Glucophone™ Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or healthcare professionals in the home and in clinical setting. Glucophone™ Blood Glucose Testing System is for testing outside the body (in vitro diagnostic use only). GlucoPhone™ Blood glucose Testing system is for use with a cellular phone. GlucoPhone™ Blood glucose Testing system is not for neonatal use and not for diagnosis or screening of diabetes. Alternate site testing is for use during times of steady state.

Device Description

The Glucophone™ Meter device combined with Cell Phone (Motorola v3) is used along with the Glucophone The Test Strip to measure the glucose level in capillary whole blood.

AI/ML Overview

The provided text describes the "Glucophone™ Blood Glucose Monitoring System" and its 510(k) submission. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria with numerical performance data.

Instead, the document states:

Performance Data: "The clinical performance evaluation using the Glucophone™ Blood Glucose Monitoring System components were conducted for the purpose of validating consumer use and 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 Glucophone "" Blood Glucose Monitoring System with respect to two predicate devices. Testing involved the verification of software requirement specifications, product requirement specifications and user interface requirement specifications from the risk analysis. The device passed all of the tests based on pre-determined Pass/Fail criteria."
Conclusion: "The data from the clinical and non clinical tests show that the Glucophone™ Blood Glucose Monitoring System is as safe and effective as the legally marketed predicate devices, the GlucoPack™ and GlucoLab™"

Based on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide specific details on sample sizes, ground truth establishment, or multi-reader studies. The document only states that testing was performed and that the device was found to be "substantially equivalent" to predicate devices, implying that its performance met the standards of those approved devices, but without quantifying that performance or the specific criteria.

Therefore, many of the requested details are not present in the provided text.

Here's a breakdown of what can be inferred or explicitly stated from the text regarding your questions:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in numerical form. The implication is that the acceptance criteria are met if the device demonstrates "substantial equivalence" to the predicate devices (GlucoPack™ and GlucoLab™) in terms of "consumer use and professional accuracy," and passes "pre-determined Pass/Fail criteria" for non-clinical aspects.
- Reported Device Performance: Not numerically reported. The text only states "Test results showed substantial equivalence" for clinical performance, and "The device passed all of the tests based on pre-determined Pass/Fail criteria" for non-clinical performance.
Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not explicitly stated, but the submission is from a Korean company (Infopia Co., Ltd.). It is likely a prospective clinical study, given the mention of "clinical performance evaluation," but this is not explicitly confirmed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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/Not specified. This device is a blood glucose monitor, not an AI-assisted diagnostic imaging device that uses human readers. The clinical evaluation would likely compare measurements from the device with a reference method (e.g., laboratory analyzer), not human interpretations.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is less relevant for a blood glucose monitoring system, as the "algorithm" is integral to the device's measurement. The clinical study implicitly evaluates the device in a "standalone" fashion (algorithm + hardware) when it states "The clinical performance evaluation using the Glucophone™ Blood Glucose Monitoring System components were conducted..."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a blood glucose monitoring system, the ground truth would typically be a highly accurate laboratory reference method for blood glucose measurement (e.g., a YSI analyzer or similar). This is not explicitly stated but is the standard for such devices.
The sample size for the training set:
- Not applicable/Not specified. For a simple electrochemical blood glucose system, there isn't typically a "training set" in the machine learning sense. Calibration and internal validation are performed during development, but this is different from a machine learning training set.
How the ground truth for the training set was established:
- Not applicable (see point 8).

In summary, the provided 510(k) summary focuses on establishing substantial equivalence to existing predicate devices rather than providing detailed quantitative performance metrics and study designs, which are often found in more extensive clinical trial reports or full 510(k) submissions.

Summary

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inopia co.,ku Blood Glucose monitoring system
510(k) for In Vitro Diagnostic Device

510(k) Summary

Attachment #4

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.

Date: May 21, 2010

MAY 2 7 2010

1091168

1. Submitter:

Submitted by:	Infopia Co.,ltd.#891, Hogye-dong, Dongan-GuAnyang, Kyunggi431-080, KoreaPhone: 82-31-460-0400Fax: 82-31-0401
Contact:	Bryan OhPhone: 1-321-267-9911Fax: 1-321-267-5582

2. Device:

Propriety Name	Glucophone™ Blood Glucose Monitoring System
Common Name	Blood Glucose Test System
Classification Name:	Glucose OxidaseSingle (specified) analyte controls
Classification:	Class II, 21 CFR 862.1345,
Product Code:	NBW, CGA, JJX

3. Predicate Device:

GlucoPack™ Blood Glucose Monitoring System(HealthPia America Corp.) K052469 GlucoLab™ Blood Glucose Monitoring System(Infopia co., Ltd.) K051285

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Description: 4.

The Glucophone™ Meter device combined with Cell Phone (Motorola v3) is used along with the Glucophone The Test Strip to measure the glucose level in capillary whole blood.

Test Principle

The principle of the test relies upon a specific type of glucose in the blood sample, the glucose oxidase reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.

5. Indications for use:

Comparison of Technological Characteristics with Predicate: 6.

The technological characteristics of the new device (Glucophone™) in comparison to two predicate devices (GlucoPack™, GlucoLab™):

The modified Glucophone™ device has the same technological characteristics as the current legally marketed predicate devices: 1. same in the meter device technology with GlucoPack™ Glucose Monitoring System (K052469) By HealthPia America Corp. and 2. same in the strip technology with GlucoLab™ Blood Glucose Monitoring System (K051285) By Infopia co., Ltd..

7. Performance Data:

Clinical: The clinical performance evaluation using the Glucophone™ Blood Glucose Monitoring System components were conducted for the purpose of validating consumer use and 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 Glucophone "" Blood Glucose Monitoring System with respect to two predicate devices. Testing involved the verification

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of software requirement specifications, product requirement specifications and user interface requirement specifications from the risk analysis. The device passed all of the tests based on pre-determined Pass/Fail criteria.

8. Conclusion

The data from the clinical and non clinical tests show that the Glucophone™ Blood Glucose Monitoring System is as safe and effective as the legally marketed predicate devices, the GlucoPack™ and GlucoLab™

Therefore we conclude that the Glucophone™ Blood Glucose Monitoring System is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

MAY 2 7 200

Infopia Co., Ltd. C/O Maria Griffin MDI Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11021

Re: K091168

Trade/Device Name: Glucophone™ Blood Glucose Testing System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: May 21, 2010 Received: May 24, 2010

Dear Ms. Griffin:

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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Courtney C. Harper, Ph.D. 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): K091168

Device Name: Glucophone™ Blood Glucose Testing System

Indication For Use:

Prescription Use (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 Benain

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)

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.