The Zenith Flex System, including the Zetheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

Device Description

The InNeuroCo 074 Zenith Flex Catheter is a variable stiffness catheter that has a catheter shaft reinforced with Stainless-Steel and Nitinol to provide support. The Stainless-Steel is wound as a double coil in the proximal section and the Nitinol is a single coil in the distal section. It has a radiopaque Platinum/lridium marker band on the distal 25 cm of the 074 Zenith Flex Catheter has a hydrophilic coating. The 074 Zenith Flex Catheter is available with an internal diameter of 0.074 inches. The outer diameter is of 0.089 inches along its proximal shaft, and 0.083 inches along its distal shaft. The 074 Zenith Flex Catheter is available in three workinq lengths: 115 cm, 125 cm, and 132 cm. The 074 Zenith Flex Catheter has a PTFE lined lumen. Accessories included with the device are a Tuohy-Borst Hemostasis Valve, two peel-away Introducers, and a Scout introducer. The Scout may be used to introduce the 074 Zenith Flex Catheter into distal vasculature, thereby helping the device reach the target anatomy.

AI/ML Overview

The provided text describes the Zenith Flex System (074 Zenith Flex Catheter) and its non-clinical data for demonstrating substantial equivalence. It does not describe a study involving an AI/Machine Learning device or algorithm. Therefore, I cannot provide details regarding acceptance criteria, sample size, ground truth, or adjudication methods in the context of an AI study.

However, I can extract the acceptance criteria and observed performance described for the non-clinical (bench and animal) testing of the Zenith Flex Catheter.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Zenith Flex Catheter & its accessories Biocompatibility
Material Mediated Pyrogen	The test article extracts must not cause a febrile reaction greater than 0.5°C in any individual subject.	Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent).
Cytotoxicity MEM Elution	The cultures treated with the test article must not have a reactivity grade greater than 2.	Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent).
Hemolysis (ASTM Method, extract human blood)	The hemolytic index above the negative control article must be less than 5%.	Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent).
Unactivated Partial Thromboplastin Time (UPTT)	There must be no statistical decrease between the UPTT of plasma exposed to the test article and to the negative or untreated control.	Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent).
Complement Activation	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.	Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent).
Dog Thromboresistance	The test articles must receive a thrombus formation score less than or equal to that of the control.	Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent).
Maximization Sensitization	The test article must elicit a positive response in less than 10% of the test animals.	Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent).
Intracutaneous Toxicity/Reactivity	The test article extracts must not induce a significantly greater biological reaction than the control.	Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent).
Acute Systemic Toxicity Test	The test article extracts must not induce a significantly greater biological reaction than the control.	Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent).
Chemical Compatibility	Product shall withstand exposure to chemicals without degradation.	Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent).
Zenith Flex Catheter Performance Testing
Working Length	Test samples should be within existing working length specification.	Zenith Flex Catheter test samples met the acceptance criteria.
Hub compatibility	Hub shall meet existing Luer specifications.	Test articles met the acceptance criteria (leveraged from K171672, materials and manufacturing processes equivalent).
Outside diameter	Test samples should be within existing outside diameter specification.	Zenith Flex Catheter test samples met the acceptance criteria.
Leak - Air	Test samples should be within existing Air - Leak specifications.	Zenith Flex Catheter test samples met the acceptance criteria.
Leak - Liquid	Test samples should be within existing Leak - Liquid specifications.	Zenith Flex Catheter test samples met the acceptance criteria.
Particulates	Test samples should be within existing Particulate specifications.	Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent).
Simulated Use - Bench	Test samples must meet predetermined user needs.	Zenith Flex Catheter test samples met the acceptance criteria.
Catheter Burst	Test sample burst pressures must meet or exceed existing minimum burst pressure specification.	Zenith Flex Catheter test samples met the acceptance criteria.
Tensile	Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications.	Zenith Flex Catheter test samples met the acceptance criteria.
Corrosion	Test samples shall exhibit no evidence of corrosion.	Test articles met the acceptance criteria (leveraged from K152202, materials and manufacturing processes equivalent).
PTFE Liner inspection	Test sample liner adhesion must meet or exceed existing PTFE Liner inspection specifications.	Zenith Flex Catheter test samples met the acceptance criteria.
Hydrophilic Coating Integrity	Test sample results must meet or exceed existing Hydrophilic Coating Integrity specifications.	Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent).
Simulated Use Testing (Aspiration)	Successfully removed the thrombi.	Zenith Flex System test samples met the acceptance criteria.
Labeling Legibility	Test samples shall demonstrate text legibility.	Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent).
Barcode	Test samples shall demonstrate readily readable barcodes.	Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent).
Sterilization (Catheter & Aspiration Tubing Set)	Sterilization load shall pose an equal or lesser challenge to sterilize than existing sterile product loads.	Sterilization loads met the acceptance criteria.
Shelf Life (Catheter & Aspiration Tubing Set)	Aged test samples must meet or exceed existing specifications.	Zenith Flex Catheter & Aspiration Tubing Set test samples met the acceptance criteria.
Torque Strength	Test sample results must meet or exceed existing torque specifications.	Zenith Flex Catheter test samples met the acceptance criteria.
Kink Resistance	Test sample results must meet or exceed existing kink resistance specifications.	Zenith Flex Catheter test samples met the acceptance criteria.
Lumen Patency	Test sample results must meet or exceed existing lumen patency specifications.	Zenith Flex Catheter test samples met the acceptance criteria.
Tip Flexibility	Zenith Flex tip flexibility results were compared to predicate device results.	Zenith Flex Catheter test samples performed comparatively against the predicate device.
Friction Force	Zenith Flex friction force results were compared to predicate device results.	Zenith Flex Catheter test samples performed comparatively against the predicate device.
Simulated Use Testing - Usability	Test samples must meet predetermined user needs.	Zenith Flex System test samples met the acceptance criteria.
Aspiration Tubing Set Performance Testing
Visual Inspection	Test samples should meet visual inspection specifications.	Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same).
Tensile	Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications.	Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same).
Leak - Liquid	Test samples should be within existing Leak - Liquid specifications.	Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same).
Leak - Air, Tubing and Control Switch	Test samples should be within existing Air - Leak specifications.	Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same).
Luer Compatibility	Hub shall meet existing Luer specifications.	Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same).
Suction Connector Separation Force	Test sample results must meet or exceed existing force specifications.	Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same).
Vacuum Drop / Suction Connector Secure Attachment	Test sample results must meet or exceed existing pressure specifications.	Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same).
Lumen Patency	Test sample results must meet or exceed existing lumen patency specifications.	Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same).
Dimensions	Test samples should be within existing dimensional specifications.	Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same).
Packaging (Catheter and Aspiration Tubing Set) Testing
Packaging - Dye Leak	Test sample shall not exhibit any visual leaks or channels.	Test articles met the acceptance criteria (leveraged from K172167, packaging is the same).
Packaging - Peel	Test sample tensile strength must meet or exceed existing tensile strength specifications.	Test articles met the acceptance criteria (leveraged from K172167, packaging is the same).
Aspiration Tubing Set Biocompatibility
Cytotoxicity MEM Elution	The cultures treated with the test article must not have a reactivity grade greater than 2.	Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same).
Maximization Sensitization	The test article must elicit a positive response in less than 10% of the test animals.	Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same).
Intracutaneous Toxicity/Reactivity	The test article extracts must not induce a significantly greater biological reaction than the control.	Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same).

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

The document does not specify exact sample sizes for each benchtop or animal test. It refers to "test samples" for bench testing and does not provide numerical counts.

For animal testing: "Clot was used to create occlusions within several arteries of swine. One side of each swine was treated with the subject Zenith Flex system and the contralateral side was treated with the reference device." The exact number of swine used is not provided.

