The pNOVUS 21 Microcatheter is indicated for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures. It is not intended for use in peripheral or coronary vasculature.

Device Description

The pNOVUS 21 Microcatheter (pNOVUS 21) is a single use microcatheter, supplied sterile using ethylene oxide (EtO), in a packing hoop, within a sealed pouch and shelf carton configuration. An introducer sheath and shaping mandrel are supplied on a backing card inside the pouch. The packaging is designed to facilitate ease of handling and aseptic presentation of the device.

The pNOVUS 21 Microcatheter is a variable stiffness single lumen catheter. The pNOVUS 21 has a radiopaque marker on the distal end to facilitate fluoroscopic visualization, and a luer hub on the proximal end to facilitate the infusion of diagnostic agents and the smooth transfer of other devices (e.g., guidewires) into the inner lumen of the microcatheter. The distal end of the microcatheter's external surface has a hydrophilic coating applied for increased lubricity during use. The pNOVUS 21 has a straight tip. Steam shaping of the distal tip allows for one-time customizing of the tip shape. There are two models of the pNOVUS 21 Microcatheter, the device model # are:

PNOV-21-160
PNOV-21-150

The pNOVUS 21 Microcatheter is intended for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures. pNOVUS 21 is generally inserted either through a sheath or guide-catheter.

AI/ML Overview

The provided text is a 510(k) summary for the pNOVUS 21 Microcatheter. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing and biocompatibility), rather than a study involving an AI/software component with specific acceptance criteria related to accuracy, sensitivity, or human-in-the-loop performance.

Therefore, many of the requested elements for describing the acceptance criteria and study that prove an AI/software device meets acceptance criteria are not present in this document. This document describes a traditional medical device (microcatheter), not an AI-powered diagnostic or therapeutic software.

However, I can extract the general "acceptance criteria" and "reported device performance" in the context of this traditional device clearance, which are primarily based on meeting defined specifications and demonstrating comparable performance to a predicate device through bench testing.

Here's an attempt to answer the prompt based on the provided text, acknowledging the limitations due to the nature of the device:

This document describes the 510(k) clearance for the pNOVUS 21 Microcatheter, which is a physical medical device, not an AI software. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating the device's physical and functional performance and biocompatibility through non-clinical testing, rather than metrics like sensitivity, specificity, mAP, FROC, or human reader improvement with AI assistance.

The overarching acceptance criterion for substantial equivalence for this device is that it performs as intended and is as safe and effective as a legally marketed predicate device. This is demonstrated through a comprehensive suite of bench tests and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes numerous bench tests conducted to ensure the pNOVUS 21 Microcatheter performs as intended and is substantially equivalent to its predicate. The "acceptance criteria" for each test are typically that "All samples met the acceptance criteria," "performance is comparable to the predicate," or "conforming to specifications." The "reported device performance" is essentially that these criteria were met.

