(135 days)
The Zenith is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
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.
The provided text describes the regulatory clearance (510(k)) of a medical device, the "Zenith" percutaneous catheter, and a summary of non-clinical data supporting its substantial equivalence to predicate devices. The document does not describe an AI/ML-enabled device or a study involving human readers or comparative effectiveness with AI. Therefore, several aspects of your request (e.g., sample sizes for test set/training set, number of experts, adjudication method, MRMC study, standalone performance, provenance of data) are not applicable to this document.
However, I can extract the acceptance criteria and study conclusions for the non-clinical performance and biocompatibility tests described.
Here's the information derived from the document, focusing on the available details:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| Biocompatibility - Material Mediated Pyrogen | The test article extracts must not cause a febrile reaction greater than 0.5°C in any individual subject. | Zenith test samples met the acceptance criteria for Material Mediated Pyrogen to demonstrate that the Zenith is substantially equivalent to the predicate device. |
| Biocompatibility - Cytotoxicity MEM Elution | The cultures treated with the test article must not have a reactivity grade greater than 2. | Zenith test samples met the acceptance criteria for Cytotoxicity MEM Elution to demonstrate that the Zenith is substantially equivalent to the predicate device. |
| Biocompatibility - Hemolysis ASTM Method, extract human blood | The hemolytic index above the negative control article must be less than 5%. | Zenith test samples met the acceptance criteria for Hemolysis ASTM Method, extract human blood to demonstrate that the Zenith is substantially equivalent to the predicate device. |
| Biocompatibility - Hemolysis, ASTM method, direct contact (human blood) | The hemolytic index above the negative control article must be less than 5%. | Zenith test samples met the acceptance criteria for Hemolysis, ASTM method, direct contact (human blood) to demonstrate that the Zenith is substantially equivalent to the predicate device. |
| Biocompatibility - Unactivated Partial Thromboplastin Time | There must be no statistical decrease between the UPTT of plasma exposed to the test article and to the negative or untreated control. | Zenith test samples met the acceptance criteria for Unactivated Partial Thromboplastin Time to demonstrate that the Zenith is substantially equivalent to the predicate device. |
| Biocompatibility - Complement Activation | There must be no statistical increase between either the C3a or SC5b-9 concentrations in plasma exposed to the test article as compared to the negative and untreated controls. | Zenith test samples met the acceptance criteria for Complement Activation to demonstrate that the Zenith is substantially equivalent to the predicate device. |
| Biocompatibility - Dog Thromboresistance | 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. |
| Biocompatibility - Maximization Sensitization | 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 demonstrate that the Zenith is substantially equivalent to the predicate device. |
| Biocompatibility - Intracutaneous Toxicity/Reactivity | The test article extracts must not induce a significantly greater biological reaction than the control. | Zenith test samples met the acceptance criteria for Intracutaneous Toxicity/Reactivity to demonstrate that the Zenith is substantially equivalent to the predicate device. |
| Biocompatibility - Acute Systemic Toxicity Test | The test article extracts must not induce a significantly greater biological reaction than the control. | Zenith test samples met the acceptance criteria for Acute Systemic Toxicity Test to demonstrate that the Zenith is substantially equivalent to the predicate device. |
| Animal Testing - Angiographic Evaluation | No units tested can cause vessel injury. | Zenith test samples met the acceptance criteria for Animal Testing- Angiographic Evaluation to demonstrate that the Zenith is substantially equivalent to the predicate device. |
| Chemical Compatibility | Chemicals have no negative effect on the catheter or accessories. | Zenith test samples met the acceptance criteria for Chemical Compatibility to demonstrate that the Zenith is substantially equivalent to the predicate device. |
| Radiographic Detectability | Product shall be visible under fluoro imaging. | Zenith test samples met the acceptance criteria for Radiographic Detectability to demonstrate that the Zenith is substantially equivalent to the predicate device. |
| Visual Inspection | 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. |
| Working Length | 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. |
| Hub compatibility | 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. |
| Outside diameter | 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. |
| Leak – Air | 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. |
| Leak – Liquid | 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. |
| Particulates | 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. |
| Simulated Use - Bench | 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. |
| Catheter Burst | 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. |
| Tensile | Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications. | Zenith test samples met the acceptance criteria for Tensile to demonstrate that the Zenith is substantially equivalent to the predicate device. |
| Corrosion | 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. (Implies Zenith is expected to meet this, based on predicate data.) |
| Packaging - Dye Leak | 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. |
| Packaging - Peel | 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. |
| Kink Resistance | Test sample kink resistance must meet or exceed existing Kink Resistance specifications. | Zenith test samples met the acceptance criteria for Kink Resistance to demonstrate that the Zenith is substantially equivalent to the predicate device. |
| Torque | 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. |
| PTFE Liner inspection | 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. |
| Hydrophilic Coating Integrity | 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. |
| Labeling Legibility | Test samples shall demonstrate text legibility. | Zenith test samples met the acceptance criteria for labeling legibility to demonstrate that the Zenith is substantially equivalent to the predicate device. |
| Barcode | 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. |
| Sterilization | 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. |
| Shelf Life | 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. |
Regarding the specific requested points that are relevant to this type of device clearance:
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for each non-clinical test performed (e.g., how many catheters were burst-tested, how many animals in the angiographic evaluation). It refers to "test samples" or "units tested."
