(745 days)
The Contour® next GEN Blood Glucose Monitoring System contour® next GEN meter, Contour® next test strips and the Contour® Diabetes app.
The Contour® next Gen Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Contour® next GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Contour® next GEN Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program.
The Contour® next GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.
The system is intended for in vitro diagnostic use only.
Contour® next GEN Blood Glucose Monitoring System is a blood glucose meter with Bluetooth Low Energy technology built in so that the meter can communicate wirelessly to smart phones and tablets. The meter uses the Contour® next test strips and Contour® next control solution. The meter can be connected to the Contour® Diabetes app. It utilizes a similar algorithm as the one used in the Contour® next ONE blood glucose meter. It uses two replaceable CR2032 coin cell batteries. The meter's shape is a traditional oval form factor and it includes an illuminated strip port with colors indicating if a glucose result is above, within, or below target.
The document provides information on the Contour® next GEN Blood Glucose Monitoring System, a medical device for quantitative measurement of glucose in fresh capillary whole blood. The device has been reviewed by the FDA and determined to be substantially equivalent to a legally marketed predicate device.
Here's an analysis of the provided text, addressing your specific questions about acceptance criteria and the study proving the device meets these criteria:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria for glucose measurement accuracy with specific numerical targets (e.g., % of readings within +/- X mg/dL or %). However, it states that "Clinical trials and bench testing showed that the Contour® next GEN Blood Glucose Monitoring System performed as intended and met the system specifications."
For glucose meters, the generally accepted accuracy standards are often based on ISO 15197 (or similar national standards). The FDA might have specific internal or guidance-based acceptance criteria for substantial equivalence claims. Given the context of a 510(k) submission, the device is being compared to a predicate, implying that its performance is equivalent to, or better than, the predicate device which presumably met relevant accuracy standards at its time of clearance.
Without direct quantitative performance data in this specific document, a table cannot be fully constructed. However, the qualitative "reported device performance" is that it "performed as intended and met the system specifications."
| Acceptance Criteria (Implied from Standard Practice for BGM Systems) | Reported Device Performance |
|---|---|
| Accuracy (e.g., ISO 15197 standard for glucose measurement) | Met system specifications and performed as intended. |
| Usability | Easy to use by typical customers. |
| Safety and Effectiveness | Substantially equivalent to predicate, implying safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Clinical trials and bench testing" and "Usability testing" but does not specify the sample sizes used for these test sets.
Similarly, data provenance (country of origin, retrospective or prospective) is not detailed in this summary. These details would typically be found in the full submission, which is not provided here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
For a blood glucose monitoring system, the "ground truth" for glucose concentration is typically established by laboratory reference methods (e.g., using a YSI glucose analyzer) rather than expert radiographic review. The document does not specify details about the personnel or their qualifications involved in establishing this reference ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically for human reader studies involving subjective interpretations (e.g., radiology). For a blood glucose meter, the "ground truth" is a quantitative measurement from a reference laboratory instrument, which doesn't involve human interpretation directly or require adjudication in the same way. Therefore, this concept is not applicable in the context of a glucose meter's accuracy testing, and no adjudication method is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is relevant for AI-assisted diagnostic imaging, where human readers interpret cases with or without AI assistance. This is not applicable to a blood glucose monitoring system, which provides a direct numerical measurement and is used by individuals for self-monitoring. The device itself is not an AI system assisting human interpretation of images. Consequently, no MRMC study or effect size for human reader improvement is mentioned or expected.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
For a blood glucose meter, the "standalone performance" is essentially the device's accuracy in measuring glucose values against a reference method. The document states that "Clinical trials and bench testing showed that the Contour® next GEN Blood Glucose Monitoring System performed as intended and met the system specifications." This implies that the device's ability to measure glucose values accurately was assessed, which is its standalone performance. The system's algorithm (mentioned as "similar algorithm as the one used in the Contour® next ONE blood glucose meter" and having "Modified terms in the equations") is intrinsic to its measurement process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for a blood glucose monitoring system is established by highly accurate laboratory reference methods for glucose measurement, typically performed on venous blood samples. These reference methods are considered the gold standard for quantifying glucose concentration. The document does not explicitly state "laboratory reference method" but this is the standard practice for such devices.
