The AXS Infinity LS Plus Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Device Description

The AXS Infinity LS Plus Long Sheath is a variable stiffness catheter that has a catheter shaft reinforced with a stainless-steel mixed coil design (single wind and cross coil wind). It has a radiopaque Platinum/Iridium marker band on the distal end. The distal 10 cm of the AXS Infinity LS Plus Long Sheath has a hydrophilic coating which reduces the insertion force and allows the catheter to traverse the vasculature more easily. The catheter has a maximum average outer diameter of 0.109", where no point is > 0.112" and a nominal inner diameter of 0.091". It is available in three working lengths: 70 cm, 80 cm, and 90 cm. The AXS Infinity LS Plus Long Sheath has a PTFElined lumen. The AXS Infinity LS Plus Long Sheath is inserted at a vascular access point to provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and a Vessel Dilator. The accessories are identical to those in the previous clearance (K172468). The AXS Infinity LS Plus Long Sheath is supplied sterile, non-pyrogenic, and intended for single use only.

AI/ML Overview

This document is a 510(k) summary for the AXS Infinity LS Plus Long Sheath, a medical device. It describes the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are presented across several tables in the document, categorized by the type of testing.

Biocompatibility Testing (Table 5-3, page 9):

#	Tests	Acceptance Criteria	Results (Pass/Fail/Other)
1	MEM elution, 48 hr. inc., triplicate L929, 24 hr. ext. (non-implant)	Replicate results from negative and media controls must all receive a 0-1 reactive grade and replicate positive controls must all receive a 3-4 reactivity grade.	Pass. All test method acceptance criteria were met. No cytotoxicity or cell lysis. Score: 0
2	Magnusson-Kligman Method, 2 extracts	Replicate results from negative and media controls must all receive a 0-1 reactive grade and replicate positive controls must all receive a 3-4 reactivity grade	Pass. The USP 0.9% Sodium Chloride for injection (NaCl) and Cottonseed Oil (CSO) extracts of the test article elicited no reaction at the challenge (0% sensitization), following an induction phase. The test article is classified as a non-sensitizer.
3	Intracutaneous Toxicity (ISO), 2 extracts	The test article extracts must not produce a significantly greater biological reaction than the control.	Pass. The test article (device) sites did not show a significantly greater biological reaction than the sites injected with the control article.
4	Material Mediated Pyrogen	The test article extract must not produce a pyrogenic response.	Pass. The test article (device) is considered non-pyrogenic.
5	Systemic Injection (ISO), 2 extracts	The test article extracts must not produce a significantly greater biological reaction than the control.	Pass. The test article (device) extracts did not cause acute adverse effects under the conditions of this assay.
6	Hemolysis, ASTM Method, indirect contact (human blood)	The negative control must produce a corrected hemolytic index of less than 2%. The positive control must produce a corrected hemolytic index of greater than 5% above the negative control. The hemolytic index of the test article must be rated 0-2 (Non-Hemolytic) when corrected with a negative control.	Pass. The difference between the hemolytic indexes of the test article and the negative control is 0.00 percent for direct contact, and 0.44 for extract; this places the test article in the non-hemolytic range.
7	Hemolysis, ASTM Method, direct contact (human blood)	The concentration of SC5b-9 in the test article should be comparable to the predicate and the negative control.	This entry appears to be misaligned, the result is missing but likely linked to item 8.
8	Complement Activation, SC5b-9	Clotting times are evaluated using analysis of variance and compared to the clotting time of the negative control. When a predicate product is tested, the results of the test article are compared to predicate values.	Pass. The SCb5-9 results for the test article were statistically similar to the predicate device after 30 minutes exposure and only marginally higher than the predicate device for 60 and 90 minutes exposure. The SCb5-9 results for the test article were statistically similar to the negative control after 30- and 90-minutes exposure and only marginally higher than the negative control following 60 minutes exposure.
9	Partial Thromboplastin Time (PTT), Human Plasma	Clotting times are evaluated using analysis of variance and compared to the clotting time of the negative control. When a predicate product is tested, the results of the test article are compared to predicate values. The positive control should show a significantly shortened clotting time when compared to the negative control. A p value of less than 0.050 demonstrates a statistically significant difference.	Pass. The average clotting time for the test article was compared to the predicate and negative control and was deemed similar when p values of clotting times were compared. Hence, this result is considered acceptable.
10	Dog Thrombogenicity	The thrombogenic potential of test article will be comparable or less than the Predicate device.	Pass. The test article thrombogenic potential was less than and comparable to the Predicate device.

