(110 days)
No
The document describes a standard blood glucose monitoring system and explicitly states it is a rebranded version of a predicate device. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance study sections.
No
The device is an in vitro diagnostic (IVD) device used for monitoring glucose levels, not for treating or preventing disease.
No
The document explicitly states: "The BaseSens I Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus".
No
The device description explicitly states that the system includes a blood glucose meter, test strips, and controls, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "The BaseSens I Blood Glucose Monitoring System should be used only for testing outside the body (in vitro diagnostic use only)." and "The BaseSens I Test Strip is intended for self-testing outside the body (in vitro diagnostic use only)."
This clearly indicates that the device is designed to perform tests on samples taken from the human body (blood) outside of the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications 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 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.
Product codes
NBW, CGA, JJX
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. The BaseSens I Blood Glucose Monitoring System and the CareSens N Blood Glucose Monitoring System including the following identical system components: BaseSens I Meter, BaseSens I Test strips, BaseSens I Control Solutions. The Control Solutions are not included in the System package. This component can be purchased separately. The BaseSens I Blood Glucose Monitoring System and the CareSens N Blood Glucose Monitoring System have identical product specifications. The components used in the manufacture of the BaseSens I meter, test strips, and control solution are identical to those of the i-Sens CareSens N meter, test strips, and control solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, forearm, palm, thigh, calf
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
Home or in clinical settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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.
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 the |
| Counter | |
| 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 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 | 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. |
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.
- 4.1.1 The BaseSens I Blood Glucose Monitoring System and the CareSens N Blood Glucose Monitoring System including the following identical system components.
- 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.
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- 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 |
| Measurement | |||
| Principle | Amperometric method | 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. | 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 | |||
| in vitro (i.e., outside | |||
| the body) diagnostic | |||
| use only. | The test strips work | ||
| with the device to | |||
| quantitatively | |||
| measure glucose in | |||
| capillary whole blood. | |||
| The test Strips are for | |||
| in vitro (i.e., outside | |||
| the body) diagnostic | |||
| use only. | The test strips work with | ||
| the device to | |||
| quantitatively measure | |||
| glucose in capillary | |||
| whole blood. The test | |||
| Strips are for in vitro (i.e., | |||
| outside the body) | |||
| diagnostic use only. | |||
| Sample | Fresh capillary whole | ||
| blood | Fresh capillary whole | ||
| blood | Fresh capillary whole | ||
| blood | |||
| 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
(%) | 2060 (below60 (below
400mg/dL) | 20
400mg/dL) | 2060 (below 400mg/dL) | | |90% | 10
|--------------------------------------------------------|----------------------------------|----------------------------------|-------------------------------------------------------|--|--|
| Glucose units | Either mg/dL or
mmol/L | Either mg/dL or
mmol/L | Either mg/dL or mmol/L | | |
| Checking the
system | Control solution | Control solution | Control solution | | |
| Alternate Site
Capability | Yes | Yes | Yes | | |
| Operating Humidity | 1090% | 1090% | | |
| Differences | | | | | |
| ltem | BaseSens I BGMS | CareSens N BGMS | CareSens BGMS | | |
| Coding | Automatic code
identification | Automatic code
identification | Manual input by button | | |
| Self-diagnosis of
code identification
function | Yes | Yes | No | | |
| Three time set
Alarms and 2-hour
post-meal Alarm | Yes | Yes | No | | |
| Post-meal flagging | Yes | Yes | No | | |
| Number of buttons | 3 buttons | 3 buttons | 2 buttons (CareSens II)
1 button (CareSens
POP) | | |
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 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.
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