Test	Acceptance Criteria (General Interpretation)	Reported Device Performance
Biocompatibility	Device extracts and materials should not cause cytotoxic effects, sensitization, irritation, systemic toxicity, or undesirable hemocompatibility reactions. The device should be non-pyrogenic and thromboresistant, with comparable thrombogenic effect to the predicate.	Cytotoxicity: No cytotoxic effect. Sensitization: No sensitization indicated. Skin irritation: No sensitization indicated. Systemic toxicity: No acute systemic toxicity indicated; deemed non-pyrogenic. Hemocompatibility: No hemolysis indicated (indirect extract & direct contact), no complement activation indicated; deemed thromboresistant; similar thrombogenic effect as predicate for PTT, Platelet, and Leukocyte Counts.
Sterilization	Device must be sterile, validated per ISO 11135:2014 & A1:2019, and AAMI TIR28:2016 for Ethylene Oxide sterilization.	Adopted into an existing validated cycle per I.E. EN ISO 11135:2014 & A1:2019 and AAMI TIR28:2016. Validated via the half-cycle method.
Shelf Life	Device must maintain design and performance specifications after specified aging (1 year accelerated aging).	Testing performed on devices subjected to 1 year accelerated aging confirmed all design and performance specification requirements were met.
Catheter Static Burst Pressure Test	The hub or any other part of the catheter shall not leak when pressurized to failure below a specified minimum pressure, meeting ISO 10555-1 Annex F.	All samples met the acceptance criteria; in line with the predicate device, supporting substantial equivalence.
Hydrophilic Coating Lubricity	Friction force on the coated section of the catheter shall be below a specified maximum friction value.	All samples met the acceptance criteria; comparable to similar marketed devices.
Particulate Matter	Amount (size and number) of particulates generated during simulated use must be similar to or less than the predicate device or similar marketed device.	All samples met the acceptance criteria of similar or less particulates than the predicate device or similar marketed device.
Torque Strength	Catheter must exceed a specified minimum number of rotations without failure.	All samples met the acceptance criteria.
Flow Rate at Maximum Rated Infusion Pressure	Flow rate must meet specified criteria for saline and 50/50 saline/contrast media.	All samples met the acceptance criteria; mean flow rate values for pNOVUS 21 are comparable to similar marketed devices and the predicate.
Radio-Detectability	Catheter must be visualized under fluoroscopy, showing equivalence in radiopacity to the predicate.	All samples passed the acceptance criteria; pNOVUS 21 and predicate device were imaged showing equivalence in terms of radiopacity.
Maneuverability / Trackability	Device must be able to reach target site in a neurovascular model.	All samples met the acceptance criteria, confirming the device meets requirements.
Pushability	Device must deliver to target site without kinking or damage.	All samples met the acceptance criteria, confirming the device meets requirements.
Kink Resistance	Device must bend to clinically relevant radii without kinking.	All samples met the acceptance criteria, confirming the device meets requirements.
Lumen Patency	Lumen must remain undamaged after simulated use.	All samples met the acceptance criteria, confirming the device meets requirements.
Tip Profile	Distal tip must be free of defects.	All samples met the acceptance criteria, confirming the device meets requirements.
Dimensional (ID, OD, Effective Length, Tip Length)	Dimensions must meet specifications.	All samples met the acceptance criteria, confirming the device meets specifications.
Tip Shapeability	Distal tip must be shapeable using the supplied mandrel.	All samples met the acceptance criteria, confirming the device meets requirements.
Flexural Fatigue	Device must show no damage after insertions and withdrawals in a simulated use neurovascular model.	All samples met the acceptance criteria, confirming the device meets requirements.
Hydrophilic Coating Length	Length of coated area must meet specifications.	All samples met the acceptance criteria, confirming the device meets specifications.
Hydrophilic Coating Integrity	Coated length must show no damage post simulated use and flexural fatigue testing compared to baseline.	All samples met the acceptance criteria, confirming the device meets requirements.
Tensile Strength	Device must withstand tensile force after pre-conditioning through a tortuous path model.	All samples met the acceptance criteria, confirming the device meets requirements.
Chemical Compatibility	ID and OD must show no damage after exposure to media.	All samples met the acceptance criteria, confirming the device meets requirements.
Interventional Device Compatibility	Device must show no damage post simulated use with compatible interventional devices.	All samples met the acceptance criteria, confirming the device meets requirements.
2nd Microcatheter Compatibility	Compatibility with a second microcatheter in a guide catheter under simulated use.	All samples met the acceptance criteria, confirming the device meets requirements.
Visual Inspection	Surface must be free of extraneous matter and defects under magnification.	All samples met the acceptance criteria, confirming the device meets requirements.
Air Leakage During Aspiration	Device must not leak air during aspiration.	All samples met the acceptance criteria, confirming the device meets requirements.
Pressure Fatigue	Device must withstand pressurization to max infusion pressure after 5 power injection cycles.	All samples met the acceptance criteria, confirming the device meets requirements.
Maximum Infusion Pressure	Device must withstand pressurization to max infusion pressure.	All samples met the acceptance criteria, confirming the device meets requirements.
Ancillary Device Compatibility	Compatibility with recommended ancillary devices must be verified.	All samples met the acceptance criteria, confirming the device performs as intended with compatible ancillary devices.
Hub/Luer Fitting	Hub must conform to ISO 80369-7.	All samples met the acceptance criteria.
Packaging Configuration	Packaging must conform to specifications during simulated use.	All samples met the acceptance criteria.
Dispenser Hoop	Presence of female luer and retention clip on each hoop must be verified.	All samples met the acceptance criteria.
Hub/Luer Markings	All required identifiers must be present on the hub.	All samples met the acceptance criteria.
Directions for Use (DFU)	Presence of DFU with each device during simulated use.	All samples met the acceptance criteria.
Usability	Usability assessed per FDA guidance and EN 62366.	All samples met the acceptance criteria, confirming the device meets requirements.
Corrosion Resistance	No signs of corrosion post exposure to required conditions.	All samples met the acceptance criteria, confirming the device meets requirements.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for each specific non-clinical bench test. It consistently reports "All samples met the acceptance criteria," indicating that a sufficient number of devices were tested to provide statistical confidence for the relevant acceptance criteria and demonstrate performance.

