(177 days)
Not Found
No
The device description focuses on mechanical components and delivery mechanisms for a fibrin sealant, with no mention of AI or ML capabilities.
No
The device is described as an applicator for mixing and delivering a fibrin sealant, it does not itself provide a therapeutic effect.
No
The device is described as an applicator for mixing and delivering fibrin sealant, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly details a physical medical device consisting of a stainless steel cannula, connectors, a replaceable tip, a sliding lock mechanism, and a trigger mechanism. It is a hardware device used for the delivery of a fibrin sealant.
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 "mixing and delivery of TISSEEL VH Fibrin Sealant." This describes a device used to apply a therapeutic substance to a patient, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a mechanical applicator for delivering a substance. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance study mentioned is "in vitro testing, in which the mixing of TISSEEL Fibrin Sealant was shown to be equivalent." This testing focuses on the device's ability to properly mix and deliver the sealant, not on its ability to perform diagnostic tests on biological samples.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide information about a person's health status. This device's function is purely for the application of a therapeutic material.
N/A
Intended Use / Indications for Use
The DUPLOREACH Extended Applicator, in conjunction with the DUPLOJECT Double-Barreled Syringe Applicator Device, is intended for the mixing and delivery of TISSEEL VH Fibrin Sealant.
Product codes
FMF
Device Description
The DUPLOREACH Extended Applicator, which consists of a stainless steel encased dual-lumen cannula that attaches to the DUPLOJECT Double-Barreled Syringe Applicator device via two screw-on leur style connectors, is used for the delivery of TISSEEL Fibrin Sealant in hard to reach locations. The Extended Applicator is equipped with a replaceable tip that is attached via a sliding lock mechanism, ensuring the tip does not detach during use. A trigger mechanism on the body of the device locks and unlocks the tip. A window above the trigger provides the user with a clear indication when the tip is in the fully locked position. Two replacement spray tips are supplied with each Extended Applicator device.
The primary changes from the predicate device are the adaptations necessary to allow the DUPLOREACH Extended Applicator to be used with the DUPLOJECT applicator device and the extension of the dual-lumen cannula before the mixing chamber. Other minor modifications were made to either support these primary changes or to enhance the functionality of the device. No modifications were made to the DUPLOJECT device to accommodate the DUPLOREACH Extended Applicator.
The modified device has been shown to be substantially equivalent to the predicate device through in vitro testing, in which the mixing of TISSEEL Fibrin Sealant was shown to be equivalent in both the cleared and modified devices.
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)
in vitro testing, in which the mixing of TISSEEL Fibrin Sealant was shown to be equivalent in both the cleared and modified devices.
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 | 30 November 2001 |
|---|---|
| 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 | DUPLOREACH Extended Applicator |
| Common/Usual/ Classification Name | Syringe, Piston |
| Predicate Device | SEALOUETTE Fibrin Sealant Applicator |
| 510(k) No. K992351 | |
| Baxter Healthcare Corporation, Baxter BioScience | |
| Device Description | The DUPLOREACH Extended Applicator, which consists of a |
| stainless steel encased dual-lumen cannula that attaches to the | |
| DUPLOJECT Double-Barreled Syringe Applicator device via two | |
| screw-on leur style connectors, is used for the delivery of TISSEEL | |
| Fibrin Sealant in hard to reach locations. The Extended Applicator | |
| is equipped with a replaceable tip that is attached via a sliding lock | |
| mechanism, ensuring the tip does not detach during use. A trigger | |
| mechanism on the body of the device locks and unlocks the tip. | |
| A window above the trigger provides the user with a clear | |
| indication when the tip is in the fully locked position. Two | |
| replacement spray tips are supplied with each Extended Applicator | |
| device. | |
| The primary changes from the predicate device are the adaptations | |
| necessary to allow the DUPLOREACH Extended Applicator to be | |
| used with the DUPLOJECT applicator device and the extension of | |
| the dual-lumen cannula before the mixing chamber. Other minor | |
| modifications were made to either support these primary changes or | |
| to enhance the functionality of the device. No modifications were | |
| made to the DUPLOJECT device to accommodate the | |
| DUPLOREACH Extended Applicator. | |
| The modified device has been shown to be substantially equivalent | |
| to the predicate device through in vitro testing, in which the mixing | |
| of TISSEEL Fibrin Sealant was shown to be equivalent in both the | |
| cleared and modified devices. | |
| The DUPLOREACH Extended Applicator, in conjunction with the | |
| Intended Use | DUPLOJECT Double-Barreled Syringe Applicator Device, is |
| intended for the mixing and delivery of TISSEEL VH Fibrin | |
| Sealant. |
TISSEEL and DUPLOJECT are trademarks of Baxter AG, Vienna Austria.
BAXTER, DUPLOREACH and SEALOUETTE are trademarks of Baxter International, Inc.
BAXTER, DUPLOJECT 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 Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling an inner graphic. The graphic features a stylized representation of three human profiles facing right, stacked one behind the other, suggesting a sense of community and support.
7 2002 JUN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Arlene Vidor Vice President. Regulatory Affairs Baxter Healthcare Corporation Baxter Bioscience Division 550 North Brand Boulevard Glendale. California 91203-1900
Re: K014088
Trade/Device Name: DUPLOREACH Extended Applicator Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: April 25, 2002 Received: April 26, 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.
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
2
Page 2 — Ms. Vidor
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 (QS) 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runros
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
| 510(k) Number | K014088 |
|---|---|
| Device Name | DUPLOREACH Extended Applicator |
| Indications for Use | The DUPLOREACH Extended Applicator, in conjunction with |
| the DUPLOJECT Double-Barreled Syringe Applicator Device, | |
| is intended for the mixing and delivery 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)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
Patricia Cuscenite
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices and General Hospital Beviegs
510(k) Number ___________________________________________________________________________________________________________________________________