(60 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon guide catheter. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as a guide catheter used to facilitate the insertion and guidance of other intravascular catheters, and for temporary vascular occlusion or as a conduit for retrieval devices. It does not actively treat a disease or condition.
No
Explanation: The device is a catheter designed for facilitating the insertion and guidance of other intravascular catheters and providing temporary vascular occlusion. It is a tool used during procedures, not for diagnosing conditions.
No
The device description clearly details a physical catheter with multiple lumens, a balloon, and various material properties and dimensions. This is a hardware medical device.
Based on the provided information, the Paragon 8F Balloon Guide Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) to facilitate the insertion and guidance of other catheters and provide temporary vascular occlusion during angiographic procedures. It also acts as a conduit for retrieval devices. These are all procedures performed directly on a patient.
- Device Description: The description details a physical catheter with a balloon, designed to be inserted into blood vessels. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside the body on biological samples. The Paragon 8F Balloon Guide Catheter is a therapeutic and interventional device used inside the body.
N/A
Intended Use / Indications for Use
The Paragon 8F Balloon Guide Catheter is in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Paragon 8F Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.
Product codes
DQY, QJP
Device Description
The Paragon™ 8F Balloon Guide Catheter (BGC) is a multi-lumen, braid-reinforced, variable stiffness catheter with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. Balloon inflation can be facilitated through the side port of the bifurcated luer hub. The 10 mm long balloon can be inflated up to a maximum volume of 0.6 mL. At this volume, the balloon diameter is 10 mm. The through-lumen extends from the center port of the bifurcated luer hub to the distal tip. The external distal segment of the catheter shaft has hydrophilic coating to reduce friction during use. The coating starts from the proximal balloon bond and extends proximally for 19 cm in length. There are two Paragon 8F BGC configurations which have working lengths of 85 cm. The difference in device length resides in the proximal shaft segment only. The 16 cm distal flexible segment and the balloon are identical for both configurations.
The Paragon 8F Balloon Guide Catheter is compatible with minimum 0.110 inch inner diameter (ID) introducer sheaths, guidewires up to 0.038 inch outer diameter (OD), and 6F catheters up to 0.085 inch OD. The Paragon 8F Balloon Guide Catheter is sterile, non-pyrogenic, and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Peripheral and neuro vascular systems.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to support the Paragon™ 8F Balloon Guide Catheter submission. The results of the design verification and validation testing (Table 2) confirm that the subject device conforms to the pre-defined specifications and test acceptance criteria are met. All samples in all 27 tests including Visual Inspection, Dimensional Inspection, Simulated Use, Kink Resistance, Coating Lubricity, Radiopacity, Delivery/Retrieval, Balloon Inflation Time, Balloon Deflation Time, Distal Tip Stiffness, Coating Integrity, Torque Strength, Shaft & Hub Tensile, Liquid Leak, Air Leak, Hub Compatibility, RHV Luer, Static Burst, Dynamic Burst, Resistance to Lumen Collapse, Corrosion Resistance, Extension Tubing Tensile, Particulate, Balloon Fatigue, Balloon Joint Integrity, Balloon Burst Volume, Balloon Diameter to Inflation Volume (Compliance), Shelf Life, Transit Testing, Packaging - Bubble Leak, Packaging - Pouch Seal Strength, and Sterility, passed the pre-determined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
8F FlowGate Balloon Guide Catheter (K153729)
Reference Device(s)
087 Balloon Guide Catheter System (K192525), Neuron™ MAX System (K111380)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
October 13, 2023
Image /page/0/Picture/1 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, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Wallaby Medical Joseph Tang Design Quality Engineer 22901 Mill Creek Drive Laguna Hills, California 92653
Re: K232437
Trade/Device Name: Paragon 8F Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: August 11, 2023 Received: August 14, 2023
Dear Joseph Tang:
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.
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).
1
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.
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 mediation-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-regulatoryassistance/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
2
Indications for Use
510(k) Number (if known)
K232437
Device Name
Paragon 8F Balloon Guide Catheter
Indications for Use (Describe)
The Paragon 8F Balloon Guide Catheter is in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Paragon 8F Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.
