(89 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a microcatheter for delivering devices and agents. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No.
The device is indicated for use in the delivery of interventional devices and infusion of diagnostic agents during diagnostic and/or therapeutic procedures, but it does not perform a therapeutic function itself.
No
This device is a microcatheter used for the delivery of interventional devices and infusion of diagnostic agents. While it is used during diagnostic procedures, the device itself is not performing diagnosis; it's a delivery tool.
No
The device description clearly states it is a physical microcatheter, a single-use hardware device, and does not mention any software component.
Based on the provided information, the pNOVUS 21 Microcatheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for the delivery of interventional devices and the infusion of diagnostic agents (like contrast media) into the neuro vasculature. This is an in vivo (within the living body) application, not an in vitro (outside the living body) test on biological samples.
- Device Description: The description details a catheter designed for insertion into blood vessels, which is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. The diagnostic agents mentioned (contrast media) are used to enhance visualization during imaging, not for in vitro analysis.
Therefore, the pNOVUS 21 Microcatheter is an invasive medical device used for interventional and diagnostic procedures within the body, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DQO, QJP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The pNOVUS 21 is solely intended for use by trained physicians in a healthcare facility/hospital.
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)
Biocompatibility: Testing for the subject pNOVUS 21 Microcatheter was conducted based on International Organization for Standardization (ISO) 10993-1:2018 and the US FDA guidance document "Use of International Standard ISO 10993-1". Key results: No cytotoxic effect, no sensitization indicated, no acute systemic toxicity indicated, deemed non-pyrogenic, no hemolysis indicated, no complement activation indicated, deemed thromboresistant, similar thrombogenic effect as the predicate device.
Sterilization: The pNOVUS 21 Microcatheter is sterilized by Ethylene Oxide gas per I.E. EN ISO 11135:2014 & A1:2019 and AAMI TIR28:2016. The sterilization cycle has been validated via the half cycle method.
Shelf Life: Devices subjected to accelerated aging (AA) processes for 1 year were tested to ensure design and performance specification requirements were met.
Non-Clinical Performance Data (Bench Testing): A full suite of performance testing on the bench was carried out on pNOVUS 21 Microcatheter. The tests included:
Catheter Static Burst Pressure Test Under Static Conditions: All samples met acceptance criteria, supporting substantial equivalence.
Hydrophilic Coating Lubricity: All samples met acceptance criteria; comparable to similar marketed devices.
Particulate Matter: All samples met acceptance criteria of similar or less particulates than the predicate device or similar marketed device.
Torque Strength: All samples met acceptance criteria.
Flow Rate at Maximum Rated Infusion Pressure: All samples met acceptance criteria; mean flow rate values comparable to similar marketed devices.
Radio-Detectability: All samples passed acceptance criteria, showing equivalence in terms of radiopacity to the predicate device.
Maneuverability / Trackability: All samples met acceptance criteria.
Pushability: All samples met acceptance criteria.
Kink Resistance: All samples met acceptance criteria.
Kink Resistance: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Lumen Patency: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Tip Profile: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Dimensional (Inner Diameter (ID), Outer Diameter (OD), Effective Length, Tip Length): All samples met the acceptance criteria, confirming the device meets specifications to ensure it performs as intended.
Tip Shapeability: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Flexural Fatigue: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Hydrophilic Coating Length: All samples met the acceptance criteria, confirming the device meets specifications to ensure it performs as intended.
Hydrophilic Coating Integrity: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Tensile Strength: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Chemical Compatibility: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Interventional Device Compatibility: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
2nd Microcatheter: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Visual Inspection: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Air Leakage During Aspiration: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Pressure Fatigue: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Maximum Infusion Pressure: All samples met acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Ancillary Device Compatibility: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Hub/Luer Fitting: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Packaging Configuration: All samples met the acceptance criteria, confirming the device meets specifications to ensure it performs as intended.
Dispenser Hoop: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Hub/Luer Markings: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Directions for Use (DFU): All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Usability: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
Corrosion Resistance: All samples met the acceptance criteria, confirming the device meets requirements to ensure it performs as intended.
