XO Cross Support Catheter

K210322 · Transit Scientific, LLC · DQY · Oct 21, 2021 · Cardiovascular

Device Facts

• Record ID: K210322
• Device Name: XO Cross Support Catheter
• Applicant: Transit Scientific, LLC
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 21, 2021
• 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 Support Catheter is a single-lumen, laser-cut metal alloy tube catheter; used in peripheral vasculature access; supports guidewire placement; facilitates wire exchanges; provides conduit for saline or diagnostic contrast agents. Operated by physicians in clinical settings under fluoroscopy. Radiopaque shaft and tip allow tracking; hydrophilic coating on distal end reduces surface friction. Device available in various lengths (90-175cm) and diameters (2Fr-4Fr). Output is physical support and fluid delivery; aids navigation through vasculature; benefits patient by enabling successful guidewire placement and diagnostic imaging.

Clinical Evidence

Bench testing only. Verification and validation included biocompatibility testing (ISO 10993-1) for cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemolysis, and complement activation. Design verification included radiopacity, tensile testing, lubricity, durability, particulate testing, and simulated use testing per ISO 10555-1.

Technological Characteristics

Single-lumen laser-cut metal alloy shaft; tapered polymer tip with radiopaque filler; hydrophilic coating on distal portion. Sizes: 2Fr to 4Fr; lengths: 90cm to 175cm. Compatible with 0.014", 0.018", and 0.035" guidewires. Sterilization: Ethylene Oxide (EO). Complies with ISO 10555-1 and ISO 10993-1.

Indications for Use

Indicated for patients requiring peripheral vascular access, specifically for guidewire support, wire exchange, and delivery of 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

• XO Cross Support Catheter (K193420)

Submission Summary (Full Text)

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October 21, 2021

Image /page/0/Picture/1 description: The image contains 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.

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

### Re: K210322

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: October 24, 2021 Received: September 22, 2021

#### 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 and Part 809); 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 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-regulatory-assistance/contact-usdivision-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

Enclosure

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# Indications for Use

510(k) Number (if known) K210322

Device Name XO Cross Support Catheter

Indications for Use (Describe)

The XO Cross is a support catheter intended to 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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| 510(k) Summary | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Transit Scientific, LLC |
| Contact Person: | Spencer Walker, MSc – Director of Regulatory Affairs<br>University of Utah/ Center for Medical Innovation<br>10 North 1900 East, Rm. 22B<br>Salt Lake City, UT 84112<br>[phone]<br>[e-mail] |
| Date Prepared: | March 19, 2021 |
| Trade Name: | XO Cross Support Catheter |
| Classification Name: | Percutaneous Catheter<br>21 CFR §870.1250, Product Code DQY |
| Device Class: | Class II |
| Predicate Device: | 510(k) No.: K193420<br>Model: XO Cross Support Catheter<br>Manufacture: Transit Scientific, LLC<br>Classification: DQY |

#### Device Description:

The XO Cross Support Catheter is identical to the predicate device in that it is a single-lumen support catheter designed to support a guidewire 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 Support Catheter within the vasculature, while under fluoroscopy. The distal end of the subject catheter is also coated with a hydrophilic coating to reduce surface friction. It is available in various lengths (90cm, 135cm, 15cm) 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.

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| Product<br>Family | Catalog No. | Description |
|---------------------------------|-------------|-----------------------------------------------------------------------------------------------|
| XO Cross<br>Support<br>Catheter | C14-090 | XO Cross 014 – 0.014-inch diameter catheter shaft in<br>90cm, 135cm, 150cm and 175cm lengths. |
| | C14-135 | |
| | C14-150 | |
| | C14-175 | |
| | C18-090 | XO Cross 018 – 0.018-inch diameter shaft, in 90cm,<br>135cm, 150cm and 175cm lengths. |
| | C18-135 | |
| | C18-150 | |
| | C18-175 | |
| | C35-090 | XO Cross 035 - 0.035-inch diameter shaft, in 90cm,<br>135cm, 150cm and 175cm lengths. |
| | C35-135 | |
| | C35-150 | |
| | C35-175 | |

### 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:

Modifications in design and materials of the previously 510(k) cleared XO Cross Support Catheter (K193420) did not result in new product codes. The following modifications were made to the subject catheter:

- . Polymer Tip Extrusion radiopaque filler % increased radiopacity for improved visibility
- Addition of Hydrophilic Coating on distal portion of catheter to reduce surface friction
- Micro-cut refinements for better manufacturability ●

It has been demonstrated that the modified XO Cross catheter is comparable to the predicate device in intended use, fundamental scientific technology, design, principles of operation and functional performance evaluations and is substantial equivalent as summarized in Table 2. Furthermore, the modified XO Cross catheter has been fully assessed within the Transit Scientific Risk Management and Design Controls systems. The differences raise no additional or different questions of safety or effectiveness from that already identified for the predicate device.