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) |
|---|---|
| ------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------- |
|X] Prescription Use (Part 21 CFR 801 Subpart D)
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary (K232437)
As required by 21 CFR 807.92:
| Applicant: | Wallaby Medical
22901 Mill Creek Drive
Laguna Hills, CA 92653 | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Primary contact: Joseph Tang
E-mail: joseph.tang@wallabyphenox.com
Phone: +1 714 904 6097 Secondary contact: Rachel McDaid
E-mail: rachel.mcdaid@wallabyphenox.com
Phone: +353 91 740 100 | |
| Date Prepared: | October 10th, 2023 | |
| Device Trade Name: | Paragon 8F Balloon Guide Catheter | |
| Device Common Name: | Balloon Guide Catheter | |
| Classification Name: | Percutaneous Catheter | |
| Regulation Number: | 21 CFR 870.1250 | |
| Product Code: | DQY, QJP | |
| Predicate Device: | 8F FlowGate Balloon Guide Catheter (K153729) | |
| Reference Device 1: | 087 Balloon Guide Catheter System (K192525) | |
| Reference Device 2: | Neuron™ MAX System (K111380) | |
Device Description
The Paragon™ 8F Balloon Guide Catheter (BGC) is a multi-lumen, braid-reinforced, variable stiffness catheter with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. Balloon inflation can be facilitated through the side port of the bifurcated luer hub. The 10 mm long balloon can be inflated up to a maximum volume of 0.6 mL. At this volume, the balloon diameter is 10 mm. The through-lumen extends from the center port of the bifurcated luer hub to the distal tip. The external distal segment of the catheter shaft has hydrophilic coating to reduce friction during use. The coating starts from the proximal balloon bond and extends proximally for 19 cm in length. There are two Paragon 8F BGC configurations which have working lengths of 85 cm. The difference in device length resides in the proximal shaft segment only. The 16 cm distal flexible segment and the balloon are identical for both configurations.
The Paragon 8F Balloon Guide Catheter is compatible with minimum 0.110 inch inner diameter (ID) introducer sheaths, guidewires up to 0.038 inch outer diameter (OD), and 6F catheters up to 0.085 inch OD. The Paragon 8F Balloon Guide Catheter is sterile, non-pyrogenic, and intended for single use only.
4
Indications for Use
The Paragon 8F Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Paragon 8F Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.
Comparison to Predicate and Reference Devices
The table below provides the comparison of technological characteristics and indications for use of the subject device with the predicate and reference devices.
| Device Name | Subject Device: | Predicate Device: | Reference Device: | Rationale for Difference |
|---|---|---|---|---|
| Paragon™ 8F | 8F FlowGate | 087 Balloon Guide | (if applicable) | |
| Balloon Guide | Balloon Guide | Catheter System | ||
| Catheter | Catheter | |||
| 510(k) No. | K232437 | K153729 | K192525 | |
| Classification | Class II, DQY, QJP | Class II, DQY | Class II, DQY | Same |
| Indication for Use | The Paragon 8F | |||
| Balloon Guide | ||||
| Catheter is indicated | ||||
| for use in facilitating | ||||
| the insertion and | ||||
| guidance of an | ||||
| intravascular | ||||
| catheter into a | ||||
| selected blood vessel | ||||
| in the peripheral and | ||||
| neuro vascular | ||||
| systems. The balloon | ||||
| provides temporary | ||||
| vascular occlusion | ||||
| during these and | ||||
| other angiographic | ||||
| procedures. The | ||||
| Paragon 8F Balloon | ||||
| Guide Catheter is | ||||
| also indicated for use | ||||
| as a conduit for | FlowGate Balloon | |||
| Guide Catheters are | ||||
| indicated for use in | ||||
| facilitating the | ||||
| insertion and guidance | ||||
