(60 days)
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.
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.
The provided text describes the acceptance criteria and the study proving the device meets these criteria for the Wallaby Medical Paragon 8F Balloon Guide Catheter (K232437). However, it focuses on the physical and biological performance of the catheter, not on an AI/ML-based medical device. Therefore, many of the requested fields related to AI/ML device validation (e.g., sample sizes for training/test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance) are not applicable to this submission.
Here's a breakdown of the available information based on the provided text, adapted to the context of a physical medical device.
Acceptance Criteria and Device Performance (for a Physical Medical Device)
| Acceptance Criteria Category | Specific Test / Requirement | Reported Device Performance (Table 2 & 3 summary) |
|---|---|---|
| Design Verification (Bench) | Visual Inspection: Verify visual surface requirements. | Pass – all samples met the pre-determined acceptance criteria. |
| Dimensional Inspection: Verify dimensional specifications. | Pass – all samples met the pre-determined acceptance criteria. | |
| Simulated Use: Evaluate device performance and accessories in a simulated anatomy model. | Pass – all samples met the pre-determined acceptance criteria. | |
| Kink Resistance: Evaluate device around clinically relevant radii and verify kink resistance. | Pass – all samples met the pre-determined acceptance criteria. | |
| Coating Lubricity: Evaluate frictional forces and verify coating lubricity. | Pass – all samples met the pre-determined acceptance criteria. | |
| Radiopacity: Evaluate marker band visibility under fluoroscopy. | Pass – all samples met the pre-determined acceptance criteria. | |
| Delivery/Retrieval: Evaluate device in an anatomical model and verify frictional force. | Pass – all samples met the pre-determined acceptance criteria. | |
| Balloon Inflation Time: Verify balloon inflation time. | Pass – all samples met the pre-determined acceptance criteria. | |
| Balloon Deflation Time: Verify balloon deflation time. | Pass – all samples met the pre-determined acceptance criteria. | |
| Distal Tip Stiffness: Evaluate distal tip deflection force and verify stiffness. | Pass – all samples met the pre-determined acceptance criteria. | |
| Coating Integrity: Evaluate device pre- and post-insertion/retrieval through a simulated vascular model and verify coating integrity. | Pass – all samples met the pre-determined acceptance criteria. | |
| Torque Strength: Evaluate device integrity after applied hub rotations with distal end held stationary and verify torque strength. | Pass – all samples met the pre-determined acceptance criteria. | |
| Shaft & Hub Tensile: Verify tensile strength. | Pass – all samples met the pre-determined acceptance criteria. | |
| Liquid Leak: Verify liquid leak requirements per ISO 10555-1. | Pass – all samples met the pre-determined acceptance criteria. | |
| Air Leak: Verify air leak requirements per ISO 10555-1. | Pass – all samples met the pre-determined acceptance criteria. | |
| Hub Compatibility: Verify BGC bifurcated luer hub requirements per ISO 80369-7. | Pass – all samples met the pre-determined acceptance criteria. | |
| RHV Luer: Verify RHV luer requirements per ISO 80369-7. | Pass – all samples met the pre-determined acceptance criteria. | |
| Static Burst: Verify static burst requirements per ISO 10555-1. | Pass – all samples met the pre-determined acceptance criteria. | |
| Dynamic Burst: Verify dynamic burst requirements per ISO 10555-1. | Pass – all samples met the pre-determined acceptance criteria. | |
| Resistance to Lumen Collapse: Demonstrate main lumen does not collapse under aspiration. | Pass – all samples met the pre-determined acceptance criteria. | |
| Corrosion Resistance: Verify corrosion resistance requirements per ISO 10555-1. | Pass – all samples met the pre-determined acceptance criteria. | |
| Extension Tubing Tensile: Verify tensile strength requirements per ISO 10555-1. | Pass – all samples met the pre-determined acceptance criteria. | |
| Particulate: Evaluate device within a simulated anatomy model and verify particulate count similar to comparator device. | Pass – all samples met the pre-determined acceptance criteria. | |
| Balloon Fatigue: Evaluate repetitive balloon inflation and deflation cycles and verify fatigue. | Pass – all samples met the pre-determined acceptance criteria. | |
