The Assure® Prism multi Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites (forearm, palm, thigh, and calf). Alternative site testing should be used only during steady-state blood glucose conditions. The system is intended for use outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with auto-disabling, single use lancing device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

Assure® Prism multi Blood Glucose Test Strips are for use with the Assure® Prism multi blood glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.

Device Description

The Assure Prism multi Blood Glucose Monitoring System (BGMS) consists of a multi use blood glucose meter, test strips, and control solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately).

The Assure Prism multi BGMS are based on an electrochemical biosensor technology (electrochemical). The System measures the glucose level in whole blood samples using a small electrical current generated in the test strips.

AI/ML Overview

The provided text describes the Assure Prism multi Blood Glucose Monitoring System and states its substantial equivalence to a predicate device (ACURA Plus Multi BGMS, K131419). It includes information about disinfection studies but does not report on the clinical performance or acceptance criteria of the glucose monitoring system directly. Therefore, it's not possible to populate all the requested sections.

Here's the information that can be extracted or deduced from the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state the acceptance criteria for the blood glucose monitoring system's accuracy, nor does it report its performance in terms of accuracy (e.g., against a reference method). It primarily focuses on the substantial equivalence to a predicate device and disinfection validation.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document mentions disinfection studies but not clinical performance studies with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as no clinical performance study with expert-established ground truth is detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

This is not applicable as the device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that involves human readers.

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

This is not applicable as the device is a blood glucose monitoring system, not an algorithm-only device. Its performance is inherent to the system (meter and test strips).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For blood glucose monitoring systems, the "ground truth" for performance studies would typically be a laboratory reference method for glucose measurement (e.g., YSI analyzer). However, the document does not detail such a study or the ground truth used.

8. The sample size for the training set

This information is not provided.

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

This information is not provided.

Summary of available information from the document:

The document largely focuses on demonstrating "substantial equivalence" of the Assure Prism multi Blood Glucose Monitoring System to a predicate device (ACURA Plus Multi Blood Glucose Monitoring System, K131419). The main points of the submission relate to:

Device Name: Assure Prism multi Blood Glucose Monitoring System
Intended Use: Quantitative measurement of glucose in fresh capillary whole blood samples from fingertips and alternative sites (forearm, palm, thigh, and calf) for multiple-patient use in professional healthcare settings to monitor diabetes control. Not for neonates or diagnosis/screening of diabetes.
Mechanism: Electrochemical biosensor technology (glucose oxidase).
Comparison to Predicate: The candidate device and predicate device consist of the same meter and test strips, with same measurement principle, scientific technology, operating ranges, and performance characteristics. Changes are limited to meter button symbols, strip logo, and validation of additional disinfectants.
Disinfection Study: Performed by an outside commercial testing service to evaluate the effectiveness of three disinfectants (Dispatch® Hospital Cleaner Disinfectant Towels with Bleach, CaviWipes1, PDI ®Super Sani-Cloth® Germicidal Disposable Wipe) in preventing the spread of blood-borne pathogens (using hepatitis B virus, HBV). Results demonstrated complete inactivation of live virus.
Durability Study: Demonstrated that 10,950 cleaning and disinfection cycles (simulating 3 years of multiple-patient use) had no effect on the performance or external materials of the meter.

The document's purpose is to obtain 510(k) clearance based on substantial equivalence, and therefore doesn't detail new clinical performance studies with specific acceptance criteria as might be seen for novel devices or software with AI components.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 7, 2015

I-SENS, INC. JOON JUNG RA TEAM MANAGER 43, BANPO-DAERO 28-GIL, SEOCHO-GU 137-873 SEOUL KOREA

Re: K151164

Trade/Device Name: Assure Prism multi Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW Dated: July 9, 2015 Received: July 10, 2015

Dear Joon Jung:

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. 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 Parts 801 and 809); medical device reporting (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.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Yung W. Chan -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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K151164

Device Name

Assure Prism multi Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for i-sens. The "i" has a green dot above it, and the rest of the word is in blue. The font is sans-serif and the logo is simple and modern.

i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 137-873, Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514

510(k) Summary

(As required by 21 CFR 807.92)

