The InNeuroCo, Inc. 091 Long Sheath is a variable stiffness catheter that has a catheter shaft reinforced with a stainless steel double coil. It has a radiopaque Platinum/lridium marker band on the distal end. The distal 10 cm of the 091 Long Sheath Catheter has a hydrophilic coating. The catheter has a nominal outer diameter of 0.109 inches and a nominal inner diameter of 0.091 inches. It is available in three working lengths: 70 cm, and 90 cm. The 091 Long Sheath has a PTFE-lined lumen. The 091 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 091 Long Sheath is supplied sterile, non-pyrogenic, and intended for single use only.

AI/ML Overview

The provided text is a 510(k) summary for the InNeuroCo 091 Long Sheath peripheral, coronary, and neuro vasculature catheter. It outlines the device's characteristics and its comparison to a predicate device, along with the results of performance testing to demonstrate substantial equivalence.

Based on the provided document, here's a description of the acceptance criteria and the study proving the device meets these criteria:

This document describes the validation of a medical device, the InNeuroCo 091 Long Sheath, for regulatory approval. It is not an AI/ML device, and therefore several of the requested sections (e.g., number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable as they relate to the validation of AI/ML algorithms, not traditional medical devices like catheters.

Acceptance Criteria and Device Performance Study for the InNeuroCo 091 Long Sheath

The InNeuroCo 091 Long Sheath is a percutaneous catheter intended for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The study conducted was a series of non-clinical (bench and animal) tests to demonstrate substantial equivalence to a legally marketed predicate device (Stryker AXS Infinity LS, K152876).

