(149 days)
No
The description focuses on the physical characteristics and intended use of a support catheter, with no mention of AI or ML capabilities. The performance studies are limited to functional and safety testing.
No
The device is a support catheter used to guide and support other instruments and deliver substances, not directly treat a medical condition.
No
Explanation: The device is described as a "support catheter intended to guide and support a guidewire...allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents," which are functional purposes rather than diagnostic ones. While it can deliver diagnostic contrast agents, the device itself does not perform or interpret diagnostic functions.
No
The device description clearly describes a physical catheter with a shaft, tip, and radiopaque properties, 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 in vivo (within the body) to support a guidewire, allow for exchanges, and deliver solutions or contrast agents within the peripheral vasculature. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a catheter designed to be inserted into the vasculature. This is consistent with an in vivo device, not an in vitro diagnostic.
- Anatomical Site: The anatomical site is the "Peripheral Vasculature," which is an in vivo location.
- Input Imaging Modality: The use of "Fluoroscopy" indicates real-time imaging of the device within the body, which is typical for in vivo procedures.
- Performance Studies: The performance studies focus on biocompatibility and design verification related to insertion and use within the body. These are not the types of studies typically performed for IVDs, which would focus on analytical and clinical performance related to testing specimens.
In summary, the function, design, and intended use of the XO Cross catheter are all consistent with a medical device used within the body for interventional procedures, not an in vitro diagnostic device used to test specimens outside the body.
N/A
Intended Use / 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.
Product codes
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
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)
Functional/Safety Testing:
The following functional tests were performed. All data met pre-determined acceptance criteria.
- 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 (
§ 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
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
1
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
2
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
3
| 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) | |
| 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."
4
| 510(k) Summary | |
|---|---|
| Submitter: | Transit Scientific, LLC. |
| Contact Person: | Spencer Walker, MSC – Director Regulatory Affairs |
| Center for Medical Innovation | |
| 10 North 1900 East, Rm 22B | |
| Salt Lake City, UT 84112 | |
| (801) 581-5080 | |
| Date Prepared: | December 5, 2019 |
| Trade Name: | XO Cross Support Catheter |
| Classification Name: | Percutaneous Catheter |
| 21 CFR §870.1250, Product Code DQY | |
| Device Class: | Class II |
| Predicate Device: | • K082561 – Quick-Cross Extreme Support Catheter, |
| Spectranetics Corporation, Inc. |
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.
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:
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
5
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 Catheters | |||
| are intended to guide and support a | ||||
| guidewire during access of the | ||||
| vasculature, allow for wire exchanges | ||||
| and provide a conduit for the delivery of | ||||
| saline solutions or diagnostic contrast | ||||
| agents. | 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. | ||||
| Classification | ||||
| Name | Cardiovascular Device - Percutaneous | |||
| Catheter | ||||
| 21 CFR §870.1250 | ||||
| Product Code: DQY | ||||
| Class II | Same | |||
| Single Use | Yes | Same | ||
| Fundamental | ||||
| Scientific | ||||
| Technology | Single | Same | ||
| Prescription | ||||
| (Rx Only) | Yes | Same | ||
| Anatomical | ||||
| Access | Peripheral Vasculature | Same | ||
| Design | Single Lumen SS braided shaft w/ | |||
| straight or angled tip. Distal 40 cm | ||||
| coated with hydrophilic coating. | Single Lumen metal alloy hypo-tube | |||
| shaft w/ tapered tip and polymer | ||||
| jacket. | ||||
| Effective | ||||
| Length (cm) | 65, 90, 135, 150 | 90, 135, 150, 175 | ||
| Catheter Sizes | 4Fr | 2Fr - 4Fr | ||
| Distal Tip | ||||
| Profile | 1.9 Fr, 2.1Fr, 3.2Fr | 1.6Fr, 1.9Fr, 3.2Fr | ||
| Shaft Outer | ||||
| Diameter | 0.034", 0.038", 0.053" | 0.029", 0.037", 0.051" |
6
| 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 | ||
| Guidewire | ||
| Compatibility | 0.014", 0.018", 0.035" | Same |
| Sheath / | ||
| Introducer | ||
| Compatibility | 4 Fr, 5 Fr | 4Fr |
| Max Infusion | ||
| Pressure | 300 psi, 500psi | Tested for manual infusion, not for |
| use 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 (