Who is the manufacturer of XO CROSS CORONARY Support Catheter?

Transit Scientific, LLC filed the 510(k) submission for XO CROSS CORONARY Support Catheter (K214107).

What is the FDA product code for XO CROSS CORONARY Support Catheter?

DQY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for XO CROSS CORONARY Support Catheter?

510(k) clearance (submission type: Traditional).

What are the predicate devices for XO CROSS CORONARY Support Catheter?

Quick Cross Extreme Support Catheter (K092396).

Who can help prepare an FDA 510(k) submission like XO CROSS CORONARY Support Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

XO CROSS CORONARY Support Catheter

K214107 · Transit Scientific, LLC · DQY · Apr 11, 2022 · Cardiovascular

Device Facts

Record ID	K214107
Device Name	XO CROSS CORONARY Support Catheter
Applicant	Transit Scientific, LLC
Product Code	DQY · Cardiovascular
Decision Date	Apr 11, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended Use

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 Story

Single-lumen support catheter; provides guidewire support, facilitates wire exchange, and acts as conduit for saline or contrast agents. Used in peripheral or coronary vasculature. Operated by physicians in clinical settings. Device features radiopaque shaft and tip for fluoroscopic tracking; hydrophilic coating on distal end reduces friction. Input: manual manipulation by clinician; Output: physical support for guidewire and fluid delivery path. Benefits: enables navigation of complex vasculature during interventional procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 for external communicating devices (≤ 24hrs) including cytotoxicity, sensitization, reactivity, toxicity, pyrogenicity, hemolysis, and PTT. Design verification included tip ID, tip tensile, distal shaft kink testing, and simulated use.

Technological Characteristics

Single-lumen laser-cut metal alloy shaft; tapered polymer tip; hydrophilic coating. Radiopaque body and tip. Available in 90cm, 135cm, 150cm, 175cm lengths; 2 Fr (0.7 mm) diameter. Sterile (EO). Biocompatibility per ISO 10993.

Indications for Use

Indicated for patients suffering from vascular disease, both coronary and peripheral, requiring guidewire support, wire exchange, or delivery of saline/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 (K092396)

Reference Devices

XO Cross Support Catheter (K210322)

Related Devices

K082561 — SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS · Spectranetics Corp. · Dec 10, 2008
K180889 — Tractus Crossing Support Catheter · Tractus Vascular, LLC · Dec 7, 2018
K092396 — SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS · Spectranetics Corp. · Sep 4, 2009
K183305 — Crossing Support Catheter · Tractus Vascular, LLC · Aug 5, 2019
K200317 — Support Catheter · Qxmedical, LLC · May 14, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K214107 Device Name XO Cross Coronary Support Catheter Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | <div> <input type="checkbox"/> </div> | <div> <input type="checkbox"/> </div> | |-------------------------------------------------|---------------------------------------|---------------------------------------| |-------------------------------------------------|---------------------------------------|---------------------------------------| 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* 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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ # 510(K) SUMMARY (21 CFR 807.92) #### GENERAL INFORMATION | Submitter: | Transit Scientific, LLC | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Spencer Walker, MSc – Director of Regulatory Affairs University of Utah/ Center for Medical Innovation 10 North 1900 East, Rm. 22B Salt Lake City, UT 84112 (801) 708-2238 Spencer.walker@hsc.utah.edu | | Date Prepared: | March 16, 2022 | | Trade Name: | XO Cross Coronary Support Catheter | | Classification Name: | Percutaneous Catheter 21 CFR §870.1250, Product Code DQY | | Device Class: | Class II | | Predicate Device: | 510(k) No.: K092396 Model: Quick Cross Extreme Support Catheter Manufacture: Spectranetics Corporation Classification: DQY | | Reference Device: | 510(k) No.: K210322 Model: XO Cross Support Catheter Manufacture: Transit Scientific, LLC Classification: DQY | ### 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. {4}------------------------------------------------ | 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: 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. ## 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 Support Catheter) | Subject Device – XO Cross Coronary Support Catheter | | Intended Use | The Intended patient population is those suffering from vascular disease, both coronary and peripheral. | The Intended patient population is those suffering from vascular disease. | The Intended patient population is those suffering from vascular disease, both coronary and peripheral. | | Ind. for Use | Quick-Cross Extreme Support Catheters are intended to guide and | The XO Cross is a support catheter intended to guide and support a guidewire | The XO Cross Coronary is a support catheter intended to guide and support a | | Table 2: Substantial Equivalence Comparison Chart | | | | | | Predicate – K092396 (Quick-Cross Catheter) | Reference – K210322 (XO Cross Support Catheter) | Subject Device – XO Cross Coronary Support Catheter | | | support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for thedelivery of saline solutions or diagnostic contrast agents. | during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents. | 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. | | Classification Name | Cardiovascular Device – Percutaneous Catheter 21 CFR §870.1250 Product Code: DQY Class II | Cardiovascular Device – Percutaneous Catheter 21 CFR §870.1250 Product Code: DQY Class II | Cardiovascular Device – Percutaneous Catheter 21 CFR §870.1250 Product Code: DQY Class II | | Single Use | Yes | Yes | Yes | | Fundamental Scientific Technology | Provide support for guidewire placement and fluid administration | Provide support for guidewire placement and fluid administration | Provide support for guidewire placement and fluid administration | | Prescription (Rx Only) | Yes | Yes | Yes | | Anatomical Access | Peripheral or Coronary Vasculature | Peripheral Vasculature | Peripheral or Coronary Vasculature | | Design | Single Lumen SS braided shaft w/ straight or angled tip. Distal end coated with hydrophilic coating. | Single Lumen metal alloy tube laser cut shaft w/ tapered tip and white polymer outer layer, with hydrophilic coating | Single Lumen metal alloy tube laser cut shaft w/ tapered tip and black polymer outer layer, with hydrophilic 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 Outer Diameter | 0.034", 0.038", 0.052 | 0.029", 0.037", 0.051" | 0.029" | | Visibility | 3 radiopaque markers | Radiopaque catheter body, polymer tip with radiopaque filler | Radiopaque catheter body, polymer tip with radiopaque filler | | Guidewire Compatibility | 0.014", 0.018", 0.035" | 0.014", 0.018", 0.035" | 0.014" | | Sheath / Introducer Compatibility | 4 Fr and 5 Fr | 2.9Fr and 4Fr | 2.9Fr | | Max Infusion Pressure | 300 psi, 500psi | Tested for manual infusion, not for use with power injectors. | Tested for manual infusion, not for use with power injectors. | | Sterility | Sterile - EO | Sterile - EO | Sterile - EO | | Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | {5}------------------------------------------------ ## Functional/Safety Testing: {6}------------------------------------------------ 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.