(595 days)
Maintain patency of vascular devices
Sterile Plastic Luer Lock Syringes of various sizes Filled with sterile saline
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for Preefil® Normal Saline Flush Syringes, focusing on its substantial equivalence to a predicate device and its intended use. It does not detail specific performance metrics, studies, or evaluation methodologies beyond the comparison with another flush device. Therefore, I cannot generate the requested table and information.
{0}------------------------------------------------
982558
| 13.0 | 510(k) Summary of Safety and Effectiveness for Preefil® Normal SalineFlush Syringes |
|---|---|
| ------ | ----------------------------------------------------------------------------------------- |
| 13.1 | Submitter: | Davis N. Bulman |
|---|---|---|
| 13.2 | Company Name: | Preefil Corporation |
| 13.3 | Address | 11815 W. Dearbourn AveMilwaukee, 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 NameTrade Name | Preefil® Normal Saline FlushSyringe |
| Classification Name | Accessory to IntravenousCatheter (880.5200) | |
| Common Name | Normal Saline Flush Syringe | |
| 13.9 | Intended Use | Maintain patency of vasculardevices |
| 13.10 | Description | Sterile Plastic Luer LockSyringes of various sizesFilled with sterile saline |
- Morgan
3/6/00
{1}------------------------------------------------
510(k) Summary (Continued)
:
13.11 Substantial Equivalence Matrix (Preefil and Vital Signs Products)
| DESCRIPTION | FLUSH SYRINGE | VASCULAR ACCESSFLUSH DEVICE |
|---|---|---|
| MANUFACTURER | PREEFIL CORPORATION | VITAL SIGNS |
| PRODUCT NAME | PREEFIL® SALINEFLUSH SYRINGE | VASCEZE™ HEPARINLOCK FLUSH SOLUTIONAND 0.9% SODIUMCHLORIDE, USPSOLUTION |
| PRODUCT CODE | FOZ | FOZ |
| K NUMBER | NOT ASSIGNED | K952645 |
| ADDRESS | MILWAUKEE, WI | TOTOWA, NJ |
| INDICATED USE | MAINTENANCE OFPATENCY OFVASCULAR DEVICES | MAINTENANCE OFPATENCY OFVASCULAR DEVICES |
| CONTENTS OF DEVICE | SODIUM CHLORIDE(0.9%) USP | SODIUM CHLORIDE(0.9%) USP |
| CONTAINMENTDEVICE FOR FLUSH | STERILE PLASTIC LUERLOCK SYRINGEVARIOUS SIZES | POLYMERICCONTAINER WITHLUER SLIP NOZZLE |
| STERILITY | FLUID PATH STERILITYPRESERVED BYASEPTIC PROCESSING | ENTIRE CONTENTS OFPACKAGE STERILIZEDBY TERMINALSTERILIZATION |
| PACKAGING | PERFORATED POLYBAG | POLYMERIC POUCHWITH TYVEK LID |
| HOW SUPPLIED | SYRINGE SIZES3-6-12 mLFILL VOLUMES 1-2-3-5-6-10 mL | 5 mL |
G. Morgan
3/6/00
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
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
{3}------------------------------------------------
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 (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{4}------------------------------------------------
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
് Division Sign-Off) vision of Dental, Infection Control, ି General Hospital Devices 11 mber 4982558
- Morgan
3/6/00
§ 880.5200 Intravascular catheter.
(a)
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.(b)
Classification. Class II (performance standards).