8. The sample size for the training set
The document does not provide information on the sample size for the training set. Blood glucose meters typically use algorithms (the document mentions "similar algorithm as the one used in the Contour® next ONE" and "Modified terms in the equations"), which might be developed using extensive calibration data. Details about this data (size, characteristics) are not available in this summary.
9. How the ground truth for the training set was established
Similar to the test set, the ground truth for any data used in training/calibration of the glucose meter's algorithm would have been established by highly accurate laboratory reference methods for glucose measurement. The document does not provide specifics on how this was established for the training data.
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December 23, 2021
Ascensia Diabetes Care Colleen Burdel Manager, Regulatory Affairs 100 Summit Lake Drive Valhalla, New York 10595
Re: K193407
Trade/Device Name: Contour® next GEN Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: November 12, 2020 Received: November 13, 2020
Dear Colleen Burdel:
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 and Radiological Health 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) K193407
Device Name
Contour® next GEN Blood Glucose Monitoring System
Indications for Use (Describe)
The Contour® next GEN Blood Glucose Monitoring System contour® next GEN meter, Contour® next test strips and the Contour® Diabetes app.
The Contour® next Gen Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Contour® next GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Contour® next GEN Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program.
The Contour® next GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.
The system is intended for in vitro diagnostic use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is a logo for Ascensia Diabetes Care. The logo features a stylized letter "A" in purple, with a blue teardrop shape next to it. Below the shapes, the word "ASCENSIA" is written in a simple, sans-serif font, and below that, the words "Diabetes Care" are written in a smaller font.
510(k) Summary
510(k) number: K193407
Date prepared: December 22, 2021
According to the requirements of 21 CFR 807.92, the following information is being submitted in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.
| 1) Submitter | Colleen BurdelHead of Product - Regulatory AffairsAscensia Diabetes Care100 Summit Lake DriveValhalla, NY 10595Phone: 914-296-2880Email address: colleen.burdel@ascensia.com |
|---|---|
| 2) Device name: | Trade name: Contour® next GEN Blood GlucoseMonitoring SystemCommon name: Blood Glucose MeterClassification name: 75 NBW; Glucose Test System,ОТС |
| 3) Predicate device: | Contour® Next ONE Blood Glucose MonitoringSystem (K160682) |
| 4) Device description: | Contour® next GEN Blood Glucose Monitoring Systemis a blood glucose meter with Bluetooth Low Energytechnology built in so that the meter can communicatewirelessly to smart phones and tablets. The meteruses the Contour® next test strips and Contour® nextcontrol solution. The meter can be connected to theContour® Diabetes app. It utilizes a similar algorithmas the one used in the Contour® next ONE bloodglucose meter. It uses two replaceable CR2032 coincell batteries. The meter's shape is a traditional ovalform factor and it includes an illuminated strip port withcolors indicating if a glucose result is above, within, orbelow target. |
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Image /page/4/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" formed by a purple triangle and a blue teardrop shape. Below the symbol, the word "ASCENSIA" is written in a bold, sans-serif font, with the words "Diabetes Care" in a smaller font underneath.
- Intended Use: The Contour® next GEN Blood Glucose Monitoring System consists of the Contour® next GEN meter, Contour next test strips and the Contour Diabetes app.
The Contour® next GEN Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Contour® next GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Contour® next GEN Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program.
The Contour® next GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.
The system is intended for in vitro diagnostic use only.
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Image /page/5/Picture/0 description: The image is a logo for Ascensia Diabetes Care. The logo features a stylized letter "A" in purple, next to a blue teardrop shape. Below the shapes, the word "ASCENSIA" is written in a dark purple sans-serif font, and below that, the words "Diabetes Care" are written in a smaller font.
