PARADIGM LINK BLOOD GLUCOSE METER

K040603 · Becton, Dickinson & CO · NBW · May 19, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040603
• Device Name: PARADIGM LINK BLOOD GLUCOSE METER
• Applicant: Becton, Dickinson & CO
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The BD Paradigm Link™ Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The BD Paradigm Link™ Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip. When used with a MiniMed Pump, the BD Paradigm Link Blood Glucose Monitor can automatically telemeter glucose values to the Model 512 Insulin Pump using radio frequency communication. The BD Paradigm Link Blood Glucose Monitor can also serve as a radio frequency interface to allow communication between the MiniMed insulin pump and a personal computer running the appropriate Medtronic MiniMed communications software.

Device Story

Handheld battery-operated blood glucose monitor; uses amperometric technology to measure glucose in 0.3 uL capillary blood samples. Device features RF telemetry to transmit glucose values to Medtronic MiniMed external insulin pumps for use in Bolus Wizard insulin dose calculations; also acts as a communication conduit to download pump data to a PC via USB. Used by patients in home settings. RF circuitry and software are identical to those in the MiniMed Paradigm 511 pump. Direct transmission reduces manual entry errors. Device includes meter, test strips, lancets, and control solution.

Clinical Evidence

No clinical data provided. The submission relies on bench testing, software documentation, and EMC testing previously cleared under K030531.

Technological Characteristics

Biosensor (glucose oxidase) technology; amperometric measurement principle. Wireless RF telemetry for data transmission to insulin pumps and PCs. Standalone meter form factor.

Indications for Use

Indicated for quantitative glucose measurement in capillary whole blood from fingertips in patients with diabetes mellitus for home monitoring of diabetes control. Not for diagnosis or screening of diabetes; not for use on neonates.

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

• Paradigm Link (K030531)
• BD Logic™ Blood Glucose Monitor
• Medtronic MiniMed ComLink™

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number: K040603
B. Purpose for Submission: The original 510(k) Premarket notification K030531 was submitted by Medtronic MiniMed and received clearance on June 17, 2003. As previously discussed with the Office of IVD, the purpose of this 510(k) is to obtain a separate clearance for Becton Dickinson Diabetes Care. This 510(k) references the original cleared 510(k) K030531 for technical information such as bench testing, software development description, EMC testing.
C. Manufacturer and Instrument Name: Paradigm Link Blood Glucose Monitor.
D. Type of Test or Tests performed: Glucose (self testing) Quantitative
E. System Descriptions:

1. Device Description:
The BD Paradigm LinkTM Blood Glucose Monitor is a handheld battery (3V) operated device intended for use in the quantitative measurement of glucose in capillary blood collected from fingertips. The BD Paradigm LinkTM Blood Glucose Monitor may be used as a stand alone blood glucose meter or used in conjunction with Medtronic MiniMed External Insulin Pumps when configured for RF telemetry.

The BD Paradigm LinkTM Blood Glucose Monitor is the result of simple design modifications to the commercially available BD LogicTM Blood Glucose Monitor (K022581). The design modifications, hardware and software, provide Radio Frequency (RF) communication (wireless communication) between the BD Paradigm LinkTM Blood Glucose Monitor and specific MiniMed external insulin pumps. The RF circuitry and embedded software used in the BD Paradigm LinkTM is the same as that used in the MiniMed Paradigm 511 External Insulin pump. The MiniMed Paradigm 511 External Insulin Pump was described in K011829 and received FDA clearance on August 18, 2000.

The Paradigm LinkTM wireless communication feature allows the user to automatically send a blood glucose value to the MiniMed 512 external insulin pump. The blood glucose value sent to the MiniMed 512 Pump may be used in the pump's Bolus Wizard. The Bolus Wizard is a user interactive feature that suggests an insulin dose based on a blood glucose value, insulin sensitivity, carbohydrates to insulin ratio and the carbohydrate content of the current meal. The direct RF transmission of the blood glucose value from the meter to the pump reduces the potential for user to misread or incorrectly

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enter blood glucose test result The MiniMed 512 External Insulin Pump and the Bolus Wizard were described in the original 510(k) Premarket Notification (K030531) submitted on 2/14/03. Reference the original submission for a description of the MiniMed 512 External Insulin Pump and the Bolus Wizard.

The wireless communication feature also allows the user to utilize the BD Paradigm LinkTM as a communication device to download device information from MiniMed external insulin pumps (model no. 511 and higher) to a PC. Currently, the user can download device information using the MiniMed ComLinkTM. The MiniMed ComLinkTM was described in K021974, which received FDA clearance on August 6, 2002. The ComLinkTM hardware consists of a radio-frequency (RF) transceiver and a single female RS-232 compatible serial communications port.

