The Zenith Flex Aspiration System, including the 046 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.

Device Description

The InNeuroCo 046 Zenith Flex Catheter is a variable stiffness catheter that has a catheter shaft reinforced with Nitinol to provide support. The proximal section has an embedded nitinol flat wire cross coil that transitions to a nitinol round wire sinqle coil in the distal end. It has a radiopaque Platinum/Iridium marker band on the distal end. The 046 Zenith Flex Catheter is available with an internal diameter of 0.046 inches. The outer diameter is 0.058 inches along the proximal shaft and 0.056 inches at the distal tip. The 046 Zenith Flex Catheter is available in two working lengths: 153 cm, and 160 cm. The 046 Zenith Flex Catheter has a PTFE-lined lumen to reduce friction as it travels over a guidewire. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and peel-away introducer. The 046 Zenith Flex Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

The other system components are: the Aspiration Tubinq Set and the VC-701 Cliq Aspirator Pump. The Aspiration Tubing Set is provided sterile and is intended for single use only. The aspiration pump is provided non-sterile and is used in multiple procedures.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the Zenith Flex Aspiration System (046 Zenith Flex Catheter). It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Penumbra 3 Max) and a reference device (071 Zenith Flex System).

The document does not describe an AI/ML-driven medical device, nor does it detail a study involving human readers or the establishment of ground truth in the context of diagnostic AI. Instead, it details the physical and mechanical performance testing of a catheter and its accessories. Therefore, many of the requested details, such as those related to AI algorithm performance, ground truth, expert adjudication, or MRMC studies, are not applicable to this document.

However, I can extract the acceptance criteria and performance information as presented for the physical device.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document provides a comprehensive table of non-clinical tests, their methods, acceptance criteria, and conclusions. Since the "performance" for all these tests is simply stated as having "met the acceptance criteria" or "passed," this table effectively serves as the performance report. I will summarize key categories, as a direct copy of the entire table would be extensive.