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.
Not Found
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
§ 870.1200 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).
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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.
1
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
2
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
3
Indications for Use
510(k) Number (if known) K242420
Device Name pNOVUS 21 Microcatheter
Indications for Use (Describe)
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.
| 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/Secondary | ||
| Code | 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:
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.
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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 Device | ||
| K221279 | Subject Device | ||
| K242420 | Justification of | ||
| Substantial | |||
| Equivalence | |||
| Device Name | pNOVUS 21 | pNOVUS 21 | N/A |
| Microcatheter | Microcatheter | ||
| Model # | PNOV-21-160 | PNOV-21-160 | |
| PNOV-21-150 | N/A | ||
| 510(k) Number | K221279 | K242420 | N/A |
| Product Classification | 21 CFR 870.1200, | ||
| 21 CFR 870.1250 | |||
| Class II | 21 CFR 870.1200, | ||
| 21 CFR 870.1250 | |||
| Class II | Same as predicate | ||
| Product Codes | DQQ, QJP | DQQ, QJP | Same as predicate |
| Device Design/Materials | Stainless steel braided | ||
| shaft, polymeric | |||
| exterior | Stainless steel | ||
| braided shaft, | |||
| Nitinol coil, | |||
| polymeric exterior | Similar to predicate. | ||
| The subject device | |||
| also includes a | |||
| nitinol coil. This is a | |||
| commonly used | |||
| component in | |||
| medical devices. | |||
| Marker Band | |||
| Material/Radiopacity | Radiopaque | ||
| Platinum/Iridium | Radiopaque | ||
| Platinum/Iridium | Same as predicate | ||
| Adhesives Used | Acrylated Urethane | ||
| and Cyanoacrylate | Acrylated Urethane | ||
| and Cyanoacrylate | Same as predicate | ||
| Hub Material | Polyamide | Polyamide | Same as predicate |
| Coating | Distal: Hydrophilic | ||
| coating | |||
| Proximal: N/A | |||
| Length: 550 mm | Distal: Hydrophilic | ||
| coating | |||
| Proximal: N/A | |||
| Length: 1000 mm | Similar to the | ||
| predicate. The | |||
| difference in | |||
| coating lengths | |||
| does not raise new | |||
| questions of safety | |||
| and effectiveness. | |||
| Mode of Action | Physical | Physical | Same as |
| predicate | |||
| Principle of Operation | The device is | ||
| advanced into the | |||
| vasculature over an | |||
| appropriately sized | |||
| guidewire. Once the | |||
| microcatheter is | |||
| inserted, it can be | |||
| advanced through | |||
| the vasculature to | |||
| the desired | |||
| location. | The device is | ||
| advanced into the | |||
| vasculature over an | |||
| appropriately sized | |||
| guidewire. Once | |||
| the microcatheter | |||
| is inserted, it can be | |||
| advanced through | |||
| the vasculature to | |||
| the desired | |||
| location. | Same as predicate | ||
| Effective Length | 160 cm | 150cm | |
| 160cm | Similar to the | ||
| predicate. | |||
| Shorter length | |||
| variant is also | |||
| offered for the | |||
| subject | |||
| device. | |||
| Outer Diameter: | Similar to the | ||
| Proximal | 2.7F | 2.7F | predicate. |
| Distal | 2.4F | 2.5F | Same as |
| predicate | |||
| Inner Diameter | 0.021" | 0.021" | Same as |
| predicate | |||
| Use | Single Use Device | Single Use Device | Same as |
| predicate | |||
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same as |
| predicate | |||
| Biocompatible | Yes | Yes | Same as |
| predicate | |||
| Shelf Life | 1 year | 1 year | Same as |
| predicate | |||
| Accessory Devices | Introducer Sheath, | ||
| Shaping Mandrel | Introducer Sheath, Shaping | ||
| Mandrel | Same as | ||
| predicate | |||
| Intended Use | |||
| Environment | Healthcare | ||
| facility/hospital. | |||
| Procedures requiring | |||
| percutaneous catheter | |||
| introduction should not | |||
| be attempted by | |||
| physicians unfamiliar | |||
| with the possible | |||
| complications. | |||
| Rx only - device | |||
| restricted to sale by | |||
| or on order of a | |||
