K Number
K103396
Device Name
COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION
Manufacturer
Date Cleared
2011-09-27

(312 days)

Product Code
Regulation Number
862.1345
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The COOL Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The COOL Blood Glucose Meter is intended for use with the COOL Blood Glucose Test Strips for the quantitative measurement of glucose in capillary whole blood from the fingertip and the alternate sites such as forearm, palm, thigh and calf. The alternate site testing should be used only during steady-state glucose conditions. The COOL Control Solutions are for use with the COOL Meter and COOL Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. The COOL Blood Glucose Monitoring System is intended for self testing outside the body by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. 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 of or screening for diabetes.
Device Description
The COOL Blood Glucose Monitoring System (BGMS) measures the glucose in whole blood sample by a small electrical current generated in the test strips and sent to the meter for measurement. The system consists of the following devices: COOL Meter (Model GM505MA), COOL Test Strips, COOL Control Solutions for two different glucose concentration ranges (called "Normal" and "Middle" ranges, sold separately), Lancing Device, Lancets, User manual, Quick reference guide and Logbook.
More Information

Not Found

No
The description focuses on electrochemical measurement of glucose and does not mention any AI/ML components or functionalities.

No.
The device is a blood glucose monitoring system, intended for measurement and monitoring, not for treating or rehabilitating a condition.

No

Explanation: The "Intended Use / Indications for Use" section explicitly states, "It is not intended for use on neonates and is not for the diagnosis of or screening for diabetes." This clearly indicates it is not a diagnostic device.

No

The device description explicitly lists hardware components such as a measuring meter, test strips, control solutions, lancing device, and lancets, in addition to software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The device is intended for the "quantitative measurement of glucose in capillary whole blood from the fingertip and the alternate sites". This involves testing a biological sample (blood) in vitro (outside the body) to obtain diagnostic information (glucose levels).
  • Device Description: The system includes a meter, test strips, and control solutions, all designed to perform a chemical reaction on a blood sample to measure glucose.
  • Care Setting: It is intended for "self testing outside the body by people with diabetes at home". This reinforces the in vitro nature of the testing.
  • Purpose: The system is used "as an aid in monitoring the effectiveness of a diabetes control program". While not for initial diagnosis, monitoring glucose levels is a key diagnostic activity for managing diabetes.

The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic purposes. This device clearly fits that description.

N/A

Intended Use / Indications for Use

The COOL Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The COOL Blood Glucose Meter is intended for use with the COOL Blood Glucose Test Strips for the quantitative measurement of glucose in capillary whole blood from the fingertip and the alternate sites such as forgaraoson m thigh and calf. The alternate site testing should be used only during steady-starts plonny, glucose conditions. The COOL Control Solutions are for use with the COOL Meter and COOL Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The COOL Blood Glucose Monitoring System is intended for self testing outside the body by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. 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 of or screening for diabetes.

Product codes (comma separated list FDA assigned to the subject device)

CGA, NBW, JJX

Device Description

The COOL Blood Glucose Monitoring System (BGMS) measures the glucose in whole blood sample by a small electrical current generated in the test strips and sent to the meter for measurement. The system consists of the following devices: COOL Meter (Model GM505MA), COOL Test Strips, COOL Control Solutions for two different glucose concentration ranges (called "Normal" and "Middle" ranges, sold separately), Lancing Device, Lancets, User manual, Quick reference guide and Logbook.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

fingertip and the alternate sites such as forearm, palm, thigh and calf.

Indicated Patient Age Range

Not intended for use on neonates.

Intended User / Care Setting

self testing outside the body by people with diabetes at home

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)

Repeatability Test (PE-01) with predetermined acceptance criteria showing SD = 0.97, Bias (A) between 0.95 and 1.05 and Bias (B) between -5 and 5. Results met acceptance criteria.
The test results confirmed that the modified electric connector of the strip operated properly with the meter. Thus, COOL BGMS demonstrated satisfactory performance and is suitable for its intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K083468

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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.

0

K103396

i-sens

i-SENS, Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191

SEP 2 7 2011

510(k) Summary

(As required by 21 CFR 807.87)

According to the requirements of 21 CFR.807.92, the following information Introduction: provides data needed to understand the basis for determining substantial equivalence.