| Balloon Joint Integrity: Evaluate tensile force and verify balloon joint integrity. | Pass – all samples met the pre-determined acceptance criteria. | |
| Balloon Burst Volume: Verify balloon burst volume. | Pass – all samples met the pre-determined acceptance criteria. | |
| Balloon Diameter to Inflation Volume (Compliance): Characterize balloon diameter for pre-defined inflation volumes. | All samples were characterized. | |
| Shelf Life: Verify device performance after accelerated aging. | Pass – all samples met the pre-determined acceptance criteria. | |
| Transit Testing: Subject device, accessories, and packaging to environmental conditioning and shipping simulation and verify performance. | Pass – all samples met the pre-determined acceptance criteria. | |
| Packaging - Bubble Leak: Evaluate packaging per ASTM F2096-11 and verify requirements. | Pass – all samples met the pre-determined acceptance criteria. | |
| Packaging - Pouch Seal Strength: Evaluate packaging per ASTM F88 Technique A (unsupported peel) and verify requirements. | Pass – all samples met the pre-determined acceptance criteria. | |
| Sterility: Subject device, accessories, and packaging to sterilization and verify requirements. | Pass – all samples met the pre-determined acceptance criteria (Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11135:2014). | |
| Biocompatibility | MEM Elution Cytotoxicity (BGC, 3-way stopcock, extension tubing, syringe, sheath, RHV): Evaluate for cytotoxicity. | Non-cytotoxic (scores of 0, no cytotoxic potential to L-929 mouse fibroblast cells). |
| ISO Intracutaneous Irritation (BGC, 3-way stopcock, extension tubing, syringe, sheath, RHV): Evaluate for irritation. | Non-irritant / Negligible Irritant (delta between test article and vehicle control <= 1 or 0). | |
| ISO Guinea Pig Maximization Sensitization (BGC, 3-way stopcock, extension tubing, syringe, sheath, RHV): Evaluate for sensitization. | Did not elicit sensitization response (test and control animal's response not greater than "0"). | |
| ISO Acute Systemic Toxicity (BGC, 3-way stopcock, extension tubing, syringe, sheath, RHV): Evaluate for systemic toxicity. | Non-toxic (no abnormal clinical signs, alive at end of 72 hours, body weight changes within acceptable parameters). | |
| ISO Material Mediated Rabbit Pyrogen (BGC, 3-way stopcock, extension tubing, syringe, sheath, RHV): Evaluate for pyrogenicity. | Non-pyrogenic (no rabbit temperature rise >= 0.5°C). | |
| Complement Activation - SC5b-9 Assays (BGC): Evaluate potential to activate complement system. | Not a potential activator of complement system (results within acceptable range, not statistically different than activated NHS control or negative control). | |
| ASTM Hemolysis - Direct Contact and Extract Method (BGC, 3-way stopcock, extension tubing, syringe, sheath, RHV): Evaluate for hemolysis. | Non-hemolytic (blank corrected hemolytic index: 0.1 or 0.0). | |
| Thromboresistance Evaluation (BGC): Evaluate resistance to thrombus formation. | Thromboresistance of the test device is similar to control (no adverse effects or clinical signs during test period, no thrombus score >3 for test or control device). | |
| In Vitro Hemocompatibility Assay (BGC): Evaluate effects on blood components. | Test article not a risk for adversely affecting concentrations of various cellular and non-cellular components in blood (test article results were within acceptable range). | |
| Partial Thromboplastin Time (PTT) (BGC): Evaluate clotting risk. | Not at risk for clotting (test article 99.5% of negative control, not statistically different from comparison article). | |
| Chemical Characterization (BGC): Evaluate extractable and leachable chemicals. | The risk is acceptable (extractable and leachable chemical characterization and toxicological risk assessment suggest negligible adverse toxic effect during intended clinical use). |
Since this is for a physical medical device (catheter) and not an AI/ML software, the following sections are either not applicable ("N/A") or cannot be extracted from the provided text, as they pertain specifically to AI/ML software validation.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The exact number of samples for each bench test is not explicitly stated in the summary, other than "all samples" met the criteria. For biocompatibility, it refers to standard GLP (Good Laboratory Practice) animal and in vitro studies, which have their own sample size guidelines.
