(106 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a steerable sheath, dilator, and guidewire. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
This device is an introducer sheath used to facilitate the placement of other catheters into the heart. It does not provide any therapeutic effect on its own.
No
The device is a steerable sheath and accessories used to introduce various cardiovascular catheters into the heart. Its purpose is to facilitate the delivery and positioning of other catheters, not to diagnose a condition itself.
No
The device description clearly details physical components such as a stainless steel braided sheath, handle with a rotating knob, hemostasis valve, side-port, distal perfusion holes, and a radiopaque tip marker. It also includes accessories like a dilator, guidewire, and guidewire straightener. This indicates it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to introduce cardiovascular catheters into the heart. This is a procedural device used in vivo (within the body) for accessing anatomical sites.
- Device Description: The description details a physical device (sheath, dilator, guidewire) used for navigation and access within the cardiovascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly used in vivo for a medical procedure.
N/A
Intended Use / Indications for Use
The Creganna-Tactx Steerable Sheath Set is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Creganna-Tactx Steerable Sheath is a stainless steel braided steerable sheath which is compatible with EP Catheters ≤ 8.7Fr and has an approximate working length of 720mm. It is designed to provide flexible catheter positioning in the cardiac anatomy. The handle is equipped with a bi-directional rotating knob to deflect the tip clockwise ≥ 180° and counterclockwise ≥ 90°. There are two different models: The Symmetric Steerable Sheath has a tip that can be deflected into two distal curve geometries of equal symmetry, with reduced stroke in one direction; and the Asymmetric Steerable Sheath - one distal curve equal to the symmetric curve geometry above and a longer 'reach' curve geometry on the opposite curve to facilitate broader steering angles.
The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side-port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The steerable sheath features distal perfusion holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
The Creganna-Tactx Steerable Sheath is packaged as a set with the following accessories that are compatible with the dimensions of the steerable sheath:
a polymer curved dilator (approximately 8.7 Fr), a 0.032" PTFE coated stainless steel J-tipped quidewire, and a guidewire J-straightener (introducer). The Set components are packaged together, provided sterile, and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, interatrial septum
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 was performed on the Creganna-Tactx Steerable Sheath Set to assure reliable design and performance in accordance with applicable standards, intended use and user requirements. In addition, comparative testing to the predicate device was performed to show substantial equivalence. The non-clinical tests performed by the company include:
Functional Testing
- Shaft and Tip Flexibility .
- Tracking Test for Dilator and EP Catheters through Sheath .
- . Torque Testing
- Kink Resistance .
- Articulation Tests .
- Simulated Use Testing .
- Hemostasis Valve Leak Test and System Leak Tests per ISO11070; .
- . Strength of Connections per ISO10555-1
Biocompatibility Testing
Testing per ISO10993-1 included the following tests:
- . Cytotoxicity Study Using the ISO Elution Method
- ISO Guinea Piq Maximization Sensitization Test .
- . ISO Intracutaneous Study in Rabbits
- . ISO Systemic Toxicity Study in Mice
- USP Pyrogen Study Material Mediated .
- . ASTM Hemolysis Study
- . C3a Complement Activation Assay
- . SC5b-9 Complement Activation Assay
- In Vivo Thromboresistance Study in the Dog .
Sterilization Validation and Packaging
Testing was performed in compliance with ISO11607-1 for Packaging of Sterile devices and ISO11135-1 for Ethylene Oxide Sterilization Validation
The test results demonstrate that the Creganna-Tactx Steerable Sheath Set meets the requirements in the applicable standards and specifications, and is substantially equivalent to legally marketed predicate device.
A GLP Animal study was performed in swine to demonstrate that the device would perform as intended and meet user requirements. Results of this testing demonstrate that the device meets user requirements and meets the intended use of the device.
Clinical studies were not deemed necessary since in vitro testing were sufficient to demonstrate safety and effectiveness by way of comparison to a legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
6. 510(k) Summary
| General Information | |
|---|---|
| Date : | April 16, 2013 |
| Classification | Class II, 21 CFR § 870.1340, Introducer, Catheter, Product code DYB |
| Trade Name | Creganna-TactxTM Steerable Sheath Set |
| Model Numbers | 139294-01, 139294-02 |
| Submitter | Creganna-Tactx Medical |
| Parkmore West | |
| Galway, Ireland | |
| Regulatory | |
| Contact | Christine E. Nichols RAC |
| Boston Biomedical Associates | |
| Phone: (508) 351-8632 | |
| Fax: (508) 351-8637 |
Intended Use
The Creganna-Tactx Steerable Sheath Set is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Predicate Device Agilis NxT™ Steerable Introducer Manufactured by St. Jude Medical (SJM)
Device Description
Steerable Sheath
The Creganna-Tactx Steerable Sheath is a stainless steel braided steerable sheath which is compatible with EP Catheters ≤ 8.7Fr and has an approximate working length of 720mm. It is designed to provide flexible catheter positioning in the cardiac anatomy. The handle is equipped with a bi-directional rotating knob to deflect the tip clockwise ≥ 180° and counterclockwise ≥ 90°. There are two different models: The Symmetric Steerable Sheath has a tip that can be deflected into two distal curve geometries of equal symmetry, with reduced stroke in one direction; and the Asymmetric Steerable Sheath - one distal curve equal to the symmetric curve geometry above and a longer 'reach' curve geometry on the opposite curve to facilitate broader steering angles.
