NIPRO HYPODERMIC NEEDLE

K052474 · Nipro Medical Corp. · FMI · Nov 10, 2005 · General Hospital

Device Facts

• Record ID: K052474
• Device Name: NIPRO HYPODERMIC NEEDLE
• Applicant: Nipro Medical Corp.
• Product Code: FMI · General Hospital
• Decision Date: Nov 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nipro Hypodermic Needles are intended for use to inject fluids into or withdraw fluids from the parts of the body.

Device Story

Nipro Hypodermic Needles are single-use, sterile devices used by healthcare professionals to inject or withdraw fluids from the body. The device consists of a needle cannula available in sizes 16-30 Gauge and lengths of 1/2 to 1 1/2 inches, featuring either regular or short bevels. The needle is inserted into the patient's body to facilitate fluid transfer. It is a manual, non-powered device used in clinical settings.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single-use hypodermic needle; 16-30 Gauge; 1/2 to 1 1/2 inch lengths; regular or short bevels; stainless steel construction; sterile; manual operation.

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from parts of the body below the surface of the skin.

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

• Nipro Branded Disposable Syringes and Needles (K944355)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for Nipro. The logo consists of a stylized, intertwined double "N" symbol on the left, followed by the word "NIPRO" in bold, sans-serif font. The logo is in black and white.

NOV 1 0 2005

# 3150 N.W. 107 Avenue Miami, Florida 33172 Tel .: [phone] Fax: [phone]

#### SUMMARY OF SAFETY AND EFFECTIVENESS NIPRO DISPOSABLE NEEDLES

807.92 (a)(1)

Contact Person:

Cary Goldsmith Marketing Manager August 31, 2005

Date of Summary Preparation:

807.92 (a)(2) Trade Name:

Common Name: Classification Name: Panel: 807.92 (a)(3)

Nipro Hypodermic Needles Hypodermic Needles Needle, Hypodermic, Single Use (880.5570) 80

807.92 (a)(4)

Description of Device:

The subject devices can be classified as single use hypodermic needles as described in 21 CFR 880.5570. Needle sizes include 16-30 Gauge, lengths of ½ to 1 ½ inches, and regular or short bevels.

### 807.92 (a)(5)

Intended Use: The Nipro Hypodermic Needles are intended for use to inject fluids into or withdraw fluids from the parts of the body.

Nipro Branded Disposable Syringes and Needles (K944355)

## 807.92 (a)(6)

Comparison of Technical Characteristics:

Legally Marketed Substantially Equivalent Device:

The Nipro subject and predicate devices are very similar in materials, design and technological characteristics. Performance, voluntary standards, and biocompatibility tests demonstrate that the devices are substantially equivalent.

Nipro® Hypodermic Needle

510(k) Premarket Notification

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem featuring a stylized eagle with three stripes emanating from its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 0 2005

Nipro Medical Corporation C/O Ms. Kaelyn B. Hadley Consultant 1384 Copperfield Court Lexington, Kentucky 40514-1268

Re: K052474

Trade/Device Name: Nipro Hypodermic Needle Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 31, 2005 Received: September 9, 2005

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.

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

#### Page 2 - Ms. Hadley

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 [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 yours.

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

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

# Indications for Use

510(k) Number (if known):

Device Name: Nipro Hypodermic Needle

Indications For Use: The Nipro Hypodermic Needle is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.

KOS2479

Anton Viner

් ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------ം പ Anasthesiology, General ricup on Control, Dental Devices

er. K452474

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nipro® Hypodermic Needle

510(k) Premarket Notification