STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES

K053120 · Excelsior Medical Corp. · FOZ · Dec 9, 2005 · General Hospital

Device Facts

• Record ID: K053120
• Device Name: STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES
• Applicant: Excelsior Medical Corp.
• Product Code: FOZ · General Hospital
• Decision Date: Dec 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

Excelsior Sterile Field Saline Flush and Heparin Lock Flush Syringes are intended for flushing IV catheters and IV tubing.

Device Story

Device consists of pre-filled saline or heparin lock flush syringes. Modification involves substitution of standard dust cover packaging with sterile field packaging. Device used in clinical settings for maintenance of IV catheters and tubing by flushing to ensure patency. Operation is manual; healthcare provider uses syringe to deliver flush solution into catheter/tubing access point. Benefits include maintenance of catheter patency and reduction of potential for occlusion.

Clinical Evidence

Bench testing only.

Technological Characteristics

Pre-filled syringes for IV flushing. No change in materials or fundamental technology from predicate. Sterile field packaging configuration.

Indications for Use

Indicated for flushing IV catheters and IV tubing.

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

• Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes

Submission Summary (Full Text)

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JEL 9 2005

K053/20

## 510(k) SUMMARY

#### Submitted by:

Ruben Martinez Director, Regulatory/Quality Excelsior Medical Corporation 1923 Heck Avenue Neptune, NJ 97753

#### Proposed Device:

Excelsior Sterile Field Saline Flush and Heparin Lock Flush Syringes

#### Predicate Device:

Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes

## Device Description and Statement of Intended Use:

The modification which is the subject of this Special 510(k) is substitution of the current dust cover packaging with Sterile Field packaging. All other aspects of the product design remain unchanged.

Excelsior Sterile Field Saline Flush and Heparin Lock Flush Svringes are intended for flushing IV catheters and IV tubing. This is the same intended use previously cleared for the currently marketed Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes.

## Summary of Technological Characteristics of New Device to Predicate Device

The technological characteristics of Excelsior Sterile Field Saline Flush and Heparin Lock Flush Syringes do not differ from the currently marketed Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes. The devices use the same fundamental scientific technology and have the same intended use.

## Discussion of Non-Clinical Tests; Conclusions Drawn from Nonclinical Tests

The results of testing conducted to verify the design modifications demonstrate acceptable performance of the device.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 9 2005

Mr. Ruben Martinez Director Regulatory/Quality Excelsior Medical Corporation 1923 Heck Avenue Neptune, New Jersey 07753

Re: K053120

K005120
Trade/Device Name: Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: November 28, 2005 Received: November 30, 2005

Dear Mr. Martinez:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave roviewed younge 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 Interstate conmisive prior to realism the been reclassified in accordance with the provisions of Amendinents, or to do rouses and metic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin application (the Act. The general controls provisions of the Act include controls provisions or tregistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (FMA), it may of subject to tach ade 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. Martinez

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 mean that I DA mas made a deters and regulations administered by other Federal agencies. of the Act of ally I ederal buter and suggest to reguirements, including, but not limited to: registration 1 ou must comply with an the Piece s ong (21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 007), idoeling systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality ajons of (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter whi anow you to oegal finding of substantial equivalence of your device to a premarket notification. The PDF results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), IT you desire specific at rioe for Jour at [phone]. Also, please note the regulation i entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Drisker [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Gretti Y. Michael Omd.

Chiu Lin, Ph.D. 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 Statement

510(k) Number (if known):

Device Name: Excelsior Saline Flush Syringes and Heparin Lock Flush Syringes

Indications For Use:

Excelsior Sterile Field Saline Flush Syringes and Heparin Lock Flush Excelsfor Stonio Piola Salino in flushing IV catheters and IV tubing.

Shula K. Murthy, M.D. 12/7/15

Anesthesiology General Hospital
on Control, Dental Devices
K 05/3/20

AND/OR Prescription Use _ (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ÀNOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)