CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)

K083468 · I-Sens, Inc. · NBW · Feb 10, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083468
• Device Name: CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 10, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The CareSens N Meter is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. CareSens N Blood Glucose System should be used only for testing outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis or screening of diabetes. Testing sites include the traditional fingertip testing along with alternate sites testing on forearm, palm, thigh and calf. CareSens N Test Strip is used with the CareSens N Blood Glucose Meter for quantitatively measuring glucose in capillary whole blood. The CareSens N Test Strip is intended for selftesting outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis of diabetes without the guidance of healthcare professional. Testing sites include the traditional fingertip testing along with alternate sites testing on forearm, palm, thigh and calf. CareSens Control A&B Solutions are a red liquid to check that both the meters and test strips are working together properly. It contains a known range of glucose as written on the bottle.

Device Story

CareSens N BGMS is an in vitro diagnostic system measuring glucose concentration in capillary whole blood. Input: capillary blood sample applied to CareSens N test strip. Principle: amperometric method using glucose oxidase enzyme; meter detects current proportional to glucose concentration. Key modification: automatic code identification via infrared sensors detecting patterns on test strips, eliminating manual coding. Features: 3-button interface, time-set alarms, 2-hour post-meal alarm, post-meal flagging. Used at home or point-of-care by patients or clinicians. Output: digital glucose reading on meter display. Benefits: simplifies user workflow, reduces errors from manual coding, aids diabetes management monitoring.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements (21 CFR 820.30) to confirm modifications met predetermined acceptance criteria.

Technological Characteristics

Blood glucose monitoring system; auto-code test strip calibration; three-button user interface; reminder alarm functionality; post-meal flagging capability. Fundamental scientific technology consistent with predicate K080923.

Indications for Use

Indicated for quantitative glucose measurement in capillary whole blood to monitor diabetes management effectiveness. For use by patients (home) or clinicians (clinical settings). Testing sites include fingertip, forearm, palm, thigh, and calf. 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

• K080923

Submission Summary (Full Text)

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IC083468

Image /page/0/Picture/1 description: The image shows a logo with the word "i-sens" in a stylized font. The "i" is lowercase and has a small circle above it, resembling a dot. The rest of the word, "-sens," is also lowercase. To the left of the word is a circular graphic with a complex, textured pattern inside. The overall design is simple and modern.

i-SENS, Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea

Tel. [phone]

# Special 510(k) SUMMARY

## FEB 1 0 2009

(As required by 2I.CFR.807.87)

| Type of 510(k): | Special |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Previously Cleared Device: | Name - CareSens Blood Glucose Monitoring System<br>510(k) number - k080923 |
| Introduction: | This 510(k) submission contains information/data on modifications made<br>to submitter's previously cleared device. The modifications do not<br>affect the intended use of the device or alter the fundamental scientific<br>technology of the device. The major modifications are the addition of<br>an automatic code identification feature, and the user interface<br>applications: alarms and post-meal flagging. |
| Submitted By: | i-SENS, Inc.<br>465-6, Wolgye-dong, Nowon-gu, Seoul, 139-845, Korea<br>Tel.) ++82-2-916-6191<br>Fax) ++82-2-942-2514<br>www.i-sens.com |
| Contact Person: | Dr. Hyun Joon Oh, Phone: [phone], Fax [phone] |
| Date Summary was Prepared: | November 6, 2008 |
| Device Name: | Trade name: CareSens N Blood Glucose Monitoring System<br>Common Name: Blood Glucose Test System<br>Classification Name: Class II, 862.1345 Glucose Blood Tester |
| Predicate Device: | We claim substantial equivalence to submitter's previously cleared<br>CareSens Blood Glucose Monitoring System ("CareSens BGMS") |
| The glucose measurement test principle: | same as CareSens BGM |
| Intended Use: | same as CareSens BGM |
| Fundamental scientific technology: | same as CareSens BGM |

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Image /page/1/Picture/0 description: The image shows the logo for i-sens. The logo consists of the word "i-sens" in a sans-serif font, with the "i" in lowercase and the rest of the word in lowercase. To the left of the word is a circular graphic made up of many small words. The words are arranged in a circular pattern, and they are all in a small font size.

i-SENS. Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. [phone]

> systems by i-SENS, Inc. (k080923) and the OneTouch® Ultra® Blood Glucose Monitoring System by LifeScan, Inc. (k024194).

