The BaseSens I Blood Glucose Monitoring System is used for the quantitative measurement of glucose levels in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. The BaseSens I Blood Glucose Monitoring System should be used only for testing outside the body (in vitro diagnostic use only). The BaseSens I Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions.

BaseSens I Test Strip is used with the BaseSens I Blood Glucose Meter for quantitatively measuring glucose in capillary whole blood. The BaseSens I Test Strip is intended for self-testing outside the body (in vitro diagnostic use only). The BaseSens I Test Strips are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions.

BaseSens I 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 Description

The BaseSens I Blood Glucose Monitoring System is identical to the i-Sens CareSens N Blood Glucose Monitoring System. The Hygieia BaseSens I Blood Glucose Monitoring System is a rebranded CareSens N System. Rebranding here is intended to be understood as all components of the CareSens N System have been relabeled with the Hygieia name BaseSens I or BaseSens I Blood Glucose Monitoring System.

The System includes the BaseSens 1 blood glucose meter, test strips and controls.

AI/ML Overview

The provided document describes the "BaseSens I Blood Glucose Monitoring System". However, it's a rebranding of an existing device, the i-Sens CareSens N Blood Glucose Monitoring System (FDA clearance K083468). The document explicitly states: "The BaseSens I Blood Glucose Monitoring System is identical to the i-Sens CareSens N Blood Glucose Monitoring System. The Hygieia BaseSens I Blood Glucose Monitoring System is a rebranded CareSens N System."

Therefore, this filing does not present a new study to prove "device meets the acceptance criteria". Instead, it argues for substantial equivalence based on the predicate device's existing clearance. The crucial statement in the document is: "The BaseSens I Blood Glucose Monitoring System does not raise any new safety and efficacy concerns when compared to the cleared CareSens N Blood Glucose Monitoring System." This implies that the acceptance criteria and performance were already met by the predicate device.

Since this is a re-branding application, it does not include a new study with specific acceptance criteria and performance data for the BaseSens I device. It relies on the previously submitted data and clearance of the i-Sens CareSens N.

Therefore, for the request, I will extract relevant information about the predicate device's characteristics and the basis for substantial equivalence, as no new study data is presented for the BaseSens I device itself.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate Device)

Given that the BaseSens I Blood Glucose Monitoring System is a rebranding and identical to the i-Sens CareSens N Blood Glucose Monitoring System, the acceptance criteria and reported performance would be those established for the i-Sens CareSens N Blood Glucose Monitoring System during its original FDA clearance (K083468). This document does not provide a table of acceptance criteria or specific performance data for the BaseSens I. It relies on the fact that its specifications are identical to the predicate.

Key specifications for both devices, implying the performance targets, are:

Item	BaseSens I BGMS	CareSens N BGMS
Enzyme	Glucose Oxidase	Glucose Oxidase
Measurement Principle	Amperometric method	Amperometric method
Test Principle	Glucose oxidase chemical reaction. The instrument measures the extent of current cause by presence of glucose in sample.	Glucose oxidase chemical reaction. The instrument measures the extent of current cause by presence of glucose in sample.
Intended use	Quantitatively measure glucose in capillary whole blood in vitro (outside the body)	Quantitatively measure glucose in capillary whole blood in vitro (outside the body)
Sample	Fresh capillary whole blood	Fresh capillary whole blood
Electrode	Carbon	Carbon
Calibration	Plasma-equivalent	Plasma-equivalent
Test Time (seconds)	5	5
Sample volume (µL)	0.5	0.5
Memory	250	250
Test Range(mg/dL)	20~600	20~600
Hematocrit range (%)	20~60 (below 400mg/dL)	20~60 (below 400mg/dL)
Glucose units	Either mg/dL or mmol/L	Either mg/dL or mmol/L
Checking the system	Control solution	Control solution
Alternate Site Capability	Yes	Yes
Operating Humidity	10~90%	10~90%

Note: This table details device characteristics that presumably met acceptance criteria in the predicate's original submission. This document does not contain specific numerical performance metrics (e.g., accuracy percentages, bias) or a direct comparison to predefined acceptance criteria for the BaseSens I.

Study Information (Based on Substantial Equivalence)

Since this is a rebranding, there is no new study performed or described in this document to prove the BaseSens I meets acceptance criteria. The claim of substantial equivalence is based on the predicate device (i-Sens CareSens N). Therefore, the following information is not applicable to this specific 510(k) submission but would have been part of the predicate device's original submission (K083468).

