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

Intended 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)

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

K040603

# MAY 1 9 2004 510K Summary of Safety and Effectiveness

## 1. Submitted By:

John Schalago Manager, Regulatory Affairs

BD Medical Diabetes Care l Becton Drive Franklin Lakes, NJ 07417-1883 Phone: [phone] Fax: [phone]

### 2. Device Name:

BD Paradigm Link™ Blood Glucose Monitor Trade Name:

Common Names: Glucose oxidase, glucose test system

Classification Name: Glucose oxidase, glucose test system

### 3. Predicate Device:

Paradigm Link - K030531

BD Logic™ Blood Glucose Monitor

Medtronic MiniMed ComLinkTM

### 4. Device Description:

The BD Paradigm Link™ Blood Glucose Monitor is an in-vitro diagnostic device for use in the quantitative measurement of glucose in capillary blood collected from fingertips. The BD Paradigm Link™ is designed to be simple and easy to use. It provides accurate blood glucose test results in 5 second while requiring a very small (0.3 µL) sample.

The BD Paradigm Link™ is also designed for wireless communication with Medtronic MiniMed External Insulin Pumps (511 and higher). When used with Medtronic MiniMed 512 External Insulin Pump, blood glucose test values obtained using the BD Paradigm Link™ can be automatically transmitted to the insulin pump for use in the Bolus Wizard feature of the Medtronic MiniMed 512 External Insulin Pump. Consumers or healthcare practitioners may also use the meter as a communication device to facilitate transfer of information between the pump and a personal computer.

Image /page/0/Picture/16 description: The image shows the number 000020. The number is written in a bold, sans-serif font. The zeros are all the same size and shape, and the two is slightly smaller than the zeros. The number is black on a white background.

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

# 510K Summary of Safety and Effectiveness (Continued) Intended 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.

# Technological Characteristics: 6.

న్.

The BD Paradigm Logic™ Blood Glucose Monitor is based on biosensor (glucose oxidase) technology. When blood is applied to the BD Test Strip, reagents on the strip react with the blood and a current is generated. The Paradigm Link™ employs amperometric technology to measure the glucose concentration in the blood sample by measuring the amount of current that is generated and flows through the electrodes on the test strip.

The BD Paradigm Link™ is designed for wireless communication using radiofrequency (RF) technology. The RF telemetry functionality of the Paradigm Link™ allows the meter to automatically telemeter glucose values to a MiniMed pump or to be used as a radio frequency interface to allow communication between a MiniMed insulin pump and a personal computer.

# 7. Performance Summary:

Laboratory and Human Factors studies demonstrate that the BD Paradigm LinkTM performed in an equivalent manner to the predicate devices and is suitable for its intended use.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E, under which a device can be marketed without pre-approval or classification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US patent Laws or their application by the courts.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing the agency's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle symbol.

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

MAY 1 9 2004

Mr. John A. Schalago MS, RAC Regulatory Affairs Manager Becton Dickinson & CO. BD Consumer Healthcare 1 Becton Drive Franklin Lakes, NJ 07417-1885

k040603 Re:

Trade/Device Name: BD Paradigm Link™ Blood Glucose Monitor Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: March 04, 2004 Received: March 30, 2004

Dear Mr. Schalago:

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).

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

# Page 2

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,

Jean M. Cooper, MS, DVM.

Tean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

# 510(k) Number (if known): K040603

Device Name: BD Paradigm Link™ Blood Glucose Monitor

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.

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Bemer
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and S

510(k) K040603

Page 1 of ___ 1__

000075