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.

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System consists of the CONTOUR® PLUS BLUE meter, the CONTOUR® PLUS blood qlucose test strips, and the CONTOUR® Diabetes app.

The CONTOUR® PLUS BLUE 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® PLUS BLUE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® PLUS BLUE 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® PLUS BLUE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The CONTOUR® PLUS blood glucose test strips are for use with the CONTOUR® PLUS BLUE meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips.

The system is intended for in vitro diagnostic use only.

Device Description

CONTOUR® NEXT GEN and CONTOUR® PLUS BLUE Blood Glucose Meters have Bluetooth Low Energy technology built in so that the meters can communicate wirelessly to smart phones and tablets. The CONTOUR® NEXT GEN meter uses the CONTOUR® NEXT blood glucose test strips and CONTOUR® NEXT control solution and CONTOUR® PLUS BLUE meter uses CONTOUR® PLUS blood glucose test strips and CONTOUR® PLUS control solution respectively. The meters can be connected to the CONTOUR® Diabetes app. Both the meters use two replaceable coin cell batteries. Both the meters' shape is a traditional oval form factor. The CONTOUR® NEXT GEN and CONTOUR® PLUS BLUE meters have smartLIGHT® and smartCOLOR® indicator features respectively to see if a glucose result is above, within, or below target range.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the CONTOUR® PLUS BLUE and CONTOUR® NEXT GEN Blood Glucose Monitoring Systems.

It's important to note that the provided FDA 510(k) clearance letter and summary primarily focus on demonstrating substantial equivalence to a predicate device, specifically for a minor modification (change in Bluetooth Low Energy microprocessor). As such, the documentation does not contain exhaustive details about the initial validation studies that established the device's fundamental accuracy and performance. Instead, it leverages previous clearances and focuses on showing that the change doesn't negatively impact performance.

Therefore, for several points requested in the prompt, the information is not available in the provided text, as the submission is for a modification rather than an entirely new device's initial clearance.

Acceptance Criteria and Device Performance

The document states that "Bench testing showed that the CONTOUR® NEXT GEN Blood Glucose Monitoring System and CONTOUR® PLUS BLUE Blood Glucose Monitoring System performed as intended and met the relevant standards (ANSI IEEE C63.27-2021, IEEE UL Std 2621.2-2022, IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION), performance testing and software testing applicable to this change."

While specific numerical acceptance criteria (e.g., accuracy percentages) and detailed reported performance metrics are not explicitly listed in this 510(k) summary, the mention of "relevant standards" and "performance testing" implies that the device met the established performance requirements for blood glucose monitoring systems. For the purpose of this specific modification submission, the critical acceptance criterion was demonstrating that the measurement function was not impacted by the change.

Given the nature of the submission (a change in microprocessor), the primary 'acceptance criteria' in this context are:

Acceptance Criterion (Implied for this K-Submission)	Reported Device Performance (as stated in the document)
Compliance with ANSI IEEE C63.27-2021	Met
Compliance with IEEE UL Std 2621.2-2022	Met
Compliance with IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION	Met
No impact on BGM measurement function due to microprocessor change	Demonstrated (through bench testing, reliability testing, software V&V)
No impact on physical system and user interface	Demonstrated
Substantial Equivalence to Predicate (K223293) and Reference (K231679)	Achieved

