The Tunnel CC is intended to be used with a guidewire to access discrete regions of the peripheral vasculature and to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.

Device Description

The Tunnel CC is a single lumen, over-the-wire endovascular catheter. The design consists of a layered tubing configuration with a hydrophilic, lubricious coating on the distal end to reduce frictional forces. The center stainless steel (SS) tubing which drives functionality including buckling resistance is cut in a continuous spiral jigsaw pattern along most of the length; it ends with longitudinal laser cuts at the distal end enabling the formation of a smooth, tapered tip that is continuous with the shaft body of the catheter. This center SS tube is sandwiched between two polymer tubes where the inside layer is PTFE and the outside layer is PEBAX. A luer hub at the user end allows flushing of saline solutions or contrast media through the inner lumen and facilitates guidewire exchanges. This device comes in 0.014", 0.018" and 0.035" guidewire compatible sizes and lengths of 90cm, 135-cm, 155-cm and 170-cm for each quidewire size.

The catheters are used to navigate tortuous peripheral vasculature while providing axial stability to enhance guidewire and device crossing of discrete lesions of the peripheral vasculature. The catheters are also used to allow for guidewire exchanges and provide a conduit for delivering saline solutions and contrast media.

AI/ML Overview

The provided document is a 510(k) summary for the Tunnel Crossing Catheter (Tunnel CC). It describes non-clinical performance testing conducted to support substantial equivalence to predicate devices, rather than a clinical study involving human patients or complex AI algorithms with ground truth determination. Therefore, many of the requested categories for a study involving AI performance or human reader analysis are not applicable to this document.

However, I can extract the relevant information regarding acceptance criteria and performance data for this device as it pertains to non-clinical testing.

Here's the information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document mentions that the device was evaluated in nonclinical testing "in accordance with FDA's recognized standards and pre-established acceptance criteria" and that "in all instances, the Tunnel CC functioned as intended." Specific quantitative acceptance criteria are not detailed in this summary; rather, it refers to compliance with ISO standards and successful completion of various tests.

Test Conducted	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility (ISO 10993)	Met ISO 10993 standards	Established / Successfully completed
Shipping simulation, environmental conditioning, and package integrity studies	Successful completion	Successfully completed
Functional bench testing (ISO 10555-1 and ISO 594-1 compliance, etc.)	Met relevant standards and pre-established acceptance criteria	Demonstrated compliance, cleared for Primary Predicate
Simulated use testing (tracking, flexibility, torquability, guidewire exchange)	Met functional performance specifications	Completed to demonstrate functional performance specifications were met and cleared for Primary Predicate
Functional bench testing (buckling and kink resistance)	Demonstrated buckling and kink resistance (equivalency to predicate)	Successfully completed
Simulated use testing (ability to cross a mock lesion)	Successfully cross a mock lesion	Successfully completed

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for each bench or simulated use test. It refers to "nonclinical performance testing." Data provenance is from internal testing conducted by Tractus Vascular, LLC to support the 510(k) submission. This is retrospective testing performed on manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study involving expert-established ground truth for a diagnostic task. The testing involved objective physical and performance characteristics of a medical device according to established engineering and medical device standards.

4. Adjudication method for the test set

Not applicable. There was no adjudication process as it was not a diagnostic study requiring interpretation of results by multiple experts.

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-assisted diagnostic device or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-only device. It is a physical medical device.

7. The type of ground truth used

For the non-clinical performance tests, the "ground truth" essentially refers to:

Compliance with recognized standards: ISO 10993, ISO 10555-1, ISO 594-1.
Meeting pre-established design specifications: For characteristics like tracking, flexibility, torquability, guidewire exchange, buckling resistance, kink resistance, and ability to cross a mock lesion. This would be determined by objective measurements and functional tests against engineering requirements.
Equivalency to predicate devices: The primary goal of a 510(k) summary is to demonstrate substantial equivalence to a legally marketed predicate.