Sample size used for the test set and the data provenance: Not provided in this document, as no new study was conducted for the BaseSens I. This would have been part of the predicate's original submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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. This device is a blood glucose monitoring system, not an AI-based diagnostic imaging tool, and does not involve human readers interpreting cases.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone blood glucose meter. Its performance would be assessed as such, but no new standalone performance study is presented here.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods (e.g., YSI analyzer) for glucose concentration. This information is not explicitly stated in this document but would have been used for the predicate device's performance claims.
The sample size for the training set: Not applicable, as this is a physical medical device (blood glucose meter and strips), not a machine learning algorithm requiring a "training set" in the conventional sense. Its calibration and operational parameters are set during manufacturing and validation, which would correspond to a rigorous design and verification process, not a "training set" for AI.
How the ground truth for the training set was established: Not applicable for the same reasons as above.

In summary: The provided document is a 510(k) submission for a rebranded medical device. It asserts substantial equivalence to a legally marketed predicate device (i-Sens CareSens N) because the devices are identical. As such, it does not present new acceptance criteria or new study data. All performance claims and conformity to acceptance criteria for the BaseSens I are implicitly covered by the predicate device's prior FDA clearance.

Summary

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

093475

SUMMARY OF SAFETY AND EFFECTIVENESS

February 16, 2010

FEB 2 4 2010

Trade Name: BaseSens I Blood Glucose Monitoring System Common Name: Blood Glucose Monitoring System Classification Name: System, Test, Blood Glucose, Over the Counter Classification Panel: Clinical Chemistry

Applicant:

Eran Bashan, Ph.D. President

Hygieia, Inc. 330 E. Liberty Street Ann Arbor, MI 48104 USA Tel: 734-527-9160 Cell: 734-316-2227 Fax: 734-623-8289

All questions and/or comments concerning this document should be made to:

Robert J. Bard, Esq. Managing Director

HealthCare Technologies Consultants PO Box 506 South Lyon, MI 48178 USA Tel: 248-573-5040 Cell: 734-330-5990

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

DESCRIPTION OF THE PRODUCT 1.0

As fully identical to the i-Sens CareSens N Blood Glucose Monitoring System, the BaseSens I Blood Glucose Monitoring System is thereby substantially equivalent to the i-Sens CareSens N Blood Glucose Monitoring System.

The Hygieia, Inc. BaseSens I Blood Glucose Monitoring System 1.1

Classification or descriptor	Name or designation
Trade Name	BaseSens I Blood Glucose Monitoring System
Common Name	Blood Glucose Monitoring System
Classification Name	System, Test, Blood Glucose, Over theCounter
Classification Panel	Chemistry
Product Code	NBW (also CGA and JJX)
Regulation Number	862.1345

The System includes the BaseSens 1 blood glucose meter, test 1.1.1 strips and controls

2.0 PREDICATE DEVICES

2,1 i-Sens CareSens Blood Glucose Monitoring System K080923 and the CareSens N Blood Glucose Monitoring System (K083468) are manufactured by i-SENS, Seoul, South Korea.
- The device under review is also manufactured by i-SENS, 2.1.1 Seoul, South Korea. The BaseSens I Blood Glucose Monitoring System is a re-branding of the CareSens N System and is substantial equivalent to the CareSens N System.

INDICATIONS FOR USE 3.0

The BaseSens I Blood Glucose Monitoring System and the CareSens N 3.1 System have the following indications for use.

BaseSens I Blood Glucose Monitoring System	CareSens N Blood Glucose Monitoring System
The BaseSens I Blood Glucose MonitoringSystem is used for the quantitative measurementof glucose levels in capillary whole blood as anaid in monitoring the effectiveness of diabetesmanagement at home or in clinical settings. TheBaseSens I Blood Glucose Monitoring Systemshould be used only for testing outside the body	Same

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

(in vitro diagnostic use only). The BaseSens I Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions
BaseSens I Test Strip is used with the BaseSens I Blood Glucose Meter for quantitatively measuring glucose in capillary whole blood. The BaseSens I Test Strip is intended for self-testing outside the body (in vitro diagnostic use only). The BaseSens I Test Strips are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions.	Same
BaseSens I Control A&B Solutions are 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.	Same.

(in vitro diagnostic use only). The BaseSens I Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions

Same

BaseSens I Control A&B Solutions are 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.

Same.

4.0 DEVICE DESCRIPTIONS

4.1 Specifications
- 4.1.1 The BaseSens I Blood Glucose Monitoring System and the CareSens N Blood Glucose Monitoring System including the following identical system components.
  - 4.1.1.1 BaseSens | Meter (included in the System package)
  - BaseSens I Test strips (included in the System 4.1.1.2 package)
  - BaseSens I Control Solutions. The Control 4.1.1.3 Solutions are not included in the System package. This component can be purchased separately.
- The BaseSens I Blood Glucose Monitoring System and the 4.1.2 CareSens N Blood Glucose Monitoring System have identical product specifications.
4.2 Materials
- The components used in the manufacture of the BaseSens I 4.2.1 meter are identical to those of the i-Sens CareSens N meter.

