AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE

K113555 · Am USA · NGT · Jan 30, 2012 · General Hospital

Device Facts

• Record ID: K113555
• Device Name: AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
• Applicant: Am USA
• Product Code: NGT · General Hospital
• Decision Date: Jan 30, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacture for the appropriate device.

Device Story

Device is a single-use, terminally sterilized plastic syringe pre-filled with 0.9% Sodium Chloride solution. Used by clinicians to flush intravenous administration sets and indwelling vascular access devices. Operation involves manual injection of saline to maintain patency of IV lines. Modification from predicate involves change in syringe component supplier. Device provides a sterile, ready-to-use solution for routine maintenance of vascular access, reducing risk of occlusion and ensuring compatibility with existing IV infrastructure.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical verification testing, including chemical-physical, functional, and product stability testing.

Technological Characteristics

Single-use plastic syringe pre-filled with 0.9% Sodium Chloride solution. Terminally sterilized with a Sterility Assurance Level (SAL) of 10^-6. No electronic components or software.

Indications for Use

Indicated for flushing compatible intravenous administration sets and indwelling intravenous access devices in patients requiring such maintenance.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• AMUSA 0.9% Sodium Chloride Flush Syringe (K111034)

Submission Summary (Full Text)

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510(k) Summary

# 113555

JAN 3 0 2012

# 510(k) Summary of Safety and Effectiveness

As required by 809.92(a)(2).

SPECIAL 510 (k) PREMARKET NOTIFICATION NUMBER:

## Submitter and Owner of the 510(k)

AMUSA 5209 Linbar Dr., Suite 640 Nashville, TN 37211 Phone: [phone] Fax: [phone]

## Official Correspondent

Karen Thomison Director of Quality Assurance AMUSA 5209 Linbar Dr., Suite 640 Nashville, TN 37211 Phone: [phone] Fax: [phone]

Date of Preparation

November 1, 2011

## 510(k) Application Number TBD

Trade/Proprietary Name

0.9% Sodium Chloride Flush Syringe

Common Name/Usual Name Saline Flush Syringe

Device Classification Name Device, Flush, Vascular Access

Regulation Number 880.5200

Device Class Class II Device

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510(k) Summary

#### Classification Panel

General Hospital

## Classification Product Code

NGT

#### INDICATIONS FOR USE

Intended use: 0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and industry intravenous access devices. Use according to the recommendations of the manufacture for the appropriate device.

### DEVICE DESCRIPTION:

The Predicate Device, 510(k) Number: K111034, AMUSA consists of a plastic syringe filled with 0.9% Sodium Chloride Flush Solution that is terminally sterilized. The predicate device filud path of 10 Section Onlonde Hush Oolution that is terminally sterlized. This is a single use device.

The Modified Device, the subject of this 510 (k), consists of a plastic syringe filled with 0.9%
Sodium Chlerida Fluch Calification that the United on the Sodium Chloride Flush Solution that is terminally sterilized. The modified device fluid path sterile has a Sterility Assurance Level (SAL) of 108. This is a single use device.

TECHNICAL DATA: The technical characteristics for the modified device do not differ from those of the currently marketed device. These devices have the same design, the same fundamental scientific characteristics, the same label have the same intended use. The proposed modification involves a change in the syringe component supplier.

Substantial Equivalence: Non-clinical verification testing for the proposed change involved chemical-physical, functional, and product stability testing. The results of testing conducted verifies the modified terminally sterilized syringe performed in an equivalent manner to the predicate terminally sterilized syringe and is safe and effective when used as intended.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The logo is black and white.

#### Public Health Service

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

JAN 3 0 2012

AM USA C/O Karen Thomison Director of Quality Assurance 5209 Linbar Drive, Suite 640 Nashville, Tennessee 37211

Re: K113555

Trade/Device Name: AM USA 0.9% Sodium Chloride Flush Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Saline, Vascular Access Flush Regulatory Class: II Product Code: NGT Dated: January 18, 2012 Received: January 19, 2012

Dear Ms. Thomison:

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 Eederal Register.

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#### Page 2 - Ms. Thomison

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,

for Anthony J. Watson

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

# Indications for Use Statement

510(k) Number (if known):

Device Name: 0.9% Sodium Chloride Flush Syringe

Indications for Use:

"0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacture for the appropriate device".

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rhd C. Chym 1/25/12

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

K113555 510(k) Number: