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 Description

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Myglucohealth Glucose Monitoring System. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with specific acceptance criteria and performance data in the format requested.

Therefore, the requested tables and specific details about acceptance criteria and study data (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) are not fully contained within the provided text.

The document primarily states that the device is equivalent to its predicate by virtue of similar materials, manufacturing methods, and intended use, and validates its wireless data transfer.

However, I can extract information related to what is available and format it to the best of my ability, highlighting where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

The document states compliance with ISO 15197 for the device in general, and then specifies a "100% correlation to actual monitor data" for the wireless transfer function. ISO 15197 sets accuracy requirements for blood glucose monitoring systems. Without the full ISO 15197 report or a specific excerpt, the precise accuracy criteria and detailed performance (e.g., bias, precision, percentage within specific error margins) cannot be fully reported from this document.

Acceptance Criteria Category	Specific Acceptance Criteria (if available)	Reported Device Performance (if available)
General Device Accuracy	Compliance with ISO 15197 (specific clauses not detailed in this document). ISO 15197 outlines accuracy requirements for BGM systems.	Not explicitly detailed in numerical performance terms in this document. The document states compliance with ISO 15197, implying these criteria were met.
Wireless Data Transfer	Data transfer from monitor to paired PC/cell phone must accurately reflect monitor data.	"100% correlation to actual monitor data" for wireless transfer.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Wireless Transfer Validation: "A significant number of users of varying demographic ages, gender, education and background were studied."
- Specific number: Not specified in the document.
Data Provenance: The document does not specify country of origin for the data, nor whether it was retrospective or prospective. It only mentions the "users" were studied, suggesting a prospective study for the wireless transfer validation. For the general device performance and ISO 15197 compliance, the document does not provide details on the study design or data provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The document focuses on the technical and regulatory aspects of device equivalence and wireless function validation, not on clinical study details involving experts for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided in the document. Since there is no mention of independent expert review or a traditional "test set" in a clinical study sense (beyond the wireless transfer validation), an adjudication method is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not performed or mentioned. This type of study is typically for evaluating diagnostic imaging systems or decision support tools where human interpretation is a key component, often comparing human performance with and without AI assistance. The Myglucohealth Glucose Monitoring System is a handheld device for quantitative measurement, which does not involve human interpretation in the same manner.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The wireless data transfer validation could be considered a form of standalone performance assessment for that specific function (algorithm in this case refers to the transmission protocol). It evaluated the system's ability to transfer data accurately without human intervention in the data's content.

Wireless Data Transfer: A standalone assessment was performed for the wireless uploading of data, demonstrating "100% correlation to actual monitor data."
Glucose Measurement Performance: The document states compliance with ISO 15197. This standard inherently requires a standalone (device-only) performance evaluation against a reference method. However, the specific study details for this compliance are not provided in the document.

7. The Type of Ground Truth Used

For Wireless Data Transfer Validation: The "actual monitor data" served as the ground truth. This means the data directly displayed on the device's screen was compared to the wirelessly transmitted data.
For Glucose Measurement Performance: For ISO 15197 compliance, the ground truth would typically be established by a laboratory reference method (e.g., a highly accurate spectrophotometric method). This is not explicitly stated but is standard practice for such device validations. The document mentions "Results are plasma calibrated to allow for easy comparison to lab method," which supports this inference.

8. The Sample Size for the Training Set

This information is not provided in the document. Blood glucose monitoring systems typically do not involve "training sets" in the machine learning sense for their core measurement function. If firmware or algorithms were optimized, this process is not detailed. The "significant number of users" were likely for validation or verification, not a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document as a training set is not explicitly mentioned for the core glucose measurement function.

Summary

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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:

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:

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

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.

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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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:

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

Regulation Number and Section

§ 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.