(249 days)
The AXS Offset Delivery Assist Catheter is intended to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.
The AXS Offset Delivery Assist Catheter ("AXS Offset") is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and delivery of appropriately sized interventional devices, such as distal access catheters (DAC), into a selected blood vessel in the neurovascular system.
The AXS Offset catheter, when used in conjunction with an appropriately sized steerable guidewire and DAC, provides a smooth interventional device system profile. The distal outer diameter (OD) of the AXS Offset catheter gradually increases from 0.036in at the RO Marker to 0.050in, 2 cm proximal to the RO marker. The bulb section with a 0.050in OD is maintained for 28 cm. then gradually decreases towards the proximal section. The overall distal profile of the AXS Offset catheter acts as a smooth transition and reduces the gap between the outer diameter of a steerable guidewire and inner diameter of a DAC while allowing for continuous saline flush through the DAC.
The catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing.
The provided document describes the acceptance criteria and study results for the AXS Offset Delivery Assist Catheter.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Testing | ||
| Dimensional Verification (Effective Length, Uncoated Length, Distal Tip OD, ID) | Meets acceptance criteria for specified dimensions. Compatible with standard neurovascular guidewires (for ID). | Meets acceptance criteria for catheter effective length, uncoated length, distal tip outer diameter, and inner diameter. Inner lumens compatible with standard neurovascular guidewires. XT-27 and AXS Offset meet same dimensional acceptance criteria. |
| Dimensional: Maximum Outer Diameter | Meets acceptance criteria. | Meets acceptance criteria for maximum outer diameter. |
| Friction Force | Meets acceptance criteria. | Meets acceptance criteria. XT-27 and AXS Offset meet the same friction force acceptance criteria. |
| Catheter Distal Tip Buckling | Meets acceptance criteria. | Meets acceptance criteria. XT-27 and AXS Offset meet the same distal tip buckling acceptance criteria. |
| Catheter Tensile Strength | Meets acceptance criteria. | Meets acceptance criteria. XT-27 and AXS Offset meet the same catheter tensile strength acceptance criteria. |
| Catheter Hub Tensile Strength | Meets acceptance criteria. | Meets acceptance criteria. XT-27, Transform, and AXS Offset meet the same catheter hub tensile strength acceptance criteria. |
| Liquid-Leakage | Meets acceptance criteria. | Meets acceptance criteria. XT-27, Transform, and AXS Offset meet the same liquid-leakage acceptance criteria. |
| Air Aspiration Leakage | Meets acceptance criteria. | Meets acceptance criteria. XT-27, Transform, and AXS Offset meet the same air aspiration leakage acceptance criteria. |
| Coating Integrity | Neither delamination at coating edges, nor coating defects (voids, scratches) baseline. No anomalies post-tracking. Coating functions as intended and exhibits appropriate integrity post-simulated use (considering lubricity, durability, and particulate generation results). | Neither Baseline nor Post-tracking test articles exhibited any delamination at coating edges or defects. Post tracking devices exhibited no anomalies. Coating functions as intended and exhibited appropriate integrity post-simulated use. |
| Track and Advance Force | Advance and retraction force in simulated use testing is equivalent to or lower than the predicate XT-27. | AXS Offset catheter advance and retraction force in simulated use testing has been demonstrated to be equivalent or lower than the predicate XT-27. |
| Flow Rate | Continuous positive displacement of saline fluid through the lumen of the DAC with the AXS Offset catheter positioned in the DAC lumen in a simulated neurovascular tortuosity model. | Testing has demonstrated a continuous positive displacement of saline fluid through the lumen of the DAC with the AXS Offset catheter positioned in the DAC lumen. Testing was conducted in a simulated neurovascular tortuosity model. |
| Catheter Kink Radius | Meets acceptance criteria. | Meets acceptance criteria. XT-27 and AXS Offset meet the same kink radius acceptance criteria. |
| Catheter Torsional Resistance | Meets acceptance criteria. | Meets acceptance criteria. XT-27 and AXS Offset meet the same torsional resistance acceptance criteria. |
| Visual Standards | Catheter length free from extraneous matter and process defects. Distal tip smooth and rounded. | Visual standards meet acceptance criteria for catheter length being free from extraneous matter and process defects and for catheter distal tip being smooth and rounded. XT-27 and AXS Offset meet the same visual standards acceptance criteria. |
| Visual and Dimensional Integrity – Chemical Compatibility | Visual, dimensional, and mandrel passage examinations show integrity of hub, inner lumen, and outer distal region after exposure to saline, non-ionic contrast, and ionic contrast. | Visual and Dimensional Integrity - Chemical Compatibility meets acceptance criteria. XT-27 and AXS Offset meet the same visual and dimensional integrity - chemical compatibility acceptance criteria. |
| Device Trackability | Evaluating physician(s) state that test articles can advance to the M1 in conjunction with the intermediate catheter in the bench model. | Device Trackability meets acceptance criteria. Evaluating physicians confirmed all test articles were able to advance to the M1 using standard access methods similar to XT-27. XT-27 and AXS Offset meet the same device trackability acceptance criteria. |
| Device - Durability and Integrity | Evaluating physician(s) state that all test articles maintain their integrity throughout the procedure using the bench model. | Device Durability and Integrity meets acceptance criteria. Evaluating physicians confirmed all test articles maintained their integrity throughout the procedure. XT-27 and AXS Offset meet the device durability and integrity acceptance criteria. |
| Guidewire Compatibility | Evaluating physician(s) state that all test articles allow smooth advancement and withdrawal of standard guidewires up to 0.018in OD. | Guidewire Compatibility meets acceptance criteria. Evaluating physicians confirmed all test articles allowed smooth advancement and withdrawal of standard guidewires up to 0.018in OD. XT-27 and AXS Offset meet the same guidewire compatibility acceptance criteria. |
| Labelling requirements | Evaluating physician(s) state that DFU and labeling of all test articles clearly identify the product and provide information adequate to ensure the safe use of the device. | Labelling Requirements meet acceptance criteria. Evaluating physicians confirmed DFU and labeling clearly identify the product and provide information adequate for safe use. XT-27 and AXS Offset meet the labeling requirements acceptance criteria. |
