(48 days)
The XableCath Catheter is intended for use with a guidewire to access discrete regions of the peripheral vasculature. The XableCath™ Crossing Catheter is intended for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.
The XableCath Crossing Catheter device is an over-the-wire (OTW) single-lumen catheter, with blunt and abrasion tip design. The catheter is offered in a product family configuration, with size models as outlined below:
Catalog Number: AbrasionTip (A), Blunt Tip (B)
Dimensions: Working Length (cm), Recommended Guidewire Inches (mm)
XC-014-065A, XC-014-065B, 65, 0.014" (0.36 mm)
XC-014-090A, XC-014-090B, 90, 0.014" (0.36 mm)
XC-014-145A, XC-014-145B, 145, 0.014" (0.36 mm)
XC-018-065A, XC-018-065B, 65, 0.018" (0.46 mm)
XC-018-090A, XC-018-090B, 90, 0.018" (0.46 mm)
XC-018-145A, XC-018-145B, 145, 0.018" (0.46 mm)
XC-035-065A, XC-035-065B, 65, 0.035" (0.89 mm)
XC-035-090A, XC-035-090B, 90, 0.035" (0.89 mm)
XC-035-145A, XC-035-145B, 145, 0.035" (0.89 mm)
The catheter shaft consists of a cortically reinforced co-polymeric material blend, with radiopague cobalt chromiumtunqsten-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 Crossing Catheter strain relief. All provided family member models are compatible with ≥4Fr introducer sheaths. All product configurations are provided sterile, single-use only.
Here's a breakdown of the acceptance criteria and study information for the XableCath Crossing Catheter, based on the provided document:
Acceptance Criteria and Device Performance
The document does not present a formal table of distinct, quantitative acceptance criteria for device performance. Instead, it details various non-clinical and clinical tests performed and states that the device was deemed "substantially equivalent" to a predicate device, and that specific endpoints were met in the clinical assessment.
However, based on the narrative, we can infer some key performance achievements:
| Acceptance Criteria (Inferred from study outcomes) | Reported Device Performance |
|---|---|
| Non-Clinical Performance: | |
| Substantially equivalent to predicate device in various physical and functional areas. | Direct product bench in-vitro comparison testing showed the subject & predicate products to be substantially equivalent in areas such as visual & technical inspections, dimensional assessment, luer syringe compatibility, guidewire compatibility, sheath compatibility, leak testing, guidewire retraction/reinsertion, catheter kink-resistance, relative radiopacity comparison, tensile testing, torque transmission & capability, corrosion testing, simulated use (iliac model), and general packaging/shelf-life. |
| Biocompatibility | Full panel biocompatibility successfully performed under GLP rigors, demonstrating all materials and construction methods passed biocompatibility (including cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity, hemolysis, thromboresistance, complement activation, partial thromboplastin time, platelet and leukocyte count, and materials mediated pyrogenicity). |
| Packaging integrity and transport challenge | Applied and successfully completed in accordance with established acceptance criteria demonstrating configurational adequacy. |
| Clinical Performance (Real-world assessment): | |
| Primary Endpoint: Successful passage within the target lesion, enabling subsequent therapy (angioplasty and/or stenting). | 98% primary endpoint achievement with successful PTA/Stenting & technical success with lesion/claudication crossing. |
| Secondary Endpoint: Absence of major adverse event attributable to XableCath Catheter product use (perforation, thrombosis, or distal embolization). | 100% secondary endpoint achievement. (Routine minor dissection in 10% of treatment subjects experiencing an access site complication, both successfully treated with standard remedial maneuvers, without any residual clinical sequelae at 30-45 day post-treatment follow-up.) No recorded minor adverse events were caused by or attributable to the XableCath Crossing Catheter deployment. |
| Human factors engineering and usability | Assessments performed to ensure subject product features could be safely and effectively used. |
Study Details
This submission describes a pre-market notification (510(k)) for the XableCath Crossing Catheter, leveraging substantial equivalence to a predicate device (eV3/Medtronic Viance Crossing® Catheter (K120533)). The study components include non-clinical (bench) testing and a real-world clinical assessment.
1. A table of acceptance criteria and the reported device performance:
- See table above. The acceptance criteria are largely inferred from the successful completion of various tests and the achievement of primary and secondary endpoints in the clinical assessment.
