065 Zenith, 074 Zenith

K171672 · Inneuroco, Inc. · DQY · Oct 19, 2017 · Cardiovascular

Device Facts

• Record ID: K171672
• Device Name: 065 Zenith, 074 Zenith
• Applicant: Inneuroco, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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

Device Story

Zenith is a single-lumen, variable-stiffness catheter used to provide a reinforcing conduit for other intravascular devices during interventional procedures. It features a polymer shaft reinforced with a stainless steel cross-coil and a PTFE-lined lumen. The device is inserted through a guide catheter or vascular sheath to access target sites in the peripheral and neuro vasculature. It includes a hydrophilic coating to facilitate tracking. Accessories include a Tuohy-Borst hemostasis valve, two split-sheath introducers, and a 'Scout' introducer for support during navigation. The device is operated by physicians in a clinical setting. By providing a stable conduit, it enables the delivery of interventional devices, potentially improving procedural success and patient outcomes. It is supplied sterile for single use.

Clinical Evidence

No clinical data. Evidence consists of bench testing (biocompatibility per ISO 10993, mechanical testing per ISO 10555-1, sterilization, shelf-life) and animal testing (porcine model for angiographic evaluation of vessel injury). All tests met acceptance criteria.

Technological Characteristics

Catheter with polymer shaft, stainless steel cross-coil reinforcement, PTFE-lined lumen, and hydrophilic coating. Radiopaque Platinum/Iridium marker band. Available in 0.065" and 0.074" internal diameters. Accessories: Tuohy-Borst hemostasis valve, split-sheath introducers, Scout introducer. Sterilized via EO (SAL 10^-6). Complies with ISO 10993-1, ISO 10555-1, ISO 594-1/2, ASTM F1929-12, ASTM F88-09, USP 788, ASTM F1980.

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

• Navien Intracranial Support Catheter (K110055)
• INTERMEDIATE CATHETER (K152202)

Submission Summary (Full Text)

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October 19, 2017

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

## Re: K171672

Trade/Device Name: Zenith (065 and 074) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 15, 2017 Received: September 18, 2017

#### Dear Ms. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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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) K171672

Device Name Zenith

Indications for Use (Describe)

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

Type of Use (*Select one or both, as applicable*)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | 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: [phone] Facsimile: 1-954-742-5989

#### Contact Information

Marianne Grunwaldt Director, Quality Assurance & Requlatory Affairs InNeuroCo, Inc 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: [phone] Facsimile: 1-954-742-5989 E-Mail: [e-mail]

## Date Prepared

September 14, 2017

### Device Trade or Proprietary Name

Zenith Hemostasis Valve Split Sheath Introducer Scout Introducer

#### Device Common or Classification Name:

Catheter, Percutaneous, 21CFR870.1250, Class II Hemostasis Valve, 21CFR870.4290, Class II Catheter Introducer, 21 CFR 870.1340, Class I

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## Product Code:

DQY (Catheter) DTL (Hemostasis Valve) DYB (Catheter Introducer)

# ldentification of the Leqally Marketed Devices to which Equivalence is Being Claimed

| Name of Predicate Device | Name of Manufacturer | 510(k) Number |
|--------------------------------------|----------------------|---------------|
| Navien Intracranial Support Catheter | Medtronic | K110055 |
| INTERMEDIATE CATHETER | InNeuroCo | K152202 |

## Device Description

The InNeuroCo Zenith product consists of a catheter, a hemostasis valve, two split sheath introducers, and a Scout introducer. The Zenith 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 catheter has a radiopaque Platinum/lridium marker band on the distal end. The Zenith product line is available in two internal diameters: 0.065 inches and 0.074 inches. The 0.065 catheter has a tapered design and is 0.079 inches outer diameter in the distal end and a 0.081 inches outer diameter in the proximal end. The 0.074 catheter has a nominal outer diameter of 0.086 inches. There are three working lengths available: 115 cm, 125 cm, and 132 cm in either diameter. The Zenith catheter has a PTFE-lined lumen throughout the catheter shaft. The catheter is flexible and has a hydrophilic coating. The Zenith catheter is inserted through a quide 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 two split sheath introducers. There is another introducer, named Scout, which provides support to the Zenith catheter while tracking to target site. The Zenith product line is supplied sterile, nonpyrogenic, and intended for single use only.

