NIPRO DISPOSABLE SYRINGE

K091279 · Nipro Medical Corporation · FMF · Aug 12, 2009 · General Hospital

Device Facts

• Record ID: K091279
• Device Name: NIPRO DISPOSABLE SYRINGE
• Applicant: Nipro Medical Corporation
• Product Code: FMF · General Hospital
• Decision Date: Aug 12, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nipro Disposable Syringe is intended to inject fluids into or withdraw fluids out of the body.

Device Story

NIPRO Disposable Syringe is a manual piston syringe consisting of a graduated barrel, plunger rod, gasket, and nozzle tip cap. Device is used by clinicians or patients to inject fluids into or withdraw fluids from the body. Operation is purely mechanical; no electronic or software components. Device is provided sterile, single-use, non-toxic, and non-pyrogenic, sterilized via Gamma radiation.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility data and performance testing compared to the predicate device.

Technological Characteristics

Piston syringe consisting of graduated barrel, plunger rod, gasket, and nozzle tip cap. Sterilized by Gamma radiation. Mechanical operation only.

Indications for Use

Indicated for the injection of fluids into or withdrawal of fluids from the body. No specific patient population, age, or gender restrictions are defined.

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 Disposable Syringe (K944355)

Submission Summary (Full Text)

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K091279 p. lot 2

Image /page/0/Picture/1 description: The image shows the logo for Nipro. The logo consists of a stylized, abstract symbol on the left and the word "NIPRO" in bold, sans-serif font on the right. The symbol is composed of two interlocked, curved shapes, creating a sense of movement and connection. The overall design is clean and modern, with a focus on simplicity and visual impact.

Florida 33172 05) 599-7174 [phone]

AUG 1 2 2009

# 510(k) Summary NIPRO® Disposable Syringe

807.92(a) (1)

Applicant: Establishment Reg.:

Nipro Medical Corporation 1056186

Contact Person:

Jessica Oswald Regulatory Affairs Specialist

Date of summary preparation: April 30, 2009

807.92(a) (2)

NIPRO® Disposable Syringe Trade Name: Common Name: disposable syringe Classification Number: 880.5860 Classification Name: Piston syringe Panel: 80 Product Code: FMF

807.92(a) (3)

Legally marketed substantial equivalent device: NIPRO Disposable Syringe (K944355)

807.92(a) (4)

Description of device:

The NIPRO Disposable syringe is a piston syringe consisting of graduated barrel, plunger rod, gasket and nozzle tip cap. Its function is mechanical and it is intended to inject fluids into or withdraw fluids out of the body. The syringe is sterile, single to only, non-toxic, non-pyrogenic and sterilized by Gamma radiation.

807.92(a) (5)

Indications for Use:

The Nipro Disposable Syringe is intended to inject fluids into or withdraw fluids out of the body.

NIPRO® Disposable Syringe (Gamma) 5 510(k) Summary

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K091277 p.20f2

#### 807.92(a) (6)

Comparison of technological characteristics:

Nipro Medical Corporation considers the modified NIPRO® Disposable Syringe Gamma to be substantially equivalent to the current NIPRO® Disposable Syringe (K944355) with regard to intended use, materials of construction, labeling, and overall performance characteristics.

#### 807.92(b) (1)

Non-clinical tests submitted:

Biocompatibility data, performance testing and comparison testing with the predicate are included in this submission and demonstrate substantial equivalence,

### 807.92(b) (3)

Conclusions drawn from non-clinical and clinical tests:

The results of the performance testing and the comparison of technological characteristics demonstrate that the NIPRO® Disposable Syringe Gamblegical characteristics
device and is a from and ff device and is safe and effective when used as intended.

NIPRO® Disposable Syringe (Gamma) 5 510(k) Summary

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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 stylized eagle with three lines representing its body and wings. The eagle is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Jessical Oswald Regulatory Affairs Specialist Nipro Medial Corporation 3150 North West 107th Avenue Miami. Florida 33172

AUG 1 2 2009

Re: K091279

Trade/Device Name: NIPRO® Disposable Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 13, 2009 Received: July 15, 2009

Dear Ms. Oswald:

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 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. Oswald

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/

CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony V. Mastrofini

Susan Runner, D.D.S., M.A. Acting Division 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:

.

Device Name: NIPRO® Disposable Syringe

Indications for Use:

The Nipro Disposable Syringe is intended to inject fluids into or withdraw fluids out of the body.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 CFR 801 Subpart D)

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

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K0912-

NIPRO® Disposable Syringe (Gamma)