Data Provenance: The tests were conducted internally by phenox Ltd or by their designated testing partners (e.g., sterilization in Trier, Germany by Rose GmbH). The data is prospective in the sense that it was generated specifically for this regulatory submission through controlled bench testing and laboratory studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable as this submission is for a physical medical device (microcatheter) and does not involve AI software requiring expert-established ground truth for image interpretation or similar diagnostic tasks. The "ground truth" for these tests are objective, measurable physical properties and performance characteristics (e.g., leak/no leak, pass/fail for specific forces, material properties).

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described because the testing involves objective measurements against predefined specifications, not subjective interpretations requiring consensus from adjudicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Reader Improvement

No MRMC study was done. This is a physical medical device, not an AI software intended to assist human readers. Therefore, there is no discussion of human reader improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective physical and functional measurements and performance specifications, as defined by relevant ISO standards, ASTM standards, and FDA guidance documents. Examples include:

Absence of cytotoxic effect, sensitization, irritation, systemic toxicity.
Measured burst pressure, friction force, particulate count, torque strength, flow rate.
Visual inspection for defects, kinks, or damage.
Confirmation of specific dimensions (ID, OD, length).
Compliance with standard requirements for luer fittings, packaging, etc.

These are not "expert consensus" or "pathology" in the sense of a diagnostic interpretation, nor are they "outcomes data" from clinical trials, as clinical trials were not deemed necessary.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI model, there is no training set or ground truth in that context.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 12, 2024

phenox Ltd Rachel McDaid Senior Regulatory Affairs Specialist Kamrick Court Ballybrit Business Park Galway H91 XY38 Ireland

Re: K242420

Trade/Device Name: pNOVUS 21 Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO, QJP Dated: August 15, 2024 Received: August 15, 2024

Dear Rachel McDaid:

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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Naira Muradyan -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K242420

Device Name pNOVUS 21 Microcatheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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K242420 510(k) Summary (21 CFR 807.92)

I. SUBMITTER

phenox Ltd, Kamrick Court, Ballybrit Business Park, Galway, Ireland H91 XY38

Contact Person: Rachel McDaid Phone: +353 (0)91 740128 Date Prepared: October 29, 2024

II. DEVICE

Device Tradename: pNOVUS 21 Microcatheter Common or Usual Name: Diagnostic intravascular catheter Classification: Class II device according to 21 CFR 870.1200 (diagnostic intravascular catheter), 21 CFR 870.1250 (catheter, percutaneous, neurovasculature) Product Code and Review Panel:

Product Code
Product Code	DQO	QJP
Primary/SecondaryCode	Primary	Secondary
Review Panel	Cardiovascular	Neurology

III. PREDICATE DEVICE

Name of Predicate Device: pNOVUS 21 Microcatheter Name of Predicate Device Manufacturer: phenox Ltd 510(k) number of Predicate Device: K221279

IV. DEVICE DESCRIPTION Device Description:

PNOV-21-160
PNOV-21-150

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Environment of Use:

The pNOVUS 21 is solely intended for use by trained physicians in a healthcare facility/hospital.