#### Indications for Use

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

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Comparison to Predicate Device

| | Predicate Device<br>Medtronic Navien | InNeuroCo, Inc.<br>Zenith | Reference<br>Device<br>InNeuroCo IC |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K110055 | K171672 | K152202 |
| Classification | 21CFR870.1250,<br>Class II | 21CFR870.1250,<br>Class II | 21CFR870.1250,<br>Class II |
| Product Code | DQY | | DQY |
| Review Panel | Cardiovascular | Cardiovascular | Cardiovascular |
| Indications For<br>Use | The Navien<br>Intracranial Support<br>Catheter is<br>indicated for the<br>introduction of<br>interventional<br>devices into the<br>peripheral and<br>neuro vasculature. | The Zenith is<br>indicated for the<br>introduction of<br>interventional devices<br>into the peripheral and<br>neuro vasculature. | The Intermediate<br>Catheter is<br>indicated for the<br>introduction of<br>interventional<br>devices into the<br>peripheral and<br>neuro vasculature. |
| Components<br>Supplied | Navien Catheter,<br>Introducer Sheath | Zenith Catheter, Peel<br>Away Introducers,<br>Hemostasis Valve,<br>Scout Introducer | Intermediate<br>Catheter, Peel<br>Away Introducer,<br>Hemostasis<br>Valve |
| Catheter Shaft<br>Material | Polymeric Catheter | Polymeric Catheter | Polymeric<br>Catheter |
| Inner Liner | PTFE | PTFE | PTFE |
| Catheter Shaft<br>Reinforcement | Nitinol | Stainless Steel | Stainless<br>Steel/Nitinol |
| Reinforcement<br>pattern | Coil | Cross Coil | Braid |
| | Predicate Device<br>Medtronic Navien | InNeuroCo, Inc.<br>Zenith | Reference<br>Device<br>InNeuroCo IC |
| Lubricious<br>Coating | Hydrophilic<br>Coating | Hydrophilic Coating | Hydrophilic<br>Coating |
| Radiopaque<br>Marker Band | Platinum/ Iridium | Platinum/ Iridium | Platinum/ Iridium |
| Packaging | PET/PE/Tyvek<br>Pouch, Hoop,<br>packaging card,<br>SBS carton | Tyvek/Nylon Pouch,<br>polyethylene support<br>tube, packaging card,<br>SBS carton | Tyvek/Nylon<br>Pouch,<br>polyethylene<br>support tube,<br>packaging card,<br>SBS carton |
| Working<br>Lengths | 105,115, 125, 130 | 115, 125, 132 cm | 105, 115, 125 cm |
| Proximal<br>Internal<br>Diameter (ID) | Navien<br>058<br>0.058<br>inches | Zenith<br>0.065<br>0.065<br>inches | 0.062 inches<br>proximal |
| | Navien<br>072<br>0.072<br>inches | Zenith<br>0.074<br>0.074<br>inches | |
| Distal ID | Navien<br>058<br>0.058<br>inches | Zenith<br>0.065<br>0.065<br>inches | 0.060 inches<br>distal |
| | Navien<br>072<br>0.072<br>inches | Zenith<br>0.074<br>0.074<br>inches | |
| Proximal Outer<br>Diameter | Navien<br>058<br>0.070<br>inches | Zenith<br>0.065<br>0.081<br>inches | 0.079 inches |
| | Navien<br>072<br>0.084<br>inches | Zenith<br>0.074<br>0.086<br>inches | |
| Distal Outer<br>Diameter | Navien<br>058<br>0.070<br>inches | Zenith<br>0.065<br>0.079<br>inches | 0.072 |
| | Navien<br>072<br>0.084<br>inches | Zenith<br>0.074<br>0.086<br>inches | |
| Peel Away<br>Introducer | Aid in catheter tip<br>introduction into<br>hemostasis valve | Aid in catheter tip<br>introduction into<br>hemostasis valve | Aid in catheter tip<br>introduction into<br>hemostasis valve |
| | Predicate Device<br>Medtronic Navien | InNeuroCo, Inc.<br>Zenith | Reference<br>Device<br>InNeuroCo IC |
| Hemostasis<br>Valve | N/A | Minimizes blood loss | Minimizes blood<br>loss |
| Luer Tapered<br>Hub | Yes<br>Yes | | Yes |
| Compatible<br>Guidewire | 0.038 | 0.038 inches | 0.038 inches |
| Scout<br>Introducer | Yes<br>No | | No |
| Sterilization | EO SAL 10-6<br>EO SAL 10-6 | | EO SAL 10-6 |
| Pyrogenicity | Nonpyrogenic | Nonpyrogenic | |
| Biocompatibility | Meets ISO 10993-<br>1:2009 | Meets ISO 10993-<br>1:2009 | Meets ISO<br>10993-1:2009 |

