Who is the manufacturer of Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm?

Inneuroco, Inc. filed the 510(k) submission for Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm (K173709).

What is the FDA product code for Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm?

DQY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm

K173709 · Inneuroco, Inc. · DQY · Jan 26, 2018 · Cardiovascular

Device Facts

Record ID	K173709
Device Name	Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
Applicant	Inneuroco, Inc.
Product Code	DQY · Cardiovascular
Decision Date	Jan 26, 2018
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended Use

The Zenith Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Device Story

Zenith Support Catheter is a single-lumen, variable-stiffness catheter designed for peripheral and neurovascular access. It features a polymer shaft reinforced with a stainless steel cross-coil, a PTFE-lined lumen, and a hydrophilic coating. A radiopaque platinum/iridium marker band is located at the distal end. The device is inserted through a guide catheter or vascular sheath to provide a reinforcing conduit for other intravascular devices. It is supplied with a Tuohy-Borst hemostasis valve and a split-sheath introducer. Used in clinical settings by physicians, the device facilitates the delivery of interventional tools. By providing a stable, lubricious pathway, it aids in navigating complex vasculature, potentially improving procedural success and reducing vessel trauma.

Clinical Evidence

Bench testing only. No clinical data presented. Non-clinical evaluation included biocompatibility (ISO 10993), radiographic detectability, visual inspection, working length, hub compatibility, leak testing (air/liquid), particulate testing, simulated use, burst pressure, tensile strength, corrosion, packaging integrity, kink resistance, torque, and coating integrity. All tests met predetermined acceptance criteria.

Technological Characteristics

Materials: Polymer shaft, stainless steel cross-coil reinforcement, PTFE-lined lumen, platinum/iridium marker band. Dimensions: 0.074" ID, 0.086" nominal OD; lengths 95, 105, 115 cm. Features: Hydrophilic coating, luer-tapered hub. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Standards: ISO 10993 (biocompatibility), ISO 10555-1 (catheter performance), ISO 594-1/2 (luer), ASTM F1929/F88 (packaging).

Indications for Use

Indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Regulatory Classification

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.

Predicate Devices

Zenith 074 (K171672)

Reference Devices

InNeuroCo SDA (K161262)

