(166 days)
The Esperance Aspiration Catheter with the Medela Dominant Flex Surgical Suction Pump and Wallaby Aspiration Tubing set is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within internal carotid, middle cerebral - Ml and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Esperance Aspiration Catheter System is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device system includes 5F and 6F catheters with inner diameters of 0.055" and 0.071", respectively, designed with three different working lengths for both sizes: 115 cm, 125 cm, and 131 cm. The device is supplied as a kit with Wallaby Aspiration Tubing Set provided with a single catheter. The distal tip of each catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy. The Esperance Aspiration Catheter System is a non-active, surgically invasive device intended for short term use within the vasculature.
The document describes the acceptance criteria and supporting studies for the Esperance Aspiration Catheter System.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a single format. Instead, it lists various tests with outcomes indicating that the device "met all pre-defined acceptance criteria" or "performs as intended and met all pre-defined acceptance criteria." For some tests, there's also a comparison to a predicate device, noting the subject device "demonstrates equivalency" or its results "were evaluated and compared to the predicate in the same test conditions and deemed substantially equivalent."
Below is a summary derived from the "Design Verification Testing - Bench" and "Biocompatibility" sections, which outlines the tests performed and the general performance statements provided. Since specific numerical acceptance criteria are not detailed in the provided text, the performance is reported as meeting these (unspecified) criteria or being comparable to the predicate device.
Table of Acceptance Criteria (Inferred) and Reported Device Performance:
| Test Category | Specific Test | Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|---|
| Bench Testing | Visual Inspection | Device meets all visual inspection requirements. | The device met all pre-defined acceptance criteria. |
| Dimensional Inspection (ID, OD, Length, etc.) | Device meets all dimensional requirements. | The device met all pre-defined acceptance criteria. | |
| Aspiration Rate | Saline flow rate meets pre-defined criteria. | The device met all pre-defined acceptance criteria. | |
| Simulated Use (preparation/assembly, interaction, lubricity, kink, clot removal) | Device performs as intended under simulated use conditions. | Device performs as intended and met all pre-defined acceptance criteria under simulated use conditions. | |
| Physician Validation (simulated clot retrieval) | Device performs as intended and is equivalent to predicate under simulated use conditions. | Device performs as intended and demonstrates equivalency to its predicate device under simulated use conditions. | |
| Delivery and Retrieval Forces | Device meets pre-defined acceptance criteria; comparable to predicate. | The device met all pre-defined acceptance criteria. Results were evaluated and compared to the predicate in the same test conditions and deemed substantially equivalent. | |
| Tip Stiffness | Device tip deflection force meets acceptance criteria; comparable to predicate. | The device met acceptance criteria. Results were evaluated and compared to the predicate in the same test conditions and deemed substantially equivalent. | |
| Tip Shaping | Shaped tip meets pre-defined acceptance criteria. | The device met the pre-defined acceptance criteria. | |
| System Tensile (hub, shaft, tip) | System meets minimum tensile requirement. | The device met all predefined acceptance criteria. | |
| Elongation to Failure | Device meets pre-defined acceptance criteria. | The device met all pre-defined acceptance criteria. | |
| Torque Strength | Device torque response meets acceptance criteria. | The device met acceptance criteria. | |
| Coating Integrity | Coating integrity maintained after insertion/retrieval. | The device met all pre-defined acceptance criteria. (6F results utilized for 5F as worst-case). | |
| Coating Lubricity | Frictional forces meet pre-defined acceptance criteria. | The device met all pre-defined acceptance criteria. | |
| Catheter Burst (Pressure) | Device does not leak, burst, and is compatible with accessories (per ISO 10555-1, ISO 594-1). | The device met acceptance criteria. | |
| Leak (Liquid & Air) | Device does not leak. | The device (catheter and tubing set) met acceptance criteria. | |
| Kink Resistance | Device resists kinking around bends with clinically relevant radii. | The device met acceptance criteria. | |
| Vacuum Resistance | Device resists lumen collapse under vacuum. | The device (catheter and tubing set) met all pre-defined acceptance criteria. | |
| Particulate | Particulate generation comparable to predicate. | The device met acceptance criteria. (6F results utilized for 5F as worst-case). | |
| Corrosion Resistance | Device is corrosion resistant per ISO 10555-1. | The catheter is corrosion resistant per ISO 10555-1. | |
| Radiopacity | Marker band is visible under fluoroscopy. | The device met the pre-defined acceptance criteria during the animal study. | |