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| Table 2: Substantial Equivalence Comparison Chart | | | | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--|--|
| | Predicate - K193420<br>(XO Cross Support Catheter) | Subject Device - K210322<br>XO Cross Support Catheter | | |
| Ind. for Use | The XO Cross is a support catheter intended to<br>guide and support a guidewire during access of<br>the peripheral vasculature, allow for wire<br>exchanges and provide a conduit for the<br>delivery of saline solutions or diagnostic<br>contrast agents. | Same | | |
| 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 | Provide support for guidewire placement and<br>fluid administration | Same | | |
| Prescription<br>(Rx Only) | Yes | Same | | |
| Anatomical<br>Access | Peripheral Vasculature | Same | | |
| Design | Single Lumen metal alloy tube laser cut<br>shaft w/ tapered tip and polymer outer<br>layer. | Single Lumen metal alloy tube<br>laser cut shaft w/ tapered tip and<br>polymer outer layer, with<br>hydrophilic coating. | | |
| Effective Length<br>(cm) | 90, 135, 150, 175 | Same | | |
| Catheter Sizes | 2Fr - 4Fr | Same | | |
| Distal Tip/<br>Crossing Profile | 1.6Fr, 1.9Fr, 3.2Fr | Same | | |
| Shaft Outer<br>Diameter | 0.029", 0.037", 0.051" | Same | | |
| Visibility | Radiopaque catheter body, polymer tip with<br>radiopaque filler | Radiopaque catheter body,<br>polymer tip with increased<br>radiopaque filler | | |
| Guidewire<br>Compatibility | 0.014", 0.018", 0.035" | Same | | |
| Sheath /<br>Introducer<br>Compatibility | 2.9Fr and 4Fr | Same | | |
| Max Infusion<br>Pressure | Tested for manual infusion, not for use with<br>power injectors. | Same | | |
| Sterility | Sterile - EO | Same | | |
| Biocompatibility | ISO 10993 | Same | | |

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# Functional/Safety Testing:

Verification & Validation activities were performed on the subject XO Cross Support Catheter to demonstrate substantial equivalence to the predicate device:

- Biocompatibility - Biocompatibility testing was done due to the added hydrophilic coating to the catheter shaft. All tests were done per the same protocol and acceptance criteria as the predicate device, and as prescribed in ISO 10993-1 and in accordance with the 2020 FDA guidance document "Use of International Standard ISO 10993-1" for an external communicating device with limited exposure (≤ 24hrs) to circulating blood. The following tests were performed and passed:
- o Cytotoxicity
- Sensitization O
- Irritation/ Intracutaneous Toxicity O
- O Acute Systemic Toxicity
- Material Mediated Pyrogenicity O
- Hemolysis Assay O
- O Complement Activation
- LAL Pyrogenicity O

o

- Design Verification -The XO Cross models all meet or exceeded both Transit Scientifics in-. house requirements, and requirements listed in ISO 10555-1.
- Polymer Tip Extrusion radiopaque filler increase
- l Radiopacity Acceptability
- = Tip ID Testing
- Tip Tensile Testing l
- Hydrophilic Coating o
- Biocompatibility Testing .
- Catheter OD Testing l
- Coating Lubricity Testing
- l Coating Durability Testing
- Distal Catheter Tensile
- Coating Particulate Testing
- Simulated Use ■
- l Coating Integrity
- I Coaxial Testing
- Packaging The proposed changes to the XO Cross Support Catheter did not affect the ● packaging or its configuration.

#### Conclusion:

The modifications to the subject XO Cross Support catheter is substantially equivalent with respect to safety and effectiveness to the legally marketed predicate device for its intended use. The minor differences between the subject XO Cross Support catheter and the predicated device has no effect on safety or effectiveness, as established through various performance test.