- Data Provenance: N/A. This applies to clinical data for AI/ML. The "data" here is the physical performance and biocompatibility of the device, typically conducted in a laboratory setting.
- Retrospective or Prospective: N/A. (Applies to AI/ML clinical data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- N/A. Ground truth in this context refers to established standards (e.g., ISO, ASTM), specified design requirements, and GLP guidelines for testing. Expert interpretation of images or other data to establish a "truth" is not relevant here.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
- N/A. This is relevant for AI/ML where multiple human readers interpret data. For physical device testing, results are objective measurements against predefined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
- N/A. This is a physical device, not an AI/ML algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- N/A. This is a physical device, not an AI/ML algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- For bench testing: Pre-defined engineering specifications, industry standards (ISO, ASTM), and design requirements.
- For biocompatibility: Standardized biological evaluation methods and acceptance criteria defined in ISO 10993 series. Animal studies (e.g., guinea pig, rabbit) are the "ground truth" for assessing biological responses.
8. The Sample Size for the Training Set:
- N/A. This applies to AI/ML software. This device does not have a "training set."
9. How the Ground Truth for the Training Set was Established:
- N/A. This applies to AI/ML software.
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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).
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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
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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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510(k) Summary (K232437)
As required by 21 CFR 807.92:
| Applicant: | Wallaby Medical22901 Mill Creek DriveLaguna Hills, CA 92653 | |
|---|---|---|
| Contact: | Primary contact: Joseph TangE-mail: joseph.tang@wallabyphenox.comPhone: +1 714 904 6097 Secondary contact: Rachel McDaidE-mail: rachel.mcdaid@wallabyphenox.comPhone: +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.
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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 8FBalloon GuideCatheter is indicatedfor use in facilitatingthe insertion andguidance of anintravascularcatheter into aselected blood vesselin the peripheral andneuro vascularsystems. The balloonprovides temporaryvascular occlusionduring these andother angiographicprocedures. TheParagon 8F BalloonGuide Catheter isalso indicated for useas a conduit for | FlowGate BalloonGuide Catheters areindicated for use infacilitating theinsertion and guidanceof an intravascularcatheter into aselected blood vesselin the peripheral andneuro vascularsystems. The balloonprovides temporaryvascular occlusionduring these and otherangiographicprocedures. TheBalloon GuideCatheter is alsoindicated for use as aconduit for retrievaldevices. | The 087 Balloon GuideCatheter System is indicatedfor use in facilitating theinsertion and guidance of anintravascular catheter into aselected blood vessel in theperipheral andneurovasculature. Theballoon provides temporaryvascular occlusion duringsuch procedures. The 087Balloon Guide CatheterSystem is also indicated foruse as a conduit for retrievaldevices. | 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,PolyurethaneInner layer: PTFE | Outer layer: Pebax,Pebax with BariumSulfate, Polyamidewith Barium SulfateInner layer: PTFE | Outer layer: Pebax,Polyamide, PolyurethaneInner layer: PTFE | The differences in the outerlayer materials do not raisenew questions of safetyand effectiveness. Thesubject device has beenevaluated via bench andbiocompatibility testing. |
| Shaft Reinforcement | Stainless steel braid | Stainless steel braid | Stainless steel coil | Same |
| Shaft Construction | Single-wall laminationshaft with fourequally spaced 0.5mm wide inflationlumens embedded inthe shaft's wallforming a multi-lumen shaft. | Dual-wall laminationshaft with an innerand outer shaftforming a coaxiallumen shaft. | Single-wall lamination shaftwith three inflation lumensembedded in the shaft's wallforming a multi-lumen shaft. | The subject device hassmall inflation channelsembedded in the shaft'swall. These differences inshaft construction do notraise new questionsregarding safety andeffectiveness. |