Data provenance: The non-clinical data is generated from laboratory (bench) and animal (swine) studies. The country of origin for the studies is not specified.

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

Not applicable in this context. The non-clinical studies rely on objective measurements and observations in laboratory and animal settings, not on expert ground truth for interpretation of images or clinical outcomes. For 'Simulated Use - Bench' and 'Simulated Use Testing - Usability', a physician's assessment was used, but details on the number or qualifications of these physicians are not provided.

4. Adjudication Method for the Test Set

Not applicable, as the tests involve objective measurements and direct observation rather than subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (catheter), not an AI/ML device for diagnostic interpretation. There was no MRMC study involving human readers and AI assistance.

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

Not applicable. This is a medical device (catheter), not an AI/ML device.

7. The Type of Ground Truth Used

For bench testing, the ground truth is based on physical and chemical properties measured against established specifications (e.g., ISO, ASTM standards).
For animal testing, the ground truth for effectiveness was "angiographic assessment of revascularization," and for safety, "angiographic assessment and histopathological assessment."

8. The Sample Size for the Training Set

Not applicable. This is a medical device (catheter); there is no "training set" in the context of an AI/ML algorithm.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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.

October 25, 2018

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

Re: K181354

Trade/Device Name: Zenith Flex System (074 Zenith Flex Catheter) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY. DTL. DYB Dated: September 21, 2018 Received: September 25, 2018

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. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about 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,

Xiaolin Zheng -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K181354

Device Name

Zenith Flex System (074 Zenith Flex Catheter)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

K181354

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 & Requlatory Affairs InNeuroCo, Inc 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: 1-305-495-3883 Facsimile: 1-954-742-5989 E-Mail: Marianne@InNeuroCo.com

Secondary Contact

Ming Cheng Chew Regulatory Consultant, Libra Medical, Inc. 8401 73rd Ave N, Suite 63 Brooklyn Park, MN 55428 Telephone: 763-232-3701 E-Mail: mcchew@libramed.com

Date Prepared

October 22, 2018

Device Trade or Proprietary Name

Zenith Flex System (074 Zenith Flex Catheter)

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Device Common or Classification Name:

Percutaneous Catheter, 21 CFR 870.1250, Class II Hemostasis Valve, 21 CFR 870.4290, Class II Catheter Introducer, 21 CFR 870.1340, Class II

Product Code:

NRY (Catheter, Thrombus Retriever) DTL (Hemostasis Valve) DYB (Catheter Introducer)

Name of Predicate Device	Name of Manufacturer	510(k) Number
Zenith Flex Catheter	InNeuroCo, Inc	K172167
Name of Reference Device	Name of Manufacturer	510(k) Number

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

Device Description

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Indications for Use

The Zenith Flex System, including the Zenith Flex Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

