(161 days)
Not Found
No
The description focuses on the physical characteristics and functional performance of a microcatheter for delivering materials, with no mention of AI or ML capabilities.
No.
The device itself is not a therapeutic device, but rather a conduit for delivering therapeutic materials.
No
The device is a microcatheter intended for the delivery of diagnostic, embolic, or therapeutic materials, but it does not perform the diagnostic function itself. It acts as a conduit.
No
The device description clearly outlines a physical medical device (microcatheter) made of metal alloy with specific physical characteristics and components, not a software-only device.
Based on the provided information, the XO Cath Microcatheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "peripheral vascular use" and "controlled and selective infusion of diagnostic, embolic or therapeutic materials into the vessel." This describes a device used within the body for delivery and access, not for testing samples outside the body.
- Device Description: The description details a catheter designed to be inserted into blood vessels, support a guidewire, and deliver substances. This is consistent with an invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is mechanical and delivery-based.
Therefore, the XO Cath Microcatheter is a medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The XO Cath Microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic or therapeutic materials into the vessel.
Product codes
KRA
Device Description
The subject XO Cath Microcatheter is a single-lumen, metal alloy shaft with micro-cuts for flexibility, designed to support a guidewire during access of the peripheral vasculature, and to provide a conduit for the delivery of embolic applications. The XO Cath Microcatheter is available in two lumen sizes, 2.0Fr and 2.6Fr.
The XO Cath 2.0Fr and 2.6Fr Microcatheters are available with a straight or bern tip shape to aid with accessing challenging anatomy. The distal outer surface of the microcatheter is coated with a hydrophilic coating. Radiopaque markers are located at the distal tip to facilitate fluoroscopic visualization. The proximal end incorporates a standard luer for ease of use and to connect with a syringe.
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)
Functional Testing:
The following testing was conducted to validate and verify that the subject device was substantially equivalent to the predicate devices. All data met pre-determined acceptance criteria.
Biocompatibility of the complete and finished XO Cath Microcatheter 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 (
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
November 29, 2023
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 & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Transit Scientific, LLC % Spencer Walker Director of Regulatory Affairs University of Utah, Center for Medical Innovation 10 North 1900 East, EHSL Rm. 22 Salt Lake City, Utah 84112
Re: K231821
Trade/Device Name: XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: October 27, 2023 Received: October 30, 2023
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Samuel G. Raben -S
for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices
2
OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231821
Device Name
XO Cath Microcatheter (E20-090-S, E20-130-S, E20-175-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-110-S, E26-130-S, E26-175-S, E26-175-S, E26-220-S, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)
Indications for Use (Describe)
The XO Cath Microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic or therapeutic materials into the vessel.
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) | □ |
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Image /page/4/Picture/0 description: The image shows the logo for Transit Scientific. The logo is in black and white and features the words "TRANSIT" stacked on top of "SCIENTIFIC." The word "TRANSIT" is in a bold, sans-serif font, while the word "SCIENTIFIC" is in a thinner, sans-serif font. There is a trademark symbol to the right of the word "SCIENTIFIC."
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: | June 20, 2023 |
| Trade Name: | XO Cath Microcatheter |
| Classification Name: | Continuous Flush Catheter |
| 21 CFR §870.1210, Product Code KRA | |
| Device Class: | Class II |
| Predicate Device: | 510(k) No.: K163701 |
| Model: Direxion and Direxion Hi-Flo Torqueable Microcathete | |
| Manufacture: Boston Scientific Corporation | |
| Classification: KRA |
Device Description:
The subject XO Cath Microcatheter is a single-lumen, metal alloy shaft with micro-cuts for flexibility, designed to support a guidewire during access of the peripheral vasculature, and to provide a conduit for the delivery of embolic applications. The XO Cath Microcatheter is available in two lumen sizes, 2.0Fr and 2.6Fr.
The XO Cath 2.0Fr and 2.6Fr Microcatheters are available with a straight or bern tip shape to aid with accessing challenging anatomy. The distal outer surface of the microcatheter is coated with a hydrophilic coating. Radiopaque markers are located at the distal tip to facilitate fluoroscopic visualization. The proximal end incorporates a standard luer for ease of use and to connect with a syringe.
