XO Cross Support Catheter

K193420 · Transit Scientific · DQY · May 6, 2020 · Cardiovascular

Device Facts

• Record ID: K193420
• Device Name: XO Cross Support Catheter
• Applicant: Transit Scientific
• Product Code: DQY · Cardiovascular
• Decision Date: May 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The XO Cross is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Device Story

XO Cross is a single-lumen support catheter used in peripheral vascular access procedures. Operated by physicians in clinical settings, it tracks over a guidewire to navigate the vasculature. The device features a metal alloy hypo-tube shaft with a tapered polymer tip; both are radiopaque for visualization under fluoroscopy. It functions as a conduit for guidewire exchange and the delivery of saline or diagnostic contrast agents. The device is manually operated and does not support power injection. By providing structural support and a pathway for interventional tools, it assists clinicians in accessing target vascular sites, potentially improving procedural efficiency and patient outcomes.

Clinical Evidence

Bench testing only. No clinical data. Verification included biocompatibility testing per ISO 10993-1 (cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity, hemolysis, complement activation, thrombogenicity) and design verification per ISO 10555-1. Packaging integrity and sterilization were also validated.

Technological Characteristics

Single-lumen support catheter; metal alloy hypo-tube shaft; tapered polymer tip with 40% tungsten loading for radiopacity. Available in lengths 90-175cm and diameters 2Fr-4Fr. Compatible with 0.014", 0.018", and 0.035" guidewires. Sterilized via ethylene oxide (EO). Complies with ISO 10993-1 and ISO 10555-1.

Indications for Use

Indicated for patients requiring peripheral vascular access to guide and support a guidewire, facilitate wire exchanges, and deliver saline or diagnostic contrast agents.

Regulatory Classification

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.

Predicate Devices

• Quick-Cross Extreme Support Catheter (K082561)

Submission Summary (Full Text)

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May 29, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Transit Scientific Spencer Walker Director of Regulatory Affairs University of Utah 10 North 1900 East, EHSL Rm. 22B Salt Lake City, Utah 84112

Re: K193420

Trade/Device Name: XO Cross Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY

Dear Spencer Walker:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 6, 2020, Specifically, FDA is updating this SE Letter to reflect that changes have been implemented to your 510(k) Summary to remove proprietary information.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Lydia Glaw, OHT2: Office of Cardiovascular Devices, 301-796-1456, or Lydia.glaw(@fda.hhs.gov.

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 Ouality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".

May 6, 2020

Transit Scientific Spencer Walker Director of Regulatory Affairs University of Utah 10 North 1900 East, EHSL Rm. 22B Salt Lake City, Utah 84112

Re: K193420/S001

Trade/Device Name: XO Cross Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 3, 2020 Received: April 6, 2020

## Dear Spencer Walker:

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

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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/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 mediation-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 [phone] or 301-796-7100).

Sincerely.

Image /page/2/Picture/5 description: The image shows the text "Lydia S. Glaw -S" in a large, sans-serif font. The text is arranged vertically, with "Lydia S." on the top line and "Glaw -S" on the bottom line. The background is a light blue color.

Digitally signed by Lydia S. Glaw -S Date: 2020.05.06 16:33:27 -04'00'

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

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| <b>Indications for Use</b> | |
| 510(k) Number ( <i>if known</i> ) | K193420 |
| Device Name | XO Cross Support Catheter |
| Indications for Use ( <i>Describe</i> ) | |
| The XO Cross is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents. | |
| Type of Use (Select one or both, as applicable) | |
| | <span style="display:inline-block; margin-right: 5px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) <span style="display:inline-block; margin-left: 20px; margin-right: 5px;">☐</span> 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. | |
| <b>*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*</b> | |
| 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: | |

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"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."

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| 510(k) Summary | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Transit Scientific, LLC. |
| Contact Person: | Spencer Walker, MSC – Director Regulatory Affairs<br>Center for Medical Innovation<br>10 North 1900 East, Rm 22B<br>Salt Lake City, UT 84112<br>[phone] |
| Date Prepared: | December 5, 2019 |
| Trade Name: | XO Cross Support Catheter |
| Classification Name: | Percutaneous Catheter<br>21 CFR §870.1250, Product Code DQY |
| Device Class: | Class II |
| Predicate Device: | • K082561 – Quick-Cross Extreme Support Catheter,<br>Spectranetics Corporation, Inc. |

# Device Description:

The XO Cross catheter is a single-lumen support catheter designed to support a quidewire during access of the peripheral vasculature, allowing for exchange of guidewires during vascular access procedures, and providing a conduit for the delivery of saline solutions or diagnostic contrast agents. The shaft and tip are both radiopaque to track the location of the XO Cross catheter within the vasculature, while under fluoroscopy. It is available in various lengths (90cm, 135cm, 150cm, 175cm) and ranges in diameter from 2 Fr (0.7 mm) to 4 Fr (1.35 mm) with a tapered polymer tip at its distal end.