| Intended Use Environment | Evaluating physician(s) state that all test articles can withstand conditions typically seen during use environment of the product. | Intended Use Environment meets acceptance criteria. Evaluating physicians confirmed all test articles withstand typical use environment conditions. XT-27 and AXS Offset meet the same intended use environment acceptance criteria. |
| Visibility | Evaluating physician(s) state that all test articles are visible under fluoroscopy during delivery to and withdrawal from the intended location. | Visibility meets acceptance criteria. Evaluating physicians confirmed all test articles are visible under fluoroscopy. XT-27 and AXS Offset meet the same visibility acceptance criteria. |
| Packaging | Visual, dimensional, and performance testing meets acceptance criteria for all packaging components (carton, labels, DFU, and pouch). | Packaging visual, dimensional, and performance testing meets the acceptance criteria for all packaging components. XT-27 and AXS Offset meet the same packaging visual, dimensional, and performance acceptance criteria. |
| Biocompatibility Testing | ||
| MEM Elution Cytotoxicity | No evidence of causing cell lysis or toxicity (grade 0). Considered non-cytotoxic. | Pass. No cytotoxicity or cell lysis. Test article is considered non-cytotoxic (grade 0). Met requirements as grade was less than grade 2. |
| Hemolysis Extract/Direct Contact Method | Hemolytic index <= 5%. | Pass. Hemolytic index for direct contact and extract was <5%. Met criteria of <5%. |
| USP Physicochemical <661> | Non-volatile residue: 7 mg; Residue on ignition: < 1 mg; Heavy metal: < 1 ppm; Buffering capacity: < 1.0 ml. No gross residuals or volatiles. | Pass. Non-volatile residue: 7 mg; Residue on ignition: < 1 mg; Heavy metal: < 1 ppm; Buffering capacity: < 1.0 ml. No gross residuals or volatiles. |
| FTIR | Baseline established. Identified polyamide type materials. | The baseline identified polyamide type materials which are constituents of the device. |
| Natural Rubber Latex (ELISA Inhibition Assay for Antigenic Protein) | No detectable latex. Latex below level of detection. | Pass. Test article extract showed no detectable latex. Latex below level of detection. Results <0.2 ug/g and >0.1ug/dm2. |
| In-vitro Blood Loop Assay with Comparison Article | Worst case score of '0', '1', or '2' (thromboresistant). | Pass. Test article (AXS DAC) received a worst case score of '1' and comparison article (Transform) received a worst case score of '1', both considered thromboresistant. |
| Guinea Pig Maximization Sensitization | No evidence of causing delayed dermal contact sensitization. Not considered a sensitizer. | Pass. No evidence of causing delayed dermal contact sensitization. Not considered a sensitizer. |
| Intracutaneous Reactivity | Difference between test extract mean score and control mean score is 0.0. Met requirements of the test. | Pass. Difference between test extract mean score and control mean score was 0.0. Met requirements of the test. |
| Acute Systemic Injection | No mortality or evidence of systemic toxicity. Met requirements of the test. | Pass. No mortality or evidence of systemic toxicity. Met requirements of the test. |
| Materials Mediated Rabbit Pyrogen | Total rise of rabbit temperatures during three-hour observation within acceptable USP limits. Nonpyrogenic. | Pass. Total rise of rabbit temperatures during the three-hour observation was within acceptable USP limits. Judged as nonpyrogenic. |
| Ames Mutagenicity | Extracts considered nonmutagenic to Salmonella typhimurium and Escherichia coli test strains. | Pass. Extracts considered nonmutagenic. |
| Genotoxicity - Mouse Lymphoma Assay | Extracts did not cause a twofold or greater increase in mean mutant frequency of the L5178Y/TK+/- cell line in either absence or presence of metabolic activation. Considered nonmutagenic. | Pass. Extracts did not cause a twofold or greater increase in mean mutant frequency. Considered nonmutagenic. |
| Partial Thromboplastin Time | Clotting time >= 50% of negative control. | Pass. Clotting time of the test article was 67% of the negative control. Met acceptance criteria of ≥50%. |
| In Vitro Hemocompatibility Assay | All counts for the test article not significantly different from the reference material. Comparable to reference material. | Pass. All counts for the test article were not significantly different from the reference material. Results comparable to reference material. |
| Complement Activation (SC5b-9) | Concentration of SC5b-9 not statistically higher than negative control. Not considered a potential activator of the complement system. | Pass. Concentration of SC5b-9 not statistically higher than negative control. Not considered a potential activator. |
| Complement Activation (C3a) | Concentration of C3a not statistically higher than negative control. Not considered a potential activator of the complement system. | Pass. Concentration of C3a not statistically higher than negative control. Not considered a potential activator. |
| In-Vivo Thromboresistance | For both test article and control, platelet counts and APTT time within normal ranges. Scored the same for thrombosis and vessel patency as control. Demonstrated comparable thromboresistance. | Pass. For both test article and control, platelet counts and APTT time were within normal ranges. Scored the same for thrombosis and vessel patency. Demonstrated comparable thromboresistance to the control article. |
| Other Testing | ||
| Endotoxin Limit | Within ANSI/AAMI ST72:2011 Endotoxin Limit of 20 Endotoxin Units per device (EU/device). | Test results are within the ANSI/AAMI ST72:2011 Endotoxin Limit of 20 EU/device. |
| Ethylene Oxide (EO) Residuals | Less than maximum allowed for EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. | EO residuals on a sample representative of the AXS Catalyst Distal Access Catheter are less than the maximum allowed per EN ISO 10993-7. |
| Shelf Life | Maintained over the duration of the labeled shelf-life (3 years). | Bench testing conducted on accelerated aged devices confirmed the shelf-life of 3 years is maintained. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state a specific numerical sample size for all tests. However, it mentions:
- Bench Testing: Performed on the "subject device" (AXS Offset Delivery Assist Catheter) to verify its performance against acceptance criteria and predicate devices. For some tests (e.g., trackability, durability, guidewire compatibility), "all test articles" were evaluated by physicians, implying a consistent test sample was used for these specific simulated use scenarios.
