ENVISION BLOOD GLUCOSE TEST SYSTEM

K082020 · Infopia Co, Ltd. · NBW · Dec 24, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082020
• Device Name: ENVISION BLOOD GLUCOSE TEST SYSTEM
• Applicant: Infopia Co, Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

System measures glucose concentration in capillary whole blood; utilizes electrochemical amperometry via glucose oxidase enzyme and potassium ferricyanide mediator on carbon-electrode test strips. User inserts strip into meter; applies blood sample; meter generates current proportional to glucose concentration. Used by patients or clinicians in home or clinical settings. Provides quantitative glucose readings; aids diabetes management. Includes meter, test strips, control solutions, lancing device, lancets. Features no-coding technology; stores 365 test results with 7, 14, 21-day averages. Supports alternate site testing (palm, arm, leg) during steady-state glucose levels. Benefits patients by enabling self-monitoring of blood glucose levels for improved glycemic control.

Clinical Evidence

Clinical performance evaluation conducted to validate consumer and professional accuracy. Results demonstrated substantial equivalence to the predicate device. Non-clinical testing included verification and validation of software, product, and user interface requirements based on risk analysis, with pass/fail criteria aligned with the predicate device specifications.

Technological Characteristics

In vitro diagnostic system using electrochemical sensing (glucose oxidase). Components include a meter and test strips. Operates via electrical current generation proportional to glucose concentration. Software-controlled measurement and display. No specific materials or connectivity standards provided.

Indications for Use

Indicated for quantitative glucose measurement in capillary whole blood from fingertip, palm, hand, arm, forearm, calf, or thigh. For use by diabetic patients or healthcare professionals to manage diabetes. Contraindicated for neonatal use and for the diagnosis or screening of diabetes.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• One Touch Ultra Blood Glucose Monitoring System (k021819)

Submission Summary (Full Text)

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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.<br>#1603, Dongil Technotown A Bldg.,<br>889-3, Kwanyang2-Dong, Dongan - Gu<br>Anyang, Kyunggi 431-716, Korea<br>Phone [phone]<br>Fax [phone] |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Bryan Oh<br>Phone: [phone]<br>Fax: [phone] |

#### 2. Device:

| Propriety Name | ENVISION™ Blood Glucose Test System |
|----------------------|---------------------------------------------------------------------------------------------------------|
| Common Name | Blood Glucose Test System |
| Classification Name: | System, test, blood glucose, over the counter<br>Glucose Oxidase<br>Single (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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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 [phone]. 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 [phone] or [phone] 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)

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Division Sign Off

Division Sian-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K082020