FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE

K090882 · Hospira, Inc. · NGT · Apr 23, 2010 · General Hospital

Device Facts

• Record ID: K090882
• Device Name: FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE
• Applicant: Hospira, Inc.
• Product Code: NGT · General Hospital
• Decision Date: Apr 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

For the flushing and assessing the patency of indwelling catheters and venipuncture devices which are designed for intermittent injection therapy, blood sampling, or fluid and nutritional therapy.

Device Story

Flush syringe pre-filled with 0.9% sodium chloride; used to flush and assess patency of indwelling catheters and venipuncture devices. Device consists of medical-grade plastic syringe containing saline. Operated by clinicians in clinical settings. Output is manual delivery of saline flush to maintain catheter patency; prevents occlusion; facilitates intermittent injection therapy, blood sampling, and fluid/nutritional delivery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Medical-grade plastic syringe pre-filled with 0.9% sodium chloride. Manual operation. Differences from predicates include sterilization method and plunger tip material/shape.

Indications for Use

Indicated for patients requiring flushing or patency assessment of indwelling catheters and venipuncture devices used for intermittent injection, blood sampling, or fluid/nutritional 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

• Modification to Syringe Pre-filled with 0.9% Sodium Chloride (K001616)
• Syringe Pre-filled with 0.9% Sodium Chloride (K953805)
• Modification to Monoject Pre-Fill 0.9% Sodium Chloride (K032438)

Submission Summary (Full Text)

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Contidential

March 2009

K0908882

Original 510(k) Premarket Notification Flush Syringe with 0.9% Sodium Chloride

#### 510(k) SUMMARY 5

# APR 2 3 2010

- Phone: [phone] Hospira, Inc. 5.1 Submitted by: D-389 Bldg. H2 Fax: [phone] N. Field Drive Lake Forest, IL 60045
Contact: Keith Dunn

- March 25, 2009 5.2 Date Prepared:
- Vascular Access Flush, Intravascular, 5.3 Name/Classification Saline, Catheter, Class 2, 80-NGT of Device:

### 0.9% Sodium Chloride Flush Syringe 5.4 Trade Name of Proposed Device:

#### 5.5 Predicate Devices:

| Device Name | 510(k) Number |
|--------------------------------------------------------------|---------------|
| Modification to Syringe Pre-filled with 0.9% Sodium Chloride | K001616 |
| Syringe Pre-filled with 0.9% Sodium Chloride | K953805 |
| Modification to Monoject Pre-Fill 0.9% Sodium Chloride | K032438 |

### 5.6 Proposed Device Description:

The proposed Flush Syringe pre-filled with 0.9% Sodium Chloride will be composed of a medical grade plastic syringe and 0.9% Sodium Chloride for the purpose of flushing and assessing the patency of indwelling catheters and venipuncture devices

### 5.7 Statement of Intended Use:

For the flushing and assessing the patency of indwelling catheters and venipuncture devices which are designed for intermittent injection therapy, blood sampling, or fluid and nutritional therapy.

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#### 510(k) SUMMARY (continued) ട്

## 5.8 Summary of Technological Characteristics of New Device Compared to Predicate Devices:

The Flush Syringe pre-filled with 0.9% Sodium Chloride as described in this submission is substantially equivalent to the predicate Flush Syringe pre-filled with 0.9% Sodium Chloride with respect to the following characteristics:

5.8.1 Similarities:

- Both devices are intended to be used to flush or assess the patency of . indwelling catheters and venipuncture devices
- The technology and operating principles are the same for both devices .
- . The fill size of the syringe

5.8.2 Differences:

- The sterilization method .
- The plunger tip material and shape .

The claim for substantial equivalence is supported by the information provided in this 510(k) submission.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes extending upwards and a ribbon-like shape below.

### Public Health Service

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

Mr. Keith Dunn Manager Hospira, Incorporated 275 North Field Drive, D-389, Building, H2 Lake Forest, Illinois 60045

APR 2 3 2010

Re: K090882

Trade/Device Name: Flush Syringe Filled with 0.9% Sodium Chloride Regulation Number: 21 CFR 880.5200 Regulation Name: Saline, Vascular Access Flush Regulatory Class: II Product Code: NGT Dated: April 12, 2010 Received: April 13, 2010

Dear Mr. Dunn:

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- Mr. Dunn

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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Slladthones
Anthony Watson, B.S., M.S., M.B.A.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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March 2009

# Indications for Use

510(k) Number (if known)

Device Name: Flush Syringe filled with 0.9% Sodium Chloride

List Numbers/Descriptions: 1078-10 30 x 10mL single use syringes, 1078-20 100 x 10mL single use syringes, 1078-25 30 x 5mL single use syringes, 1078-35 100 x 5mL single use syringes, 1078-23 30 x 3mL single use syringes, and 1078-33 100 x 3mL single use syringes.

Indications for Use:

For the flushing and assessing the patency of indwelling catheters and venipuncture devices which are designed for intermittent injection therapy, blood sampling, or fluid and nutritional therapy.

Prescription Use X (Part 21 CFR 801 Subpart D) ANDIOR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Susan Tipton

Division of Anesthesiology, General Hosp Infection Control, Dental Device

510(k) Number: K090857