(496 days)
The CareSens N Feliz BT Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Feliz BT Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens N Feliz BT Blood Glucose Monitoring System is comprised of the CareSens N Blood Glucose Test Strips and the CareSens N Feliz BT Blood Glucose Meter.
This FDA 510(k) clearance letter for the CareSens N Feliz BT Blood Glucose Monitoring System does not contain the detailed information required to answer all the questions about specific acceptance criteria and the study that proves the device meets those criteria.
The letter primarily confirms that the device is substantially equivalent to a predicate device and outlines regulatory obligations. It does not include performance data, study design details, or specific acceptance criteria for analytical or clinical performance characteristics of the glucose monitoring system.
Therefore, I cannot provide a complete answer with the requested information based only on the provided text.
However, based on common practices for glucose monitoring systems, I can infer some general aspects and state what information is missing.
Here's an assessment based on the available text and what would typically be found in a 510(k) submission for such a device:
1. A table of acceptance criteria and the reported device performance
Information Not Provided in the Text. The FDA 510(k) letter does not include a table of acceptance criteria or performance data. For a blood glucose monitoring system, this table would typically refer to the ISO 15197 standard (or equivalent FDA guidance) for accuracy of blood glucose measurements.
Typical Acceptance Criteria (Inferred, not from provided text):
| Criterion | Typical Acceptance Limit (Example, per ISO 15197:2013) | Reported Device Performance (Missing) |
|---|---|---|
| Accuracy (Difference from Reference Method) | (For glucose concentration < 100 mg/dL): ≥ 95% of results within ±15 mg/dL of reference | (Not reported in document) |
| (For glucose concentration ≥ 100 mg/dL): ≥ 95% of results within ±15% of reference | (Not reported in document) | |
| System Accuracy (Consolidated) | ≥ 99% of results within ISO 15197 combined error limits across all concentrations. | (Not reported in document) |
| Precision (Repeatability) | Coefficient of Variation (CV) < 5% (typically under controlled conditions) | (Not reported in document) |
| Intermediate Precision | CV < 7.5% (typically under varying conditions) | (Not reported in document) |
| Hematocrit Interference | % bias within acceptable limits across hematocrit range | (Not reported in document) |
| Interfering Substances | No clinically significant interference from common exogenous/endogenous substances | (Not reported in document) |
| Operating Conditions (Temperature, Humidity) | Meets accuracy criteria within specified ranges | (Not reported in document) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Information Not Provided in the Text. The letter does not specify sample sizes for test sets or the provenance of the data. For a glucose meter, the test set would typically involve a prospective clinical study with a sufficient number of subjects (e.g., 100-200 patients) to ensure statistically robust results across the measuring range and for different glycemic conditions. The country of origin and whether the study was retrospective or prospective would be detailed in the full 510(k) submission.
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)
Information Not Provided in the Text. This question is typically more relevant for diagnostic imaging AI devices where human readers establish ground truth. For a blood glucose monitoring system, the "ground truth" is established by a highly accurate laboratory reference method, such as a hexokinase or glucose oxidase method calibrated to an NIST traceable standard. There aren't "experts" in the sense of human readers for this type of device's primary performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Information Not Provided in the Text. Adjudication methods like 2+1 or 3+1 are used for expert consensus in imaging studies. For a blood glucose meter, the "ground truth" is determined by the reference laboratory instrument, not by expert adjudication. Comparisons are made directly between the device's reading and the reference method's reading.
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
Not Applicable. An MRMC comparative effectiveness study is specific to medical imaging devices where human readers interpret images, often with and without AI assistance. The CareSens N Feliz BT Blood Glucose Monitoring System is a standalone device that provides a quantitative measurement of glucose; it does not involve human interpretation of images or AI assistance to human readers in its primary function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, inherently. The performance of a blood glucose monitor is by its nature "standalone" or "algorithm only" in terms of how it processes the blood sample and produces a reading. The device measures glucose electromagnetically or electrochemically and outputs a numerical value. There is no human-in-the-loop performance in the measurement itself (though a human performs the test). The device's accuracy is evaluated directly against a reference method. The letter confirms substantial equivalence without detailing this study, but such a standalone analytical performance study would definitely have been conducted.
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 a reference laboratory method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer, or equivalent methods based on hexokinase or glucose oxidase reactions) that is highly accurate and traceable to international standards (e.g., NIST). This is considered the "gold standard" for glucose concentration measurement.
8. The sample size for the training set
Information Not Provided in the Text. Blood glucose meters typically do not have a "training set" in the sense of machine learning algorithms that learn from data. The measurements are based on chemical reactions and electrical signals, with firmware programmed to convert these signals into glucose concentrations. Any "training" or calibration would happen during the manufacturing process and be validated analytically, not through a data-driven training set in the AI sense. If there are advanced algorithms, the training set size would not be disclosed in this FDA letter.
9. How the ground truth for the training set was established
Not Applicable/Information Not Provided in the Text. As explained above, blood glucose meters do not typically use "training sets" and "ground truth" in the same way AI algorithms do. Their fundamental principle relies on well-established chemical/electrochemical reactions. Calibration and quality control are done against reference materials and methods, but this is different from establishing ground truth for a machine learning model's training data.
In summary: The provided FDA 510(k) clearance letter serves as regulatory approval but does not contain the detailed technical and scientific study information (like performance metrics, study design, sample sizes, and ground truth establishment methods) necessary to fully answer the specific questions about the device's acceptance criteria and the studies proving it meets them. This information would be found in the full 510(k) submission document, which is not publicly available in this format.
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October 5, 2021
i-SENS, Inc. Joon Ho Jung RA Team Deputy Senior Manager 43, Banpo-daero 28-gil, Seocho-gu Seoul, 06646 Republic of Korea
Re: K201394
Trade/Device Name: CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: August 30, 2021 Received: September 3, 2021
Dear Joon Ho Jung:
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) K201394
Device Name
CareSens N Feliz BT Blood Glucose Monitoring System
Indications for Use (Describe)
The CareSens N Feliz BT Blood Glucose Monitoring System is comprised of the CareSens N Blood Glucose Test Strips and the CareSens N Feliz BT Blood Glucose Meter.
The CareSens N Feliz BT Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Feliz BT Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
| 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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§ 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.