Design Verification - Bench Testing (Table 5-4, page 11):

| Design Requirement/Test Name | Acceptance Criteria | Results |
|---|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tensile Strength | Peak tensile force shall be ≥ 15N at all joints | Pass. Two deviations were identified. The deviations did not impact the outcome of Tensile Strength testing. Refer to the summary of the deviations provided below. In all cases, the 90/95 confidence/reliability was higher than the specification of 15N. |
| PTFE Delamination | PTFE liner shall not delaminate. Any observed delamination within 1 mm of the cut is not considered a failure. | Pass. All samples did not exhibit any PTFE delamination. |
| Torque Strength | Catheter shall withstand at least one 360 degree turn of the hub | Pass. A reliability analysis was completed at 85% reliability and 95% confidence (8.50 turns minimum torque strength). |
| Catheter Burst | Product shall not burst below 44 psi | Pass. The minimum catheter burst pressure recorded was 119.7 psi. In addition, the 85%/95% lower bound value at 117.28 psi is greater than the lower specification limit of 44 psi. |
| Leak (Liquid) | No liquid leaking from hub and catheter shaft at 44 psi for 30 second duration | Pass. All units passed the liquid leak test. |
| Leak (Air) | No air shall leak into the catheter assembly during manual aspiration | Pass. All units passed air leakage testing. |
| Catheter Dimensional Testing (ID, OD, and Working Lengths) | The ID of the catheters shall be ≥ 0.090" | Pass. 95% confidence lower bound is 0.0914", which is greater than the lower specification limit of 0.090". |
| | The average OD of the catheter shall be ≤ 0.110" over the length of the catheter where no point measured shall be > 0.112" maximum | Pass. The average OD, the 95% confidence, 90% reliability upper bound is 0.109886" which is less than 0.110". For max OD, the 95% confidence, 90% reliability upper bound is 0.0110" which is less than 0.112", max OD. |
| | The catheter working length shall be within 2 cm of nominal | Pass. For catheter working length, the 95% confidence, 90% reliability lower bound is 89.72 cm and the upper bound is 90.23 cm, which is within 2 cm of nominal (90 cm). |
| Chemical Compatibility | Product shall withstand exposure to the following chemicals without degradation: Saline, Dextrose, Heparin, Contrast | Pass. All units passed chemical compatibility. |
| Kink Resistance | The kink resistance shall be: ≤ 0.215" at the distal most material ≤ 2" at the proximal most material | Pass. All units passed kink resistance. |
| Visual Inspection (Transitions and Tip) | The catheter shall have progressively lower durometer moving from proximal end to distal tip with smooth transition points to facilitate navigation through tortuous vascular anatomy. The catheter's distal tip shall be visibly tapered. | Pass. Units were inspected for smooth transitions and rounded tip. All units met the acceptance criteria and passed the transitions and tip visual inspection. |

