(23 days)
The Contour® next GEN Blood Glucose Monitoring System consists of the Contour® next GEN meter, Contour® next blood glucose 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 blood glucose test strips and CONTOUR® NEXT control solution. The meter can be connected to the CONTOUR® Diabetes app. It uses two replaceable CR2032 or DL2032 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 provided text describes a 510(k) summary for the CONTOUR® next GEN Blood Glucose Monitoring System. This submission focuses on demonstrating substantial equivalence to a predicate device due to minor modifications (e.g., changes to internal meter circuitry due to component end-of-life, changes to packaging, user guide format, and test strip packaging from bottled to foil-packed).
The information provided is typical for a 510(k) submission of a blood glucose monitoring system, which primarily relies on analytical performance data (accuracy of glucose measurements) to demonstrate that the device performs as intended and is substantially equivalent to a predicate. This type of device does not involve an AI algorithm with a training or test set, nor does it involve expert reviews, ground truth establishment through consensus, or MRMC studies.
Therefore, the requested information regarding AI acceptance criteria and study details (sample sizes for training/test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this specific device submission. The device described is a physical medical device (blood glucose meter and test strips), not an AI-powered diagnostic system.
However, I can extract information related to the performance testing mentioned, even if it's not structured around AI-specific criteria.
Key takeaway: This document does not describe an AI medical device.
Information applicable to the device (even without AI context):
-
A table of acceptance criteria and the reported device performance:
The document states: "Verification testing against well-established methods showed that the modified CONTOUR® NEXT GEN Blood Glucose Monitoring System, with the proposed changes outlined herein, performed as intended and met the system specifications."
It also mentions: "Validation testing with the proposed black and white pamphlet User Guide demonstrated that the CONTOUR® NEXT GEN Blood Glucose Monitoring System continued to be easy to use by typical customers."
However, the specific numerical acceptance criteria and reported performance data are not detailed in this 510(k) summary. For a blood glucose meter, this would typically involve accuracy metrics (e.g., % of results within ±X% of reference, ISO 15197 compliance). This summary only states that they were met. -
Sample sizes used for the test set and the data provenance:
Not explicitly stated in the provided text. For a blood glucose meter, validation studies would involve a sufficient number of blood samples (from various glucose concentrations) and potentially human subject testing for usability/accuracy. The provenance would likely be from clinical sites where these tests were performed. -
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):
Not applicable, as this is not an AI diagnostic device. Ground truth for blood glucose meters is established by reference laboratory methods (e.g., YSI or hexokinase method) on the same blood samples. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. -
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:
Not applicable, as this is not an AI diagnostic device. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI algorithm. The device itself is the "standalone" entity that performs the glucose measurement. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a blood glucose monitoring system, the ground truth for glucose levels is established using a highly accurate and precise laboratory reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer, or a hexokinase enzymatic method). -
The sample size for the training set:
Not applicable, as this is not an AI device with a training set. -
How the ground truth for the training set was established:
Not applicable, as this is not an AI device.
In summary, the provided document is a 510(k) premarket notification for a blood glucose monitoring system, which is a physical diagnostic device. It does not contain information about AI algorithm development, training, or testing, and therefore, most of the requested details are not relevant to this specific submission.
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November 18, 2022
Ascensia Diabetes Care US Inc. Larnie James Head of Regulatory Operations 100 Summit Lake Drive Valhalla, NY 10595
Re: K223293
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: October 25, 2022 Received: October 26, 2022
Dear Larnie James:
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.
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
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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 (OS) 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 mediation-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,
Digitally signed by Paula Caposino -S Date: 2022.11.18
Paula Caposino, Ph.D. Acting 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) K223293
Device Name
Contour® next GEN Blood Glucose Monitoring System
Indications for Use (Describe)
The Contour® next GEN Blood Glucose Monitoring System consists of the Contour® next GEN meter, Contour® next blood glucose 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 shows 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 text "ASCENSIA" is written in a dark purple sans-serif font, with the words "Diabetes Care" in a smaller font size underneath.