Note: For a full, initial clearance of a blood glucose meter, specific accuracy criteria (e.g., ISO 15197) would be provided, often specifying percentages of readings within a certain deviation from a reference method (e.g., laboratory analyzer) for different glucose ranges. These details are not in the provided modification summary.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified for this particular submission's testing. The document states "Bench testing including reliability testing, software verification and validation, and confirmation of no impacts to BGM measurement was conducted." This type of testing typically involves a set number of meters and strips, and controlled blood samples, but the exact quantities are not detailed in this summary.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing described is "bench testing," implying laboratory-based evaluation. The document also states "The modified devices also relied on previously conducted analytical testing to support substantial equivalence." This suggests some data would be retrospective from prior clearances. The "clinical testing was leveraged from the previous clearances," meaning no new clinical trials were conducted for this specific modification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Specified. For a blood glucose meter, "ground truth" for accuracy is typically established by comparative measurements against a laboratory reference method (e.g., a YSI Glucose Analyzer) using blood samples with known glucose concentrations, not by expert consensus on visual review as might be the case for imaging devices. The document does not describe the specific ground truth establishment method for the bench testing beyond stating "confirmation of no impacts to BGM measurement." For the leveraged clinical testing (from previous submissions), the ground truth would have been established using a laboratory reference method, but the details are not provided here.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation of data (e.g., radiology reads) to resolve discrepancies. This document describes bench testing for a physical/electrical device modification and leveraging prior clinical data, neither of which involves such adjudication processes.
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:
- No. This is a blood glucose monitoring system, not an AI-powered image analysis or diagnostic tool involving human readers. Therefore, an MRMC study is not relevant or performed for this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially Applicable. Blood glucose meters are essentially standalone algorithms (or systems) that provide a numerical output. The "bench testing" and "confirmation of no impacts to BGM measurement" assessed the device's performance directly, independent of a human "in the loop" for the measurement itself, beyond the act of sampling. The focus was on the performance of the meter and strips, and the impact of the new microprocessor on that performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Analytical Reference Method. For blood glucose meters, the ground truth for accuracy is established by a highly accurate laboratory reference method (e.g., YSI Glucose Analyzer) that measures glucose concentration in blood samples. This is a scientific, analytical measurement, not based on expert consensus or pathology. While not explicitly detailed for this submission's testing, it would have been the ground truth for the "previously conducted analytical testing" and "clinical testing leveraged from the previous clearances."
The sample size for the training set:
- Not Applicable / Not Specified. This document describes a modification to an existing, cleared device, not the development of a new device or an AI/machine learning model that would have a traditional "training set." The performance assessments are validation efforts, not model training.
How the ground truth for the training set was established:
- Not Applicable. See point 7.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 27, 2024

Ascensia Diabetes Care US Inc. Divya Munjpara Principal Regulatory Affairs Specialist 5 Wood Hollow Road Parsippany, New Jersey 07054

Re: K241787

Trade/Device Name: CONTOUR® PLUS BLUE Blood Glucose Monitoring System; 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: June 20, 2024 Received: June 21, 2024

Dear Divya Munipara:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Joshua Balsam -S

Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K241787

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 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)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241787 Device Name

CONTOUR® PLUS BLUE Blood Glucose Monitoring System

Indications for Use (Describe)

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System consists of the CONTOUR® PLUS BLUE meter, the CONTOUR® PLUS blood qlucose test strips, and the CONTOUR® Diabetes app.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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" appearing in a smaller font size underneath.

510(k) Summary for K241787

Date prepared: August 13, 2024

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) Applicant/Correspondent Contact
	Correspondent Contact	Divya MunjparaPrincipal Regulatory Affairs SpecialistAscensia Diabetes Care US Inc.5 Wood Hollow RoadParsippany, NJ 07054Phone: 914-236-1832Email address: divya.munjpara@ascensia.com
	Consultant	Robin MartinRegulatory Affairs ConsultantKinetic Compliance Solutions, LLCMilwaukee, WI 53201Phone: 414-380-9690Email address: robin.martin@ascensia.com
	2) Device name:	Trade names:CONTOUR® NEXT GEN Blood Glucose Monitoring SystemCONTOUR® PLUS BLUE Blood Glucose Monitoring SystemCommon name: Glucose test systemClassification name: System, Test, Blood Glucose, Over TheCounterRegulation Number: 21 CFR 862.1345Product Code: NBW
	3) Predicate device:	Primary Predicate: CONTOUR® NEXT GEN Blood Glucose MonitoringSystem (K223293)Reference Device: CONTOUR® PLUS BLUE Blood Glucose MonitoringSystem (K231679)
	4) Device Description	CONTOUR® NEXT GEN and CONTOUR® PLUS BLUE Blood GlucoseMeters have Bluetooth Low Energy technology built in so that themeters can communicate wirelessly to smart phones and tablets. TheCONTOUR® NEXT GEN meter uses the CONTOUR® NEXT bloodglucose test strips and CONTOUR® NEXT control solution andCONTOUR® PLUS BLUE meter uses CONTOUR® PLUS blood glucosetest strips and CONTOUR® PLUS control solution respectively. Themeters can be connected to the CONTOUR® Diabetes app. Both themeters use two replaceable coin cell batteries. Both the meters' shapeis a traditional oval form factor. The CONTOUR® NEXT GEN and

