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.

Device Description

Catheter, Percutaneous

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: XableCath Support Catheter

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than explicitly listing quantitative acceptance criteria and then demonstrating performance against them in a tabular format. Instead, it details various tests and their successful completion, implying that "passing" each test constitutes meeting an implicit acceptance criterion.

However, based on the Performance Testing section and the Summary of non-clinical tests conducted, we can infer the acceptance criteria and reported performance:

Acceptance Criteria (Inferred from tests conducted)	Reported Device Performance (Implied "Pass" or "Acceptable")
Visual & Technical Inspections	Equivalent to predicate
Dimensional Assessment & Comparisons	Equivalent to predicate
Luer Syringe Compatibility	Equivalent to predicate
Guidewire Compatibility	Equivalent to predicate
Sheath Compatibility	Equivalent to predicate
Leak Testing	Equivalent to predicate
Guidewire Retraction/Reinsertion	Equivalent to predicate
Catheter Kink-Resistance	Equivalent to predicate
Relative Radiopacity Comparison	Equivalent to predicate
Tensile Testing (proximal & distal)	Equivalent to predicate
Torque Transmission & Capability	Equivalent to predicate
Corrosion Testing	Equivalent to predicate
Simulated Use (iliac model)	Equivalent to predicate
General Packaging, Shelf-Life/Expiry	Successfully completed; configurational adequacy demonstrated
Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous, Reactivity, Hemolysis, Systemic Toxicity (Acute), Complement Activation, Thromboresistance, Platelet and Leukocyte Count, Partial Thromboplastin Time, Materials Mediated Pyrogenicity)	All utilized materials and methods of construction/processing passed biocompatibility rigors (successfully performed in accord with product classification, under GLP rigors).
Packaging Integrity & Transport Challenge Testing	Successfully completed in accordance with established acceptance criteria
Clinical Safety (Intra-procedural complications)	No procedural complications attributable to the XableCath Support Catheter in 27 uses across 26 patients. No thrombosis, arterial rupture, or distal embolization.
Clinical Effectiveness (Performance as intended)	All arterial access sites and segments typically used for lower extremity angiography were used/traversed safely. The device performed as intended as an over-the-wire PAD catheter for guidewire and other interventional product exchange. (80 arterial segments traversed, no new questions of safety and effectiveness, no intra-procedural complications observed).
Post-procedure follow-up (6-8 weeks)	No complications noted at a mean follow-up of 53 days post-procedure office visit attributable to the XableCath Support Catheter. No XableCath Support Catheter related vessel perforation, major dissection, or distal debris embolization, nor abrasion tip post-procedural clinical sequelae were observed.
Infusion Pressure/Burst Strength	≥300 psi (Stated as a characteristic, implies meeting a minimum)

2. Sample size used for the test set and data provenance

Sample Size for Clinical (In-vivo) Testing: 26 patients (20 male, 6 female), using 27 XableCath Support Catheters.
Data Provenance: The study was a "real-world actual-use assessment" and "real-world validation study cohort" conducted as part of product design validation. The document does not explicitly state the country of origin, but given it's an FDA submission, it's highly likely to be U.S.-based or from a country adhering to similar regulatory standards. It is a prospective collection of data from actual patient procedures for validation purposes.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts

Number of Experts: One operating physician was responsible for medically observing patients in follow-up. It can be inferred that multiple experts (interventional cardiologists/radiologists) were involved in the procedures themselves, as the collective actions and observations during the "real-world actual-use assessment" formed the basis of the safety and performance evaluation. However, only one "operating physician" is explicitly mentioned for follow-up. Ground truth for device performance and complications during the procedure would be established by the proceduralists.
Qualifications of Experts: The document refers to "operating physician(s)" and the context of procedures like angiography and PAD interventions implies that these are interventional cardiologists or radiologists with expertise in peripheral vascular interventions. Specific years of experience are not mentioned.