510(k) Summary K223293
Date prepared: November 18, 2022
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 | Larnie JamesHead of Regulatory OperationsAscensia Diabetes Care US Inc100 Summit Lake DriveValhalla, NY 10595 |
|---|---|
| 2) Device name: | Trade name: Contour® NEXT GEN Blood GlucoseMonitoring SystemCommon name: Blood Glucose Monitoring SystemClassification name: 75 NBW; Glucose Test System,OTCRegulation Number: 21 CFR 862.1345 |
| 3) Predicate device: | CONTOUR® NEXT GEN Blood Glucose MonitoringSystem (K193407) |
| 4) Device description: | CONTOUR® NEXT GEN Blood Glucose MonitoringSystem is a blood glucose meter with Bluetooth LowEnergy technology built in so that the meter cancommunicate wirelessly to smart phones and tablets.The meter uses the CONTOUR® NEXT blood glucosetest strips and CONTOUR® NEXT control solution. Themeter can be connected to the CONTOUR® Diabetesapp. It uses two replaceable CR2032 or DL2032 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" in purple, next to a blue teardrop shape. Below these symbols, the word "ASCENSIA" is written in a sans-serif font, with the words "Diabetes Care" in a smaller font size underneath.
The CONTOUR® NEXT GEN Blood Glucose 5) Intended Use: Monitoring System consists of the CONTOUR® NEXT GEN meter, CONTOUR® NEXT blood glucose 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 selftesting 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 diaqnosis 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 "A" shape in purple next to a blue water droplet. Below the shapes, the word "ASCENSIA" is written in a sans-serif font, with the words "Diabetes Care" written in a smaller font below it.
Data demonstrating substantial equivalence
A comparison of the modified device and predicate device is provided in the table below:
| Feature | CONTOUR® NEXT GEN(Predicate device K193407) | CONTOUR® NEXT GEN(Subject Device) |
|---|---|---|
| Meter | CONTOUR® NEXT GEN BloodGlucose Meter | Same as predicate |
| Meter circuitboard | CONTOUR® NEXT GEN BloodGlucose Meter circuit board | Replacement or alternative metercircuit board components withsame or equivalent specifications |
| Test strips | CONTOUR® NEXT BloodGlucose Test Strips | Same as predicate |
| Meter Kitouter cartonbox | Carton Box Dimensions:12.065 x 6.985 x 16.670 cm | Smaller Carton Box Dimensions:11.5 x 5.0 x 16.5 cm |
| Meter Kitpackagingconfiguration | The CONTOUR®NEXT GENBlood Glucose Monitoring SystemMeter Kit contents are packedalongside each other in the MeterKit. | The CONTOUR® NEXT GENBlood Glucose Monitoring SystemMeter Kit contents are packedinside the carrying case inside theMeter Kit. |
| The CONTOUR® NEXT BloodGlucose Test Strips are bottled. | The CONTOUR® NEXT BloodGlucose Test Strips are foil-packed. | |
| User Guide | Color booklet format | Folded black and white pamphletMinor content labeling changes |
Performance Testing
Verification testing against well-established methods showed that the modified CONTOUR® NEXT GEN Blood Glucose Monitoring System, with the proposed changes outlined herein, performed as intended and met the system specifications.
The meter circuit board changes were made due to the end-of-life of components and addition of alternative suppliers.
Validation testing with the proposed black and white pamphlet User Guide demonstrated that the CONTOUR® NEXT GEN Blood Glucose Monitoring System continued to be easy to use by typical customers.
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Image /page/6/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 purple, with the words "Diabetes Care" written in a smaller font below it.
Conclusion
The modified CONTOUR® NEXT GEN Blood Glucose Monitoring System has been shown to be substantially equivalent to the predicate device, the CONTOUR® NEXT GEN Blood Glucose Monitoring System (K193407).
§ 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.