	Predicate DeviceInNeuroCo, Inc.071 Zenith Flex	Reference DevicePenumbra Ace 68	Subject DeviceInNeuroCo, Inc.074 Zenith Flex
510(k) Number	K172167	K161064	K181354
Classification	Class II	Class II	Same
Product Code	NRY	NRY	Same
Review Panel	Neurology	Neurology	Same
Indications ForUse	The Zenith Flex System,including the Zenith FlexCatheter, AspirationTubing Set, and VC-701Cliq Aspirator Pump, isindicated in therevascularization ofpatients with acuteischemic strokesecondary to intracraniallarge vessel occlusivedisease (within theinternal carotid, middlecerebral - M1 and M2segments, basilar, andvertebral arteries) within8 hours of symptomonset. Patients who areineligible for intravenoustissue plasminogenactivator (IV t-PA) or whofailed IV t-PA therapy arecandidates for treatment.	The PenumbraSystem is intendedfor use in therevascularization ofpatients with acuteischemic strokesecondary tointracranial largevessel occlusivedisease (within theinternal carotid,middle cerebral- M1 and M2segments, basilar,and vertebralarteries) within 8hours of symptomonset.	Same as 071Zenith Flex
	Predicate DeviceInNeuroCo, Inc.071 Zenith Flex	Reference DevicePenumbra Ace 68	Subject DeviceInNeuroCo, Inc.074 Zenith Flex
ComponentsSupplied	Zenith Flex Catheter,Peel Away Introducer,Hemostasis Valve, ScoutIntroducer	PenumbraReperfusionCatheter, AspirationPump,Pump/Canister	Same as 071Zenith Flex
Catheter ShaftMaterial	Polyether Block Amide(PEBAX),Polycarbonate/Urethane,Nylon	Pebax, Nylon,Urethane	Same as 071Zenith Flex
Inner Liner	PTFE	PTFE	Same
Hub Material	Polycarbonate	Grilamid	Same as 071Zenith Flex
Strain Relief	Polyolefin	Polyolefin, PETYellow, Grilamid	Same as 071Zenith Flex
Catheter ShaftReinforcement	Stainless Steel/Nitinol	Stainless Steel/Nitinol	Same
Reinforcementpattern	Coil	Coil	Same
LubriciousCoating	Hydrophilic Coating	Hydrophilic Coating	Same
RadiopaqueMarker Band	Platinum/ Iridium	Platinum/ Iridium	Same
CatheterPackaging	Tyvek/Nylon Pouch,polyethylene supporttube, packaging card,SBS carton	Tyvek/Nylon Pouch,polyethylene supporttube, packaging card,SBS carton	Same
Sterilization	Ethylene Oxide	Ethylene Oxide	Same
Pyrogenicity	Nonpyrogenic	Nonpyrogenic	Same
Working Lengths	115, 125, 132 cm	115, 120, 125, 127,132 cm	Same as 071Zenith Flex
Inside Diameter(ID)	0.071 in	0.068 in min.	0.074 in
	Predicate DeviceInNeuroCo, Inc.071 Zenith Flex	Reference DevicePenumbra Ace 68	Subject DeviceInNeuroCo, Inc.074 Zenith Flex
Proximal OuterDiameter	0.085 in max	0.084 in max	0.089 in max
Distal OuterDiameter	0.082 in nominal	0.084 in max	0.083 in nominal
Shelf Life	3 years	3 years	Same
Introducer	Peel away to aid incatheter tip introductioninto hemostasis valveScout to help with thenavigation	Included as part ofthe Separator with atorque device	Same as 071Zenith Flex
Hemostasis Valve	Polycarbonate, SiliconeO-Ring, Side Port	Polycarbonate,Silicone O-Ring, SidePort	Same
Luer Tapered Hub	Yes	Yes	Same
CompatibleGuidewire	0.038 inches	0.038 inches	Same
Scout Introducer	Yes	No	Same as 071Zenith Flex
Aspiration Method	Pump	Pump	Same
AspirationPressure	22-28 in Hg	20-29 in Hg	Same as 071Zenith Flex

Comparison to Predicate Device

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Summary of Non-Clinical Data

The subject device has the same materials, packaging, manufacturing process, and sterilization process as the predicate device. Therefore, testing was only conducted for specifications that were affected by the catheter size change.

Animal Testing

Clot was used to create occlusions within several arteries of swine. One side of each swine was treated with the subject Zenith Flex system and the contralateral side was treated with the reference device. The study included two follow up evaluations: 3 days and 30 days.

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There were 3 endpoints of the study: angiographic assessment of revascularization to establish effectiveness, angiographic assessment and histopathological assessment to demonstrate safety. As testing included the reference device, results were compared to demonstrate substantial equivalence.

