MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS

K081703 · Entra Health Systems, Ltd. · NBW · Jan 8, 2009 · Clinical Chemistry

Device Facts

• Record ID: K081703
• Device Name: MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS
• Applicant: Entra Health Systems, Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Myglucohealth glucose monitoring system provides a quick and easy way for diabetic patients to measure and self-monitor blood glucose levels. The system is comprised of the MGH-BT1 (w/Bluetooth wireless download capability) or the MGH-1 (w/o Bluetooth) blood glucose meter, control solution and test strips that carry a biosensor used for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals. The results obtained are plasma calibrated to allow for easy comparison to the laboratory method. Further, results from either meter may be uploaded to a memory device through a standard RS32 connection, or, with the –BT1 model, wirelessly transmitted to a Bluetooth capable PC or Cell phone. The Myglucohealth glucose monitoring systems are not to be used for the diagnosis 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 uses electrochemical biosensor technology; capillary action draws blood into test strip chamber. Meter measures current resulting from glucose oxidation by glucose oxidase enzyme; current magnitude proportional to glucose concentration. Results displayed in 3 seconds. Used by diabetic patients or healthcare professionals for self-monitoring. MGH-1 model connects to PC via RS232; MGH-BT1 model transmits data wirelessly to Bluetooth-enabled PC or cell phone. Output allows patients to track glucose levels; aids in diabetes management. Not for diagnosis or screening.

Clinical Evidence

No clinical trials reported. Substantial equivalence supported by bench testing, including compliance with ISO 15197 and IEC/EN 61010-1:2001/61010-2-101:2002 standards. Wireless data transmission validated for accuracy with 100% correlation to monitor data.

Technological Characteristics

Electrochemical biosensor; glucose oxidase (Aspergillus niger) enzyme; hexaammineruthenium (III) chloride mediator; carbon electrode. Amperometric measurement principle. Dimensions: 76 x 56 x 18 mm; weight: 45g. Power: 3V Li battery. Connectivity: RS232 (MGH-1) or Bluetooth (MGH-BT1). Auto-coding via color tag on test strips. Complies with ISO 15197:2003.

Indications for Use

Indicated for diabetic patients or healthcare professionals for quantitative measurement of glucose in capillary whole blood (fingertip, palm, hand, arm, forearm, calf, thigh). Contraindicated for neonatal use, screening/diagnosis of diabetes, critically ill, dehydrated, or hyperosmolar patients. Alternate site testing restricted to steady-state conditions.

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

• HMD Biomedical "Evolution" blood glucose monitor (K072369)

Submission Summary (Full Text)

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Entrallealth Systems, USA 338 Galloway Valley Ct. Alpine, CA 91901

K081703

# SUMMARY OF SAFETY AND EFFECTIVENESS In accordance with 21CFR part 807.92

JAN - 8 2009

#### DEVICE NAME: Myglucohealth Models MGH-1 and MGH-BT1

PREDICATE DEVICE HMD Biomedical "Evolution" blood glucose monitor (reference K072369)

DESCRIPTION: Reference CLASSIFICATION: 862.1345: Blood glucose monitoring systems that include a monitor, control solution and test strips with biosensor.

## INTENDED USE:

Systems are intended for the quantitative measurement of the concentration of glucose in whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals. Results are plasma calibrated to allow for easy comparison to lab method. The Myglucohealth glucose monitoring systems are 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.

# SUBSTANTIAL EQUIVALENCE STATEMENT:

The Myglucohealth blood glucose monitoring system is equivalent in safety and effectiveness to the HMD Biomedical "Evolution" device by virtue of the following:

1) Similar materials of construction including use of the same PCB, software and strips. Case design is different, however the MGH-BT1 monitor is tested and found to be in compliance to:

- o ISO 15197
- CB test scheme to IEC/EN 61010-1:2001 and o 61010-2-101: 2002

2) Equivalent manufacturing methods as both the MGH and predicate (Evolution) systems (including monitor, control solution and strips) are manufactured by the same entity.

- Although unlike the predicate, the Myglucohealth MGH-BT1 system provides for the 3) wireless uploading of data from the monitor via Bluetooth transmission to a Bluetooth paired PC or cell phone. However, the wireless transfer of data has been validated and demonstrates a 100% correlation to actual monitor data. A significant number of users of varying demographic ages, gender, education and background were studied.
4) The intended use of the MGH monitors is the same as the predicate device.

Therefore, there are no substantive differences between the products defined in this 510/k) sub-mission and the predicate device.

Signed: Carlos Gonzalez

Dated: June 4, 2008

Regulatory Affairs Consultant to Entra Health Systems, USA p://413) 513-6343

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three legs.

### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Entra Health Systems, Ltd. c/o Carlos Gonzalez 7833 Knollbrook Dr. Pleasanton, CA 94588

JAN - 8 2009

Re: k081703

> Trade Name: Myglucohealth Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Monitoring System Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: December 23, 2008 Received: December 29, 2008

## Dear Mr. Gonzalez:

We have reviewed your Section 510(k) premarket notification of intent to market the device of referenced above and have determined the device is substantially equivalent (for the indictions 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, ilsting 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 D22. ' In a

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 CED Don 000 hill be Act's requirements, including, but not limited to: registred. " registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice in 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 10gally 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 fron the Division of Small Manufacturers, International and Consumer Assistance at its toll-free mobile [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Corg C. He

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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# Indication for Use

# 510(k) Number (if known): K081703

# Device Name: Myglucohealth Glucose Monitoring Systems

Indication For Use:

The Myglucohealth glucose monitoring system provides a quick and easy way for diabetic patients to measure and self-monitor blood glucose levels. The system is comprised of the MGH-BT1 (w/Bluetooth wireless download capability) or the MGH-1 (w/o Bluetooth) blood glucose meter, control solution and test strips that carry a biosensor used for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals. The results obtained are plasma calibrated to allow for easy comparison to the laboratory method. Further, results from either meter may be uploaded to a memory device through a standard RS32 connection, or, with the-BT1 model, wirelessly transmitted to a bluetooth capable PC or Cell phone. The Myglucohealth glucose monitoring systems are not to be used for the diagnosis 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 X (21 CFR Part 801 Subpart D)

### And/Or

Over the Counter Use x (21 CFR Part 801 Subpart C)

(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)

Carol C. Benson

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

510(k) K081703