1. Table of Acceptance Criteria and Reported Device Performance

Test	Test Method Summary	Acceptance Criteria	Reported Device Performance (Conclusions)
Biocompatibility-Material Mediated Pyrogen Testing	Completed per ISO 10993-11	The test article extracts must not cause a febrile reaction greater than 0.5°C in any individual subject.	Test results for the InNeuroCo Super Distal Access (K161262) and the Zenith Catheter (K171672) were leveraged as materials and manufacturing processes are equivalent. Met acceptance criteria.
Biocompatibility-Cytotoxicity MEM Elution	Completed per ISO 10993-5	The cultures treated with the test article must not have a reactivity grade greater than 2.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Biocompatibility-Hemolysis ASTM Method, extract human blood	Completed per ISO 10993-4	The hemolytic index above the negative control article must be less than 5%.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Biocompatibility-Hemolysis, ASTM method, direct contact (human blood)	Completed per ISO 10993-4	The hemolytic index above the negative control article must be less than 5%.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Biocompatibility-Unactivated Partial Thromboplastin Time	Completed per ISO 10993-4	There must be no statistical decrease between the UPTT of plasma exposed to the test article and to the negative or untreated control.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Biocompatibility-Complement Activation	Completed per ISO 10993-4	There must be no statistical increase between either the C3a or SC5b-9 concentrations in plasma exposed to the test article as compared to the negative and untreated controls.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Biocompatibility-Dog Thrombogenicity	Completed per ISO 10993-4	The test articles must receive a thrombus formation score less than or equal to that of the control.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Biocompatibility-Maximization Sensitization	Completed per ISO 10993-10	The test article must elicit a positive response in less than 10% of the test animals.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Biocompatibility-Intracutaneous Toxicity/Reactivity	Completed per ISO 10993-10	The test article extracts must not induce a significantly greater biological reaction than the control.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Biocompatibility-Acute Systemic Toxicity Test	Completed per ISO 10993-11	The test article extracts must not induce a significantly greater biological reaction than the control.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Animal Testing-Angiographic Evaluation	Product evaluated within a porcine model for clinically significant injury.	No units tested can cause vessel injury.	Test article met the acceptance criteria for Animal Testing.
Bench Testing - Chemical Compatibility	Catheter exposed to chemicals readily available in a clinical setting.	Chemicals have no negative effect on the catheter or accessories.	Leveraged results from InNeuroCo Super Distal Access (K161262). Met acceptance criteria.
Bench Testing - Visual Inspection	Completed per ISO 10555-1	Catheter shall appear free from damage, including a rounded tip and smooth transition points.	091 Long Sheath test samples met the acceptance criteria.
Bench Testing - Dimensions	Completed per ISO 10555-1	Test samples should be within existing dimensional specifications.	091 Long Sheath test samples met the acceptance criteria. Leveraged results for Hemostasis Valve from InNeuroCo Super Distal Access (K161262), which also met the criteria.
Bench Testing - Hub compatibility	Completed per ISO 594-1 and ISO 594-2	Hub shall meet existing Luer specifications.	Leveraged results for the 091 Long Sheath and Dilator from InNeuroCo Intermediate Catheter (K152202) and for the Hemostasis Valve from Super Distal Access (K161262). All tested samples met the acceptance criteria.
Bench Testing - Leak - Air	Completed per ISO 10555-1	Test samples should be within existing Air – Leak specifications.	091 Long Sheath test samples met the acceptance criteria.
Bench Testing - Leak - Liquid	Completed per ISO 10555-1	Test samples should be within existing Leak - Liquid specifications.	091 Long Sheath test samples met the acceptance criteria.
Bench Testing - Particulates	Completed per USP 788	Test samples should be within existing Particulate specifications.	091 Long Sheath test samples met the acceptance criteria.
Bench Testing - Simulated Use	LS underwent simulated use testing by a physician in a benchtop model.	Test samples must meet predetermined user needs.	091 Long Sheath test samples met the acceptance criteria.
Bench Testing - Catheter Burst	Completed per ISO 10555-1	Test sample burst pressures must meet or exceed existing minimum burst pressure specification.	091 Long Sheath test samples met the acceptance criteria. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Tensile	Completed per ISO 10555-1	Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications.	091 Long Sheath test samples met the acceptance criteria. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Corrosion	Completed per ISO 10555-1	Test samples shall exhibit no evidence of corrosion.	Leveraged results from InNeuroCo Intermediate Catheter (K152202). All samples met the acceptance criteria. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Packaging - Dye Leak	Completed per ASTM F1929-12	Test sample shall not exhibit any visual leaks or channels.	091 Long Sheath test samples met the acceptance criteria. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Packaging - Peel	Completed per ASTM F88-09	Test sample tensile strength must meet or exceed existing tensile strength specifications.	091 Long Sheath test samples met the acceptance criteria. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Kink Resistance	Samples are subjected to different diameters until kink is observed.	Test sample kink resistance must meet or exceed existing Kink Resistance specifications.	091 Long Sheath test samples met the acceptance criteria. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Torque	Conditioned samples are torqued to failure.	Test sample torque results must meet or exceed existing torque specifications.	091 Long Sheath test samples met the acceptance criteria. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - PTFE Liner inspection	LS was challenged to demonstrate liner adherence.	Test sample liner adhesion must meet or exceed existing PTFE Liner inspection specifications.	091 Long Sheath test samples met the acceptance criteria. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Hydrophilic Coating Integrity	Conditioned samples were repeatedly exposed to friction to demonstrate that the hydrophilic coating is not affected.	Test sample results must meet or exceed existing Hydrophilic Coating Integrity specifications.	091 Long Sheath test samples met the acceptance criteria. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Labeling Legibility	Label is legible after printing.	Test samples shall demonstrate text legibility.	091 Long Sheath test samples met the acceptance criteria. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Barcode	Barcode is readable with a standard barcode reader.	Test samples shall demonstrate readily readable barcodes.	091 Long Sheath test samples met the acceptance criteria. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sterilization	ISO 11135 and AAMI TIR 28	Sterilization load shall pose an equal or lesser challenge to sterilize than existing sterile product loads.	091 Long Sheath sterilization load met the acceptance criteria. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bacterial Endotoxin	AAMIST72	Test samples must meet the bacterial endotoxin acceptance criteria.	The 091 Long Sheath samples met the acceptance criteria. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Shelf Life	ASTM F1980	Aged test samples must meet or exceed existing specifications.	091 Long Sheath test samples met the acceptance criteria. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

Sample Size: The exact sample sizes for each specific test are not explicitly enumerated in the provided summary table. The statements typically indicate "Test samples" or "All samples," implying that a sufficient number were tested according to the referenced ISO or ASTM standards.
Data Provenance: The data is a mix of:
- Direct testing: For many bench tests (e.g., Visual Inspection, Leaks, Particulates, Simulated Use, Catheter Burst, Tensile, Kink Resistance, Torque, PTFE Liner inspection, Hydrophilic Coating Integrity, Labeling Legibility, Barcode, Sterilization, Bacterial Endotoxin, Shelf Life). These tests were conducted on the 091 Long Sheath.
- Leveraged data: For all biocompatibility tests, Chemical Compatibility, Hub compatibility, and Corrosion, data was leveraged from previously approved InNeuroCo devices (Super Distal Access K161262, Zenith Catheter K171672, and Intermediate Catheter K152202). This leveraging is justified by stating that the materials and manufacturing processes are equivalent.
- Animal Testing: Product evaluated within a porcine model for angiographic evaluation.
Retrospective/Prospective: All described testing appears to be prospective (new tests conducted for this device and leveraged results from other devices), not retrospective analysis of existing clinical data.
Country of Origin: Not specified in the document, but given the FDA 510(k) submission, it would be expected to follow US or internationally recognized standards. The company address is in Florida, USA.