Zenith Flex Performance Testing

To demonstrate substantial equivalence between the subject 074 Zenith Flex Catheter and the predicate 071 Zenith Flex Catheter and the reference Penumbra ACE 68 Catheter, performance testing was conducted. The testing covered verification and validation testing, including biocompatibility, bench testing, sterilization and shelf life. Additionally, some tests were leveraged from previous testing conducted by InNeuroCo. The tests were performed using standard test methods and pre-determined acceptance criteria and all samples passed. Therefore, this test data supports the argument that the 074 Zenith Flex Catheter has similar performance characteristics as the predicate device and the reference device. All of the testing conducted to demonstrate substantial equivalence are presented in the following table.

Test	Test MethodSummary	Acceptance Criteria	Conclusions
Zenith Flex Catheter& its accessoriesBiocompatibility-Material MediatedPyrogen	Testing completed perISO 10993-11	The test article extracts mustnot cause a febrile reactiongreater than 0.5°C in anyindividual subject.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subject ZenithFlex Catheter as the materialsand manufacturing processesare equivalent. Test articles metthe acceptance criteria.
Zenith Flex Catheter& its accessoriesBiocompatibility-Cytotoxicity MEMElution	Testing completed perISO 10993-5	The cultures treated with thetest article must not have areactivity grade greater than2.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subject ZenithFlex Catheter as the materialsand manufacturing processesare equivalent. Test articles metthe acceptance criteria.
Zenith Flex Catheter & itsaccessoriesBiocompatibility- HemolysisASTM Method, extracthuman blood	Testing completed perISO 10993-4	The hemolytic indexabove the negative controlarticle must be less than5%.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent. Testarticles met the acceptance
Test	Test MethodSummary	Acceptance Criteria	Conclusions
Zenith Flex Catheter &its accessoriesBiocompatibility-Hemolysis, ASTM	Testing completed perISO 10993-4	The hemolytic indexabove the negative controlarticle must be less than5%.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent. Testarticles met the acceptancecriteria.
Zenith Flex Catheter &its accessoriesBiocompatibility-Unactivated PartialThromboplastin Time	Testing completed perISO 10993-4	There must be nostatistical decreasebetween the UPTT ofplasma exposed to thetest article and to thenegative or untreatedcontrol.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent. Testarticles met the acceptancecriteria.
Zenith Flex Catheter &its accessoriesBiocompatibility-Complement Activation	Testing completed perISO 10993-4	There must be nostatistical increasebetween either the C3a orSC5b-9 concentrations inplasma exposed to thetest article as compared tothe negative anduntreated controls	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent. Testarticles met the acceptancecriteria.
Zenith Flex Catheter &its accessoriesBiocompatibility-DogThromboresistance	Testing completed perISO 10993-4	The test articles mustreceive a thrombusformation score less thanor equal to that of thecontrol.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent. Testarticles met the acceptancecriteria.
Zenith Flex Catheter &its accessoriesBiocompatibility-MaximizationSensitization	Testing completed perISO 10993-10	The test article must elicita positive response in lessthan 10% of the testanimals.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent. Testarticles met the acceptancecriteria.
Test	Test MethodSummary	Acceptance Criteria	Conclusions
Zenith Flex Catheter &its accessoriesBiocompatibility-IntracutaneousToxicity/Reactivity	Testing completed perISO 10993-10	The test article extractsmust not induce asignificantly greaterbiological reaction thanthe control.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent. Testarticles met the acceptancecriteria.
Zenith Flex Catheter &its accessoriesBiocompatibility-AcuteSystemic Toxicity Test	Testing completed perISO 10993-11	The test article extractsmust not induce asignificantly greaterbiological reaction thanthe control.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent. Testarticles met the acceptancecriteria.
Chemical Compatibility(Zenith Flex Catheter)	Catheter exposed tochemicals readilyavailable in a clinicalsetting.	Product shall withstandexposure to chemicalswithout degradation.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent. Testarticles met the acceptancecriteria.
