DUOPROSS NEEDLE

K052445 · Duopross Meditech Corporation · FMI · Dec 5, 2005 · General Hospital

Device Facts

• Record ID: K052445
• Device Name: DUOPROSS NEEDLE
• Applicant: Duopross Meditech Corporation
• Product Code: FMI · General Hospital
• Decision Date: Dec 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The DuoProSS Needle device is a sterile hypodermic needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Device Story

DuoProSS Needle is a sterile, single-use, standard hypodermic needle. Device consists of stainless steel cannula, polypropylene hub, and polypropylene needle guard, assembled with epoxy glue. Used by clinicians to inject or withdraw fluids from subcutaneous or deeper body tissues. Device is provided sterile via ethylene oxide sterilization. Simple mechanical device; no electronic or software components.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: stainless steel cannula, polypropylene hub, epoxy glue, polypropylene needle guard. Single-lumen hypodermic needle. Sterilization: ethylene oxide. No software or electronic components.

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from body tissues below the skin surface. No specific patient population, age, or gender restrictions stated.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• Terumo Disposable Hypodermic Needle (K771203)

Submission Summary (Full Text)

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K052445

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DEC 5 2005

## 510(k) SUMMARY

#### K NUMBER

#### SPONSOR

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

# SUBMITTED BY

Ferguson Medical Consultant to DuoProSS

### CLASSIFICATION NAME

Needle, Hypodermic, Single Lumen

#### CLASSIFICATION NUMBER

21 CFR 880.5570/Procode 90 FMI

### PROPRIETARY DEVICE NAME

DuoProSS Needle

### DEVICE DESCRIPTION

The DuoProSS Needle device is a sterile, single use, standard hypodermic needle. The device is available in various Gauges and lengths.

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K052445 page 2 of 2

Each needle device consists of a stainless steel cannula sealed with epoxy glue into a polypropylene hub. The assembly has a protective polypropylene needle shield. The device is packaged in a peal-back pouch and sterilized by ethylene oxide.

#### DESIGN AND MATERIALS

The DuoProSS Needle device consists of 4 parts or materials: a stainless steel cannula, a polypropylene hub, epoxy glue and a polypropylene needle guard. Please see List of Components and Materials table.

#### INTENDED USE

The DuoProSS Needle device is a sterile hypodermic needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

#### SUBSTANTIAL EQUIVALENCE

Terumo Disposable Hypodermic Needle (K771203) and others.

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### 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 5 2005

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

Re: K052445

Trade/Device Name: DUOPROSS NEEDLE Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: November 23, 2005 Received: November 28, 2005

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 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.

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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 your 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 (240) 276- 0115. 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 yours,

Smitie Y. Michie, M.D.

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

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K052445

### Indications For Use

510(k) Number (If known):

14052445

Device Name: DUOPROSS NEEDLE

Indications For Use:

The DuoProSS Needle device is a sterile hypodermic needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

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)

William M. Burdick
For Anthony D. Watson
12/5/05

f Anesthesiology, General Hospital,
Section Control, Dental Devices

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