| Tubing Set Bench | Set Tensile (Luer, suction connector) | Connectors meet minimum tensile requirement. | The tubing set connectors met all predefined acceptance criteria. |
| Tubing Set Functionality & Label Verification | Functionality and labeling perform as intended. | Tubing set met all pre-defined acceptance criteria. | |
| Luer Hub Bench | ISO 80369-7 & 80369-20 (Dimension, Leakage, Stress Cracking, Separation, etc.) | Luer hub dimensions, leakage resistance, stress cracking resistance, and resistance to separation/overriding meet standard requirements. | The device Luer hub met the pre-defined specifications for all listed ISO tests. |
| Biocompatibility | Cytotoxicity (MTT – L-929) | No cytotoxic potential. | Non-cytotoxic. |
| Irritation (ISO Intracutaneous) | Non-irritant. | Non-irritant. | |
| Sensitization (ISO Guinea Pig Maximization) | No sensitization response. | Did not elicit sensitization response. | |
| Systemic Toxicity (ISO Acute Systemic) | No abnormal clinical signs of toxicity; alive at 72 hours; acceptable body weight changes. | Non-toxic. | |
| Pyrogenicity (ISO Material Mediated Rabbit) | No rabbit temperature rise >= 0.5°C. | Non-pyrogenic. | |
| Complement Activation (SC5b-9) | Acceptable range compared to control device. | Test article complement activation has similar performance as the control. | |
| Hemolysis (ASTM - Direct Contact & Extract) | Non-hemolytic. | Test device is non-hemolytic. | |
| Platelet & Leukocyte counts | Counts within acceptable ranges and comparable to control. | Counts of test device are within acceptable ranges and similar to control. | |
| Partial Thromboplastin Time (PTT) | Test and predicate device have similar performance; not an activator of intrinsic coagulation pathway. | Test and predicate device have similar performance. Test and control articles are not considered an activator of the intrinsic coagulation pathway. | |
| Thromboresistance Evaluation | No adverse effects or clinical signs; no thrombus score >3 for test or control device. | Thromboresistance of test device is similar to control. | |
| Sterilization & Shelf Life | Sterilization Assurance Level (SAL) | SAL of 10^-6^ in accordance with ISO 11135:2014. | The sterilization cycle was verified to ensure a sterility assurance level (SAL) of 10^-6^. |
| Aging Studies (packaging integrity, seal strength, device functionality) | Catheters and packaging remain functional for labeled use-by date; all acceptance criteria met. | Aging studies were performed and met all acceptance criteria. | |
| Animal Study (6F model) | Safety, Usability, Performance (preparation, sheath interaction, lubrication, kink, device condition) | Demonstrated safety, usability, and substantial equivalence to predicate.Gross necropsy and histopathology show safety. | The subject device is safe, usable, and is substantially equivalent to the predicate device. An interventionalist assessed safety and usability, and safety was evaluated by gross necropsy and histopathology of treated vessels and downstream tissues and organs. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not provide specific numerical sample sizes for most bench tests (e.g., how many catheters were visually inspected or how many were subjected to tensile testing). For the animal study, it mentions a "porcine model" but doesn't specify the number of animals used.
- Data Provenance: The studies were non-clinical bench, animal, and biological compatibility testing, indicating laboratory-generated data (bench tests, biocompatibility assays) and animal study data (porcine model). The country of origin is not explicitly stated, but the submission is to the U.S. FDA. The studies are prospective in the sense that they were conducted for this submission, rather than retrospective analysis of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Bench Testing (Physician Validation): The "Physician Validation" test mentioned that the device was "evaluated in a simulated anatomy model by physicians." The exact number of physicians is not specified, nor are their specific qualifications (e.g., "radiologist with 10 years of experience").
- Animal Study: For the animal study, an "interventionalist assessed the safety and usability of the subject and predicate devices." Again, the specific number and detailed qualifications of this interventionalist are not provided.
- For other tests, ground truth was based on established engineering standards or biological assay protocols, not expert consensus in the same way.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth, especially for the "physician validation" or "interventionalist assessment." The general phrasing "met all pre-defined acceptance criteria" suggests that results were compared against predetermined thresholds or qualitative expectations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The studies focused on technical performance, safety, and equivalence to a predicate device via non-clinical means (bench and animal testing). The comparison involved subjective assessment by physicians/interventionalists in simulated or animal settings, but not in a formal MRMC design to measure human reader improvement with AI assistance. This device is not an AI-powered diagnostic tool, but a medical intervention device.