Working Length(Zenith Flex Catheter)	Testing completed perISO 10555-1	Test samples should bewithin existing workinglength specification.	Zenith Flex Catheter testsamples met the acceptancecriteria for Working Length todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice.
Hub compatibility(Zenith Flex Catheter)	Testing completed perISO 594-1 and ISO594-2	Hub shall meet existingLuer specifications.	Test results for the ZenithCatheter (K171672) wereleveraged for the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent. Testarticles met the acceptancecriteria.
Test	Test MethodSummary	Acceptance Criteria	Conclusions
Outside diameter(Zenith FlexCatheter)	Testing completed perISO 10555-1	Test samples should bewithin existing outsidediameter specification.	Zenith Flex Catheter testsamples met the acceptancecriteria for Outside diameter todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice.
Leak - Air(Zenith Flex Catheter)	Testing completed perISO 10555-1	Test samples should bewithin existing Air - Leakspecifications.	Zenith Flex Catheter testsamples met the acceptancecriteria for Leak - Air todemonstrate that the ZenithFlex Catheteris substantiallyequivalent to the predicatedevice.
Leak - Liquid(Zenith Flex Catheter)	Testing completed perISO 10555-1	Test samples should bewithin existing Leak -Liquid specifications.	Zenith Flex Catheter testsamples met the acceptancecriteria for Leak – Liquid todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice.
Particulates(Zenith Flex Catheter)	Samples conditioned inbenchtop anatomicalmodel.Testing completed perUSP 788	Test samples should bewithin existing Particulatespecifications.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent. Testarticles met the acceptance
Simulated Use - Bench(Zenith Flex Catheter)	Zenith Flex underwentsimulated use testing bya physician in abenchtop model	Test samples must meetpredetermined user needs	Zenith Flex Catheter testsamples met the acceptancecriteria for Simulated Use- Bench to demonstrate thatthe Zenith Flex Catheter issubstantially equivalent to thepredicate device.
Catheter Burst(Zenith Flex Catheter)	Testing completed perISO 10555-1	Test sample burstpressures must meet orexceed existing minimumburst pressurespecification.	Zenith Flex Catheter testsamples met the acceptancecriteria for Catheter Burst todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice.
Test	Test MethodSummary	Acceptance Criteria	Conclusions
Tensile(Zenith Flex Catheter)	Testing completed perISO 10555-1	Test sample ultimatetensile strength must meetor exceed existing tensilestrength specifications.	Zenith Flex Catheter testsamples met the acceptancecriteria for Tensile todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice.
Corrosion(Zenith Flex Catheter)	Testing completed perISO 10555-1	Test samples shall exhibitno evidence of corrosion.	Test results for theIntermediate Catheter(K152202) were leveraged forthe subject Zenith FlexCatheter as the materials andmanufacturing processes areequivalent. Test articles metthe acceptance criteria.
PTFE Liner inspection(Zenith Flex Catheter)	Zenith Flex waschallenged todemonstrate lineradherence.	Test sample lineradhesion must meet orexceed existing PTFELiner inspectionspecifications.	Zenith Flex Catheter testsamples met the acceptancecriteria for PTFE Linerinspection to demonstrate thatthe Zenith Flex Catheter issubstantially equivalent to thepredicate device.
Hydrophilic CoatingIntegrity(Zenith Flex Catheter)	Conditioned sampleswere repeatedly exposedto friction and introducedinto an anatomical modelto demonstrate that thehydrophilic coating is notaffected.	Test sample results mustmeet or exceed existingHydrophilic CoatingIntegrity specifications.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent.Test articles met theacceptance criteria.
Simulated Use Testing(Zenith Flex System)	Using a simulated model,the samples retrievedthrombi with anaspiration pump	Successfully removed thethrombi	Zenith Flex System testsamples met the acceptancecriteria for Aspiration todemonstrate that the ZenithFlex System is substantiallyequivalent to the predicatedevice
Test	Test MethodSummary	Acceptance Criteria	Conclusions
Labeling Legibility	Label is legible afterprinting.	Test samples shalldemonstrate text legibility.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent.Test articles met theacceptance criteria.