- Biocompatibility Testing: Conducted on "the AXS Offset Delivery Assist Catheter" (though specific counts are not given for all tests, e.g., "The test article extract showed no evidence..."). Some biocompatibility data was leveraged from the predicate device (Transform Occlusion Balloon Catheter).
- Data Provenance: The studies are described as "verification and validation testing" and "bench testing," and involve "simulated use conditions" and "bench models." This indicates the data is from prospective in-vitro (bench) studies and simulated clinical use rather than real-world human data. There is no mention of country of origin for the data; it's likely conducted by Stryker Neurovascular per regulatory guidelines.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Number of Experts: For tests like Device Trackability, Device Durability and Integrity, Guidewire Compatibility, Labelling Requirements, Intended Use Environment, and Visibility, the acceptance criteria explicitly state "the evaluating physician/s must state..." This implies one or more physicians were involved.
- Qualifications of Experts: The document explicitly refers to them as "evaluating physician/s," confirming they are medical doctors. No specific details about their years of experience or specialization (e.g., neuroradiologist, neurosurgeon) are provided beyond the general term "physician."
4. Adjudication Method for the Test Set:
For the tests involving physician evaluation (e.g., Trackability, Durability, etc.):
- The phrasing "the evaluating physician/s must state" suggests that a consensus or agreement among the participating physicians was required to meet the acceptance criteria.
- It does not specify a quantitative adjudication method like 2+1 or 3+1. It could imply either a single physician's assessment or an unstated consensus approach if multiple physicians were involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The studies described are primarily bench testing, simulated use, and biocompatibility evaluations to demonstrate substantial equivalence to predicate devices, not to measure human reader improvement with AI assistance. The device is a physical catheter, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The device is a physical medical instrument (catheter), not a software algorithm. Therefore, "standalone algorithm performance" is not relevant. The device's performance is intrinsically tied to its physical interaction and manipulation, often by a human operator (physician) in a clinical or simulated environment.
7. The Type of Ground Truth Used:
The "ground truth" for the various tests aligns with the nature of the test:
- Mechanical/Physical Tests: Ground truth is based on engineering specifications and measurements (e.g., dimensions, force, flow rates) and adherence to recognized standards (e.g., ISO, ASTM, EN).
- Simulated Use Tests (physician evaluated): Ground truth is based on expert consensus/opinion from the evaluating physician(s) regarding performance characteristics like trackability, durability, guidewire compatibility, and visibility in a bench model.
- Biocompatibility Tests: Ground truth is established through adherence to biological testing standards (e.g., EN ISO 10993 parts) and the resulting biological and chemical properties observed (e.g., cytotoxicity, hemolytic index, pyrogenicity, mutagenicity, thromboresistance).
8. The Sample Size for the Training Set:
Not applicable. The AXS Offset Delivery Assist Catheter is a physical medical device. It does not use machine learning or AI, and therefore does not have a "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 28, 2017
Stryker Neurovascular Angelica Beckmann Director, Regulatory Affairs 47900 Bayside Parkway Fremont, California 94538
Re: K163259
Trade/Device Name: AXS Offset Delivery Assist Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 29, 2017 Received: June 30, 2017
Dear Ms. Beckmann:
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 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.
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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/Resourcesfor You/Industry/default.htm.
Sincerely,
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Summary
| Device Trade Name: | AXS Offset Delivery Assist Catheter | ||||
|---|---|---|---|---|---|
| Common Name: | Percutaneous Catheter | ||||
| Classification Name: | Percutaneous Catheter, 21CFR 870.1250 Class II | ||||
| Product Code: | DQY | ||||
| Submitter: | Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538Facility Registration #2954917 | ||||
| Contact: | Angelica BeckmannDirector, Regulatory AffairsTel 510 - 413-2900Fax 510 - 413-2588 | ||||
| Date Prepared: | July 27, 2017 | ||||
| Predicate Device: | Primary Predicate Device K113778(clearance grantedApril 20, 2012) Excelsior XT-27 Microcatheter Reference Predicate Device |
| K122576 | Transform Occlusion Balloon Catheter |
|---|---|
| (clearance grantedJanuary 11, 2013) |
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Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
Device Description
The AXS Offset Delivery Assist Catheter ("AXS Offset") is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and delivery of appropriately sized interventional devices, such as distal access catheters (DAC), into a selected blood vessel in the neurovascular system.
The AXS Offset catheter, when used in conjunction with an appropriately sized steerable guidewire and DAC, provides a smooth interventional device system profile. The distal outer diameter (OD) of the AXS Offset catheter gradually increases from 0.036in at the RO Marker to 0.050in, 2 cm proximal to the RO marker. The bulb section with a 0.050in OD is maintained for 28 cm. then gradually decreases towards the proximal section. The overall distal profile of the AXS Offset catheter acts as a smooth transition and reduces the gap between the outer diameter of a steerable guidewire and inner diameter of a DAC while allowing for continuous saline flush through the DAC.
The catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing.
Accessories
No accessories are provided with the AXS Offset.
Indications for Use
The Indications for Use are similar to the predicate devices and are as follows: The AXS Offset Delivery Assist Catheter is intended to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.
Technological Characteristics and Product Feature Comparison
The subject device, AXS Offset Delivery Assist Catheter is substantially equivalent to the predicate devices in terms of:
- indications for use ●
- fundamental scientific technology
- fundamental design ●
- materials and processes for packaging and sterilization of devices ●
A tabular comparison of the specific technological characteristics between the predicate devices and subject device is provided below.
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| Characteristics | Subject Device | Primary Predicate Device | Reference Predicate Device |
|---|---|---|---|
| Device Name | AXS Offset Delivery AssistCatheter | Excelsior® XT-27Microcatheter | Transform Occlusion BalloonCatheter |
| 510(k) | Current Notification | K113778 | K122576 |
| DeviceClassification/Product Code | Class II/ DQY(Percutaneous catheters) | Class II/ DQY(Percutaneous catheters) | Class II/MJN(Temporary IntravascularOccluding Catheter) |
| Intended Use | The AXS Offset DeliveryAssist Catheter is intended toassist in the delivery ofinterventional devices, suchas distal access catheters, inthe neurovasculature. | Stryker NeurovascularExcelsior XT-27Microcatheter is intended toassist in the delivery ofdiagnostic agents (such ascontrast media), therapeuticagents, and non-liquidinterventional devices (suchas stents) that are indicatedfor use in theneurovasculature and with acatheter of 0.027 inches ininner diameter. | The Stryker NeurovascularTransForm Occlusion BalloonCatheters are indicated for usein the neuro and peripheralvasculature to temporarily stopor control blood flow and forballoon assisted embolization ofintracranial aneurysms. |
| Characteristics | Subject Device | Primary Predicate Device | Reference Predicate Device |
| Device Name | AXS Offset Delivery AssistCatheter | Excelsior® XT-27Microcatheter | Transform Occlusion BalloonCatheter |
| 510(k) | Current Notification | K113778 | K122576 |
| Principle ofOperations | Delivery Assist Catheters areused to access and navigatethe vasculature as well as todeliver Distal AccessCatheters (DAC). The AXSOffset Delivery AssistCatheter is inserted through aDAC and guided through thevasculature with the aid of aguidewire (over-the-wirecatheter). | Microcatheters are used toaccess and navigate thevasculature as well as todeliver diagnostic therapeuticagents, and/or interventionaldevices. Typically thesevascular microcatheters areinserted with a guide catheterand guided through thevasculature with the aid of aguidewire (over-the-wiremicrocatheters). | The device is advanced into thevasculature using an 0.014 inchOD guidewire and inside a5F or larger guide catheterplaced in the femoral artery.The radiopaque markers areobserved under fluoroscopy as aguide to positioning the balloonat the intended treatment site.Once at the treatment site, theguidewire is used to seal thedistal end of the catheterallowing inflation of theballoon. A mixture of saline andcontrast is injected into thecatheter lumen to inflate theballoon to its nominal volume;fluoroscopy is used to ensureproper positioning. Oncebeyond the distal tip of thecatheter, the guidewire can bemoved distally or proximallywhile maintaining ballooninflation. |
Product Feature Comparison of Subject Device with Predicate Devices (K113778, K122576)
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Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
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Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
| Characteristics | Subject Device | Primary Predicate Device | Reference Predicate Device |
|---|---|---|---|
| Device Name | AXS Offset Delivery Assist | Excelsior ® XT-27 | Transform Occlusion Balloon |
| Catheter | Microcatheter | Catheter | |
| 510(k) | Current Notification | K113778 | K122576 |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
Design Comparison of Subject Device with Predicate Devices (K113778, K122576)
| Proposed Device | Predicate Device | Predicate Device | Rationale for difference(if applicable) | |
|---|---|---|---|---|
| Feature | AXS Offset DeliveryAssist Catheter | Excelsior® XT-27Microcatheter | Transform OcclusionBalloon Catheter | |
| Current Notification | K113778 | K122576 | ||
| Proximal OD | 3.0F (1.0mm) | 2.9F (0.97mm) | 2.8F (0.95mm) | No significant difference |
| Distal OD | 2.7F (0.91mm) | 2.7F (0.91mm) | 2.7F (0.95mm) | N/A - Same as primary predicate |
| Feature | Proposed Device | Predicate Device | Predicate Device | Rationale for difference(if applicable) |
| AXS Offset DeliveryAssist Catheter | Excelsior® XT-27Microcatheter | Transform OcclusionBalloon Catheter | ||
| Current Notification | K113778 | K122576 | ||
| MaximumCatheterDiameter(distal section) | 3.8F (1.27mm)*reference figure | 2.7F (0.91mm)*reference figure | 3.8F(1.27mm)*reference figure | The AXS Offset outside diameteris similar to the predicate devices.AXS Offset has the samematerials as the predicate as seenin table 13-7. Thrombogenicitytesting demonstrated no risk ofthrombosis for the AXS OffsetCatheter like the predicate device.Biocompatibility testing was alsocompleted to show no increasedrisk compared to the predicatedevices. The bench testing wasperformed in a neurovasculartortuosity model to confirm thecontinuous flush solution will beadequately maintained betweenthe AXS Offset and DAC duringuse. |
| ID | 0.53mm (.021in) | 0.69mm (0.027in) | 0.31mm (.0124in) | AXS Offset ID of .021" is withinthe ranges of both predicatedevices. .021" ID is a commonsize for a catheter of this lengthand OD. |
| Feature | Proposed Device | Predicate Device | Predicate Device | Rationale for difference(if applicable) |
| AXS Offset DeliveryAssist Catheter | Excelsior® XT-27Microcatheter | Transform OcclusionBalloon Catheter | ||
| Current Notification | K113778 | K122576 | ||
| HydrophilicCoatingLength | 80cm | 80cm | 80cm - 83cm | N/A - Same as primary predicate |
| EffectiveLength | 150cm | 135 cm150 cm | 150 cm - 153cm | N/A - Same as primary predicate |
| Tip Length | 2cm | 6 cm18 cm | 1cm - 3cm | AXS Offset tip length of 2cm issimilar to the predicate devices.The tip length is used to describethe section distal of the bulbfeature of the AXS Offset but thetip length does not significantlyaffect the product performance.The materials of the tip are moreimpactful to productperformance. Both AXS Offsetand Excelsior XT-27 have thesame distal tip materials anddistal OD and thus have similarperformance. |
| Tip Shape | Straight | Straight | Straight | N/A - Same as primary predicate |
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Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
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Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
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Risk Assessment
Risk assessment of the AXS Offset Delivery Assist Catheter has been conducted in accordance with EN ISO 14971 and Stryker Neurovascular's risk management procedures. Stryker Neurovascular has determined that the AXS Offset Delivery Assist Catheter raises no new safety or effectiveness issues.
