MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)

K131641 · Nipro Medical Corporation · FMF · Aug 28, 2013 · General Hospital

Device Facts

• Record ID: K131641
• Device Name: MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
• Applicant: Nipro Medical Corporation
• Product Code: FMF · General Hospital
• Decision Date: Aug 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Monoject 60mL Syringe is a manual, single-use piston syringe; consists of calibrated polypropylene barrel, moveable plunger, and thermoplastic elastomer gasket. Available in Luer lock, Luer slip, and catheter tip configurations. Operates via manual plunger depression/retraction to inject or withdraw fluids. Used in clinical settings by healthcare professionals. Device provides fluid delivery or aspiration; benefits patient by enabling controlled fluid administration or removal. Sterilized by gamma irradiation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Polypropylene (barrel/plunger), thermoplastic elastomer (gasket). Design: 60mL capacity, calibrated barrel, three nozzle types (Luer lock, Luer slip, catheter tip). Luer nozzle compliant with ISO 594. Sterilization: Gamma irradiation. Single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring injection or withdrawal of fluids from the body. No specific age or gender restrictions.

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

• Becton Dickinson Syringes (K980987)
• Terumo Syringe with/without Needle (K063613)

Submission Summary (Full Text)

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# 510(k) Summary: Monoject 60mL Syringe

| 807.92(a)(1) | |
|------------------------------|----------------------------------------------------------------------------------------|
| Applicant: | Nipro Medical Corporation<br>3150 NW 107th Ave.<br>Miami FL 33172<br>Tel: [phone] |
| Establishment Reg.: | 1056186 |
| Contact Person: | Jessica Oswald-McLeod<br>Regulatory Affairs Specialist |
| Date of summary preparation: | May 31, 2013 |
| 807.92(a)(2) | |
| Trade Name: | Monoject 60mL Syringe |
| Common Name: | syringe, piston |

AUG 28 2013

Classification Name: piston syringe Regulation Number: 21 CFR 880.5860 Panel: 80 Product Code: FMF

# 807.92(a)(3)

・

Legally marketed substantial equivalent device: Becton Dickinson Syringes K980987 Terumo Syringe with/without Needle K063613

# 807.92(a)(4)

# Description of device:

The Monoject 60mL Syringe is a standard piston syringe without needle. It consists of 3 parts; a calibrated hollow barrel, with a moveable plunger and an attached gasket. It is available in three nozzle types: Luer lock, luer slip and catheter tip. The barrel is made from polypropylene and is designed with clear graduation for easy use. The luer barrel nozzle has an ISO 594 compliant male luer 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 30 devices, and the master case contains 12 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 60mL Syringe performs equivalent to the predicate device and is safe and effective when used as intended.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

## August 28, 2013

Nipro Medical Corporation Ms. Jessica Oswald-Mcleod Regulatory Affairs Specialist 3150 N.W 107" Avenue DORAL FL 33172

Re: K131641

Trade/Device Name: MONOJECT 60mL Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: August 1, 2013 Received: August 20, 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.

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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm 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/Picture/5 description: The image shows the name "Mary S. Runner" in a bold, sans-serif font. The text is black and appears to be printed on a white background. There is some noise or artifacts around the text, possibly from scanning or compression.

Kwame Ulmer M.S. Acting Division 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:________________________________________________________________________________________________________________________________________________________________

Device Name: Monoject 60mL Syringe

Indications for Use:

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Richard C. |
|--|---------------------|
| | Chapman |
| | 2013.08.28 15:26:11 |
| | -04'00' |

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

| 510(k) Number: | K131641 |
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|----------------|---------|

Monoject 60mL Syringe

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