8. The sample size for the training set

Not applicable. There is no training set for an algorithm as this is a physical medical device, not an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

Summary

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January 19, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Tractus Vascular, LLC Janet Burpee, CEO/CTO 20 Meridian Road, Unit 9B Eatontown, New Jersey 07724

Re: K221163

Trade/Device Name: Tunnel Crossing Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: December 15, 2022 Received: December 19, 2022

Dear Janet Burpee:

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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Samuel G. Raben -S

for Lydia Glaw

Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221163

Device Name Tunnel Crossing Catheter (Tunnel CC)

Indications for Use (Describe)

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 Tunnel™ Crossing Catheter

Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared

Janet Burpee, CEO Tractus Vascular, LLC. 20 Meridian Road, Unit 9B Eatontown, NJ 07724 Phone: (732) 590-1470

Date Prepared: April 20, 2022

Name and Classification of Device

Tunnel™ Crossing Catheter (Tunnel CC or Subject Device) Name of Device:

Common Name: Percutaneous Crossing Catheter

Classification Name: 21 CFR 870.1250, Class II, product code PDU

Predicate Devices

Primary Predicate: Medtronic Vascular's Viance™ Catheter (K120533)

Reference Predicate: Tractus™ Crossing Support Catheter (K180889 & K183305)

Device Description

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comes in 0.014", 0.018" and 0.035" guidewire compatible sizes and lengths of 90cm, 135-cm, 155-cm and 170-cm for each quidewire size.

Intended Use/Indications for Use

The Tunnel CC is intended to be used with a guidewire to access discrete reqions of the peripheral vasculature and to facilitate the intraluminal placement of conventional quidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.

Technological Characteristics

The Subject Device and the Reference Predicate are the same device with no proposed changes and is described below.

This device is a single lumen, over-the-wire catheter. The design consists of a layered tubing configuration. The center tubing is stainless steel which is cut in a continuous jigsaw spiral pattern with a laser cut distal end which is formed to a smooth, tapered tip that is continuous with the shaft body of the catheter (i.e. no bonds). This center tube is sandwiched between two polymer tubes where the inside layer is PTFE and the outside layer is PEBAX; both inner and outer polymer tubes are common catheter materials. A luer hub at the user end allows flushing of saline solutions or contrast media through the inner lumen and facilitates guidewire exchanges. The catheter has a lubricious coating on the distal portion to reduce frictional forces. Both the Subject Device and the Reference Predicate consist of 0.014", 0.018" and 0.035" guidewire compatible sizes and lengths of 90cm, 135-cm, 155-cm and 170-cm with a total matrix of 12 configurations.

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The overall construction of both the Subject Device and Primary Predicate are similar. Both devices (a) consist of an outer, inner, and center tubing configuration; (b) have an inner and outer tubing consisting of Pebax; (c) have a PTFE inner liner; (d) have a center tubing consisting of stainless steel; and (e) a hydrophilic coating on the distal end to reduce frictional forces and enhance tracking. The stainlesssteel center tubing for the Subject Device consists of a spiral, laser cut configuration. Comparatively, the stainless-steel center tubing of the Reference Predicate is coiled. The Primary Predicate includes a torque device, coaxially positioned over the outer shaft at the proximal portion. The Subject Device does not provide a torque device. Nonetheless, the principle of operation is the same where both features provide increased catheter flexibility and kink resistance, which is required for navigating tortuous peripheral vasculature while also providing axial stability to enhance crossing of stenotic and occlusive lesions in the vasculature.

Both devices are packaged in Tyvek pouches and provided sterile for single use.

Performance Data

The following nonclinical performance testing has been conducted to support the substantial equivalence of the Tunnel CC to its predicate devices. In all instances, the Tunnel CC functioned as intended.

. All of the following was demonstrated for the 510(k)-Cleared-Indication, and therefore, demonstrated for the Subject Device.
- Biocompatibility of the patient-contacting components of the device O was established in accordance with ISO 10993.
- Shipping simulation, environmental conditioning, and package o integrity studies were successfully completed.
- Functional bench testing was conducted (including demonstrated o compliance with relevant standards such as ISO 10555-1 and ISO 594-1) and was cleared for the Primary Predicate.
- o Simulated use testing to assess the tracking, flexibility, torquability and guidewire exchange was completed to demonstrate functional performance specifications were met and cleared for the Primary Predicate.
. Equivalency to the Primary Predicate's ability to support a guidewire and facilitate access in discrete regions was demonstrated for the Expanded-Indication as follows.
- Functional bench testing to demonstrate buckling and kink o resistance.

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o Simulated use testing to assess the ability to cross a mock lesion was successfully completed.

Conclusions

The Tunnel CC is a percutaneous catheter, Class II device that has been evaluated in nonclinical testing in accordance with FDA's recognized standards and pre-established acceptance criteria. Performance tests on the Subject Device related to the 510(k)-Cleared-Indication and Expanded-Indication are compared to the Primary Predicate and Reference Predicate, respectively. Testing demonstrated that the device performs as intended. The Tunnel CC is substantially equivalent to the referenced predicates.

Regulation Number and Section

§ 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).