Shelf Life (3-Year Accelerated Aging) (Table 5-5, page 14):

| Design Requirement/Test Name | Acceptance Criteria | Results |
|---|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tensile Strength | Peak tensile force shall be ≥ 15N at all joints | Pass. All samples had a peak tensile force of less than 15N. |
| PTFE Delamination | PTFE liner shall not delaminate. Any observed delamination within 1 mm of the cut is not considered a failure. | Pass. All samples did not exhibit any PTFE delamination. |
| Torque Strength | Catheter shall withstand at least one 360 degree turn of the hub | Pass. All samples withstood at least one 360 degree turn of the hub. |
| Catheter Burst | Product shall not burst below 44 psi | Pass. All samples had a burst rate greater than the lower specification limit of 44 psi. |
| Leak (Liquid) | No liquid leaking from hub and catheter shaft at 44 psi for 30 second duration | Pass. All units passed the liquid leak test. |
| Leak (Air) | No air shall leak into the catheter assembly during manual aspiration | Pass. All units passed air leakage testing. |
| Catheter Dimensional Testing (ID, OD, and Working Lengths) | The ID of the catheters shall be ≥ 0.090" | Pass. The ID of all catheters was greater than the lower specification limit of 0.090". |
| | The average OD of the catheter shall be ≤ 0.110" over the length of the catheter where no point measured shall be > 0.112" maximum | Pass. The average OD of all catheters was less than 0.110". The max OD of all catheters was less than 0.112". |
| | The catheter working length shall be within 2 cm of nominal | Pass. The working length of all catheters was within 2 cm of nominal. |
| Kink Resistance | The kink resistance shall be: ≤ 0.215" at the distal most material ≤ 2" at the proximal most material | Pass. All units passed kink resistance. |
| Visual Inspection (Transitions and Tip) | The catheter shall have progressively lower durometer moving from proximal end to distal tip with smooth transition points to facilitate navigation through tortuous vascular anatomy. The catheter's distal tip shall be visibly tapered. | Pass. Units were inspected for smooth transitions and rounded tip. All units met the acceptance criteria and passed the transitions and tip visual inspection. |

Sterilization Testing (Table 5-6, page 17):

Test Name	Acceptance Criteria	Results
EO Residuals Testing	The total EO content of the AXS Infinity LS Plus was no more than 4 mg and the ECH level no more than 9 mg following 12 hours heated aeration for 1X product and 2X product.	Pass.
Bioburden Testing	The average corrected bioburden count should be less than 111 CFU/product unit. The types/groupings of microorganisms present in the bioburden should be similar to those observed with the exiting products.	Pass.
LAL Testing	LAL results were < 2.15 EU/device (0.06 EU/ml).	Pass.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state a specific numerical sample size for each individual test. Instead, it generally refers to "all samples," "all units," or implies multiple replicates by stating "replicate results" or "triplicate." For Design Verification (Bench Testing) and Shelf Life (Accelerated Aging), a reliability analysis is mentioned for some tests (e.g., Tensile Strength, Torque Strength, Catheter Burst, Dimensional Testing), which typically involves a defined sample size to achieve the stated confidence and reliability levels (e.g., 90/95 confidence/reliability). However, the exact sample numbers are not provided in this summary.
Data Provenance: The studies are described as "non-clinical data," "benchtop testing," "simulated-use testing," and "animal testing." No human clinical data was used for this submission. The testing was conducted by Stryker Neurovascular. The data is prospective in nature as it was generated specifically for this 510(k) submission to demonstrate equivalence. The provenance is internal to the manufacturer, Stryker Neurovascular, based in Fremont, CA, USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This submission pertains to a physical medical device (catheter) and relies on engineering and laboratory test results rather than expert interpretation of medical images or other diagnostic data. Therefore, the concept of "experts" establishing a "ground truth" in the clinical diagnostic sense is not directly applicable here. The "ground truth" for each non-clinical test is defined by the established and accepted engineering standards and validated test methodologies (e.g., ISO, ASTM standards, internal validated protocols). The "experts" would be the qualified engineers and technicians performing and verifying these tests. Their specific numbers and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of data requiring adjudication. The results are quantitative measurements against predefined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document explicitly states, "No clinical study was conducted as bench testing and previously performed animal testing was determined to be sufficient for verification and validation purposes" (page 17). Therefore, no MRMC study or AI-related comparative effectiveness study was performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No. This device is a physical medical catheter, not an algorithm or AI product.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is based on:

Established Industry Standards and Regulations: Such as ISO 10993-1:2018 for Biocompatibility, EN ISO 14971:2012 for Risk Assessment, and ASTM methods for Hemolysis.
Pre-determined Acceptance Criteria: Developed based on the device's intended use, safety, performance, and comparison to the predicate device.
Physical Measurements and Chemical Analyses: Performed in a laboratory setting.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The tested devices are physical products.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 29, 2019

Stryker Neurovascular Shivani Patel Senior Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538

Re: K193034

Trade/Device Name: AXS Infinity LS Plus Long Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 30, 2019 Received: October 31, 2019

Dear Shivani Patel:

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/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Xiaolin Zheng, Ph.D. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193034

Device Name AXS Infinity LS Plus Long Sheath

Indications for Use (Describe)

The AXS Infinity LS Plus Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

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)

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510(k) Summary (K193034)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Introduction:

According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for a determination of substantial equivalence.

Submitter Name, Address, and Content:

Submitter:	Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538-6515(FDA Registration Number: 3008853977)
Contact:	Shivani PatelSenior Staff Regulatory Affairs SpecialistPhone: 510-413-2772Email: shivani.patel2@stryker.com
Date Prepared:	November 27, 2019
Device Name and Classification:
Trade/Proprietary Name:	AXS Infinity LS™ Plus Long Sheath
Common Name:	Percutaneous Catheter

Classification Name: Catheter, Percutaneous

Classification Regulation: 21CFR 870.1250
Class: Class II

Product Code: DQY

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Legally Marketed Predicate Device:

Table 5-1: Legally Marketed Predicate Device
Name of PredicateDevice	Name ofManufacturer	510(k) Number
AXS Infinity LSTM PlusLong Sheath	StrykerNeurovascular	K172468

Device Description:

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Indications for Use

The AXS Infinity LS™ Plus Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Technological Characteristics and Product Feature Comparison

The AXS Infinity LS Plus Long Sheath is composed of a PTFE inner liner, a reinforcing stainless-steel single and cross-coil wind middle layer, and a polymer jacket outer layer. A polycarbonate Luer hub is bonded onto the proximal end. The device features segmented, progressively softer distal segments with a soft tip, designed to minimize vessel trauma, which contains a radiopaque platinum iridium marker band to provide visualization by fluoroscope. Stryker Neurovascular has demonstrated that the AXS Infinity LS Plus Long Sheath (modified) is substantially equivalent to the Predicate device (K172468), based on same or similar materials, same intended use, similar design and the same fundamental operating principles. A comparison of the Subject device with the Predicate device is summarized in Table 5-2, below.

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Table 5-2: Product Feature Comparison of Subject Device to Predicate Device
Detail	Submission SubjectDeviceAXS Infinity LS Plus LongSheath	Predicate DeviceAXS Infinity LS Plus LongSheath
Legal Manufacturer	Stryker Neurovascular	Same
510(k) Number	K193034	K172468
Device Trade Name	AXS Infinity LS Plus LongSheath	Same
Regulation Number	21 CFR 870.1250	Same
Regulation Name	Percutaneous Catheter	Same
Classification	II	Same
Product Code	DQY	Same
Intended Use/Indicationfor Use	The AXS Infinity LS PlusLong Sheath is indicated forthe introduction ofinterventional devices intothe peripheral, coronary andneuro vasculature.	Same
Components Supplied	Sheath, Vessel Dilator,Hemostasis Valve	Same
Catheter Distal andMid-Shaft Material	Polyether Block Amide(PEBAX) and Chronoflex	Same
Proximal Shaft Material	Coextrusion of Grilamid (outerlayer) and Pebax 55D (innerlayer)	Single extrusion of Vestamid
Catheter ShaftReinforcement	Mixed Coil Winding (Singleand cross coil)	Cross-Coil winding
Adhesive	Adhesive with light cureprocess	Adhesive with humidity cureprocess
Inner Liner	PTFE	Same
Hub Material	Polycarbonate	Same
Strain Relief	Polyolefin	Same
Lubricious Coating	Harland Hydrophilic Coating	Same
Radiopaque MarkerBand	Platinum/Iridium	Same
Packaging	Tyvek/Nylon Pouch,polyethylene support tube	Same
Table 5-2: Product Feature Comparison of Subject Device to Predicate Device
Detail	Submission SubjectDeviceAXS Infinity LS Plus LongSheath	Predicate DeviceAXS Infinity LS Plus LongSheath
	packaging card, SBS Carton
Sterilization	Ethylene Oxide	Same
Pyrogenicity	Nonpyrogenic	Same
Working Lengths	70, 80, 90 cm	Same
Internal Diameter	0.91 in	Same
Outer Diameter	.109	Same
Accessories	Tuohy-Borst Hemostasis Valve Vessel Dilator	Same