6. Standalone (Algorithm Only) Performance Study
This question is not applicable. The Esperance Aspiration Catheter System is a physical medical device, not an algorithm or AI software. Therefore, there is no "standalone (algorithm only)" performance to evaluate.
7. Type of Ground Truth Used
- Bench Testing: Ground truth was primarily based on:
- Engineering Specifications: Pre-defined dimensional requirements, tensile strength, burst pressure, flow rates, etc.
- Performance Metrics: Qualitative and quantitative assessments against intended function (e.g., "kink resistance," "lubricity," "clot removal").
- Predicate Device Comparison: Establishing equivalence to the performance of a legally marketed predicate device.
- Biocompatibility Testing: Ground truth was based on:
- Standardized Assay Results: Outcomes of well-established biological tests (e.g., cytotoxicity, irritation, sensitization) conforming to ISO 10993 standards, with defined thresholds for acceptance.
- Control Device Comparison: Comparison to a control or predicate to establish similar biological interaction.
- Animal Study: Ground truth for safety and usability stemmed from:
- Interventionalist Assessment: Expert observation and qualitative evaluation of device handling and performance.
- Pathology/Histopathology: Gross necropsy and microscopic examination of tissues for adverse effects.
8. Sample Size for the Training Set
This question is not applicable. The Esperance Aspiration Catheter System is a physical medical device, not an algorithm that requires a "training set" in the context of machine learning. The term "training set" is usually associated with AI/ML model development.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
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November 16, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with a stylized image of three human profiles. To the right of the seal, there is a blue square with the letters "FDA" in white. To the right of the blue square, there is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Wallaby Medical Nathaniel Knock Director of Quality and Regulatory Affairs 22901 Mill Creek Drive Laguna Hills, California 92653
Re: K211697
Trade/Device Name: Esperance Aspiration Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: October 15, 2021 Received: October 19, 2021
Dear Nathaniel Knock:
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 (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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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, 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) K211697
Device Name
Esperance Aspiration Catheter System
Indications for Use (Describe)
The Esperance Aspiration Catheter with the Medela Dominant Flex Surgical Suction Pump and Wallaby Aspiration Tubing set is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within internal carotid, middle cerebral - Ml and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
| 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Number: K211697
As required by 21 CFR 807.92:
| Applicant: | Wallaby Medical22901 Mill Creek DriveLaguna Hills, CA 92653 |
|---|---|
| Contact: | Nathaniel Knock |
| Phone Number | 1 949.480.9466 |
| Date Prepared: | 10/15/21 |
| Device Trade Name: | Esperance Aspiration Catheter System |
| Device Common Name: | Catheter, Thrombus Retriever |
| Product Code | NRY |
| Classification Name: | Percutaneous Catheter, 21 CFR 870.1250 |
| 5F Predicate Device Name: | Penumbra Reperfusion Catheter 054, Penumbra Separator 054(K090752) |
| 6F Predicate Device Name: | Penumbra System ACE 64 and ACE 68 Reperfusion Catheters(K142458) |
a. Device Description
The Esperance Aspiration Catheter System is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device system includes 5F and 6F catheters with inner diameters of 0.055" and 0.071", respectively, designed with three different working lengths for both sizes: 115 cm, 125 cm, and 131 cm. The device is supplied as a kit with Wallaby Aspiration Tubing Set provided with a single catheter. The distal tip of each catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.
The Esperance Aspiration Catheter System is a non-active, surgically invasive device intended for short term use within the vasculature.
