CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM

K130696 · I-Sens, Inc. · NBW · Aug 21, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130696
• Device Name: CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 21, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended 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. 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 Story

System measures capillary whole blood glucose via amperometric assay using glucose oxidase enzyme. User applies 0.5 µL blood sample to test strip; meter detects electrical current proportional to glucose concentration. Device includes meter, test strips, and control solutions. Designed for home self-testing (single-patient) or professional healthcare settings (multiple-patient). Multiple-patient version requires auto-disabling, single-use lancing devices and validated disinfection protocols using Clorox Germicidal Wipes. Meter features include test strip ejector, 500-test memory, and multi-day average calculation (1, 7, 14, 30, 90 days). Output displayed on meter screen; aids patients and clinicians in monitoring diabetes control effectiveness. Device housing shape and battery type (AAA alkaline) updated from predicate.

Clinical Evidence

Bench testing performed per ISO 15197:2003(E) including system accuracy, repeatability, and intermediate precision. User performance evaluation assessed accuracy and usability. Results compared to YSI laboratory reference method. Disinfection studies confirmed efficacy of Clorox Germicidal Wipes against HBV and material durability over simulated 3-5 year usage cycles.

Technological Characteristics

Electrochemical biosensor; glucose oxidase (Aspergillus sp.) reagent. Amperometric measurement method. Wireless Bluetooth connectivity for data transmission. Meter housing, test strips, and control solutions. Designed for single-patient (home) or multi-patient (professional) use with validated disinfection protocols.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (fingertip/alternative sites) for diabetes management. For home use (single-patient) or professional healthcare settings (multi-patient). Contraindicated for neonates; not for diabetes diagnosis or screening.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• CareSens N Blood Glucose Monitoring System (k083468)

Submission Summary (Full Text)

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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. [phone]

## 510(k) Summary

(As required by 21 CFR 807.92)