Device Description:

CareSens N Blood Glucose Monitoring System ("CareSens N BGMS") is an in vitro diagnostic device designed to measure the concentration of glucose in capillary whole blood with CareSens N Test Strips. The CareSens N model consists of the CareSens N meter (Model GM505IA, GM505IB, GM505IC: IA, IB and IC indicates the color of the devices, respectively, black, white, and light blue.), CareSens N test strips, and CareSens control solutions for two different glucose concentration ranges (called "Normal" and "Middle" ranges), lancing device, lancets, user manual, quick reference guide and a logbook.

#### Comparison to Submitter's Previously Cleared Device (k080923):

Modifications:

Automatic code identification by the meter through detection of a marked pattern on each strip, so that the user does not input code information.

For the meter, the only difference is the addition of code identification sensors in the meter, while all other major elcctronic components are the same as those of CareSens BGMS. Please refer to Page 3 of Section 10 Specifications for details.

For the strip, the only difference is printing code-specific marks on the back side of each strip with infrared absorbing ink, while all the reagent components and mcasurement process are the same as those of CareSens BGMS. Please refer to Page 11 of Section 10 Specifications for details.

Alarms (Three time set alarms, and 2-hour post meal alarm) Post-meal flagging of test results Number of Buttons on the meter is three

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Image /page/2/Picture/0 description: The image shows the logo for i-SENS, a company that specializes in biosensor technology. The logo features a stylized lowercase "i" with a circular element above it, followed by the text "sens" in a bold, sans-serif font. The logo is simple and modern, reflecting the company's focus on innovation and technology.

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| Common Features | | |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Item | CareSens N BGMS | CareSens BGMS |
| Enzyme | Glucose Oxidase | |
| Measurement principle | Amperometric method | |
| Test principle | Glucose Oxidase chemical reaction. The instrument measures the extent of current cause by presence of glucose in sample. | |
| Intended use | The test strips work with the device to quantitatively measure glucose in capillary whole blood. The test Strips are for <i>in vitro</i> (i.e., outside the body) diagnostic use only. | |
| Sample | Fresh capillary whole blood | |
| Electrode | Carbon | |
| Calibration | Plasma-equivalent | |
| Test Time (second) | 5 | |
| Sample volume (µL) | 0.5 | |
| Memory | 250 | |
| Test Range(mg/dL) | 20~600 | |
| Hematocrit range (%) | 20~60 (below 400mg/dL) | |
| Glucose units | Either mg/dL or mmol/L | |
| Checking the system | Control solution | |
| Alternate Site | Yes | |
| Capability | | |
| Operating Humidity | 10~90% | |
| Differences | | |
| Item | CareSens N BGMS | CareSens BGMS |
| Coding | Automatic code identification | Manual input by button |
| Self-diagnosis of code<br>identification function | Yes | No |
| Three time set Alarms<br>and 2-hour post-meal<br>Alarm | Yes | No |
| Post-meal flagging | Yes | No |
| Number of buttons | 3 buttons | 2 buttons (CareSens II)<br>1 button (CareSens POP) |

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i-SENS, Inc.

Image /page/3/Picture/1 description: The image shows a logo for "i-sens". The logo is composed of a stylized letter "i" followed by the word "sens". The "i" is surrounded by a circular pattern of small dots, giving it a technological or digital feel. The word "sens" is written in a bold, sans-serif font, and the overall design is simple and modern.

465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. [phone]

Since for CareSens N, the glucose measurement test principle, intended use, and fundamental scientific technology are the same as the submitter's unmodified device (k080923), there is no reason to expect that the performance would be different, but most of the performance evaluation tests done for the unmodified device were repeated to confirm that performance still satisfies the acceptance criteria. For performance evaluation, the following summary table shows the tests that were repeated.

Additionally, the substantial equivalence report for comparison to OneTouch® Ultra® is provided in Section 11.

