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.

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.

AI/ML Overview

The provided text describes the submission for a 510(k) premarket notification for the XO Cross Support Catheter, which is a revised version of a previously cleared device. The document primarily focuses on demonstrating substantial equivalence to the predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting.

Here's an analysis of the requested information based on the provided text:

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

The document does not present a table of specific acceptance criteria with corresponding performance statistics for the device in terms of clinical outcomes or diagnostic accuracy. Instead, it details that "Verification & Validation activities were performed on the subject XO Cross Support Catheter to demonstrate substantial equivalence to the predicate device."

The closest the document comes to "acceptance criteria" and "reported performance" is in the context of the functional/safety testing and biocompatibility testing. For these, the acceptance criteria are generally "passed" or "met/exceeded" internal requirements and ISO standards.

Acceptance Criteria Category	Specific Test/Evaluation	Reported Device Performance
Biocompatibility	Cytotoxicity (ISO 10993-1)	Passed (per the same protocol as predicate)
	Sensitization (ISO 10993-1)	Passed (per the same protocol as predicate)
	Irritation/Intracutaneous Toxicity (ISO 10993-1)	Passed (per the same protocol as predicate)
	Acute Systemic Toxicity (ISO 10993-1)	Passed (per the same protocol as predicate)
	Material Mediated Pyrogenicity (ISO 10993-1)	Passed (per the same protocol as predicate)
	Hemolysis Assay (ISO 10993-1)	Passed (per the same protocol as predicate)
	Complement Activation (ISO 10993-1)	Passed (per the same protocol as predicate)
	LAL Pyrogenicity (ISO 10993-1)	Passed (per the same protocol as predicate)
Design Verification	Radiopacity Acceptability (Polymer Tip Extrusion)	Met or exceeded Transit Scientific's in-house requirements
	Tip ID Testing	Met or exceeded Transit Scientific's in-house requirements
	Tip Tensile Testing	Met or exceeded Transit Scientific's in-house requirements
	Biocompatibility Testing (Hydrophilic Coating)	Passed
	Catheter OD Testing	Met or exceeded Transit Scientific's in-house requirements
	Coating Lubricity Testing	Met or exceeded Transit Scientific's in-house requirements
	Coating Durability Testing	Met or exceeded Transit Scientific's in-house requirements
	Distal Catheter Tensile	Met or exceeded Transit Scientific's in-house requirements
	Coating Particulate Testing	Met or exceeded Transit Scientific's in-house requirements
	Simulated Use	Met or exceeded Transit Scientific's in-house requirements
	Coating Integrity	Met or exceeded Transit Scientific's in-house requirements
	Coaxial Testing	Met or exceeded Transit Scientific's in-house requirements
	Overall Design Verification (ISO 10555-1 requirements)	All models met or exceeded requirements

2. Sample size 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 details on a 'test set' in the context of clinical data or patient outcomes. The testing described is primarily pre-clinical (biocompatibility, engineering design verification). Therefore, information on sample size and data provenance for a clinical test set is not available.

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)

This information is not applicable to the provided document. The submission is for a medical device (support catheter), not an AI/diagnostic software. Ground truth, in the sense of expert consensus on imaging or pathology, is not part of this type of submission. The "ground truth" for the engineering and biocompatibility tests would be the established scientific methods and standards (e.g., ISO 10993-1, ISO 10555-1) and internal specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. There is no clinical 'test set' involving human interpretation or adjudication for this device submission.

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

This information is not applicable. The device is a physical support catheter and not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a physical support catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the evaluations performed is based on:

International Standards: ISO 10993-1 for biocompatibility and ISO 10555-1 for catheter design verification.
Internal Requirements: Transit Scientific's in-house specifications for design verification tests (e.g., radiopacity, tip ID, tensile, lubricity, durability, particulate, integrity, coaxial).

8. The sample size for the training set

This information is not applicable. The document does not describe the development of an AI algorithm with a training set. The descriptions relate to physical device design and manufacturing.

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

This information is not applicable. As there is no AI algorithm or training set discussed, this question is not relevant to the provided content.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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 AffairsUniversity of Utah/ Center for Medical Innovation10 North 1900 East, Rm. 22BSalt Lake City, UT 84112(801) 581-5080Spencer.walker@hsc.utah.edu
Date Prepared:	March 19, 2021
Trade Name:	XO Cross Support Catheter
Classification Name:	Percutaneous Catheter21 CFR §870.1250, Product Code DQY
Device Class:	Class II
Predicate Device:	510(k) No.: K193420Model: XO Cross Support CatheterManufacture: Transit Scientific, LLCClassification: DQY

Device Description:

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ProductFamily	Catalog No.	Description
XO CrossSupportCatheter	C14-090	XO Cross 014 – 0.014-inch diameter catheter shaft in90cm, 135cm, 150cm and 175cm lengths.
	C14-135
	C14-150
	C14-175
	C18-090	XO Cross 018 – 0.018-inch diameter shaft, in 90cm,135cm, 150cm and 175cm lengths.
	C18-135
	C18-150
	C18-175
	C35-090	XO Cross 035 - 0.035-inch diameter shaft, in 90cm,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(XO Cross Support Catheter)	Subject Device - K210322XO Cross Support Catheter
Ind. for Use	The XO Cross is a support catheter intended toguide and support a guidewire during access ofthe peripheral vasculature, allow for wireexchanges and provide a conduit for thedelivery of saline solutions or diagnosticcontrast agents.	Same
ClassificationName	Cardiovascular Device - PercutaneousCatheter21 CFR §870.1250Product Code: DQYClass II	Same
Single Use	Yes	Same
FundamentalScientificTechnology	Provide support for guidewire placement andfluid administration	Same
Prescription(Rx Only)	Yes	Same
AnatomicalAccess	Peripheral Vasculature	Same
Design	Single Lumen metal alloy tube laser cutshaft w/ tapered tip and polymer outerlayer.	Single Lumen metal alloy tubelaser cut shaft w/ tapered tip andpolymer outer layer, withhydrophilic coating.
Effective Length(cm)	90, 135, 150, 175	Same
Catheter Sizes	2Fr - 4Fr	Same
Distal Tip/Crossing Profile	1.6Fr, 1.9Fr, 3.2Fr	Same
Shaft OuterDiameter	0.029", 0.037", 0.051"	Same
Visibility	Radiopaque catheter body, polymer tip withradiopaque filler	Radiopaque catheter body,polymer tip with increasedradiopaque filler
GuidewireCompatibility	0.014", 0.018", 0.035"	Same
Sheath /IntroducerCompatibility	2.9Fr and 4Fr	Same
Max InfusionPressure	Tested for manual infusion, not for use withpower 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

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.

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).