(135 days)
No
The device description and performance studies focus on the physical and mechanical properties of a catheter and its accessories, with no mention of AI or ML.
No.
The device is described as a catheter used for the introduction of interventional devices into the peripheral and neuro vasculature, providing access and a reinforcing conduit. It facilitates therapeutic procedures by enabling the delivery of other devices, but it does not directly deliver therapy itself.
No
The Zenith is described as a catheter used for the introduction of interventional devices, providing access to a target site and a reinforcing conduit. Its function is to facilitate procedures, not to diagnose conditions.
No
The device description clearly outlines multiple physical components including a catheter, hemostasis valve, split sheath introducers, and a Scout introducer, all of which are hardware. The performance studies also focus on the physical and material properties of these hardware components.
Based on the provided information, the Zenith device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for the "introduction of interventional devices into the peripheral and neuro vasculature." This describes a device used within the body for procedural purposes, not for testing samples outside the body.
- Device Description: The description details a catheter and accessories designed for insertion into blood vessels. This aligns with an invasive medical device, not an IVD.
- Performance Studies: The performance studies focus on biocompatibility, physical properties (burst strength, tensile strength, etc.), and simulated use within a vascular model. These are typical tests for invasive medical devices, not IVDs which would involve analytical performance studies on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Zenith device is an invasive medical device used for interventional procedures, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Zenith is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY, DTL, DYB
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/Iridium 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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The document summarizes several non-clinical performance tests:
- Biocompatibility (Material Mediated Pyrogen, Cytotoxicity MEM Elution, Hemolysis ASTM Method (extract human blood), Hemolysis ASTM method (direct contact human blood), Unactivated Partial Thromboplastin Time, Complement Activation, Dog Thromboresistance, Maximization Sensitization, Intracutaneous Toxicity/Reactivity, Acute Systemic Toxicity Test): All Zenith test samples met the acceptance criteria to demonstrate substantial equivalence to the predicate device.
- Animal Testing-Angiographic Evaluation: Product evaluated within a porcine model for clinically significant injury. Acceptance criteria: No units tested can cause vessel injury. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Chemical Compatibility: Catheter exposed to chemicals readily available in a clinical setting. Acceptance criteria: Chemicals have no negative effect on the catheter or accessories. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Radiographic Detectability: Testing completed per ISO 10555-1. Acceptance criteria: Product shall be visible under fluoro imaging. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Visual Inspection: Testing completed per ISO 10555-1. Acceptance criteria: Catheter shall appear free from damage, including a rounded tip and smooth transition points. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Working Length: Testing completed per ISO 10555-1. Acceptance criteria: Test samples should be within existing working length specification. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Hub compatibility: Testing completed per ISO 594-1 and ISO 594-2. Acceptance criteria: Hub shall meet existing Luer specifications. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Outside diameter: Testing completed per ISO 10555-1. Acceptance criteria: Test samples should be within existing outside diameter specification. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Leak – Air: Testing completed per ISO 10555-1. Acceptance criteria: Test samples should be within existing Air – Leak specifications. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Leak – Liquid: Testing completed per ISO 10555-1. Acceptance criteria: Test samples should be within existing Leak – Liquid specifications. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Particulates: Testing completed per USP 788. Acceptance criteria: Test samples should be within existing Particulate specifications. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Simulated Use - Bench: Zenith underwent simulated use testing by a physician in a benchtop model. Acceptance criteria: Test samples must meet predetermined user needs. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Catheter Burst: Testing completed per ISO 10555-1. Acceptance criteria: Test sample burst pressures must meet or exceed existing minimum burst pressure specification. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Tensile: Testing completed per ISO 10555-1. Acceptance criteria: Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Corrosion: Testing completed per ISO 10555-1. Acceptance criteria: Test samples shall exhibit no evidence of corrosion. Conclusion: Test results for the predicate device were leveraged for the Zenith as the materials and manufacturing processes are equivalent.
- Packaging - Dye Leak: Testing completed per ASTM F1929-12. Acceptance criteria: Test sample shall not exhibit any visual leaks or channels. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Packaging - Peel: Testing completed per ASTM F88-09. Acceptance criteria: Test sample tensile strength must meet or exceed existing tensile strength specifications. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Kink Resistance: Samples are subjected to different diameters until kink is observed. Acceptance criteria: Test sample kink resistance must meet or exceed existing Kink Resistance specifications. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Torque: Conditioned samples are torqued to failure. Acceptance criteria: Test sample torque results must meet or exceed existing torque specifications. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- PTFE Liner inspection: Zenith was challenged to demonstrate liner adherence. Acceptance criteria: Test sample liner adhesion must meet or exceed existing PTFE Liner inspection specifications. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Hydrophilic Coating Integrity: Conditioned samples were repeatedly exposed to friction to demonstrate that the hydrophilic coating is not affected. Acceptance criteria: Test sample results must meet or exceed existing Hydrophilic Coating Integrity specifications. Conclusion: Zenith test samples met the acceptance criteria to demonstrate substantial equivalence.