Test Category	Test Method Summary	Acceptance Criteria	Reported Device Performance (Conclusions)
Biocompatibility	ISO 10993 Series (e.g., -4, -5, -10, -11)	- Must not cause febrile reaction > 0.5°C- Reactivity grade < 2- Hemolytic index < 5%- No statistical decrease in UPTT- No statistical increase in C3a or SC5b-9- Thrombus formation score <= control- Positive response in < 10% animals- Not induce significantly greater biological reaction than control	- Zenith Flex Catheter (K172167) results leveraged, as materials and processes are equivalent. All test articles met acceptance criteria.- Aspiration Tubing Set (identical to K172167 component) results leveraged. All test articles met acceptance criteria.
Physical & Mechanical	ISO 10555-1, ISO 80369, USP 788 (as guide), Benchtop anatomical model, Force gauge	- Within existing working length, diameter, and particulate specifications.- Meet existing Luer specifications.- Meet or exceed existing leak, burst pressure, tensile strength, torque, kink resistance, and lumen patency specifications.- No evidence of corrosion.- Meet or exceed PTFE Liner and Hydrophilic Coating Integrity specifications.- Withstand chemical exposure without degradation.	- All Zenith Flex Catheter test samples met acceptance criteria for Working Length, Hub compatibility, Diameters, Leak (Air/Liquid), Particulates, Catheter Burst, Tensile, PTFE Liner inspection, Hydrophilic Coating Integrity, Toque Strength, Kink Resistance, Lumen Patency, and Chemical Compatibility.- Performed comparatively against predicate device in Tip Flexibility and Friction Force.- All Aspiration Tubing Set test samples met acceptance criteria (many leveraged from K172167) for Visual Inspection, Tensile, Leak (Liquid/Air), Luer Compatibility, Suction Connector Separation Force, Vacuum Drop/Suction Connector Secure Attachment, Lumen Patency, and Dimensions.
Performance (Simulated Use)	Physician in a benchtop model, Simulated model with thrombi and aspiration pump	- Test samples must meet predetermined user needs.- Successfully removed thrombi.	- Zenith Flex Catheter test samples met the acceptance criteria for Simulated Use - Bench.- Zenith Flex System test samples met the acceptance criteria for Simulated Use – Usability and Aspiration (successfully removed thrombi).
Sterilization & Shelf Life	ISO 11135, AAMI TIR 28, ASTM F1980, ASTM F1929-12, ASTM F88-09	- Sterilization load poses equal or lesser challenge.- Aged samples meet or exceed existing specifications.- No visual leaks or channels.- Tensile strength meets or exceeds existing specifications.	- Sterilization loads met acceptance criteria for Zenith Flex and Aspiration Tubing Set (leveraged from K172167).- Zenith Flex Catheter test samples met acceptance criteria for shelf life. Aspiration Tubing Set shelf life leveraged from K172167. All packaging tests (Dye Leak, Peel) for both catheter & tubing set met criteria (many leveraged from K172167).
Accessories (Peel-Away)	Pull to failure, Measurement of unsplit length and diameters	- Tensile strength meets or exceeds specified.- Length and diameter measurements meet specified.	- Peel-Away Introducer tests for Peel Force, Unsplit Length, and Diameters leveraged from K172167 and met acceptance criteria.
Accessories (Hemostasis)	Exposed to chemicals, Inside diameter measurement	- Withstand chemical exposure without degradation.- Inside diameter measurement meets specified.	- Hemostasis Valve tests for Chemical Compatibility and Dimensional leveraged from K172167 and met acceptance criteria.
Labeling	Visual inspection after printing, Readability with standard barcode reader	- Demonstrate text legibility.- Demonstrate readily readable barcodes.	- Labeling Legibility and Barcode tests leveraged from K172167 and met acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document repeatedly states that "test samples" were used for various non-clinical (benchtop) and animal tests, and that these samples "met the acceptance criteria." However, it does not explicitly state the specific sample size (N) for each individual test. It implies N>0 and that enough samples were tested to demonstrate compliance.
Data Provenance:
- Non-Clinical (Bench) Testing: This was conducted by InNeuroCo, Inc. (location: Sunrise, Florida, USA). The testing was done in a controlled lab environment.
- Animal Testing: Conducted in swine, implying a prospective study design for the animal component. The document does not specify the country of origin for the animal study, but given the company's US location and FDA submission, it's likely primarily US-based or conducted under equivalent regulatory standards.
- Clinical Data (Literature Review): A review of "published clinical study articles" was conducted. This refers to existing, likely retrospective, clinical data from external sources and studies. No new clinical trials were performed for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document describes a physical medical device (catheter system) and its performance validation through bench and animal testing. It does not involve diagnostic imaging or AI for which ground truth established by experts would be relevant. The "ground truth" for this device's performance is objective measurements (e.g., dimensions, burst pressure, tensile strength, successful thrombi removal in models) and histopathological/angiographic assessments in animal models.
A "physician" was involved in "simulated use testing," but this was for usability and performance in a benchtop model, not for establishing a diagnostic ground truth. Their qualifications are not specified beyond being a "physician."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As an AI/ML related concept, adjudication by multiple experts is not relevant to the physical and mechanical testing of a catheter system.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, not applicable. This document is for a physical medical device (catheter) and does not involve AI or human readers for diagnostic purposes.

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

No, not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For non-clinical bench testing: The "ground truth" for acceptance was based on predefined physical, mechanical, and performance specifications (e.g., measurements being within specified ranges, successful functional outcomes like thrombi removal, absence of leaks or degradation).
For animal testing: The "ground truth" for effectiveness and safety was based on angiographic assessment of revascularization and histopathological assessment.

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 component, there is no training set or associated ground truth establishment process in that context.

Summary

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

August 2, 2019

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

Re: K190338

Trade/Device Name: Zenith Flex Aspiration System (046 Zenith Flex Catheter) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: July 3, 2019 Received: July 5, 2019

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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

Sincerely,

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

Enclosure

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Indications for Use

510(k) Number (if known) K190338

Device Name

Zenith Flex Aspiration System (046 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

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

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

February 12, 2019

Device Trade or Proprietary Name Zenith Flex Aspiration System (046 Zenith Flex Catheter)

Device Common or Classification Name:

Catheter, Percutaneous, 21 CFR 870.1250, Class II

Product Code: NRY (Catheter)

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

Name of Predicate Device	Name of Manufacturer	510(k) Number
3 Max	Penumbra	K113163

Identification of the Legally Marketed Device used as the Reference Device

Name of Reference Device	Name of Manufacturer	510(k) Number
Zenith Flex System(071 Zenith Flex)	InNeuroCo, Inc	K172167

Device Description

Indications for Use

The Zenith Flex Aspiration System, including the 046 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 seqments, 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.

