AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE

K111034 · Am USA · NGT · Jul 14, 2011 · General Hospital

Device Facts

• Record ID: K111034
• Device Name: AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
• Applicant: Am USA
• Product Code: NGT · General Hospital
• Decision Date: Jul 14, 2011
• 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, sterile plastic syringe pre-filled with 0.9% sodium chloride solution. Used by clinicians to flush intravenous administration sets and indwelling vascular access devices to maintain patency. The device functions as a manual delivery system for the saline solution. The subject device differs from the predicate only in the sterilization process, utilizing terminal radiation sterilization instead of aseptic filling. The device is used in clinical settings where intravenous therapy is administered.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included chemical-physical, functional, and product stability testing to confirm equivalence following the change to terminal radiation sterilization.

Technological Characteristics

Plastic syringe pre-filled with 0.9% sodium chloride solution. Terminal radiation sterilization (SAL 10^-6). Single-use. No electronic or software components.

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

• Baxter Healthcare (K984590)

Submission Summary (Full Text)

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# 111034

JUL 1 4 2011

5.122

510(k) Summary

# -- 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

April 4, 2011

## 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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2111034
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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 indwelling intravenous access devices. Use according to the recommendations of the manufacture for the appropriate device.

### DEVICE DESCRIPTION:

The Predicate Device, 510(k) Number: K984590 (Baxter Healthcare), consists of a sterile plastic syringe aseptically filled with 0.9% Sodium Chloride Flush Solution. The predicate device is fluid path sterile with a Sterility Assurance Level (SAL) of 10 . This is a single use device. AMUSA is the legal owner of the Baxter 510(k) K984590.

The Modified Device, the subject of this 510 (k), consists of a non-sterile plastic syringe filled with 0.9% Sodium Chloride Flush Solution that is sterilized by the addition of terminal sterilization (Radiation). The modified device is fluid path sterility Assurance Level (SAL) of 10 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 labeling, and have the same intended use. The proposed modification involves a change in the process. All other aspects of the product design remain the same.

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 device and is safe and effective when used as intended. Other companies have FDA clearance for 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 Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the seal is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three bars instead of one.

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

Ms. Karen Thomison Director of Quality Assurance AM USA 5209 Lindbar Drive, Suite 640 Nashville, Tennessee 37217

JUL 1 4 2011

Re: K111034

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 20, 2011 Received: June 24, 2011

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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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/AboutFD A/CentersOffices/CDRH/CDR HOffices/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/Report aProblem/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. Mutoon

Cinthism U. on ataen
Anthony D. Watson, B.S., M.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

Attachment 1

# 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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Concurrence of CDRH, Office of Device Evaluation (ODE)

Elaine S. Marshall

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

510(k) Number: K111034