EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM

K072369 · Hmd Biomedical, LLC · NBW · Mar 21, 2008 · Clinical Chemistry

Device Facts

• Record ID: K072369
• Device Name: EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Hmd Biomedical, LLC
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Evolution™ 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. Evolution™ 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 steady- state times when alucose is not changing rapidly.

Device Story

Evolution™ Blood Glucose Testing System measures glucose concentration in whole blood samples. System consists of a meter and test strips. Principle of operation: electrochemical; glucose oxidase in test strip reacts with blood glucose to generate electrical current; meter measures current to calculate and display glucose concentration. Used by patients or healthcare professionals in home or clinical settings. Output provides quantitative glucose results to assist in diabetes management. Alternate site testing permitted during steady-state glucose levels.

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 blood glucose monitor. Electrochemical sensing principle using glucose oxidase. Handheld form factor. System includes meter and test strips. Software-controlled measurement and display of electrical current.

Indications for Use

Indicated for quantitative blood glucose measurement in diabetic patients or healthcare professionals to aid diabetes management. Samples from fingertip, palm, hand, arm, forearm, calf, or thigh. Contraindicated for diabetes diagnosis and neonatal use.

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

• Lifescan One Touch Ultra (k021819)

Submission Summary (Full Text)

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# 510(k) Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. MAR 2 I 2008 The assigned 510(K) Number is K072369.

Date: March 19, 2008

#### 1. Submitter:

| Submitted by: | HMD Biomedical LLC<br>8855 Grissom Pkwy<br>Titusville, FL. 32780 |
|---------------|------------------------------------------------------------------|
| Contact: | Merrell Shye<br>Phone: [phone]<br>Fax: [phone] |

#### 2. Device:

| Propriety Name | Evolution™ 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 Evolution™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the Evolution™ 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

HMD Biomedical LLC.

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generation an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood qlucose result.

# 5. Indications for use:

Indications For Use: The Evolution™ 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. Evolution™ 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 steady- state times when alucose is not changing rapidly.

# 6. Comparison of Technological Characteristics with Predicate:

The technological characteristics of the new device (EVOLUTION™) in comparison to the predicate device (OneTouch(BUItra®):

The modified EVOLUTION™ device has the same technological characteristics as the current legally marketed predicate device, OneTouch(@Ultra®Blood Glucose Monitoring System (K021819) By LifeScan Inc.

# 7. Performance Data:

Clinical: The clinical performance evaluation using the EVOLUTION™ 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 EVOLUTION™ 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 EVOLUTION™ Blood Glucose Monitoring System is as safe, as effective, and performs as well as the legally marketed predicate device, the ONE TOUCH(®) Ultra®.

HMD Biomedical LLC.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

HMD Biomedical LLC c/o Ms. Merrell Shye 8855 Grissom Parkway Titusville, FL 32780

MAR 2 1 2008

Re: k072369

Trade/Device Name: HMD Evolution Blood Glucose Testing System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: March 10, 2008 Received: March 11, 2008

Dear Merrell Shye:

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. 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 equivalence 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-free number [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.

Yean 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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Indications of Use Statement

510(K) Number(if known): K072369 Device Number: Evolution™ Blood Glucose Test

Indications For Use: The Evolution™ Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in whole blood 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. Evolution™ 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 steady- state times when glucose is not changing rapidly.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-the-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND / OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

072369