NIPRO HYPODERMIC NEEDLE

K013293 · Nipro Medical Corp. · FMI · Dec 14, 2001 · General Hospital

Device Facts

• Record ID: K013293
• Device Name: NIPRO HYPODERMIC NEEDLE
• Applicant: Nipro Medical Corp.
• Product Code: FMI · General Hospital
• Decision Date: Dec 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nipro Hypodernic Needle is intended to be used to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.

Device Story

Nipro Hypodermic Needle is a single-lumen needle used for fluid injection or withdrawal from body tissues. Available in Type L (1.5 inch) and Type S (0.75 to 1 inch) lengths. Device is used by healthcare professionals in clinical settings. Operation involves manual insertion into the patient to facilitate fluid transfer. Benefits include standard access for parenteral administration or fluid aspiration. No complex electronics or software involved.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single-lumen hypodermic needle; available in Type L (1.5 inch) and Type S (0.75-1 inch) lengths. Classified under 21 CFR 880.5570, Product Code FMI. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring injection of fluids into or withdrawal of fluids from body tissues below the skin surface.

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 Hypodermic Needle (K944355)

Submission Summary (Full Text)

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KOI 3293

Image /page/0/Picture/1 description: The image shows the logo for Nipro Medical Corporation. The logo consists of a stylized graphic to the left of the word "NIPRO" in bold, sans-serif font. Below this is the text "NIPRO MEDICAL CORPORATION" and the address "3150 N.W. 107 Avenue".

Miami, Florida 33172 Tel: [phone] Fax: [phone] DEC 1 4 2001

## SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO HYPODERMIC NEEDLE

\$807.92 (a)(1)

Contact Person: Eiji Shinozaki

Hypodermic Single Lumen Needle
21 CFR 880.5570

Date of Summary Preparation: December 4, 2001

\$807.92 (a)(3)

Legally Marketed Substantially Equivalent Device: K944355 Nipro Hypodermic Needle

\$807.92 (a)(4)

·

Description of the Device:

The devices that we intend to m rket are hypodermic needles as described in 21 CFR \$880.5570. Two types of hypodernic needles will be available: types L (long) and S (short). Type L hypodermic needles are 11/2 to 11/2 inches long and Type S necdles 74 to 1 inch long.

\$807.92 (a)(5)

Intended Use:

The Nipro Hypodernic Needle is : tended to be used to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.

8807.92 (a)(6)

Comparison of Technical Characte ristics:

Nipro Hypodermic Needles are smilar in design, technical, performance, and biological characteristics to those marketed inder K944355.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2001

Ms. Kaelyn B. Hadley Consultant Nipro Medical Corporation 1384 Copperfield Court Lexington, Kentucky 40514

Re: K013293

Trade/Device Name: Nipro® Hypodermic Needle Regulation Number: 880.5570 Regulation Name: Hypodermic Needle Regulatory Class: II Product Code: FMI Dated: September 27, 2001 Received: October 2, 2001

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 the Pouchal P 600g, 100g, 1herefore, market the device, subject to the general appear as approvisions of the Act. The general controls provisions of the Act include controls providers 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 (1 Mr.), it inch obe 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 1 od inust compry with and 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 CF R Pat 807), adolity 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 This letter will and w you to began mainly of substantial equivalence of your device to 3 rott) promanced nowledge 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 Office of Compliance vice, 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 noutheation (21 OF ICP at 1077). In 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,

Susan Runne

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): KOL3293

Device name: Nipro® Hypodermic Needli _

Indications for use: The Nipro® Hypode: mic Needle is intended to be used to inject fluids into or withdraw fluids from parts of the body be נוש the surface of the skin

Atuar Cucurita

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 293 5 . 0(k) Number .

(Do not write below this line- continue ( 1 another page if needed.)

Concurrence of CDRH, )ffice of Device Evaluation (ODE)

Prescription Use J (Per 21 CFR 801.109)

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