| physician. | Healthcare facility/hospital. | ||
| Procedures requiring | |||
| percutaneous catheter | |||
| introduction should not be | |||
| attempted by physicians | |||
| unfamiliar with the possible | |||
| complications. | |||
| Rx only - device restricted to | |||
| sale by or on order of a | |||
| physician. | Same as | ||
| predicate | |||
| Packaging | |||
| Components/Configuration | Device is stored within a | ||
| HDPE Packaging Hoop | |||
| with Tubing Clips, sealed | |||
| within a Tyvek Pouch, | |||
| which is then packaged | |||
| in a product carton. | Device is stored within a | ||
| HDPE Packaging Hoop with | |||
| Tubing Clips, sealed within a | |||
| Tyvek Pouch, which is then | |||
| packaged in a product carton. | Same as | ||
| predicate |
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 | ||
| Cytotoxicity | ||
| ISO 10993-5 | MTT-L929 fibroblast cells | No cytotoxic effect. |
| Sensitization | ||
| ISO 10993-10 | Magnusson-Kligman Maximization | No sensitization indicated. |
| Skin irritation | ||
| ISO 10993-10 | ||
| ISO 10993-23 | Intracutaneous Reactivity (ISO) | No sensitization indicated. |
| Systemic toxicity | ||
| ISO 10993-11 | Systemic Injection (ISO) | |
| Material Mediated Pyrogenicity test | No acute systemic toxicity indicated. | |
| pNOVUS 21 is deemed non-pyrogenic. | ||
| Hemocompatibility | ||
| ISO 10993-4 | Hemolysis (ASTM method) indirect extract | |
| Hemolysis (ASTM method) direct contact | ||
| Complement activation | ||
| In Vitro Thrombogenicity Blood Loop Assay | ||
| Partial 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 Burst | ||
| Pressure Test Under | ||
| Static Conditions | The catheter was tested for static burst | |
| pressure under static conditions as per | ||
| ISO 10555-1 Annex F, until failure (until | ||
| burst or leak). The catheter must exceed | ||
| a specified minimum pressure. | All samples met the acceptance criteria that | |
| the hub or any other part of the catheter | ||
| shall not leak when pressurized to failure | ||
| below a minimum specified pressure. This is | ||
| in line with the predicate device, thus, | ||
| supporting substantial equivalence. | ||
| Hydrophilic Coating | ||
| Lubricity | The catheter hydrophilic coating | |
| lubricity is tested by applying a pinch | ||
| force to the coated section of the | ||
| catheter. The friction force shall be | ||
| below the specified maximum | ||
| friction value for that segment. | All samples met the acceptance criteria. The | |
| pNOVUS 21 was found to be comparable to | ||
| similar marketed devices. | ||
| Particulate Matter | The catheter particulate matter was | |
| tested by calculating the size and | ||
| number of particulates generated | ||
| during simulated use of the device in a | ||
| neurovascular model. | Particulate testing was performed on the | |
| pNOVUS 21, predicate, and similar | ||
| marketed devices. pNOVUS 21 met the | ||
| acceptance criteria of similar or less | ||
| particulates than the predicate device or | ||
| similar marketed device. | ||
| Torque Strength | The catheter was evaluated for torque | |
| strength by rotating the specimen | ||
| until failure, the catheter must exceed | ||
| a specified minimum number of | ||
| rotations. | All samples met the acceptance criteria. Both | |
| the subject device and the predicate were | ||
| tested to same acceptance criteria. | ||
| Flow Rate at Maximum | ||
| Rated Infusion Pressure | The flow rate at the maximum rated | |
| infusion pressure was measured | ||
| using the following injectate media: | ||
| saline, 50/50 mix of saline and | ||
| contrast medium. | All samples met the acceptance criteria. The | |
| mean flow rate values for the pNOVUS 21 | ||
| similar marketed devices | ||
| and | ||
| are | ||
| comparable for the injectate media tested. | ||
| Radio-Detectability | The catheter is visualized under | |
| fluoroscopy. | All samples passed the acceptance criteria. | |
| pNOVUS 21 and the predicate device were | ||
| imaged showing equivalence in terms of | ||
| radiopacity. | ||
| Maneuverability / | ||
| Trackability | The device is tested for its ability to | |
| reach target site in a neurovascular | ||
| model. | All samples met the acceptance criteria, | |