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

Not Applicable. This is a traditional medical device (catheter) validation, not an AI/ML algorithm. Ground truth for device performance is established through standardized physical, chemical, biological, and animal testing, not human expert interpretation of data.
For "Simulated Use" testing, it mentions "by a physician," indicating one or more physicians were involved in that specific assessment, but their number and specific qualifications are not detailed beyond "physician."

4. Adjudication Method for the Test Set

Not Applicable. As this is not an AI/ML study, there is no need for adjudication of conflicting expert opinions on a dataset. Test results are objective measurements against defined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not relevant for the validation of a physical medical device like a catheter.

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

Not Applicable. There is no AI algorithm being validated in this submission. The "device" is a physical catheter.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:
- Standardized Test Methods: Adherence to established international (ISO, ASTM, USP) and industry standards for material properties, mechanical performance, biocompatibility, and sterility.
- Physical Measurements: Objective measurements of dimensions, burst pressure, tensile strength, etc.
- Chemical/Biological Assays: Results from biocompatibility tests (e.g., cytotoxicity, hemolysis, pyrogenicity, sensitization) and bacterial endotoxin tests.
- Functional Demonstrations: Successful performance in simulated use environments and in an animal model (porcine model for angiographic evaluation, showing no vessel injury).
- Predetermined Specifications: Comparison against established product specifications and the performance of the predicate device.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device, so there is no "training set."

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

Not Applicable. As there is no AI/ML training set, this question is not relevant.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 6, 2017

InNeuroCo, Inc. Marianne Grunwaldt Director, Quality Assurance and Regulatory Affairs 4635 NW 103rd Avenue Sunrise, Florida 33351

Re: K172468

Trade/Device Name: 091 Long Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY, DTL, GCC Dated: November 3, 2017 Received: November 6, 2017

Dear Marianne Grunwaldt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Carlos L. Pena -S

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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Indications for Use

510(k) Number (if known) K172468

Device Name 091 Long Sheath

Indications for Use (Describe)

The 091 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasulature.

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

Submitter's Name and Address

InNeuroCo, Inc. 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: 1-954-742-5988 Facsimile: 1-954-742-5989

Contact Information

Marianne Grunwaldt Director, Quality Assurance & Regulatory Affairs InNeuroCo, Inc 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: 1-954-703-5271 Facsimile: 1-954-742-5989 E-Mail: Marianne@InNeuroCo.com

Date Prepared

December 4, 2017

Device Trade or Proprietary Name

091 Long Sheath

Device Common or Classification Name:

Catheter, Percutaneous, 21CFR870.1250, Class II Hemostasis Valve, 21CFR870.4290, Class II Vessel Dilator, 21 CFR 870.4200, Class I

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Product Code:

DQY (Catheter) DTL (Hemostasis Valve) GCC (Vessel Dilator)

Identification of the Legally Marketed Devices to which Equivalence is Being Claimed

Name of Predicate Device	Name of Manufacturer	510(k) Number
AXS Infinity LS	Stryker	K152876

Device Description

Indications for Use

The 091 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

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Comparison to Predicate Device