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Comparison to Predicate Device

	Predicate DevicePenumbra 3 Max	Subject DeviceInNeuroCo, Inc.046 Zenith Flex Catheter
510(k) Number	K113163	K190338
Classification	Class II	Same
Product Code	NRY	Same
Review Panel	Neurology	Same
Indications ForUse	The Penumbra System is intendedfor use in the revascularization ofpatients with acute ischemic strokesecondary to intracranial largevessel occlusive disease (in theinternal carotid, middle cerebral -M1 and M2 segments, basilar, andvertebral arteries) within 8 hours ofsymptom onset.	The Zenith Flex Aspiration System,including the 046 Zenith FlexCatheter, Aspiration Tubing Set, andVC-701 Cliq Aspirator Pump, isindicated in the revascularization ofpatients with acute ischemic strokesecondary to intracranial largevessel occlusive disease (within theinternal carotid, middle cerebral– M1 and M2 segments, basilar,and vertebral arteries) within 8hours of symptom onset. Patientswho are ineligible for intravenoustissue plasminogen activator (IV t-PA) or who failed IV t-PA therapyare candidates for treatment.
ComponentsSupplied in thecatheter package	3Max Reperfusion Catheter,	046 Zenith Flex Catheter, PeelAway Introducer, HemostasisValve
Systemcomponents	Catheter, Pump, Aspiration Tubing	Same
Catheter ShaftMaterial	Polyether Block Amide (PEBAX),Urethane, Nylon	Same
Inner Liner	PTFE	Same
Hub Material	Polycarbonate	Same
Strain Relief	Stainless Steel	Polyolefin
Catheter ShaftReinforcement	Stainless Steel/Nitinol	Same
Reinforcementpattern	Coil	Same
LubriciousCoating	Hydrophilic Coating	Same
RadiopaqueMarker Band	Platinum/ Iridium	Same
CatheterPackaging	Tyvek/Nylon Pouch, polyethylenesupport tube, packaging card,carton	Same
Sterilization	Ethylene Oxide	Same
Pyrogenicity	Nonpyrogenic	Same
Working Lengths	153 cm, 160 cm	Same
Inside Diameter(ID)	0.043 in distal0.035 in proximal	0.046 in
Proximal OuterDiameter	0.062 in	0.058 in
Distal OuterDiameter	0.050 in nominal	0.056 in
Introducer	Peelaway to aid in catheter tipintroduction into hemostasis valve	Peelaway to aid in catheter tipintroduction into hemostasis valve
Hemostasis Valve	Yes	Same
Luer Tapered Hub	Yes	Same
Aspiration Method	Pump	Same
AspirationPressure	20-29 in Hg	22-28 in Hg
	Reference DeviceInNeuroCo, Inc.071 Zenith Flex	Subject DeviceInNeuroCo, Inc.046 Zenith Flex Catheter
510(k) Number	K172167	K190338
Classification	Class II	Same
Product Code	NRY	Same
Review Panel	Neurology	Same
Indications ForUse	The Zenith Flex Aspiration System,including the Zenith Flex Catheter,Aspiration Tubing Set, and VC-701Cliq Aspirator Pump, is indicated inthe revascularization of patientswith acute ischemic strokesecondary to intracranial largevessel occlusive disease (withinthe internal carotid, middle cerebral- M1 and M2 segments, basilar,and vertebral arteries) within 8hours of symptom onset. Patientswho are ineligible for intravenoustissue plasminogen activator (IV t-PA) or who failed IV t-PA therapyare candidates for treatment.	Same
ComponentsSupplied in thecatheter package	Zenith Flex Catheter, Peel AwayIntroducer, Hemostasis Valve,Scout Introducer	046 Zenith Flex Catheter, PeelAway Introducer, HemostasisValve
Systemcomponents	Catheter, Pump, Aspiration Tubing	Same
Catheter ShaftMaterial	Polyether Block Amide (PEBAX),Urethane, Nylon	Same
Inner Liner	PTFE	Same
Hub Material	Polycarbonate	Same
Strain Relief	Polyolefin	Same
Catheter ShaftReinforcement	Stainless Steel/Nitinol	Same
Reinforcementpattern	Coil	Same
LubriciousCoating	Hydrophilic Coating	Same
RadiopaqueMarker Band	Platinum/ Iridium	Same
CatheterPackaging	Tyvek/Nylon Pouch, polyethylenesupport tube, packaging card, SBScarton	Same
Sterilization	Ethylene Oxide	Same
Pyrogenicity	Nonpyrogenic	Same
Working Lengths	115, 125, 132 cm	153 cm, 160 cm
Inside Diameter(ID)	0.071 in	0.046 in
Proximal OuterDiameter	0.085 in	0.058 in
Distal OuterDiameter	0.082 in nominal	0.056 in
Introducer	Peelaway to aid in catheter tipintroduction into hemostasis valveScout to help with the navigation	Peelaway to aid in catheter tipintroduction into hemostasis valve
Hemostasis Valve	Yes	Same
Luer Tapered Hub	Yes	Same
Aspiration Method	Pump	Same
AspirationPressure	22-28 in Hg	Same