V. INDICATIONS FOR USE

Table 1: Comparison of Indications for Use of the pNOVUS 21 Microcatheter and predicate device pNOVUS 21 Microcatheter

Parameter	Predicate Device K221279	Subject Device K242420
Indications for Use	The pNOVUS 21 Microcatheter is indicated for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures. It is not intended for use in peripheral or coronary vasculature.	The pNOVUS 21 Microcatheter is indicated for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures. It is not intended for use in peripheral or coronary vasculature.
Parameter	Predicate DeviceK221279	Subject DeviceK242420	Justification ofSubstantialEquivalence
Device Name	pNOVUS 21	pNOVUS 21	N/A
	Microcatheter	Microcatheter
Model #	PNOV-21-160	PNOV-21-160PNOV-21-150	N/A
510(k) Number	K221279	K242420	N/A
Product Classification	21 CFR 870.1200,21 CFR 870.1250Class II	21 CFR 870.1200,21 CFR 870.1250Class II	Same as predicate
Product Codes	DQQ, QJP	DQQ, QJP	Same as predicate
Device Design/Materials	Stainless steel braidedshaft, polymericexterior	Stainless steelbraided shaft,Nitinol coil,polymeric exterior	Similar to predicate.The subject devicealso includes anitinol coil. This is acommonly usedcomponent inmedical devices.
Marker BandMaterial/Radiopacity	RadiopaquePlatinum/Iridium	RadiopaquePlatinum/Iridium	Same as predicate
Adhesives Used	Acrylated Urethaneand Cyanoacrylate	Acrylated Urethaneand Cyanoacrylate	Same as predicate
Hub Material	Polyamide	Polyamide	Same as predicate
Coating	Distal: HydrophiliccoatingProximal: N/ALength: 550 mm	Distal: HydrophiliccoatingProximal: N/ALength: 1000 mm	Similar to thepredicate. Thedifference incoating lengthsdoes not raise newquestions of safetyand effectiveness.
Mode of Action	Physical	Physical	Same aspredicate
Principle of Operation	The device isadvanced into thevasculature over anappropriately sizedguidewire. Once themicrocatheter isinserted, it can beadvanced throughthe vasculature tothe desiredlocation.	The device isadvanced into thevasculature over anappropriately sizedguidewire. Oncethe microcatheteris inserted, it can beadvanced throughthe vasculature tothe desiredlocation.	Same as predicate
Effective Length	160 cm	150cm160cm	Similar to thepredicate.Shorter lengthvariant is alsooffered for thesubjectdevice.
Outer Diameter:			Similar to the
Proximal	2.7F	2.7F	predicate.
Distal	2.4F	2.5F	Same aspredicate
Inner Diameter	0.021"	0.021"	Same aspredicate
Use	Single Use Device	Single Use Device	Same aspredicate
Sterilization	Ethylene Oxide	Ethylene Oxide	Same aspredicate
Biocompatible	Yes	Yes	Same aspredicate
Shelf Life	1 year	1 year	Same aspredicate
Accessory Devices	Introducer Sheath,Shaping Mandrel	Introducer Sheath, ShapingMandrel	Same aspredicate
Intended UseEnvironment	Healthcarefacility/hospital.Procedures requiringpercutaneous catheterintroduction should notbe attempted byphysicians unfamiliarwith the possiblecomplications.Rx only - devicerestricted to sale byor on order of aphysician.	Healthcare facility/hospital.Procedures requiringpercutaneous catheterintroduction should not beattempted by physiciansunfamiliar with the possiblecomplications.Rx only - device restricted tosale by or on order of aphysician.	Same aspredicate
PackagingComponents/Configuration	Device is stored within aHDPE Packaging Hoopwith Tubing Clips, sealedwithin a Tyvek Pouch,which is then packagedin a product carton.	Device is stored within aHDPE Packaging Hoop withTubing Clips, sealed within aTyvek Pouch, which is thenpackaged in a product carton.	Same aspredicate