| Device Name | Subject Device:Paragon™ 8FBalloon GuideCatheter | Predicate Device:8F FlowGateBalloon GuideCatheter | Reference Device:087 Balloon GuideCatheter System | Rationale for Difference(if applicable) |
| The subject device has beenevaluated via bench andbiocompatibility testing. | ||||
| Radiopacity | Distal tip has oneradiopaque Pt-Irmarker band andstainless-steelreinforcement in thecatheter shaft,rendering the shaftvisible underfluoroscopy. | Distal tip has oneradiopaque Pt-Irmarker band andstainless-steelreinforcement in thecatheter shaft,rendering the shaftvisible underfluoroscopy. | Distal tip has two radiopaquePt-Ir marker bands andstainless steel reinforcementin the catheter shaftrendering the shaft visibleunder fluoroscopy. | Same |
| Coating | Hydrophilic Coating | None | Hydrophilic Coating | Since the predicate devicedoes not have a hydrophiliccoating, a reference deviceis utilized for coating relatedbenchtop testing todemonstrate substantialequivalence. |
| Compliant BalloonMaterial | Low durometer(52A)polyurethane | Silicone elastomer | Low durometer urethane | The material differences donot raise new questions ofsafety and effectiveness. Thesubject device has beenevaluated via bench andbiocompatibility testing. |
| Hub | Polyamide | Polyurethane | Similar | The material differences donot raise new questions ofsafety and effectiveness.The subject device has beenevaluated via bench andbiocompatibility testing. |
| Strain Relief | Pebax | Pebax, Polyolefin | Polyolefin | The material differences donot raise new questions ofsafety and effectiveness. Thesubject device has beenevaluated via bench andbiocompatibility testing. |
| Accessories | ||||
| AccessoriesProvided | RHV (1), Peel-AwaySheaths (2), Three-WayStopcocks (2), 1 mLSyringe (1),Extension Tubing (1) | RHV (1), Peel-AwaySheaths (2), Luer-Activated Valve (1),Dilator (1), TuohyBorst Valve withSideport (1), ExtensionTubing (1) | Three-Way Stopcock (1), Peel-Away Sheath (1), HubExtension (1), 1 mL Syringe(1) | Similar. The differences donot raise new questions ofsafety and effectiveness. |
| Dimensions | ||||
| Balloon CatheterLabeled OuterDiameter | 8F (0.109 in) | 8F (0.106 in) | 8.4F (0.110 in) | Similar |
| Balloon CatheterLabeled InnerDiameter | 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 predicatedevice. |
| Radiopaque MarkerBand Location | 0.04 in from the distaltip edge | 0.08 in from the distal tipedge | 0.06 in from the distal tipedge (distal of the balloon)and 0.66 in from the distal tipedge (proximal of theballoon) | Similar |
| Maximum Balloon | 0.6mL | 0.6mL | 0.6mL | Same |
| Device Name | Subject Device:Paragon™ 8FBalloon GuideCatheter | Predicate Device:8F FlowGateBalloon GuideCatheter | Reference Device:087 Balloon GuideCatheter System | Rationale for Difference(if applicable) |
| Tip Shapes | Straight | Straight | Straight | Same |
| Packaging | ||||
| Pouch | Polyamide/Tyvek pouch | Tyvek and LLDPE/NylonFilm Pouch, Chipboardcarton | Similar | Similar - packagingmaterials are similar andcommon for medicaldevices and maintainsterility of the devicethroughout the shelf life. |
| Tubing | Polyethylenetubes | Polyethylene tubes | Polyethylene tubes | Same |
| Packaging Card | HDPE | HDPE | HDPE | Same |
| SterilizationMethod | EtO | EtO | EtO | Same |
| How Supplied | Sterile, single use | Sterile, single use | Sterile, single use | Same |
| Sterility AssuranceLevel | 10-6 | 10-6 | 10-6 | Same |
| Shelf Life | 12 months | 36 months | 36 months | A 12-month shelf life wasvalidated for the subjectdevice. |
Table 1: Comparison to Predicate and Reference Devices
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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 thepre-determinedacceptance criteria |
| Dimensional Inspection | To verify the dimensional specifications are met. | Pass – all samples met thepre-determinedacceptance criteria |
| Simulated Use | To evaluate the performance of the device and accessoriesin simulated anatomy model. | Pass – all samples met thepre-determinedacceptance criteria |
| Kink Resistance | To evaluate the device around bends of clinically relevantradii and verify kink resistance requirements are met. | Pass – all samples met thepre-determined acceptancecriteria |
| Coating Lubricity | To evaluate frictional forces and verify coating lubricityrequirements are met. | Pass – all samples met thepre-determinedacceptance criteria |
| Radiopacity | To evaluate marker band visibility under fluoroscopy. | Pass – all samples met thepre-determinedacceptance 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 InflationVolume (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
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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.
