(501 days)
The IWL2020 Blood Glucose Monitoring System is comprised of the IWL2020 meter and IWL2020 test strips. The IWL2020 Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip as an aid in monitoring the effectiveness of glucose control.
The IWL2020 Blood Glucose Monitoring System is intended for in vitro diagnostic single patient use by people with diabetes at home.
The IWL2020 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.
The IWL2020 Blood Glucose Monitoring System consists of the following components:
- IWL2020 Meter
- IWL2020 Blood Glucose Test Strips
- IWL2020 Control Solutions
The IWL2020 Blood Glucose Monitoring System is a handheld device that incorporates features to aid in self-monitoring of blood glucose. The blood glucose results are displayed on the screen and stored in the meter's memory, and may also be transmitted via Bluetooth Low Energy (BLE) wireless communication. Our blood glucose monitoring system creates a glucose result from an amperometric reaction. Capillary whole blood from the user's fingertip reacts with the chemicals in the test strip to create a harmless electrical current in the test strip. The blood glucose meter reads the current and gives a blood glucose result.
The provided text describes the acceptance criteria and a study to prove that the device (IWL2020 Blood Glucose Monitoring System) meets these criteria. The study focuses on demonstrating the substantial equivalence of the IWL2020 system to a legally marketed predicate device (Accu-Chek Guide Blood Glucose Monitoring System).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text outlines performance metrics rather than explicitly listing acceptance criteria as a separate table. However, the "Clinical Performance" section presents accuracy targets which can be interpreted as acceptance criteria based on standard glucose monitoring device expectations.
| Acceptance Criteria (Accuracy vs. Lab Reference) | Reported Device Performance (IWL2020 Blood Glucose Monitoring System) |
|---|---|
| Within ±20% of laboratory reference | 99% (346 of 350 results) |
| Within ±15% of laboratory reference | 96% (336 of 350 results) |
| Within ±10% of laboratory reference | 88% (307 of 350 results) |
| Within ±5% of laboratory reference | 63% (220 of 350 results) |
Additional Non-Clinical Performance Criteria and Results (from "Non-Clinical & Clinical Testing Summary and Conclusions"):
- Measurement Range: 20-600 mg/dL (Supported by Linearity Evaluation)
- Precision (Within-Run Evaluation):
- Glucose Level 1 (20 mg/dL): 1.1 mg/dL SD
- Glucose Level 2 (40 mg/dL): 1.2 mg/dL SD
- Glucose Level 3 (80 mg/dL): 1.8 mg/dL SD
- Glucose Level 4 (130 mg/dL): 2.1 %CV
- Glucose Level 5 (200 mg/dL): 2.3 %CV
- Glucose Level 6 (325 mg/dL): 2.7 %CV
- Glucose Level 7 (450 mg/dL): 2.6 %CV
- Glucose Level 8 (550 mg/dL): 2.6 %CV
- Precision (Intermediate Precision Evaluation):
- Glucose Level 1 (27.8 mg/dL): 1.3 mg/dL SD
- Glucose Level 2 (44.4 mg/dL): 1.3 mg/dL SD
- Glucose Level 3 (113.6 mg/dL): 2.6 %CV
- Glucose Level 4 (291.9 mg/dL): 2.3 %CV
- Glucose Level 5 (495.1 mg/dL): 2.0 %CV
- Glucose Level 6 (541.4 mg/dL): 2.2 %CV
- Linearity (R-squared for All Lots): 0.9985 (indicating strong linearity across the measurement range)
- Interference: All compounds met acceptance criteria except abnormally high concentrations of ascorbic acid (> 5 mg/dL) and xylose.
- Flex Studies: System operated within specified ranges and displayed errors correctly when outside operating ranges.
- Electromagnetic Interference and Electrical Safety: Passed according to national and international standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Performance Test Set: 350 results (implicitly, as 346/350, 336/350, etc., are reported).
- Data Provenance:
- Country of Origin: United States.
- Retrospective or Prospective: Prospective. The text states: "A clinical (user evaluation) study was conducted with IWL2020 Blood Glucose Monitoring System in the intended user population, i.e. lay persons who perform self-testing using capillary whole blood, in the United States." This implies a specifically designed study for evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The text states the clinical performance was "compared to the Roche/Hitachi cobas c 501 PCA-HK reference method." It also mentions "blood glucose readings obtained by trained technicians."
- This suggests the ground truth was established by a laboratory reference method, operated by "trained technicians." The number and specific qualifications (e.g., years of experience) of these technicians, or the experts overseeing the laboratory method, are not explicitly stated.
4. Adjudication Method for the Test Set
- The text does not mention any adjudication method (e.g., 2+1, 3+1) for the clinical performance data. The comparison is directly between the device readings and the laboratory reference method readings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not performed as described.