Results of verification and validation testing have demonstrated the subject device is substantially equivalent to the predicate devices.
Testing Summary
The results of verification and validation testing conducted on the subject device demonstrate that it performs as designed, and is suitable for its intended use. Specifically, the following tests were performed on the subject device:
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Stryker Neurovascular
Premarket Notification, Traditional 510(k)
AXS Offset Delivery Assist Catheter
| Test | Test Method | Results |
|---|---|---|
| DimensionalVerification | Verified dimensionsusing specifiedmeasurement tool | Dimensional verification meets acceptance criteria for cathetereffective length, uncoated length, distal tip outer diameter, andinner diameter |
| Substantial Equivalence: XT-27 and AXS Offset meet the samedimensional effective length, uncoated length, and distal tip outerdiameter acceptance criteria | ||
| For inner diameter, XT-27 and AXS Offset meet their respectivedimensional inner diameter acceptance criteria. The inner lumensof both devices are compatible with standard neurovascular guidewires. | ||
| Dimensional:Maximum OuterDiameter | Verified dimensionsusing specifiedmeasurement tool | Dimensional verification meets acceptance criteria for maximumouter diameter |
| Substantial Equivalence: XT-27 and AXS Offset meet theirrespective dimensional (maximum outer diameter) acceptancecriteria. The differences in the max OD between the XT27 andAXS Offset are related to the differences in the indications for useof both devices. | ||
| Friction Force | Measured frictionforce to determinethe lubricity anddurability of thecoating on a cathetershaft using a frictiontester | Friction force meets acceptance criteriaSubstantial Equivalence: XT-27 and AXS Offset meet the samefriction force acceptance criteria. |
| Catheter Distal TipBuckling | Measured forcerequired to buckledistal shaft using tipbuckling tester | Distal tip buckling meets acceptance criteriaSubstantial Equivalence: XT-27 and AXS Offset meet the samedistal tip buckling acceptance criteria. |
| Catheter TensileStrength | Measured cathetershaft peak tensilestrength using Instrontensile tester per testguideline, ISO10555-1 Peak Tensile Force | Catheter tensile strength meets acceptance criteriaSubstantial Equivalence: XT-27 and AXS Offset meet the samecatheter tensile strength acceptance criteria. |
| Catheter Hub TensileStrength | Measured cathetershaft to hub tensilejunction strengthusing Instron tensiletester per testguideline, ISO10555-1 Peak Tensile Force | Catheter hub tensile strength meets acceptance criteriaSubstantial Equivalence: XT-27, Transform, and AXS Offset meetthe same catheter hub tensile strength acceptance criteria. |
| Liquid-Leakage | Determined whetherliquid leaks from thecatheter underpressure per EN ISO10555-1:2013 and EN1707:1996 | Liquid-leakage meets acceptance criteriaSubstantial Equivalence: XT-27, Transform, and AXS Offset meetthe same liquid-leakage acceptance criteria. |
| Air Aspiration Leakage | Determined whetherair leaks into the hubassembly duringaspiration per ENISO 10555-1:2013and EN 1707:1996. | Air aspiration leakage meets acceptance criteriaSubstantial Equivalence: XT-27, Transform, and AXS Offset meetthe same air aspiration leakage acceptance criteria. |
| Particle Analysis forCatheters | Performed simulateduse procedures for in vitro acute phaseparticulatecharacterizationusing a particlecounter | Particle analysis characterization testing completed and is forreference only.Particulate count results for the AXS Offset in all particulate sizeranges are similar or lower than the predicate device XT-27 |
| Coating Integrity | Checked visualcondition of catheterand notedobservations of thecatheter coatingsbefore and aftersimulated use | Neither the Baseline test articles nor the Post-tracking test articlesexhibited any delamination at coating edges (either proximal ordistal). The Baseline test articles did not exhibit any coating defects(voids or scratches). The post tracking devices exhibited noanomolies along the 80cm coating length. When considered inconjunction with coating lubricity and durability results and theparticulate generation results, the coating functions as intended andhas exhibited appropriate integrity (via visual assessment) postsimulated use. |
| Track and AdvanceForce | Measured theadvance andretraction force insimulated useconditions from thepetrous segment ofthe internal carotidartery to the M1 ofthe middle cerebralartery. | AXS Offset catheter advance and retraction force in simulated usetesting has been demonstrated to be equivalent or lower than thepredicate XT-27. |
| Flow Rate | Measured flow ratefor saline infusionthrough a DistalAccess Catheter(DAC) when theAXS Offset catheterwas positioned withinthe lumen of theDAC. | Testing has demonstrated a continuous positive displacement ofsaline fluid through the lumen of the DAC with the AXS Offsetcatheter positioned in the DAC lumen. Testing was conducted in asimulated neurovascular tortuosity model. |
| Catheter Kink Radius | Measured the kinkradius of catheterusing a fixture | Catheter kink radius meets acceptance criteriaSubstantial Equivalence: XT-27 and AXS Offset meet the samekink radius acceptance criteria. |
| Catheter TorsionalResistance | Measured thestrength of cathetershaft while it rotatesin a clinicallyrelevant vascular pathto determine howmany turns (360-degree rotations) arerequired to break theshaft | Catheter torsional resistance meets acceptance criteriaSubstantial Equivalence: XT-27 and AXS Offset meet the sametorsional resistance acceptance criteria. |