	StrykerAXS Infinity LS	InNeuroCo 091 LongSheath
510(k) Number	K152876	K172468
Classification	21CFR870.1250, Class II	21CFR870.1250, Class II
Product Code	DQY	Same
Review Panel	Cardiovascular	Same
Indications For Use	The AXS Infinity LS isindicated for theintroduction ofinterventional devicesinto the peripheral,coronary, and neurovasculature.	The 091 Long Sheath isindicated for theintroduction ofinterventional devicesinto the peripheral,coronary, and neurovasculature.
ComponentsSupplied	Sheath, Vessel Dilator,Hemostasis Valve	Same
Catheter ShaftMaterial	Polyether Block Amide,(PEBAX) andChronoflex	Same
Inner Liner	PTFE	Same
Hub Material	Polycarbonate	Same
Strain Relief	Polyolefin	Same
Catheter ShaftReinforcement	Stainless Steel Braid	Stainless Steel Double-Coil
Lubricious Coating	Harland HydrophilicCoating	Same
Radiopaque MarkerBand	Platinum/ Iridium	Same
	StrykerAXS Infinity LS	InNeuroCo 091 Long Sheath
Packaging	Tyvek/Nylon Pouch, polyethylene support tube, packaging card, SBS carton	Same
Sterilization	Ethylene Oxide	Same
Pyrogenicity	Nonpyrogenic	Same
Working Lengths	70, 80, 90 cm	Same
Internal Diameter	0.088 inches	0.091 inches
Outer Diameter	0.109 inches	Same
Vessel Dilator	Aid in sheath introduction during procedure	Same
Hemostasis Valve	Minimizes blood loss	Same
Luer Tapered Hub	Yes	Same

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091 Long Sheath Performance Testing