| of an intravascular | ||||
| catheter into a | ||||
| selected blood vessel | ||||
| in the peripheral and | ||||
| neuro vascular | ||||
| systems. The balloon | ||||
| provides temporary | ||||
| vascular occlusion | ||||
| during these and other | ||||
| angiographic | ||||
| procedures. The | ||||
| Balloon Guide | ||||
| Catheter is also | ||||
| indicated for use as a | ||||
| conduit for retrieval | ||||
| devices. | The 087 Balloon Guide | |||
| Catheter System is indicated | ||||
| for use in facilitating the | ||||
| insertion and guidance of an | ||||
| intravascular catheter into a | ||||
| selected blood vessel in the | ||||
| peripheral and | ||||
| neurovasculature. The | ||||
| balloon provides temporary | ||||
| vascular occlusion during | ||||
| such procedures. The 087 | ||||
| Balloon Guide Catheter | ||||
| System is also indicated for | ||||
| use as a conduit for retrieval | ||||
| devices. | Same | |||
| Anatomical | retrieval devices. | |||
| Peripheral and neuro | Peripheral and neuro | Peripheral and neuro | Same | |
| Locations | vasculature | vasculature | vasculature | |
| Catheter Shaft | ||||
| Material | Outer layer: Pebax, | |||
| Polyamide, | ||||
| Polyurethane | ||||
| Inner layer: PTFE | Outer layer: Pebax, | |||
| Pebax with Barium | ||||
| Sulfate, Polyamide | ||||
| with Barium Sulfate | ||||
| Inner layer: PTFE | Outer layer: Pebax, | |||
| Polyamide, Polyurethane | ||||
| Inner layer: PTFE | The differences in the outer | |||
| layer materials do not raise | ||||
| new questions of safety | ||||
| and effectiveness. The | ||||
| subject device has been | ||||
| evaluated via bench and | ||||
| biocompatibility testing. | ||||
| Shaft Reinforcement | Stainless steel braid | Stainless steel braid | Stainless steel coil | Same |
| Shaft Construction | Single-wall lamination | |||
| shaft with four | ||||
| equally spaced 0.5 | ||||
| mm wide inflation | ||||
| lumens embedded in | ||||
| the shaft's wall | ||||
| forming a multi- | ||||
| lumen shaft. | Dual-wall lamination | |||
| shaft with an inner | ||||
| and outer shaft | ||||
| forming a coaxial | ||||
| lumen shaft. | Single-wall lamination shaft | |||
| with three inflation lumens | ||||
| embedded in the shaft's wall | ||||
| forming a multi-lumen shaft. | The subject device has | |||
| small inflation channels | ||||
| embedded in the shaft's | ||||
| wall. These differences in | ||||
| shaft construction do not | ||||
| raise new questions | ||||
| regarding safety and | ||||
| effectiveness. | ||||
| Device Name | Subject Device: | |||
| Paragon™ 8F | ||||
| Balloon Guide | ||||
| Catheter | Predicate Device: | |||
| 8F FlowGate | ||||
| Balloon Guide | ||||
| Catheter | Reference Device: | |||
| 087 Balloon Guide | ||||
| Catheter System | Rationale for Difference | |||
| (if applicable) | ||||
| The subject device has been | ||||
| evaluated via bench and | ||||
| biocompatibility testing. | ||||
| Radiopacity | Distal tip has one | |||
| radiopaque Pt-Ir | ||||
| marker band and | ||||
| stainless-steel | ||||
| reinforcement in the | ||||
| catheter shaft, | ||||
| rendering the shaft | ||||
| visible under | ||||
| fluoroscopy. | Distal tip has one | |||
| radiopaque Pt-Ir | ||||
| marker band and | ||||
| stainless-steel | ||||
| reinforcement in the | ||||
| catheter shaft, | ||||
| rendering the shaft | ||||
| visible under | ||||
| fluoroscopy. | Distal tip has two radiopaque | |||
| Pt-Ir marker bands and | ||||
| stainless steel reinforcement | ||||
| in the catheter shaft | ||||
| rendering the shaft visible | ||||
| under fluoroscopy. | Same | |||
| Coating | Hydrophilic Coating | None | Hydrophilic Coating | Since the predicate device |
| does not have a hydrophilic | ||||
| coating, a reference device | ||||