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The 046 Zenith Flex catheter is very similar to the predicate Penumbra 3Max device. The catheter are built using similar materials – Pebax, Urethane, and Nylon for the shaft with a PTFE liner. Both devices have a stainless steel coil reinforcement for the shaft and have a polycarbonate hub. Each device has a hydrophilic coating with platinum/iridium marker bands for visualization. The 046 Zenith Flex catheter has a polyolefin strain relief compared to a stainless steel for the predicate

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device; however, this difference is not significant as the polyolefin strain relief provides the same function, passed all performance testing, and passed the relevant biocompatibility testing.

The sizing of the catheters is also similar. The working lengths are the same for both devices. The proximal and distal OD of 046 Zenith Flex Catheter is 0.058 inches and 0.056 inches, respectively, compared to 0.062 inches proximal OD and 0.050 inches distal OD of the predicate device. The difference in OD is small and the 046 Zenith Flex Catheter has an overall smaller profile when entering the body than the predicate. The inner diameter of the 046 Zenith Flex Catheter is larger than the predicate due to a thinner wall.

Both devices go through EO sterilization and use a pump for aspiration. The 046 Zenith Flex Catheter has a narrower aspiration pressure operation range, but this range is within the predicate's operating pressure range.

Comparison to Reference Device

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Summary of Non-Clinical Data

Biocompatibility tests conducted with the 046 Zenith Flex catheter and its accessories were selected in accordance with ISO 10993-1 quidelines (Biological Evaluation of Medical Devices) for limited duration (< 24 hours), external communicating devices, contacting blood. Studies were conducted pursuant to 21CFR58, Good Laboratory Practices. Biocompatibility testing found the 046 Zenith Flex Catheter to be biocompatible and non-pyrogenic.

Biocompatibility tests conducted with the Aspiration Tubing Set were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for a surface device in contact with intact skin for limited (< 24 hours) duration. Studies were conducted pursuant to 21CFR58, Good Laboratory Practices. Biocompatibility testing found the Aspiration Tubing Set to be biocompatible.

The conclusions drawn from the physical, mechanical, and performance testing of the subject 046 Zenith Flex Catheter demonstrates that the product is Substantially Equivalent to the legally marketed predicate device.

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 predicate device. The study included two follow up evaluations: 3 days and 30 days. There were 3 endpoints of the study: angiographic assessment of revascularization to establish effectiveness, anqiographic assessment and histopathological assessment to demonstrate safety. As testing included the predicate device, results were compared to demonstrate substantial equivalence.