Barcode	Barcode is readable witha standard barcodereader.	Test samples shalldemonstrate readilyreadable barcodes	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex as the materialsand manufacturing processesare equivalent. Test articlesmet the acceptance criteria.
Sterilization(Zenith Flex Catheter &Aspiration Tubing Set)	ISO 11135 andAAMI TIR 28	Sterilization load shallpose an equal or lesserchallenge to sterilize thanexisting sterile productloads.	Sterilization loads met theacceptance criteria forsterilization to demonstratethat the Zenith Flex and theAspiration Tubing Set issubstantially equivalent to thepredicate device.
Shelf Life(Zenith Flex Catheter &Aspiration Tubing Set)	ASTM F1980	Aged test samples mustmeet or exceed existingspecifications	Zenith Flex Catheter &Aspiration Tubing Set testsamples met the acceptancecriteria for shelf life todemonstrate that the ZenithFlex Catheter & AspirationTubing Set are substantiallyequivalent to the predicatedevice.
Toque Strength(Zenith Flex Catheter)	Samples were placed inanatomical model andtorqued until failure	Test sample results mustmeet or exceed existingtorque specifications.	Zenith Flex Catheter testsamples met the acceptancecriteria for torque todemonstrate that the subjectZenith Flex Catheter issubstantially equivalent to thepredicate device
Test	Test MethodSummary	Acceptance Criteria	Conclusions
Kink Resistance(Zenith Flex Catheter)	Reduction in flow wasevaluated while sampleswere exposed toappropriate tortuosity	Test sample results mustmeet or exceed existingkink resistancespecifications.	Zenith Flex Catheter testsamples met the acceptancecriteria for kink resistance todemonstrate that the subjectZenith Flex Catheter issubstantially equivalent to thepredicate device
Lumen Patency(Zenith Flex Catheter)	Samples were placed inbenchtop anatomicalmodel and evaluated forlumen collapse duringaspiration	Test sample results mustmeet or exceed existinglumen patencyspecifications.	Zenith Flex Catheter testsamples met the acceptancecriteria for lumen patency todemonstrate that the subjectZenith Flex Catheter issubstantially equivalent to thepredicate device
Tip Flexibility(Zenith Flex Catheter)	Samples were deflected,and associated forceswere measured	Zenith Flex tip flexibilityresults were compared topredicate device results.	Zenith Flex Catheter testsamples performedcomparatively against thepredicate devicedemonstrating that the subjectZenith Flex Catheter issubstantially equivalent to thepredicate device
Friction Force(Zenith Flex Catheter)	Samples were trackedthrough benchtopanatomical model andfrictional forces weremeasured	Zenith Flex friction forceresults were compared topredicate device results.	Zenith Flex Catheter testsamples performedcomparatively against thepredicate devicedemonstrating that the subjectZenith Flex Catheter issubstantially equivalent to thepredicate device
Simulated Use Testing- Usability(Zenith Flex System)	Zenith Flex underwentsimulated use testing by aphysician in a benchtopmodel	Test samples must meetpredetermined user needs	Zenith Flex System testsamples met the acceptancecriteria for Simulated Use- Usability to demonstrate thatthe Zenith Flex System issubstantially equivalent to thepredicate device.
Test	Test MethodSummary	Acceptance Criteria	Conclusions
Visual Inspection (AspirationTubing Set)	Finished Devices wereinspected for damagevisually	Test samples should meetvisual inspectionspecifications.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as theaspiration tubing is the same.Test articles met theacceptance criteria.
Tensile(Aspiration Tubing Set)	Finished devices wereelongated until failure	Test sample ultimatetensile strength must meetor exceed existing tensilestrength specifications.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as theaspiration tubing is the same.Test articles met theacceptance criteria.
Leak - Liquid(Aspiration TubingSet)	Tubing pressurized withfluid and inspected for leak	Test samples should bewithin existing Leak -Liquid specifications.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as theaspiration tubing is the same.Test articles met theacceptance criteria.
Leak - Air, Tubing andControl Switch(Aspiration Tubing Set)	Tubing samples evaluatedfor air leak duringaspiration	Test samples should bewithin existing Air - Leakspecifications.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as theaspiration tubing is the same.Test articles met theacceptance criteria.