#### Performance evaluation summary of modified device, CareSens N BGMS

The report numbers PE-01 to PE-17 in this table indicate those of the unmodified device (k080923), and the methods used for the tests can be found in that prior application. Please note that the actual reports for tests PE-01 to PE-17 that were repeated for CareSens N, are not included in this submission. .

| Report<br>No. | Title | Pre-determined Acceptance Criteria | Results | | |
|---------------|---------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| PE-01 | Repeatability Test | Concentration | Precision | Satisfactory | |
| | | <100 mg/dL | SD<7.7 mg/dL | | |
| | | ≥100 mg/dL | CV<7.5% | | |
| PE-02 | Intermediate Precision test | Concentration | Precision | Satisfactory | |
| | | <100 mg/dL | SD<7.7 mg/dL | | |
| | | ≥100 mg/dL | CV<7.5% | | |
| PE-03 | Linearity Study | linear response within 20~600mg/dL | | Satisfactory | |
| PE-04-1 | Shelf Lifetime Test for Test<br>Strips (Before Opening) | N/A | | These tests not repeated because<br>all aspects of the strip chemistry<br>are the same, and the marking<br>on the back should not affect<br>shelf life. | |
| PE-04-2 | Shelf Lifetime Test for Test<br>Strips (After Opening) | N/A | | | |
| PE-05 | System Accuracy Test<br>(CareSens N vs. YSI) | Concentration | Accuracy | | |
| | | <75 mg/dL | within ±15<br>mg/dL | Satisfactory | |
| | | ≥75mg/dL | within ± 20% | | |
| PE-06 | Hematocrit Effect Test | Hct range | Bias (%) | | Satisfactory |
| | | 20-60% | within ±15 % | | |
| PE-07 | Interference Test | | Deviations are within ±15 % of the measurement<br>for the samples with no interferent. | | Satisfactory |
| PE-08 | Substantial Equivalence | | The distribution of test results in A-region of the Error<br>Grid is over 95%. | | Satisfactory |
| PE-09 | Consumer Study | | The distribution of test results in A-region of the Error<br>Grid is over 95%. | | Satisfactory |
| PE-10 | Point-of-Care(POC) Study | | The distribution of test results in A-region of the Error<br>Grid is over 95%. | | Satisfactory |
| PE-11 | Temperature Study | Temp. range | Bias (%) | | Satisfactory |
| | | 10-40°C | within ±10 % | | |
| PE-12 | Humidity Study | Humidity range | Bias (%) | | Satisfactory |
| | | 10-90% | within ±10 % | | |
| PE-13 | Altitude Test | The distribution of test results in A-region of the Error<br>Grid is over 95%. | | | Satisfactory |
| PE-14 | Alternate site Study | The distribution of test results in A-region of the Error<br>Grid is over 95%. | | | Satisfactory |
| PE-15 | Drop Test | Height | Acceptance | | Satisfactory |
| | | 0.5, 1.0, 1.5m | within ±5 mg/dL | | |
| PE-16 | Vibration Test | RPM | Acceptance | | |
| | | (50~60Hz) , | | | Satisfactory |
| | | 300, 600, 1200 | within ±5 mg/dL | | |
| PE-17 | Control solution | | N/A | | Test not repeated because the<br>control solutions for both<br>systems are the same. |

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Image /page/4/Picture/0 description: The image shows the logo for i-sens. The logo features a stylized globe with a small plus sign in the center, followed by the word "i-sens" in a bold, sans-serif font. The globe is made up of small circles, giving it a textured appearance. The overall design is simple and modern.

i-SENS, Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. [phone]

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Image /page/5/Picture/0 description: The image shows a logo for a company called i-sens. The logo features a stylized letter 'i' followed by the word 'sens' in a simple, sans-serif font. To the left of the 'i' is a circular graphic composed of many small, interconnected dots, creating a textured, almost globe-like effect. The overall design is clean and modern, suggesting a technology or innovation-focused company.

Based on risk analysis provided in Section 14, the following validation activities were carried out and submitted in this application under the Scction Numbers specified.