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Table 3: Biocompatibility Testing
| TestBalloon Guide Catheter | Standard | Results | Conclusion |
|---|---|---|---|
| MEM ElutionCytotoxicity | Cytotoxicity10993-5 | Test article scored 0 at 48 hours. | Non-cytotoxic |
| MTT - L-929Cytotoxicity Study | Cytotoxicity10993-5 | 1XMEM test extract showed no cytotoxicpotential to L-929 mouse fibroblast cellsundiluted or at any dilution. | Non-cytotoxic |
| ISO IntracutaneousIrritation (GLP - 2Extracts) | Irritation orIntracutaneousReactivity10993-10 | The delta between the average scores of theextract of the test article and the vehiclecontrol are 0.0; 0.0. | Non-irritant |
| ISO Guinea PigMaximizationSensitization (GLP - 2Extracts) | Sensitization10993-10 | Test and control animal's response notgreater than "0". | Did not elicitsensitization response |
| ISO Acute SystemicToxicity (GLP - 2Extracts) | Systemic Toxicity10993-11 | None of the animals were observed withabnormal clinical signs indicative of toxicityfor 72 hours. All were alive at the end of72 hours and body weight changes werewithin acceptable parameters. | Non-toxic |
| ISO MaterialMediated RabbitPyrogen (GLP) | Pyrogen10993-11 | No rabbit temperature rise >=0.5°C. | Non-pyrogenic |
| ComplementActivation -SC5b-9Assays (GLP) | Results were within acceptable range andnot statistically different than activatedNHS control or negative control. | Not a potentialactivator ofcomplement system | |
| ASTM Hemolysis -Direct Contact andExtract Method (GLP) | Blank corrected hemolytic index: 0.1. | Test device is non-hemolytic | |
| ThromboresistanceEvaluation (GLP - 4Hour - 3 Dog) | Hemocompatibility10993-4 | No adverse effects or clinical signs during testperiod and no thrombus score >3 foreither test or control device. | Thromboresistance ofthe test device issimilar to control |
| In VitroHemocompatibilityAssay with Sponsor-Supplied Comparison(GLP) | Test article results were within acceptablerange. | Test article not a riskfor adversely affectingconcentrations ofvarious cellular andnon-cellularcomponents in blood | |
| Partial ThromboplastinTime (PTT) withSponsor- SuppliedComparisonArticle (GLP) | Test article was found to be 99.5% of thenegative control and not statisticallydifferent from the comparison article. | Not at risk for clotting | |
| ChemicalCharacterization-Physiochemical Testsfor Plastics (BufferingCapacity, Non-Volatile Residue (NVR)and HeavyMetals) | ChemicalCharacterization 10993-18 | Extractable and leachable chemicalcharacterization and the toxicological riskassessment of the BGC device suggest thatthe likelihood of having any adverse toxiceffect is negligible during intended clinicaluse. | The risk is acceptable |
| 3-Way Stopcock andExtension Tubing | |||
| MEM ElutionCytotoxicity | Cytotoxicity10993-5 | Test article scored 0 at 24, 48, and 72hours. | Non-cytotoxic |
| ISO IntracutaneousIrritation (GLP – 2 | Irritation orIntracutaneous | The delta between the average scores of theextract of the test article and the vehicle | Non-irritant |
| Test | Standard | Results | Conclusion |
| Extracts) | Reactivity10993-10 | control are ≤1. | |
| ISO Guinea PigMaximizationSensitization (GLP - 2Extracts) | Sensitization10993-10 | Test and control animal's response notgreater than "0". | Did not elicit sensitizationresponse |
| ISO Acute SystemicToxicity (GLP – 2Extracts) | Systemic Toxicity10993-11 | None of the animals were observed withabnormal clinical signs indicative of toxicityfor 72 hours. All were alive at the end of72 hours and body weight changes werewithin acceptable parameters. | Non-toxic |
| ISO MaterialMediated RabbitPyrogen (GLP) | Pyrogen 10993-11 | No rabbit temperature rise >=0.5°C. | Non-pyrogenic |
