meter reads the current and gives the blood glucose result.
Acceptance Criteria and Device Performance Study for ACCU-CHEK® Aviva System
This document describes the acceptance criteria and the study that demonstrates the ACCU-CHEK® Aviva System meets these criteria, based on the provided FDA 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria in the typical "pass/fail" format often seen for performance studies. Instead, it focuses on demonstrating substantial equivalence to a predicate device (ACCU-CHEK Advantage system, K010362 and K032552) through similarities and highlighted differences which represent technological advancements and improved features. The "reported device performance" is inferred from the described benefits and technological improvements that are inherently tied to performance.
| Aspect | Acceptance Criteria (Inferred from Predicate Equivalence and Benefits) | Reported Device Performance (ACCU-CHEK Aviva) |
|---|---|---|
| Intended Use | Quantitatively measure glucose in capillary whole blood for persons with diabetes or healthcare professionals for home/facility monitoring. | Meets this criterion; indicated for professional use and over-the-counter sale. Professionals can test capillary and venous blood, lay users are limited to capillary whole blood. Testing sites include fingertip, palm, forearm, upper arm, thigh, and calf. |
| Sample Type | Utilize whole blood samples (capillary or venous). | Utilizes whole blood samples (capillary or venous for professionals, capillary only for lay users). |
| Operating Environment | Suitable for home and professional use. | Intended for use in the home or healthcare facilities. |
| Closed System | Test strips and controls designed for use only with the specific system. | Test strips and controls are designed to be used only with the ACCU-CHEK Aviva system. |
| Test Strip Storage | Store at room temperature, less than 90°F. Do not freeze. | Same storage conditions: room temperature, less than 90°F. Do not freeze. |
| Quality Control Procedure | Defined procedure for when to test quality controls. | Same quality control procedure: when cap is left off vial, new vial opened, meter dropped, result doesn't agree with user's feeling, or to check system performance. |
| Reportable Range | 10 – 600 mg/dL. | Same reportable range: 10 – 600 mg/dL. |
| Warnings and Precautions | For in vitro diagnostic use only. | For in vitro diagnostic use only. |
| Monitor Coding Process | Use a code key, included in test strip vial, inserted into the meter. | Uses a code key, included in the test strip vial, inserted into the meter. |
| Test Strip Packaging | Provide test strips in a desiccated vial. | Provides test strips in a desiccated vial. |
| Identification of Control | Implicitly, a reliable method for distinguishing controls from blood samples. (Predicate: Manual flagging) | Automatically distinguishes control solutions from whole blood samples, improving usability and reducing user error compared to the predicate. |
| Test Sample Volume | Implicitly, a practical and sufficient volume. (Predicate: 4.0 uL) | Requires 0.6 uL, a significant reduction from the predicate's 4.0 uL, indicating improved efficiency and potentially less discomfort for the user. |
| Test Time | Implicitly, a reasonable time for results. (Predicate: 26 seconds) | Provides results in 5 seconds, a substantial reduction from the predicate's 26 seconds, enhancing user convenience. |
| Test Strip Expiration | Implicitly, clear information regarding expiration. (Predicate: Labeling only) | Code key contains expiration date, and the system informs the user when the code key has expired, providing an additional fail-safe against using expired strips, an improvement over the predicate's labeling-only notification. |
| Test Strip Technology | Implicitly, a robust and accurate measurement principle. (Predicate: Electrical biamperometry) | Utilizes both AC/DC electrical impedance information, which is described as a new technology allowing for several fail-safes. This implies improved accuracy and reliability compared to the predicate's electrical biamperometry. |
| Blood Glucose Range Labeling | Provide appropriate guidance on normal blood glucose ranges. | Provides updated labeling instructions for normal fasting (74-106 mg/dL) and post-meal (<140 mg/dL) blood glucose ranges for non-diabetics, and advises consultation with a doctor for diabetic ranges. This is a subtle update to the predicate's ranges (70-105 mg/dL fasting) but aligns with current understanding at the time. |
| Test Strip Integrity | Implicitly, reliable performance even under varying conditions; protection against compromised strips. (Predicate: Not explicitly detailed fail-safes) | Performs more than 150 checks on the integrity of each test strip prior to use. Strips exposed to excessive heat or humidity are not used to generate results, ensuring result accuracy. |
| Environmental Compensation | Implicitly, accurate results across physiological variations like temperature and hematocrit. (Predicate: Not explicitly detailed compensation) | Automatically compensates for some variation in temperature and hematocrit through the AC electrical information channel, indicating improved accuracy and robustness across different user conditions compared to the predicate. |
| User Lockout (Expiration) | Implicitly, prevention of using inoperable or expired components. | Automatically locks out the user after the test strip expiration date has been exceeded, preventing potentially inaccurate results from expired strips, a significant safety and reliability improvement. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for a specific "test set" or a detailed performance validation study with specific number of participants. It rather focuses on demonstrating substantial equivalence based on features and technological differences. Therefore, details regarding the country of origin of the data or whether it was retrospective or prospective are also not available in the provided text.
