(115 days)
The DUPLOJECT EASY-PREP System is indicated for the preparation and application of TISSEEL VH Fibrin Sealant.
The DUPLOJECT EASY-PREP System is a collection of standard components used for the reconstitution and application of TISSEEL VH Fibrin Sealant. The system consists of the following components: two double-ended Fluid Transfer Spikes, a QUIK-FILL Syringe Filler and a pre-assembled DUPLOJECT Double-Barreled Syringe Applicator.
This document is a 510(k) premarket notification for the DUPLOJECT EASY-PREP Fibrin Sealant Preparation and Application System. It is a submission for a medical device that facilitates the reconstitution and application of TISSEEL VH Fibrin Sealant. The FDA has determined the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria or the study that proves the device meets specific performance criteria. This is common for 510(k) submissions, especially for devices classified as Class II, where substantial equivalence to predicate devices is the primary mechanism for market clearance, rather than extensive clinical efficacy studies with predefined acceptance criteria.
Therefore, I cannot provide the requested information in the format of a table detailing acceptance criteria and reported device performance, or details about sample sizes, ground truth establishment, or multi-reader studies, as these data points are not present in the provided document.
The document primarily focuses on:
- Device identification and submitter information.
- Classification and predicate devices.
- A brief description of the device and its intended use.
- The FDA's determination of substantial equivalence and market clearance.
{0}------------------------------------------------
| Date Prepared | 28 February 2002 |
|---|---|
| 510(k) No. | |
| Submitter | Baxter Healthcare CorporationBaxter BioScience550 North Brand BoulevardGlendale, CA 91203 |
| Contact | Arlene VidorVice President, Regulatory Affairs, North America |
| Device Name | DUPLOJECT EASY-PREPFibrin Sealant Preparation and Application System |
| Common/Usual/Classification Name | Syringe, Piston |
| Predicate Devices | DUPLOJECT Dual-Barreled Applicator Device510(k) No. K973510Baxter Healthcare Corporation, Baxter BioScienceSEALOUETTE Fibrin Sealant Applicator510(k) No. K992351Baxter Healthcare Corporation, Baxter BioScienceNeedleless Transfer Device510(k) No. K001831Medimop Medical Projects Ltd. |
| Device Description | The DUPLOJECT EASY-PREP System is a collection of standardcomponents used for the reconstitution and application ofTISSEEL VH Fibrin Sealant. The system consists of the followingcomponents: two double-ended Fluid Transfer Spikes, aQUIK-FILL Syringe Filler and a pre-assembled DUPLOJECTDouble-Barreled Syringe Applicator. |
| Intended Use | The DUPLOJECT EASY-PREP System is indicated for thepreparation and application of TISSEEL VH Fibrin Sealant. |
TISSEEL and DUPLOJECT are trademarks of Baxter AG, Vienna Austria.
BAXTER and SEALOUETTE are trademarks of Baxter International, Inc.
BAXTER, DUPLOJECT, SEALOUETTE and TISSEEL are registered in the US Patent and Trademark Office.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines beneath them, all rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2002
Ms. Arlene Vidor Vice President, Regulatory Affairs Baxter Healthcare Corporation Baxter Bioscience 550 N. Brand Boulevard Glendale. California 91203-1900
Re: K020666
Trade/Device Name: DUPLOJECT EASY-PREP System Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 17, 2002 Received: May 21, 2002
Dear Ms. Vidor:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{2}------------------------------------------------
Page 2 - Ms. Vidor
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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timb Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
{3}------------------------------------------------
INDICATIONS FOR USE STATEMENT
| 510(k) Number | K020666 |
|---|---|
| Device Name | DUPLOJECT EASY-PREPFibrin Sealant Preparation and Application System |
| Indications for Use | The DUPLOJECT EASY-PREP System is indicated for thepreparation and application of TISSEEL VH Fibrin Sealant. |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use _ (Per 21 CFR 801.109)
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
Sign Off
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).