Data demonstrating substantial equivalence
A detailed comparison of the modified device and predicate device is provided in the tables below:
Table of Similarities between Contour® next GEN to Contour® next ONE (K160682):
| Feature | Contour® next ONE(Predicate Device; K160682) | Contour® next GEN(Subject Device) |
|---|---|---|
| Test strip | CONTOUR® NEXT Test strips | Same as predicate |
| Test strip chemistry | FAD-GDH (MLB as themediator) | Same as predicate |
| Blood sample volume | 0.6µL | Same as predicate |
| Test count-down time | 5 seconds | Same as predicate |
| Applied voltage pattern | Multi-pulse | Same as predicate |
| Glucose range | 20-600 mg/dL | Same as predicate |
| Controls | CONTOUR® NEXT Control | Same as predicate |
| Control solution ranges | Level 1 and 2 | Same as predicate |
| Battery type | CR 2032 | Same as predicate |
| Automatic calibration | Yes | Same as predicate |
| Enhanced error detection fortest strips exposed to areducing agent | Yes | Same as predicate |
| Enhanced error detection forcontrol solution not mixed | Yes | Same as predicate |
| Enhanced error detection forperturbed test strips | Yes | Same as predicate |
| Wireless Technology | Bluetooth Low Energy to smartphones and tablets | Same as predicate |
| PC Connection | Micro-USB Port | Same as predicate |
| Test Memory | 800 Results | Same as predicate |
| Color Indicator forAbove/Below Target | Illuminated strip port, withcolors, indicating whether aglucose result is above, within,or below target | Same as predicate |
| Sample re-applicationcapability | 60-second re-application time | Same as predicate |
| Compatibility withCONTOUR® DIABETES app | Yes | Same as predicate |
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Image /page/6/Picture/0 description: The image contains the logo for Ascensia Diabetes Care. The logo features a stylized letter 'A' formed by a purple triangle on the left and a blue teardrop shape on the right. Below the symbol, the word 'ASCENSIA' is written in a bold, sans-serif font, with the words 'Diabetes Care' appearing in a smaller font size underneath.
Table of Differences between Contour® next GEN and Contour® next ONE (K160682):
| Feature | Contour® next ONE(Predicate Device;K160682) | Contour® next GEN(Subject Device) |
|---|---|---|
| Form Factor | Rectangular Shape | Traditional Oval Shape |
| Algorithm | Multiple regressionequations | Modified terms in the equations |
| Buttons | 1 center button withup/down rocker button | 1 'OK' button with up/down rockerbutton |
| Display | LCD with 7-segments andicons | Non-back lit, segmented display |
| Test Result Trends(Averages) | No | Yes |
| Test Reminders | No | Yes |
| Meal markers | Pre-meal, post-meal, fastingand no mark | Pre-meal, post-meal, and no mark |
| Bluetooth (Low Energy)Version | 4.1 | 4.2 |
Image /page/6/Picture/3 description: The image shows a Contour Next Gen blood glucose meter. The meter's display reads 12:23 PM 4/12 and a blood sugar level of 93 mg/dL. The meter has an OK button and up and down arrow buttons.
Contour® next GEN Blood Glucose Meter (Subject Device)
Image /page/6/Picture/5 description: The image shows a blood glucose meter displaying a reading of 93 mg/dL. The time displayed on the meter is 9:41 AM, and the date is 3/8/15. There is also an apple icon displayed on the screen.
Contour® next ONE Blood Glucose Meter (Predicate Device)
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Image /page/7/Picture/0 description: The image contains the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" in purple, next to a blue teardrop shape. Below these symbols, the word "ASCENSIA" is written in a bold, sans-serif font, with the words "Diabetes Care" appearing in a smaller font size underneath.
Summary of Performance Testing
Clinical trials and bench testing showed that the Contour® next GEN Blood Glucose Monitoring System performed as intended and met the system specifications.
Usability testing was conducted to ensure that the Contour® next GEN Blood Glucose Monitoring System was easy to use by typical customers.
Conclusions from Performance Evaluations
Based on the outcome of the performance testing conducted, the Contour® next GEN Blood Glucose Monitoring System is substantially equivalent to the predicate Contour® next ONE Blood Glucose Monitoring System (K160682).
§ 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.