NIPRO BLOOD COLLECTION NEEDLE

K992699 · Nipro Medical Corp. · FMI · Feb 14, 2000 · General Hospital

Device Facts

• Record ID: K992699
• Device Name: NIPRO BLOOD COLLECTION NEEDLE
• Applicant: Nipro Medical Corp.
• Product Code: FMI · General Hospital
• Decision Date: Feb 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The Nipro Blood Collection Needle are intended to be used to collect blood for various blood tests.

Device Story

Nipro Blood Collection Needle is a single-lumen hypodermic needle used for blood collection. Available in gauges 18, 20, 21, and 22, with lengths ranging from 20 to 40 mm. Device is used by healthcare professionals in clinical settings to facilitate blood sampling for diagnostic testing. Operation involves standard venipuncture techniques. The needle provides a sterile, single-use pathway for blood to be drawn from a patient into a collection container.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single lumen hypodermic needle. Materials: stainless steel SUS 304, synthetic rubber, polypropylene (PP), epoxy resin adhesive, and silicone oil lubricant. Available in 18, 20, 21, 22 gauge; 20-40 mm lengths. Class II device (21 CFR 880.5570).

Indications for Use

Indicated for the collection of blood for various blood tests in patients requiring phlebotomy.

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

• Exel International Blood collection needle (K861152A)

Submission Summary (Full Text)

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K99^{2699}

FEB 1 4 2000

Image /page/0/Picture/2 description: The image shows the logo for Nipro. The logo consists of a stylized, intertwined double helix symbol on the left, followed by the word "NIPRO" in bold, sans-serif font. The logo is black and white.

NIPRO MEDICAL CORPORATION 10877 N.W. 33rd Street Miami, Florida 33172 Tel.: [phone] Fax: [phone]

## SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® BLOOD COLLECTION NEEDLE

8807.92 (a)(1)

Contact Person:

Luis Candelario General Manager

August 2, 1999 Date of Summary Preparation:

\$807.92 (a)(2)

Trade Name: Nipro® Blood Collection Needle

Blood Collection Needle Common Name:

Classification Name: Hypodermic Single Lumen Needle (21 CFR 880.5570) Establishment Registration Number: 9611446 Class: II Panel: 80 Procodes: FMI

\$807.92 (a)(3)

Legally Marketed Substantially Equivalent Device: Exel International Blood collection needle (K861152A)

\$807.92 (a)(4)

| Description of Device: | The Nipro Blood collection needles that we intend to<br>market include gauges 18, 20, 21, and 22. Each gauge is<br>available in various lengths from 20 to 40 mm. |
|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Blood Collection Needles are described in hypodermic<br>single lumen needle (21 CFR 880.5570). | |
| The materials used for the components include stainless<br>steel SUS 304 (SS), synthetic rubber, and polypropylene | |

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(PP). Epoxy resin as an adhesive and silicone oil as a lubricant are also used.

8807.92 (a)(5)

The blood collection needles are intended to be used to collect Intended Use: blood for various blood tests.

§807.92 (a)(6)

Comparison of Technical Characteristics:

The Nipro and Exel devices are exactly the same devices, therefore, all technical characteristics are identical.

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing right, with flowing lines above them that resemble a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2000

Nipro Medical Corporation c/o Ms. Kaelyn B. Hadley Nipro Medical Corporation Consultant C.L. McIntosh & Associates, Incorporated 1384 Copperfield Court Lexington, Kentucky 40514-1268

Re: K992699 Nipro® Blood Collection Needle Trade Name: Regulatory Class: II Product Code: FMI Dated: November 24, 1999 November 26, 1999 Received:

Dear Ms. Hadley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Paqe 2 - Ms. Hadley

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/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

510(k) Number (if known) Device Name: Nipro Blood Collection Needle

Indications for Use: The Nipro Blood Collection Needle are intended to be used to collect blood for various blood tests.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use

Palica monite
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital, Devices
510(k) Number 4995499

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