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

Device Description

The XO Cross Coronary Support Catheter is a single-lumen support catheter designed to support a guidewire during access of the peripheral or coronary 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 Coronary 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, 175cm), with a diameter of 2 Fr (0.7 mm) and with a tapered polymer tip at its distal end.

AI/ML Overview

The provided text describes a medical device, the XO Cross Coronary Support Catheter, and its 510(k) submission to the FDA for substantial equivalence. However, the document does not contain information about:

Acceptance criteria for an AI/ML powered device. The device described is a physical catheter, not an AI/ML software.
A study proving the device meets AI/ML specific acceptance criteria.
Sample size for test sets or data provenance (these are relevant for AI/ML validation).
Number of experts or their qualifications for ground truth.
Adjudication methods.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Stand-alone performance of an algorithm.
Types of ground truth used (e.g., pathology, outcomes data).
Sample size for training sets.
How ground truth for training sets was established.

The document details the following for the physical catheter device:

Device Performance and Testing:

The document focuses on demonstrating substantial equivalence to a predicate device (Quick Cross Extreme Support Catheter, K092396) and a reference device (XO Cross Support Catheter, K210322). The "performance" assessment is based on functional and safety testing of the catheter, not on specific output metrics typically associated with AI/ML systems (like accuracy, sensitivity, specificity, etc.).

Biocompatibility Testing:

Tests performed and passed: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Bacterial Endotoxin LAL, Hemolysis, Complement Activation, Partial Thromboplastin Time (PTT), Blood Platelet and Leukocyte Count.
Method: 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 device used the same materials and processes as the reference device, with an additional assessment for a new black polymer outer layer.

Design Verification (Performance Bench Testing):

Tests performed or fulfilled: Tip ID Testing, Tip Tensile Testing, Distal Shaft Kink Testing, Simulated Use.
Purpose: To ensure the catheter met applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence.

Comparative Analysis (Substantial Equivalence):

The document presents a comparison (Table 2) between the subject device, the predicate device, and the reference device across various attributes like:

Intended Use
Indications for Use
Classification Name
Single Use
Fundamental Scientific Technology
Prescription (Rx Only)
Anatomical Access
Design
Effective Length (cm)
Distal Tip/Crossing Profile
Shaft Outer Diameter
Visibility
Guidewire Compatibility
Sheath / Introducer Compatibility
Max Infusion Pressure
Sterility
Biocompatibility

Conclusion:

The submission concludes that the XO Cross Coronary Support Catheter is substantially equivalent in safety and effectiveness to the legally marketed predicate and reference devices. The minor design differences (longer tapered tip, modified strain relief, outer polymer layer color change, minimum kink specifications, minimum tip ID and tensile specifications) were assessed and determined to "raise no additional or different questions of safety or effectiveness."

In summary, the provided document is a 510(k) clearance letter and summary for a physical medical device (catheter), not an AI/ML-powered device. Therefore, it does not contain the specific information requested regarding AI/ML acceptance criteria and validation studies.

Summary

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April 11, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that 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: K214107

Trade/Device Name: XO CROSS CORONARY Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 16, 2022 Received: March 18, 2022

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

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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 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 (OS) 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,

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) K214107

Device Name XO Cross Coronary Support Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	---------------------------------------	---------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) SUMMARY (21 CFR 807.92)

GENERAL INFORMATION

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) 708-2238Spencer.walker@hsc.utah.edu
Date Prepared:	March 16, 2022
Trade Name:	XO Cross Coronary Support Catheter
Classification Name:	Percutaneous Catheter21 CFR §870.1250, Product Code DQY
Device Class:	Class II
Predicate Device:	510(k) No.: K092396Model: Quick Cross Extreme Support CatheterManufacture: Spectranetics CorporationClassification: DQY
Reference Device:	510(k) No.: K210322Model: XO Cross Support CatheterManufacture: Transit Scientific, LLCClassification: DQY

Device Description:

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Table 1: XO Cross Coronary Support Catheter Model Numbers
Product Family	Model No.	Description
XO Cross Coronary Support Catheter	CC-090-H	XO Cross Coronary – 0.014-inch diameter catheter shaft in 90cm, 135cm, 150cm and 175cm lengths.
	CC-135-H
	CC-150-H
	CC-175-H

Indications for Use:

Comparative Analysis:

Modifications to the previously 510(k) cleared XO Cross Support Catheter (K210322) resulted in a new indication for use (i.e. use in coronary vasculature). To support this change a few minor modifications in design were made which resulted in new the product codes. The following modifications were made to the subject catheter:

Longer Tapered Tip ●
Modified Strain Relief ●
Outer polymer layer color changes to black ●
. Minimum Kink Specifications
Minimum Tip ID and Tensile Specifications

It has been demonstrated that the modified XO Cross Coronary catheter is comparable to the predicate device in fundamental scientific technology, design, materials, principles of operation and functional performance evaluations and is substantial equivalent as summarized in Table 2. Furthermore, the XO Cross Coronary 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.

