GLUCOPRO EVO INFUSION PUMP

K013309 · Nipro Diabetes Systems, Inc. · LZG · Jun 24, 2002 · General Hospital

Device Facts

• Record ID: K013309
• Device Name: GLUCOPRO EVO INFUSION PUMP
• Applicant: Nipro Diabetes Systems, Inc.
• Product Code: LZG · General Hospital
• Decision Date: Jun 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GlucoPro Infusion Pump is intended for the subcutaneous infusion of insulin.

Device Story

GlucoPro Infusion Pump is a syringe-based pump for subcutaneous insulin delivery. Device uses compatible infusion sets and GlucoPro syringes as drug reservoirs; syringe attaches to pump via screw threads. User sets continuous basal infusion rates and selects bolus delivery. Pump includes safety features and alarms for infusion errors or system malfunctions. Operated by user for continuous insulin administration. Benefits include precise, automated insulin delivery to manage insulin-dependent conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Electrical piston infusion pump; dimensions 91mm x 52mm x 21mm; weight 80g; power source 3V Duracell CR-2 battery (30-60 day life); screw-thread syringe attachment; subcutaneous delivery mechanism.

Indications for Use

Indicated for subcutaneous insulin infusion in patients requiring insulin therapy.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• Disetronic H-Tron Plus V100 infusion pump (K973044)
• Minimed Model 507 (K960001)

Submission Summary (Full Text)

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Ka/3309

JUN 2 4 2002

SO N.W. 107 Ave Mismi Florida 3317 1. [phone] Fax: [phone]

## SUMMARY OF S \FETY AND EFFECTIVENESS Gl. copro™ Infusion Pump

\$807.92 (a)(1)

Contact Person:

Kirk Ramey Senior Vice President

June 19, 2002

Date of Summary Preparation:

\$807.92 (a)(2)

Trade Name:

Glucopre M Infusion Pump

Classification Name: Electrical vision infusion pump (21 CFR \$880.5725), Class II

\$807.92 (a)(3)

Legally Marketed Substantially Equivalent Devices: Disetronic H-Tron Plus V100 infusion pump (K973044) and Minimed Model 507 (K960001)

\$807.92 (a)(4)

The Gluc. Pro Infusion Pump is intended for use with the disposable Description of Device: compatible infusion sets and the GlucoPro syringe for subcutaneous delivery of insulin. The catheter or needle of the compatible infusion set is inserted into the subcutaneous tissue of the user and is connected to the syringe that it the drug reservoir. The syringe is installed in the infusion pump and attached by means of screw threads. The medicine solution is delivered and infused info the user continuously. The user sets continuous basal infusion rate and selects bolus delivery. The infusion punip contains many safety teatures including alarms to indicate infusion error or system malfunction.

The pump is 91 mm wide, 52 mm in leight, and 21 mm in depth. It weighs 80 grams. The power is supplied by a Duracell CR-2 (3V) ba tery (or equivalent) that should last 30 - 60 days.

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5807,92 (a)(5)

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Intended Use:

The GlucoPro Infusion Pump is intended for the subcutaneous infusion of insulin.

\$807.92 (a)(6)

Comparison of Technical Characteristics:

The GlucoPro Infusion Pump is similar to legally marketed devices with the same intended use and design.

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Image /page/2/Picture/12 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2002

C/O Ms. Kaelyn B. Hadley Consultant Nipro Diabetes Systems, Incorporated 1384 Copperfield Court Lexington, Kentucky 40514

Re: K013309

Trade/Device Name: GlucoPro Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: March 21, 2002 Received: March 28, 2002

Dear Ms. Hadley:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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.

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Page 2 - Ms. Hadley

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timot A. Ulatowski Directdr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K013309

## Indications for Use Statement

510(k) number (if known): K013309

Device name: GlucoPro Infusion Pump

Common Name: Syringe pump

Classification Name: Electrical piston infusion pump

Product code: LZG

Classification: 880.5725, Class II

Indications for use: The GlucoPro Infision Pump is intended for the subcutaneous infusion of insulin.

(Please do not write below this line- concinue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use
/(optional Format 1-2-9)

K. Autchison

(Division Sign-Off) Division of Dental, Infection Control, and Ganeral Hospital Devices ్