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Risk Assessment

A Risk Assessment of the AXS Infinity LS Plus Long Sheath with design changes has been conducted in accordance with EN ISO 14971:2012 Medical devices- Application of risk management to medical devices. Based on the similarity in design and identical intended use of the AXS Infinity LS Plus Long Sheath, the same risk and risk mitigation activities were applied. There were no changes in functionality. Additionally, a risk analysis was conducted at several points throughout the design process and documented throughout the process in updates to the DHF, and where necessary, updates to risk documentation. An impact assessment was also performed to analyze the effect of the proposed modifications to the existing AXS Infinity LS Plus Long

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Sheath. Results of testing are appropriate for determining that the AXS Infinity LS Plus Long Sheath is substantially equivalent to the legally marketed Predicate device.

Summary of Non-Clinical Data

Testing was conducted for the specifications that were impacted by the changes to the AXS Infinity LS Plus Long Sheath: Proximal shaft material (coextrusion); mixed coil winding pattern and pitch; modifications to the wall thickness and lengths of different polymer sections along the catheter shaft; modification to the outer diameter and use of a different adhesive to secure the marker band. Summary descriptions of the testing, which substantiates the safe and effective performance of the subject device and its substantial equivalence to the Predicate device is provided below.

. Biocompatibility
Design Verification (Benchtop Testing) ●
Sterilization .
. Design Validation (Simulated-Use Testing)

Biocompatibility

Biocompatibility testing was conducted on the Subject device, the modified AXS Infinity LS Plus Long Sheath. The studies were selected in accordance with ISO 10993-1:2018 guidelines, based on the classification as an External Communication Device used within the circulating blood for a limited (<24 hour) duration. The results of biocompatibility testing are presented below:

