The SOLUSmobile Blood Glucose Management System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by a single patient with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program, and should not be shared. SOLUSmobile is not intended for the diagnosis of or screening for diabetes mellitus, nor for use in neonates. The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions. This system contains an audible readout function that provides an audible message of test results for users. The SOLUSmobile Blood Glucose Management System uses cellular data transmission to send test results to a cloud server, Telemed-Gluconet.

The SOLUSmobile Blood Glucose Test Strips are to be used with the SOLUSmobile Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood from the finger and the forearm. These test strips are intended for use by a single patient with diabetes mellitus at home and should not be shared.

The SOLUSmobile Control Solutions are for use with SOLUSMobile Meter and Test Strips to check that the meters and test strips are working together properly and that the test is performing correction. A control test that falls within the stated range indicates the user technique is appropriate and the test strip and meter are functioning properly.

Device Description

The SOLUSmobile (Model 6134) is a product kit consisting of blood glucose meter, test strips, control solutions, a lancing device, lancets, battery charger and charging cable, and instructions for use.

To perform a test, a glucose test strip is inserted into the top of the monitor. When a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured. The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.

An embedded cellular communications module within the SOLUSmobile meter enables automatic wireless data transmission over the Wireless cellular network between the meter and a Central Data Repository (Cloud server).

The test strips, control solutions, lancing device, and lancets are identical to previously cleared devices. The fundamental scientific technology of the SOLUSmobile except the device's communications capabilities remains unchanged from the legally marketed predicate device, SOLO V2 (K093764).

AI/ML Overview

This document describes the SOLUSmobile Blood Glucose Management System (Model 6134), but it does not contain the specific performance study results, acceptance criteria, or most of the other requested details regarding clinical validation of glucose measurement accuracy.

The provided text focuses on:

Device Description and Intended Use: Explains what the device is, how it works, and its purpose (quantitative measurement of glucose in capillary whole blood for diabetes management).
Comparison to Predicate Device: Highlights changes from a previous model (SOLO V2), primarily related to wireless data transmission, battery improvements, and minor physical alterations.
Performance Studies (General): Mentions that disinfection studies were performed to validate cleaning procedures and ensure efficacy against blood-borne pathogens (HBV). It also states robustness studies were conducted to simulate 3 years of use. It broadly refers to "verification and validation testing" to assess changes and demonstrate that "design outputs... meet the predetermined acceptance criteria of the design input requirements."
Conclusion: States that the device demonstrates "satisfactory performance, is suitable for its intended use, and is substantially equivalent to the predicate device."
FDA K-Number Letter and Indications for Use: Standard regulatory documents.

Missing Information:

The document explicitly states "Performance Studies" but then only details disinfection and robustness studies, along with a general statement about meeting predetermined acceptance criteria. It does not provide data from studies assessing the accuracy of the glucose measurements themselves (e.g., against laboratory reference methods, or ISO 15197 standards). Therefore, I cannot extract the specific acceptance criteria for glucose accuracy or the reported device performance in those terms.

Without this crucial information, I cannot complete most of the requested table and detailed bullet points.

Based on the available information, here is what can be inferred or stated about the device and its validation, with clear indications of what is missing:

1. Acceptance Criteria and Reported Device Performance

For Glucose Measurement Accuracy:

Acceptance Criteria for Glucose Measurement: NOT PROVIDED IN THE TEXT. Typically, blood glucose meters are evaluated against standards like ISO 15197, which define accuracy criteria (e.g., a certain percentage of results within ±15% or ±20% of a reference value for different glucose ranges). This document does not state such criteria or present results that meet them.
Reported Device Performance for Glucose Measurement: NOT PROVIDED IN THE TEXT. The document does not share any data on the accuracy (e.g., bias, precision, percentage agreement with a reference method) of the SOLUSmobile's glucose readings.

For Disinfection Efficacy and Robustness (the only studies detailed):

Acceptance Criteria	Reported Device Performance Statement
Complete inactivation of live virus (HBV)	"Clorox® Bleach Germicidal Wipes (EPA Reg. No. 67619-12) was validated, demonstrating complete inactivation of live virus for use with the meter and lancing device."
No change in performance or external materials after simulated use	"The robustness studies were also conducted and demonstrated that there was no change in performance or in the external materials of the meter and lancing device after 11,000 cycles of cleaning and 11,000 cycles of disinfection to simulate the claimed 3 years of use by lay users."
Hazards within acceptable range after mitigation	"All hazards caused by the changes to the predicate device and the cleaning and disinfection were within the acceptable range after risk mitigation."

