(245 days)
The XableCath catheter is intended to be used to facilitate access to discrete regions of the peripheral vasculature in conjunction with steerable guidewires. This device may be used to facilitate placement and exchange of guidewires and other interventional devices.
The XableCath Support Catheter device is an over-the-wire (OTW) single-lumen catheter, with blunt tip design. The catheter is offered in a product family configuration, with size models as outlined in the table below:
| Catalog Number Blunt Tip (B) | French Size | Working Length (cm) | Recommended Guidewire Inches (mm) |
|---|---|---|---|
| XC-014-065B | 5Fr | 65 | 0.014" (0.36 mm) |
| XC-014-090B | 5Fr | 90 | 0.014" (0.36 mm) |
| XC-014-145B | 5Fr | 145 | 0.014" (0.36 mm) |
| XC-018-065B | 6Fr | 65 | 0.018" (0.46 mm) |
| XC-018-090B | 6Fr | 90 | 0.018" (0.46 mm) |
| XC-018-145B | 6Fr | 145 | 0.018" (0.46 mm) |
| XC-035-065B | 7Fr | 65 | 0.035" (0.89 mm) |
| XC-035-090B | 7Fr | 90 | 0.035" (0.89 mm) |
| XC-035-145B | 7Fr | 145 | 0.035" (0.89 mm) |
The catheter shaft consists of a cortically reinforced co-polymeric material blend, with radiopaque cobalt chromiumtungsten-nickel distal tip. The proximal portion is comprised of an olefin strain relief and polycarbonate hub, which includes a female luer connection with the catheter lumen. The catheter pass-through lumen is used to advance the catheter over an appropriately sized guidewire for intravascular advancement to the target site. Component connections are ensured through inter-mechanical locks and utilization of medical grade adhesives. Catheter quidewire compatibility size/length are declared on the XableCath Support Catheter strain relief. All provided family member models are compatible with >=4Fr introducer sheaths. All configurations are provided sterile, single-use only.
The document describes the XableCath Support Catheter and its substantial equivalence determination to a predicate device, the Merit Medical SureCross® Catheter (K123311). This is a 510(k) premarket notification, which relies on demonstrating substantial equivalence rather than independent proof of safety and effectiveness through clinical trials like a PMA.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission refer to the non-clinical (bench) testing performed to demonstrate that the XableCath Support Catheter is as safe and effective as the predicate device. There is no mention of an AI-powered device or a study involving human readers or expert ground truth for image interpretation.
Here's a breakdown based on the provided text, focusing on the device's performance relative to the predicate rather than AI-specific criteria:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal "acceptance criteria" table with specific quantitative thresholds. Instead, it describes various non-clinical (bench) tests and states that the subject device was found to be "substantially equivalent" to the predicate in these areas. The performance is assessed comparatively.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Direct Product Bench In-vitro Comparison Testing | ||
| Visual & Technical Inspections | Comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| Luer Syringe Compatibility | Compatible with standard luer syringes, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| Sheath Compatibility | Compatible with introducer sheaths, comparable to predicate. All models compatible with ≥4Fr introducer sheaths. | Subject & predicate products shown to be substantially equivalent. All provided family member models are compatible with ≥4Fr introducer sheaths. |
| Guidewire Retraction/Reinsertion | Smooth and effective, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| Relative Radiopacity Comparison | Adequate visibility under fluoroscopy, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| Torque Transmission & Capability | Effective torque transmission, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| Simulated Use (Iliac model) | Effective performance in simulated use, comparable to predicate. Ease of insertion and tracking yields equivalent product delivery performance. | Subject & predicate products shown to be substantially equivalent. |
| Dimensional Assessment & Comparisons | Within acceptable variations, comparable to predicate. | "Similarly offered working lengths, and identical dimensional guidewire compatibility (i.e., 0.014", and 0.035")." Subject & predicate products shown to be substantially equivalent. Outer Diameters vary by model but are compared. |