Related Devices

K171672 — 065 Zenith, 074 Zenith · Inneuroco, Inc. · Oct 19, 2017
K243593 — AXS Lift Intracranial Base Catheter · Stryker Neurovascular · Feb 18, 2025
K200206 — AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter · Stryker Neurovascular · Feb 27, 2020
K230775 — SOFIA EX Intracranial Support Catheter · MicroVention, Inc. · Sep 14, 2023
K191237 — CERENOVUS Large Bore Catheter · Codman & Shurtleff, Inc. · Nov 8, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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. January 26, 2018 InNeuroCo, Inc. Marianne Grunwaldt Director, Quality Assurance and Regulatory Affairs 4635 NW 103rd Avenue Sunrise, Florida 33351 Re: K173709 Trade/Device Name: Zenith Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY, DTL, DYB Dated: January 4, 2018 Received: January 5, 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # William J. Heetderks -A 2018.01.26 16:50:00 -05'00' 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K173709 Device Name Zenith Support Catheter Indications for Use (Describe) The Zenith Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) SUMMARY ### ADMINISTRATIVE INFORMATION | Date of Summary Preparation: | December 1st, 2017 | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CONTACT INFORMATION | | | Submitter/Manufacturer | InNeuroCo Inc 4635 NW 103rd Avenue Sunrise, Florida 33351 Tel: 1-954-742-5988 Fax: 1-954-742-5989 | | Primary Submission Contact | Marianne Grunwaldt Cell:1-305-495-3883 Fax: 1-954-742-5988 Email: Marianne@InNeuroCo.com | | Secondary Submission Contact | Ming Cheng Chew Regulatory Consultant, Libra Medical, 8401 73rd Ave North, Suite 63 Brooklyn Park, MN 55428 Cell: 763-232-3701 Fax: 763-477-6357 Email: mcchew@libramed.com | #### DEVICE INFORMATION Device Trade or Proprietary Name Zenith Support Catheter Device Common or Classification Name: Catheter, Percutaneous, 21 CFR 870.1250, Class II Hemostasis Valve, 21 CFR 870.4290, Class II Catheter Introducer, 21 CFR 870.1340, Class II Product Code: DQY (Catheter) DTL (Hemostasis Valve) DYB (Catheter Introducer) Inc. {4}------------------------------------------------ ### IDENTIFICATION OF THE LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS BEING CLAIMED | Name of Predicate Device | Name of Manufacturer | 510(k) Number | |--------------------------|----------------------|---------------| | Zenith 074 | InNeuroCo | K171672 | ## DEVICE DESCRIPTION The InNeuroCo Zenith Support product consists of a catheter, a hemostasis valve, and a split sheath introducer. The Zenith Support catheter is a single lumen, variable stiffness catheter that has an outer polymer shaft and is reinforced with a Stainless Steel cross coil. The Zenith Support catheter has a radiopaque Platinum/Iridium marker band on the distal end. The Zenith Support is available with an internal diameter of 0.074 inches and a nominal outer diameter of 0.086 inches. There are three working lengths available: 95 cm, 105 cm, and 115 cm in either diameter. The Zenith Support catheter has a PTFE-lined lumen throughout the catheter shaft. The catheter is flexible and has a hydrophilic coating. The Zenith Support catheter is inserted through a guide catheter or vascular sheath, provides access to the target site, and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a split sheath introducer. The Zenith product line is supplied sterile, non-pyrogenic, and intended for single use only. ## INDICATIONS FOR USE / INTENDED USE The Zenith Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. | | Predicate Device InNeuroCo, Inc. Zenith 074 | Reference Device InNeuroCo SDA | InNeuroCo, Inc. Zenith Support | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K171672 | K161262 | K173709 | | Classification | 21CFR870.1250, Class II | 21CFR870.1250, Class II | 21CFR870.1250, Class II | | Product Code | DQY | DQY | DQY | | Review Panel | Cardiovascular | Cardiovascular | Cardiovascular | | | Predicate Device InNeuroCo, Inc. Zenith 074 | Reference Device InNeuroCo SDA | InNeuroCo, Inc. Zenith Support | | Indications For Use | The Zenith is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. | The Super Distal Access (SDA) is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. | The Zenith Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. | | Components Supplied | Zenith Catheter, Peel Away Introducers, Hemostasis Valve, Scout Introducer | Catheter, Peel Away Introducer, Hemostasis Valve | Zenith Support Catheter, Peel Away Introducer, Hemostasis Valve | | Catheter Shaft Material | Polymeric Catheter | Polymeric Catheter | Polymeric Catheter | | Inner Liner | PTFE | PTFE | PTFE | | Catheter Shaft Reinforcement | Stainless Steel | Stainless Steel/Nitinol | Stainless Steel | | Reinforcement pattern | Cross Coil | Braid | Cross Coil | | Lubricious Coating | Hydrophilic Coating | Hydrophilic Coating | Hydrophilic Coating | | Radiopaque Marker Band | Platinum/ Iridium | Platinum/ Iridium | Platinum/ Iridium | | Packaging | Tyvek/Nylon Pouch, polyethylene support tube, packaging card, SBS carton | Tyvek/Nylon Pouch, polyethylene support tube, packaging card, SBS carton | Tyvek/Nylon Pouch, polyethylene support tube, packaging card, SBS carton | | Working Lengths | 115, 125, 132 cm | 105, 115, 125 cm | 95, 105, 115 cm | | | Predicate Device InNeuroCo, Inc. Zenith 074 | Reference Device InNeuroCo SDA | InNeuroCo, Inc. Zenith Support | | Proximal Internal Diameter (ID) | 0.074 inches | 0.062 inches | 0.074 inches | | Distal ID | 0.074 inches | 0.060 inches distal | 0.074 inches | | Proximal Outer Diameter | 0.086 inches | 0.079 inches | 0.086 inches | | Distal Outer Diameter | 0.086 inches | 0.072 | 0.086 inches | | Peel Away Introducer | Aid in catheter tip introduction into hemostasis valve | Aid in catheter tip introduction into hemostasis valve | Aid in catheter tip introduction into hemostasis valve | | Hemostasis Valve | Minimizes blood loss | Minimizes blood loss | Minimizes blood loss | | Luer Tapered Hub | Yes | Yes | Yes | | Compatible Guidewire | 0.038 inches | 0.038 inches | 0.038 inches | | Scout Introducer | Yes | No | No | | Sterilization | EO SAL 10-6 | EO SAL 10-6 | EO SAL 10-6 | | Pyrogenicity | Nonpyrogenic | Nonpyrogenic | Nonpyrogenic | | Biocompatibility | Meets ISO 10993- 1:2009 | Meets ISO 10993-1:2009 | Meets ISO 10993-1:2009 | # COMPARISON TO THE PREDICATE DEVICE {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ ## SUMMARY OF NON-CLINICAL DATA Each non-clinical test was analyzed to determine whether or not re-testing should be conducted for the Zenith Support Catheter. The results of the analysis and re-testing showed that the Zenith Support Catheter is substantially equivalent to the predicate device. {8}------------------------------------------------ | Test | Test Method Summary | Acceptance Criteria | Re-Tested? | Analysis | |--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibilit y-Material Mediated Pyrogen | Testing completed per ISO 10993-11 | The test article extracts must not cause a febrile reaction greater than 0.5°C in any individual subject. | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device. Manufacturing process is identical to the predicate. Only the segment lengths were changed and pitch adjustments were within the predicate device's tolerance | | Biocompatibilit y- Cytotoxicity MEM Elution | Testing completed per ISO 10993-5 | The cultures treated with the test article must not have a reactivity grade greater than 2. | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device. Manufacturing process is identical to the predicate. Only the segment lengths were changed and pitch adjustments were within the predicate device's tolerance | | Biocompatibilit y-Hemolysis ASTM Method, extract human blood | Testing completed per ISO 10993-4 | The hemolytic index above the negative control article must be less than 5%. | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device. Manufacturing process is identical to the predicate. Only the segment lengths were changed and pitch adjustments were within the predicate device's tolerance | | Biocompatibilit y-Hemolysis, ASTM method, | Testing completed per ISO 10993-4 | The hemolytic index above the negative control | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device. | | Test | Test Method Summary | Acceptance Criteria | Re-Tested? | Analysis | | direct contact (human blood) | | article must be less than 5%. | | Manufacturing process is identical to the predicate. Only the segment lengths were changed and pitch adjustments were within the predicate device's tolerance | | Biocompatibilit y-Unactivated Partial Thromboplastin Time | Testing completed per ISO 10993-4 | There must be no statistical decrease between the UPTT of plasma exposed to the test article and to the negative or untreated control. | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device. Manufacturing process is identical to the predicate. Only the segment lengths were changed and pitch adjustments were within the predicate device's tolerance | | Biocompatibilit y-Complement Activation | Testing completed per ISO 10993-4 | There must be no statistical increase between either the C3a or SC5b-9 concentrations in plasma exposed to the test article as compared to the negative and untreated controls. | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device. Manufacturing process is identical to the predicate. Only the segment lengths were changed and pitch adjustments were within the predicate device's tolerance | | Biocompatibilit y-Dog Thromboresista nce | Testing completed per ISO 10993-4 | The test articles must receive a thrombus formation score less than or equal to that of the control. | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device. Manufacturing process is identical to the predicate. Only the segment lengths were changed and pitch adjustments were within the predicate device's tolerance | | Test | Test Method Summary | Acceptance Criteria | Re-Tested? | Analysis | | Biocompatibilit y-Maximization Sensitization | Testing completed per ISO 10993-10 | The test article must elicit a positive response in less than 10% of the test animals. | Testing was not repeated for the Zenith Support Catheter | changed and pitch adjustments were within the predicate device's tolerance There are no material changes from the predicate device. Manufacturing process is identical to the predicate. Only the segment lengths were changed and pitch adjustments were within the predicate device's tolerance | | Biocompatibilit y- Intracutaneous Toxicity/Reacti vity | Testing completed per ISO 10993-10 | The test article extracts must not induce a significantly greater biological reaction than the control. | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device. Manufacturing process is identical to the predicate. Only the segment lengths were changed and pitch adjustments were within the predicate device's tolerance | | Biocompatibilit y-Acute Systemic Toxicity Test | Testing completed per ISO 10993-11 | The test article extracts must not induce a significantly greater biological reaction than the control. | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device. Manufacturing process is identical to the predicate. Only the segment lengths were changed and pitch adjustments were within the predicate device's tolerance | | Test | Test Method Summary | Acceptance Criteria | Re-Tested? | Analysis | | Animal Testing- Angiographic Evaluation | Product evaluated within a porcine model for clinically significant injury. | No units tested can cause vessel injury. | Testing was not repeated for the Zenith Support Catheter | The tips, materials, and transitions are identical to the predicate, and the initial evaluation for the predicate included the use of the device without the Scout Introducer | | Chemical Compatibility | Catheter exposed to chemicals readily available in a clinical setting. | Chemicals have no negative effect on the catheter or accessories. | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device | | Radiographic Detectability | Testing completed per ISO 10555-1 | Product shall be visible under