Test	Test MethodSummary	Acceptance Criteria	Conclusions	PredicateDevice Testing(Yes/Unknown)
Biocompatibility-MaterialMediated Pyrogen	Testingcompleted perISO 10993-11	The test articleextracts must notcause a febrilereaction greaterthan 0.5°C in anyindividual subject.	Test results for theInNeuroCo SuperDistal Access(K161262) and theZenith Catheter(K171672) wereleveraged for the091 Long Sheathas the materialsand manufacturing	Yes
Test	Test MethodSummary	Acceptance Criteria	Conclusions	PredicateDevice Testing(Yes/Unknown)
Biocompatibility-Cytotoxicity MEM Elution	Testingcompleted perISO 10993-5	The culturestreated with the testarticle must nothave a reactivitygrade greater than2.	Test results for theInNeuroCo SuperDistal Access(K161262) and theZenith Catheter(K171672) wereleveraged for the091 Long Sheathas the materialsand manufacturingprocesses areequivalent. Testarticles met theacceptancecriteria forCytotoxicity MEMElution.	Yes
Biocompatibility-Hemolysis ASTMMethod, extract humanblood	Testingcompleted perISO 10993-4	The hemolyticindex above thenegative controlarticle must be lessthan 5%.	Test results for theInNeuroCo SuperDistal Access(K161262) and theZenith Catheter(K171672) wereleveraged for the091 Long Sheathas the materialsand manufacturingprocesses areequivalent. Testarticles met theacceptancecriteria forHemolysis ASTM	Yes
Test	Test MethodSummary	Acceptance Criteria	Conclusions	PredicateDevice Testing(Yes/Unknown)
Biocompatibility-Hemolysis, ASTMmethod, direct contact(human blood)	Testingcompleted perISO 10993-4	The hemolyticindex above thenegative controlarticle must be lessthan 5%.	Method, extracthuman blood.Test results for theInNeuroCo SuperDistal Access(K161262) and theZenith Catheter(K171672) wereleveraged for the091 Long Sheathas the materialsand manufacturingprocesses areequivalent. Testarticles met theacceptancecriteria forHemolysis, ASTMmethod, directcontact (humanblood).	Yes
Biocompatibility-Unactivated PartialThromboplastin Time	Testingcompleted perISO 10993-4	There must be nostatistical decreasebetween the UPTTof plasma exposedto the test articleand to the negativeor untreatedcontrol.	Test results for theInNeuroCo SuperDistal Access(K161262) and theZenith Catheter(K171672) wereleveraged for the091 Long Sheathas the materialsand manufacturingprocesses areequivalent. Testarticle met theacceptancecriteria forUnactivatedPartialThromboplastinTime.	Yes
Test	Test MethodSummary	Acceptance Criteria	Conclusions	PredicateDevice Testing(Yes/Unknown)
Biocompatibility-Complement Activation	Testingcompleted perISO 10993-4	There must be nostatistical increasebetween either theC3a or SC5b-9concentrations inplasma exposed tothe test article ascompared to thenegative anduntreated controls.	Test results for theInNeuroCo SuperDistal Access(K161262) and theZenith Catheter(K171672) wereleveraged for the091 Long Sheathas the materialsand manufacturingprocesses areequivalent. Testarticle met theacceptancecriteria forComplementActivation.	Yes
Biocompatibility-DogThrombogenicity	Testingcompleted perISO 10993-4	The test articlesmust receive athrombus formationscore less than orequal to that of thecontrol.	Test results for theInNeuroCo SuperDistal Access(K161262) and theZenith Catheter(K171672) wereleveraged for the091 Long Sheathas the materialsand manufacturingprocesses areequivalent. Testarticle met theacceptancecriteria for DogThromboresistance.	Yes
Biocompatibility-MaximizationSensitization	Testingcompleted perISO 10993-10	The test articlemust elicit apositive responsein less than 10% ofthe test animals.	Test results for theInNeuroCo SuperDistal Access(K161262) and theZenith Catheter(K171672) were	Yes
Test	Test MethodSummary	Acceptance Criteria	Conclusions	PredicateDevice Testing(Yes/Unknown)
			leveraged for the091 Long Sheathas the materialsand manufacturingprocesses areequivalent. Testarticle met theacceptancecriteria forMaximizationSensitization.
Biocompatibility-IntracutaneousToxicity/Reactivity	Testingcompleted perISO 10993-10	The test articleextracts must notinduce asignificantly greaterbiological reactionthan the control.	Test results for theInNeuroCo SuperDistal Access(K161262) and theZenith Catheter(K171672) wereleveraged for the091 Long Sheathas the materialsand manufacturingprocesses areequivalent. Testarticle met theacceptancecriteria forIntracutaneousToxicity/Reactivity.	Yes
Biocompatibility-AcuteSystemic Toxicity Test	Testingcompleted perISO 10993-11	The test articleextracts must notinduce asignificantly greaterbiological reactionthan the control.	Test results for theInNeuroCo SuperDistal Access(K161262) and theZenith Catheter(K171672) wereleveraged for the091 Long Sheathas the materialsand manufacturingprocesses areequivalent. Test	Yes
Test	Test MethodSummary	Acceptance Criteria	Conclusions	PredicateDevice Testing(Yes/Unknown)
Animal Testing-Angiographic Evaluation	Productevaluated withina porcine modelfor clinicallysignificantinjury.	No units tested cancause vessel injury.	Test article metthe acceptancecriteria for AnimalTesting-	Yes
Bench Testing -Chemical Compatibility	Catheterexposed tochemicalsreadily availablein a clinicalsetting.	Chemicals have nonegative effect onthe catheter oraccessories.	Test results for theInNeuroCo SuperDistal Access(K161262) wereleveraged for the091 Long Sheathas the materialsand manufacturingprocesses areequivalent. Testarticles met theacceptancecriteria forChemicalCompatibility	Yes
Bench Testing - VisualInspection	Testingcompleted perISO 10555-1	Catheter shallappear free fromdamage, includinga rounded tip andsmooth transitionpoints.	091 Long Sheathtest samples metthe acceptancecriteria for VisualInspection.	Yes