2. Sample sized used for the test set and the data provenance:
- Non-Clinical Test Set: The document does not specify exact sample sizes for each non-clinical bench test but indicates that "Direct product bench in-vitro comparison testing" was performed on the subject and predicate devices. No specific number of devices tested is provided.
- Clinical Test Set:
- Sample Size: 49 patients underwent lesion modifying therapeutic intravascular treatment with XableCath Catheters.
- Data Provenance: This was a "real-world assessment," implying prospective data collection in clinical settings where the device was used. No specific country of origin is mentioned, but the sponsoring company location (Salt Lake City, Utah) suggests US-based or international clinical sites.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Non-Clinical: Not specified. Testing would typically involve qualified engineers and lab personnel.
- Clinical: The "real-world assessment" involved "physicians" administering the treatment and assessing outcomes. While their specific qualifications (e.g., interventional cardiologists, radiologists) are not detailed, it can be assumed they are qualified medical professionals experienced in peripheral arterial disease re-canalization and intervention. The document mentions "clinical outcomes," which would be determined by these treating physicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Non-Clinical: Not applicable in the context of expert adjudication. Bench testing results are typically based on objective measurements and established test protocols.
- Clinical: No formal external adjudication method (like 2+1 or 3+1 expert review) is mentioned for the clinical outcomes. The outcomes (primary and secondary endpoints, adverse events) were reported from the real-world treatment context, presumably as recorded and assessed by the treating clinicians.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a physical medical catheter, not an AI or imaging software, so MRMC studies involving human readers and AI assistance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical catheter, not an algorithm. Its standalone performance is demonstrated through the non-clinical and clinical studies where it is used as a tool by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Non-Clinical: The "ground truth" for non-clinical tests was based on objective measurements, adherence to ISO standards (ISO 10555-1, ISO 10993), and engineering performance criteria.
- Clinical: The "ground truth" for the clinical study was based on patient outcomes data, specifically:
- Successful passage within the target lesion and enablement of subsequent therapy (angioplasty and/or stenting).
- Absence of major adverse events attributed to the device (perforation, thrombosis, distal embolization).
- Resolution of minor adverse events without residual clinical sequelae.
8. The sample size for the training set:
- Not applicable. This submission describes a medical device, not an AI model, so there is no "training set" in the context of machine learning. The non-clinical and clinical data serve as validation/verification of the device's performance.
9. How the ground truth for the training set was established:
- Not applicable. As a physical medical device, there is no "training set" or corresponding ground truth establishment in the machine learning sense. The device's design and manufacturing are based on engineering principles and preclinical testing, and its clinical efficacy is evaluated through the real-world patient outcomes mentioned above.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services USA logo, which features a stylized caduceus. To the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name in blue text.
January 21, 2018
XableCath, Inc. Mr. Rick Gaykowski Chief Regulatory Officer 417 S. Wakara Way, Ste 3510 Salt Lake Citv. Utah 84108-1457
Re: K183357
Trade/Device Name: XableCath Crossing Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: November 19, 2018 Received: December 4, 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. 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/cdrl/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 801and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
{1}------------------------------------------------
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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.
| Gregory | |
|---|---|
| For | O'Connell |
| 2019.01.21 | |
| 10:37:48 -05'00' |
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K183357
Device Name XableCath™ Crossing Catheter
Indications for Use (Describe)
The XableCath Catheter is intended for use with a guidewire to access discrete regions of the peripheral vasculature. The XableCath™ Crossing Catheter is intended for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.
| 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) |
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."