b. Indication for Use
The Esperance Aspiration Catheter with the Medela Dominant Flex Surgical Suction Pump and Wallaby Aspiration Tubing set is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
c. Predicate Comparison
The predicate devices for the 5F and 6F Esperance Aspiration Catheter System models are the Penumbra Reperfusion Catheter 054, Penumbra Separator 054 (K090752) and the Penumbra System ACE 64 and ACE 68 Reperfusion Catheters (K142458), respectively. The tables below describe the technological differences between the 5F and 6F Esperance Aspiration Catheter and the predicate Penumbra Reperfusion Catheters 054 and ACE68, respectively:
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| Device Name | Predicate Device:Penumbra ReperfusionCatheter 054 | Subject Device:Esperance AspirationCatheter System (5F) | Rationale for Difference (ifapplicable) |
|---|---|---|---|
| 510(k) No. | K090752 | K211697 | |
| Classification | Class II, NRY | SAME | N/A- SAME |
| Intended Use | The Penumbra System isintended for use in therevascularization of patientswith acute ischemic strokesecondary to intracranial largevessel occlusive disease (withinthe internal carotid, middlecerebral – M1 and M2segments, basilar, and vertebralarteries) within 8 hours ofsymptom onset. | The Esperance AspirationCatheter with the MedelaDominant Flex Surgical SuctionPump and Wallaby AspirationTubing set is intended for usein the revascularization ofpatients with acute ischemicstroke secondary tointracranial large vesselocclusive disease (withininternal carotid, middlecerebral – M1 and M2segments, basilar, andvertebral arteries) within 8hours of symptom onset.Patients who are ineligible forintravenous tissueplasminogen activator (IV t-PA) or who fail IV t-PA therapyare candidates for treatment. | Both devices utilize anaspiration pump as part of therevascularization process |
| Materials | |||
| Shaft | |||
| Extrusions | Outer layer:Tecoflex (thermoplasticpolyurethane), Pellethane(thermoplastic polyurethane),Pebax (polyether block amide),Vestamid (polyamide)Inner layer:PTFE | Outer layer:Tecothane (polyurethaneelastomer), Pebax (polyetherblock amide), Vestamid(polyamide)Inner layer:PTFE | Both device materials arebiocompatible, designed to beused in vasculature |
| WireReinforcement | SS flat coil | Nitinol coil and braid | |
| Components | |||
| Hub | Grilamid (TR55) | Nylon | Both device materials are |
| Coating | Hydrophilic Coating | Hydrophilic Coating | biocompatible, designed to beused in vasculature |
| Strain Relief | Stainless Steel 304 | Thermoplastic vulcanizate,polypropylene | |
| Strain Relief[Hub Sleeve] | Grilamid (TR55) | N/A | N/A- subject device has nostrain relief hub sleeve |
| ID Band | Polyolefin, PET yellow [black ink] | N/A | N/A- subject device has no IDband |
| Colorant | Clear/Natural or Purple | Natural or Green or Blue | Both device colorants areapproved for use in medicaldevice applications |
| Marker Band | C-cut Pt/Ir Band | SAME | N/A- SAME |
| Device Name | Predicate Device:Penumbra ReperfusionCatheter 054 | Subject Device:Esperance AspirationCatheter System (5F) | Rationale for Difference (ifapplicable) |
| TipConfiguration | Straight, steam shapeable byuser | Straight, steam shapeable byuser | N/A- SAME |
| Accessories | |||
| ShapingMandrel | Not Reported | Stainless Steel | The shaping mandrel suppliedwith the Esperance AspirationCatheter System wasconsidered in biocompatibilityassessments |
| PeelableSheath | PTFE | PTFE | N/A- SAME |
| RotatingHemostasisValve | Polycarbonate, silicone ring | Polycarbonate, silicone ring | N/A- SAME |
| Dimensions | |||
| Shaft | |||
| Proximal OD | 0.080 in Max | 0.069 in Max | Both devices are evaluated to |
| Distal OD | 0.066 in Max | 0.065 in Max | achieve proper placementduring revascularization. |
| Proximal ID | 0.064 in Min | 0.054 in Min | Both devices are evaluated to |
| Distal ID | 0.054 in Min | 0.054 in Min | allow for revascularizationthrough the ID of the device |
| EffectiveLength | 125 – 132 cm | 115 – 131 cm | Both devices are evaluated toachieve proper placementduring revascularization |
| Coating Length | 30 cm | 60 cm | Both devices are evaluated toachieve proper placementduring revascularization |
| Accessories | |||
| PeelableSheath | Not Reported | 0.092 in ID | The peelable sheath ID isdesigned to be compatible withthe 5F Esperance AspirationCatheter System |
| ShapingMandrel | 0.038 in OD | 0.035 in OD | Both devices are evaluated forability to retain shape aftershaping with the mandrel |
| Packaging Material | |||
| Pouch | Polyester/polyethylene/Tyvek | Tyvek to nylon | Packaging materials are similarand common for medical |