| Leak Testing | No leaks, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| Catheter Kink-Resistance | Resistant to kinking, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| Tensile Testing (proximal & distal) | Adequate tensile strength, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| Corrosion Testing | No significant corrosion, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| General Packaging, Shelf-life/Expiry | Stable and effective packaging over shelf-life, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. Packaging integrity, transport challenge testing, and shelf-life testing were applied and successfully completed in accordance with established acceptance criteria demonstrating configurational adequacy. |
| Infusion Pressure/Burst Strength | ≥300 psi burst strength. | Reported: ≥300 psi, matching predicate. |
| Biocompatibility | Meet GLP rigors for biocompatibility (e.g., non-cytotoxic, non-irritating). | Full panel biocompatibility successfully performed under GLP rigors, demonstrating all utilized materials and methods of construction/processing passed biocompatibility rigors. (Specific tests: Cytotoxicity, Irritation/Intracutaneous Reactivity, Hemolysis, Complement Activation, Platelet and Leukocyte Count, Sensitization, Systemic Toxicity (Acute), Thromboresistance, Partial Thromboplastin Time, Materials Mediated Pyrogenicity). |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes (e.g., number of catheters) used for each bench test. The provenance is internal laboratory testing ("bench in-vitro comparison testing") likely conducted by the manufacturer, XableCath, Inc., to support their 510(k) submission. The data is non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device clearance based on substantial equivalence to a predicate, not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for these tests comes from objective physical measurements and established biological safety testing protocols (e.g., ISO standards, GLP practices).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not an imaging study requiring human adjudication of interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical medical catheter, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests would be established by:
- Physical standards and measurements: e.g., using calipers for dimensional checks, force gauges for tensile strength, calibrated pressure sensors for burst strength.
- Standardized test methods/protocols: e.g., ISO 10555-1 for intravascular catheters, and GLP (Good Laboratory Practice) guidelines for biocompatibility tests.
- Analytical chemistry/biology results: For biocompatibility, results from established lab assays (e.g., cell culture for cytotoxicity, animal models for systemic toxicity).
- Comparison to predicate: A key "ground truth" in a 510(k) is often the performance of the predicate device, with the new device needing to demonstrate comparable performance.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 7, 2017
XableCath, Inc. Mr. Rick Gaykowski Chief Regulatory Officer 417 S. Wakara Way, Suite 3510 Salt Lake City, UT 84108
Re: K170041
Trade/Device Name: XableCath Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: July 19, 2017 Received: July 24, 2017
Dear Mr. Gaykowski:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170041
Device Name XableCath Support Catheter
Indications for Use (Describe)
The XableCath catheter is intended to be used to facilitate access to discrete regions of the peripheral vasculature in conjunction with steerable guidewires. This device may be used to facilitate placement and exchange of guidewires and other interventional devices.
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) |
|---|---|
| -------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------- |
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Section 6 510(k) SUMMARY
XableCath Support Catheter
| Date prepared: | August 28, 2017 | ||
|---|---|---|---|
| Submitter information [21 CFR 807.929(a)(1)] | |||
| Name: | XableCath, Inc. | ||
| Address: | 417 S. Wakara Way, Ste 3510, Salt Lake City, Utah 84108-1457 | ||
| Phone Number: | (617) 447-4000 Mobile | ||
| Fax number: | N/A | ||
| Establishment Registration Number: | Yet to be secured | ||
| Name of contact person: | Rick Gaykowski, Chief Regulatory Officer | ||
| Name of the device [21 CFR 807.92(a)(2)] | |||
| Trade or proprietary name: | XableCath Support Catheter | ||
| Common or usual name: | Peripheral Vascular Support Catheter | ||
| Classification name: | Percutaneous Catheter | ||
| Classification number: | 21 CFRR 870.1250, Procode DQY | ||
| Legally marketed device(s) to which equivalence is claimed [21 CFR 807.92(a)(3)] | |||
| Merit Medical SureCross® Catheter (K123311) | |||