| is utilized for coating related | ||||
| benchtop testing to | ||||
| demonstrate substantial | ||||
| equivalence. | ||||
| Compliant Balloon | ||||
| Material | Low durometer | |||
| (52A) | ||||
| polyurethane | Silicone elastomer | Low durometer urethane | The material differences do | |
| not raise new questions of | ||||
| safety and effectiveness. The | ||||
| subject device has been | ||||
| evaluated via bench and | ||||
| biocompatibility testing. | ||||
| Hub | Polyamide | Polyurethane | Similar | The material differences do |
| not raise new questions of | ||||
| safety and effectiveness. | ||||
| The subject device has been | ||||
| evaluated via bench and | ||||
| biocompatibility testing. | ||||
| Strain Relief | Pebax | Pebax, Polyolefin | Polyolefin | The material differences do |
| not raise new questions of | ||||
| safety and effectiveness. The | ||||
| subject device has been | ||||
| evaluated via bench and | ||||
| biocompatibility testing. | ||||
| Accessories | ||||
| Accessories | ||||
| Provided | RHV (1), Peel-Away | |||
| Sheaths (2), Three-Way | ||||
| Stopcocks (2), 1 mL | ||||
| Syringe (1), | ||||
| Extension Tubing (1) | RHV (1), Peel-Away | |||
| Sheaths (2), Luer- | ||||
| Activated Valve (1), | ||||
| Dilator (1), Tuohy | ||||
| Borst Valve with | ||||
| Sideport (1), Extension | ||||
| Tubing (1) | Three-Way Stopcock (1), Peel- | |||
| Away Sheath (1), Hub | ||||
| Extension (1), 1 mL Syringe | ||||
| (1) | Similar. The differences do | |||
| not raise new questions of | ||||
| safety and effectiveness. | ||||
| Dimensions | ||||
| Balloon Catheter | ||||
| Labeled Outer | ||||
| Diameter | 8F (0.109 in) | 8F (0.106 in) | 8.4F (0.110 in) | Similar |
| Balloon Catheter | ||||
| Labeled Inner | ||||
| Diameter | 0.087 in | 0.084 in | 0.087 in | Similar |
| Working Lengths | 85 cm, 95 cm | 85 cm, 95 cm | 90 cm, 95 cm, | |
| 100 cm | Same as the predicate | |||
| device. | ||||
| Radiopaque Marker | ||||
| Band Location | 0.04 in from the distal | |||
| tip edge | 0.08 in from the distal tip | |||
| edge | 0.06 in from the distal tip | |||
| edge (distal of the balloon) | ||||
| and 0.66 in from the distal tip | ||||
| edge (proximal of the | ||||
| balloon) | Similar | |||
| Maximum Balloon | 0.6mL | 0.6mL | 0.6mL | Same |
| Device Name | Subject Device: | |||
| Paragon™ 8F | ||||
| Balloon Guide | ||||
| Catheter | Predicate Device: | |||
| 8F FlowGate | ||||
| Balloon Guide | ||||
| Catheter | Reference Device: | |||
| 087 Balloon Guide | ||||
| Catheter System | Rationale for Difference | |||
| (if applicable) | ||||
| Tip Shapes | Straight | Straight | Straight | Same |
| Packaging | ||||
| Pouch | Polyamide/Tyvek pouch | Tyvek and LLDPE/Nylon | ||
| Film Pouch, Chipboard | ||||
| carton | Similar | Similar - packaging | ||
| materials are similar and | ||||
| common for medical | ||||
| devices and maintain | ||||
| sterility of the device | ||||
| throughout the shelf life. | ||||
| Tubing | Polyethylene | |||
| tubes | Polyethylene tubes | Polyethylene tubes | Same | |
| Packaging Card | HDPE | HDPE | HDPE | Same |
| Sterilization | ||||
| Method | EtO | EtO | EtO | Same |
| How Supplied | Sterile, single use | Sterile, single use | Sterile, single use | Same |
| Sterility Assurance | ||||
| Level | 10-6 | 10-6 | 10-6 | Same |
| Shelf Life | 12 months | 36 months | 36 months | A 12-month shelf life was |
| validated for the subject | ||||
| device. |
Table 1: Comparison to Predicate and Reference Devices
5
6
To establish substantial equivalence of the subject device the device meets the design specification and requirements, non-clinical bench and biological compatibility testing were conducted per the risk analysis. The testing performed and results are summarized below.