- The study was a user evaluation (clinical performance) to assess how well "non-professional, inexperienced lay persons" obtained accurate readings with the IWL2020 system compared to a laboratory reference. It does not compare human readers with AI assistance versus without AI assistance. The IWL2020 is a blood glucose monitoring system, not an AI-powered image analysis tool for diagnostic imaging, which is where MRMC studies are typically applied.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- The primary clinical performance study described is the user evaluation, which involves "lay persons who perform self-testing." This inherently includes human-in-the-loop performance.
- However, the "Non-Clinical & Clinical Testing Summary and Conclusions" section also includes various non-clinical evaluations (e.g., Within-Run Precision, Intermediate Precision, Linearity, Interference, Flex Studies, Electromagnetic Interference, Electrical Safety). These tests assess the device's technical performance in a controlled setting, which can be seen as standalone testing of the algorithm/device's core functionality, without user variability being the primary focus. Specifically, the "System Accuracy" refers to the accuracy of the device's readings when compared to a reference method, which is an assessment of the device's inherent capability.
7. Type of Ground Truth Used
- Laboratory Reference Method: The ground truth for the clinical performance study was established using the "Roche/Hitachi cobas c 501 PCA-HK reference method." This is a highly accurate laboratory instrument.
8. Sample Size for the Training Set
- The document describes testing and validation, but it does not explicitly state the sample size used for a training set. Blood glucose monitoring systems typically derive their algorithms from fundamental electrochemical principles and calibrations, rather than machine learning models that require distinct training sets in the same way as, for example, an AI imaging diagnostic tool. The "linearity evaluation" used blood samples from eleven glucose concentration levels run on 36 IWL2020 meters using strips from three lots, which would contribute to the device's calibration or "training" in a broad sense, but not in the context of a 'training set' for a deep learning model.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not explicitly mentioned in the context of a machine learning model, the method for establishing its ground truth is not detailed. For the device's fundamental calibration and performance, the "linearity evaluation" involved preparing blood samples at "eleven blood glucose concentration levels." These concentrations would typically be precisely measured by a highly accurate laboratory reference method (like the Roche/Hitachi cobas c 501 PCA-HK or similar primary standards) to serve as the ground truth for establishing the device's internal calibration curve.
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May 6, 2022
Roche Diabetes Care, Inc. Kelly Brennan Regulatory Compliance Lead 9115 Hague Road Indianapolis, Indiana 46250-0457
Re: K203711
Trade/Device Name: IWL2020 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: January 31, 2022 Received: February 1, 2022
Dear Kelly Brennan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-Torres. Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203711
Device Name
IWL2020 Blood Glucose Monitoring System
Indications for Use (Describe)
The IWL2020 Blood Glucose Monitoring System is comprised of the IWL2020 meter and IWL2020 test strips. The IWL2020 Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip as an aid in monitoring the effectiveness of glucose control.
The IWL2020 Blood Glucose Monitoring System is intended for in vitro diagnostic single patient use by people with diabetes at home.
The IWL2020 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K203711 - IWL2020 Blood Glucose Monitoring System 510(k) Summary
Submitter Details [21 CFR 807.92(a)(1)]
Submitter Name: Roche Diabetes Care, Inc. Submitter Address: 9115 Hague Road Indianapolis, IN 46250-0457; United States of America Submitter Contact Telephone: 317-361-9101 Submitter Contact: Ms. Kelly Brennan Submitter Contact Email: kelly.brennan@roche.com Secondary Contact Name: Roche Diabetes Care, Inc. Secondary Contact Address: 9115 Hague Road Indianapolis, IN 46250-0457; United States of America Secondary Contact Telephone: 317-840-9231 Secondary Contact: Ms. Ginger Emrich Secondary Contact Email: qinger.emrich@roche.com
Device Name [21 CFR 807.92(a)(2)]
Device Trade Name: IWL2020 Blood Glucose Monitoring System Common Name: Glucose test system Classification Names: Blood Glucose Test System, Over the Counter; Glucose dehydrogenase Regulation Number: 862.1345, Class II Product Code: NBW
Legally Marketed Predicate Devices [21 CFR 807.92(a)(3)]
Predicate #: K160944 Predicate Trade Name: Accu-Chek Guide Blood Glucose Monitoring System Product Code: NBW
Device Description Summary [21 CFR 807.92(a)(4)]
The IWL2020 Blood Glucose Monitoring System consists of the following components:
- IWL2020 Meter
- IWL2020 Blood Glucose Test Strips
- IWL2020 Control Solutions
The IWL2020 Blood Glucose Monitoring System is a handheld device that incorporates features to aid in self-monitoring of blood glucose. The blood glucose results are displayed on the screen and stored in the meter's memory, and may also be transmitted via Bluetooth Low Energy (BLE) wireless communication. Our blood glucose monitoring system creates a glucose result from an amperometric reaction. Capillary whole blood from the user's fingertip reacts with the chemicals in the test strip to create a harmless electrical current in the test strip. The blood glucose meter reads the current and gives a blood glucose result.