Introduction	According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence.
Type of 510(k)	Special 510(k)
SubmitterInformation	i-SENS, Inc.43, Banpo-daero 28-gil, Seocho-gu 137-873, Seoul, KoreaTel.) +82-2-916-6191Fax) +82-2-942-2514e-mail: jhjung@i-sens.comContact Person: Joon Ho Jung
Prepared Date	April, 29th, 2015
Device NameandClassification	Trade name: Assure Prism multi Blood Glucose Monitoring SystemCommon name: Blood Glucose Test SystemClassification product code: NBW, CGARegulation number: 21 CFR 862.1345 Glucose Test SystemClassification panel: 75, ChemistryDevice class: Class II
Predicate DeviceInformation	Device name: ACURA Plus Multi Blood Glucose Monitoring System510(k) number: K131419
DeviceDescription	The Assure Prism multi Blood Glucose Monitoring System (BGMS) consists of amulti use blood glucose meter, test strips, and control solutions with twodifferent glucose concentrations ("Control A" and "Control B" ranges, soldseparately).The Assure Prism multi BGMS are based on an electrochemical biosensortechnology (electrochemical). The System measures the glucose level in wholeblood samples using a small electrical current generated in the test strips.
Intended Use:	The Assure Prism multi Blood Glucose Monitoring System is intended for thequantitative measurement of glucose in fresh capillary whole blood samples drawnfrom the fingertips and alternative sites (forearm. palm. thigh. and calf).

{4}------------------------------------------------

Alternative site testing should be used only during steady-state blood glucoseconditions. The system is intended for use outside the body (in vitro diagnostic use)and is intended for multiple-patient use in professional healthcare settings as an aidto monitor the effectiveness of diabetes control. The system is only used with auto-disabling, single use lancing device. It is not intended for use on neonates and is notfor the diagnosis or screening diabetes.Assure Prism multi Blood Glucose Test Strips are for use with the Assure Prismmulti blood glucose meter to quantitatively measure glucose in fresh capillary wholeblood samples drawn from the fingertips and alternatives sites.
Comparison tothe PredicateDevice	The candidate device and the predicate device consist of the same meter and teststrips. The measurement principle, fundamental scientific technology, operatingranges, and performance characteristics of the candidate device remain the sameas those of the predicate device. Assure Prism multi has not changed since its CLIAcategorization. Additional 3 disinfectants have been validated in order to be usedwith the system upon clearance. Accordingly, there have been some labelingchanges made in accordance with the addition of the 3 disinfectants. The differencesin appearance of meter and test strips are as follows.
	Features	ACURA Plus Multi BGMS(Predicate device, K131419)	Assure Prism multi BGMS(Candidate deviceK151164/CR140257)
	Metershell	Differences in meter button symbols (functions remain the same)
		Image: ACURA Plus Multi BGMS meter	Image: Assure Prism multi BGMS meter

{5}------------------------------------------------

	StripLogo
	Image: ACURA strip	Image: arkray strip
Type of Test	Quantitative, Amperometric method, Glucose oxidase ( Aspergillus sp. )
Test Principle	The reagent on the test strip produces a small electrical current using glucose as asubstrate in the blood sample. The meter converts electrical current to glucoseconcentration.
Summary ofPre-cleaningand Disinfection	The device is intended for multiple patients use in a professional healthcare setting.Disinfection study was performed on the meter by an outside commercial testingservice to evaluate effectiveness of disinfectants, Dispatch® Hospital CleanerDisinfectant Towels with Bleach (EPA Reg. No: 56392-7), CaviWipes1 (EPA Reg.No: 46781-13), and PDI ®Super Sani-Cloth® Germicidal Disposable Wipe (EPAReg. No: 9480-4) in preventing the spread of blood-borne pathogens, using hepatitisB virus (HBV). The results demonstrated complete inactivation of live virusinoculated on the materials of the meter.
	We have also demonstrated that 10,950 each of cleaning and disinfection cycles formeter with the same disinfectant designed to simulate 3 years of multiple-patient use has no effect on the performance or the external materials of the meter.
Conclusion	Based on the submitted information in this premarket notification, thecandidate device is substantially equivalent to the predicate device. Further,the candidate device has met the performance, safety, and effectiveness of thedevice for its intended use.

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.