- The data provenance is from non-clinical laboratory and animal studies (e.g., ISO standards, ASTM standards, porcine model). It is not human subject data, so concepts like "country of origin" or "retrospective/prospective" as they apply to clinical studies are not applicable.
- For biocompatibility tests, it mentions "extract human blood" for some hemolysis tests.
- For the Angiographic Evaluation, it explicitly states it was a "porcine model."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the studies described are non-clinical (laboratory and animal testing). The "ground truth" for these tests comes from adherence to established scientific and regulatory standards (e.g., ISO 10993, ASTM, USP) and predefined physical/chemical limits.
- For "Simulated Use - Bench," it mentions "by a physician," implying one or more physicians were involved in the benchtop evaluation, but their number and specific qualifications are not detailed beyond "physician."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable to non-clinical laboratory or animal studies. Ground truth is determined by test results against defined acceptance criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a percutaneous catheter, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm/AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For non-clinical tests, the "ground truth" is determined by meeting predefined technical specifications, industry standards (e.g., ISO, ASTM), and biological safety parameters. For example, a burst pressure test's ground truth is a numerical value compared to a specification. For biocompatibility, it's the absence of adverse biological reactions per standard protocols. For the animal study, it's the absence of "clinically significant injury."
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires training data.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.
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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 DeviceMedtronic Navien | InNeuroCo, Inc.Zenith | ReferenceDeviceInNeuroCo 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 ForUse | The NavienIntracranial SupportCatheter isindicated for theintroduction ofinterventionaldevices into theperipheral andneuro vasculature. | The Zenith isindicated for theintroduction ofinterventional devicesinto the peripheral andneuro vasculature. | The IntermediateCatheter isindicated for theintroduction ofinterventionaldevices into theperipheral andneuro vasculature. |
| ComponentsSupplied | Navien Catheter,Introducer Sheath | Zenith Catheter, PeelAway Introducers,Hemostasis Valve,Scout Introducer | IntermediateCatheter, PeelAway Introducer,HemostasisValve |
| Catheter ShaftMaterial | Polymeric Catheter | Polymeric Catheter | PolymericCatheter |
| Inner Liner | PTFE | PTFE | PTFE |
| Catheter ShaftReinforcement | Nitinol | Stainless Steel | StainlessSteel/Nitinol |
| Reinforcementpattern | Coil | Cross Coil | Braid |
| Predicate DeviceMedtronic Navien | InNeuroCo, Inc.Zenith | ReferenceDeviceInNeuroCo IC | |
| LubriciousCoating | HydrophilicCoating | Hydrophilic Coating | HydrophilicCoating |
| RadiopaqueMarker Band | Platinum/ Iridium | Platinum/ Iridium | Platinum/ Iridium |
| Packaging | PET/PE/TyvekPouch, Hoop,packaging card,SBS carton | Tyvek/Nylon Pouch,polyethylene supporttube, packaging card,SBS carton | Tyvek/NylonPouch,polyethylenesupport tube,packaging card,SBS carton |
| WorkingLengths | 105,115, 125, 130 | 115, 125, 132 cm | 105, 115, 125 cm |
| ProximalInternalDiameter (ID) | Navien0580.058inches | Zenith0.0650.065inches | 0.062 inchesproximal |
| Navien0720.072inches | Zenith0.0740.074inches | ||
| Distal ID | Navien0580.058inches | Zenith0.0650.065inches | 0.060 inchesdistal |
| Navien0720.072inches | Zenith0.0740.074inches | ||
| Proximal OuterDiameter | Navien0580.070inches | Zenith0.0650.081inches | 0.079 inches |
| Navien0720.084inches | Zenith0.0740.086inches | ||
| Distal OuterDiameter | Navien0580.070inches | Zenith0.0650.079inches | 0.072 |
| Navien0720.084inches | Zenith0.0740.086inches | ||
| Peel AwayIntroducer | Aid in catheter tipintroduction intohemostasis valve | Aid in catheter tipintroduction intohemostasis valve | Aid in catheter tipintroduction intohemostasis valve |
| Predicate DeviceMedtronic Navien | InNeuroCo, Inc.Zenith | ReferenceDeviceInNeuroCo IC | |
| HemostasisValve | N/A | Minimizes blood loss | Minimizes bloodloss |
| Luer TaperedHub | YesYes | Yes | |
| CompatibleGuidewire | 0.038 | 0.038 inches | 0.038 inches |