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Intended Use/Indications for Use [21 CFR 807.92(a)(5)]
The IWL2020 Blood Glucose Monitoring System is comprised of the WL2020 test strips.
The IWL2020 Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip as an aid in monitoring the effectiveness of glucose control.
The IWL2020 Blood Glucose Monitoring System is intended for in vitro diagnostic single patient use by people with diabetes at home.
The IWL2020 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.
Indications for Use Comparison [21 CFR 807.92(a)(5)]
The indications for use of the candidate device are the same as the predicate with the exception that the Alternate Site Testing (AST) claim will not be made with the candidate device.
Technological Comparison [21 CFR 807.92(a)(6)]
The IWL2020 Blood Glucose Monitoring System measurement engine, measurement principle, and control solutions are the same as those used in the Accu-Chek Guide Blood Glucose Monitoring System. The candidate and predicate devices share the same technological characteristics including design, material, chemical composition, principle of operation, and energy source. The IWL2020 Blood Glucose Monitoring System differs from the cleared Accu-Chek Guide Blood Glucose Monitoring System as follows:
- Guide Blood Glucose Monitoring System: Palm, Forearm, Upper Arm;
- IWL2020 Blood Glucose Monitoring System: No AST claim
- Guide Blood Glucose Monitoring System: Dot Matrix Display;
- IWL2020 Blood Glucose Monitoring System: Fixed Segment
- Guide Blood Glucose Monitoring System: 1 Button;
- IWL2020 Blood Glucose Monitoring System: 2 Buttons
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Similarities / Differences from Candidate Device to Predicate Device
| Product feature | Accu-Chek GuideBlood GlucoseMonitoring System(Predicate Device) | IWL2020 Blood GlucoseMonitoring System(Candidate Device) |
|---|---|---|
| Indications for Use | Quantitative measurement ofglucose (sugar) in freshcapillary whole bloodsamples. | Same |
| Alternate Site Testing | Palm, Forearm, and Upper Arm | No AST Claim |
| Enzyme | FAD-GDH | Same |
| Test Principle | Amperometric Detection | Same |
| Primary Container (test stripvial) | Black, flip top oval vial, holdsup to 50 strips | Black flip top round vial, holdsup to 50 strips |
| Sample Volume | 600 nanoliters | Same |
| Sample Test Time | ≤ 5 seconds | Same |
| Measurement Range | 20-600 mg/dL | Same |
| Units of Measurement | mg/dL | Same |
| Hematocrit Range | 10-65% | Same |
| Operating Temperature Range | 4-45 °C | Same |
| Operating Relative HumidityRange | 10-90% | Same |
| Maximum Altitude | 10,150 feet | Same |
| Underdose Detection | Yes | Same |
| Batteries | 2 CR2032 | Same |
| Control Solution | Aqueous, 2 Levels | Same |
| Display | Dot Matrix LCD | Fixed Segment LCD |
| Backlight | Yes | Same |
| Buttons | 1 | 2 |
| Strip Ejector | Yes | Same |
| Connectivity | USB for PC connectivity andBLE (Bluetooth Low Energy)for wireless connectivity | Same |
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Non-Clinical & Clinical Testing Summary and Conclusions [21 CFR 807.92(b)]
Design verification and validation testing was performed to ensure the IWL2020 Blood Glucose Monitoring System met design specifications and requirements. Testing is summarized below:
Within-Run Precision Evaluation
Ten replicate assays were each run on ten IWL2020 meters using three strip lots. Venous blood samples at eight concentration levels were used in the testing. The results are summarized below.
| Glucose Level | Mean | Standard Deviation or % CV |
|---|---|---|
| 1 (20 mg/dL) | 16.6 | 1.1 mg/dL |
| 2 (40 mg/dL) | 38.3 | 1.2 mg/dL |
| 3 (80 mg/dL) | 82.5 | 1.8 mg/dL |
| 4 (130 mg/dL) | 138.7 | 2.1 |
| 5 (200 mg/dL) | 216.7 | 2.3 |
| 6 (325 mg/dL) | 367.0 | 2.7 |
| 7 (450 mg/dL) | 479.7 | 2.6 |
| 8 (550 mg/dL) | 575.1 | 2.6 |
Intermediate Precision Evaluation
Ten replicate assays were each run on ten IWL2020 meters using three strip lots. Linearity solutions at six concentration levels were used in the testing. The results are summarized below.
| Glucose Level | Mean | Standard Deviation or %CV |
|---|---|---|
| 1 | 27.8 | 1.3 mg/dL |
| 2 | 44.4 | 1.3 mg/dL |
| 3 | 113.6 | 2.6 |
| 4 | 291.9 | 2.3 |
| 5 | 495.1 | 2.0 |
| 6 | 541.4 | 2.2 |
Linearity Evaluation
Blood samples were prepared to a hematocrit range of 36-52% and were run on 36 IWL2020 meters using strips from three lots. Samples were prepared at eleven blood glucose concentration levels as shown below.