Design Verification Testing – Bench
Performance testing was conducted to support the Paragon™ 8F Balloon Guide Catheter submission. The results of the design verification and validation testing (Table 2) confirm that the subject device conforms to the pre-defined specifications and test acceptance criteria are met.
| Performance Bench Testing Summary | ||
|---|---|---|
| Test | Description | Results |
| Visual Inspection | To verify the visual surface requirements are met. | Pass – all samples met the |
| pre-determined | ||
| acceptance criteria | ||
| Dimensional Inspection | To verify the dimensional specifications are met. | Pass – all samples met the |
| pre-determined | ||
| acceptance criteria | ||
| Simulated Use | To evaluate the performance of the device and accessories | |
| in simulated anatomy model. | Pass – all samples met the | |
| pre-determined | ||
| acceptance criteria | ||
| Kink Resistance | To evaluate the device around bends of clinically relevant | |
| radii and verify kink resistance requirements are met. | Pass – all samples met the | |
| pre-determined acceptance | ||
| criteria | ||
| Coating Lubricity | To evaluate frictional forces and verify coating lubricity | |
| requirements are met. | Pass – all samples met the | |
| pre-determined | ||
| acceptance criteria | ||
| Radiopacity | To evaluate marker band visibility under fluoroscopy. | Pass – all samples met the |
| pre-determined | ||
| acceptance criteria | ||
| Performance Bench Testing Summary | ||
| Test | Description | Results |
| Delivery/Retrieval | To evaluate the device in an anatomical model and verify frictional force requirements are met. | Pass - all samples met the pre-determined acceptance criteria |
| Balloon Inflation Time | To verify balloon inflation time requirements are met. | Pass – all samples met the pre-determined acceptance criteria |
| Balloon Deflation Time | To verify balloon deflation time requirements are met. | Pass - all samples met the pre-determined acceptance criteria |
| Distal Tip Stiffness | To evaluate distal tip deflection force and verify distal tip stiffness requirements are met. | Pass - all samples met the pre-determined acceptance criteria |
| Coating Integrity | To evaluate device pre- and post-insertion and retrieval through a simulated vascular model and verify coating integrity requirements are met. | Pass - all samples met the pre-determined acceptance criteria |
| Torque Strength | To evaluate device integrity after applied hub rotations with distal end held stationary and verify torque strength requirements are met. | Pass - all samples met the pre-determined acceptance criteria |
| Shaft & Hub Tensile | To verify tensile strength requirements are met. | Pass - all samples met the pre-determined acceptance criteria |
| Liquid Leak | To verify liquid leak requirements per ISO 10555-1 are met. | Pass - all samples met the pre-determined acceptance criteria |
| Air Leak | To verify air leak requirements per ISO 10555-1 are met. | Pass - all samples met the pre-determined acceptance criteria |
| Hub Compatibility | To verify BGC bifurcated luer hub requirements per ISO 80369-7 are met. | Pass - all samples met the pre-determined acceptance criteria |
| RHV Luer | To verify RHV luer requirements per ISO 80369-7 are met. | Pass - all samples met the pre-determined acceptance criteria |
| Static Burst | To verify static burst requirements per ISO 10555-1 are met. | Pass - all samples met the pre-determined acceptance criteria |
| Dynamic Burst | To verify dynamic burst requirements per ISO 10555-1 are met. | Pass - all samples met the pre-determined acceptance criteria |
| Resistance to Lumen Collapse | To demonstrate that the main lumen does not collapse under aspiration. | Pass – all samples met the pre-determined acceptance criteria |
| Corrosion Resistance | To verify corrosion resistance requirements per ISO 10555-1 are met. | Pass – all samples met the pre-determined acceptance criteria |