| Device description [21 CFR 807.92(a)(4)] | |||
| The XableCath Support Catheter device is an over-the-wire (OTW) single-lumen catheter, with blunt tip design. The catheter is offered in a product family configuration, with size models as outlined in the table below: | |||
| Catalog Number | Dimensions | ||
| Blunt Tip (B) | French Size | Working Length (cm) | Recommended Guidewire Inches (mm) |
| XC-014-065B | 5Fr | 65 | 0.014" (0.36 mm) |
| XC-014-090B | 5Fr | 90 | 0.014" (0.36 mm) |
| XC-014-145B | 5Fr | 145 | 0.014" (0.36 mm) |
| XC-018-065B | 6Fr | 65 | 0.018" (0.46 mm) |
| XC-018-090B | 6Fr | 90 | 0.018" (0.46 mm) |
| XC-018-145B | 6Fr | 145 | 0.018" (0.46 mm) |
| XC-035-065B | 7Fr | 65 | 0.035" (0.89 mm) |
| XC-035-090B | 7Fr | 90 | 0.035" (0.89 mm) |
| XC-035-145B | 7Fr | 145 | 0.035" (0.89 mm) |
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The catheter shaft consists of a cortically reinforced co-polymeric material blend, with radiopaque cobalt chromiumtungsten-nickel distal tip. The proximal portion is comprised of an olefin strain relief and polycarbonate hub, which includes a female luer connection with the catheter lumen. The catheter pass-through lumen is used to advance the catheter over an appropriately sized guidewire for intravascular advancement to the target site. Component connections are ensured through inter-mechanical locks and utilization of medical grade adhesives. Catheter quidewire compatibility size/length are declared on the XableCath Support Catheter strain relief. All provided family member models are compatible with ≥4Fr introducer sheaths. All configurations are provided sterile, single-use only.
Indications for Use [21 CFR 807.92(a)(5)]
The XableCath catheter is intended to facilitate access to discrete regions of the peripheral vasculature in conjunction with steerable quidewires. This device may be used to facilitate placement and exchange of quidewires and other interventional devices.
Comparison of the technological characteristics with the predicate device [21 CFR 807.92(a)(6)]
The subject devices and predicate devices are based on the following similar technological elements:
The XableCath Support Catheter indication for use is comparable to the predicate device, with direct overlap for peripheral application. Both device systems provide support access to the vasculature, utilize similar insertion and deployment principles, and allow for quidewire and other interventional device exchanges. Both products are for use in endovascular catheter utilization and deployment. Both products are configured with uniquely design distal tip regions for intravascular passage across stenotic regions. Furthermore, both catheters possess similarly offered working lengths, and identical dimensional quidewire compatibility (i.e., 0.014", and 0.035").
Both products have similar intended therapeutic applications, used in similar patient populations, and employ equivalent technological characteristics in achieving desired technical methods-of-action through manual advancement under fluoroscopic imaging. Similar categories of product materials comprise the subject and predicate products, with both containing hub/luer, shaft body, and distal tip design regions.
The following table illustrates comparable features of the subject and predicate products:
Substantial Equivalence Comparison
| Substantial Equivalence Comparison | ||
|---|---|---|
| Product Information | SubjectXableCath Support Catheter | PredicateMerit Medical SureCross®Catheter |
| 510(k) # | TBDThis Submission | K123311 |
| FDA Classification | Class II | Class II |
| Regulation Number | 870.1250 | 870.1250 |
| Product Code | DQY | DQY |
| Indications for Use | The XableCath catheter isintended to be used to facilitateaccess to discrete regions of theperipheral vasculature inconjunction with steerableguidewires. This device may beused to facilitate placement andexchange of guidewires and otherinterventional devices. | The Access & Support Catheter isintended for use during coronary andperipheral interventional proceduresto guide and support guidewires,traverse discrete portions of thevasculature, allow for guidewireexchange and provide a conduit forinfusion of saline solution, diagnosticcontrast agents and therapeuticagents. |
| Proximal Luer/Hub | HDPE | HDPE |
| Strain Relief | Olefin | PEBA |
| Catheter Shaft | Nylon, Single lumen | HDPE, Single lumen |
| Markers | Cobalt-chromium/SS | Pt/Ir |
| Coating | N/A | Hydrophilic |
| Infusion Pressure/Burst Strength | ≥300 psi | ≥300 psi |
| Outer Diameter | Varies by ModelProximal: 0.043", 0.053", 0.062"Distal: 0.060", 0.070", 0.080"Tip: 0.052", 0.063", 0.071" | Varies by ModelProximal: 0.039", 0.044", 0.063"Distal: 0.0265", 0.0305", 0.0505"Tip: 0.0195", 0.0225", 0.0405" |