- Labeling Legibility: Label is legible after printing. Acceptance criteria: Test samples shall demonstrate text legibility. Conclusion: Zenith test samples met the acceptance criteria for labeling legibility to demonstrate that the Zenith is substantially equivalent to the predicate device.
- Barcode: Barcode is readable with a standard barcode reader. Acceptance criteria: Test samples shall demonstrate readily readable barcodes. Conclusion: Zenith test samples met the acceptance criteria for barcode testing to demonstrate that the Zenith is substantially equivalent to the predicate device.
- Sterilization: ISO 11135 and AAMI TIR 28. Acceptance criteria: Sterilization load shall pose an equal or lesser challenge to sterilize than existing sterile product loads. Conclusion: Zenith sterilization load met the acceptance criteria to demonstrate that the Zenith is substantially equivalent to the predicate device.
- Shelf Life: ASTM F1980. Acceptance criteria: Aged test samples must meet or exceed existing specifications. Conclusion: Zenith test samples met the acceptance criteria for shelf life to demonstrate that the Zenith is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/5 description: The image shows the text "Carlos L. Pena -S" in a simple, sans-serif font. The text is left-aligned and appears to be part of a signature or nameplate. The letters are clear and legible, with a consistent font size and style. The background is plain and does not distract from the text.
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)
| 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 & Requlatory Affairs InNeuroCo, Inc 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: 1-305-495-3883 Facsimile: 1-954-742-5989 E-Mail: Marianne@InNeuroCo.com
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
Medtronic Navien | InNeuroCo, Inc.
Zenith | Reference
Device
InNeuroCo IC |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K110055 | K171672 | K152202 |
| Classification | 21CFR870.1250,
Class II | 21CFR870.1250,
Class II | 21CFR870.1250,
Class II |
| Product Code | DQY | | DQY |
| Review Panel | Cardiovascular | Cardiovascular | Cardiovascular |
| Indications For
Use | The Navien
Intracranial Support
Catheter is
indicated for the
introduction of
interventional
devices into the
peripheral and
neuro vasculature. | The Zenith is
indicated for the
introduction of
interventional devices
into the peripheral and
neuro vasculature. | The Intermediate
Catheter is
indicated for the
introduction of
interventional
devices into the
peripheral and
neuro vasculature. |
| Components
Supplied | Navien Catheter,
Introducer Sheath | Zenith Catheter, Peel
Away Introducers,
Hemostasis Valve,
Scout Introducer | Intermediate
Catheter, Peel
Away Introducer,
Hemostasis
Valve |
| Catheter Shaft
Material | Polymeric Catheter | Polymeric Catheter | Polymeric
Catheter |
| Inner Liner | PTFE | PTFE | PTFE |
| Catheter Shaft
Reinforcement | Nitinol | Stainless Steel | Stainless
Steel/Nitinol |
| Reinforcement
pattern | Coil | Cross Coil | Braid |
| | Predicate Device
Medtronic Navien | InNeuroCo, Inc.
Zenith | Reference
Device
InNeuroCo IC |
| Lubricious
Coating | Hydrophilic
Coating | Hydrophilic Coating | Hydrophilic
Coating |
| Radiopaque
Marker Band | Platinum/ Iridium | Platinum/ Iridium | Platinum/ Iridium |
| Packaging | PET/PE/Tyvek
Pouch, Hoop,
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 | 105,115, 125, 130 | 115, 125, 132 cm | 105, 115, 125 cm |
| Proximal
Internal
Diameter (ID) | Navien
058
0.058
inches | Zenith
0.065
0.065
inches | 0.062 inches
proximal |
| | Navien
072
0.072
inches | Zenith
0.074
0.074
inches | |
| Distal ID | Navien
058
0.058
inches | Zenith
0.065
0.065
inches | 0.060 inches
distal |
| | Navien
072
0.072
inches | Zenith
0.074
0.074
inches | |
| Proximal Outer
Diameter | Navien
058
0.070
inches | Zenith
0.065
0.081
inches | 0.079 inches |
| | Navien
072
0.084
inches | Zenith
0.074
0.086
inches | |
| Distal Outer
Diameter | Navien
058
0.070
inches | Zenith
0.065
0.079
inches | 0.072 |
| | Navien
072
0.084
inches | Zenith
0.074
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 |
| | Predicate Device
Medtronic Navien | InNeuroCo, Inc.
