CareSens N LINK Blood Glucose Monitoring System: The CareSens N LINK 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 such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The system is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes. The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N LINK Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.

CareSens N LINK Multi Blood Glucose Monitoring System: The CareSens N LINK 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 such as the 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) 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. The CareSens N Multi Blood Glucose Test Strips are for use with the CareSens N LINK Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.

Device Description

The CareSens N LINK Blood Glucose Monitoring System (BGMS) consists of a blood glucose meter, single use test strips, and control solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately). The CareSens N LINK Multi BGMS consists of a blood glucose meter, multi use test strips and the control solutions("Control A" and "Control B" ranges). The CareSens N LINK and CareSens N LINK Multi BGMS are based on an electrochemical biosensor technology (electrochemical). The Systems measure the glucose level in whole blood samples using a small electrical current generated in the test strips.

AI/ML Overview

Here's an analysis of the acceptance criteria and study findings for the CareSens N LINK Blood Glucose Monitoring System, based on the provided 510(k) summary:

Key Takeaways:

This submission focuses on demonstrating substantial equivalence to a predicate device (CareSens N Blood Glucose Monitoring System).
The primary method for demonstrating this was analytical performance testing based on ISO 15197:2003(E) and a user performance evaluation.
The document explicitly states that the wireless data transfer "demonstrates a 100% correlation to actual monitor data," which serves as an acceptance criterion for that specific feature.
The provided document does not contain detailed acceptance criteria for the blood glucose measurement accuracy itself, nor the specific results alongside those criteria. It broadly states the device "performed similarly" and "All testing demonstrated safety and effectiveness."

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
System Accuracy (per ISO 15197:2003(E))	"performed similarly to both the predicate device as well as to a laboratory reference method, the Yellow Springs Instrument (YSI)."	Specific numeric acceptance criteria (e.g., % within ±15 mg/dL or ±20%) and results are not provided in this summary.
Repeatability	"All testing demonstrated safety and effectiveness of the candidate device and substantial equivalence to the predicate device."	Specific numeric acceptance criteria and results are not provided.
Intermediate Precision	"All testing demonstrated safety and effectiveness of the candidate device and substantial equivalence to the predicate device."	Specific numeric acceptance criteria and results are not provided.
User Performance Evaluation	"assessed accuracy of results and usability of the device in the hands of intended users." Findings contributed to the conclusion of "safety and effectiveness."	Specific acceptance criteria for user performance (e.g., passing rate, error types) and results are not provided.
Wireless Data Transmission Accuracy	"demonstrates a 100% correlation to actual monitor data."	This is explicitly stated as an achieved performance metric for the new Bluetooth feature.
Disinfection Effectiveness	"complete inactivation of live virus inoculated on the materials of the meter and lancing device" (using CLOROX GERMICIDAL Wipes).	This shows the device meets the criterion for allowing effective disinfection for multi-patient use.
Disinfection Durability	"10,950 each of pre-cleaning and disinfection cycles for meter... has no effect on the performance or the external materials of the meter."	This demonstrates the device's durability for disinfection over its intended lifespan.

Study Details

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided summary. The summary mentions "analytical performance testing" and "user performance evaluation" but does not give the number of samples or subjects used for each.
- Data Provenance: Not explicitly stated. However, given the submitter's address (Seoul, Korea), it can be inferred that the testing might have been conducted in South Korea or through contracted services. The document does not specify if the data was retrospective or prospective.
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):
- For the system accuracy evaluation, the "Yellow Springs Instrument (YSI)" is mentioned as the laboratory reference method. The YSI is a highly accurate laboratory-grade glucose analyzer, effectively serving as the "expert" or gold standard for glucose measurement.
- No human experts were used to establish the ground truth for glucose values.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the ground truth for glucose values was established by a laboratory reference instrument (YSI), not through human expert adjudication.
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:
- No MRMC comparative effectiveness study was performed or is relevant to this type of device (blood glucose monitoring system). This is not an AI-assisted diagnostic imaging device that involves human readers interpreting cases.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the "analytical performance testing" including system accuracy, repeatability, and intermediate precision, assessed the device's performance standalone against the YSI reference method and its own internal consistency. The device itself is an algorithm (or electrochemical process) that measures glucose without human interpretation of the primary data.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Analytical Ground Truth: A laboratory reference method, specifically the Yellow Springs Instrument (YSI), was used as the ground truth for glucose concentration measurements.
- Disinfection Ground Truth: Inactivation of live Hepatitis B virus (HBV) was used as the ground truth for the effectiveness of the disinfectant.
The sample size for the training set:
- Not applicable. Blood glucose meters typically do not use "training sets" in the same way machine learning models do. Their underlying technology (electrochemical biosensor) and algorithms are based on established chemical and electrical principles rather than learned patterns from data.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of this device's development as described. The device's calibration and performance are based on the electrochemical reaction and robust engineering, not on machine learning training data.