5
Image /page/5/Picture/1 description: The image shows the logo for Transit Scientific. The logo is in black and white and features the word "TRANSIT" in large, bold letters on the top line. Below that, the word "SCIENTIFIC" is written in smaller letters. The logo has a clean and modern design.
| Table 1: XO Cath Microcatheter Model Numbers | |
|---|---|
| Model No. | Description |
| E20-090-S | XO Cath Microcatheter – 2.0 Fr diameter, and 90cm length, Straight Tip |
| E20-110-S | XO Cath Microcatheter - 2.0 Fr diameter, and 110cm length, Straight Tip |
| E20-130-S | XO Cath Microcatheter – 2.0 Fr diameter, and 130cm length, Straight Tip |
| E20-150-S | XO Cath Microcatheter – 2.0 Fr diameter, and 150cm length, Straight Tip |
| E20-175-S | XO Cath Microcatheter - 2.0 Fr diameter, and 175cm length, Straight Tip |
| E20-220-S | XO Cath Microcatheter – 2.0 Fr diameter, and 220cm length, Straight Tip |
| E20-090-B | XO Cath Microcatheter - 2.0 Fr diameter, and 90cm length, Bern Tip |
| E20-110-B | XO Cath Microcatheter – 2.0 Fr diameter, and 110cm length, Bern Tip |
| E20-130-B | XO Cath Microcatheter – 2.0 Fr diameter, and 130cm length, Bern Tip |
| E20-150-B | XO Cath Microcatheter – 2.0 Fr diameter, and 150cm length, Bern Tip |
| E20-175-B | XO Cath Microcatheter – 2.0 Fr diameter, and 175cm length, Bern Tip |
| E20-220-B | XO Cath Microcatheter – 2.0 Fr diameter, and 220cm length, Bern Tip |
| E26-090-S | XO Cath Microcatheter – 2.6 Fr diameter, and 90cm length, Straight Tip |
| E26-110-S | XO Cath Microcatheter – 2.6 Fr diameter, and 110cm length, Straight Tip |
| E26-130-S | XO Cath Microcatheter – 2.6 Fr diameter, and 130cm length, Straight Tip |
| E26-150-S | XO Cath Microcatheter – 2.6 Fr diameter, and 150cm length, Straight Tip |
| E26-175-S | XO Cath Microcatheter - 2.6 Fr diameter, and 175cm length, Straight Tip |
| E26-220-S | XO Cath Microcatheter – 2.6 Fr diameter, and 220cm length, Straight Tip |
| E26-090-B | XO Cath Microcatheter - 2.6 Fr diameter, and 90cm length, Bern Tip |
| E26-110-B | XO Cath Microcatheter - 2.6 Fr diameter, and 110cm length, Bern Tip |
| E26-130-B | XO Cath Microcatheter – 2.6 Fr diameter, and 130cm length, Bern Tip |
| E26-150-B | XO Cath Microcatheter – 2.6 Fr diameter, and 150cm length, Bern Tip |
| E26-175-B | XO Cath Microcatheter - 2.6 Fr diameter, and 175cm length, Bern Tip |
| E26-220-B | XO Cath Microcatheter - 2.6 Fr diameter, and 220cm length, Bern Tip |
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Image /page/6/Picture/1 description: The image shows the logo for Transit Scientific. The word "TRANSIT" is in all caps and bolded on the top line. The word "SCIENTIFIC" is in all caps on the second line, but it is not bolded.
Indications for Use:
The XO Cath Microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic or therapeutic materials into the vessel.
Comparative Analysis:
It has been demonstrated that the XO Cath Microcatheter is comparable to the predicate device in intended use, fundamental scientific technology, design, principles of operation and functional performance evaluations. The XO Cath Microcatheter has been fully assessed within the Transit Scientific Risk Management and Design Controls systems. All necessary verification steps met pre-determined acceptance criteria to determine performance as compared to the predicate.