Zenith Flex Performance Testing

To demonstrate substantial equivalence between the subject 046 Zenith Flex Catheter and the reference 071 Zenith Flex Catheter and the predicate Penumbra 3 Max 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 046 Zenith Flex Catheter has similar performance characteristics as

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the predicate device and the reference device. All 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) were usedto support the biocompatibilityof the subject Zenith FlexCatheter as the materials andmanufacturing processes areequivalent. 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) wereused to support thebiocompatibility of the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent.Test articles met theacceptance 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) were usedto support the biocompatibilityof the subject Zenith FlexCatheter as the materials andmanufacturing processes areequivalent. Test articles metthe acceptance criteria.
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) wereused to support thebiocompatibility of the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent.Test articles met theacceptance criteria.
Test	Test MethodSummary	Acceptance Criteria	Conclusions
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) wereused to support thebiocompatibility of the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent.Test articles met theacceptance criteria.
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) wereused to support thebiocompatibility of the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent.Test articles met theacceptance criteria.
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) wereused to support thebiocompatibility of the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent.Test articles met theacceptance criteria.
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) wereused to support thebiocompatibility of the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent.Test articles met theacceptance criteria.
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) wereused to support thebiocompatibility of the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent.Test articles met theacceptance criteria.
Test	Test MethodSummary	Acceptance Criteria	Conclusions
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) were usedto support the biocompatibilityof the subject Zenith FlexCatheter as the materials andmanufacturing processes areequivalent. Test articles metthe acceptance criteria.
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) wereused to support the materialstability of the subject ZenithFlex Catheter as the materialsand manufacturing processesare equivalent. Test articlesmet the acceptance criteria.
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 80369	Hub shall meet existingLuer specifications.	Zenith Flex Catheter testsamples met the acceptancecriteria for hub compatibility todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice.
Diameters(Zenith Flex Catheter)	Testing completed perISO 10555-1	Test samples should bewithin existing outside orinside diameterspecification.	Zenith Flex Catheter testsamples met the acceptancecriteria for Outside diameter todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice.
Test	Test MethodSummary	Acceptance Criteria	Conclusions
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 Catheter is 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 as a guide.	Test samples should bewithin existing Particulatespecifications.	Zenith Flex Catheter testsamples met the acceptancecriteria for particulates todemonstrate that the Zenith
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 used tosupport this endpoint for thesubject Zenith Flex Catheter asthe 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.	Zenith Flex Catheter testsamples met the acceptancecriteria for particulates todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice.
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(product label and productpeel-away label)	Label is legible afterprinting.	Test samples shalldemonstrate text legibility.	Test results for the ZenithFlex Catheter (K172167) wereused to support thisassessment of the subjectZenith Flex Catheter as thematerials and manufacturingprocesses are equivalent.Test articles met theacceptance criteria.
Barcode(product label and productpeel-away label)	Barcode is readable witha standard barcodereader.	Test samples shalldemonstrate readilyreadable barcodes	Test results for the Zenith FlexCatheter (K172167) were usedto support this assessment forthe subject Zenith Flex as thematerials and manufacturingprocesses are equivalent. Testarticles met the acceptancecriteria.
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 (TheAspiration Tubing Set isidentical to that supplied aspart of the cleared Zenith FlexSystem (K172167)). issubstantially equivalent to thepredicate device.
Test	Test MethodSummary	Acceptance Criteria	Conclusions