Summary

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

K130696

Image /page/0/Picture/1 description: The image contains a logo with the text 'i-sens' in a stylized font. The 'i' in 'i-sens' is lowercase and has a circular dot above it. The word 'sens' is in lowercase and is connected to the 'i'. A circle surrounds the entire 'i-sens' text, enclosing the logo within a circular border.

27-36 Gwangun-ro, Nowon-gu, Seoul 139-845, Korea

Tel. 82-2-916-6191

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):	Traditional 510(k)
SubmitterInformation:	i-SENS, Inc.27-36 Gwangun-ro, Nowon-gu, Seoul 139-845, KoreaTel.) +82-33-903-0767Fax) +82-33-748-6191e-mail: cylim@i-sens.comContact Person: Chae Yun Lim
Prepared Date:	March 13, 2013
Device NameandClassification	Trade names: CareSens N LINK Blood Glucose Monitoring SystemCareSens N LINK 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 Device	CareSens N Blood Glucose Monitoring System (K083468)
DeviceDescription	The CareSens N LINK Blood Glucose Monitoring System (BGMS) consists of ablood glucose meter, single use test strips, and control solutions with two differentglucose concentrations ("Control A" and "Control B" ranges, sold separately).The CareSens N LINK Multi BGMS consists of a blood glucose meter, multi usetest strips and the control solutions("Control A" and "Control B" ranges).The CareSens N LINK and CareSens N LINK Multi BGMS are based on anelectrochemical biosensor technology (electrochemical). The Systems measure theglucose level in whole blood samples using a small electrical current generated inthe test strips.
Intended Use:	CareSens N LINK Blood Glucose Monitoring SystemThe CareSens N LINK Blood Glucose Monitoring System is intended for thequantitative measurement of glucose in fresh capillary whole blood samples drawnfrom the fingertips and alternative sites such as the forearm, palm, thigh, and calf.Alternative site testing should be used only during steady-state blood glucoseconditions. The CareSens N LINK Blood Glucose Monitoring System is intendedfor self testing outside the body ( in vitro ) by people with diabetes at home as anaid to monitor the effectiveness of diabetes control. The system is intended to beused by a single person and should not be shared. It is not intended for use onneonates and is not for the diagnosis or screening of diabetes.The CareSens N Single Blood Glucose Test Strips are for use with the CareSens NLINK Blood Glucose Meter to quantitatively measure glucose in fresh capillarywhole blood samples drawn from the fingertips and alternative sites.CareSens N LINK Multi Blood Glucose Monitoring SystemThe CareSens N LINK Multi Blood Glucose Monitoring System is intended forthe quantitative measurement of glucose in fresh capillary whole blood samplesdrawn from the fingertips and alternative sites such as the forearm, palm, thigh,and calf. Alternative site testing should be used only during steady-state bloodglucose conditions. The system is intended for use outside the body ( in vitro ) andis intended for multiple-patient use in professional healthcare settings as an aid tomonitor 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 isnot for the diagnosis or screening of diabetes.The CareSens N Multi Blood Glucose Test Strips are for use with the CareSens NLINK Multi Blood Glucose Meter to quantitatively measure glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites.
Comparison tothe PredicateDevice	The candidate devices have the following features that are identical to thepredicate device:Intended use Measurement principle Fundamental scientific technology Operating ranges
	The candidate devices are different from the predicate device for the followingaspects:
	The shape of meter's housing Test result average range Memory capacity Battery type Test strip ejector
	The candidate devices and predicate device use same control solutions.
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 single patient home use and multiple patients use in aprofessional healthcare setting. Disinfection studies were performed on the meterand lancing device by an outside commercial testing service to evaluateeffectiveness of disinfectant, CLOROX GERMICIDAL Wipes (EPA Reg. No:67619-12), in preventing the spread of blood-borne pathogens, using hepatitis Bvirus (HBV). The results demonstrated complete inactivation of live virusinoculated on the materials of the meter and lancing device.We have also demonstrated that 10,950 each of pre-cleaning and disinfectioncycles for meter with the same disinfectant designed to simulate 3 years ofmultiple-patient use or 5 years (260 each of pre-cleaning and disinfection cyclesfor meter and lancing device) of single patient device use has no effect on theperformance or the external materials of the meter and lancing device (for singlepatient use only).
Datademonstratingsubstantialequivalence	The candidate device was tested in accordance with ISO 15197:2003(E).Analytical performance testing included system accuracy, repeatability, andintermediate precision testing. A user performance evaluation assessed accuracyof results and usability of the device in the hands of intended users. The candidatedevice performed similarly to both the predicate device as well as to a laboratoryreference method, the Yellow Springs Instrument (YSI). All testing demonstratedsafety and effectiveness of the candidate device and substantial equivalence to thepredicate device.
	Although unlike the predicate device, the candidate device provides for thewireless uploading of data from the monitor via Bluetooth transmission to aBluetooth paired digital devices such as the PC. However, the wireless transfer ofdata has been validated and demonstrates a 100% correlation to actual monitordata.Therefore, there are no substantive differences between the products defined inthis 510(k) submission and the predicate device.
Conclusion	Based on the submitted information in this premarket notification, thecandidate devices are substantially equivalent to the predicate device.Further, the candidate devices have met the performance, safety, andeffectiveness of the device for its intended use.