| PackagingHoop | Polyethylene | HDPE | devices. Both packagingconfigurations maintainsterility of the device throughshelf life |
| Packaging Card | Polyethylene | HDPE | |
| Display Carton | SBS Paperboard | SBS Paperboard | N/A- SAME |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | N/A- SAME |
| How Supplied | Sterile, Single Use | Sterile, Single Use | N/A- SAME |
| Shelf Life | 36 Months | 12 months | A 1 year shelf life is sufficientto allow for use of the device |
| Aspiration Pump and Tubing | |||
| AspirationPump | Penumbra System withPenumbra ENGINE VacuumPump (cleared under K180008)of -29.2 in Hg with disposablecanister | Medela Dominant FlexSurgical Suction PumpVacuum of -29.2 in Hg withdisposable canister | Both pumps are evaluatedwith their respective systemto allow forrevascularization |
| Device Name | Predicate Device:Penumbra ReperfusionCatheter 054 | Subject Device:Esperance AspirationCatheter System (5F) | Rationale for Difference (ifapplicable) |
| AspirationTubing | 112 inch lengthTubing ID = 0.110 inch | 112 inch lengthTubing ID = 0.110 inchIntegrated valve for vacuumcontrol | Both aspiration tubing setsare evaluated with theirrespective system to allowfor revascularization |
Table 1 5F Esperance Aspiration Catheter System Technological Comparison to Predicate Penumbra Reperfusion Catheter 054
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Table 2 6F Esperance Aspiration Catheter System Technological Comparison to Predicate Penumbra System ACE 68 Reperfusion Catheter
| Device Name | Predicate Device:Penumbra System ACE 68Reperfusion Catheter | Subject Device:Esperance AspirationCatheter System (6F) | Rationale for Difference (ifapplicable) |
|---|---|---|---|
| 510(k) No. | K142458 | K211697 | |
| Classification | Class II, NRY | SAME | N/A- SAMEBoth devices utilize anaspiration pump as part of therevascularization process |
| Intended Use | The Penumbra System isintended for use in therevascularization of patientswith acute ischemic strokesecondary to intracranial largevessel occlusive disease (withinthe internal carotid, middlecerebral - M1 and M2 segments,basilar, and vertebral arteries)within 8 hours of symptomonset. The Reperfusion CathetersACE 64 and ACE 68 are intendedfor use in revascularizationwithin the Internal Carotid Artery(ICA) within 8 hours of symptomonset. | The Esperance AspirationCatheter with the MedelaDominant Flex Surgical SuctionPump and Wallaby AspirationTubing set is intended for usein the revascularization ofpatients with acute ischemicstroke secondary tointracranial large vesselocclusive disease (withininternal carotid, middlecerebral – M1 and M2segments, basilar, andvertebral arteries) within 8hours of symptom onset.Patients who are ineligible forintravenous tissueplasminogen activator (IV t-PA) or who fail IV t-PA therapyare candidates for treatment. | |
| Materials | |||
| Shaft | |||
| Extrusions | Outer layer:Tecoflex (thermoplasticpolyurethane), Pellethane(thermoplastic polyurethane),Pebax (polyether block amide),Vestamid (polyamide)Inner layer:PTFE | Outer layer:Tecothane (polyurethaneelastomer), Pebax (polyetherblock amide), Vestamid(polyamide)Inner layer:PTFE | Both device materials arebiocompatible, designed to beused in vasculature |
| WireReinforcement | SS and Nitinol coil | Nitinol coil and braid | |
| Components | |||
| Hub | Grilamid (TR55) | Nylon | |
| Coating | Hydrophilic Coating | Hydrophilic Coating | Both device materials arebiocompatible, designed to beused in vasculature |
| Strain Relief | Stainless Steel 304 | Thermoplastic vulcanizate,polypropylene | |
| Strain Relief[Hub Sleeve] | Grilamid (TR55) | N/A | N/A- subject device has nostrain relief hub sleeve |
| Device Name | Predicate Device:Penumbra System ACE 68Reperfusion Catheter | Subject Device:Esperance AspirationCatheter System (6F) | Rationale for Difference (ifapplicable) |
| ID Band | Polyolefin, PET yellow [black ink] | N/A | N/A- subject device has no IDband |
| Colorant | Clear/Natural or Purple | Natural or Green or Blue | Both device colorants areapproved for use in medicaldevice applications |
| Marker Band | C-cut Pt/Ir Band | C-cut Pt/Ir Band | N/A- SAME |
| TipConfiguration | Straight, steam shapeable byuser | Straight, steam shapeable byuser | N/A- SAME |
| Accessories | |||
| ShapingMandrel | Not Reported | Stainless Steel | The shaping mandrel suppliedwith the Esperance AspirationCatheter System wasconsidered in biocompatibilityassessments |
| PeelableSheath | PTFE | PTFE | N/A- SAME |
| RotatingHemostasisValve | Polycarbonate, silicone ring | Polycarbonate, silicone ring | N/A- SAME |
| Dimensions | |||
| Shaft | |||
| Proximal OD | 0.084 in Max | SAME | N/A- SAME |