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# Summary of Non-Clinical Data

Biocompatibility tests conducted with the Zenith catheter and its accessories were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for limited duration (< 24 hours), external communicating devices, contacting blood. Studies were conducted pursuant to 21 CFR 58, Good Laboratory Practices. Biocompatibility testing found the Zenith to be biocompatible and non-pyrogenic.

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

# Zenith Performance Testing

| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate Device<br>Testing<br>(Yes/Unknown) |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Biocompatibility-<br>Material Mediated<br>Pyrogen | Testing<br>completed per<br>ISO 10993-11 | The test article<br>extracts must not<br>cause a febrile<br>reaction greater | Zenith test samples<br>met the acceptance<br>criteria for Material<br>Mediated Pyrogen | Yes |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate Device<br>Testing<br>(Yes/Unknown) |
| | | than 0.5°C in any<br>individual subject. | to demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | |
| Biocompatibility-<br>Cytotoxicity MEM<br>Elution | Testing<br>completed per<br>ISO 10993-5 | The cultures treated<br>with the test article<br>must not have a<br>reactivity grade<br>greater than 2. | Zenith test samples<br>met the acceptance<br>criteria for<br>Cytotoxicity MEM<br>Elution to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Yes |
| Biocompatibility-<br>Hemolysis ASTM<br>Method, extract<br>human blood | Testing<br>completed per<br>ISO 10993-4 | The hemolytic index<br>above the negative<br>control article must<br>be less than 5%. | Zenith test samples<br>met the acceptance<br>criteria for<br>Hemolysis ASTM<br>Method, extract<br>human blood to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Yes |
| Biocompatibility-<br>Hemolysis, ASTM<br>method, direct<br>contact (human<br>blood) | Testing<br>completed per<br>ISO 10993-4 | The hemolytic index<br>above the negative<br>control article must<br>be less than 5%. | Zenith test samples<br>met the acceptance<br>criteria for<br>Hemolysis, ASTM<br>method, direct<br>contact (human<br>blood) to<br>demonstrate that<br>the Zenith is<br>substantially | Yes |
| Test | Test Method Summary | Acceptance Criteria | Conclusions | Predicate Device Testing (Yes/Unknown) |
| Biocompatibility- 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. | equivalent to the predicate device. Zenith test samples met the acceptance criteria for Unactivated Partial Thromboplastin Time to demonstrate that the Zenith is substantially equivalent to the predicate device. | Yes |
| Biocompatibility- 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. | Zenith test samples met the acceptance criteria for Complement Activation to demonstrate that the Zenith is substantially equivalent to the predicate device. | Yes |
| Biocompatibility- Dog Thromboresistance | Testing completed per ISO 10993-4 | The test articles must receive a thrombus formation score less than or equal to that of the control. | Zenith test samples met the acceptance criteria for Dog Thromboresistance to demonstrate that the Zenith is substantially equivalent to the predicate device. | Yes |
| Biocompatibility- Maximization Sensitization | Testing completed per ISO 10993-10 | The test article must elicit a positive response in less than 10% of the test animals. | Zenith test samples met the acceptance criteria for Maximization Sensitization to | Yes |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate Device<br>Testing<br>(Yes/Unknown) |
| Biocompatibility-<br>Intracutaneous<br>Toxicity/Reactivity | Testing<br>completed per<br>ISO 10993-10 | The test article<br>extracts must not<br>induce a<br>significantly greater<br>biological reaction<br>than the control. | Zenith test samples<br>met the acceptance<br>criteria for<br>Intracutaneous<br>Toxicity/Reactivity<br>to demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Yes |