| Extension Tubing Tensile | To verify tensile strength requirements per ISO 10555- 1 are met. | Pass - all samples met the pre-determined acceptance criteria |
| Particulate | To evaluate the device within a simulated anatomy model and verify particulate count is similar to the comparator device. | Pass – all samples met the pre-determined acceptance criteria |
| Balloon Fatigue | To evaluate repetitive balloon inflation and deflation cycles and verify fatigue requirements are met. | Pass - all samples met the pre-determined acceptance criteria |
| Balloon Joint Integrity | To evaluate tensile force and verify balloon joint integrity requirements are met. | Pass - all samples met the pre-determined acceptance criteria |
| Performance Bench Testing Summary | ||
| Test | Description | Results |
| Balloon Burst Volume | To verify balloon burst volume requirements are met. | Pass - all samples met the pre-determined acceptance criteria |
| Balloon Diameter to Inflation | ||
| Volume (Compliance) | To characterize balloon diameter for pre-defined balloon inflation volumes. | All samples were characterized |
| Shelf Life | To verify device performance after accelerated aging. | Pass - all samples met the pre-determined acceptance criteria |
| Transit Testing | To subject the device, accessories, and packaging to environmental conditioning and shipping simulation and verify performance requirements are met. | Pass - all samples met the pre-determined acceptance criteria |
| Packaging - Bubble Leak | To evaluate packaging per ASTM F2096-11 and verify requirements are met. | Pass - all samples met the pre-determined acceptance criteria |
| Packaging - Pouch Seal Strength | To evaluate packaging per ASTM F88 Technique A (unsupported peel) and verify requirements are met. | Pass - all samples met the pre-determined acceptance criteria |
| Sterility | To subject the device, accessories, and packaging to sterilization and verify the requirements are met. | Pass - all samples met the pre-determined acceptance criteria |
Table 2: Paragon™ 8F Balloon Guide Catheter Bench Testing Summary
7
8
Animal Study
Animal study was not deemed necessary to demonstrate substantial equivalence.
Sterilization and Shelf Life
The subject device is sterilized using an Ethylene Oxide (EtO) sterilization cycle. The sterilization cycle was verified to ensure a sterility assurance level (SAL) of 10° in accordance with ISO 11135:2014, Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation, and routine control of a sterilization process for medical devices.
Shelf-life studies for the subject device have demonstrated that the subject device and packaging remain functional for the labeled use by date. Shelf-life studies for packaging integrity, seal strength, and device functionality were performed and met all acceptance criteria.
Biocompatibility
Biocompatibility evaluation for the subject device was performed in accordance with ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. Biocompatibility testing completed for the device is included in Table 3.
9
Table 3: Biocompatibility Testing
| Test
| Balloon Guide Catheter | Standard | Results | Conclusion |
|---|---|---|---|
| MEM Elution | |||
| Cytotoxicity | Cytotoxicity | ||
| 10993-5 | Test article scored 0 at 48 hours. | Non-cytotoxic | |
| MTT - L-929 | |||
| Cytotoxicity Study | Cytotoxicity | ||
| 10993-5 | 1XMEM test extract showed no cytotoxic | ||
| potential to L-929 mouse fibroblast cells | |||
| undiluted or at any dilution. | Non-cytotoxic | ||
| ISO Intracutaneous | |||
| Irritation (GLP - 2 | |||
| Extracts) | Irritation or | ||
| Intracutaneous | |||
| Reactivity | |||
| 10993-10 | The delta between the average scores of the | ||
| extract of the test article and the vehicle | |||
| control are 0.0; 0.0. | Non-irritant | ||
| ISO Guinea Pig | |||
| Maximization | |||