Table 5-3: Summary of Biocompatibility Test Results
#	Tests	Acceptance Criteria	Results(Pass/Fail/Other)
1	MEM elution, 48hr. inc., triplicateL929, 24 hr. ext.(non-implant)	Replicate results from negative andmedia controls must all receive a in.2in. reactive grade and replicatepositive controls must all receive a 3-4reactivity grade.	Pass.All test method acceptance criteriawere met. No cytotoxicity or celllysis,Score: 0
Table 5-3: Summary of Biocompatibility Test Results
#	Tests	Acceptance Criteria	Results(Pass/Fail/Other)
2	Magnusson-Kligman Method,2 extracts	Replicate results from negative andmedia controls must all receive a in.2in. reactive grade and replicatepositive controls must all receive a 3-4reactivity grade	Pass.The USP 0.9% Sodium Chloride forinjection (NaCl) and Cottonseed Oil(CSO) extracts of the test articleelicited no reaction at the challenge(0% sensitization), following aninduction phase. The test article isclassified as a non-sensitizer.
3	IntracutaneousToxicity (ISO),2 extracts	The test article extracts must notproduce a significantly greaterbiological reaction than the control.	Pass.The test article (device) sites did notshow a significantly greaterbiological reaction than the sitesinjected with the control article.
4	Material MediatedPyrogen	The test article extract must notproduce a pyrogenic response.	Pass.The test article (device) isconsidered non-pyrogenic.
5	Systemic Injection(ISO), 2 extracts	The test article extracts must notproduce a significantly greaterbiological reaction than the control.	Pass.The test article (device) extracts didnot cause acute adverse effectsunder the conditions of this assay.
6	Hemolysis, ASTMMethod, indirectcontact (humanblood)	The negative control must produce acorrected hemolytic index of less than2%. The positive control must producea corrected hemolytic index of greaterthan 5% above the negative control.The hemolytic index of the test articlemust be rated 0-2 (Non-Hemolytic)when corrected with a negative control.	Pass.The difference between thehemolytic indexes of the test articleand the negative control is 0.00percent for direct contact, and 0.44for extract; this places the testarticle in the non-hemolytic range.
7	Hemolysis, ASTMMethod, directcontact (humanblood)	The concentration of SC5b-9 in the testarticle should be comparable to thepredicate and the negative control.
Table 5-3: Summary of Biocompatibility Test Results
#	Tests	Acceptance Criteria	Results(Pass/Fail/Other)
8	ComplementActivation, SC5b-9	Clotting times are evaluated usinganalysis of variance and compared tothe clotting time of the negative control.When a predicate product is tested, theresults of the test article are comparedto predicate values.	Pass.The SCb5-9 results for the testarticle were statistically similar tothe predicate device after 30minutes exposure and onlymarginally higher than the predicatedevice for 60 and 90 minutesexposure.The SCb5-9 results for the testarticle were statistically similar tothe negative control after 30- and90-minutes exposure and onlymarginally higher than the negativecontrol following 60 minutesexposure.
9	PartialThromboplastinTime (PTT),Human Plasma	Clotting times are evaluated usinganalysis of variance and compared tothe clotting time of the negative control.When a predicate product is tested, theresults of the test article are comparedto predicate values. The positivecontrol should show a significantlyshortened clotting time when comparedto the negative control. A p value ofless than 0.050 demonstrates astatistically significant difference.	Pass.The average clotting time for thetest article was compared to thepredicate and negative control andwas deemed similar when p valuesof clotting times were compared.Hence, this result is consideredacceptable
10	DogThrombogenicity	The thrombogenic potential of testarticle will be comparable or less thanthe Predicate device.	Pass. The test article thrombogenicpotential was less than andcomparable to the Predicate device.

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Design Verification-Bench Testing

Performance testing was conducted to demonstrate substantial equivalence between the Subject device, AXS Infinity LS Plus Long Sheath (modified), and the currently cleared AXS Infinity LS Plus Long Sheath (Predicate device). The tests were performed using standard test methods and pre-determined acceptance criteria, and all samples passed. Therefore, the data provided herein supports the argument that the AXS Infinity LS Plus Long Sheath has similar performance characteristics as the Predicate device. The packaging and accessories are unchanged from the predicate device and no additional testing was needed. All the testing conducted to demonstrate equivalence is presented in Table 5-4, which follows.