Identical to the ComLinkTM, data is downloaded from an external insulin pump to a PC via the Paradigm LinkTM using RF telemetry. In addition, the BD Paradigm LinkTM RF communication protocol to allow pump/meter/PC RF communication is a replica of the ComLinkTM. The BD Paradigm LinkTM is connected to a PC using the BD USB Interface Cable (K023219). Reference figure 111.1 for an overview of PC data download configuration. The BD Paradigm LinkTM Blood Glucose Monitor kit consists the following components:

- BD Paradigm LinkTM Blood Glucose Monitor
- BD Test Strips
- BD Ultra-Fine 33 Lancets
- BD Lancet Device
- BD Control Solution
- labeling

The BD Test Strips, BD Control Solution and lancet devices were described in the BD Logic 5 10(k) Premarket Notification, K022581.

2. Principles of Operation:
Employs amperometric technology to measure the glucose concentrations in the blood sample by measuring the amount of current that is generated and flows through the electrodes on the test strip.

3. Modes of Operation:
Uses 0.3 uL of capillary whole blood to fill the sample chamber

4. Specimen Identification:
Time and date of test

5. Specimen Sampling and Handling:
Self testing capillary blood from fingerstick

6. Calibration:
Lot Specific coded calibration

7. Quality Control:
Control Solution were described in the BD Logic 510(k) Premarket Notification, K022581

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8. Software:

FDA has reviewed the applicant’s Hazard Analysis and software
Documentation: Yes ☐ X or No ☐ (K030531)

F. Regulatory Information:

1. Regulation Section:
21CFR §862.1345 -Glucose test system.

2. Classification:
2

3. Product Code:
NBW

4. Panel:
CH

G. Intended Use:

1. Indication(s) for Use:
The BD Paradigm Link Blood Glucose Monitor is intended to be ue for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

The BD Paradigm Link Blood Glucose Monitor is specifically indicated to the quantitative measurement of glucose in whole blood samples obtained from the fingertip.

2. Special Condition for use Statement(s):

H. Substantial Equivalence Information:

1. Predicate device name(s) and 510(k) numbers:
BD Logic Blood Glucose Monitor (K022581)

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## 2. Comparison with Predicate Device:

### Predicate Device Comparison

| | Paradigm Link™
Principal Device | BD Logic™ Blood Glucose Monitor
Predicate Device, K022501 |
| --- | --- | --- |
| Intended Use | The Paradigm Link™ Blood Glucose Monitor is intended for quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes mellitus and is not intended for use on neonates. | The BD Logic™ Blood Glucose Monitor is intended for quantitative measurement of glucose in who o blood. It is intended for use by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes mellitus and is not intended for use on neonates. |
| System components | • Meter
• Test Strips
• Normal Control Solution
• Lancing Device and lancets | • Meter
• Test Strips
• Normal Control Solution
• Lancing Device and lancets |
| Test Method | Glucose oxidase/Amperometric detection | Glucose oxidase/Amperometric detection |
| Test Strip Calibration | Manual | Manual |
| Sample | Capillary Whole Blood | Capillary Whole Blood |
| Test Strip Volume | 0.3 μl | 0.3 μl |
| Sample application | End of strip capillary draw | End of strip capillary draw |
| Test range | 20 - 600 mg/dl | 20 - 600 mg/dl |
| Test time | 5 seconds | 5 seconds |
| Hematocrit range | 25 - 60% | 25 - 60% |
| Temperature range | 59 F to 102 F | 59 F to 102 F |
| Relative Humidity | 10 - 90 % | 10 - 90 % |
| Altitude | Up to 10,000 ft | Up to 10,000 ft |
| Memory | Up to 250 glucose and control results
Up to 250 Insulin records | Up to 250 glucose and control results
Up to 250 Insulin records |
| Data Port | Yes | Yes |
| Pump to PC
Communication via
meter/USB: | No | Yes |
| RF Data Transfer of
Glucose Result: | No | Yes |
| Communication Device | Yes | Yes |
| --- | --- | --- |
| For use with Minimed External Insulin Pumps | Yes | Yes |
| RF telemetry technology | Yes | Yes |
| PC Connection | USB | Serial |
| Acts a conduit for data download | Yes | Yes |
| Operate at a 916.5 MHz RF frequency | Yes | Yes |
| Comply with EN/ISO and FCC standards for EMU/EMC, safety, and RF devices | Yes | Yes |

## I. Standard/Guidance Document Referenced (if applicable):

See Premarket Notification (K030531)

## J. Performance Characteristics:

1. **Analytical Performance:**

a. Accuracy:
Not Applicable

b. Precision/Reproducibility:
Not Applicable

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c. Linearity:
Not Applicable

d. Carryover:
Not Applicable

e. Interfering Substances:
Not Applicable

2. Other Supportive Instrument Performance Data Not Covered Above:
None

K. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.