4. Adjudication method for the test set

The document does not explicitly state an adjudication method (like 2+1 or 3+1). The "operating physician" observed patients in follow-up, and findings during the procedure would have been documented by the medical team. The conclusions drawn are from "real-world actual-use assessment" and "real-world validation," suggesting that the medical community's standard practices for evaluating device performance and adverse events during and after such procedures would apply. This typically involves the proceduralist's assessment and follow-up clinical evaluation, but not a formal, independent adjudication panel as might be seen for subjective AI interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. This device is a physical medical instrument (a support catheter), not an AI algorithm for diagnostic imaging interpretation. Therefore, the concept of human readers improving with AI assistance is not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. As stated above, this is a physical medical device, not a standalone AI algorithm. The performance described is its standalone mechanical and functional operation.

7. The type of ground truth used

For the clinical study:

Expert Clinical Assessment and Outcomes Data:
- Intra-procedural observations: Adequacy of passage, procedural complications (e.g., dissection, thrombosis, rupture, embolization) as observed by the operating physician(s) and documented during the angiography procedures.
- Post-procedural follow-up: Clinical sequelae (complications attributable to the device) observed at a mean of 53 days post-procedure office visit by the operating physician. This constitutes direct observation of patient outcomes.

8. The sample size for the training set

Not applicable. This document describes a physical medical device validation, not an AI/machine learning model that requires a training set. The "design validation" and "verification tests" relate to engineering principles and clinical observational assessments rather than model training.

9. How the ground truth for the training set was established

Not applicable. (See point 8).

Summary

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Image /page/0/Picture/0 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

May 15, 2018

XableCath, Inc. Mr. Rick Gaykowski Chief Regulatory Officer 417 South Wakara Way, Suite 3510 Salt Lake City, Utah 84108-1457

Re: K180986

Trade/Device Name: XableCath Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 7, 2018 Received: April 16, 2018

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole G. Ibrahim -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) K180986

Device Name XableCath Support Catheter

Indications for Use (Describe)

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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| X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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K180986

XableCath

Special 510(k) Special 510(k)
XableCath™ Support Catheter

510(k) SUMMARY XableCath™ Support Catheter

Submitter Information [21 CFR 807.929(a)(1)]
Name	XableCath, Inc.
Address	417 S Wakara Way, Suite 3510Salt Lake City, UT 84108-1457USA
Phone number	617-447-4000 Mobile
Fax number	N/A
EstablishmentRegistration Number	Yet to be secured
Name of contactperson(s)	Rick Gaykowski, Chief Regulatory Officer, PrimaryLisa Dunlea, Pres/CEO, Secondary
Date prepared	April 7, 2018
Name of the device [21 CFR 807.92(a)(2)]
Trade or proprietaryname	XableCath Support Catheter
Common or usualname	Peripheral Vascular Support Catheter
Classification name	Class II
Regulation	21 CFR 870.1250
Product Code(s)	DQY
Legally marketeddevice(s) to whichequivalence is claimed[21 CFR 807.92(a)(3)]	XableCath Support Catheter, cleared under 510(k) K170041
Device description[21 CFR 807.92(a)(4)]	Catheter, Percutaneous
Indications for use[21 CFR 807.92(a)(5)]	The XableCath catheter is intended to be used to facilitate access to discreteregions of the peripheral vasculature in conjunction with steerable guidewires.This device may be used to facilitate placement and exchange of guidewires andother interventional devices.
Summary of the technological characteristics of the device compared to the predicate device[21 CFR 807.92(a)(6)]
Feature	Subject Device: XableCath SupportCatheter
	Predicate Device: XableCath SupportCatheter
Proximal Luer/Hub	HDPE
	HDPE
Strain Relief	Olefin	Olefin
Catheter Shaft	Nylon, Single lumen	Nylon, Single lumen
Markers	Cobalt-chromium/SS	Cobalt-chromium/SS
Distal Tip	Abrasion	Blunt
Distal Tip Material	Cobalt chromium alloy	Cobalt chromium alloy
Coating	N/A	N/A
InfusionPressure/BurstStrength	≥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: 0.043", 0.053", 0.062"Distal: 0.060", 0.070", 0.080"Tip: 0.052", 0.063", 0.071
		GuidewireCompatibility	0.014", 0.018", 0.035"
Guide Catheter (max)			≥4Fr
Access Sheath (max)	≥4Fr	≥4Fr
Effective WorkingLength	65, 90, 145cm	65, 90, 145cm
	Deployment	OTW - Manual	OTW - Manual
Sterilization Method	Gamma(SAL - 10-6)	Gamma(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 Tyvek/PETPouch, SBS Carton
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: GeneralRequirements	ISO 10555-1 Second Edition 2013-07-01. Intravascular catheters --Sterile, single-use intravascularcatheters -- Part 1: GeneralRequirements
Indications for Use		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 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.
Performance Data [21 CFR 807.92(b)]
Summary of non-clinical tests conducted for determination of substantial equivalence[21 CFR 807.92(b)(1)]
As required by the risk analysis, the following verification tests have been conducted on the XableCath Support Catheter (please refer to Section 17 for additional information):
Direct product bench in-vitro comparison testing has shown the subject & predicate products to be equivalent, via assessment within the following areas:
Visual & technical inspections Luer syringe compatibility Sheath compatibility Guidewire retraction/reinsertion Relative radiopacity comparison Torque transmission & capability Simulated use (iliac model)		Dimensional assessment & comparisons Guidewire compatibility Leak Testing Catheter kink-resistance Tensile testing (proximal & distal) Corrosion testing General 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:
Cytotoxicity Irritation/Intracutaneous Hemolysis Complement Activation Platelet and Leukocyte Count	Sensitization Reactivity Systemic Toxicity (Acute) Thromboresistance Partial Thromboplastin Time Materials 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)]
Twenty-six (26) patients (20 male (77%), 6 female (23%)) whose mean age was 69 years old (range of 55 - 94 years) underwent angiography of the lower extremity through various arterial access sites including femoral, brachial, and radial locations, using 27 XableCath Support Catheters abrasion-tip configuration of various lengths and sizes as part of product design validation (worst-case orientation). Fluoroscopy and angiography were used in each patient to assess the passage adequacy of all XableCath catheters. Each patient was medically observed in follow-up by the same operating physician approximately 6-8 weeks after the PAD interventional procedure.