| Sensitization (GLP - 2 | |||
| Extracts) | Sensitization | ||
| 10993-10 | Test and control animal's response not | ||
| greater than "0". | Did not elicit | ||
| sensitization response | |||
| ISO Acute Systemic | |||
| Toxicity (GLP - 2 | |||
| Extracts) | Systemic Toxicity | ||
| 10993-11 | None of the animals were observed with | ||
| abnormal clinical signs indicative of toxicity | |||
| for 72 hours. All were alive at the end of | |||
| 72 hours and body weight changes were | |||
| within acceptable parameters. | Non-toxic | ||
| ISO Material | |||
| Mediated Rabbit | |||
| Pyrogen (GLP) | Pyrogen | ||
| 10993-11 | No rabbit temperature rise >=0.5°C. | Non-pyrogenic | |
| Complement | |||
| Activation -SC5b-9 | |||
| Assays (GLP) | Results were within acceptable range and | ||
| not statistically different than activated | |||
| NHS control or negative control. | Not a potential | ||
| activator of | |||
| complement system | |||
| ASTM Hemolysis - | |||
| Direct Contact and | |||
| Extract Method (GLP) | Blank corrected hemolytic index: 0.1. | Test device is non- | |
| hemolytic | |||
| Thromboresistance | |||
| Evaluation (GLP - 4 | |||
| Hour - 3 Dog) | Hemocompatibility | ||
| 10993-4 | No adverse effects or clinical signs during test | ||
| period and no thrombus score >3 for | |||
| either test or control device. | Thromboresistance of | ||
| the test device is | |||
| similar to control | |||
| In Vitro | |||
| Hemocompatibility | |||
| Assay with Sponsor- | |||
| Supplied Comparison | |||
| (GLP) | Test article results were within acceptable | ||
| range. | Test article not a risk | ||
| for adversely affecting | |||
| concentrations of | |||
| various cellular and | |||
| non-cellular | |||
| components in blood | |||
| Partial Thromboplastin | |||
| Time (PTT) with | |||
| Sponsor- Supplied | |||
| Comparison | |||
| Article (GLP) | Test article was found to be 99.5% of the | ||
| negative control and not statistically | |||
| different from the comparison article. | Not at risk for clotting | ||
| Chemical | |||
| Characterization- | |||
| Physiochemical Tests | |||
| for Plastics (Buffering | |||
| Capacity, Non- | |||
| Volatile Residue (NVR) | |||
| and Heavy | |||
| Metals) | Chemical | ||
| Characterization 10993- | |||
| 18 | Extractable and leachable chemical | ||
| characterization and the toxicological risk | |||
| assessment of the BGC device suggest that | |||
| the likelihood of having any adverse toxic | |||
| effect is negligible during intended clinical | |||
| use. | The risk is acceptable | ||
| 3-Way Stopcock and | |||
| Extension Tubing | |||
| MEM Elution | |||
| Cytotoxicity | Cytotoxicity | ||
| 10993-5 | Test article scored 0 at 24, 48, and 72 | ||
| hours. | Non-cytotoxic | ||
| ISO Intracutaneous | |||
| Irritation (GLP – 2 | Irritation or | ||
| Intracutaneous | The delta between the average scores of the | ||
| extract of the test article and the vehicle | Non-irritant | ||
| Test | Standard | Results | Conclusion |
| Extracts) | Reactivity | ||
| 10993-10 | control are ≤1. | ||
| ISO Guinea Pig | |||
| Maximization | |||
| Sensitization (GLP - 2 | |||
| Extracts) | Sensitization | ||
| 10993-10 | Test and control animal's response not | ||
| greater than "0". | Did not elicit sensitization | ||
| response | |||
| ISO Acute Systemic | |||
| Toxicity (GLP – 2 | |||
| Extracts) | Systemic Toxicity | ||
| 10993-11 | None of the animals were observed with | ||
| abnormal clinical signs indicative of toxicity | |||
| for 72 hours. All were alive at the end of | |||
| 72 hours and body weight changes were | |||
| within acceptable parameters. | Non-toxic | ||
| ISO Material | |||
| Mediated Rabbit | |||
| Pyrogen (GLP) | Pyrogen 10993-11 | No rabbit temperature rise >=0.5°C. | Non-pyrogenic |
| ASTM Hemolysis – | |||
| Direct Contact and | |||
| Extract Method | |||
| (GLP) | Hemocompatibility | ||
| 10993-4 | Blank corrected hemolytic index: 0.1. | Test device is non- | |