The Indications for Use statement of the subject device is the same as that of the predicate device.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Table 2: Comparison of technological characteristics of the pNOVUS 21 Microcatheter and predicate device pNOVUS 21 Microcatheter

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VII. PERFORMANCE DATA

Biocompatibility

Biocompatibility testing for the subject pNOVUS 21 Microcatheter was conducted based on International Organization for Standardization (ISO) 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process," and the US FDA guidance document "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process"" (2020). The Introducer Sheath (P1066) and Shaping Mandrel (P1142) accessories remain unchanged since prior clearance under K221279.

Table 3 below summarizes biocompatibility testing performed on the pNOVUS 21 Microcatheter.

Test	Test Description	Conclusion
pNOVUS 21 Test Results
CytotoxicityISO 10993-5	MTT-L929 fibroblast cells	No cytotoxic effect.
SensitizationISO 10993-10	Magnusson-Kligman Maximization	No sensitization indicated.
Skin irritationISO 10993-10ISO 10993-23	Intracutaneous Reactivity (ISO)	No sensitization indicated.
Systemic toxicityISO 10993-11	Systemic Injection (ISO)Material Mediated Pyrogenicity test	No acute systemic toxicity indicated.pNOVUS 21 is deemed non-pyrogenic.
HemocompatibilityISO 10993-4	Hemolysis (ASTM method) indirect extractHemolysis (ASTM method) direct contactComplement activationIn Vitro Thrombogenicity Blood Loop AssayPartial Thromboplastin Time (PTT)Platelet and Leukocyte Count	No hemolysis indicated.No hemolysis indicated.No complement activation indicated.pNOVUS 21 is deemed thromboresistant.Similar thrombogenic effect as the predicate device.Similar thrombogenic effect as the predicate device

Table 3: Biocompatibility Testing Results for pNOVUS 21 Microcatheter

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Sterilization

The pNOVUS 21 Microcatheter is sterilized by Ethylene Oxide gas. Sterilization takes place in Trier, Germany by Rose GmbH.

The pNOVUS 21 has been adopted into an existing validated cycle per I.E. EN ISO 11135:2014 & A1:2019 and AAMI TIR28:2016.

Standards utilized in regards to sterilization:

ISO 11135:2014 & A1:2019 "Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices"

FDA guidance documents utilized in regards to sterilization: "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labelled as Sterile" (2016)

The sterilization cycle has been validated via the half cycle method.

Shelf Life

Shelf life conditioning has been completed and testing has been performed on devices subjected to the accelerated aging (AA) process to represent 1 year of aged units. Devices subjected to 1 year AA were tested to ensure design and performance specification requirements were met after the one year shelf life that pNOVUS 21 Microcatheter will have at commercialization.

FDA Guidance Documents utilized in regards to shelf life:

"Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019)

"Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters - Class II Special Controls Guidance for Industry and FDA" (2010)

Non-Clinical Performance Data

The following non-clinical performance tests were performed to support the substantial equivalence determination. These are summarized below.

PERFORMANCE TESTING - BENCH

A full suite of performance testing on the bench was carried out on pNOVUS 21. The results of this testing demonstrated compliance to all the design attributes and that the device performs as intended. The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, demonstrate substantial equivalence to the cited predicate device. Table 4 below summarizes the tests and results.

