MONOJECT 12ML SYRINGE

K130049 · Nipro Medical Corporation · FMF · Feb 14, 2013 · General Hospital

Device Facts

• Record ID: K130049
• Device Name: MONOJECT 12ML SYRINGE
• Applicant: Nipro Medical Corporation
• Product Code: FMF · General Hospital
• Decision Date: Feb 14, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The syringe is intended to inject or withdraw fluids from the body.

Device Story

Monoject 12mL Syringe is a manual, single-use piston syringe; consists of calibrated polypropylene barrel, moveable plunger, and thermoplastic elastomer gasket. Features ISO 594 compliant male 6% taper luer lock tip for connection to compatible hubs. Used by clinicians to inject or withdraw fluids from body. Device is sterile, individually packaged, and intended for manual operation. No electronic or automated components.

Clinical Evidence

No clinical data; bench testing only. Performance verification included liquid/air leakage, separation force, unscrewing torque, ease of assembly, resistance to overriding, stress cracking, graduation tolerance, dead space, piston/plunger separation, chemical testing, bacterial endotoxin testing, and biocompatibility.

Technological Characteristics

Materials: Polypropylene (barrel, plunger), thermoplastic elastomer (gasket). Design: 3-part piston syringe, ISO 594 compliant male 6% taper luer lock. Sterilization: Gamma irradiation. Single-use. No software or electronic components.

Indications for Use

Indicated for injection or withdrawal of fluids from the body in patients requiring such procedures.

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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K130049

3150 NW 107th Avenue Miami FL 33172 Tel: [phone] Fax: 305,592,4621

## 510(k) Summary: Monoject 12mL Syringe

807.92(a)(1)

Applicant:

Nipro Medical Corporation 3150 NW 107" Ave. Miami FL 33172 Tel: [phone] 1056186

Establishment Reg .:

Contact Person:

Jessica Oswald-McLeod Regulatory Affairs Specialist

Date of summary preparation:

January 9, 2013

#### 807.92(a)(2)

Trade Name: Monoject 12mL Syringe Common Name: syringe, piston Classification Name: piston syringe Regulation Number: 21 CFR 880.5860 Panel: 80 Product Code: FMF

### 807.92(a)(3)

Legally marketed substantial equivalent device: K944355 - NIPRO Disposable Syringe

#### 807.92(a)(4)

Description of device:

The Monoject 12 mL Syringe is a standard piston syringe without needle. It consists of 3 parts; a calibrated hollow barrel, with a moveable plunger and attached gasket. The barrel is made from polypropylene and is designed with clear graduation for easy use. The barrel nozzle has an ISO 594 compliant male 6% taper luer lock tip for fitting any female luer taper hub that is also ISO 594 compliant. The plunger is made from polypropylene. The gasket is made from thermoplastic elastomer material. The syringe is individually packaged in a peel blister that ensures the sterility of the device until the package is opened. This is a single use only device. An inner box contains 100 devices, and the outer box contains 10 inner boxes. This syringe is sterilized by gamma irradiation.

#### 807.92(a)(5)

Indications for Use:

The syringe is intended to inject or withdraw fluids from the body.

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#### 807.92(a){6)

Comparison of technological characteristics:

The syringe is substantially equivalent to the predicate device in the following technological characteristics:

- Physical characteristics .
- . Operational mode
- Basic Scientific Technology ●
- Intended Use .

#### 807.92(b)(1)

Non-clinical tests submitted:

Performance testing was conducted to verify that the device is safe and effective for its intended use. These tests include: liquid leakage, air leakage, separation force, unscrewing torque, ease of assembly, resistance to overriding, stress cracking, tolerance on graduation capacity, maximum dead space, air leakage past syringe piston during aspiration and for separation of piston and plunger, air and liquid leakage at piston under compression, minimum over length of scale to nominal capacity mark, force required to operate plunger, individual package integrity, chemical testing, bacterial endotoxin testing and biocompatibility testing. These tests along with their associated results and conclusions are included in this submission.

#### 807.92(b)(2)

Clinical tests:

This submission does not warrant any clinical testing, therefore no clinical testing performed for or provided in this submission.

#### 807.92(b)(3)

Conclusions drawn from non-clinical and clinical tests:

The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the Monoject 12mL Syringe performs equivalent to the predicate device and is safe and effective when used as intended.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

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

February 14, 2013

Nipro Medical Corporation Ms. Jessica Oswald-Mcleod Regulatory Affairs Specialist North American Division 3150 N.W. 107th Avenue MIAMI. FL 33172

Re: K130049

Trade/Device Name: Monoject 12ml Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: January 4, 2013 Received: January 17, 2013

Dear Ms. Oswald-Mcleod:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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

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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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/3/Figure/6 description: The image shows a logo with the letters "FDA" in a stylized, outlined font. Above the letters, there is some handwritten text that is difficult to read due to the handwriting style. The logo appears to be a black and white image with a simple design.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, 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: K | 300UQ

Device Name: Monoject 12mL Syringe

Indications for Use:

The syringe is intended to inject 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Tejashri Rurohit-Sheth, M.D.
Clinical Deputy Direction, Direction, DAGRID
2013.02.15 13:17:23 -05-17:23 - 05:50
2013.02.15 13:17:23 - 05:17:23 - 05:50:00

## (Division Sign-Off)

)ivision of Anesthesiology, General Hospital nfection Control, Dental Devices

K130049 510(k) Number:

Monoject 12mL Syringe