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

Image /page/1/Picture/0 description: The image contains a logo with the text "i-sens" in a stylized font. The "i" is lowercase and enclosed in a circle. The word "sens" is also lowercase and connected to the "i". The logo appears to be for a company named i-sens.

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

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

Image /page/3/Picture/0 description: The image shows a logo with the word "i-sens" in a stylized font. The "i" is lowercase and has a circular design above it, resembling a stylized atom or a target. The rest of the word "sens" is in lowercase as well, with a slightly bolder font. The logo has a simple and modern design.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services-USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized eagle or bird in flight.

Public Health Service

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

August 21, 2013

i-SENS. Inc C/O Chae Yun Lim 27-36 Gwangun-ro, Nowon-gu, Seoul 139-845, Korea

Re: K130696

Trade/Device Name: CareSens N Link Blood Glucose Monitoring System CareSens N Link Multi Blood Glucose Monitoring System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: July 10, 2013 Received: July 11, 2013

Dear Chae Yun Lim:

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. Iisting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2-Chae Yun Lim

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/McdicalDevices/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/Resourcesfor You/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

{6}------------------------------------------------

Indications for Use Form

510(k) Number (if known): K130696

Device Name: CareSens N LINK Blood Glucose Monitoring System

Indications for Use:

The CareSens N LINK 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 such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The system is intended for self-testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N LINK Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use ਮ (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 Diagnostics and Radiological Health (OIR)

Katherine Serrano -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) k1320696

Page 1 of 2

{7}------------------------------------------------

Indications for Use Form

510(k) Number (if known): K130696

Device Name: CareSens N LINK Multi Blood Glucose Monitoring System

Indications for Use:

The CareSens N LINK 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 such as the 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) 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.

The CareSens N Multi Blood Glucose Test Strips are for use with the CareSens N LINK Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter 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 Diagnostics and Radiological Health (OIR)

Katherine Serrano -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K130696

Page Dof 2

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.