| Biocompatibility-<br>Acute Systemic<br>Toxicity Test | Testing<br>completed per<br>ISO 10993-11 | The test article<br>extracts must not<br>induce a<br>significantly greater<br>biological reaction<br>than the control. | Zenith test samples<br>met the acceptance<br>criteria for Acute<br>Systemic Toxicity<br>Test to demonstrate<br>that the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Yes |
| Animal Testing-<br>Angiographic<br>Evaluation | Product<br>evaluated within<br>a porcine model<br>for clinically<br>significant injury. | No units tested can<br>cause vessel injury. | Zenith test samples<br>met the acceptance<br>criteria for Animal<br>Testing-<br>Angiographic<br>Evaluation to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Yes |
| Chemical<br>Compatibility | Catheter<br>exposed to | Chemicals have no<br>negative effect on | Zenith test samples<br>met the acceptance | Unknown |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate Device<br>Testing<br>(Yes/Unknown) |
| | chemicals<br>readily available<br>in a clinical<br>setting. | the catheter or<br>accessories. | criteria for Chemical<br>Compatibility to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | |
| Radiographic<br>Detectability | Testing<br>completed per<br>ISO 10555-1 | Product shall be<br>visible under fluoro<br>imaging. | Zenith test samples<br>met the acceptance<br>criteria for<br>Radiographic<br>Detectability to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Yes – part of <i>in vivo</i><br>testing |
| Visual Inspection | Testing<br>completed per<br>ISO 10555-1 | Catheter shall<br>appear free from<br>damage, including a<br>rounded tip and<br>smooth transition<br>points. | Zenith test samples<br>met the acceptance<br>criteria for Visual<br>Inspection to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Yes |
| Working Length | Testing<br>completed per<br>ISO 10555-1 | Test samples<br>should be within<br>existing working<br>length specification. | Zenith test samples<br>met the acceptance<br>criteria for Working<br>Length to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Yes |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate Device<br>Testing<br>(Yes/Unknown) |
| Hub compatibility | Testing<br>completed per<br>ISO 594-1 and<br>ISO 594-2 | Hub shall meet<br>existing Luer<br>specifications. | Zenith test samples<br>met the acceptance<br>criteria for Hub<br>compatibility to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Yes |
| Outside diameter | Testing<br>completed per<br>ISO 10555-1 | Test samples<br>should be within<br>existing outside<br>diameter<br>specification. | Zenith test samples<br>met the acceptance<br>criteria for Outside<br>diameter to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Yes |
| Leak – Air | Testing<br>completed per<br>ISO 10555-1 | Test samples<br>should be within<br>existing Air – Leak<br>specifications. | Zenith test samples<br>met the acceptance<br>criteria for Leak –<br>Air to demonstrate<br>that the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Yes |
| Leak – Liquid | Testing<br>completed per<br>ISO 10555-1 | Test samples<br>should be within<br>existing Leak –<br>Liquid<br>specifications. | Zenith test samples<br>met the acceptance<br>criteria for Leak –<br>Liquid to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Yes |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate Device<br>Testing<br>(Yes/Unknown) |
| | | | equivalent to the<br>predicate device. | |
| Particulates | Testing<br>completed per<br>USP 788 | Test samples<br>should be within<br>existing Particulate<br>specifications. | Zenith test samples<br>met the acceptance<br>criteria for<br>Particulates to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Yes |
| Simulated Use -<br>Bench | Zenith<br>underwent<br>simulated use<br>testing by a<br>physician in a<br>benchtop model | Test samples must<br>meet predetermined<br>user needs | Zenith test samples<br>met the acceptance<br>criteria for<br>Simulated Use -<br>Bench to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Yes |
| Catheter Burst | Testing<br>completed per<br>ISO 10555-1 | Test sample burst<br>pressures must<br>meet or exceed<br>existing minimum<br>burst pressure<br>specification. | Zenith test samples<br>met the acceptance<br>criteria for Catheter<br>Burst to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Yes |
