GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX

K014114 · Nipro Diabetes Systems, Inc. · FMF · Jun 26, 2002 · General Hospital

Device Facts

• Record ID: K014114
• Device Name: GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX
• Applicant: Nipro Diabetes Systems, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Jun 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Glucopro Syringe is intended for subcutaneous infusion of medicine solutions, such as insulin.

Device Story

Glucopro Syringe functions as a medication reservoir for external infusion pumps; used for subcutaneous delivery of insulin. Device attaches to infusion set inserted into patient subcutaneous tissue. Components include stainless steel, polypropylene, and silicone. Used in clinical or home settings by patients or caregivers to facilitate continuous or programmed insulin delivery. Benefits patient by providing reliable reservoir for pump-based medication administration.

Clinical Evidence

Bench testing only.

Technological Characteristics

Piston syringe; materials include stainless steel, polypropylene, and silicone. Mechanical reservoir design for use with external infusion pumps. Class II device (21 CFR 880.5860).

Indications for Use

Indicated for subcutaneous infusion of insulin in patients requiring external infusion pump therapy. Compatible with infusion sets inserted into subcutaneous tissue.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Disetronic Medical Systems AG, 3.15mL cartridge

Reference Devices

• GlucoPro (K011120)

Submission Summary (Full Text)

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K014 114

JUN 2 6 2002

Image /page/0/Picture/2 description: The image shows the logo for Nipro Corporation. The logo consists of a stylized symbol resembling two interlocked loops, followed by the word "NIPRO" in a bold, sans-serif font. The color of both the symbol and the text is black, contrasting with the white background.

3150 N W 107 Aver Miami, Florida 33171 Tel : [phone] Fax: [phone]

## SUMMARY OF SAFETY AND EFFECTIVENESS Glucopro™ Syringe

§807.92 (a)(1)

Contact Person:

Kirk Ramey Senior Vice President

December 7, 2001

Date of Summary Preparation:

§807.92 (a)(2)

Glucopro™ Syringe Trade Name:

Syringe Common Name:

Classification Name: Piston Syringe (21 CFR §880.5860), Class II

§807.92 (a)(3)

Legally Marketed Substantially Equivalent Device: Disetronic Medical Systems AG, 3.15mL cartridge

\$807.92 (a)(4)

The Glucopro Syringe is a medication reservoir placed Description of Device: within an infusion pump and attached to an infusion set for infusion of medicine solutions, such as insulin. The materials used for the components include: stainless steel; polypropylene; and, silicone. All of these materials are typically used in medical devices.

\$807.92 (a)(5)

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Intended Use:

The Glucopro Syringe is intended for subcutaneous infusion of medicine solutions, such as insulin.

## క్ర807.92 (a)(6)

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Comparison of Technical Characteristics:

The Glucopro Syringe is similar to legally marketed devices with the same intended use and design.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2002

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

Re: K014114

Trade/Device Name: Glucopro™ Syringe Regulation Number: 880.5860 Regulation Name: Syringe Regulatory Class: II Product Code: FMF Dated: April 2, 2002 Received: April 11, 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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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,

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

Enclosure

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## Indications for Use Statement

510(k) number (if known): KQ14114

Device name: Glucopro Syringe

Common Name: Syringe

Classification Name: Piston Syringe

Product code: FMF

Classification: 880.5860, Class II

Indications for use: The Glucopro syringe is intended for use in the subcutancous infusion of insuline to tast "Inte GlucoPro (K011120) or compatible infusion set is inserted into the subcutaneous tissue of the user and it is connected to the Glucopro Syringe. The insulin is infused from an external infusion pump.

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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 )

Patricia Ciccarelli

(Division Sign-Off) Division of Dental, Infection Control. and General Hospital D 510(k) Number _