(103 days)
No
The description focuses on the physical characteristics and function of a support catheter, with no mention of AI or ML capabilities.
No.
The device facilitates access and delivery, but does not directly treat a disease or condition.
No
The device is a support catheter for guiding guidewires and delivering fluids/contrast agents, not for diagnosing conditions. Its primary functions are mechanical support and conduit.
No
The device description clearly describes a physical catheter with a shaft, tip, radiopaque components, and a hydrophilic coating, indicating it is a hardware device.
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 within the body to support a guidewire, allow for exchanges, and deliver solutions or contrast agents. This is an in vivo application, meaning it's used on or within a living organism.
- Device Description: The description reinforces the in vivo nature of the device, detailing its use within the vasculature and its radiopaque properties for tracking under fluoroscopy.
- 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.) to provide information for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be used directly within the body for procedural support or delivery.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral or Coronary 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 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: 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.
- Design Verification: Performance bench testing was conducted to ensure that the XO Cross Coronary Catheter met the applicable design and performance requirements throughout 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: Tip ID Testing, Tip Tensile Testing, Distal Shaft Kink Testing, Simulated Use.
- Packaging: The proposed changes to the XO Cross Support Catheter did not affect the packaging or its configuration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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) | ||
|---|---|---|
| ------------------------------------------------- | --------------------------------------- | --------------------------------------- |
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 (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.