(595 days)
Not Found
No
The device description is for simple saline-filled syringes, and there are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is described as a "Sterile Plastic Luer Lock Syringes of various sizes Filled with sterile saline" intended to "Maintain patency of vascular devices." This function is primarily for maintenance and preparation of other devices rather than directly treating a disease or condition in a patient, which is the hallmark of a therapeutic device. The predicate device also suggests a maintenance rather than therapeutic function.
No
The device is described as "Sterile Plastic Luer Lock Syringes of various sizes Filled with sterile saline" and its intended use is to "Maintain patency of vascular devices." This indicates it is used for maintenance and flushing, not for diagnosing a condition or disease. The predicate device is also a "HEPARIN LOCK FLUSH SOLUTION AND 0.9% SODIUM CHLORIDE, USP SOLUTION", reinforcing its non-diagnostic purpose.
No
The device description explicitly states it is "Sterile Plastic Luer Lock Syringes of various sizes Filled with sterile saline," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Maintain patency of vascular devices." This is a therapeutic or procedural use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as "Sterile Plastic Luer Lock Syringes of various sizes Filled with sterile saline." This is a medical device used for flushing or maintaining vascular access, not for analyzing biological samples.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The predicate device listed (K952645) is also a solution for maintaining vascular access, further supporting that this device is not an IVD.
N/A
Intended Use / Indications for Use
Maintain patency of vascular devices
Product codes
FOZ
Device Description
Sterile Plastic Luer Lock Syringes of various sizes Filled with sterile saline
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
982558
| 13.0 | 510(k) Summary of Safety and Effectiveness for Preefil® Normal Saline
Flush Syringes |
| ------ | ----------------------------------------------------------------------------------------- |
|---|
| 13.1 | Submitter: | Davis N. Bulman |
|---|---|---|
| 13.2 | Company Name: | Preefil Corporation |
| 13.3 | Address | 11815 W. Dearbourn Ave |
| 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 | |
| Trade Name | Preefil® Normal Saline Flush | |
| Syringe | ||
| Classification Name | Accessory to Intravenous | |
| Catheter (880.5200) | ||
| Common Name | Normal Saline Flush Syringe | |
| 13.9 | Intended Use | Maintain patency of vascular |
| devices | ||
| 13.10 | Description | Sterile Plastic Luer Lock |
| Syringes of various sizes | ||
| Filled 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 ACCESS
FLUSH DEVICE |
|---------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| MANUFACTURER | PREEFIL CORPORATION | VITAL SIGNS |
| PRODUCT NAME | PREEFIL® SALINE
FLUSH SYRINGE | VASCEZE™ HEPARIN
LOCK FLUSH SOLUTION
AND 0.9% SODIUM
CHLORIDE, USP
SOLUTION |
| PRODUCT CODE | FOZ | FOZ |
| K NUMBER | NOT ASSIGNED | K952645 |
| ADDRESS | MILWAUKEE, WI | TOTOWA, NJ |
| INDICATED USE | MAINTENANCE OF
PATENCY OF
VASCULAR DEVICES | MAINTENANCE OF
PATENCY OF
VASCULAR DEVICES |
| CONTENTS OF DEVICE | SODIUM CHLORIDE
(0.9%) USP | SODIUM CHLORIDE
(0.9%) USP |
| CONTAINMENT
DEVICE FOR FLUSH | STERILE PLASTIC LUER
LOCK SYRINGE
VARIOUS SIZES | POLYMERIC
CONTAINER WITH
LUER SLIP NOZZLE |
| STERILITY | FLUID PATH STERILITY
PRESERVED BY
ASEPTIC PROCESSING | ENTIRE CONTENTS OF
PACKAGE STERILIZED
BY TERMINAL
STERILIZATION |
| PACKAGING | PERFORATED POLY
BAG | POLYMERIC POUCH
WITH TYVEK LID |
| HOW SUPPLIED | SYRINGE SIZES
3-6-12 mL
FILL 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