| Visual Standards | Visually checkedcatheter length forextraneous matterand process defects.Additionally,checked for smoothand rounded distal tipusing specifiedmeasurement tools | Visual standards meet acceptance criteria for catheter length beingfree from extraneous matter and process defects and for catheterdistal tip being smooth and rounded.Substantial Equivalence: XT-27 and AXS Offset meet the samevisual standards acceptance criteria. |
| Visual andDimensional Integrity– ChemicalCompatibility | Performed visual,dimensional, andmandrel passageexaminations todetermine visual anddimensional integrityof the hub, innerlumen, and outerdistal region ofcatheter afterexposure to saline,non-ionic contrast,and ionic contrast. | Visual and Dimensional Integrity - Chemical Compatibility meetsacceptance criteriaSubstantial Equivalence: XT-27 and AXS Offset meet the samevisual and dimensional integrity - chemical compatibilityacceptance criteria. |
| Device Trackability | The device wasadvanced to the M1using standard accessmethods similar toXT-27. In order tomeet acceptancecriteria, the evaluatingphysician/s must statethat the test articlescan advance to theM1 in conjunctionwith the intermediatecatheter in the benchmodel. | Device Trackability meets acceptance criteriaSubstantial equivalence: XT-27 and AXS Offset meet the samedevice trackability acceptance criteria.After advancing the Test article with the intermediate catheters inthe model, the physicians confirmed that all of the test articles wereable to advance to the M1 using standard access methods similar toXT-27. |
| Device - Durabilityand Integrity | The integrity of thedevice was assessedthroughout theduration of theprocedure using thebench model. In orderto meet acceptancecriteria, the evaluatingphysician/s must statethat all test articlesmaintain theirintegrity throughoutprocedure. | Device Durability and Integrity meets acceptance criteriaThe evaluating physicians confirmed that the all test articlesmaintained their integrity throughout procedure.Substantial Equivalence: XT-27 and AXS Offset meet the device-durability and integrity acceptance criteria. |
| GuidewireCompatibility | Guidewires up to0.018in OD wereallowed to advanceand withdraw fromthe AXS Offsetdevice during theprocedure using thebench model. In | Guidewire Compatibility meets acceptance criteriaThe evaluating physicians confirmed that all test articles allowedsmooth advancement and withdrawal of standard guidewires up to0.018in OD. |
| order to meetacceptance criteria,the evaluatingphysician/s must statethat all test articlesallow smoothadvancement andwithdrawal ofstandard guidewiresup to 0.018in OD. | Substantial Equivalence: XT-27 and AXS Offset meet the sameguidewire compatibility acceptance criteria. | |
| Labelling requirements | The physician readthe DFU and labeling.In order to meetacceptance criteria,the evaluatingphysician/s must statethat DFU and labelingof all test articlesclearly identify theproduct and provideinformation adequateto ensure the safe useof the device. | Labelling Requirements meet acceptance criteriaThe evaluating physicians confirmed that the DFU and labeling ofall test articles clearly identify the product and provide informationadequate to ensure the safe use of the device.Substantial Equivalence: XT-27 and AXS Offset meet the labelingrequirements acceptance criteria. |
| Intended UseEnvironment | During the procedureusing the benchmodel, the device wasassessed whether itwithstood thesimulated useconditions. In orderto meet acceptancecriteria, the evaluatingphysician/s must statethat all test articlescan withstandconditions that cantypically be seenduring useenvironment of theproduct. | Intended Use Environment meets acceptance criteriaThe evaluating physicians confirmed that all Test articles withstandconditions that can typically be seen during use environment of theproduct.Substantial Equivalence: XT-27 and AXS Offset meet the sameintended use environment acceptance criteria. |
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Stryker Neurovascular
Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
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Stryker Neurovascular
Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
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Stryker Neurovascular
Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
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Stryker Neurovascular Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
| Visibility | The visibility of thetip of the AXS Offset(marker) was assessedusing fluoroscopyduring delivery to andwithdrawal from theintended location inthe bench model. Inorder to meetacceptance criteria,the evaluatingphysician/s must statethat all test articles arevisible underfluoroscopy duringdelivery to andwithdrawal from theintended location. | Visibility meets acceptance criteriaThe evaluating physicians confirmed that all test articles are visibleunder fluoroscopy during delivery to and withdrawal from theintended location.Substantial Equivalence: XT-27 and AXS Offset meet the samevisibility acceptance criteria. |
|---|---|---|
| Packaging | Performed packagingvisual, dimensional,and performancetesting on carton,labels, DFU, andpouch | Packaging visual, dimensional, and performance testing meets theacceptance criteria for all packaging components (carton, labels,DFU, and pouch).Substantial Equivalence: XT-27 and AXS Offset meet the samepackaging visual, dimensional, and performance acceptance criteria. |
Biocompatibility
The AXS Offset Delivery Assist Catheter was assessed for impact to biocompatibility. All proposed materials to be used in the AXS Offset Delivery Assist Catheter as per this assessment have a history of safe clinical use throughout the medical device industry and/or within Stryker Neurovascular and have supporting biocompatibility data. The materials used and the manufacturing process used in the AXS Offset Delivery Assist Catheter are the same or very similar to materials used in the cleared reference predicate Transform Occlusion Balloon Catheter (K122576).