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Image /page/5/Picture/0 description: The image contains the logo for Ascensia Diabetes Care. The logo features a purple triangle above a blue teardrop shape. Below the shapes, the word "ASCENSIA" is written in purple, followed by the words "Diabetes Care" in a smaller font. The words "CONTOUR® PLUS BLUE" are written in blue at the bottom of the image.

S BLUE meters have smartLIGHT® and smartCOLOR® indicator features respectively to see if a glucose result is above, within, or below target range.

5) Intended Use:

CONTOUR® NEXT GEN:

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 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® PLUS BLUE:

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System consists of the CONTOUR® PLUS BLUE meter, the CONTOUR® PLUS blood qlucose test strips, and the CONTOUR® Diabetes app.

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Image /page/6/Picture/0 description: The image shows the Ascensia Diabetes Care logo. The logo consists of a purple triangle and a blue teardrop shape. Below the logo, the words "ASCENSIA Diabetes Care" are written in purple. The text "fresh capillary whole blood drawn from the fingertips" is written below the logo.

The system is intended for in vitro diagnostic use only.

1. Indications for Use Comparison to the Predicate:
1. Technological Comparison to the Predicate:

The subject CONTOUR® NEXT GEN Blood Glucose Monitoring System and CONTOUR® PLUS BLUE Blood Glucose Monitoring System have the same intended use as the predicate device.

The subject CONTOUR® NEXT GEN Blood Glucose Monitoring System and CONTOUR® PLUS BLUE Blood Glucose Monitoring System are substantially equivalent to its predicate CONTOUR® NEXT GEN Blood Glucose Monitoring System (K223293). The subject devices have the same intended use, measurement principle, operating principle, electrochemical reaction as its predicate. In terms of performance characteristics, the CONTOUR® NEXT GEN Blood Glucose Monitoring System is identical to the predicate device and the CONTOUR® PLUS BLUE Blood Glucose Monitoring System is identical to the reference device.

Description of Change

The proposed modification is to use an alternate Bluetooth Low Energy (BLE) microprocessor for the CONTOUR® NEXT GEN and CONTOUR® PLUS BLUE Blood Glucose Monitoring Systems.

Non-Clinical and Clinical Tests Summary

Bench testing showed that the CONTOUR® NEXT GEN Blood Glucose Monitoring System and CONTOUR® PLUS BLUE Blood Glucose Monitoring System performed as intended and met the relevant standards (ANSI IEEE C63.27-2021, IEEE UL Std 2621.2-2022, IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION), performance testing and software testing applicable to this change.

Bench testing including reliability testing, software verification and validation, and confirmation of no impacts to BGM measurement was conducted to support substantial equivalence. The modified devices also relied on previously conducted analytical testing to support substantial equivalence.

The bench testing demonstrated the measurement function was not impacted by the change and the physical system and the user interface were not impacted by the change. Therefore, usability testing and clinical testing was leveraged from the previous clearances to support substantial equivalence.

Conclusions

Based on the data and information submitted, the CONTOUR® NEXT GEN Blood Glucose Monitoring System and CONTOUR® PLUS BLUE Blood Glucose Monitoring System are substantially equivalent to the predicate device (CONTOUR® NEXT GEN Blood Glucose Monitoring System: K223293).

Regulation Number and Section

§ 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.