It has been demonstrated that the XO Cath Microcatheter 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 or similar operating principle
- . Similar performance specifications
- Similar patient-user interface
| | Subject Device –
(XO Cath 2.0 Fr) | Predicate –
K163701 (Direxion
Microcatheter) | Subject Device –
(XO Cath 2.6 Fr) | Predicate –
K163701 (Direxion
Hi-Flo
Microcatheter) | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Ind. for Use | The XO Cath
Microcatheter is intended
for peripheral vascular
use. The microcatheter
can be used for
controlled and selective
infusion of diagnostic,
embolic, or therapeutic
materials into the vessel | The Direxion
Microcatheters is
intended for peripheral
vascular use. The
microcatheter can be
used for controlled and
selective infusion of
diagnostic, embolic, or
therapeutic materials into
the vessel. | The XO Cath
Microcatheter is
intended for peripheral
vascular use. The
microcatheter can be
used for controlled and
selective infusion of
diagnostic, embolic, or
therapeutic materials
into the vessel. | The Direxion HI-FLO
Torqueable
Microcatheters is
intended for peripheral
vascular use. The
microcatheter can be
used for controlled and
selective infusion of
diagnostic, embolic, or
therapeutic materials
into the vessel. | |
| Classification
Name | Cardiovascular Device - Continuous Flush Catheter
21 CFR §870.1210
Product Code: KRA
Class II | | | | |
| Single Use | Yes | | | | |
| Prescription (Rx
Only) | Yes | | | | |
| Table 2: Substantial Equivalence Comparison Chart | | | | | |
| | Subject Device -
(XO Cath 2.0 Fr) | Predicate -
K163701 (Direxion
Microcatheter) | Subject Device -
(XO Cath 2.6 Fr) | Predicate -
K163701 (Direxion
Hi-Flo
Microcatheter) | |
| Anatomical
Access | Peripheral vasculature | | | | |
| Effective
Length (cm) | 90cm, 110cm,
130cm, 150cm,
175cm, and 220cm | 105cm, 130cm,
155cm | 90cm, 110cm,
130cm, 150cm,
175cm, and 220cm | 105cm, 130cm,
155cm | |
| Shaft Outer
Diameter | Distal: 2.0 Fr
Proximal: 2.6 Fr | Distal: 2.4 Fr
Proximal: 2.7 Fr | Distal: 2.6 Fr
Proximal: 2.75Fr | Distal: 2.8 Fr
Proximal: 3.0 Fr | |
| Inner Lumen | 0.021" | 0.021" | 0.027" | 0.027" | |
| Max Pressure
(PSI) | 1200 | | | | |
| Max Flow Rate
(mL/s) | 2.0Fr x 130cm:
3.0 mL/s | 2.4Fr x 130cm:
3.1 mL/s | 2.6Fr x 130cm:
5.8 mL/s | 2.8Fr x 130cm:
5.6 mL/s | |
| Dead Space
Volume (mL) | 2.0Fr x 130cm:
0.47 mL | 2.4Fr x 130cm:
0.46 mL | 2.6Fr x 130cm:
0.66 mL | 2.8Fr x 130cm:
0.64 mL | |
| Hydrophilic
Coating | Yes | | | | |
| Visibility/
Radiopacity | Radiopaque Marker Bands on catheter body | | | | |
| Guidewire
Compatibility | Max 0.018" | Max 0.018" | Max 0.021" | Max 0.021" | |
| Guide
Catheter
Compatibility | Min. 0.038 in | Min. 0.035 in | Min. 0.038 in | Min. 0.038 in | |
| Embolic
Compatibility | ≤ 700 Micron spheres
≤ 500 Micron particles
Coils & Plugs (max
0.021" recommended
microcatheter
compatible)
Liquid Embolics
(DMSO.
Lipiodol/Ethiodol,
Cyanoacrylate
adhesives) | ≤ 700 Micron spheres
≤ 500 Micron particles
Coils (max 0.018"
recommended
microcatheter
compatible)
Liquid Embolics
(DMSO.
Lipiodol/Ethiodol,
Cyanoacrylate
adhesives, Ethanol) | ≤ 900 Micron spheres
≤ 700 Micron particles
Coils & Plugs (max
0.027" recommended
microcatheter
compatible)
Liquid Embolics
(DMSO,
Lipiodol/Ethiodol,
Cyanoacrylate
adhesives) | ≤ 900 Micron spheres
≤ 710 Micron particles
Liquid Embolics
(DMSO,
Lipiodol/Ethiodol,
Cyanoacrylate
adhesives, Ethanol) | |
| Tip Shape | Straight, Bern | Straight, Bern, J,
Swan | Straight, Bern | Straight, Bern, J,
Swan | |
| Shapable | No | Some SKUs (via
steam) | No | Some SKUs (via
steam) | |
7
Functional Testing:
The following testing was conducted to validate and verify that the subject device was substantially equivalent to the predicate devices. All data met pre-determined acceptance criteria.
8
TRANSIT
SCIENTIFIC™
- Biocompatibility Biocompatibility of the complete and finished XO Cath Microcatheter ● 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 (