(161 days)
The Envision™ Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in capillary whole blood taken from the fingertip, ventral palm, dosal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. ENVISION™ Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of or screening of diabetes or for neonatal use. Alternate site testing should be done during steady- state times when glucose is not changing rapidly.
The ENVISION™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the ENVISION™ Test strip. The principle of the test replies upon a specific type of glucose in blood sample, the oxidase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generation an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
This document describes the regulatory submission for the ENVISION™ Blood Glucose Test System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics as one might find for a novel device or AI/ML product.
As such, the information typically requested in your prompt (e.g., sample sizes for test/training sets, detailed ground truth establishment, MRMC studies, specific performance metrics like F1, accuracy, etc.) is not explicitly provided or applicable in the context of this 510(k) summary for a blood glucose monitor. Blood glucose monitoring systems are evaluated against established performance standards and predicate devices, which typically involve accuracy studies comparing device readings to a laboratory reference method.
However, I will extract and infer the closest available information based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. Instead, it refers to the performance of the predicate device as the benchmark for "substantial equivalence." The reported device performance is a general statement of meeting this equivalence.
| Performance Metric Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Clinical Performance | Substantial equivalence to the predicate device (LifeScan One Touch® Ultra® Blood Glucose Monitoring System) validation for consumer use and professional accuracy. | "Test results showed substantial equivalence." |
| Non-Clinical (Verification, Validation, Testing) | Pass/Fail criteria based on specifications cleared for the predicate device. | "Results showed substantial equivalence." |
| Overall Conclusion | As safe, effective, and performs as well as the legally marketed predicate device. | "The ENVISION™ Blood Glucose Monitoring System is as safe, as effective, and performs as well as the legally marketed predicate device, the ONE TOUCH® Ultra®." |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "clinical performance evaluation" without providing the number of subjects or samples.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be "prospective" in the sense that performance evaluations were conducted for the purpose of validating the consumer use for the user and the professional accuracy of the ENVISION™ system.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not provided because blood glucose monitoring systems typically use a laboratory reference method (e.g., a YSI analyzer) as the "ground truth" for glucose concentration, not expert consensus on images or other subjective data. No mention of experts for ground truth is made.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" for blood glucose measurements is typically an objective laboratory reference method, not an adjudicated expert opinion.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images. This device is a blood glucose monitor.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device itself is a standalone system (monitor + test strips) that provides a direct glucose reading. The "clinical performance evaluation" assessed its accuracy against a reference, which is essentially a standalone performance assessment in a clinical setting. There is no "human-in-the-loop" in the interpretation of the numerical glucose result from the device.
7. The Type of Ground Truth Used
The ground truth implicitly used for accuracy assessments in blood glucose monitoring systems is a laboratory reference method for glucose measurement (e.g., using a YSI glucose analyzer). While not explicitly stated in the provided text, this is the standard practice for validating such devices. The document refers to "professional accuracy," which implies comparison to a highly accurate reference.
8. Sample Size for the Training Set
Not applicable. This device is a measurement system, not a machine learning model that requires a "training set" in the conventional sense. Its performance is based on the electrochemical reaction and calibrated sensor, not a learned algorithm from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this blood glucose monitoring device.
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510(k) Summary
EXHIBIT #1
1082020
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. The assigned 510(K) Number is not applicable.
DEC 2 4 2008
Date: July 15, 2008
Submitter: 1.
| Submitted by: | Infopia Co.,ltd.#1603, Dongil Technotown A Bldg.,889-3, Kwanyang2-Dong, Dongan - GuAnyang, Kyunggi 431-716, KoreaPhone +82-31-423-6170Fax +82-31-423-6171 |
|---|---|
| Contact: | Bryan OhPhone: 1-321-267-9911Fax: 1-321-267-5582 |
2. Device:
| Propriety Name | ENVISION™ Blood Glucose Test System |
|---|---|
| Common Name | Blood Glucose Test System |
| Classification Name: | System, test, blood glucose, over the counterGlucose OxidaseSingle (specified) analyte controls |
| Classification: | Class II, 21 CFR 862.1345, |
| Product Code: | NBW, CGA, JJX |
3. Predicate Device:
We claim substantial equivalence to the LifeScan One Touch® Ultra @ Blood Glucose Monitoring System (K021819) By LifeScan Inc.
4. Description:
The ENVISION™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the ENVISION™ Test strip.
The test principle is:
This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test replies upon a specific type of glucose in blood sample, the oxidase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generation an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
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Indications for use: 5.
The Envision™ Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in whole blood taken from the fingertip, ventral palm, dosal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. ENVISION™ Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of diabetes or for neonatal use. Alternate site testing should be done during steadystate times when glucose is not changing rapidly.
Comparison of Technological Characteristics with Predicate: 6.
The technological characteristics of the new device (ENVISION™) in comparison to the predicate device (OneTouch® Ultra® ):
The modified ENVISION™ device has the same technological characteristics as the current legally marketed predicate device, OneTouch® Ultra® Glucose Monitoring System (K021819) By LifeScan Inc.
7. Performance Data:
Clinical: The clinical performance evaluation using the ENVISION™ Blood Glucose Monitoring System components were conducted for the purpose of validating the consumer use for the user and the professional accuracy. Test results showed substantial equivalence.
Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the ENVISION™ Blood Glucose Monitoring System with respect to the predicate device. Testing involved the verification of software requirement specifications, product requirement specifications and user interface requirement specifications from risk analysis. Pass or fail criteria were based on the specification cleared for the predicate device and results showed substantial equivalence.
8. Conclusion
The conclusion drawn from the clinical and non clinical tests is that the ENVISION™ Blood Glucose Monitoring System is as safe, as effective, and performs as well as the legally marketed predicate device, the ONE TOUCH® Ultra® .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the eagle. The image is in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Infopia Co., Ltd. c/o Ms. Maria F Griffin MDI Consultants 55 Northern Blvd. Suite 200 Great Neck, NY 11021 Hayward, CA 94545
DEC 2 4 2008
Re: K082020
Trade Name: Envision Blood Glucose Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW, CGA Dated: November 20, 2008 Received: November 21, 2008
Dear Ms. Griffin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have dctermined 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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial source of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.v.M.
Yéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K082020
Device Name: ENVISION™ Blood Glucose Testing System
Indication For Use:
The Envision™ Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in capillary whole blood taken from the fingertip, ventral palm, dosal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. ENVISION™ Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of or screening of diabetes or for neonatal use. Alternate site testing should be done during steady- state times when glucose is not changing rapidly.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
And/Or
Over the Counter Use X
(21 CFR Part 801 Subpart D) Subpart C)
(21 CFR Part 801
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
ctny
Division Sign Off
Division Sian-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082020
§ 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.