Bench Testing -Dimensions	Testingcompleted perISO 10555-1	Test samplesshould be withinexistingdimensionalspecifications.	091 Long Sheathtest samples metthe acceptancecriterial fordimensions. Testresults for the	Yes
Test	Test MethodSummary	Acceptance Criteria	Conclusions	PredicateDevice Testing(Yes/Unknown)
			InNeuroCo SuperDistal Access(K161262) wereleveraged for theHemostasis Valve,which met thedimensionalacceptancecriteria.
Bench Testing - Hubcompatibility	Testingcompleted perISO 594-1 andISO 594-2	Hub shall meetexisting Luerspecifications.	Test results for theInNeuroCoIntermediateCatheter(K152202) wereleveraged for the091 Long Sheathand the Dilator asthe materials andmanufacturingprocesses areequivalent. Thetest results for theSuper DistalAccess (K161262)were leveraged forthe 091 LongSheathHemostasis Valve.All tested samplesmet theacceptancecriteria for Hubcompatibility.	Yes
Bench Testing - Leak -Air	Testingcompleted perISO 10555-1	Test samplesshould be withinexisting Air – Leakspecifications.	091 Long Sheathtest samples metthe acceptancecriteria for Leak -Air.	Yes
Test	Test MethodSummary	Acceptance Criteria	Conclusions	PredicateDevice Testing(Yes/Unknown)
Bench Testing - Leak -Liquid	Testingcompleted perISO 10555-1	Test samplesshould be withinexisting Leak -Liquidspecifications.	091 Long Sheathtest samples metthe acceptancecriteria for Leak -Liquid.	Yes
Bench Testing -Particulates	Testingcompleted perUSP 788	Test samplesshould be withinexisting Particulatespecifications.	091 Long Sheathtest samples metthe acceptancecriteria forParticulates.	Yes
Bench Testing -Simulated Use	LS underwentsimulated usetesting by aphysician in abenchtop model	Test samples mustmeetpredetermined userneeds	091 Long Sheathtest samples metthe acceptancecriteria forSimulated Use -Bench.	Yes
Bench Testing - CatheterBurst	Testingcompleted perISO 10555-1	Test sample burstpressures mustmeet or exceedexisting minimumburst pressurespecification.	091 Long Sheathtest samples metthe acceptancecriteria forCatheter Burst.	Yes
Bench Testing - Tensile	Testingcompleted perISO 10555-1	Test sampleultimate tensilestrength must meetor exceed existingtensile strengthspecifications.	091 Long Sheathtest samples metthe acceptancecriteria.	Yes
Bench Testing -Corrosion	Testingcompleted perISO 10555-1	Test samples shallexhibit no evidenceof corrosion.	Test results for theInNeuroCoIntermediateCatheter(K152202) wereleveraged for the091 Long Sheathas the materialsand manufacturingprocesses are	Yes
Test	Test MethodSummary	Acceptance Criteria	Conclusions	PredicateDevice Testing(Yes/Unknown)
Bench Testing -Packaging - Dye Leak	Testingcompleted perASTM F1929-12	Test sample shallnot exhibit anyvisual leaks orchannels	equivalent. Allsamples met theacceptancecriteria.091 Long Sheathtest samples metthe acceptancecriteria forPackaging - DyeLeak.	Yes
Bench Testing -Packaging - Peel	Testingcompleted perASTM F88-09	Test sample tensilestrength must meetor exceed existingtensile strengthspecifications.	091 Long Sheathtest samples metthe acceptancecriteria forPackaging - Peel.	Yes
Bench Testing - KinkResistance	Samples aresubjected todifferentdiameters untilkink isobserved.	Test sample kinkresistance mustmeet or exceedexisting KinkResistancespecifications.	091 Long Sheathtest samples metthe acceptancecriteria for KinkResistance.	Yes
Bench Testing - Torque	Conditionedsamples aretorqued tofailure	Test sample torqueresults must meetor exceed existingtorquespecifications.	091 Long Sheathtest samples metthe acceptancecriteria for Torque.	Yes
Bench Testing - PTFELiner inspection	LS waschallenged todemonstrateliner adherence.	Test sample lineradhesion mustmeet or exceedexisting PTFE Linerinspectionspecifications.	091 Long Sheathtest samples metthe acceptancecriteria for PTFELiner inspection.	Yes
Bench Testing -Hydrophilic CoatingIntegrity	Conditionedsamples wererepeatedlyexposed tofriction to	Test sample resultsmust meet orexceed existingHydrophilic Coating	091 Long Sheathtest samples metthe acceptancecriteria for	Yes
Test	Test MethodSummary	Acceptance Criteria	Conclusions	PredicateDevice Testing(Yes/Unknown)
	demonstratethat thehydrophiliccoating is notaffected.	Integrityspecifications.	HydrophilicCoating Integrity.
Bench Testing - LabelingLegibility	Label is legibleafter printing.	Test samples shalldemonstrate textlegibility.	091 Long Sheathtest samples metthe acceptancecriteria for labelinglegibility.	Yes
Bench Testing - Barcode	Barcode isreadable with astandardbarcode reader.	Test samples shalldemonstratereadily readablebarcodes	091 Long Sheathtest samples metthe acceptancecriteria for barcodetesting.	Yes
Sterilization	ISO 11135 andAAMI TIR 28	Sterilization loadshall pose an equalor lesser challengeto sterilize thanexisting sterileproduct loads.	091 Long Sheathsterilization loadmet theacceptancecriteria forsterilization.	Yes
Bacterial Endotoxin	AAMIST72	Test samples mustmeet the bacterialendotoxinacceptance criteria	The 091 LongSheath samplesmet the acceptancecriteria for bacterialendotoxins.	Yes
Shelf Life	ASTM F1980	Aged test samplesmust meet orexceed existingspecifications	091 Long Sheathtest samples metthe acceptancecriteria for shelflife.	Yes

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Summary of Non-Clinical Data

The conclusions drawn from the physical, mechanical, and performance testing of the subject 091 Long Sheath along with the data leveraged from other commercially available products demonstrate that the product is Substantially Equivalent to 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).