(259 days)
No
The device description and performance studies focus on the physical characteristics and functional performance of a support catheter, with no mention of AI or ML.
No
This device is a support catheter used for guidewire access, wire exchanges, and delivery of solutions, not for directly treating a disease or condition.
No
The device is a support catheter used to guide wires, allow wire exchanges, and deliver saline solutions or diagnostic contrast agents. While it facilitates the delivery of diagnostic contrast agents, it does not itself perform any diagnostic function such as analyzing data or providing a diagnosis.
No
The device description clearly outlines a physical catheter with a shaft, tip, radiopaque components, and a hydrophilic coating. The performance studies detail biocompatibility and design verification tests related to the physical properties and materials of the catheter, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) to support a guidewire, allow for wire exchanges, and deliver solutions or contrast agents within the peripheral vasculature.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like radiopacity for tracking under fluoroscopy and a hydrophilic coating for easier navigation within the vasculature.
- Function: The device's function is to assist in procedures performed directly on the patient's circulatory system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is used directly within the body during a medical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral Vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Cytotoxicity
- Sensitization
- Irritation/ Intracutaneous Toxicity
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Hemolysis Assay
- Complement Activation
- LAL Pyrogenicity
- 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
- Radiopacity Acceptability
- Tip ID Testing
- Tip Tensile Testing
- Hydrophilic Coating
- Biocompatibility Testing
- Catheter OD Testing
- Coating Lubricity Testing
- Coating Durability Testing
- Distal Catheter Tensile
- Coating Particulate Testing
- Simulated Use
- Coating Integrity
- Coaxial Testing
- Polymer Tip Extrusion radiopaque filler increase
- Packaging The proposed changes to the XO Cross Support Catheter did not affect the packaging or its configuration.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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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3
| 510(k) Summary | |
|---|---|
| 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) 581-5080 | |
| Spencer.walker@hsc.utah.edu | |
| Date Prepared: | March 19, 2021 |
| Trade Name: | XO Cross Support Catheter |
| Classification Name: | Percutaneous Catheter |
| 21 CFR §870.1250, Product Code DQY | |
| Device Class: | Class II |
| Predicate Device: | 510(k) No.: K193420 |
| Model: XO Cross Support Catheter | |
| Manufacture: Transit Scientific, LLC | |
| 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.
4
| Product
| Family | Catalog No. | Description |
|---|---|---|
| XO Cross | ||
| Support | ||
| Catheter | C14-090 | XO Cross 014 – 0.014-inch diameter catheter shaft in |
| 90cm, 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.
5
| Table 2: Substantial Equivalence Comparison Chart | ||||
|---|---|---|---|---|
| Predicate - K193420 | ||||
| (XO Cross Support Catheter) | Subject Device - K210322 | |||
| XO Cross Support Catheter | ||||
| Ind. 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. | Same | |||
| Classification | ||||
| Name | Cardiovascular Device - Percutaneous | |||
| Catheter | ||||
| 21 CFR §870.1250 | ||||
| Product Code: DQY | ||||
| Class II | Same | |||
| Single Use | Yes | Same | ||
| Fundamental | ||||
| Scientific | ||||
| Technology | Provide support for guidewire placement and | |||
| fluid administration | Same | |||
| Prescription | ||||
| (Rx Only) | Yes | Same | ||
| Anatomical | ||||
| Access | Peripheral Vasculature | Same | ||
| Design | Single Lumen metal alloy tube laser cut | |||
| shaft w/ tapered tip and polymer outer | ||||
| layer. | Single Lumen metal alloy tube | |||
| laser cut shaft w/ tapered tip and | ||||
| polymer outer layer, with | ||||
| hydrophilic 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 Outer | ||||
| Diameter | 0.029", 0.037", 0.051" | Same | ||
| Visibility | Radiopaque catheter body, polymer tip with | |||
| radiopaque filler | Radiopaque catheter body, | |||
| polymer tip with increased | ||||
| radiopaque filler | ||||
| Guidewire | ||||
| Compatibility | 0.014", 0.018", 0.035" | Same | ||
| Sheath / | ||||
| Introducer | ||||
| Compatibility | 2.9Fr and 4Fr | Same | ||
| Max Infusion | ||||
| Pressure | Tested for manual infusion, not for use with | |||
| power injectors. | Same | |||
| Sterility | Sterile - EO | Same | ||
| Biocompatibility | ISO 10993 | Same |
6
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
- Polymer Tip Extrusion radiopaque filler increase
- 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.