SYREX PRE-FILLED SYRINGE

K023740 · Excelsior Medical Corp. · NZW · May 13, 2003 · General Hospital

Device Facts

• Record ID: K023740
• Device Name: SYREX PRE-FILLED SYRINGE
• Applicant: Excelsior Medical Corp.
• Product Code: NZW · General Hospital
• Decision Date: May 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

Flushing of IV catheters and IV tubing only. Prior to and after administration of intermittent medication, entirely flush the catheter and or tubing with Heparin Lock Flush Solution, either USP 10 Units/mL or USP 100 Units/mL. Use in accordance with any warning or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.

Device Story

Syrex Pre-Filled Syringe contains Heparin Lock Flush Solution (10 or 100 Units/mL). Used by clinicians to flush IV catheters and tubing before and after intermittent medication administration. Prevents catheter occlusion; maintains patency. Not intended for systemic anticoagulation. Device is a pre-filled, single-use syringe.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pre-filled syringe containing Heparin Lock Flush Solution (USP 10 or 100 Units/mL). Single-use, sterile, non-pyrogenic. Class II device (21 CFR 880.5200).

Indications for Use

Indicated for flushing of IV catheters and IV tubing in patients requiring intermittent medication administration. Not for use in anticoagulant 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the bird. The logo is simple and clean, with a focus on the symbolic representation of the department.

Public Health Service

MAY 19 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Lumia President Excelsior Medical Corporation 1923 Heck Avenue Neptune, New Jersey 07753

Re: K023740

Trade/Device Name: Syrex Pre-Filled Syringe, Heparin Lock Flush Solution, USP 10 and 100 Units/ml Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NZW Dated: May 6, 2003 Received: May 7, 2003

Dear Mr. Lumia:

This letter corrects our substantially equivalent letter of May 13, 2003.

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 (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.

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. Lumia

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Susan Luane

Susan Runner, DDS, MA Acting 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 Statement

510(k) Number: K023740

Syrex Pre-Filled Syringe Device Name:

Indication for Use:

Flushing of IV catheters and IV tubing only. Prior to and after administration of intermittent medication, entirely flush the catheter and or tubing with Heparin Lock Flush Solution, either USP 10 Units/mL or USP 100 Units/mL. Use in accordance with any warning or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.

Protect from freezing and avoid excessive heat. Store at 25°C (77° F); excursions permitted to 15° - 30°C (59°-86°F)

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

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

Murphy 16

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

Division Sign-Off Office of Device Evaluation

510(k) K023740

510(k) Number: K023740