| ASTM Hemolysis –Direct Contact andExtract Method(GLP) | Hemocompatibility10993-4 | Blank corrected hemolytic index: 0.1. | Test device is non-hemolytic |
| 1 mL Syringe | |||
| MEM ElutionCytotoxicity | Cytotoxicity10993-5 | Test article scored 0 at 48 hours. | Non-cytotoxic |
| ISO IntracutaneousIrritation (GLP – 2Extracts) | Irritation orIntracutaneousReactivity10993-10 | The delta between the average scores ofthe extract of the test article and thevehicle control are ≤1. | Non-irritant |
| ISO Guinea PigMaximizationSensitization (GLP-2Extracts) | Sensitization10993-10 | Test and control animal's response notgreater than "0". | Did not elicit sensitizationresponse |
| ISO Acute SystemicToxicity (GLP-2Extracts) | Systemic Toxicity10993-11 | None of the animals were observed withabnormal clinical signs indicative of toxicityfor 72 hours. All were alive at the end of72 hours and body weight changes werewithin acceptable parameters. | Non-toxic |
| ISO MaterialMediated RabbitPyrogen (GLP) | Pyrogen 10993-11 | No rabbit temperature rise >=0.5°C. | Non-pyrogenic |
| ASTM Hemolysis -Direct Contact andExtract Method (GLP) | Hemocompatibility10993-4 | Blank corrected hemolytic index: 0.1 | Test device is non-hemolytic |
| Peel-Away Sheath | |||
| MTT - L-929Cytotoxicity Study | Cytotoxicity10993-5 | Test article scored 0 at 24, 48, and 72hours. | Non-cytotoxic |
| ISO IntracutaneousIrritation (GLP – 2Extracts) | Irritation orIntracutaneousReactivity10993-10 | The delta between the average scores of theextract of the test article and the vehiclecontrol are <1. | Non-irritant |
| ISO Guinea PigMaximizationSensitization (GLP-2Extracts) | Sensitization10993-10 | Test and control animal's response notgreater than "0". | Did not elicit sensitizationresponse |
| ISO Acute SystemicToxicity (GLP – 2Extracts) | Systemic Toxicity10993-11 | None of the animals were observed withabnormal clinical signs indicative of toxicityfor 72 hours. All were alive at the end of72 hours and body weight changes werewithin acceptable parameters. | Non-toxic |
| ISO Material | Pyrogen 10993-11 | within acceptable parameters.No rabbit temperature rise >=0.5°C. | Non-pyrogenic |
| Mediated Rabbit | |||
| Test | Standard | Results | Conclusion |
| Pyrogen (GLP) | |||
| ASTM Hemolysis -Direct Contact andExtract Method (GLP) | Hemocompatibility10993-4 | Blank corrected hemolytic index: 0.1. | Test device is non-hemolytic |
| RHV | |||
| Cytotoxicity MEMElution | Cytotoxicity10993-5 | Percent Cell Lysis: 0%Cytotoxic Score: 0 | Non-Cytotoxic |
| ISO IntracutaneousIrritation (GLP – 2Extracts) | Irritation orIntracutaneousReactivity10993-10 | The delta between the average scores of theextract of the test article and the vehiclecontrol are 0.0; 0.0. | Negligible Irritant |
| ISO Guinea PigMaximizationSensitization (GLP - 2Extracts) | Sensitization10993-10 | Test and control animal's response notgreater than "0". | Did not elicit sensitizationresponse |
| ISO Acute SystemicToxicity (GLP - 2Extracts) | Systemic Toxicity 10993-11 | None of the animals were observed withabnormal clinical signs indicative of toxicityfor 72 hours. All were alive at the end of72 hours and body weight changes werewithin acceptable parameters. | Non-toxic |
| ISO MaterialsMediated RabbitPyrogen (GLP) | Pyrogen 10993-11 | No rabbit temperature rise ≥0.5°C. | Non-pyrogenic |
| ASTM Hemolysis -Direct Contact andExtract Method(GLP) | Hemocompatibility10993-4 | Blank corrected hemolytic index: 0.0, 0.1. | Test device is non-hemolytic |
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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.
§ 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).