Test	Test Method Summary	Results
Catheter Static BurstPressure Test UnderStatic Conditions	The catheter was tested for static burstpressure under static conditions as perISO 10555-1 Annex F, until failure (untilburst or leak). The catheter must exceeda specified minimum pressure.	All samples met the acceptance criteria thatthe hub or any other part of the cathetershall not leak when pressurized to failurebelow a minimum specified pressure. This isin line with the predicate device, thus,supporting substantial equivalence.
Hydrophilic CoatingLubricity	The catheter hydrophilic coatinglubricity is tested by applying a pinchforce to the coated section of thecatheter. The friction force shall bebelow the specified maximumfriction value for that segment.	All samples met the acceptance criteria. ThepNOVUS 21 was found to be comparable tosimilar marketed devices.
Particulate Matter	The catheter particulate matter wastested by calculating the size andnumber of particulates generatedduring simulated use of the device in aneurovascular model.	Particulate testing was performed on thepNOVUS 21, predicate, and similarmarketed devices. pNOVUS 21 met theacceptance criteria of similar or lessparticulates than the predicate device orsimilar marketed device.
Torque Strength	The catheter was evaluated for torquestrength by rotating the specimenuntil failure, the catheter must exceeda specified minimum number ofrotations.	All samples met the acceptance criteria. Boththe subject device and the predicate weretested to same acceptance criteria.
Flow Rate at MaximumRated Infusion Pressure	The flow rate at the maximum ratedinfusion pressure was measuredusing the following injectate media:saline, 50/50 mix of saline andcontrast medium.	All samples met the acceptance criteria. Themean flow rate values for the pNOVUS 21similar marketed devicesandarecomparable for the injectate media tested.
Radio-Detectability	The catheter is visualized underfluoroscopy.	All samples passed the acceptance criteria.pNOVUS 21 and the predicate device wereimaged showing equivalence in terms ofradiopacity.
Maneuverability /Trackability	The device is tested for its ability toreach target site in a neurovascularmodel.	All samples met the acceptance criteria,confirming the device meets requirementsto ensure it performs as intended.
Pushability	A force is applied to the shaft of thecatheter in order to deliver it to thetarget site without kinking or damageto the catheter.	All samples met the acceptance criteria,confirming the device meets requirements toensure it performs as intended.
Kink Resistance	The catheter is tested at differentlocations for its ability to bend toclinically relevant radii without kinking.	All samples met the acceptance criteria,confirming the device meets requirements toensure it performs as intended.
Lumen Patency	The device is subjected to simulateduse in a neurovascular model and thelumen inspected for damage.	All samples met the acceptance criteria,confirming the device meets requirements toensure it performs as intended.
Tip Profile	The distal tip of the device is inspectedfor defects.	All samples met the acceptance criteria,confirming the device meets requirements toensure it performs as intended.
Dimensional (InnerDiameter (ID), OuterDiameter (OD), EffectiveLength, Tip Length)	The dimensions of the catheter and thecatheter tip are measured.	All samples met the acceptance criteria,confirming the device meets specifications toensure it performs as intended.
Tip Shapeability	The distal tip of the catheter is shapedusing the shaping mandrel suppliedwith pNOVUS 21.	All samples met the acceptance criteria,confirming the device meets requirementsto ensure it performs as intended.