| Introduction: | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
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| Type of 510(k): | Traditional 510(k) |
| Submitter<br>Information: | i-SENS, Inc.<br>27-36 Gwangun-ro, Nowon-gu, Seoul 139-845, Korea<br>Tel.) [phone]<br>Fax) [phone]<br>e-mail: [e-mail]<br>Contact Person: Chae Yun Lim |
| Prepared Date: | March 13, 2013 |
| Device Name<br>and<br>Classification | Trade names: CareSens N LINK Blood Glucose Monitoring System<br><br>CareSens N LINK Multi Blood Glucose Monitoring System<br>Common name: Blood Glucose Test System<br>Classification product code: NBW, CGA<br>Regulation number: 21 CFR 862.1345 Glucose Test System<br>Classification panel: 75, Chemistry<br>Device class: Class II |
| Predicate Device | CareSens N Blood Glucose Monitoring System (k083468) |
| Device<br>Description | The CareSens N LINK Blood Glucose Monitoring System (BGMS) consists of a<br>blood glucose meter, single use test strips, and control solutions with two different<br>glucose concentrations ("Control A" and "Control B" ranges, sold separately).<br>The CareSens N LINK Multi BGMS consists of a blood glucose meter, multi use<br>test strips and the control solutions("Control A" and "Control B" ranges).<br>The CareSens N LINK and CareSens N LINK Multi BGMS are based on an<br>electrochemical biosensor technology (electrochemical). The Systems measure the<br>glucose level in whole blood samples using a small electrical current generated in<br>the test strips. |
| Intended Use: | CareSens N LINK Blood Glucose Monitoring System<br>The CareSens N LINK Blood Glucose Monitoring System is intended for the<br>quantitative measurement of glucose in fresh capillary whole blood samples drawn<br>from the fingertips and alternative sites such as the forearm, palm, thigh, and calf.<br>Alternative site testing should be used only during steady-state blood glucose<br>conditions. The CareSens N LINK Blood Glucose Monitoring System is intended<br>for self testing outside the body ( <i>in vitro</i> ) by people with diabetes at home as an<br>aid to monitor the effectiveness of diabetes control. The system is intended to be<br>used by a single person and should not be shared. It is not intended for use on<br>neonates and is not for the diagnosis or screening of diabetes.<br>The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N<br>LINK Blood Glucose Meter to quantitatively measure glucose in fresh capillary<br>whole blood samples drawn from the fingertips and alternative sites.<br>CareSens N LINK Multi Blood Glucose Monitoring System<br>The CareSens N LINK Multi Blood Glucose Monitoring System is intended for<br>the quantitative measurement of glucose in fresh capillary whole blood samples<br>drawn from the fingertips and alternative sites such as the forearm, palm, thigh,<br>and calf. Alternative site testing should be used only during steady-state blood<br>glucose conditions. The system is intended for use outside the body ( <i>in vitro</i> ) and<br>is intended for multiple-patient use in professional healthcare settings as an aid to<br>monitor the effectiveness of diabetes control. The system is only used with auto-<br>disabling, single use lancing device. It is not intended for use on neonates and is<br>not for the diagnosis or screening of diabetes.<br>The CareSens N Multi Blood Glucose Test Strips are for use with the CareSens N<br>LINK Multi Blood Glucose Meter to quantitatively measure glucose in fresh<br>capillary whole blood samples drawn from the fingertips and alternative sites. |
| Comparison to<br>the Predicate<br>Device | The candidate devices have the following features that are identical to the<br>predicate device:<br>Intended use Measurement principle Fundamental scientific technology Operating ranges |
| | The candidate devices are different from the predicate device for the following<br>aspects: |
| | 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 ( <i>Aspergillus sp.</i> ) |
| Test Principle | The reagent on the test strip produces a small electrical current using glucose as a<br>substrate in the blood sample. The meter converts electrical current to glucose<br>concentration. |
| Summary of<br>Pre-cleaning<br>and Disinfection | The device is intended for single patient home use and multiple patients use in a<br>professional healthcare setting. Disinfection studies were performed on the meter<br>and lancing device by an outside commercial testing service to evaluate<br>effectiveness of disinfectant, CLOROX GERMICIDAL Wipes (EPA Reg. No:<br>67619-12), in preventing the spread of blood-borne pathogens, using hepatitis B<br>virus (HBV). The results demonstrated complete inactivation of live virus<br>inoculated on the materials of the meter and lancing device.<br>We have also demonstrated that 10,950 each of pre-cleaning and disinfection<br>cycles for meter with the same disinfectant designed to simulate 3 years of<br>multiple-patient use or 5 years (260 each of pre-cleaning and disinfection cycles<br>for meter and lancing device) of single patient device use has no effect on the<br>performance or the external materials of the meter and lancing device (for single<br>patient use only). |
| Data<br>demonstrating<br>substantial<br>equivalence | The candidate device was tested in accordance with ISO 15197:2003(E).<br>Analytical performance testing included system accuracy, repeatability, and<br>intermediate precision testing. A user performance evaluation assessed accuracy<br>of results and usability of the device in the hands of intended users. The candidate<br>device performed similarly to both the predicate device as well as to a laboratory<br>reference method, the Yellow Springs Instrument (YSI). All testing demonstrated<br>safety and effectiveness of the candidate device and substantial equivalence to the<br>predicate device. |
| | Although unlike the predicate device, the candidate device provides for the<br>wireless uploading of data from the monitor via Bluetooth transmission to a<br>Bluetooth paired digital devices such as the PC. However, the wireless transfer of<br>data has been validated and demonstrates a 100% correlation to actual monitor<br>data.<br>Therefore, there are no substantive differences between the products defined in<br>this 510(k) submission and the predicate device. |
| Conclusion | Based on the submitted information in this premarket notification, the<br>candidate devices are substantially equivalent to the predicate device.<br>Further, the candidate devices have met the performance, safety, and<br>effectiveness of the device for its intended use. |

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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.

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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 [phone] or [phone] 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

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## 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

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### 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

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