The history of safe use and supporting biological test data leveraged from for the reference predicate devices noted above, indicates potential exposure to these existing materials at the amounts present under the proposed clinical conditions of use for the AXS Offset Delivery Assist Catheter will be toxicologically insignificant.
The minor material and manufacturing differences between the AXS Offset Delivery Assist Catheter and the cleared reference predicate device are considered low risk in terms of impact to the biocompatibility of the AXS Offset Delivery Assist Catheter. Therefore, the supporting Transform Occlusion Balloon Catheter (K122576) biocompatibility test data presented in Transform Occlusion Balloon Catheter Biocompatibility Results Summary Table are applicable to the AXS Offset Delivery Assist Catheter.
Although these differences are considered low risk for the biocompatibility of the AXS
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Offset Delivery Assist Catheter, screening tests were conducted to further provide supporting evidence that these differences do not adversely impact the product. The AXS Offset Delivery Assist Catheter Biocompatibility Results Summary table summarizes the biocompatibility tests that were conducted using the AXS Offset Delivery Assist Catheter. EN ISO 10993 parts are referenced where applicable.
| Test | Test Summary | Conclusion |
|---|---|---|
| MEM ElutionCytotoxicity/Part 5 | The test article extractshowed no evidence ofcausing cell lysis or toxicity,with a grade of 0 (noreactivity). | Pass.No cytotoxicity or cell lysis.The test article is considerednon-cytotoxic. |
| Hemolysis Extract/DirectContact Method/Part 4 | The hemolytic index for thetest article in direct contactwith blood and for theextractwas <5%. | Pass.Results are considered pass ifthe hemolytic index of thetest article is 5% or less. |
| USP Physicochemical<661>/Part 18 | The results for the test articlewere:Non-volatile residue: 7 mgResidue on ignition: < 1 mgHeavy metal: < 1 ppmBuffering capacity: < 1.0 ml | Pass.The test results indicate thereare no gross residuals orvolatiles. |
| FTIR / Part 18 | FTIR scan done to establishbaseline for reference only | The baseline identifiedpolyamide type materialswhich are constituents of thedevice. |
| Natural Rubber Latex | ||
| ELISA Inhibition Assay forAntigenic Protein | The test article extractshowed no detectable latex. | Pass.Latex below level ofdetection. |
| ASTM D6499-12 | ||
| In-vitro Blood Loop Assaywith Comparison Article | The test article (AXS DAC)received a worst case scoreof '1.' And the comparisonarticle (Transform) receiveda worst case score of '1'where for a score of 0, 1 or 2the test article is deemedthromboresistant. | Pass.Both the test article (AXSDAC) and comparisonarticle (Transform)considered thromboresistant. |
| Test | Test Summary | Conclusion |
| MEM Elution Cytotoxicity/Part 5 | The test article extract showedno evidence of causing celllysis or toxicity, with a grade of0 (no reactivity). | Pass.The test article extract met therequirements of the test since thegrade was less than a grade 2 (mildreactivity). |
| Guinea Pig MaximizationSensitization/Part 10 | The test article showed noevidence of causing delayeddermal contact sensitization. | Pass.The test article is not considered asensitizer. |
| Intracutaneous Reactivity/Part 10 | The difference between testextract mean score and thecontrol mean score was 0.0. | Pass.The test article met therequirements of the test. |
| Acute Systemic Injection/Part 11 | There was no mortality orevidence of systemic toxicity. | Pass.The test article met therequirements of the test. |
| Materials Mediated RabbitPyrogen/Part 11 | The total rise of rabbittemperatures during the threehour observation was withinacceptable USP limits. | Pass.The test article was judged asnonpyrogenic. |
| Ames Mutagenicity/Part 3 | The test article extracts wereconsidered to be nonmutagenicto Salmonella typhimurium teststrains and to Escherichia colitest strains. | Pass.The test article was considerednonmutagenic |
| Genotoxicity - Mouse LymphomaAssay/Part 3 | The test article extracts did notcause a twofold or greaterincrease in the mean mutantfrequency of the L5178Y/TK+/-cell line in either the absence orpresence of metabolicactivation. | Pass.The test article was considerednonmutagenic |
| Hemolysis Direct Contact andExtract Method/Part 4 | The hemolytic index for thetest article in direct contactwith blood was 0.0%, and thehemolytic index for the testarticle extract was 0.1%. | Pass.The test article met the criteria of<5%. |
| Partial Thromboplastin Time/Part 4 | Clotting time of the test articlewas 67% of the negativecontrol. | Pass.The test article met the acceptancecriteria of ≥50%. |
| In Vitro HemocompatibilityAssay/Part 4 | All counts for the test articlewere not significantly differentfrom the reference material. | Pass.Results for the test articlecomparable to the referencematerial. |
| Complement Activation (SC5b-9)/Part 4 | Concentration of SC5b-9 forthe test article was notstatistically higher than thenegative control. | Pass.The test article was not consideredto be a potential activator of thecomplement system. |
| Test | Test Summary | Conclusion |
| Complement Activation(C3a)/Part 4 | Concentration of C3a for thetest article was not statisticallyhigher than the negativecontrol. | Pass.The test article was not consideredto be a potential activator of thecomplement system. |
| USP Physicochemical <661>/Part 18 | The results for the test articlewere:Non-volatile residue: 1 mgResidue on ignition: < 1 mgHeavy metal: < 1 ppmBuffering capacity: < 1.0 | Pass.The test results indicated there areno gross residuals or volatiles. |
| Natural Rubber LatexELISA Inhibition Assay forAntigenic ProteinASTM D6499-07 | The results for the test articlewere <0.2 ug/g and>0.1ug/dm2 | Pass.The results for the test article wereconsidered passing. |
| In-Vivo Thromboresistance | For both the test article andcontrol, platelet counts andAPTT time were within normalranges. The test article andcontrol article scored the samefor thrombosis and vesselpatency. | Pass.The test article demonstratedcomparable thromboresistance tothe control article. |
AXS Offset Delivery Assist Catheter Biocompatibility Results Summary
The following tests were leveraged from biocompatibility testing conducted with the Transform Occlusion Balloon Catheter:
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Transform Occlusion Balloon Catheter Biocompatibility Results Summary
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Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
Biocompatibility testing previously conducted for Transform Occlusion Balloon Catheter product is representative of the AXS Offset Delivery Assist Catheter product due to similarity of materials, manufacturing processes and design. There are no new manufacturing processes, processing aids or chemicals (fillers, additives, cleaning agents etc.) for the manufacture of the AXS Offset device. Screening tests were conducted on AXS Offset Delivery Assist Catheter devices to further provide supporting evidence that the minor differences do not adversely impact the product.
