Who is the manufacturer of Paragon 8F Balloon Guide Catheter?

Wallaby Medical filed the 510(k) submission for Paragon 8F Balloon Guide Catheter (K232437).

What is the FDA product code for Paragon 8F Balloon Guide Catheter?

DQY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Paragon 8F Balloon Guide Catheter?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Paragon 8F Balloon Guide Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Paragon 8F Balloon Guide Catheter

Q: What are the predicate devices for Paragon 8F Balloon Guide Catheter?

8F FlowGate Balloon Guide Catheter (K153729).

K232437 · Wallaby Medical · DQY · Oct 13, 2023 · Cardiovascular

Device Facts

Record ID	K232437
Device Name	Paragon 8F Balloon Guide Catheter
Applicant	Wallaby Medical
Product Code	DQY · Cardiovascular
Decision Date	Oct 13, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

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.

Device Story

Multi-lumen, braid-reinforced, variable stiffness catheter with distal compliant balloon and radiopaque marker. Balloon inflation via bifurcated luer hub side port; through-lumen for catheter/guidewire passage. Hydrophilic coating on distal shaft reduces friction. Used in peripheral and neurovascular procedures; operated by physicians. Provides temporary vascular occlusion to assist angiographic procedures and acts as a conduit for retrieval devices. Benefits include improved catheter navigation and vessel access.

Clinical Evidence

Bench testing only. No clinical data.

Technological Characteristics

Multi-lumen, braid-reinforced catheter. Materials: Pebax, Polyamide, Polyurethane (outer); PTFE (inner); Pt-Ir marker. Stainless steel braid reinforcement. Hydrophilic coating. 8F diameter. EtO sterilization. ISO 10555-1, ISO 80369-7, ISO 10993-1 compliance.

Indications for Use

Indicated for facilitating insertion and guidance of intravascular catheters into peripheral and neurovascular blood vessels, providing temporary vascular occlusion during angiographic procedures, and serving as a conduit for retrieval devices.

Regulatory Classification

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.

Predicate Devices

8F FlowGate Balloon Guide Catheter (K153729)

Reference Devices

087 Balloon Guide Catheter System (K192525)
Neuron™ MAX System (K111380)

Submission Summary (Full Text)

{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) | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| |X] Prescription Use (Part 21 CFR 801 Subpart D) |_ | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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.…

Paragon 8F Balloon Guide Catheter

Device Facts

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Paragon 8F Balloon Guide Catheter

Device Facts

Indications for Use

Device Story

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Technological Characteristics

Indications for Use

Regulatory Classification

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

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