(115 days)
Not Found
No
The summary describes a system of standard components for preparing and applying a fibrin sealant, with no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No.
The device is indicated for the preparation and application of a fibrin sealant, which is a drug, not for directly treating a medical condition itself.
No
Explanation: The device is indicated for the "preparation and application of TISSEEL VH Fibrin Sealant" and its components are used for "reconstitution and application". This describes a therapeutic or procedural role, not a diagnostic one.
No
The device description explicitly lists physical components (spikes, syringe filler, syringe applicator) and does not mention any software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "preparation and application of TISSEEL VH Fibrin Sealant." This describes a process of preparing and delivering a therapeutic substance, not a diagnostic test performed on a sample taken from the body.
- Device Description: The components listed (spikes, syringe filler, syringe applicator) are all tools for handling and applying a substance, not for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The DUPLOJECT EASY-PREP System's function is purely related to the preparation and application of a therapeutic product.
N/A
Intended Use / Indications for Use
The DUPLOJECT EASY-PREP System is indicated for the preparation and application of TISSEEL VH Fibrin Sealant.
Product codes
FMF
Device Description
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.
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
§ 880.5860 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).
0
| Date Prepared | 28 February 2002 |
|---|---|
| 510(k) No. | |
| Submitter | Baxter Healthcare Corporation |
| Baxter BioScience | |
| 550 North Brand Boulevard | |
| Glendale, CA 91203 | |
| Contact | Arlene Vidor |
| Vice President, Regulatory Affairs, North America | |
| Device Name | DUPLOJECT EASY-PREP |
| Fibrin Sealant Preparation and Application System | |
| Common/Usual/ | |
| Classification Name | Syringe, Piston |
| Predicate Devices | DUPLOJECT Dual-Barreled Applicator Device |
| 510(k) No. K973510 | |
| Baxter Healthcare Corporation, Baxter BioScience |
SEALOUETTE Fibrin Sealant Applicator
510(k) No. K992351
Baxter Healthcare Corporation, Baxter BioScience
Needleless Transfer Device
510(k) No. K001831
Medimop Medical Projects Ltd. |
| Device Description | 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. |
| Intended Use | The DUPLOJECT EASY-PREP System is indicated for the
preparation 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-PREP |
| Fibrin Sealant Preparation and Application System | |
| Indications for Use | The DUPLOJECT EASY-PREP System is indicated for the |
| preparation 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__________________________________________________________________________________________________________________________________________________________
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(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_