NIPRO DISPOSABLE SYRINGES

K030683 · Nipro Medical Corp. · FMF · Oct 31, 2003 · General Hospital

Device Facts

• Record ID: K030683
• Device Name: NIPRO DISPOSABLE SYRINGES
• Applicant: Nipro Medical Corp.
• Product Code: FMF · General Hospital
• Decision Date: Oct 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nipro Disposable Syringes are intended for use to inject fluids into or withdraw fluids from the body.

Device Story

Nipro Disposable Syringes are sterile, single-use piston syringes used for fluid injection or withdrawal. Available in various sizes (1 mL to 100 mL) and configurations (flat-head, circular irrigation, screw nozzle). Operated by clinicians or healthcare personnel in clinical settings. Device functions via manual piston displacement to create pressure differentials for fluid transfer. Benefits include sterile, disposable delivery/aspiration of fluids, reducing cross-contamination risks.

Clinical Evidence

Bench testing only.

Technological Characteristics

Piston syringe design; various sizes (1-100 mL); configurations include flat-head, circular irrigation, and screw nozzle. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from the body. No specific patient population, age, or disease state restrictions provided.

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)

Submission Summary (Full Text)

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K030683

10/31/03

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

## SUMMARY OF SAFETY AND EFFECTIVENESS NIPRO DISPOSABLE SYRINGES

\$807.92 (a)(1)

Contact Person:

Cary Goldsmith Product Manager March 4, 2003

Date of Summary Preparation:

5807.92 (a)(2) Trade Name: Common Name: Classification Name:

Nipro Disposable Syringes Sterile Disposable Syringe with/without needle Piston Syringe, Hypodermic Single Lumen Syringe (\$880.5860)

### \$807.92 (a)(3)

Legally Marketed Substantially Equivalent Device: Nipro Branded Disposable Syringes (K944355)

## S807.92 (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 here are: flat-head; circular irrigation syringes; and, screw nozzle syringes. Various sizes are described including: 1, 2, 2.5, 3, 5, 10, 20, 30, 50, and 100 milliliters.

#### 9807.92 (a)(5)

Intended Use: The Nipro Disposable Syringes are intended for use to inject fluids into or withdraw fluids from the body.

#### 9807.92 (a){6)

Comparison of Technical Characteristics:

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

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PublicHealth Service

Image /page/1/Picture/2 description: The image shows a black and white logo. The logo features a stylized bird-like symbol with three curved lines forming its body and wings. The bird is facing right. Encircling the bird is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA' in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

OCT 31 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030683

Trade/Device Name: Nipro Disposable Syringes Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 22,2003 Received: September 23,2003

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.

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## 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/dsma/dsmamain.html

Sincerely yours.

Chiu Lin, Ph. 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 Statement

510(k) number (if known): K030 c 93

**Device name:** Nipro Disposable Syringes

Device name: Nipro Disposable Syringes
Indications for use: The Nipro Disposable Syringes are intended for use to inject fluids into or withdraw fluids from the body.

Patricia Cicceretti

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

510(k) Number. K030682

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

OR

Concurrence of CDRH, Office of Device Evaluation(ODE )

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Prescription Use v (Ber 21 CFR 801.109)

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

Nipro® Disposable Syringes

210(k)

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