| ScoutIntroducer | YesNo | No | |
| Sterilization | EO SAL 10-6EO SAL 10-6 | EO SAL 10-6 | |
| Pyrogenicity | Nonpyrogenic | Nonpyrogenic | |
| Biocompatibility | Meets ISO 10993-1:2009 | Meets ISO 10993-1:2009 | Meets ISO10993-1:2009 |
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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 MethodSummary | Acceptance Criteria | Conclusions | Predicate DeviceTesting(Yes/Unknown) |
|---|---|---|---|---|
| Biocompatibility-Material MediatedPyrogen | Testingcompleted perISO 10993-11 | The test articleextracts must notcause a febrilereaction greater | Zenith test samplesmet the acceptancecriteria for MaterialMediated Pyrogen | Yes |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions | Predicate DeviceTesting(Yes/Unknown) |
| than 0.5°C in anyindividual subject. | to demonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | |||
| Biocompatibility-Cytotoxicity MEMElution | Testingcompleted perISO 10993-5 | The cultures treatedwith the test articlemust not have areactivity gradegreater than 2. | Zenith test samplesmet the acceptancecriteria forCytotoxicity MEMElution todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Yes |
| Biocompatibility-Hemolysis ASTMMethod, extracthuman blood | Testingcompleted perISO 10993-4 | The hemolytic indexabove the negativecontrol article mustbe less than 5%. | Zenith test samplesmet the acceptancecriteria forHemolysis ASTMMethod, extracthuman blood todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Yes |
| Biocompatibility-Hemolysis, ASTMmethod, directcontact (humanblood) | Testingcompleted perISO 10993-4 | The hemolytic indexabove the negativecontrol article mustbe less than 5%. | Zenith test samplesmet the acceptancecriteria forHemolysis, ASTMmethod, directcontact (humanblood) todemonstrate thatthe Zenith issubstantially | 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 MethodSummary | Acceptance Criteria | Conclusions | Predicate DeviceTesting(Yes/Unknown) |
| Biocompatibility-IntracutaneousToxicity/Reactivity | Testingcompleted perISO 10993-10 | The test articleextracts must notinduce asignificantly greaterbiological reactionthan the control. | Zenith test samplesmet the acceptancecriteria forIntracutaneousToxicity/Reactivityto demonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Yes |
| Biocompatibility-Acute SystemicToxicity Test | Testingcompleted perISO 10993-11 | The test articleextracts must notinduce asignificantly greaterbiological reactionthan the control. | Zenith test samplesmet the acceptancecriteria for AcuteSystemic ToxicityTest to demonstratethat the Zenith issubstantiallyequivalent to thepredicate device. | Yes |
| Animal Testing-AngiographicEvaluation | Productevaluated withina porcine modelfor clinicallysignificant injury. | No units tested cancause vessel injury. | Zenith test samplesmet the acceptancecriteria for AnimalTesting-AngiographicEvaluation todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Yes |
| ChemicalCompatibility | Catheterexposed to | Chemicals have nonegative effect on | Zenith test samplesmet the acceptance | Unknown |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions | Predicate DeviceTesting(Yes/Unknown) |
| chemicalsreadily availablein a clinicalsetting. | the catheter oraccessories. | criteria for ChemicalCompatibility todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | ||
| RadiographicDetectability | Testingcompleted perISO 10555-1 | Product shall bevisible under fluoroimaging. | Zenith test samplesmet the acceptancecriteria forRadiographicDetectability todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Yes – part of in vivotesting |
| Visual Inspection | Testingcompleted perISO 10555-1 | Catheter shallappear free fromdamage, including arounded tip andsmooth transitionpoints. | Zenith test samplesmet the acceptancecriteria for VisualInspection todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Yes |
| Working Length | Testingcompleted perISO 10555-1 | Test samplesshould be withinexisting workinglength specification. | Zenith test samplesmet the acceptancecriteria for WorkingLength todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Yes |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions | Predicate DeviceTesting(Yes/Unknown) |
| Hub compatibility | Testingcompleted perISO 594-1 andISO 594-2 | Hub shall meetexisting Luerspecifications. | Zenith test samplesmet the acceptancecriteria for Hubcompatibility todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Yes |
