(247 days)
No
The description focuses on the mechanical function and physical properties of a catheter, with no mention of AI/ML capabilities or data processing beyond standard functional testing.
No
The device aids in interventional procedures by supporting guidewires, facilitating access, and delivering solutions, but it does not directly treat a disease or condition. Its function is primarily supportive and diagnostic (delivery of contrast media).
No
The device is a support catheter intended to facilitate access and delivery of substances during interventional procedures, not to diagnose medical conditions.
No
The device description clearly states it is a family of single-lumen, over-the-wire catheters, which are physical hardware components used in interventional procedures. The performance studies also focus on physical characteristics and functionality of the catheter.
Based on the provided information, the Tractus CSC is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used during interventional procedures within the body (coronary and peripheral vasculatures) to support guidewires, facilitate access, and deliver substances. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The description of the catheter and its function aligns with a device used directly within the patient's circulatory system.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. Its purpose is procedural support and delivery.
- Anatomical Site: The specified anatomical sites are within the living body.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the catheter for its intended in vivo use (biocompatibility, thromboresistance, trackability, etc.). There are no studies related to diagnostic accuracy or performance with biological samples.
IVD devices are typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Tractus CSC does not fit this description.
N/A
Intended Use / Indications for Use
The Tractus CSC is intended to be used during interventional procedures in the coronary and peripheral vasculatures to support a guidewire and facilitate access in discrete regions, allow for guidewire exchanges, and provide a conduit for delivering saline solutions and contrast media.
Product codes
DQY
Device Description
The CSC consists of a family of single-lumen, over-the-wire catheters offered in a variety of sizes for compatibility with a range of guidewire as well as effective lengths. The catheters are used to navigate tortuous peripheral and coronary vasculatures while providing axial stability to enhance quidewire crossing of discrete lesions of the vasculature. The catheters are also used to allow for guidewire exchanges, and provide a conduit for delivering saline solutions and contrast media.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculatures
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)
The following nonclinical performance testing has been conducted to support the substantial equivalence of the CSC to its predicate devices. In all instances, the CSC functioned as intended.
- Biocompatibility of the patient-contacting components of the device was established in accordance with ISO 10993.
- Anticoagulated porcine thromboresistance study
- Shipping simulation, environmental conditioning, and package integrity studies were completed.
- Functional bench testing was conducted (including demonstrated compliancewith relevant standards such as ISO 10555-1 and ISO 594-1).
- Simulated Use Testing was completed to demonstrate functional performance specifications were met.
- Coating Integrity (Blue Dye Test, Lubricity)
- Radiopacity Testing
- Particulate Testing
- Flexibility
- Trackability
- Guidewire Compatibility
- Retraction
- Torque Testing
- Particulate Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 7, 2018
Tractus Vascular LLC % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103
Re: K180889
Trade/Device Name: Tractus Crossing Support Catheter (CSC) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 29, 2018 Received: October 30, 2018
Dear Janice Hogan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lydia S. Glaw Digitally signe
-S
ou=FDA, ou=P
0.9.2342.19200
Date: 2018.12.0
Digitally signed by Lydia S. Glaw -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Lydia S. Glaw -S,
0.9.2342.19200300.100.1.1=2001460079
Date: 2018.12.07 15:07:23 -05'00'
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180889
Device Name
Tractus Crossing Support Catheter (CSC)
Indications for Use (Describe)
The Tractus CSC is intended to be used during interventional procedures in the coronary and peripheral vasculatures to support a guidewire and facilitate access in discrete regions, allow for guidewire exchanges, and provide a conduit for delivering saline solutions and contrast media.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY - K180889
Tractus Vascular LLC's Crossing Support Catheter (CSC)
Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared
Janet Burpee, CEO Tractus Vascular, LLC. 15 Christopher Way Eatontown, NJ 07724 Phone: 732-996-8513
Date Prepared: November 27, 2018
Name of Device
Crossing Support Catheter (CSC)
Common or Usual Name
Percutaneous Crossing Catheter
Classification Name:
21 CFR 870.1250, Class II, product code DQY
Predicate Devices
Quick Cross® Extreme Support Catheters (K092396) (Primary Predicate)
TOTAL across™ (K133539) (Reference Predicate)
PrimiTM Support Catheter (K132701) (Reference Predicate)
Intended Use/Indications for Use
The Tractus CSC is intended to be used during interventional procedures in the coronary and peripheral vasculatures to support a guidewire and facilitate access in discrete regions, allow for guidewire exchanges, and provide a conduit for delivering saline solutions and contrast media.