| hemolytic | |||
| 1 mL Syringe | |||
| MEM Elution | |||
| Cytotoxicity | Cytotoxicity | ||
| 10993-5 | Test article scored 0 at 48 hours. | Non-cytotoxic | |
| ISO Intracutaneous | |||
| Irritation (GLP – 2 | |||
| Extracts) | Irritation or | ||
| Intracutaneous | |||
| Reactivity | |||
| 10993-10 | The delta between the average scores of | ||
| the extract of the test article and the | |||
| vehicle control are ≤1. | Non-irritant | ||
| ISO Guinea Pig | |||
| Maximization | |||
| Sensitization (GLP-2 | |||
| Extracts) | Sensitization | ||
| 10993-10 | Test and control animal's response not | ||
| greater than "0". | Did not elicit sensitization | ||
| response | |||
| ISO Acute Systemic | |||
| Toxicity (GLP-2 | |||
| Extracts) | Systemic Toxicity | ||
| 10993-11 | None of the animals were observed with | ||
| abnormal clinical signs indicative of toxicity | |||
| for 72 hours. All were alive at the end of | |||
| 72 hours and body weight changes were | |||
| within acceptable parameters. | Non-toxic | ||
| ISO Material | |||
| Mediated Rabbit | |||
| Pyrogen (GLP) | Pyrogen 10993-11 | No rabbit temperature rise >=0.5°C. | Non-pyrogenic |
| ASTM Hemolysis - | |||
| Direct Contact and | |||
| Extract Method (GLP) | Hemocompatibility | ||
| 10993-4 | Blank corrected hemolytic index: 0.1 | Test device is non- | |
| hemolytic | |||
| Peel-Away Sheath | |||
| MTT - L-929 | |||
| Cytotoxicity Study | Cytotoxicity | ||
| 10993-5 | Test article scored 0 at 24, 48, and 72 | ||
| hours. | Non-cytotoxic | ||
| ISO Intracutaneous | |||
| Irritation (GLP – 2 | |||
| Extracts) | Irritation or | ||
| Intracutaneous | |||
| Reactivity | |||
| 10993-10 | The delta between the average scores of the | ||
| extract of the test article and the vehicle | |||
| control are =0.5°C. | Non-pyrogenic | ||
| Mediated Rabbit | |||
| Test | Standard | Results | Conclusion |
| Pyrogen (GLP) | |||
| ASTM Hemolysis - | |||
| Direct Contact and | |||
| Extract Method (GLP) | Hemocompatibility | ||
| 10993-4 | Blank corrected hemolytic index: 0.1. | Test device is non- | |
| hemolytic | |||
| RHV | |||
| Cytotoxicity MEM | |||
| Elution | Cytotoxicity | ||
| 10993-5 | Percent Cell Lysis: 0% | ||
| Cytotoxic Score: 0 | Non-Cytotoxic | ||
| ISO Intracutaneous | |||
| Irritation (GLP – 2 | |||
| Extracts) | Irritation or | ||
| Intracutaneous | |||
| Reactivity | |||
| 10993-10 | The delta between the average scores of the | ||
| extract of the test article and the vehicle | |||
| control are 0.0; 0.0. | Negligible Irritant | ||
| ISO Guinea Pig | |||
| Maximization | |||
| Sensitization (GLP - 2 | |||
| Extracts) | Sensitization | ||
| 10993-10 | Test and control animal's response not | ||
| greater than "0". | Did not elicit sensitization | ||
| response | |||
| ISO Acute Systemic | |||
| Toxicity (GLP - 2 | |||
| Extracts) | Systemic Toxicity 10993- | ||
| 11 | None of the animals were observed with | ||
| abnormal clinical signs indicative of toxicity | |||
| for 72 hours. All were alive at the end of | |||
| 72 hours and body weight changes were | |||
| within acceptable parameters. | Non-toxic | ||
| ISO Materials | |||
| Mediated Rabbit | |||
| Pyrogen (GLP) | Pyrogen 10993-11 | No rabbit temperature rise ≥0.5°C. | Non-pyrogenic |
| ASTM Hemolysis - | |||
| Direct Contact and | |||
| Extract Method | |||
| (GLP) | Hemocompatibility | ||
| 10993-4 | Blank corrected hemolytic index: 0.0, 0.1. | Test device is non- | |
| hemolytic |
10
11
Clinical Study
Clinical study was not deemed necessary to demonstrate substantial equivalence.
Conclusion
The Paragon™ 8F Balloon Guide Catheter is substantially equivalent to the predicate device, 8F FlowGate Balloon Guide Catheter (K153729), based on successful completion of non-clinical bench testing, biocompatibility, sterility, and comparison of the device operating principle, technological characteristics, and indications for use.