| Outside diameter | Testingcompleted perISO 10555-1 | Test samplesshould be withinexisting outsidediameterspecification. | Zenith test samplesmet the acceptancecriteria for Outsidediameter todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Yes |
| Leak – Air | Testingcompleted perISO 10555-1 | Test samplesshould be withinexisting Air – Leakspecifications. | Zenith test samplesmet the acceptancecriteria for Leak –Air to demonstratethat the Zenith issubstantiallyequivalent to thepredicate device. | Yes |
| Leak – Liquid | Testingcompleted perISO 10555-1 | Test samplesshould be withinexisting Leak –Liquidspecifications. | Zenith test samplesmet the acceptancecriteria for Leak –Liquid todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Yes |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions | Predicate DeviceTesting(Yes/Unknown) |
| equivalent to thepredicate device. | ||||
| Particulates | Testingcompleted perUSP 788 | Test samplesshould be withinexisting Particulatespecifications. | Zenith test samplesmet the acceptancecriteria forParticulates todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Yes |
| Simulated Use -Bench | Zenithunderwentsimulated usetesting by aphysician in abenchtop model | Test samples mustmeet predetermineduser needs | Zenith test samplesmet the acceptancecriteria forSimulated Use -Bench todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Yes |
| Catheter Burst | Testingcompleted perISO 10555-1 | Test sample burstpressures mustmeet or exceedexisting minimumburst pressurespecification. | Zenith test samplesmet the acceptancecriteria for CatheterBurst todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Yes |
| Tensile | Testingcompleted perISO 10555-1 | Test sampleultimate tensilestrength must meetor exceed existing | Zenith test samplesmet the acceptancecriteria for Tensileto demonstrate that | Yes |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions | Predicate DeviceTesting(Yes/Unknown) |
| tensile strengthspecifications. | the Zenith issubstantiallyequivalent to thepredicate device. | |||
| Corrosion | Testingcompleted perISO 10555-1 | Test samples shallexhibit no evidenceof corrosion. | Test results for thepredicate devicewere leveraged forthe Zenith as thematerials andmanufacturingprocesses areequivalent. | Yes |
| Packaging - DyeLeak | Testingcompleted perASTM F1929-12 | Test sample shallnot exhibit anyvisual leaks orchannels | Zenith test samplesmet the acceptancecriteria forPackaging - DyeLeak todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Unknown |
| Packaging - Peel | Testingcompleted perASTM F88-09 | Test sample tensilestrength must meetor exceed existingtensile strengthspecifications. | Zenith test samplesmet the acceptancecriteria forPackaging - Peel todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Unknown |
| Kink Resistance | Samples aresubjected todifferent | Test sample kinkresistance mustmeet or exceedexisting Kink | Zenith test samplesmet the acceptancecriteria for KinkResistance to | Yes |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions | Predicate DeviceTesting(Yes/Unknown) |
| diameters untilkink is observed. | Resistancespecifications. | demonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | ||
| Torque | Conditionedsamples aretorqued to failure | Test sample torqueresults must meetor exceed existingtorquespecifications. | Zenith test samplesmet the acceptancecriteria for Torque todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Yes |
| PTFE Linerinspection | Zenith waschallenged todemonstrateliner adherence. | Test sample lineradhesion mustmeet or exceedexisting PTFE Linerinspectionspecifications. | Zenith test samplesmet the acceptancecriteria for PTFELiner inspection todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Unknown |
| HydrophilicCoating Integrity | Conditionedsamples wererepeatedlyexposed tofriction todemonstrate thatthe hydrophiliccoating is notaffected. | Test sample resultsmust meet orexceed existingHydrophilic CoatingIntegrityspecifications. | Zenith test samplesmet the acceptancecriteria forHydrophilic CoatingIntegrity todemonstrate thatthe Zenith issubstantiallyequivalent to thepredicate device. | Unknown |
| Labeling Legibility | Label is legibleafter printing. | Test samples shalldemonstrate textlegibility. | Zenith test samplesmet the acceptancecriteria for labelinglegibility todemonstrate 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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§ 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).