(198 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a standard introducer set, with no mention of AI or ML.
No.
The device is used to gain access to the vascular system for the introduction of other catheter-based devices; it does not directly provide therapy.
No
Explanation: The device, an introducer set, is intended to provide access to the vascular system for the introduction of other catheter-based devices. It does not perform any diagnostic function itself.
No
The device description clearly outlines a physical introducer set composed of a dilator and introducer sheath with a flush port, external coating, and PTFE liner. The performance studies also focus on physical properties and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide femoral access to the vascular system" for the introduction of other devices. This is a procedural device used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description details a physical introducer set (dilator and sheath) used for accessing blood vessels. It does not describe a device that analyzes samples in vitro (outside the body) to provide diagnostic information.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the device (pressure integrity, tensile strength, leakage, insertion/removal force, kink testing, particulate testing) and biocompatibility. These are typical tests for medical devices used in procedures, not for IVDs which would focus on analytical performance (sensitivity, specificity, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
In summary, the Lotus™ Introducer Set is a medical device used for accessing the vascular system during a procedure, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Lotus Introducer Set is intended to provide femoral access to the vascular system.
Product codes
DYB
Device Description
The Lotus™ Introducer Set is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction of catheter-based devices into the vascular system. The Lotus Introducer Set will be inserted into the femoral artery using conventional minimally invasive catheterization techniques. The Lotus Introducer Set is composed of a dilator and an introducer sheath with a flush port. The design features a PTFE liner on the ID of the introducer sheath and an external coating on both the introducer sheath and the dilator. When activated, the external hydrophilic coating increases the lubricity of the surface to aid in delivery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral artery
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
In vitro testing was performed on the Creganna-Tactx Lotus™ Introducer Set to assure reliable design and performance in accordance with applicable standards, intended use and user requirements. The non-clinical tests performed by the company include:
- Introducer shaft pressure integrity
- Corrosion resistance
- Introducer shaft tensile strength ●
- Tensile strength of Hub to Introducer Shaft joint
- Tensile strength of Luer to Dilator Shaft joint ●
- Tensile strength of Dilator Shaft
- Introducer valve leakage, unloaded
- . Introducer valve leakage, loaded with device/ loaded with guidewire
- Insertion / Removal force of Dilator
- . Dilator to guidewire interface – Insertion / Removal
- Kink testing
- Particulate Testing
Biocompatibility tests included:
- Cytotoxicity
- Sensitization
- . Irritation / intracutaneous reactivity
- Systemic toxicity (acute)
- Hemolysis Study, Direct Contact
- Complement Activation Assay
- Thromboresistance Study
The test results demonstrate that the Creganna-Tactx Lotus™ Introducer Set meets the requirements in the applicable standards and specifications, and is substantially equivalent to legally marketed predicate device. Clinical studies were not deemed necessary since in vivo testing and a literature review were sufficient to demonstrate safety and effectiveness by way of comparison to a legally marketed predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol consisting of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 27, 2014
Creganna-Tactx Medical % Niall Fox Sr. Regulatory Affairs Specialist Parkmore West Galway, Ireland
Re: K140338
Trade/Device Name: Creganna-Tactx Lotus Introducer Set (small), Creganna-Tactx Lotus Introducer Set (large) Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: Class II Product Code: DYB Dated: July 18, 2014 Received: July 23, 2014
Dear Niall Fox,
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. 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
1
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 devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours,
M.A. Hillebrand
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K140338 Indications for Use Statement
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Indications for Use: The Lotus Introducer Set is intended to provide femoral access to the vascular system. Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
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510(k) Summary
General Information
| Date : | January 31, 2013 |
|---|---|
| Classification | Class II, 21 CFR § 870.1340, Catheter introducer |
| Trade Name | Creganna-Tactx Lotus™ Introducer Set |
| Model Numbers | 139809-01, 139809-02 |
| Submitter | Creganna-Tactx Medical |
| Parkmore West | |
| Galway, Ireland | |
| Regulatory Contact | Niall Fox |
| Senior Regulatory Affairs Specialist | |
| Creganna-Tactx Medical | |
| Parkmore West | |
| Galway, Ireland | |
| Tel: + 91 474457 | |
| Email: niall.fox@creganna.com |
Intended Use
The Lotus™ Introducer Set is intended to provide femoral access to the vascular system.
Predicate Device
RetroFlex3 Introducer Set cleared via 510(k) K093877. It is manufactured by Edwards Life Sciences.
Device Description
The Lotus™ Introducer Set is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction of catheter-based devices into the vascular system. The Lotus Introducer Set will be inserted into the femoral artery using conventional minimally invasive catheterization techniques. The Lotus Introducer Set is composed of a dilator and an introducer sheath with a flush port. The design features a PTFE liner on the ID of the introducer sheath and an external coating on both the introducer sheath and the dilator. When activated, the external hydrophilic coating increases the lubricity of the surface to aid in delivery.
4
Materials
The Creganna-Tactx Lotus™ Introducer Set assembly is comprised of materials that are commonly used in medical device applications.
Testing
In vitro testing was performed on the Creganna-Tactx Lotus™ Introducer Set to assure reliable design and performance in accordance with applicable standards, intended use and user requirements. The non-clinical tests performed by the company include:
- Introducer shaft pressure integrity
- Corrosion resistance
- Introducer shaft tensile strength ●
- Tensile strength of Hub to Introducer Shaft joint
- Tensile strength of Luer to Dilator Shaft joint ●
- Tensile strength of Dilator Shaft
- Introducer valve leakage, unloaded
- . Introducer valve leakage, loaded with device/ loaded with guidewire
- Insertion / Removal force of Dilator
- . Dilator to guidewire interface – Insertion / Removal
- Kink testing
- Particulate Testing
Biocompatibility
- Cytotoxicity
- Sensitization
- . Irritation / intracutaneous reactivity
- Systemic toxicity (acute)
- Hemolysis Study, Direct Contact
- Complement Activation Assay
- Thromboresistance Study
The test results demonstrate that the Creganna-Tactx Lotus™ Introducer Set meets the requirements in the applicable standards and specifications, and is substantially equivalent to legally marketed predicate device.
Clinical studies were not deemed necessary since in vivo testing and a literature review were sufficient to demonstrate safety and effectiveness by way of comparison to a legally marketed predicate device.
Summary of Substantial Equivalence
5
Creganna-Tactx Medical believes the Creganna-Tactx Lotus™ Introducer 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.