{3}------------------------------------------------
510(k) Section 6 510(k) SUMMARY
XableCath Crossing Catheter
| Date prepared: | November 03, 2018 |
|---|---|
| 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 RegistrationNumber: | 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 Crossing Catheter |
| Common or usual name: | Peripheral Vascular Catheter |
| Classification name: | Percutaneous Catheter |
| Classification number: | 21 CFR 870.1250, Procode PDU |
| Legally marketed device(s) to which equivalence is claimed[21 CFR 807.92(a)(3)] | |
| eV3/Medtronic Viance Crossing® Catheter (K120533) | |
| Device description [21 CFR 807.92(a)(4)] | |
| The XableCath Crossing Catheter device is an over-the-wire (OTW) single-lumen catheter, with blunt and abrasion tipdesign. The catheter is offered in a product family configuration, with size models as outlined below: |
| Catalog Number | Dimensions | ||
|---|---|---|---|
| AbrasionTip (A) | BluntTip (B) | WorkingLength(cm) | RecommendedGuidewireInches (mm) |
| XC-014-065A | XC-014-065B | 65 | 0.014" (0.36 mm) |
| XC-014-090A | XC-014-090B | 90 | 0.014" (0.36 mm) |
| XC-014-145A | XC-014-145B | 145 | 0.014" (0.36 mm) |
| XC-018-065A | XC-018-065B | 65 | 0.018" (0.46 mm) |
| XC-018-090A | XC-018-090B | 90 | 0.018" (0.46 mm) |
| XC-018-145A | XC-018-145B | 145 | 0.018" (0.46 mm) |
| XC-035-065A | XC-035-065B | 65 | 0.035" (0.89 mm) |
| XC-035-090A | XC-035-090B | 90 | 0.035" (0.89 mm) |
{4}------------------------------------------------
XableCath Crossing Catheter Traditional 510(k), K183357
| XC-035-145A | XC-035-145B | 145 | 0.035" (0.89 mm) |
|---|---|---|---|
| ------------- | ------------- | ----- | ------------------ |
The catheter shaft consists of a cortically reinforced co-polymeric material blend, with radiopague cobalt chromiumtunqsten-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 Crossing Catheter strain relief. All provided family member models are compatible with ≥4Fr introducer sheaths. All product configurations are provided sterile, single-use only.
Indications for Use [21 CFR 807.92(a)(5)]
The XableCath Catheter is intended for use with a quidewire to access discrete regions of the peripheral vasculature.
The XableCath Crossing Catheter is intended for use to facilitate the intraluminal placement of conventional quidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of 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 Crossing 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 have an 0.014" product offering possessing similarly offered working lengths, and identical guidewire compatibility. Additionally, the subject XableCath Crossing Catheter offers additional dimensional working versions as well (i.e., 0.018", and 0.035") within the product family.
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 reqions.
The following table illustrates comparable features of the subject and predicate products:
| Substantial Equivalence Comparison | ||
|---|---|---|
| Product Information | Subject | Predicate |
| XableCath Crossing Catheter | Medtronic Viance Crossing®Catheter | |
| 510(k) # | K183357This Submission | K120533 |
| FDA Classification | Class II | Class II |
| Regulation Number | 870.1250 | 870.1250 |
| Product Code | PDU (projected) | PDU |
| Indications for Use | The XableCath Catheter isintended for use with a guidewireto access discrete regions of theperipheral vasculature.The XableCath Crossing Catheteris intended for use to facilitate theintraluminal placement of | The Viance Catheter is intended foruse with a guidewire to accessdiscrete regions of the peripheralvasculature.When used as part of the CovidienPeripheral System, the VianceCatheter is indicated for use to |
| Proximal Luer/Hub | HDPE | Polycarbonate |
| Strain Relief | Olefin | None |
| Catheter Shaft | PEBAX/SS braiding/Nylon, Singlelumen | PEBAX / SS braiding, Single lumen |
| Markers | Cobalt-chromium/SS | SS |
| Coating | None | Hydrophilic |
| Distal Tip | Atraumatic (Blunt, Abrasionversions) | Atraumatic |
| 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", 0.0710.014", 0.018", 0.035" | 0.039" |
| GuidewireCompatibility | 0.014", 0.018", 0.035" | 0.014" |
| Guide Catheter (max) | ≥4Fr | ≥6Fr |
| Access Sheath (max) | ≥4Fr | ≥6Fr |
| Effective WorkingLength | 65, 90, 145cm | 135cm |
| Deployment | OTW - Manual | OTW - Manual |
| Mechanism of Action | Manual proximal manipulation viaaxial and torsional applied forcestransmitted through catheter length | Manual proximal manipulation viaaxial and torsional applied forcestransmitted through catheter length |
| System Design | Proximal Hub/Handle/LuerCatheter ShaftDistal Tip | Proximal Hub/Handle/LuerCatheter ShaftDistal Tip |
| Duration of Therapy | Short-term use | Short-term use |
| 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, clinical outcomes. |
| Packaging | Sterile thermal sealed Tyvek/PETPouch, SBS Carton | Sterile thermal sealed pouch, SBSCarton |
| physician. Hospital, Lab/SurgicalSuite | physician. 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 (as applicable) |
| Tensile, Dimensional,Insertion/Withdrawal, Distal Tip,Kink, Torque, Surface Defects,Corrosion, Luer and Hub testing,Radiopacity, Packaging,Biocompatibility ISO 10993 | Tensile, Dimensional,Insertion/Withdrawal, Distal Tip,Kink, Coating, Torque, SurfaceDefects, Corrosion, Luer and Hubtesting, Radiopacity, Packaging,Biocompatibility ISO 10993 |
Substantial Equivalence Comparison
{5}------------------------------------------------
{6}------------------------------------------------
XableCath Crossing Catheter Traditional 510(k), K183357
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, . 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 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 subject and predicate products are offered in 0.014" workhorse models, whilst the subject product is also . offered in 0.018", and 0.035" versions as well.
