(27 days)
The Oh' Care Lite Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Oh'Care Lite Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The Oh' Care Lite Smart Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The Oh'Care Lite Smart Blood Glucose Test Strips are for use with the Oh'Care Lite Smart Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.
The proposed Oh'Care Lite Smart Blood Glucose Monitoring System consists of a meter, test strips, control solution and a lancing device. This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.
The provided text describes the 510(k) submission for the Oh'Care Lite Smart Blood Glucose Monitoring System. However, it does not contain the detailed acceptance criteria, reported device performance (precision, accuracy, etc.), or study results needed to complete most of your requested information. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device and mentions general performance data without specifics.
Therefore, for many of your points, I can only state that the information is not provided in the given text.
Here's an attempt based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. Typically, for a blood glucose meter, this would include accuracy criteria (e.g., ISO 15197:2013 standards) comparing device readings to a reference method (YSI). | Not provided in the document. The document states "The device passed all of the tests based on pre-determined Pass/Fail criteria." but does not list the specific performance metrics or their results. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided in the document.
- Data provenance: Not provided in the document.
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)
- Not applicable/Provided: For a blood glucose meter, ground truth is typically established using a laboratory reference method (e.g., YSI analyzer), not human experts for interpretation. The document does not specify the reference method used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Provided: Adjudication by human experts is not typically part of the ground truth establishment for a blood glucose meter's analytical performance.
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: This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance was done (implied): The document states "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices" and that "The device passed all of the tests based on pre-determined Pass/Fail criteria." This implies that the device's analytical performance was assessed on its own. Specific results are not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implied ground truth: For blood glucose monitoring systems, the ground truth is typically established by laboratory reference methods, such as a YSI glucose analyzer, which provides a highly accurate measurement of glucose concentration in blood samples. This document does not explicitly state the reference method, but it is standard practice.
8. The sample size for the training set
- Not applicable/Provided: This device is a traditional medical device (blood glucose meter) and does not appear to involve machine learning or AI models with distinct "training sets" in the conventional sense. The "training set" concept is typically for AI algorithm development.
9. How the ground truth for the training set was established
- Not applicable/Provided: As there's no mention of a training set for an AI model, this question is not relevant.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 19, 2018
OSANG Healthcare Co., Ltd. c/o Priscilla Chung, Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt Irvine, CA 92620
Re: K182286
Trade/Device Name: Oh'Care Lite Smart Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 30, 2018 Received: August 23, 2018
Dear Priscilla Chung:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K182286
Device Name
Oh'Care Lite Smart Blood Glucose Monitoring System
Indications for Use (Describe)
The Oh' Care Lite Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Oh'Care Lite Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The Oh' Care Lite Smart Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The Oh'Care Lite Smart Blood Glucose Test Strips are for use with the Oh'Care Lite Smart Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.
| 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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510(k) Summary
(K182286)
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 09/12/2018
Applicant / Submitter: 1.
OSANG Healthcare Co., Ltd. 132, Anyangcheondong-Ro Dongan-Gu Anyang, Gyeonggido, 14040, Republic of Korea Tel : +82-31-460-0415 Fax : +82-31-460-0401
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine, CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device:
- = Trade Name: Oh'Care Lite Smart Blood Glucose Monitoring System
- · Classification Name: Blood Glucose Test System
- Classification regulation: 21 CFR Part 862.1345
- " Product Code: NBW
4. Predicate Device:
K132966, GluNEO Lite Blood Glucose Monitoring System and GluNEO Lite Professional Blood Glucose Monitoring System
5. Description:
The proposed Oh'Care Lite Smart Blood Glucose Monitoring System consists of a meter, test strips, control solution and a lancing device. This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.
510(k) Submission
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6. Indications for use:
Oh'Care Lite Smart Blood Glucose Monitoring System
The Oh Care Lite Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Oh'Care Lite Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The Oh' Care Lite Smart Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The Oh' Care Lite Smart Blood Glucose Test Strips are for use with the Oh' Care Lite Smart Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.
7. Comparison to the Cleared Device
The modifications are adding Bluetooth module for wireless data transfer, change in the meter appearance, and change in device name.
Other than these modifications, the modified meter has the following similarities to the cleared device:
- · has the same intended use,
- · uses the same operating principle,
- · adopts the same use environment and calibration method.
8. Performance Data
Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria.
Disinfection Study: Disinfectant CaviWipes with the EPA registration number of 46781-8 has been validated demonstrating complete inactivation of live virus of use with the meter.
9. Conclusion
The conclusion drawn from the verification/validation activities is that the subject devices is substantially equivalent to the predicated device.
§ 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.