(177 days)
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.
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 is a medical device designed for the mixing and delivery of TISSEEL VH Fibrin Sealant in hard-to-reach locations. The device's substantial equivalence to a predicate device, the SEALOUETTE Fibrin Sealant Applicator (K992351), was established through in vitro testing. This study focused on demonstrating equivalent mixing performance between the new device and the predicate.
Here's a breakdown of the available information regarding acceptance criteria and the study:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalent mixing of TISSEEL Fibrin Sealant | "the mixing of TISSEEL Fibrin Sealant was shown to be equivalent in both the cleared and modified devices." |
- Note: The specific quantitative metrics for "equivalent mixing" (e.g., blend uniformity, setting time, tensile strength of the mixed sealant) are not provided in the submission summary. The statement simply asserts that equivalence was demonstrated.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: This information is not explicitly stated in the provided summary. The summary refers to "in vitro testing", which typically involves multiple experimental runs, but the exact number of tests or samples is not disclosed.
- Data Provenance: The study was in vitro testing, meaning it was conducted in a controlled laboratory environment rather than on human or animal subjects. The country of origin of the data is not specified, but the submitter is Baxter BioScience, an American company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable to this type of submission. The "ground truth" for in vitro performance studies is typically established by laboratory measurements and established scientific protocols for evaluating sealant mixing, not by expert consensus or interpretations in the way it would be for diagnostic imaging or clinical outcomes.
4. Adjudication Method for the Test Set
- This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human assessment of data (e.g., radiology reads) where there might be disagreement among experts. For in vitro testing, the results are derived from objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. MRMC studies are related to human performance in interpreting data (e.g., medical images) and are not relevant for an in vitro performance study of a device like this.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone study was done. The "in vitro testing" mentioned is inherently a standalone performance evaluation of the device itself, without human-in-the-loop performance enhancement. It assesses the device's ability to perform its intended function (mixing TISSEEL Fibrin Sealant).
7. The Type of Ground Truth Used
- The ground truth was established through objective laboratory measurements related to the mixing of TISSEEL Fibrin Sealant. While the specific metrics are not detailed, this would typically involve assessing the homogeneity of the mixed components, potentially looking at physical properties like setting time or ultimately the integrity/performance of the formed sealant.
8. The Sample Size for the Training Set
- This information is not applicable. This device is not an AI/ML algorithm that requires a "training set." The performance was evaluated through direct testing of the physical device.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable, as there was no training set for an AI/ML model.
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| 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.
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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
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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
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INDICATIONS FOR USE STATEMENT
| 510(k) Number | K014088 |
|---|---|
| Device Name | DUPLOREACH Extended Applicator |
| Indications for Use | The DUPLOREACH Extended Applicator, in conjunction withthe DUPLOJECT Double-Barreled Syringe Applicator Device,is intended for the mixing and delivery of TISSEEL VH FibrinSealant. |
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 ___________________________________________________________________________________________________________________________________
§ 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).