DUOPROSS SYRINGES

K042500 · Duopross Meditech Corporation · FMF · Feb 22, 2005 · General Hospital

Device Facts

• Record ID: K042500
• Device Name: DUOPROSS SYRINGES
• Applicant: Duopross Meditech Corporation
• Product Code: FMF · General Hospital
• Decision Date: Feb 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The DuoProSS Syringes device is intended to be used to inject fluids into, or withdraw fluids from, the body. The 1ml DuoPross Insulin Syringe is intended for the injection of insulin into the body.

Device Story

DuoProSS Syringes are sterile, single-use, manual piston syringes. Available in 1, 1 (insulin), 2, 5, 10, 20, and 60 cc/ml volumes with luer slip or luer lock configurations. Device consists of a calibrated polypropylene barrel, movable plunger, and Kraton IR isoprene rubber piston; some configurations include an attached needle. Operated manually by clinicians or patients for fluid injection or withdrawal. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: Polypropylene (barrel), Kraton IR isoprene rubber (piston). Manual operation; no energy source. Dimensions: 1-60 cc/ml volumes. Configurations: Luer slip or luer lock, with or without attached needle. Sterile, single-use.

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from the body, including insulin injection for the 1ml insulin syringe variant. Intended for general patient populations requiring fluid administration or withdrawal.

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

• DuoPro Safety Syringe (K020623)
• Modified DuoPro Safety Syringe (K022806)
• 1 ml Bak'Snap DuoPro Safety Syringe (K031594)
• 10 ml Bak'Snap DuoPro Safety Syringe (K034031)
• Becton-Dickinson (BD) Single-Use Hypodermic and Insulin Syringes (K980987)

Submission Summary (Full Text)

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## 510(k) SUMMARY

### K NUMBER

K042500

### SPONSOR

DuoProSS Meditech Corporation 27 Sarah Drive Farmingdale, NY 11735 Phone: [phone] Fax: [phone]

### SUBMITTED BY

Ferguson Medical Consultant to DuoProSS

### CLASSIFICATION NAME

Piston Syringe

### CLASSIFICATION NUMBER

21 CFR 880.5680/Procode 80 FMF

### PROPRIETARY DEVICE NAME

DuoProSS Syringes

# DEVICE DESCRIPTION

The DuoProSS Syringes device is a sterile, single use, standard piston syringe, designed for manual use. The device is available in 1, 1 (insulin), 2, 5, 10, 20 and 60 cc/ml volumes with luer slip or luer lock configurations.

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Each syringe consists of a calibrated hollow barrel and movable plunger. At the distal end of the syringe is a male connector nozzle for fitting the female connector hub of a single lumen needle. Configurations are supplied with and without the needle already attached to the syringe.

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### DESIGN AND MATERIALS

The DuoProSS Syringes device consists of 3 parts: a barrel, a plunger, a piston and a needle. The barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The piston is made from Kraton IR, a highly inert isoprene rubber. Please see List of Components and Materials table.

### INTENDED USE

The DuoProSS Syringes device is intended to be used to inject fluids into, or withdraw fluids from, the body.

### SUBSTANTIAL EQUIVALENCE

K020623 DuoPro Safety Syringe

K022806 Modified DuoPro Safety Syringe

K031594 1 ml Bak'Snap DuoPro Safety Syringe

K034031 10 ml Bak'Snap DuoPro Safety Svringe

K980987 Becton-Dickinson (BD) Single-Use Hypodermic and Insulin Syringes and others

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its wings and body. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.

FEB 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DuoProSS Meditech Corporation C/O Mr. Frank Ferguson Official Corespondent Ferguson Medical 12200 Academy Road NE #931 Albuquerque, New Mexico 87111

Re: K042500

Trade/Device Name: DUOPROSS SYRINGES-1ml Insulin Syringe and Duopross Syring (General USE) Regulation Number: 880.5680 Regulation Name: Pediatric Position Holder Regulatory Class: II Product Code: FMF Dated: December 28, 2004 Received: December 13, 2004

Dear Mr. Ferguson:

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 enclosurc) 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 Ecderal Register.

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Page 2 - Mr. Ferguson

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 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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/industry/support/index.html.

Sincerely vours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K0412500

# Indications For Use

K042500 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

DUOPROSS SYRINGES – 1ml Insulin Syringe Device Name:

Indications For Use:

The 1ml DuoPross Insulin Syringe is intended for the injection of insulin into the body.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton D. luc

. Bion Sign-Off) ision of Anesthesiology, General Hospital, rection Control. Dental Devices

11:4) Number__________________________________________________________________________________________________________________________________________________________________

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K042500

# Indications For Use

510(k) Number (If known): K042500

Device Name: DUOPROSS SYRINGES

Indications For Use:

The DuoPross Syringes device is used to inject fluids into, or withdraw fluids from, the body.

Prescription Use _ XX __ (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 Device Evaluation (ODE)

.............................................................................................................................................................................. -25

:) sion Sign-Off) : Ision of Anesthesiology, General Hospital, Traction Control, Dental Devices

(k) Number ___________________________________________________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________

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