Luer Compatibility(Aspiration Tubing Set)	Testing completed per ISO80369-7	Hub shall meet existingLuer specifications.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as theaspiration tubing is the same.Test articles met theacceptance criteria.
Test	Test MethodSummary	Acceptance Criteria	Conclusions
Suction ConnectorSeparation Force (AspirationTubing Set)	Force to separate suctionconnector from cannisterwas evaluated using forcegauge	Test sample results mustmeet or exceed existingforce specifications.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as theaspiration tubing is the same.Test articles met theacceptance criteria.
Vacuum Drop / SuctionConnector SecureAttachmentAspiration Tubing Set)	Vacuum pressuremeasured at source andtip to evaluate pressuredifference	Test sample results mustmeet or exceed existingpressure specifications.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as theaspiration tubing is the same.Test articles met theacceptance criteria.
Lumen Patency(Aspiration Tubing Set)	Samples were evaluatedfor lumen collapse duringaspiration	Test sample results mustmeet or exceed existinglumen patencyspecifications.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as theaspiration tubing is the same.Test articles met theacceptance criteria.
Dimensions(Aspiration Tubing Set)	Critical dimensions weremeasured.	Test samples should bewithin existing dimensionalspecifications.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as theaspiration tubing is the same.Test articles met theacceptance criteria.
Packaging - Dye Leak(Zenith Flex Catheter andAspiration Tubing Set)	Testing completed perASTM F1929-12	Test sample shall notexhibit any visual leaks orchannels	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as thepackaging is the same. Testarticles met the acceptancecriteria.
Test	Test MethodSummary	Acceptance Criteria	Conclusions
Packaging - Peel(Zenith Flex Catheter andAspiration Tubing Set)	Testing completed perASTM F88-09	Test sample tensilestrength must meet orexceed existing tensilestrength specifications.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as thepackaging is the same. Testarticles met the acceptancecriteria.
Aspiration Tubing SetBiocompatibility-Cytotoxicity MEM Elution	Testing completed per ISO10993-5	The cultures treated withthe test article must nothave a reactivity gradegreater than 2.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as theaspiration tubing is the same.Test articles met theacceptance criteria.
Aspiration Tubing SetBiocompatibility-Maximization Sensitization	Testing completed per ISO10993-10	The test article must elicita positive response in lessthan 10% of the testanimals.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as theaspiration tubing is the same.Test articles met theacceptance criteria.
Aspiration Tubing SetBiocompatibility-IntracutaneousToxicity/Reactivity	Testing completed per ISO10993-10	The test article extractsmust not induce asignificantly greaterbiological reaction thanthe control.	Test results for the Zenith FlexCatheter (K172167) wereleveraged for the subjectZenith Flex Catheter as theaspiration tubing is the same.Test articles met theacceptance criteria.

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Performance Data - Clinical

No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes. A review was conducted considering published clinical study articles that featured the Reference Device and other devices with similar dimensions used for direct aspiration. The literature review was used to support the proposed indications for use under the NRY product code by leveraging clinical outcomes from devices that are considered technologically similar.

Summary of Substantial Equivalence

The performance characteristics and the test results demonstrate that the 074 Zenith Flex Catheter meets the acceptance criteria to determine that the 074 Zenith Flex Catheter is substantially equivalent to the predicate device. Furthermore, the intended use, the operating principles, the design, materials and the results of biocompatibility testing, shelf-life, packaging and sterilization processes are all equivalent and support the all devices are

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technologically similar. Lastly, the review of published clinical data also supports the use of the 074 Zenith Flex Catheter under the NRY product code based on the similar technological characteristics to devices currently available.

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).