Table 5-4: Summary of Design Verification (Bench Testing)
Design Requirement/Test Name		Acceptance Criteria	Results
7	Tensile Strength	Peak tensile force shall be$\geq$ 15N at all joints	Pass.Two deviations were identified. Thedeviations did not impact the outcomeof Tensile Strength testing. Refer to thesummary of the deviations providedbelow. In all cases, the 90/95confidence/reliability was higher thanthe specification of 15N.
7	PTFEDelamination	PTFE liner shall notdelaminate. Any observeddelamination within 1 mmof the cut is not considereda failure.	Pass.All samples did not exhibit any PTFEdelamination.
7	Torque Strength	Catheter shall withstand atleast one 360 degree turnof the hub	Pass.A reliability analysis was completed at85% reliability and 95% confidence(8.50 turns minimum torque strength).
Table 5-4: Summary of Design Verification (Bench Testing)
Design Requirement/Test Name	Acceptance Criteria	Results
8	Catheter Burst	Product shall not burstbelow 44 psi	Pass.The minimum catheter burst pressurerecorded was 119.7 psi. In addition, the85%/95% lower bound value at 117.28psi is greater than the lowerspecification limit of 44 psi.
10	Leak (Liquid)	No liquid leaking from huband catheter shaft at44 psi for 30 secondduration	Pass.All units passed the liquid leak test.
10	Leak (Air)	No air shall leak into thecatheter assembly duringmanual aspiration	Pass.All units passed air leakage testing.
11, 12,17	CatheterDimensionalTesting (ID, OD,and WorkingLengths)	The ID of the cathetersshall be ≥ 0.090"	Pass.95% confidence lower bound is0.0914". which is greater than the lowerspecification limit of 0.090".
		The average OD of thecatheter shall be ≤ 0.110"over the length of thecatheter where no pointmeasured shall be >0.112" maximum	Pass.The average OD, the 95% confidence,90% reliability upper bound is0.109886" which is less than 0.110".For max OD, the 95% confidence, 90%reliability upper bound is 0.0110" whichis less than 0.112" , max OD.
		The catheter workinglength shall be within 2 cmof nominal	Pass.For catheter working length, the 95%confidence, 90% reliability lower boundis 89.72 cm and the upper bound is90.23 cm, which is within 2 cm ofnominal (90 cm).
13	ChemicalCompatibility	Product shall withstandexposure to the followingchemicals withoutdegradation:• Saline• Dextrose• Heparin	Pass.All units passed chemical compatibility.
Table 5-4: Summary of Design Verification (Bench Testing)
Design Requirement/Test Name		Acceptance Criteria	Results
		Contrast
17	Kink Resistance	The kink resistance shall be:≤ 0.215" at the distal most material ≤ 2" at the proximal most material	Pass.All units passed kink resistance.
17 &18	Visual Inspection(Transitions andTip)	The catheter shall have progressively lower durometer moving from proximal end to distal tip with smooth transition points to facilitate navigation through tortuous vascular anatomy.-The catheter's distal tip shall be visibly tapered	Pass.Units were inspected for smooth transitions and rounded tip. All units met the acceptance criteria and passed the transitions and tip visual inspection.

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Shelf Life

Performance testing was conducted to demonstrate that the Subject device maintains functionality throughout the 3-year shelf life. The tests were performed using standard test methods and pre-determined acceptance criteria, and all samples passed. Therefore, the data provided herein supports the argument that the AXS Infinity LS Plus Long Sheath has similar performance characteristics as the Predicate device. All the testing conducted to demonstrate equivalence is presented in Table 5-5, which follows.