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Section 7
Page 3 of 4

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XableCath

Within the real-world actual-use assessment. 80 arterial segments were traversed by the XableCath Support Catheter ranging from the radial to the tibial arteries. Within each of the therapeutic vascular deployments, there were no procedural complications attributable to the XableCath Support Catheter. There was one intravascular procedural complication recorded (minor dissection), attributable to post XableCath Support Catheter placement balloon angioplasty, that was uneventfully treated with stent placement. No thrombosis, arterial rupture, or distal embolization occurred in this extended validation assessment. Furthermore, there were no complications noted at a mean follow-up of 53 days postprocedure office visit attributable to the XableCath Support Catheter.

From real-world validation, the following points are concluded from the aforenoted controlled assessment of the XableCath Support Catheter performed on 26 PAD subjects:

Available sized XableCath Support Catheter abrasion tip configurations raise no new ● questions of safety and effectiveness, with no intra-procedural complications observed within
. Every arterial access site typically used for lower extremity angiography was used during the assessment;
. Every arterial segment an operator typically passes in lower extremity angiography was safely traversed within the assessment; and
. The XableCath Support Catheter abrasion tip configuration when used in accordance with provided instructions can perform as intended as an over-the-wire PAD catheter for use in exchange of guidewires and other interventional products.

Hence, design & in-vivo validation evidence has been firmly established for the subject XableCath Support Catheter product demonstrating both design adequacy and deployment/utilization safety of tip design. The conducted assessment was performed on a real-world validation study cohort (i.e., appropriate demographic group, range of peripheral artery disease, lesion length, calcification range, subject frailty, access site spectrum, traversed vasculature range, and intravascular tissue concerns subject to the full spectrum of therapeutic cautions). As directly identified above, specific attention was paid to vessel perforation, major dissection, or distal debris embolization, of which no XableCath Support Catheter related occurrences were clinically noted, nor were abrasion tip post-procedural clinical sequelae observed. Thus, XableCath Support Catheter tip design (abrasion tip configuration) has been duly confirmed via robust design validation & direct real-world worst-case in-vivo application.

Conclusions drawn [21 CFR 807.92(b)(3)]

Based upon unaltered intended use, basal product design, methods of deployment, target population and anatomical site for use, and direct bench comparative assessment the qathered evidence summarized & described within this pre-market notification application demonstrates the XableCath Support Catheter has been shown to be substantially equivalent to the identified 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.

Regulation Number and Section

§ 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).