(247 days)
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.
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.
This document concerns a 510(k) premarket notification for a medical device called the Tractus Crossing Support Catheter (CSC). The information provided is for a traditional medical device and not an AI/ML powered device. As such, the requested information about AI model performance, multi-reader multi-case studies, standalone algorithm performance, and training/test set details related to AI/ML are not applicable.
However, I can provide the relevant information for the nonclinical performance testing conducted for this traditional medical device.
1. A table of acceptance criteria and the reported device performance
The document states that "Functional bench testing was conducted (including demonstrated compliance with relevant standards such as ISO 10555-1 and ISO 594-1)" and "Simulated Use Testing was completed to demonstrate functional performance specifications were met." While specific numerical acceptance criteria and performance results are not detailed in this summary, the overall statement is that the device met these specifications and functioned as intended.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Established in accordance with ISO 10993 | Established (passed) |
| Thromboresistance | Acceptable thromboresistance (porcine study) | Anticoagulated porcine thromboresistance study completed |
| Packaging & Sterility | Maintain sterility and integrity | Shipping simulation, environmental conditioning, and package integrity studies completed |
| Functional Bench Testing | Compliance with ISO 10555-1 and ISO 594-1; Met functional performance specifications | Conducted and compliant; Functional specifications met |
| Simulated Use Testing | Met functional performance specifications | Completed and functions as intended |
| Coating Integrity | Acceptable coating integrity (e.g., no delamination, good lubricity) | Coating Integrity (Blue Dye Test, Lubricity) completed |
| Radiopacity | Visible under fluoroscopy | Radiopacity Testing completed |
| Particulate | Below specified limits | Particulate Testing completed |
| Flexibility | Met flexibility requirements | Flexibility Testing completed |
| Trackability | Acceptable tracking performance | Trackability completed |
| Guidewire Compatibility | Compatible with specified guidewire sizes | Guidewire Compatibility completed |
| Retraction | Acceptable retraction performance | Retraction Testing completed |
| Torque Testing | Acceptable torque transfer and performance | Torque Testing completed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide specific sample sizes for each test. The tests listed are primarily bench tests and an in-vitro animal study (porcine). Data provenance typical for clinical studies (country of origin, retrospective/prospective) is not applicable here as these are nonclinical performance studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device notification is for a traditional catheter, and performance data is based on nonclinical (bench and animal) testing, not on human expert interpretation of diagnostic images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to clinical studies involving human interpretation or consensus, which is not the nature of the tests performed for this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the nonclinical tests, the "ground truth" is defined by established engineering and biological standards, measurement methods (e.g., ISO standards), and physical performance specifications. For instance, biocompatibility is assessed against ISO 10993, and functional performance against defined engineering parameters.
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML powered device.
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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
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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
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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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------ |
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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.
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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).
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- 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.
§ 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).