(745 days)
Not Found
No
The document describes a standard blood glucose monitoring system with Bluetooth connectivity to a mobile app. It explicitly states it uses a "similar algorithm" to a previous, non-AI/ML predicate device and makes no mention of AI, ML, or related concepts.
No.
The device is intended for "monitoring the effectiveness of a diabetes control program" by measuring glucose, not for treating any condition.
No
The "Intended Use / Indications for Use" section explicitly states, "The Contour® next GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use." It is intended for monitoring, not diagnosis.
No
The device description explicitly states that the system includes a "blood glucose meter with Bluetooth Low Energy technology built in," "Contour® next test strips," and "Contour® next control solution," in addition to the Contour® Diabetes app. This indicates the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The Contour® next GEN Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use)..." and "The system is intended for in vitro diagnostic use only."
- Definition of IVD: An in vitro diagnostic device is a medical device intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes. This device fits this definition as it measures glucose in a blood sample outside the body.
- Purpose: The device is used to quantitatively measure glucose in fresh capillary whole blood, which is a diagnostic measurement performed outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
NBW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
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.
1
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
2
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) |
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."
3
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 Burdel
Head of Product - Regulatory Affairs
Ascensia Diabetes Care
100 Summit Lake Drive
Valhalla, NY 10595
Phone: 914-296-2880
Email address: colleen.burdel@ascensia.com |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name: | Trade name: Contour® next GEN Blood Glucose
Monitoring System
Common name: Blood Glucose Meter
Classification name: 75 NBW; Glucose Test System,
ОТС |
| 3) Predicate device: | Contour® Next ONE Blood Glucose Monitoring
System (K160682) |
| 4) Device description: | 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. |
4
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.
5
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 the
mediator) | 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 for
test strips exposed to a
reducing agent | Yes | Same as predicate |
| Enhanced error detection for
control solution not mixed | Yes | Same as predicate |
| Enhanced error detection for
perturbed test strips | Yes | Same as predicate |
| Wireless Technology | Bluetooth Low Energy to smart
phones and tablets | Same as predicate |
| PC Connection | Micro-USB Port | Same as predicate |
| Test Memory | 800 Results | Same as predicate |
| Color Indicator for
Above/Below Target | Illuminated strip port, with
colors, indicating whether a
glucose result is above, within,
or below target | Same as predicate |
| Sample re-application
capability | 60-second re-application time | Same as predicate |
| Compatibility with
CONTOUR® DIABETES app | Yes | Same as predicate |
6
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 regression
equations | Modified terms in the equations |
| Buttons | 1 center button with
up/down rocker button | 1 'OK' button with up/down rocker
button |
| Display | LCD with 7-segments and
icons | Non-back lit, segmented display |
| Test Result Trends
(Averages) | No | Yes |
| Test Reminders | No | Yes |
| Meal markers | Pre-meal, post-meal, fasting
and 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)
7
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).