fluoro imaging. | Testing was not repeated for the Zenith Support Catheter | The marker bands are identical to the predicate | | Visual Inspection | Testing completed per ISO 10555-1 | Catheter shall appear free from damage, including a rounded tip and smooth transition points. | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device | | Working Length | Testing completed per ISO 10555-1 | Test samples should be within existing working length specification. | Testing was not repeated for the Zenith Support Catheter | The segment lengths do not impact the cut to length step in addition the working length test compares the output to the target length | | Hub compatibility | Testing completed per ISO 594-1 and ISO 594-2 | Hub shall meet existing Luer specifications. | Testing was not repeated for the Zenith Support Catheter | The hub is identical to the predicate device | | Outside diameter | Testing completed per ISO 10555-1 | Test samples should be within existing outside | Testing was not repeated for the Zenith Support Catheter | OD is unaffected by the working length change | | Test | Test Method Summary | Acceptance Criteria | Re-Tested? | Analysis | | Leak – Air | Testing completed per ISO 10555-1 | Test samples should be within existing Air - Leak specifications. | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device | | Leak – Liquid | Testing completed per ISO 10555-1 | Test samples should be within existing Leak - Liquid specifications. | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device | | Particulates | Testing completed per USP 788 | Test samples should be within existing Particulate specifications. | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device | | Simulated Use - Bench | Zenith underwent simulated use testing by a physician in a benchtop model | Test samples must meet predetermined user needs | Yes | Zenith Support Catheter test samples met the acceptance criteria for Simulated Use- Bench to demonstrate that it is substantially equivalent to the predicate device | | Catheter Burst | Testing completed per ISO 10555-1 | Test sample burst pressures must meet or exceed existing minimum burst pressure specification. | Testing was not repeated for the Zenith Support Catheter. | There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device | | Test | Test Method Summary | Acceptance Criteria | Re-Tested? | Analysis | | Tensile | Testing completed per ISO 10555-1 | Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications. | Testing was not repeated for the Zenith Support Catheter | The bonds and joints are the same as the predicate Zenith 074 device. Any pitch adjustments are within the tolerance of the predicate device. | | Corrosion | Testing completed per ISO 10555-1 | Test samples shall exhibit no evidence of corrosion. | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device | | Packaging - Dye Leak | Testing completed per ASTM F1929- 12 | Test sample shall not exhibit any visual leaks or channels | Testing was not repeated for the Zenith Support Catheter | The packaging is identical to the cleared reference SDA device | | Packaging - Peel | Testing completed per ASTM F88-09 | Test sample tensile strength must meet or exceed existing tensile strength specifications. | Testing was not repeated for the Zenith Support Catheter | The packaging is identical to the cleared reference SDA device | | Kink Resistance | Samples are subjected to different diameters until kink is observed. | Test sample kink resistance must meet or exceed existing Kink Resistance specifications. | Testing was not repeated for the Zenith Support Catheter | All transitions are the same, only the location of the transition changes, in addition, the pitch adjustments are within the Zenith 074 tolerance | | Torque | Conditioned samples are torqued to failure | Test sample torque results must meet or exceed existing torque specifications. | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device | | PTFE Liner inspection | Zenith was challenged to | Test sample liner adhesion must | Testing was not repeated for the | There are no material changes | | Test | Test Method Summary | Acceptance Criteria | Re-Tested? | Analysis | | | demonstrate liner adherence. | meet or exceed existing PTFE Liner inspection specifications. | Zenith Support Catheter | from the predicate device, and pitch adjustments are within the tolerance of the predicate device | | Hydrophilic Coating Integrity | Conditioned samples were repeatedly exposed to friction to demonstrate that the hydrophilic coating is not affected. | Test sample results must meet or exceed existing Hydrophilic Coating Integrity specifications. | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device | | Labeling Legibility | Label is legible after printing. | Test samples shall demonstrate text legibility. | Testing was not repeated for the Zenith Support Catheter substantially equivalent to the predicate device. | The label is almost identical to the predicate device, except that the Scout Introducer is removed from the labeling | | Barcode | Barcode is readable with a standard barcode reader. | Test samples shall demonstrate readily readable barcodes | Testing was not repeated for the Zenith Support Catheter | Barcodes are similar to the predicate | | Sterilization | ISO 11135 and AAMI TIR 28 | Sterilization load shall pose an equal or lesser challenge to sterilize than existing sterile product loads. | Testing was not repeated for the Zenith Support Catheter | The Zenith Support Catheter was adopted into the Zenith Family Sterilization Cycle | | Shelf Life | ASTM F1980 | Aged test samples must meet or exceed existing specifications | Testing was not repeated for the Zenith Support Catheter | There are no material changes from the predicate device, therefore shelf life testing conducted for the Zenith 074 still applies | # Table 1: Non-Clinical Testing Analysis {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------

Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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