0.9% SODIUM CHLORIDE FLISH SYRINGE

K120836 · Am USA · NGT · Jul 12, 2012 · General Hospital

Device Facts

• Record ID: K120836
• Device Name: 0.9% SODIUM CHLORIDE FLISH SYRINGE
• Applicant: Am USA
• Product Code: NGT · General Hospital
• Decision Date: Jul 12, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

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

Device Story

0.9% Sodium Chloride Flush Syringe is a single-use, pre-filled plastic syringe containing 0.9% sodium chloride solution. It is used by clinicians to flush intravenous administration sets and indwelling vascular access devices. The device is terminally sterilized to a Sterility Assurance Level (SAL) of 10^-6. The modified device features a sterile exterior barrier, allowing for use within a sterile field, unlike the predicate which only maintained fluid path sterility. The device is manually operated by healthcare providers. It functions as a simple delivery mechanism for saline to maintain patency of intravenous access lines.

Clinical Evidence

Bench testing only. No clinical data provided. Verification included chemical-physical, functional, and package validation studies to confirm the integrity of the sterile barrier.

Technological Characteristics

Plastic syringe pre-filled with 0.9% sodium chloride solution. Terminally sterilized (SAL 10^-6). Features a sterile barrier packaging system for sterile field use. Manual operation; no software or electronic components.

Indications for Use

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

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

• K111034

Submission Summary (Full Text)

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510(k) Summary

## 510(k) Summary of Safety and Effectiveness

As required by 809.92(a)(2).

## special 510 (k) Premarket notification number: KL20 836

JUL 12 2012

## 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 3/13/12

## 510(k) Application Number

#### 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

INDIOATHONO FOR OOE intended use. 0.3% Odding Online Plaalling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

#### DEVICE DESCRIPTION:

The Predicate Device, 510(k) Number: K111034, cleared on July14, 2011 consists of a plastic rre Predicate Device, o ro(ty Namber. It Frob Solution that is terminally sterilized. The predicate synige is fluid path sterile with a Sterlity Assurance Level (SAL) of 10°. This is a single use device packaged in a dust cover.

The Modified Device, the subject of this 510 (k), consists of a plastic syringe filled with 0.99% The Modified Device, the Subject of this of (1)) otterilized. The modified device has a sterile outlum Onlon of the sterility of the fluid, fluid path and the exterior of the device. The package that maintains the sterily of the package is not open and aseptic techniques modified device out bo acounte Level (SAL) is 10 - This is a single use device.

Technical Data: The technical characteristics of the syringe for the modified device do not r ecoffnour Duta. The confined characted device. These syringes have the same design, the differ from those of the ouriently manietics, and have the same intended use. The proposed Same innualhemal selemans, and hostitution the dust cover with a stelle barrier modification involves a change in pastialistics for use in a sterile field. All other aspects of the syringe design remain the same.

Substantial Equivalence: Non-clinical verification testing for the proposed change involved Shemical-physical, functional, and package validation studies. The result of testing conducted verifies that the change in sterile packaging of the modified device performed in an equivalent venties that the change in Steme packaging of the used as intended. Other manner to the products as not special 510(k)s submitted with similar changes.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

Ms. Karen Thomison Director of Quality and Regulatory Affairs AMUSA 5209 Linbar Drive, Suite 640 Nashville, Tennessee 37211

JUL 12 2012

Re: K120836

Trade/Device Name: 0.9% Sodium Chloride Flush Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: June 11, 2012 Received: June 13, 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 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 (OS) 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 vours,

FR Bisley
Turkett MD

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

#### Enclosure

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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 manufacturer for the appropriate device".

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rohit Gangulin
(Division Sign-Off) 7/12/12

Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: K120836

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