### Indications for Use:

The XO Cross is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

### Comparative Analysis:

It has been demonstrated that the XO Cross catheter is comparable to the predicate device in intended use, fundamental scientific technology, design, principles of operation and functional performance evaluations. The XO Cross catheter has been fully assessed within the Transit Scientific Risk Management and Design Controls systems. All

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necessary verification steps met pre-determined acceptance criteria to confirm substantial equivalence.

It has been demonstrated that the XO Cross is comparable to the predicate device in the following manner:

- Same intended use ●
- Same indications for use
- Same fundamental scientific technology ●
- Same or similar material properties ●
- Same operating principle
- Same or similar performance specifications
- . Same or similar patient-user interface

| Table 1: Substantial Equivalence Comparison Chart | | | | |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | Predicate - K082561<br>(Quick-Cross Catheter) | Subject Device:<br>XO Cross Catheter | | |
| Ind. for Use | Quick-Cross Extreme Support Catheters<br>are intended to guide and support a<br>guidewire during access of the<br>vasculature, allow for wire exchanges<br>and provide a conduit for the delivery of<br>saline solutions or diagnostic contrast<br>agents. | The XO Cross is a support catheter<br>intended to guide and support a<br>guidewire during access of the<br>peripheral vasculature, allow for wire<br>exchanges and provide a conduit for<br>the delivery of saline solutions or<br>diagnostic contrast agents. | | |
| Classification<br>Name | Cardiovascular Device - Percutaneous<br>Catheter<br>21 CFR §870.1250<br>Product Code: DQY<br>Class II | Same | | |
| Single Use | Yes | Same | | |
| Fundamental<br>Scientific<br>Technology | Single | Same | | |
| Prescription<br>(Rx Only) | Yes | Same | | |
| Anatomical<br>Access | Peripheral Vasculature | Same | | |
| Design | Single Lumen SS braided shaft w/<br>straight or angled tip. Distal 40 cm<br>coated with hydrophilic coating. | Single Lumen metal alloy hypo-tube<br>shaft w/ tapered tip and polymer<br>jacket. | | |
| Effective<br>Length (cm) | 65, 90, 135, 150 | 90, 135, 150, 175 | | |
| Catheter Sizes | 4Fr | 2Fr - 4Fr | | |
| Distal Tip<br>Profile | 1.9 Fr, 2.1Fr, 3.2Fr | 1.6Fr, 1.9Fr, 3.2Fr | | |
| Shaft Outer<br>Diameter | 0.034", 0.038", 0.053" | 0.029", 0.037", 0.051" | | |

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| Table 1: Substantial Equivalence Comparison Chart | | |
|---------------------------------------------------|-----------------------------------------------|------------------------------------------------------------------|
| | Predicate - K082561<br>(Quick-Cross Catheter) | Subject Device:<br>XO Cross Catheter |
| Visibility | 3 radiopaque markers | Radiopaque catheter body, 40%<br>tungsten loading polymer tip |
| Guidewire<br>Compatibility | 0.014", 0.018", 0.035" | Same |
| Sheath /<br>Introducer<br>Compatibility | 4 Fr, 5 Fr | 4Fr |
| Max Infusion<br>Pressure | 300 psi, 500psi | Tested for manual infusion, not for<br>use with power injectors. |
| Sterility | Sterile - EO | Same |
| Biocompati-<br>bility | ISO 10993 | Same |

### Functional/Safety Testing:

The following functional tests were performed. All data met pre-determined acceptance criteria.

- o Biocompatibility - Biocompatibility of the complete and finished XO Cross catheter has been verified according to the requirements and testing prescribed in ISO 10993-1 and in accordance with FDA guidance document "Use of International Standard ISO 10993-1" for an external communicating device with limited exposure (<24hrs) to circulating blood. Per ISO 10993-1, testing included the following:
- Cytotoxicity O
- o Irritation/ Intracutaneous Toxicity
- Sensitization O
- Systemic Injection O
- Material Mediated Pyrogenicity O
- Hemolysis Complete O
- Complement Activation o
- o Thrombogenicity
- Design Verification -The XO Cross models all meet or exceeded both Transit o Scientifics in-house requirements, and requirements listed in ISO 10555-1. Packaging integrity was validated in conjunction with the sterilization studies.

#### Conclusion:

The XO Cross support catheter is substantially equivalent to the cited predicate device. Additionally, the XO Cross support catheter met all acceptance criteria to confirm substantial equivalence.