3. Number of Experts and Their Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for a test set. This type of detail is typically found in clinical performance studies where expert review is necessary, which is not fully detailed here.
4. Adjudication Method
As no explicit "test set" and ground truth establishment by experts is detailed, no adjudication method (e.g., 2+1, 3+1, none) is mentioned or applicable based on the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not mentioned in the provided document. The device is a glucose meter, intended for direct measurement rather than interpretation of images or signals by multiple human readers, so such a study would generally not be relevant.
6. Standalone Performance Study
While a detailed study with specific performance metrics (e.g., accuracy against a laboratory reference method with a defined sample size) is not provided in a summary table within this document, the fact that the device automatically provides a glucose result implies a standalone performance was conducted/demonstrated as part of the overall regulatory submission. The document states "Blood is applied to the end of the test strip, and a glucose result is reported," and describes how the meter reads the current and gives the blood glucose result, confirming its independent operational capability. However, the exact methodology and results of such a standalone study (e.g., accuracy, precision) are not detailed in this summary.
7. Type of Ground Truth Used
For a glucose meter, the "ground truth" for evaluating accuracy typically involves comparison against a laboratory reference method (e.g., YSI analyzer, hexokinase method). While the document does not explicitly state the ground truth method used, it is standard practice for glucose meters to be validated against such methods. "Expert consensus," "pathology," or "outcomes data" would generally not be the primary ground truth for glucose measurements.
8. Sample Size for the Training Set
The document does not explicitly mention a training set sample size. Glucose meters typically do not involve machine learning models that require a distinct "training set" in the same way AI-powered image analysis systems do. The development and calibration of such devices usually involve extensive testing with various blood samples to ensure accuracy and robustness across different physiological conditions, which could be considered an iterative development and testing process.
9. How the Ground Truth for the Training Set Was Established
Since a distinct "training set" in the context of machine learning is not implied or detailed, the document does not describe how ground truth for a training set was established. The development likely involved calibrating the electrical response of the test strip technology against known glucose concentrations, derived from laboratory reference methods on blood samples.
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| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| 1) Submitter name, address, contact | Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250(317)845-2000 |
| Contact Person: Scott Thiel | |
| Date Prepared: December 15, 2004 | |
| 2) Device name | Proprietary name: ACCU-CHEK® Aviva System |
| Common name: Whole blood glucose test system | |
| Classification name: 75, LFR, Glucose dehydrogenase, glucose | |
| 3) Predicate device | We claim substantial equivalence to the ACCU-CHEK Advantage system, K010362 and K032552. |
| 4) Device description | The ACCU-CHEK Aviva system utilizes reagent test strips stored within a desiccated vial. A test strip is removed from the vial and inserted into the meter. Upon insertion, the meter is activated. Blood is applied to the end of the test strip, and a glucose result is reported. |
| The test principle is: | |
| Blood from the test site works with the chemicals in the test strip to make a small electrical current in the test strip. The meter reads the current and gives the blood glucose result. |
Continued on next page
K 003474
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- Intended Use The ACCU-CHEK® Aviva system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring blood glucose in the home or health care facility. The device is indicated for professional use and over-thecounter sale. Professionals may use the test strips to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.
The Roche Diagnostics ACCU-CHEK Aviva system is substantially 6) Comparison to predicate equivalent to other products in commercial distribution intended for similar device use. Most notably it is substantially equivalent to the currently marketed ACCU-CHEK Advantage system.