Table 2: Substantial Equivalence Comparison Chart
	Predicate – K092396(Quick-Cross Catheter)	Reference - K210322(XO Cross SupportCatheter)	Subject Device –XO Cross CoronarySupport Catheter
Intended Use	The Intended patientpopulation is those sufferingfrom vascular disease, bothcoronary and peripheral.	The Intended patientpopulation is those sufferingfrom vascular disease.	The Intended patientpopulation is thosesuffering from vasculardisease, both coronary andperipheral.
Ind. for Use	Quick-Cross ExtremeSupport Catheters areintended to guide and	The XO Cross is a supportcatheter intended to guideand support a guidewire	The XO Cross Coronary isa support catheter intendedto guide and support a
Table 2: Substantial Equivalence Comparison Chart
	Predicate – K092396(Quick-Cross Catheter)	Reference – K210322(XO Cross SupportCatheter)	Subject Device –XO Cross CoronarySupport Catheter
	support a guidewire duringaccess of the vasculature,allow for wire exchanges andprovide a conduit for thedelivery of saline solutions ordiagnostic contrast agents.	during access of theperipheral vasculature, allowfor wire exchanges andprovide a conduit for thedelivery of saline solutions ordiagnostic contrast agents.	guidewire during access ofthe peripheral or coronaryvasculature, allow for wireexchanges and provide aconduit for the delivery ofsaline solutions ordiagnostic contrast agents.
ClassificationName	Cardiovascular Device –Percutaneous Catheter21 CFR §870.1250Product Code: DQYClass II	Cardiovascular Device –Percutaneous Catheter21 CFR §870.1250Product Code: DQYClass II	Cardiovascular Device –Percutaneous Catheter21 CFR §870.1250Product Code: DQYClass II
Single Use	Yes	Yes	Yes
FundamentalScientificTechnology	Provide support forguidewire placement andfluid administration	Provide support forguidewire placement andfluid administration	Provide support forguidewire placement andfluid administration
Prescription(Rx Only)	Yes	Yes	Yes
AnatomicalAccess	Peripheral or CoronaryVasculature	Peripheral Vasculature	Peripheral or CoronaryVasculature
Design	Single Lumen SS braidedshaft w/ straight orangled tip. Distal endcoated with hydrophiliccoating.	Single Lumen metal alloytube laser cut shaft w/tapered tip and whitepolymer outer layer, withhydrophilic coating	Single Lumen metal alloytube laser cut shaft w/tapered tip and blackpolymer outer layer, withhydrophilic coating
Effective Length(cm)	65, 90, 135, 150	90, 135, 150, 175	90, 135, 150, 175
Distal Tip/Crossing Profile	1.9 Fr, 2.1Fr, 3.2Fr	1.6Fr, 1.9Fr, 3.2Fr	1.6Fr
Shaft OuterDiameter	0.034", 0.038", 0.052	0.029", 0.037", 0.051"	0.029"
Visibility	3 radiopaque markers	Radiopaque catheterbody, polymer tip withradiopaque filler	Radiopaque catheter body,polymer tip withradiopaque filler
GuidewireCompatibility	0.014", 0.018", 0.035"	0.014", 0.018", 0.035"	0.014"
Sheath /IntroducerCompatibility	4 Fr and 5 Fr	2.9Fr and 4Fr	2.9Fr
Max InfusionPressure	300 psi, 500psi	Tested for manualinfusion, not for use withpower injectors.	Tested for manual infusion,not for use with powerinjectors.
Sterility	Sterile - EO	Sterile - EO	Sterile - EO
Biocompatibility	ISO 10993	ISO 10993	ISO 10993

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Functional/Safety Testing:

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

Biocompatibility The subject XO Cross Coronary is manufactured using the same . materials and processes except for the black polymer outer layer as compared to the reference XO Cross which was manufactured with a white polymer outer layer on the OD of the catheter shaft. The additional biocompatibility testing was completed for the subject device 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:
- I Cytotoxicity
- l Sensitization
- l Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Bacterial Endotoxin LAL
- I Hemolysis
- Complement Activation
- l Partial Thromboplastin Time (PTT)
- Blood Platelet and Leukocyte Count
Design Verification Performance bench testing was conducted to ensure that the XO . Cross Coronary Catheter met the applicable design and performance requirements throuqhout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence to the predicate and reference devices. The following performance testing was performed or fulfilled with the XO Cross Coronary Catheter.
- O Tip ID Testing
- Tip Tensile Testing O
- Distal Shaft Kink Testing o
- Simulated Use O
Packaging The proposed changes to the XO Cross Support Catheter did not affect the ● packaging or its configuration.

Conclusion:

The subject XO Cross Coronary Support Catheter is substantially equivalent with respect to safety and effectiveness to the legally marketed predicate and reference devices. The minor differences between the subject XO Cross Coronary Support catheter and the predicate and reference devices have no effect on safety or effectiveness, as established through various performance tests.

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).