The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side-port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The steerable sheath features distal perfusion holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
1
Steerable Sheath Set
The Creganna-Tactx Steerable Sheath is packaged as a set with the following accessories that are compatible with the dimensions of the steerable sheath:
a polymer curved dilator (approximately 8.7 Fr), a 0.032" PTFE coated stainless steel J-tipped quidewire, and a guidewire J-straightener (introducer). The Set components are packaged together, provided sterile, and is intended for single use only.
Materials
The Creganna-Tactx Steerable Sheath Set assembly is comprised of materials that are commonly used in medical device applications.
Testing
In vitro testing was performed on the Creganna-Tactx Steerable Sheath Set to assure reliable design and performance in accordance with applicable standards, intended use and user requirements. In addition, comparative testing to the predicate device was performed to show substantial equivalence. The non-clinical tests performed by the company include:
Functional Testing
- Shaft and Tip Flexibility .
- Tracking Test for Dilator and EP Catheters through Sheath .
- . Torque Testing
- Kink Resistance .
- Articulation Tests .
- Simulated Use Testing .
- Hemostasis Valve Leak Test and System Leak Tests per ISO11070; .
- . Strength of Connections per ISO10555-1
Biocompatibility Testing
Testing per ISO10993-1 included the following tests:
- . Cytotoxicity Study Using the ISO Elution Method
- ISO Guinea Piq Maximization Sensitization Test .
- . ISO Intracutaneous Study in Rabbits
- . ISO Systemic Toxicity Study in Mice
- USP Pyrogen Study Material Mediated .
- . ASTM Hemolysis Study
- . C3a Complement Activation Assay
- . SC5b-9 Complement Activation Assay
- In Vivo Thromboresistance Study in the Dog .
Sterilization Validation and Packaging
Testing was performed in compliance with ISO11607-1 for Packaging of Sterile devices and ISO11135-1 for Ethylene Oxide Sterilization Validation
The test results demonstrate that the Creganna-Tactx Steerable Sheath Set meets the requirements in the applicable standards and specifications, and is substantially equivalent to legally marketed predicate device.
2
A GLP Animal study was performed in swine to demonstrate that the device would perform as intended and meet user requirements. Results of this testing demonstrate that the device meets user requirements and meets the intended use of the device.
Clinical studies were not deemed necessary since in vitro testing were sufficient to demonstrate safety and effectiveness by way of comparison to a legally marketed predicate device.
Summary of Substantial Equivalence
Creganna-Tactx Medical believes the Creganna-Tactx Steerable Sheath Set is substantially equivalent to the predicate product. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's three main goals: protecting the health of all Americans, providing essential human services, and strengthening the nation's health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1. 2013
Creganna Medical Devices % Christine Nichols Regulatory Affairs Manager Boston Biomedical Associates 386 West Main Street Suite 7 Northborough, MA 01532 US
Re: K131079
Trade/Device Name: Creganna-Tactx™ Steerable Sheath Set Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer. Catheter Regulatory Class: Class II Product Code: DYB Dated: July 1, 2013 Received: July 2, 2013
Dear Ms. Nichols:
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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Christine Nichols
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Kenneth J.
Cavanaugh-S
for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Traditional 510(k) Premarket Notification: Creganna-Tactx™ Steerable Sheath Set
:
...
. -
5. Indications for Use Statement
K131079 510(k) Number (if known):
Use:
Device Name: Creganna-Tactx™ Steerable Sheath Set
The Creganna-Tactx Steerable Sheath Set is indicated when introducing Indications for various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Prescription Use ____________________________________________________________________________________________________________________________________________________________ AND/OR (Per 21 CFR 801 Subpart D)
Over-The-Counter Use (Per 21 CFR 801 Subpart C) .
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kenneth J. Cavanaugh -S
Page 30 of 67
Page 30 of 67