| confirming the device meets requirements | ||
| to ensure it performs as intended. | ||
| Pushability | A force is applied to the shaft of the | |
| catheter in order to deliver it to the | ||
| target site without kinking or damage | ||
| to the catheter. | All samples met the acceptance criteria, | |
| confirming the device meets requirements to | ||
| ensure it performs as intended. | ||
| Kink Resistance | The catheter is tested at different | |
| locations for its ability to bend to | ||
| clinically relevant radii without kinking. | All samples met the acceptance criteria, | |
| confirming the device meets requirements to | ||
| ensure it performs as intended. | ||
| Lumen Patency | The device is subjected to simulated | |
| use in a neurovascular model and the | ||
| lumen inspected for damage. | All samples met the acceptance criteria, | |
| confirming the device meets requirements to | ||
| ensure it performs as intended. | ||
| Tip Profile | The distal tip of the device is inspected | |
| for defects. | All samples met the acceptance criteria, | |
| confirming the device meets requirements to | ||
| ensure it performs as intended. | ||
| Dimensional (Inner | ||
| Diameter (ID), Outer | ||
| Diameter (OD), Effective | ||
| Length, Tip Length) | The dimensions of the catheter and the | |
| catheter tip are measured. | All samples met the acceptance criteria, | |
| confirming the device meets specifications to | ||
| ensure it performs as intended. | ||
| Tip Shapeability | The distal tip of the catheter is shaped | |
| using the shaping mandrel supplied | ||
| with pNOVUS 21. | All samples met the acceptance criteria, | |
| confirming the device meets requirements | ||
| to 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 Coating | ||
| Length | 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 Coating | ||
| Integrity | 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. |
| Interventional | ||
| Device | ||
| Compatibility | 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 During | ||
| Aspiration | 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 Infusion | ||
| Pressure | 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 Device | ||
| Compatibility | 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 ISO | |
| 80369-7. | All samples met the acceptance criteria, | |
| confirming the device meets requirements | ||
| to ensure it performs as intended. | ||
| Packaging Configuration | During simulated use testing, the | |
| configuration of the packaging is | ||
| verified as per specification. | All samples met the acceptance criteria, | |
| confirming the device meets specifications | ||
| to ensure it performs as intended. | ||
| Dispenser Hoop | During simulated use testing, the | |
| presence of a female luer and | ||
| retention clip on each of the | ||
| dispenser hoops is verified. | All samples met the acceptance criteria, | |
| confirming the device meets requirements | ||
| to ensure it performs as intended. | ||
| Hub/Luer Markings | The hub of the catheter is inspected to | |
| ensure all required identifiers are | ||
| present. | All samples met the acceptance criteria, | |
| confirming the device meets requirements | ||
| to ensure it performs as intended. | ||
| Directions for Use (DFU) | During simulated use testing, the | |
| presence of a DFU with each device is | ||
| verified. | All samples met the acceptance criteria, | |
| confirming the device meets requirements | ||
| to ensure it performs as intended. | ||
| Usability | The usability of the pNOVUS 21 was | |
| assessed per FDA guidance "Applying | ||
| Human Factors and Usability | ||
| Engineering to Medical Devices" and | ||
| EN 62366 "Medical Devices - Part 1: | ||
| Application for Usability Engineering to | ||
| Medical Devices." | All samples met the acceptance criteria, | |
| confirming the device meets requirements | ||
| to ensure it performs as intended. | ||
| Corrosion Resistance | The pNOVUS 21 is visually inspected for | |
| signs of corrosion post exposure to | ||
| required conditions. | All samples met the acceptance criteria, | |
| confirming the device meets requirements | ||
| to 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.