2. Sample size used for the test set and the data provenance

For Glucose Measurement Accuracy: NOT PROVIDED IN THE TEXT. Sample size (number of subjects, number of blood samples) and data provenance for studies demonstrating glucose measurement accuracy are not mentioned.
For Disinfection and Robustness Studies: Sample sizes for these specific studies (e.g., number of devices tested for disinfection, number of cycles for robustness) are not precisely stated, though "11,000 cycles" are mentioned for robustness. Data provenance (e.g., country of origin, retrospective/prospective) for these studies is not specified, other than being conducted by "an outside testing service."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For Glucose Measurement Accuracy: NOT PROVIDED IN THE TEXT. Ground truth for glucose accuracy typically involves a highly accurate laboratory reference method (e.g., YSI analyzer), rather than expert consensus. No details on this are provided.
For Disinfection and Robustness Studies: Not applicable to "experts" for ground truth in the traditional sense; these are laboratory-based tests.

4. Adjudication method for the test set

For Glucose Measurement Accuracy: NOT PROVIDED IN THE TEXT.
For Disinfection and Robustness Studies: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

NOT APPLICABLE. This device is a blood glucose meter, not an AI-powered diagnostic imaging system requiring human reader interpretation. No MRMC study was done, nor would it be relevant for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

YES, implicitly. Blood glucose meters inherently operate in a "standalone" fashion (algorithm-only) to measure and display glucose values. The output is directly presented to the user. The document implies this by discussing the meter's function and wireless transmission of results. However, direct "standalone performance" data (like accuracy metrics) are not provided.

7. The type of ground truth used

For Glucose Measurement Accuracy: NOT PROVIDED IN THE TEXT. For blood glucose meters, the ground truth is typically a highly accurate laboratory reference method (e.g., YSI glucose analyzer) that measures plasma glucose concentration.
For Disinfection Efficacy: Live virus (HBV) was used.
For Robustness: Performance of the meter and external materials.

8. The sample size for the training set

NOT APPLICABLE / NOT PROVIDED IN THE TEXT. This device is not described as using a machine learning algorithm that requires a "training set" in the context of diagnostic pattern recognition. The fundamental technology is electrochemical, detecting glucose concentrations directly.

9. How the ground truth for the training set was established

NOT APPLICABLE / NOT PROVIDED IN THE TEXT. As the device is not described as having an AI-driven "training set" for its core function, this question is not relevant.

Summary

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510(k) Summary

1. Submitter Information

Company name: Biotest Medical Corporation . Contact person: Fred Lee Address: No. 3-2, Chien-kuo road, TEPZ Tantzu, 427, Taichung, Taiwan Phone: 886-4-2532-6668 Fax: 886-4-2532-6593 E-mail: leesc311@mail.biotestsystems.com

2. Name of Device

Trade Name: SOLUSmobile Blood Glucose Management System (Model 6134) Common Name: In Vitro Diagnostic Glucose Test System Classification: Glucose Test System

21 CFR 862.1345 (Class II)

21 CFR 862.1660 (Class I)

Classification Panel: Clinical Chemistry

Product Code: NBW, System, Test, Blood Glucose, Over-the-Counter & Prescription.

CGA, Glucose Oxidase, Glucose

JJX, Quality Control Material

3. Predicate Device

Trade Name: SOLO V2 Blood Glucose Management System (Model 6131) Common Name: In Vitro Diagnostic Glucose Test System Submitter: Biotest Medical Corporation 510(k) Number: K093764

4. Device Description

The SOLUSmobile (Model 6134) is a product kit consisting of blood glucose

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meter, test strips, control solutions, a lancing device, lancets, battery charger and charging cable, and instructions for use.

5. Intended Use/Indications for Use

· Intended Use:

See Indications for Use below.

• Indications for Use:

SOLUSmobile Blood Glucose Management System (Model 6134)

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transmission to send test results to a cloud server, Telemed-Gluconet.

SOLUSmobile Blood Glucose Test Strips

SOLUSmobile Control Solutions

6. Comparison to Predicate Device

For the proposed SOLUSmobile device, the modifications from the cleared SOLO V2 (K093764) include the following:

Replacement of the original feature of cabled data download to a PC by automatic wireless data transmission capable of sending the test results over the wireless cellular network to a Central Data Repository at a preset time interval in a dav
This feature allows the meter to use cellular data transmission to automatically send test results to a Central Data Repository (Cloud Server) at a preset time interval in a dav.

