MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L

K993515 · Medefil, Inc. · FOZ · Feb 25, 2000 · General Hospital

Device Facts

• Record ID: K993515
• Device Name: MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L
• Applicant: Medefil, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Feb 25, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)

Device Story

Normal Saline I.V. Flush Syringe; pre-filled syringe containing sterile normal saline; used by clinicians to flush in-dwelling intravenous access devices (IVAD). Purpose: maintain patency of IV lines by preventing occlusion; prevent medication incompatibility. Device provides sterile saline solution in a ready-to-use format; eliminates need for manual syringe filling; reduces risk of contamination; improves clinical workflow efficiency.

Clinical Evidence

No clinical data provided; device is a standard sterile saline flush syringe.

Technological Characteristics

Sterile normal saline solution pre-filled in a syringe; intended for single-use; manual operation; non-electronic; no software or algorithm.

Indications for Use

Indicated for maintaining patency of in-dwelling intravenous access devices (IVAD) in patients requiring IV 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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Image /page/0/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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines forming the body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2000

Mr. Pradeep Aqqarwal President - CEO Medefil, Incorporated 492 Lunt Avenue 60193 Schaumburq, Illinois

Re: K993515 Normal Saline I.V. Flush Syringe Trade Name: Requlatory Class: II Product Code: FOZ Dated: February 3, 2000 February 4, 2000 Received:

Dear Mr. Aggarwal:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Aggarwal

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fdaggov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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Medefil, Inc. October 1999 Sterile Normal Saline I. V. Flush Syringe Indications For Use

> of Page

510(k) Number (if known):

Normal Saline I. V. Flush Syringe Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

## FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use ✓
(Per 21 CFR 801,109)

or

ver-the-counter use --

(Optional Format 3-10-98)

Paltase Cacceniti

Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number

000020