Device Description
The CSC consists of a family of single-lumen, over-the-wire catheters offered in a variety of sizes for compatibility with a range of guidewire as well as effective lengths. The catheters are used to navigate tortuous peripheral and coronary vasculatures while providing axial stability to enhance quidewire crossing of discrete lesions of the vasculature. The catheters are also used to allow for guidewire exchanges, and provide a conduit for delivering saline solutions and contrast media.
4
Technological Characteristics
The CSC has similar technological characteristics as its predicate devices. Both the CSC and the primary predicate are single lumen, over-the-wire catheters that include a luer hub to allow for flushing of saline solutions and contrast media. Both the CSC and primary predicate facilitate guidewire exchanges and are compatible with 0.018" guidewires for use in the peripheral and coronary vasculatures under fluoroscopy with 4F sheaths. Furthermore, both the CSC and the primary predicate allow for device visualization using 3 visual bands and feature tapered distal tips.
The overall construction of both the CSC and the primary predicate are similar. Both catheters consist of an outer, inner, and center tubing configuration. The outer tubing of both the subject device and primary predicate consist of Pebax with hydrophilic coating on the distal end to reduce frictional forces and enhance tracking. The inner tubing of both the subject device and the primary predicate is a PTFE liner. Further, the material composition of the center tubing for both the subject and primary predicate is the same (i.e. stainless steel), with slightly different configurations (spiral laser cut versus braided). Despite this difference in configuration the principle of operation is the same. Furthermore, the spiral laser cut inner tubing design of the subject device has been cleared for the TOTAL across reference predicate (K133539) which was also cleared for substantially the same indications for use as the subject device.
The overall dimensions of the subject device and the primary predicate are similar. The subject device has slightly longer working length range than the primary predicate (90 – 170 cm for the subject device versus 90 - 150 cm for the primary predicate). However, similar working lengths have been cleared for the Primi Catheter reference predicate (90 cm to 170 cm) which was cleared for a nearly identical indication for use compared to the subject device.
Both the subject device and the primary predicate are provided sterile via EO sterilization and are non-pyrogenic. Further, both devices are packaged in Tyvek pouches.
Therefore, the subject CSC has very similar technological characteristics as the primary predicate, as well as the reference devices.
Performance Data
The following nonclinical performance testing has been conducted to support the substantial equivalence of the CSC to its predicate devices. In all instances, the CSC functioned as intended.
- . Biocompatibility of the patient-contacting components of the device was established in accordance with ISO 10993.
- Anticoagulated porcine thromboresistance study
- Shipping simulation, environmental conditioning, and package integrity studies were . completed.
- . Functional bench testing was conducted (including demonstrated compliancewith relevant standards such as ISO 10555-1 and ISO 594-1).
5
- Simulated Use Testing was completed to demonstrate functional performance specifications were met.
- Coating Integrity (Blue Dye Test, Lubricity)
- Radiopacity Testing ●
- Particulate Testing
- Flexibility .
- Trackability ●
- Guidewire Compatibility
- Retraction ●
- Torque Testing ●
- . Particulate Testing
Substantial Equivalence
The CSC has the same intended use as the primary predicate device and substantially the same indications for use as the reference devices. The subject device also has similar technological characteristics and principles of operation as the predicate devices. Minor differences, including device sizing, materials, number and location of radiopaque markers, do not raise different questions of safety or effectiveness and performance testing demonstrated that the subject device performs in a substantially equivalent manner. Therefore, the subject CSC is substantially equivalent to its predicate devices.
Conclusions
Tractus Vascular LLC's CSC is a Percutaneous Catheter, Class II device that has been evaluated in nonclinical testing in accordance with FDA's recognized standards and preestablished acceptance criteria. Testing demonstrated that the device performs as intended. The CSC is substantially equivalent to its predicate devices.