Shelf Life(Zenith Flex Catheter &Aspiration Tubing Set)	ASTM F1980	Aged test samples mustmeet or exceed existingspecifications	Zenith Flex Catheter testsamples met the acceptancecriteria for shelf life. TheAspiration Tubing Set isidentical to that supplied aspart of the cleared Zenith FlexSystem (K172167). Therefore,shelf life evaluation for thiscomponent was based oncompleted testing submitted inK172167. Test articles met theacceptance criteriaThis demonstrates that theZenith Flex Catheter &Aspiration Tubing Set aresubstantially equivalent to thepredicate device.
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
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
Test	Test MethodSummary	Acceptance Criteria	Conclusions
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.
Visual Inspection (AspirationTubing Set)	Finished Devices wereinspected for damagevisually	Test samples should meetvisual inspectionspecifications.	The Aspiration Tubing Set isidentical to that supplied aspart of the cleared Zenith FlexSystem (K172167). Therefore,visual inspection evaluationfor this component was basedon completed testingsubmitted in K172167. Testarticles met the acceptancecriteria
Tensile(Aspiration Tubing Set)	Finished devices wereelongated until failure	Test sample ultimatetensile strength must meetor exceed existing tensilestrength specifications.	The Aspiration Tubing Set isidentical to that supplied aspart of the cleared Zenith FlexSystem (K172167). Therefore,tensile evaluation for thiscomponent was based oncompleted testing submitted inK172167. Test articles met theacceptance criteria
Test	Test MethodSummary	Acceptance Criteria	Conclusions
Leak - Liquid(Aspiration TubingSet)	Tubing pressurized withfluid and inspected for leak	Test samples should bewithin existing Leak -Liquid specifications.	The Aspiration Tubing Set isidentical to that supplied aspart of the cleared Zenith FlexSystem (K172167). Therefore,leak-liquid evaluation for thiscomponent was based oncompleted testing submitted inK172167. 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.	The Aspiration Tubing Set isidentical to that supplied aspart of the cleared Zenith FlexSystem (K172167). Therefore,leak-air, tubing and controlswitch evaluation for thiscomponent was based oncompleted testing submitted inK172167. Test articles met theacceptance criteria
Luer Compatibility(Aspiration Tubing Set)	Testing completed per ISO80369-7	Hub shall meet existingLuer specifications.	The Aspiration Tubing Set isidentical to that supplied aspart of the cleared Zenith FlexSystem (K172167). Therefore,luer compatibility evaluationfor this component was basedon completed testingsubmitted in K172167. Testarticles met the acceptancecriteria
Suction ConnectorSeparation Force (AspirationTubing Set)	Force to separate suctionconnector from cannisterwas evaluated using forcegauge	Test sample results mustmeet or exceed existingforce specifications.	The Aspiration Tubing Set isidentical to that supplied aspart of the cleared Zenith FlexSystem (K172167). Therefore,suction connector separationforce evaluation for thiscomponent was based oncompleted testing submitted inK172167. Test articles metthe acceptance criteria.
Test	Test MethodSummary	Acceptance Criteria	Conclusions
Vacuum Drop / SuctionConnector SecureAttachment(Aspiration Tubing Set)	Vacuum pressuremeasured at source andtip to evaluate pressuredifference	Test sample results mustmeet or exceed existingpressure specifications.	The Aspiration Tubing Set isidentical to that supplied aspart of the cleared Zenith FlexSystem (K172167). Therefore,vacuum drop/suctionconnector secure attachmentevaluation for this componentwas based on completedtesting submitted in K172167.Test articles met theacceptance criteria.
Lumen Patency(Aspiration Tubing Set)	Samples were evaluatedfor lumen collapse duringaspiration	Test sample results mustmeet or exceed existinglumen patencyspecifications.	The Aspiration Tubing Set isidentical to that supplied aspart of the cleared Zenith FlexSystem (K172167). Therefore,lumen patency evaluation forthis component was based oncompleted testing submitted inK172167. Test articles metthe acceptance criteria .
Dimensions(Aspiration Tubing Set)	Critical dimensions weremeasured.	Test samples should bewithin existing dimensionalspecifications.	The Aspiration Tubing Set isidentical to that supplied aspart of the cleared Zenith FlexSystem (K172167). Therefore,dimensions evaluation for thiscomponent was based oncompleted testing submitted inK172167. Test articles metthe acceptance criteria.
Packaging - Dye Leak(Zenith Flex Catheter)	Testing completed perASTM F1929-12	Test sample shall notexhibit any visual leaks orchannels	Zenith Flex Catheter testsamples met the acceptancecriteria for packaging peel todemonstrate that the subjectZenith Flex Catheter issubstantially equivalent tothe predicate device.
Test	Test MethodSummary	Acceptance Criteria	Conclusions
Packaging - Dye Leak(Aspiration Tubing Set)	Testing completed perASTM F1929-12	Test sample shall notexhibit any visual leaks orchannels	The Aspiration Tubing Set isidentical to that supplied aspart of the cleared Zenith FlexSystem (K172167). Thecomponent is packaged in thesame packaging as suppliedas part of the cleared ZenithFlex System (K172167).Therefore, packaging - dyeleak evaluation for thiscomponent was based oncompleted testing submitted inK172167. Test articles metthe acceptance criteria.