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| Level | Glucose Concentration Level |
|---|---|
| 1 | 1-9 mg/dL |
| 2 | 15-25 mg/dL |
| 3 | 30-50 mg/dL |
| 4 | 51-70 mg/dL |
| 5 | 80-100 mg/dL |
| 6 | 110-130 mg/dL |
| 7 | 135-165 mg/dL |
| 8 | 175-225 mg/dL |
| 9 | 275-325 mg/dL |
| 10 | 420-480 mg/dL |
| 11 | 550-650 mg/dL |
Linear regression analysis results are shown below.
| Strip Lot | Slope | Y-Intercept | R-squared |
|---|---|---|---|
| All Lots | 1.07 | 0.9342 | 0.9985 |
The results of the linearity study support the glucose measurement range of 20-600 mg/dL for the IWL2020 Blood Glucose Monitoring System.
Interference
Interference testing was performed and all compounds met the acceptance criteria with the exception of abnormally high concentrations (> 5 mg/dL) of ascorbic acid and xylose.
The labeling contains the following limitations:
"Abnormally high concentrations (greater than 5 mg/dL) of ascorbic acid (vitamin C) may cause inaccurate results. High-dose vitamin C therapy that would result in abnormally high concentrations is typically prescribed by your healthcare professional. If you are not sure if this applies to you, please check with your healthcare professional."
"Do not use during or soon after xylose absorption testing since xylose may cause inaccurate results. Xylose absorption testing is performed under the supervision of a doctor. Ask your doctor how long to wait after xylose testing before performing a blood glucose test."
Flex Studies
Flex studies were used to validate the insensitivity of the test system to performance variation due to factors that may contribute to erroneous results when used in home use settings rather than in laboratory or professional healthcare settings. The robustness of the system was validated through mechanical vibration and shock testing, operating conditions (temperature and humidity) testing, altitude effects testing, and stability testing. Additional sources of error that were tested included samples outside the measuring range, short sample detection, sample perturbation, intermittent sampling, and testing with used strips. In all of the tests, the system operated within its specified operating ranges even under stress conditions, and errors were correctly displayed when outside the meter's operating ranges.
Electromagnetic Interference and Electrical Safety
The system passed electrical and safety testing according to national and international standards including IEC 61010-1, IEC 60601-1-2, IEC 61010-2-101, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-6, and IEC 61000-4-8.
The system passed EMC testing to national and international standards including IEC 60601-1-2, and FCC 47 CFR 15 Part B.
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Software
Based on the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005, testing and documentation for Major level of concern software was completed.
Clinical Performance
A clinical (user evaluation) study was conducted with IWL2020 Blood Glucose Monitoring System in the intended user population, i.e. lay persons who perform self-testing using capillary whole blood, in the United States. The study data were presented evaluating the system accuracy of the IWL2020 Blood Glucose Monitoring System compared to the Roche/Hitachi cobas c 501 PCA-HK reference method. Study results indicated that non-professional, inexperienced lay persons were able to obtain sufficiently accurate blood glucose readings when using the IWL2020 Blood Glucose Monitoring System compared to the comparator Roche/Hitachi cobas c 501 PCA-HK blood glucose readings obtained by trained technicians. In addition, the participating lay persons were questioned and responded as satisfied with the ease of operation by following the Instructions for Use in the User Guide and the overall performance of the IWL2020 Blood Glucose Monitoring System. Users were able to achieve the following level of accuracy compared to the reference method:
| (within ±20% of laboratory) | (99%) 346 of 350 results |
|---|---|
| Accurate Results (within ±15% of laboratory) | (96%) 336 of 350 results |
| More Accurate Results (within ±10% of laboratory) | (88%) 307 of 350 results |
| Most Accurate Results (within ±5% of laboratory) | (63%) 220 of 350 results |
Conclusions
The results of nonclinical and clinical performance testing demonstrate that the candidate device has a substantially equivalent safety and effectiveness profile to the predicate device and should perform as intended in the specified use conditions as well as the predicate device per required standards.
§ 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.