Following completion of testing and review of materials, the AXS Offset Delivery Assist Catheter is considered to have no residual risk of biological hazards. It meets requirements as outlined in EN ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process for an externally communicating, circulating blood and limited contact (≤24 hrs) duration device.
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Sterilization and Shelf life
The AXS Catalyst Distal Access Catheter and all system components are sterilized with100% Ethylene Oxide. The AXS Catalyst Distal Access Catheter is provided sterile to a sterility assurance level (SAL) of 10-6, and is for single use only.
The test results for this device are within the ANSI/AAMI ST72:2011 Endotoxin Limit of 20 Endotoxin Units per device (EU/device). Bacterial endotoxin (pyrogen) testing of the AXS Offset Delivery Assist Catheter will be monitored to ensure product release meets specifications.
Ethylene oxide (EO) residuals on a sample representative of the AXS Catalyst DistalAccess Catheter are less than the maximum allowed for EO residuals per EN ISO 10993-7 for a limited contact delivery system -externally communicating.
The labeled shelf life for the AXS Offset is 3 years. Bench testing was conducted on accelerated aged AXS Offset Delivery Assist Catheters to confirm the shelf-life of the device is maintained over the duration of the labeled shelf-life.
Summary of Substantial Equivalence
The subject device is substantially equivalent to the predicate devices based on similar intended use / indications for use, same or similar materials, same fundamental design, and the same fundamental operating principles. Minor differences between the subject and predicate devices do not introduce different questions of safety and effectiveness. The conclusions drawn from risk assessments and the bench testing conducted using the subject device demonstrate that the device performs as designed, is suitable for its intended use, and that the benefits of the device outweigh any residual risks when used in accordance with device Instructions for Use.
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Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
| Feature | Proposed DeviceAXS OffsetDelivery AssistCatheterCurrentNotification | Predicate DeviceExcelsior® XT-27 MicrocatheterK113778 | PredicateDeviceTransformOcclusionBalloonCatheterK122576 | Rationale for difference(if applicable) |
|---|---|---|---|---|
| ProximalOuterDiameter | 3.0F (1.0mm) | 2.9F (0.97mm) | 2.8F (0.95mm) | No significant difference |
| Distal TipOuterDiameter | 2.7F (0.91mm) | 2.7F (0.91mm) | 2.7F (0.95mm) | N/A - Same as primarypredicate |
| MaximumCatheterDiameter(distalsection) | 3.8F (1.27mm) | 2.7F (0.91mm) | 3.8F(1.27mm) | The AXS Offset outsidediameter is the same asthe Transform andsimilar to the XT-27predicate devices. Thedifferences betweenXT27 and AXS Offsetare related to thedifferences in theindications for use. |
| InnerDiameter | 0.53mm (.021in) | 0.69mm (0.027in) | 0.31mm(.0124in) | AXS Offset ID of .021"is within the ranges ofboth predicate devices..021" ID is a commonsize for a catheter of thislength and OD. |
| HydrophilicCoatingLength | 80cm | 80cm | 80cm - 83cm | N/A - Same as primarypredicate |
| Feature | Proposed DeviceAXS OffsetDelivery AssistCatheterCurrentNotification | Predicate DeviceExcelsior® XT-27 MicrocatheterK113778 | PredicateDeviceTransformOcclusionBalloonCatheterK122576 | Rationale for difference(if applicable) |
| EffectiveLength | 150cm | 135 cm150 cm | 150 cm - 153cm | N/A - Same as primarypredicate |
| Tip Length | 2cm | 6 cm18 cm | 1cm - 3cm | AXS Offset tip length of2cm is in the range of thepredicate Transform, butmuch shorter than theXT-27 predicate. Tipmaterials impact productperformance more thantip length. Both AXSOffset and Excelsior XT-27 have the same distaltip materials and distalOD and thus have similarperformance. |
| Tip Shape | Straight | StraightPre-shaped | Straight | N/A - Same as primarypredicate |
Comparison Summary Table for Design
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Premarket Notification, Traditional 510(k) AXS Offset Delivery Assist Catheter
§ 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).