#### Validation Activities for Modified Features

The test reports in this table are included in this submission, and can be found under the Section Numbers below.

| Section<br>Numbers | Title | Pre-determined Acceptance Criteria | Results |
|--------------------|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 12-11 | Code<br>Identification<br>Test | 100% correct recognition of 15 types of code marks printed on<br>the backside of the strip. | Satisfactory |
| 12-22 | Test of self-<br>diagnosis of<br>code<br>identification | The meter should recognize any malfunction in the code-<br>reading sensors. If the code recognition sensor is faulty by any<br>causes, meter should detect the malfunction and display Er6<br>message to prevent the user from reading inaccurate results. | Satisfactory |
| 13<br>(TR-EI-15)3 | Alarm Test | The meter should alarm at preset times within $\pm$ 1 min. | Satisfactory |
| 13<br>(TR-EI-16) | Time Test | The meter clock should display correct time within $\pm$ 1 min<br>after an extended period of observation (120 hours). | Satisfactory |
| 13<br>(TR-EI-17) | Data Average<br>Test | The averages (for 14-day, and before and after meal)<br>calculated by meter software should be same as those<br>calculated manually with spreadsheet. | Satisfactory |
| 13<br>(TR-EI-18) | ADC Function<br>Test | Within 2152 $\sim$ 2406 (12bit ADC) | Satisfactory |
| 13<br>(TR-EI-19)4 | Memory Test | All test results saved on meter memory (as many as 250 data)<br>should exactly match the manually recorded data. | Satisfactory |

¹ Page 19 of Section 14 Risk analysis: H11-C11.2 Error of code recognition function

² Page 19 of Section 14 Risk analysis: H11-C11.1 Error (shorted or disconnected circuit) in the infraced photoreflectors

for auto coding function

³ Page 20 of Section 14 Risk analysis: H16 software

⁴ Page 20 of Section 14 Risk analysis: H16 software-C16.3 Functional error of memory recall

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Image /page/6/Picture/0 description: The image shows a logo with the word "isens" in a stylized font. The "i" in "isens" is designed to look like an eye, with a circular shape above the letter. The rest of the letters in "isens" are in lowercase and have a bold, sans-serif font. The logo appears to be for a company or organization named "isens."

i-SENS, Inc. Tel. [phone] Wolgye-dong, Nowon-gu, Seoul 139-845, Korea

| 15-15 | Electromagnetic Compatibility Report | It should meet the EMC test regulations given in p3 of the title report (Electronic Compatibility Report). | Satisfactory |
|-------|--------------------------------------|------------------------------------------------------------------------------------------------------------|--------------|
| 15-2 | Electrical Safety Report | It should comply with the test regulations given in p1 of the title report. | Satisfactory |

#### Conclusion:

:

All predetermined acceptance criteria were satisfied. The data also demonstrates that the CareSens N BGMS is substantially equivalent to the following predicate device systems:

k080923 - i-SENS, Inc. CareSens Blood Glucose Monitoring System k024194 - LifeScan, Inc. OneTouch® Ultra® Blood Glucose Monitoring System

^్ Page 16 of Section 14 Risk analysis: H4 electromagnetic field compatibility

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The text is likely part of a document or sign, indicating an association with a public health organization.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

I-Sens, Inc. c/o Hyun Joon Oh Division Manager, Quality Assurance 465-6 Wolgye-Dong, Nowon-Gu Seoul, Republic of Korea 139-845

FEB 1 0 2009

Re: k083468

> Trade Name: CareSens N Blood Glucose Monitoring System Regulation Number: 21 CFR 862, 1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW. CGA. JJX Dated: January 26, 2009 Received: January 26, 2009

Dear Hyun Joon Oh:

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 either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

Image /page/7/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three bodies, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

signature

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics Device Evaluation and Safety Center for Devices and Radiological Health

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### Indication for Use

510(k) Number (if known): 长۵૪ 3468

Device Name: CareSens N Blood Glucose Monitoring System

Indication For Use: The CareSens N Meter is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. CareSens N Blood Glucose System should be used only for testing outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis or screening of diabetes. Testing sites include the traditional fingertip testing along with alternate sites testing on forearm, palm, thigh and calf.

CareSens N Test Strip is used with the CareSens N Blood Glucose Meter for quantitatively measuring glucose in capillary whole blood. The CareSens N Test Strip is intended for selftesting outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis of diabetes without the guidance of healthcare professional. Testing sites include the traditional fingertip testing along with alternate sites testing on forearm, palm, thigh and calf.

CareSens Control A&B Solutions are a red liquid to check that both the meters and test strips are working together properly. It contains a known range of glucose as written on the bottle.

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 (OVD)

Yici May acting

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K083468