● Addition of an Airplane Mode Button

This feature allows users to turn on or off the meter's wireless communications capabilities. When the button is in the "Off" position, communications capabilities are available. When the button is in the "On" position, the communications module is turned off.

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● Change of the meter's battery from Alkaline AAA battery to a rechargeable Li-polymer battery

This feature allows users to recharge the meter's Li-polymer battery by plugging the Micro USB connector on the charging cable into the Micro USB port on the right hand side of the meter and connecting the other end of the charging cable to an electrical outlet. ·

● Addition of backlight

This feature allows users to see the LCD display more clearly when the meter is on. The backlight will be automatically on when the meter is on and the backlight will be automatically off when the meter is off.

· Addition of an ear phone jack

This feature allows users to hear the meter's audible output through an ear phone plugged into the meter's ear phone jack.

· Rearrangement of control buttons

The location of Up(YA)/Down(▼N) Buttons, Language Selection Button

the "M" Left Function Button and "R" Left Function Button are rearranged and placed at the front side of the meter, right below the LCD screen and speaker slot.

● Modification of outer plastic case dimension

The plastic cover of the meter is modified to be longer (19mm), slightly wider(3.3mm) and thicker (2.8 mm) in dimension than that of the predicate SOLO V2 (Model 6131). No changes were made to the materials used for. The change was made for style purposes and accommodating the addition of an embedded cellular communications module within the meter.

Product sterilization, shelf-life, and biocompatibility are unaffected by the modifications and are equivalent to the legally marketed the SQLO V2 device (K093764).

These modifications are eligible for the Special 510(k) process, as they do not

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affect the intended use or alter the fundamental scientific technology of the cleared device.

7. Performance Studies

The device (SOLUSmobile) is intended for single-patient use. Cleaning and disinfection of the devices are different processes. Cleaning is the process of removing dirt or touch contaminants while disinfection is the process of killing viruses.

Disinfection studies were performed on the meter and lancing device by an outside testing service to determine the disinfection efficacy of the meter and lancing device to the recommended cleaning and disinfection procedure, and its effectiveness in preventing the spread of blood-borne pathogens, particularly hepatitis B virus (HBV). Clorox® Bleach Germicidal Wipes (EPA Reg. No. 67619-12) was validated, demonstrating complete inactivation of live virus for use with the meter and lancing device. The robustness studies were also conducted and demonstrated that there was no change in performance or in the external materials of the meter and lancing device after 11,000 cycles of cleaning and 11,000 cycles of disinfection to simulate the claimed 3 years of use by lay users.

A risk assessment following the standard ISO 14971:20071 was performed and verification and validation testing was conducted to assess the changes to demonstrate that the design outputs of the modified device meet the predetermined acceptance criteria of the design input requirements. All hazards caused by the changes to the predicate device and the cleaning and disinfection were within the acceptable range after risk mitigation. Therefore, the SOLUSmobile is substantially equivalent to the predicate the SOLO V2 (K093764).

8. Conclusion

The SOLUSmobile Blood Glucose Management System, Model 6134 demonstrates satisfactory performance, is suitable for its intended use, and is substantially equivalent to the predicate device.

1 ISO 14971:2007. Medical devices - Application of risk management to medical devices.

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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a bird or a flame. The symbol is composed of three curved lines that form the shape of a person's arms and head, with a wing-like shape extending from the arms.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gibtly Silver Spring, MD 20993-0002

June 28, 2013

Biotest Medical Corporation C/O Fred Lee No. 3-2, Chien-kuo Road TEPZ Tantzu, 427, TAICHUNG TAIWAN

Re: K123559

Trade/Device Name: SOLUSmobile Blood Glucose Management System, (Model 6134) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX Dated: June 21, 2013 Received: June 24, 2013

Dear Mr. Lec:

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 10 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Lee

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol C. Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K123559

Device Name: SOLUSmobile Blood Glucose Management System, Model 6134

Indications for Use:

SOLUSmobile Blood Glucose Management System (Model 6134)

SOLUSmobile Blood Glucose Test Strips

SOLUSmobile Control Solutions

AND/OR Over-The-Counter Use Prescription Use X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

Katherine Serrano -S

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k) ki23559

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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.