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 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.

AI/ML Overview

The provided text is a 510(k) summary for the XO Cross Support Catheter. It outlines the device description, indications for use, and a comparison to a predicate device. However, it does not contain detailed information about specific acceptance criteria or the study data that proves the device meets those criteria, especially in the context of device performance metrics with numerical values or statistical analyses.

The document states that "All necessary verification steps met pre-determined acceptance criteria to confirm substantial equivalence" and "All data met pre-determined acceptance criteria" for functional tests, but it does not specify what those criteria are beyond general statements. It also doesn't describe the methodology of any studies that would demonstrate these criteria were met in a quantifiable way.

Therefore, I cannot populate the table or answer most of the specific questions as the required information is not present in the provided text.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Functional/Safety Testing:
Biocompatibility (ISO 10993-1)	Met ISO 10993-1 requirements (Cytotoxicity, Irritation/Intracutaneous Toxicity, Sensitization, Systemic Injection, Material Mediated Pyrogenicity, Hemolysis Complete, Complement Activation, Thrombogenicity)
Design Verification (ISO 10555-1)	Met or exceeded Transit Scientific's in-house requirements and ISO 10555-1 requirements
Packaging integrity	Validated in conjunction with sterilization studies
Max Infusion Pressure	Tested for manual infusion, not for use with power injectors (No specific pressure limit given for manual infusion, implying it passed internal criteria for manual use)
Materials (similar to predicate)	Uses single Lumen metal alloy hypo-tube shaft with tapered tip and polymer jacket, different from predicate's SS braided shaft (This is a design difference, not a performance metric)
Dimensions (similar to predicate)	Various lengths (90cm, 135cm, 150cm, 175cm), diameters (2Fr to 4Fr), and distal tip profiles (1.6Fr, 1.9Fr, 3.2Fr), similar to, but not identical to, predicate (Again, a design spec, not a performance metric with specific acceptance criteria)
Visibility (radiopaque markers)	Radiopaque catheter body, 40% tungsten loaded polymer tip, different from predicate's 3 radiopaque markers (Design difference)
Guidewire Compatibility	0.014", 0.018", 0.035" (Same as predicate)
Sheath/Introducer Compatibility	4Fr (Predicate mentions 4Fr, 5Fr. Subject device is only 4Fr, but "same" is noted in the table)
Sterility (EO)	Sterile - EO (Same as predicate)

Missing Information:

Specific quantitative acceptance criteria for each functional test (e.g., maximum acceptable cytotoxicity index, specific force required for kink resistance in design verification).
Quantitative results of the functional tests against the specific criteria.
Any performance testing related to guidewire support strength, catheter trackability, pushability, or other in-use functional attributes beyond basic material and design verification.

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

Missing. The document does not describe any specific "test set" in terms of patient data or clinical samples that would have a sample size or provenance. The "functional/safety testing" refers to laboratory-based verification, and no sample sizes for these tests are provided.

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

Not applicable. This information would typically be relevant for studies involving qualitative assessments, such as image interpretation or clinical diagnosis. The described testing is primarily laboratory-based engineering and biocompatibility testing. No "ground truth" established by experts in this context is mentioned.

4. Adjudication method for the test set

Not applicable. See point 3.

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 device is a physical medical device (support catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used

For the functional/safety testing, the "ground truth" would be the standards and specifications (e.g., ISO 10993, ISO 10555) that the device must meet, as well as the manufacturer's own internal design requirements. These are objective engineering and biological standards. There is no "expert consensus," "pathology," or "outcomes data" ground truth described for the tests mentioned.

8. The sample size for the training set

Not applicable. This device is a physical medical device. There is no concept of a "training set" as there would be for AI/machine learning models.

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

Not applicable. See point 8.

Summary

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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 (1-800-638-2041 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
Indications for Use
510(k) Number ( if known )	K193420
Device Name	XO Cross Support Catheter
Indications for Use ( Describe )
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)
	☑ 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 Regulatory AffairsCenter for Medical Innovation10 North 1900 East, Rm 22BSalt Lake City, UT 84112(801) 581-5080
Date Prepared:	December 5, 2019
Trade Name:	XO Cross Support Catheter
Classification Name:	Percutaneous Catheter21 CFR §870.1250, Product Code DQY
Device Class:	Class II
Predicate Device:	• K082561 – Quick-Cross Extreme Support Catheter,Spectranetics Corporation, Inc.

Device Description:

Indications for Use:

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(Quick-Cross Catheter)	Subject Device:XO Cross Catheter
Ind. for Use	Quick-Cross Extreme Support Cathetersare intended to guide and support aguidewire during access of thevasculature, allow for wire exchangesand provide a conduit for the delivery ofsaline solutions or diagnostic contrastagents.	The XO Cross is a support catheterintended to guide and support aguidewire during access of theperipheral vasculature, allow for wireexchanges and provide a conduit forthe delivery of saline solutions ordiagnostic contrast agents.
ClassificationName	Cardiovascular Device - PercutaneousCatheter21 CFR §870.1250Product Code: DQYClass II	Same
Single Use	Yes	Same
FundamentalScientificTechnology	Single	Same
Prescription(Rx Only)	Yes	Same
AnatomicalAccess	Peripheral Vasculature	Same
Design	Single Lumen SS braided shaft w/straight or angled tip. Distal 40 cmcoated with hydrophilic coating.	Single Lumen metal alloy hypo-tubeshaft w/ tapered tip and polymerjacket.
EffectiveLength (cm)	65, 90, 135, 150	90, 135, 150, 175
Catheter Sizes	4Fr	2Fr - 4Fr
Distal TipProfile	1.9 Fr, 2.1Fr, 3.2Fr	1.6Fr, 1.9Fr, 3.2Fr
Shaft OuterDiameter	0.034", 0.038", 0.053"	0.029", 0.037", 0.051"

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Table 1: Substantial Equivalence Comparison Chart
	Predicate - K082561(Quick-Cross Catheter)	Subject Device:XO Cross Catheter
Visibility	3 radiopaque markers	Radiopaque catheter body, 40%tungsten loading polymer tip
GuidewireCompatibility	0.014", 0.018", 0.035"	Same
Sheath /IntroducerCompatibility	4 Fr, 5 Fr	4Fr
Max InfusionPressure	300 psi, 500psi	Tested for manual infusion, not foruse with power injectors.
Sterility	Sterile - EO	Same
Biocompati-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.

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).