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

The components used in the manufacture of the BaseSens I 4.2.2 test strips are identical to those of the i-Sens CareSens N test strips.
4.2.3 The components used in the manufacture of the BaseSens I control solution are identical to those of the i-Sens CareSens N control solution.

COMPARISON OF BASESENS SYSTEM AND ITS PREDICATES 5.0

Device Features
Item	BaseSens I BGMS	CareSens N BGMS	CareSens BGMS
Enzyme	Glucose Oxidase	Glucose Oxidase	Glucose Oxidase
MeasurementPrinciple	Amperometric method	Amperometric method	Amperometric method
Test Principle	Glucose oxidasechemical reaction.The instrumentmeasures the extentof current cause bypresence of glucosein sample.	Glucose oxidasechemical reaction.The instrumentmeasures the extentof current cause bypresence of glucosein sample.	Glucose oxidasechemical reaction. Theinstrument measures theextent of current causeby presence of glucosein sample,
Intended use	The test strips workwith the device toquantitativelymeasure glucose incapillary whole blood.The test Strips are forin vitro (i.e., outsidethe body) diagnosticuse only.	The test strips workwith the device toquantitativelymeasure glucose incapillary whole blood.The test Strips are forin vitro (i.e., outsidethe body) diagnosticuse only.	The test strips work withthe device toquantitatively measureglucose in capillarywhole blood. The testStrips are for in vitro (i.e.,outside the body)diagnostic use only.
Sample	Fresh capillary wholeblood	Fresh capillary wholeblood	Fresh capillary wholeblood
Electrode	Carbon	Carbon	Carbon
Calibration	Plasma-equivalent	Plasma-equivalent	Plasma-equivalent
Test Time (seconds)	5	5	5
Sample volume (µL)	0.5	0.5	0.5
Memory	250	250	250
Test Range(mg/dL)	20~600	20~600	20~600

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

Hematocrit range(%)	20~60 (below400mg/dL)	20~60 (below400mg/dL)	20~60 (below 400mg/dL)
Glucose units	Either mg/dL ormmol/L	Either mg/dL ormmol/L	Either mg/dL or mmol/L
Checking thesystem	Control solution	Control solution	Control solution
Alternate SiteCapability	Yes	Yes	Yes
Operating Humidity	10~90%	10~90%	10~90%
Differences
ltem	BaseSens I BGMS	CareSens N BGMS	CareSens BGMS
Coding	Automatic codeidentification	Automatic codeidentification	Manual input by button
Self-diagnosis ofcode identificationfunction	Yes	Yes	No
Three time setAlarms and 2-hourpost-meal Alarm	Yes	Yes	No
Post-meal flagging	Yes	Yes	No
Number of buttons	3 buttons	3 buttons	2 buttons (CareSens II)1 button (CareSensPOP)

Conclusion: The BaseSens | Blood Glucose Monitoring System does not raise any new safety and efficacy concerns when compared to the cleared CareSens N Blood Glucose Monitoring System.

The BaseSens I Blood Glucose Monitoring System is identical to the i-Sens CareSens N Blood Glucose Monitoring System. The Hygieia BaseSens I Blood Glucose Monitoring System is a rebranded CareSens N Blood Glucose Monitoring System. As fully identical to the i-Sens CareSens N Blood Glucose Monitoring System, the BaseSens I Blood Glucose Monitoring System is thereby substantially equivalent to the i-Sens CareSens N Blood Glucose Monitoring System.

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

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or other bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird image.

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

FEB 2 4 2010

Hygieia, Inc. c/o Healthcare Technologies Consultants Robert J. Bard, Esq. Managing Director P.O. Box 506 South Lyon, MI 48178

K093475 Trade/Device Name: BaseSens I Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: January 17, 2010 Received: January 19, 2010

Dear Robert J. Bard:

Re:

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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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

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 vours.

Signature

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

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

Indication for Use

510(k) Number (K093475):

Device Name: BaseSens I Blood Glucose Monitoring System

Indication for Use: The BaseSens I Blood Glucose Monitoring System is used for the quantitative measurement of glucose levels in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. The BaseSens I Blood Glucose Monitoring System should be used only for testing outside the body (in vitro diagnostic use only). The BaseSens I Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions.

BaseSens I 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 X (21 CFR Part 801 Subpart D) Over the Counter Use x (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

and/or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K093425

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.