Despite these noted differences between the subject and predicate products, these attributes are determined to be cumulatively insignificant and do not raise new questions of safety and effectiveness of these products 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 substantiallyequivalent, via assessment within the following areas: | ||
| ○ | Visual & technical inspections | Dimensional assessment & comparisons | |
| ○ | Luer syringe compatibility | Guidewire compatibility | |
| ○ | Sheath compatibility | Leak Testing | |
| ○ | Guidewire retraction/reinsertion | Catheter kink-resistance | |
| ○ | Relative radiopacity comparison | Tensile testing (proximal & distal) | |
| ○ | Torque transmission & capability | Corrosion testing | |
| ○ | Simulated use (iliac model) | 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 | Sensitization | |
| ○ | Irritation/Intracutaneous Reactivity | Systemic Toxicity (Acute) | |
| ○ | Hemolysis | Thromboresistance | |
| ○ | Complement Activation | Partial Thromboplastin Time | |
| ○ | Platelet and Leukocyte Count | Materials Mediated Pyrogenicity |
{7}------------------------------------------------
- Packaging integrity, transport challenge 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 mandated, yet were performed on the subject product to verify actual performance of the device in real-world conditions, secondary to limitations of effective animal modeling for peripheral vascular disease. From real-world assessment. 49 patients underwent lesion modifying therapeutic intravascular treatment with XableCath Catheters for peripheral arterial disease re-canalization. Primary endpoint was successful passage within the target lesion, enabling subsequent therapy (angioplasty and/or stenting), whilst the secondary endpoint was absence of major adverse event attributable to XableCath Catheter product use (perforation, thrombosis, or distal embolization).
Treatment cohort demographics were 21 females (43%) and 28 males (57%). with a mean age of 71 years (range of 48-94 vears). Presenting comorbidities (at least one) within the population was 100%, with Diabetes Mellitus (25 (51%) being the most common. Peripheral Artery Disease (PAD) classification using the Rutherford Scale (1986, revised 1997) was applied, with Rutherford Class 3-4 in 29 (59%) of the cohort, and Rutherford Class 5-6 in 20 (41%) of the treatment population. The number of lesions treated were 52, associating >100 arterial segments traversed, with treated mean lesion length (cm) of targeted occlusions being 5.6cm. Additionally, vascular lesions treated included liac 8 (15%), Femoral – AK Popliteal 36 (68%), BK Popliteal 2 (4%), and Tibial 7 (13%), being those common as PAD therapeutic targets. Lesion characteristics were of an occlusive magnitude that wire and balloon passage was not possible in 15% and 73% of cases respectively, with 54% being Chronic Total Occlusions (CTO) and 81% categorized as moderate/severe calcification.
From these clinical applications, a 98% primary endpoint result was achieved with successful PTA/Stenting & technical success with lesion/claudication crossing. Additionally, 100% secondary endpoint achievement was attained, with routine minor dissection in 10% of treatment subjects experiencing an access site complication both being successfully treated with standard remedial maneuvers, without any residual clinical sequelae at 30 - 45-day post-treatment follow-up (5.6 week average). Of significance, none (0%) of the recorded minor adverse events were either caused by or attributable to the XableCath Crossing Catheter deployment. In addition, human factors engineering and usability assessments were performed to ensure subject product features could be safely and effectively used.
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 within this pre-market notification application demonstrates the XableCath Crossing Catheter is shown to be substantially equivalent to the predicate device. Furthermore, the XableCath Crossing 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).