Table 5-5: Summary of 3-Year Accelerated Aging
	Design Requirement/Test Name	Acceptance Criteria	Results
7	Tensile Strength	Peak tensile force shall be$≥$ 15N at all joints	Pass.All samples had a peak tensile force ofless than 15N.
7	PTFEDelamination	PTFE liner shall notdelaminate. Any observeddelamination within 1 mmof the cut is not considereda failure.	Pass.All samples did not exhibit any PTFEdelamination.
7	Torque Strength	Catheter shall withstand atleast one 360 degree turnof the hub	Pass.All samples withstood at least one 360degree turn of the hub.
8	Catheter Burst	Product shall not burstbelow 44 psi	Pass.All samples had a burst rate greaterthan the lower specification limit of 44psi.
10	Leak (Liquid)	No liquid leaking from huband catheter shaft at44 psi for 30 secondduration	Pass.All units passed the liquid leak test.
Table 5-5: Summary of 3-Year Accelerated Aging
	Design Requirement/Test Name	Acceptance Criteria	Results
10	Leak (Air)	No air shall leak into thecatheter assembly duringmanual aspiration	Pass.All units passed air leakage testing.
11, 12,17	CatheterDimensionalTesting (ID, OD,and WorkingLengths)	The ID of the cathetersshall be ≥ 0.090"	Pass.The ID of all catheters was greater thanthe lower specification limit of 0.090".
		The average OD of thecatheter shall be ≤ 0.110"over the length of thecatheter where no pointmeasured shall be >0.112" maximum	Pass.The average OD of all catheters wasless than 0.110".The max OD of all catheters was lessthan 0.112".
		The catheter workinglength shall be within 2 cmof nominal	Pass.The working length of all catheters waswithin 2 cm of nominal.
17	Kink Resistance	The kink resistance shallbe:• ≤ 0.215" at thedistal most material• ≤ 2" at the proximalmost material	Pass.All units passed kink resistance.
17 &18	Visual Inspection(Transitions andTip)	The catheter shall haveprogressively lowerdurometer moving fromproximal end to distal tipwith smooth transitionpoints to facilitatenavigation throughtortuous vascular anatomy.-The catheter's distal tipshall be visibly tapered	Pass.Units were inspected for smoothtransitions and rounded tip. All unitsmet the acceptance criteria and passedthe transitions and tip visual inspection.

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Sterilization

Testing was conducted to assess the impact of the proposed design and process changes on sterilization which included Bioburden, EO Residuals and Pyrogenicity testing. Results confirmed there was no adverse impact due to the proposed changes, Refer to Table 5-6, below, for a summary of sterilization testing results.

Table 5-6: Summary of Sterilization Testing Results
Test Name	Acceptance Criteria	Results
EO ResidualsTesting	The total EO content of the AXSInfinity LS Plus was no morethan 4 mg and the ECH level nomore than 9 mg following 12hours heated aeration for 1Xproduct and 2X product	Pass.
BioburdenTesting	The average correctedbioburden count should be lessthan 111 CFU/ productunit. The types/groupings ofmicroorganisms present in thebioburden should be similar tothose observed with the exitingproducts.	Pass.
LAL Testing	LAL results were < 2.15 EU/device (0.06 EU/ml)	Pass.

Design Validation- Simulated-Use Testing

The modified AXS Infinity LS Plus Long Sheath (Subject device) was evaluated through simulated use testing using standard bench top models which included tortuosity of worst-case pathways in which the AXS Infinity LS Plus Long Sheath would traverse. The modified AXS Infinity LS Plus Long sheath met all relevant user needs.

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Performance Data- Animal Testing

Animal testing previously conducted for the AXS Infinity LS Plus Long Sheath was used to support the changes to the AXS Infinity LS Plus Long Sheath. Prior to design changes, Simulated Use- Animal Testing was performed to support the previously cleared AXS Infinity LS Plus Long Sheath and can be found in K172468 (cleared as 091 Long Sheath). Additional testing was not performed because the proposed design changes do not impact the overall safety and efficacy of the device.

Performance Data - Clinical

No clinical study was conducted as bench testing and previously performed animal testing was determined to be sufficient for verification and validation purposes.

Summary of Substantial Equivalence

Stryker Neurovascular has demonstrated the AXS Infinity LS™ Plus Long Sheath is substantially equivalent to the Predicate device, AXS Infinity LS Plus Long Sheath (K172468), based on same intended use / indications for use, same or similar materials, same fundamental design, and the same operating principles. The conclusions drawn from risk assessments and the bench testing conducted using the Subject device demonstrate that the Subject device is suitable for the indication for use. Additionally, the testing results summarized above along with the risk assessment demonstrate that the benefits of the device outweigh any residual risks when used in accordance with device Instructions for Use.

Stryker Neurovascular has demonstrated that the AXS Infinity LS™ Plus Long Sheath is as safe, as effective, and performs as well as the legally marketed Predicate device.

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).