Packaging - Peel(Zenith Flex Catheter)	Testing completed perASTM F88-09	Test sample tensilestrength must meet orexceed existing tensilestrength specifications.	Zenith Flex Catheter testsamples met the acceptancecriteria for packaging peel todemonstrate that the subjectZenith Flex Catheter issubstantially equivalent tothe predicate device.
Packaging - Peel(Aspiration Tubing Set)	Testing completed perASTM F88-09	Test sample tensilestrength must meet orexceed existing tensilestrength specifications.	The Aspiration Tubing Set isidentical to that supplied aspart of the cleared Zenith FlexSystem (K172167). Thecomponent is packaged in thesame packaging as suppliedas part of the cleared ZenithFlex System (K172167).Therefore, packaging - dyeleak evaluation for thiscomponent was based oncompleted testing submitted inK172167. Test articles metthe acceptance criteria.
Test	Test MethodSummary	Acceptance Criteria	Conclusions
Aspiration Tubing SetBiocompatibility-Cytotoxicity MEM Elution	Testing completed per ISO10993-5	The cultures treated withthe test article must nothave a reactivity gradegreater than 2.	The Aspiration Tubing Set isidentical to that supplied aspart of the cleared Zenith FlexSystem (K172167). Therefore,the biocompatibility evaluationfor this component was basedon completed testingsubmitted in K172167. Testarticles met the acceptancecriteria.
Aspiration Tubing SetBiocompatibility-Maximization Sensitization	Testing completed per ISO10993-10	The test article must elicita positive response in lessthan 10% of the testanimals.	The Aspiration Tubing Set isidentical to that supplied aspart of the cleared Zenith FlexSystem (K172167). Therefore,the biocompatibility evaluationfor this component was basedon completed testingsubmitted in K172167. Testarticles met the acceptancecriteria.
Aspiration Tubing SetBiocompatibility-IntracutaneousToxicity/Reactivity	Testing completed per ISO10993-10	The test article extractsmust not induce asignificantly greaterbiological reaction thanthe control.	The Aspiration Tubing Set isidentical to that supplied aspart of the cleared Zenith FlexSystem (K172167). Therefore,the biocompatibility evaluationfor this component was basedon completed testingsubmitted in K172167. Testarticles met the acceptancecriteria.
Peel Force(Peel-Away Introducer)	Test samples were pulledto failure	Test sample tensilestrength must meet orexceed existing tensilestrength specifications.	Test results for the Zenith FlexCatheter (K172167) were usedto support this assessment forthe subject Zenith Flex Catheteras the Peel-Away Introducer isthe same. Test articles met theacceptance criteria.
Test	Test MethodSummary	Acceptance Criteria	Conclusions
Unsplit length(Peel-Away Introducer)	Unsplit length of the testsamples was measured	Test sample lengthmeasurement must meetor exceed existingdimensionalspecifications.	Test results for the Zenith FlexCatheter (K172167) were usedto support this assessment forthe subject Zenith Flex Catheteras the Peel-Away Introducer isthe same. Test articles met theacceptance criteria.
Diameters(Peel-Away Introducer)	Test samples should bewithin existing outside orinside diameterspecification.	Test sample inside andoutside diametermeasurement must meetor exceed existingdimensionalspecifications.	Test results for the ZenithFlex Catheter (K172167) wereused to support thisassessment for the subjectZenith Flex Catheter as thePeel-Away Introducer is thesame. Test articles met theacceptance criteria.
Chemical Compatibility(Hemostasis valve)	Hemostasis valveexposed to chemicalsreadily available in aclinical setting.	Product shall withstandexposure to chemicalswithout degradation.	Test results for theHemostasis valve packagedwith Zenith Flex Catheter(K172167) were used tosupport this assessment forthe subject hemostasis valvepackaged with Zenith FlexCatheter as the materials areequivalent. Test articles metthe acceptance criteria.
Dimensional(Hemostasis valve)	Test samples should bewithin inside diameterspecification.	Test sample insidediameter measurementmust meet or exceedexisting dimensionalspecifications.	Test results for the Hemostasisvalve packaged with ZenithFlex Catheter(K172167) were used tosupport this assessment forthe subject hemostasis valvepackaged with Zenith FlexCatheter as the materials areequivalent. Test articles metthe acceptance 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 predicate 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 046 Zenith Flex Catheter meets the acceptance criteria to determine that the 046 Zenith Flex Catheter is substantially equivalent to the predicate device. Furthermore, the operating principles, the design, materials and the results of biocompatibility testing, shelf-life, packaging and sterilization processes are all equivalent and support the conclusion that all devices are technologically similar. Lastly, the review of published clinical data also supports the 046 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).