Flexural Fatigue	The catheter is inspected for damage following insertions and withdrawals in a simulated use neurovascular model.	All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Hydrophilic CoatingLength	The length of the coated area of the catheter is measured.	All samples met the acceptance criteria, confirming the device meets specifications to ensure it performs as intended.
Hydrophilic CoatingIntegrity	The coated length of the device is inspected for damage post simulated use and flexural fatigue testing. Results are compared to a baseline taken prior to testing.	All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Tensile Strength	The catheter is tested to failure under tensile force following pre- conditioning by tracking through a tortuous path model.	All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Chemical Compatibility	The ID and OD of the catheter are inspected for damage following exposure to media.	All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
InterventionalDeviceCompatibility	The catheter is inspected for damage post simulated use testing with compatible interventional devices in a neurovascular model.	All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
2nd Microcatheter	A second microcatheter with a specified OD in parallel with the pNOVUS 21 is tested under simulated use conditions in a guide catheter with a specified ID.	All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Visual Inspection	The catheter surface, including hydrophilic coated segment, is inspected for extraneous matter and surface defects under magnification.	All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Air Leakage DuringAspiration	The catheter is tested for air leakage during aspiration using a syringe attached to the hub.	All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Pressure Fatigue	The catheter is pressurized to the maximum rate infusion pressure following 5 power injection cycles at the maximum rated infusion pressure.	All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Maximum InfusionPressure	The catheter is pressurized to the maximum infusion pressure.	All samples met acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Ancillary DeviceCompatibility	Simulated use testing is performed to verify compatibility with the compatible device recommendations included in the device labelling.	All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Hub/Luer Fitting	The catheter hub is tested per ISO80369-7.	All samples met the acceptance criteria,confirming the device meets requirementsto ensure it performs as intended.
Packaging Configuration	During simulated use testing, theconfiguration of the packaging isverified as per specification.	All samples met the acceptance criteria,confirming the device meets specificationsto ensure it performs as intended.
Dispenser Hoop	During simulated use testing, thepresence of a female luer andretention clip on each of thedispenser hoops is verified.	All samples met the acceptance criteria,confirming the device meets requirementsto ensure it performs as intended.
Hub/Luer Markings	The hub of the catheter is inspected toensure all required identifiers arepresent.	All samples met the acceptance criteria,confirming the device meets requirementsto ensure it performs as intended.
Directions for Use (DFU)	During simulated use testing, thepresence of a DFU with each device isverified.	All samples met the acceptance criteria,confirming the device meets requirementsto ensure it performs as intended.
Usability	The usability of the pNOVUS 21 wasassessed per FDA guidance "ApplyingHuman Factors and UsabilityEngineering to Medical Devices" andEN 62366 "Medical Devices - Part 1:Application for Usability Engineering toMedical Devices."	All samples met the acceptance criteria,confirming the device meets requirementsto ensure it performs as intended.
Corrosion Resistance	The pNOVUS 21 is visually inspected forsigns of corrosion post exposure torequired conditions.	All samples met the acceptance criteria,confirming the device meets requirementsto ensure it performs as intended.

Table 4: Summary of Non-Clinical Bench Testing

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Standards utilized in regards to bench testing:

ISO 10555-1:2013/A1:2017 "Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements"

ISO 80369-20 "Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods"

ISO 80369-7:2016 "Small-bore connectors for liquids and gases in healthcare application - Part 7: Connectors for intravascular or hypodermic applications'

ISO 62366-1: 2015 + AC:2015 &A1 2020 "Medical Devices- Part 1: Application of Usability Engineering to Medical Devices"

ASTM F640-12 "Standard Test Methods for Determining Radiopacity for Medical Use"

FDA Guidance Documents utilized in regards to bench testing:

"Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019)

"Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters - Class II Special Controls Guidance for Industry and FDA" (2010)

"Applying Human Factors and Usability Engineering to Medical Devices" (2016)

Animal Study

Animal testing was not performed on the pNOVUS 21 Microcatheter as successful completion of nonclinical performance testing was deemed sufficient to establish substantial equivalence.

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Clinical Testing

Clinical testing was not performed on the pNOVUS 21 Microcatheter as no human studies were deemed necessary to establish substantial equivalence.

VIII. CONCLUSIONS

Phenox Ltd has demonstrated that the subject pNOVUS 21 Microcatheter is substantially equivalent to the predicate pNOVUS 21 Microcatheter (K221279). The subject device has the same intended use, similar technological characteristics, similar materials, and same operating principles as the predicate device. The differences do not raise new questions of safety or effectiveness. The subject device has been demonstrated to perform as intended through successful non-clinical performance testing.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).