The ACCU-CHEK Aviva system is similar to the ACCU-CHEK Advantage 7) Similarities to predicate system in the following ways: device
| Topic | Comment |
|---|---|
| Intended Use | Both systems are intended for testingglucose in whole blood by personswith diabetes or by health careprofessionals in the home or inhealth care facilities. |
| Closed system | Each systems' test strips andcontrols are designed to be used onlywith that system. |
| Sample types | Both systems utilize whole bloodsamples (capillary or venous). |
| Home and Professional use | Both systems are intended to be usedby persons in their home, or byhealth care professionals in healthcare facilities. |
| Test strip storage conditions | Store at room temperature, less than90°F. Do not freeze. |
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:
| Topic | Comment |
|---|---|
| Quality control procedure | Quality controls are tested when the cap is left off the vial of test strips, when a new vial is opened, if the meter is dropped, if the result does not agree with the way the user feels, whenever the user wishes to check to performance of the system. |
| Reportable range | 10 – 600 mg/dL |
| Warnings and precautions | Both systems are for in vitro diagnostic use only. |
| Monitor coding process | Both systems use a code key, included in the test strip vial, inserted into the meter. |
| Test strip packaging | Both systems provide test strips in a desiccated vial. |
- Similarities to predicate device (continued)
Continued on next page
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- Differences from predicate device
The ACCU-CHEK Aviva system and the ACCU-CHEK Advantage system differ in the following ways:
| Topic | ACCU-CHEK Aviva | ACCU-CHEKAdvantage |
|---|---|---|
| Identification of controlsolution results | Automaticallydistinguishes controlsolutions from wholeblood samples. | User must identify(flag) the controlsolution resultmanually. |
| Test sample volumeTest time | 0.6 uL5 seconds | 4.0 uL26 seconds (ComfortCurve test strips) |
| Expiration | In addition toinformation included inlabeling, the code keycontains expiration dateof associated test strips.System informs userwhen code key hasexpired. | No notification ofexpiration beyond thatincluded in labeling. |
| Test strip technology | The system utilizesboth AC/DC electricalimpedance information. | The system utilizeselectricalbiamperometryinformation. |
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| Topic | ACCU-CHEK Aviva | ACCU-CHEKAdvantage |
|---|---|---|
| Labeling instructionsregarding expectedresults | The normal fastingblood glucose range foran adult withoutdiabetes is 74 – 106mg/dL. Two hoursafter meals, the bloodglucose range for anadult without diabetesis less than 140 mg/dL.For people withdiabetes: please consultyour doctor for theblood glucose rangeappropriate for you. | The normal fastingadult blood glucoserange for a non-diabeticis 70 – 105 mg/dL.One to two hours aftermeals, normal bloodglucose levels shouldbe less than 140 mg/dL.Doctors will determinethe range that isappropriate for theirindividual patients. |
- Differences from predicate device (continued)
Benefits ACCU-CHEK Aviva's new test strip technology is convenient and easy-touse. Its look, feel, and handling are similar and familiar to conventional reagent test strip users.
ACCU-CHEK Aviva's new test strip technology also allows for the addition of several new test strip fail-safes:
- The ACCU-CHEK Aviva system performs more than 150 checks on . the integrity of each test strip prior to use. Strips that have been exposed to excessive heat or humidity are not used to generate test results.
- . The ACCU-CHEK Aviva system automatically compensates for some variation in temperature and hematocrit through the AC electrical information channel.
- The ACCU-CHEK Aviva system automatically locks out the user . after the test strip expiration date has been exceeded.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
APR 2 7 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Scott Thiel Regulatory Affairs Program Principal Roche Diagnostics Corp. 9115 Hague Rd Indianapolis, IN 46260
K043474 Re: Trade/Device Name: ACCU-CHEK® Aviva System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR, JJX Dated: March 28, 2005 Received: March 29, 2005
Dear Mr. Thiel:
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 logally marketed predicate device results in a classification for your device and thus, perceits 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 mobile (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Jean M. Cooper, MS, DUM
Jean M. Cooper, MS, D.V.M. 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: K043474
Device Name: ACCU-CHEK® Aviva System
Indications For Use:
The ACCU-CHEK® Aviva system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring blood glucose in the home or health care facility. The device is intended for professional use and over-the-counter sale. Professionals may use the test strip to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and S
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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.