| Tensile | Testing<br>completed per<br>ISO 10555-1 | Test sample<br>ultimate tensile<br>strength must meet<br>or exceed existing | Zenith test samples<br>met the acceptance<br>criteria for Tensile<br>to demonstrate that | Yes |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate Device<br>Testing<br>(Yes/Unknown) |
| | | tensile strength<br>specifications. | the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | |
| Corrosion | Testing<br>completed per<br>ISO 10555-1 | Test samples shall<br>exhibit no evidence<br>of corrosion. | Test results for the<br>predicate device<br>were leveraged for<br>the Zenith as the<br>materials and<br>manufacturing<br>processes are<br>equivalent. | Yes |
| Packaging - Dye<br>Leak | Testing<br>completed per<br>ASTM F1929-12 | Test sample shall<br>not exhibit any<br>visual leaks or<br>channels | Zenith test samples<br>met the acceptance<br>criteria for<br>Packaging - Dye<br>Leak to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Unknown |
| Packaging - Peel | Testing<br>completed per<br>ASTM F88-09 | Test sample tensile<br>strength must meet<br>or exceed existing<br>tensile strength<br>specifications. | Zenith test samples<br>met the acceptance<br>criteria for<br>Packaging - Peel to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Unknown |
| Kink Resistance | Samples are<br>subjected to<br>different | Test sample kink<br>resistance must<br>meet or exceed<br>existing Kink | Zenith test samples<br>met the acceptance<br>criteria for Kink<br>Resistance to | Yes |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate Device<br>Testing<br>(Yes/Unknown) |
| | diameters until<br>kink is observed. | Resistance<br>specifications. | demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | |
| Torque | Conditioned<br>samples are<br>torqued to failure | Test sample torque<br>results must meet<br>or exceed existing<br>torque<br>specifications. | Zenith test samples<br>met the acceptance<br>criteria for Torque to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Yes |
| PTFE Liner<br>inspection | Zenith was<br>challenged to<br>demonstrate<br>liner adherence. | Test sample liner<br>adhesion must<br>meet or exceed<br>existing PTFE Liner<br>inspection<br>specifications. | Zenith test samples<br>met the acceptance<br>criteria for PTFE<br>Liner inspection to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Unknown |
| Hydrophilic<br>Coating Integrity | Conditioned<br>samples were<br>repeatedly<br>exposed to<br>friction to<br>demonstrate that<br>the hydrophilic<br>coating is not<br>affected. | Test sample results<br>must meet or<br>exceed existing<br>Hydrophilic Coating<br>Integrity<br>specifications. | Zenith test samples<br>met the acceptance<br>criteria for<br>Hydrophilic Coating<br>Integrity to<br>demonstrate that<br>the Zenith is<br>substantially<br>equivalent to the<br>predicate device. | Unknown |
| Labeling Legibility | Label is legible<br>after printing. | Test samples shall<br>demonstrate text<br>legibility. | Zenith test samples<br>met the acceptance<br>criteria for labeling<br>legibility to<br>demonstrate that | Unknown |
| Test | Test Method Summary | Acceptance Criteria | Conclusions | Predicate Device Testing (Yes/Unknown) |
| Barcode | Barcode is readable with a standard barcode reader. | Test samples shall demonstrate readily readable barcodes | Zenith test samples met the acceptance criteria for barcode testing to demonstrate that the Zenith is substantially equivalent to the predicate device. | Unknown |
| Sterilization | ISO 11135 and AAMI TIR 28 | Sterilization load shall pose an equal or lesser challenge to sterilize than existing sterile product loads. | Zenith sterilization load met the acceptance criteria for sterilization to demonstrate that the Zenith is substantially equivalent to the predicate device. | Yes |
| Shelf Life | ASTM F1980 | Aged test samples must meet or exceed existing specifications | Zenith test samples met the acceptance criteria for shelf life to demonstrate that the Zenith is substantially equivalent to the predicate device. | Yes |

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