Zenith | Reference
Device
InNeuroCo IC |
| Hemostasis
Valve | N/A | Minimizes blood loss | Minimizes blood
loss |
| Luer Tapered
Hub | Yes
Yes | | Yes |
| Compatible
Guidewire | 0.038 | 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 | |
| Biocompatibility | Meets ISO 10993-
1:2009 | Meets ISO 10993-
1:2009 | Meets ISO
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 (in vivo
testing |
| Visual Inspection | Testing
completed per
ISO 10555-1 | Catheter shall
appear free from
damage, including a
rounded tip and
smooth transition
points. | Zenith test samples
met the acceptance
criteria for Visual
Inspection to
demonstrate that
the Zenith is
substantially
equivalent to the
predicate device. | Yes |
| Working Length | Testing
completed per
ISO 10555-1 | Test samples
should be within
existing working
length specification. | Zenith test samples
met the acceptance
criteria for Working
Length to
demonstrate that
the Zenith is
substantially
equivalent to the
predicate device. | Yes |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions | Predicate Device
Testing
(Yes/Unknown) |
| Hub compatibility | Testing
completed per
ISO 594-1 and
ISO 594-2 | Hub shall meet
existing Luer
specifications. | Zenith test samples
met the acceptance
criteria for Hub
compatibility to
demonstrate that
the Zenith is
substantially
equivalent to the
predicate device. | Yes |
| Outside diameter | Testing
completed per
ISO 10555-1 | Test samples
should be within
existing outside
diameter
specification. | Zenith test samples
met the acceptance
criteria for Outside
diameter to
demonstrate that
the Zenith is
substantially
equivalent to the
predicate device. | Yes |
| Leak – Air | Testing
completed per
ISO 10555-1 | Test samples
should be within
existing Air – Leak
specifications. | Zenith test samples
met the acceptance
criteria for Leak –
Air to demonstrate
that the Zenith is
substantially
equivalent to the
predicate device. | Yes |
| Leak – Liquid | Testing
completed per
ISO 10555-1 | Test samples
should be within
existing Leak –
Liquid
specifications. | Zenith test samples
met the acceptance
criteria for Leak –
Liquid to
demonstrate that
the Zenith is
substantially
equivalent to the
predicate device. | Yes |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions | Predicate Device
Testing
(Yes/Unknown) |
| | | | equivalent to the
predicate device. | |
| Particulates | Testing
completed per
USP 788 | Test samples
should be within
existing Particulate
specifications. | Zenith test samples
met the acceptance
criteria for
Particulates to
demonstrate that
the Zenith is
substantially
equivalent to the
predicate device. | Yes |
| Simulated Use -
Bench | Zenith
underwent
simulated use
testing by a
physician in a
benchtop model | Test samples must
meet predetermined
user needs | Zenith test samples
met the acceptance
criteria for
Simulated Use -
Bench to
demonstrate that
the Zenith is
substantially
equivalent to the
predicate device. | Yes |
| Catheter Burst | Testing
completed per
ISO 10555-1 | Test sample burst
pressures must
meet or exceed
existing minimum
burst pressure
specification. | Zenith test samples
met the acceptance
criteria for Catheter
Burst to
demonstrate that
the Zenith is
substantially
equivalent to the
predicate device. | Yes |
| Tensile | Testing
completed per
ISO 10555-1 | Test sample
ultimate tensile
strength must meet
or exceed existing | Zenith test samples
met the acceptance
criteria for Tensile
to demonstrate that | Yes |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions | Predicate Device
Testing
(Yes/Unknown) |
| | | tensile strength
specifications. | the Zenith is
substantially
equivalent to the
predicate device. | |
| Corrosion | Testing
completed per
ISO 10555-1 | Test samples shall
exhibit no evidence
of corrosion. | Test results for the
predicate device
were leveraged for
the Zenith as the
materials and
manufacturing
processes are
equivalent. | Yes |
| Packaging - Dye
Leak | Testing
completed per
ASTM F1929-12 | Test sample shall
not exhibit any
visual leaks or
channels | Zenith test samples
met the acceptance
criteria for
Packaging - Dye
Leak to
demonstrate that
the Zenith is
substantially
equivalent to the
predicate device. | Unknown |
| Packaging - Peel | Testing
completed per
ASTM F88-09 | Test sample tensile
strength must meet
or exceed existing
tensile strength
specifications. | Zenith test samples
met the acceptance
criteria for
Packaging - Peel to
demonstrate that
the Zenith is
substantially
equivalent to the
predicate device. | Unknown |
| Kink Resistance | Samples are
subjected to
different | Test sample kink
resistance must
meet or exceed
existing Kink | Zenith test samples
met the acceptance
criteria for Kink
Resistance to | Yes |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions | Predicate Device
Testing
(Yes/Unknown) |
| | diameters until
kink is observed. | Resistance
specifications. | demonstrate that
the Zenith is
substantially
equivalent to the
predicate device. | |
| Torque | Conditioned
samples are
torqued to failure | Test sample torque
results must meet
or exceed existing
torque
specifications. | Zenith test samples
met the acceptance
criteria for Torque to
demonstrate that
the Zenith is
substantially
equivalent to the
predicate device. | Yes |
| PTFE Liner
inspection | Zenith was
challenged to
demonstrate
liner adherence. | Test sample liner
adhesion must
meet or exceed
existing PTFE Liner
inspection
specifications. | Zenith test samples
met the acceptance
criteria for PTFE
Liner inspection to
demonstrate that
the Zenith is
substantially
equivalent to the
predicate device. | Unknown |
| 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. | Zenith test samples
met the acceptance
criteria for
Hydrophilic Coating
Integrity to
demonstrate that
the Zenith is
substantially
equivalent to the
predicate device. | Unknown |
| Labeling Legibility | Label is legible
after printing. | Test samples shall
demonstrate text
legibility. | Zenith test samples
met the acceptance
criteria for labeling
legibility to
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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