BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE

K982558 · Bd/Preefil · FOZ · Mar 8, 2000 · General Hospital

Device Facts

• Record ID: K982558
• Device Name: BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE
• Applicant: Bd/Preefil
• Product Code: FOZ · General Hospital
• Decision Date: Mar 8, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Maintain patency of vascular devices

Device Story

The Preefil® Normal Saline Flush Syringe is a sterile, plastic, Luer-lock syringe pre-filled with 0.9% USP sodium chloride. It is used by healthcare providers to flush vascular access devices to maintain patency. The device is supplied in various sizes (3, 6, 12 mL) with fill volumes ranging from 1 to 10 mL. It functions as a manual delivery system for saline solution, replacing the need for manual syringe filling. The device is intended for clinical use in settings where vascular access maintenance is required.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile plastic Luer lock syringe; contains 0.9% USP sodium chloride; various sizes (3, 6, 12 mL); fluid path sterility maintained via aseptic processing.

Indications for Use

Indicated for the maintenance of patency of vascular devices.

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

• VASCEZE™ Heparin Lock Flush Solution and 0.9% Sodium Chloride, USP Solution (K952645)

Submission Summary (Full Text)

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982558

| 13.0 | 510(k) Summary of Safety and Effectiveness for Preefil® Normal Saline<br>Flush Syringes |
|------|-----------------------------------------------------------------------------------------|
|------|-----------------------------------------------------------------------------------------|

| 13.1 | Submitter: | Davis N. Bulman |
|-------|-------------------------------|--------------------------------------------------------------------------------------|
| 13.2 | Company Name: | Preefil Corporation |
| 13.3 | Address | 11815 W. Dearbourn Ave<br>Milwaukee, WI 53226 |
| 13.4 | Contact Person | Kurt Ebenhoe/QA Manager |
| 13.5 | Telephone # of Contact Person | 414-475-7565 |
| 13.6 | Fax # of Contact Person | 414-475-5117 |
| 13.7 | Date of Summary Preparation | 7/9/98 |
| 13.8 | Device Name<br>Trade Name | Preefil® Normal Saline Flush<br>Syringe |
| | Classification Name | Accessory to Intravenous<br>Catheter (880.5200) |
| | Common Name | Normal Saline Flush Syringe |
| 13.9 | Intended Use | Maintain patency of vascular<br>devices |
| 13.10 | Description | Sterile Plastic Luer Lock<br>Syringes of various sizes<br>Filled with sterile saline |

6. Morgan
3/6/00

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## 510(k) Summary (Continued)

:

## 13.11 Substantial Equivalence Matrix (Preefil and Vital Signs Products)

| DESCRIPTION | FLUSH SYRINGE | VASCULAR ACCESS<br>FLUSH DEVICE |
|---------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| MANUFACTURER | PREEFIL CORPORATION | VITAL SIGNS |
| PRODUCT NAME | PREEFIL® SALINE<br>FLUSH SYRINGE | VASCEZE™ HEPARIN<br>LOCK FLUSH SOLUTION<br>AND 0.9% SODIUM<br>CHLORIDE, USP<br>SOLUTION |
| PRODUCT CODE | FOZ | FOZ |
| K NUMBER | NOT ASSIGNED | K952645 |
| ADDRESS | MILWAUKEE, WI | TOTOWA, NJ |
| INDICATED USE | MAINTENANCE OF<br>PATENCY OF<br>VASCULAR DEVICES | MAINTENANCE OF<br>PATENCY OF<br>VASCULAR DEVICES |
| CONTENTS OF DEVICE | SODIUM CHLORIDE<br>(0.9%) USP | SODIUM CHLORIDE<br>(0.9%) USP |
| CONTAINMENT<br>DEVICE FOR FLUSH | STERILE PLASTIC LUER<br>LOCK SYRINGE<br>VARIOUS SIZES | POLYMERIC<br>CONTAINER WITH<br>LUER SLIP NOZZLE |
| STERILITY | FLUID PATH STERILITY<br>PRESERVED BY<br>ASEPTIC PROCESSING | ENTIRE CONTENTS OF<br>PACKAGE STERILIZED<br>BY TERMINAL<br>STERILIZATION |
| PACKAGING | PERFORATED POLY<br>BAG | POLYMERIC POUCH<br>WITH TYVEK LID |
| HOW SUPPLIED | SYRINGE SIZES<br>3-6-12 mL<br>FILL VOLUMES 1-2-3-5-<br>6-10 mL | 5 mL |

G. Morgan

3/6/00

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**MAR - 8 2000**

Mr. Greg Morgan BD Medical Quality/Regulatory BD/Preefil 1 Becton Drive New Jersey 07417 Franklin Lakes,

K982558 Re : BD Preefil® Normal Saline Flush Syringe Trade Name: Requlatory Class: II Product Code: FOZ Dated: January 3, 2000 January 7, 2000 Received:

Dear Mr. Morgan:

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 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

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Page 2 - Mr. Morgan

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 labelinq regulation (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 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.fda.gov/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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12.0 Indications for use statement: BD Prefill Normal Saline flush syringes are 12.0 Indications for use statement. BD Trenil Normal Gallio Morroginal Provinces.

Patino Cuesite

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6. Morgan
3/6/00