| Guidewire Compatibility | 0.014", 0.018", 0.035" | 0.014", 0.018", 0.035" |
| Guide Catheter (max) | ≥4Fr | 5Fr |
| Access Sheath (max) | ≥4Fr | 5Fr |
| Effective Working Length | 65, 90, 145cm | 65, 90, 135, 150cm |
| Deployment | OTW - Manual | OTW - Manual |
| Sterilization Method | Gamma(SAL – 10-6) | EO(SAL – 10-6) |
| Single Use, Sterile | Yes | Yes |
| Labeling | Individual IFU: Warning, Cautions,Contraindications, tables, images,organized outline. | Individual IFU: Warning, Cautions,Contraindications, tables, images,organized outline. |
| Packaging | Sterile thermal sealed Tyvek/PETPouch, SBS Carton | Sterile thermal-sealed Pouch, SBSCarton |
| Use Environment | Rx Only – By or on the order of aphysician. Hospital, Lab/SurgicalSuite | Rx Only – By or on the order of aphysician. Hospital, Lab/SurgicalSuite |
| Performance Testing | ISO 10555-1 Second Edition 2013-07-01. Intravascular catheters --Sterile, single-use intravascularcatheters -- Part 1: General | ISO 10555-1 Second Edition 2013-07-01. Intravascular catheters --Sterile, single-use intravascularcatheters -- Part 1: General |
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The following technological differences exist between the subject and predicate devices:
The subject and predicate devices have slightly differing distal tip configurations, unique to their particular design, .
{6}------------------------------------------------
| and overall product composition. Nevertheless, both product distal tip designs are intended to achieve the same outcomes and have been shown to be commensurate in performance through comparative assessment. | ||
|---|---|---|
| • | The predicate product contains an exterior hydrophilic coating over the distal 40cm of length, whilst the subject product does not. Nevertheless, ease of insertion and tracking within applied models yields equivalent product delivery performance through comparative assessment. | |
| • | The predicate product is indicated for coronary application, and for delivery of diagnostic/therapeutic solutions, whilst the subject product is not. | |
| Despite these noted differences between the subject and predicate products, these attributes are determined to be cumulatively insignificant as demonstrated through direct product comparative assessment. | ||
| Performance Data [21 CFR 807.92(b)] | ||
| Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)] | ||
| • | Direct product bench in-vitro comparison testing has shown the subject & predicate products to be substantially equivalent, via assessment within the following areas: | |
| Visual & technical inspectionsLuer syringe compatibilitySheath compatibilityGuidewire retraction/reinsertionRelative radiopacity comparisonTorque transmission & capabilitySimulated use (iliac model) | Dimensional assessment & comparisonsGuidewire compatibilityLeak TestingCatheter kink-resistanceTensile testing (proximal & distal)Corrosion testingGeneral packaging, shelf-life/expiry | |
| • | Full panel biocompatibility was successfully performed in accord with product classification, under GLP rigors, demonstrating that all utilized materials and methods of construction/processing passed biocompatibility rigors. Conducted test included: | |
| CytotoxicityIrritation/Intracutaneous ReactivityHemolysisComplement ActivationPlatelet and Leukocyte Count | SensitizationSystemic Toxicity (Acute)ThromboresistancePartial Thromboplastin TimeMaterials Mediated Pyrogenicity | |
| • | Packaging integrity, transport challenge testing, and shelf-life testing were applied and successfully completed in accordance with established acceptance criteria demonstrating configurational adequacy. | |
| Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)] | ||
| No clinical tests were necessary. However human factors engineering and usability assessments were performed. | ||
| Conclusions drawn [21 CFR 807.92(b)(3)] | ||
| Based upon the overlapping intended use, basal product designs, methods of deployment, target population and anatomical site overlap, and direct bench comparative assessment the preponderance of gathered evidence within this pre-market notification application demonstrates the XableCath Support Catheter has been shown to be substantially equivalent to the predicate device. Furthermore, the XableCath Support Catheter raises no new questions of safety or effectiveness when compared directly to the predicate device, and is therefore justifiably concluded to be substantially equivalent for declared intended use. |
§ 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).