510(k) Number is: K103396

Type of 510(k): Special 510(k)

Submitted By: i-SENS, Inc. 465-6, Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel.) +82-2-916-6191 Fax) +82-2-942-2514 www.i-sens.com

Martin Saperstein Contact Person: GOODMAN & SAPERSTEIN Tel.) 1-516-227-2100 Fax) 1-516-227-2108

COOL Blood Glucose Monitoring System Device Name: Trade name: Glucose Test System Common Name:

| Device
Classification: | Product Code | Classification | Regulation
Section | Panel |
|---------------------------|--------------------------------------------------------|----------------|-----------------------|------------------|
| | CGA - glucose oxidase,
glucose | Class II | 21 CFR
862.1345 | 75,
Chemistry |
| | NBW - system, test, blood
glucose, over the counter | Class II | 21 CFR
862.1345 | 75,
Chemistry |

1

i-SENS, Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191

  • COOL Control Solution

| Product Code | Classification | Regulation
Section | Panel |
|--------------------------------|----------------|-----------------------|------------------|
| JJX - Quality control material | Class I | 21 CFR
862.1660 | 75,
Chemistry |

Quantitative, Amperometric method Type of Test: Enzyme: Glucose oxidase (Aspergillus sp.)

System Description: The COOL Blood Glucose Monitoring System (BGMS) measures the glucose in whole blood sample by a small electrical current generated in the test strips and sent to the meter for measurement. The system consists of the following devices: COOL Meter (Model GM505MA), COOL Test Strips, COOL Control Solutions for two different glucose concentration ranges (called "Normal" and "Middle" ranges, sold separately), Lancing Device, Lancets, User manual, Quick reference guide and Logbook.

The COOL Blood Glucose Meter is intended for use with the COOL Blood Intended Use: Glucose Test Strips for the quantitative measurement of glucose in capillary whole blood from the fingertip and the alternate sites such as forearm, palm, thigh and calf. The alternate site testing should be used only during steadystate blood glucose conditions. The COOL Control Solutions are for use with the COOL Meter and COOL Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. The COOL Blood Glucose Monitoring System is intended for self testing outside the body by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. 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 of or screening for diabetes.

Predicate Device:Device name:CareSens N Blood Glucose Monitoring System
510(k) Number:K083468

2

Image /page/2/Picture/0 description: The image shows a logo with the text "i-sens" in a stylized font. The "i" is lowercase and has a small circle above it, resembling a dot. The "sens" part of the word is in a bold, rounded font. The entire word is enclosed within a partial circle, which starts above the "i" and curves around the word, ending near the bottom of the "s".

i-SENS, Inc. Tel. 82-2-916-6191 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea

Comparison withThe modified COOL BGMS has the following similarities to the predicate
Predicate Device:device:
1) same intended use,
2) same operating principle,
3) same fundamental scientific technology,
4) same product specifications,
5) same operating ranges,
6) manufactured by the same process.
The modifications from the predicate device are as follows:

l ) Meter outer casing design change,

  1. Electric connector pattern of test strip change.

The COOL BGMS has the same fundamental scientific technology as the Technological predicate CareSens N BGMS. Characteristics:

The all specifications of the COOL BGMS are identical the CareSens N Assessment of Performance: BGMS. The differences are only the physical design of meter and electric connector pattern of the test strip. Accordingly, the performance evaluations such as altitude, hematocrit studies were not conducted. But, to verify whether the modified electric connector of COOL test strip operates properly with the COOL meter, the repeatability and linearity tests were conducted. The test results confirmed that the modified electric connector of the strip operated properly with the meter. Thus, COOL BGMS demonstrated satisfactory performance and is suitable for its intended use.

3

| Report No. &
Title | Pre-determined Acceptance Criteria | | Met pre-determined
acceptance criteria? | | |
|--------------------------------|---------------------------------------|-------------------------------|--------------------------------------------|--|--|
| PE-01
Repeatability
Test | Interval | Mean concentration
(mg/dL) | Yes | | |
| | 1 | 30 to 50 | | | |
| | 2 | 51 to