NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE

K051574 · Nipro Medical Corp. · FMF · Aug 26, 2005 · General Hospital

Device Facts

• Record ID: K051574
• Device Name: NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
• Applicant: Nipro Medical Corp.
• Product Code: FMF · General Hospital
• Decision Date: Aug 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Disposable Hypodermic Syringes with or without Needle are intended for use to inject fluids into or withdraw fluids from the body.

Device Story

Disposable piston-style syringes used for fluid injection or withdrawal. Available in luer lock, slip-tip, eccentric, and catheter tip configurations; sizes range from 1 to 60 mL. May be supplied with or without needles. Used in clinical or home settings by healthcare professionals or patients. Operates via manual plunger displacement to create pressure differentials for fluid transfer. Provides a sterile, single-use delivery mechanism for medications or fluid aspiration.

Clinical Evidence

Bench testing only. Performance tests demonstrated that the devices meet voluntary standards for syringes and are substantially equivalent to the predicate devices.

Technological Characteristics

Piston syringe design per 21 CFR 880.5860. Configurations: luer lock, slip-tip, eccentric, catheter tip. Sizes: 1, 3, 5, 10, 20, 30, 60 mL. Sterile, single-use. Materials and design consistent with predicate devices.

Indications for Use

Indicated for the injection of fluids into or withdrawal of fluids from the body. Intended for use by clinicians or patients in prescription or over-the-counter settings.

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

• Nipro Branded Disposable Syringes (K944355)
• Nipro Branded Disposable Syringes (K030683)

Submission Summary (Full Text)

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Kos-1574

Image /page/0/Picture/1 description: The image shows the logo and contact information for Nipro Medical Corporation. The logo features a stylized graphic element next to the word "NIPRO" in bold, uppercase letters. Below the logo is the company name, followed by the address 3150 N.W. 107 Avenue, Miami, Florida 33172, and the telephone number [phone] and fax number [phone].

AUG 2 6 2005

## SUMMARY OF SAFETY AND EFFECTIVENESS DISPOSABLE HYPODERMIC SYRINGES

807.92 (a)(1)

Contact Person:

Cary Goldsmith Marketing Manager June 6, 2005

Date of Summary Preparation:

807.92 (a)(2)

Trade Name: Common Name: Classification Name:

Disposable Hypodermic Syringes with or without Needle Sterile Disposable Syringe with/without needle Syringe, Piston (880.5860) Hypodermic Single Lumen Needle (880.5570)

### 807.92 (a)(3)

Legally Marketed Substantially Equivalent Device:

Nipro Branded Disposable Syringes (K944355 and K030683)

#### 807.92 (a)(4)

Description of Device:

The subject devices can be classified as piston syringes as described in 21 CFR 880.5860. Among the syringe types described are: luer lock, slip-tip, eccentric, and catheter tip. Syringes will be packaged with and without needles. Various sizes are described including: 1, 3, 5, 10, 20, 30, and 60 milliliters.

## 807.92 (a)(5)

Intended Use: The Disposable Hypodermic Syringes with or without Needle are intended for use to inject fluids into or withdraw fluids from the body.

# 807.92 (a)(6)

Comparison of Technical Characteristics:

The subject and Nipro predicate devices are similar in materials, design and technological characteristics. Performance tests demonstrated that the devices are substantially equivalent and meet voluntary standards for syringes.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that resemble a human figure.

AUG 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051574

Trade/Device Name: NIPRO Disposable Syringe with or without needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: June 6, 2005 Received: June 14, 2005

Dear Dr. 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.

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Page 2 - Ms. Hadley

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase be advisou that I Drivision that your device complies with other requirements of the Act that I Dri Hab intato a and regulations administered by other Federal agencies. You must of any I edetar statuates and 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. product ractiation of to begin marketing your device as described in your Section 510(k) rms letter witification. The FDA finding of substantial equivalence of your device to a legally promanted modicate 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 11 you a seen 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,

E. Susan Sumner
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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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K05 1574

Device Name: Disposable Hypodermic Syringes with or without Needles

Indications For Use: The Disposable Hypodermic Syringes and Needles are intended for use to inject fluids into or withdraw fluids from the body.

Prescription Use
(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)

Chas. Martin

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

Kysls74 510(k) Number:_