| Distal OD | 0.084 in Max | SAME | N/A- SAME |
| Proximal ID | 0.068 in Min | 0.070 in Min | Both devices are evaluated to |
| Distal ID | 0.068 in Min | 0.070 in Min | allow for revascularizationthrough the ID of the device |
| EffectiveLength | 115 – 132 cm | 115 – 131 cm | Both devices are evaluated toachieve proper placementduring revascularization |
| Coating Length | 30 cm | 60 cm | Both devices are evaluated toachieve proper placementduring revascularization |
| Accessories | |||
| PeelableSheath | Not Reported | 0.092 in ID | The peelable sheath ID isdesigned to be compatible withthe 6F Esperance AspirationCatheter System |
| ShapingMandrel | 0.038 in OD | 0.035 in OD | Both devices are evaluated forability to retain shape aftershaping with the mandrel |
| Packaging Material | |||
| Pouch | Polyester/polyethylene/Tyvek | Tyvek to nylon | Packaging materials are similarand common for medical |
| PackagingHoop | Polyethylene | HDPE | devices. Both packagingconfigurations maintain |
| Packaging Card | Polyethylene | HDPE | sterility of the device throughshelf life. |
| Display Carton | SBS Paperboard | SBS Paperboard | N/A- SAME |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | N/A- SAME |
| How Supplied | Sterile, Single Use | Sterile, Single Use | N/A- SAME |
| Shelf Life | 36 Months | 12 months | A 1 year shelf life is sufficientto allow for use of the device |
| Device Name | Predicate Device:Penumbra System ACE 68Reperfusion Catheter | Subject Device:Esperance AspirationCatheter System (6F) | Rationale for Difference (ifapplicable) |
| AspirationPump | Penumbra System withPenumbra ENGINE VacuumPump (cleared under K180008)of -29.2 in Hg with disposablecanister | Medela Dominant FlexSurgical Suction PumpVacuum of -29.2 in Hg withdisposable canister | Both pumps are evaluatedwith their respective systemto allow forrevascularization |
| AspirationTubing | 112 inch lengthTubing ID = 0.110 inch | 112 inch lengthTubing ID = 0.110 inchIntegrated valve for vacuumcontrol | Both aspiration tubing setsare evaluated with theirrespective system to allowfor revascularization |
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To establish the substantial equivalence of the Esperance Aspiration Catheter System to the predicate devices and meet the requirements of the risk analysis (FMECA), non-clinical bench, animal, and biological compatibility testing was conducted and driven by the risk analysis. The testing performed, and results, are summarized below:
Design Verification Testing - Bench
Performance testing was conducted to support the Esperance Aspiration Catheter System submission. The results of the design verification and validation testing performed confirm that the Esperance Aspiration Catheter System conforms to the pre-defined acceptance criteria. Testing included:
| Test | 5F Result | 6F Result |
|---|---|---|
| Visual Inspection | The device was evaluated to verify the visual inspection requirements were met.The device met all pre-defined acceptance criteria. | The device was evaluated to verify the visual inspection requirements were met.The device met all pre-defined acceptance criteria. |
| Dimensional Inspection (ID, OD, Overall Length, Working Length, Coating Length, Distal Tip to Marker Band, Hub/Strain Relief Length) | The device was evaluated to verify the dimensional requirements were met. The device met all pre-defined acceptance criteria. | The device was evaluated to verify the dimensional requirements were met. The device met all pre-defined acceptance criteria. |
| Aspiration Rate | The device was evaluated to verify the flow rate of saline. The device met all pre-defined acceptance criteria. | The device was evaluated to verify the flow rate of saline. The device met all pre-defined acceptance criteria. |
| Simulated Use | The device was evaluated in a simulated anatomy model for: preparation/ease of assembly, introducer sheath interaction, introducer peel away, compatibility with guidewire/microcatheter, lubricity and durability of hydrophilic coating, kink resistance, removal/aspiration of clots. Device performs as intended and met all pre-defined acceptance criteria under simulated use conditions. | The device was evaluated in a simulated anatomy model for: preparation/ease of assembly, introducer sheath interaction, introducer peel away, compatibility with guidewire/microcatheter, lubricity and durability of hydrophilic coating, kink resistance, removal/aspiration of clots. Device performs as intended and met all pre-defined acceptance criteria under simulated use conditions. |
| Physician Validation (simulated clot retrieval) | The device was evaluated in a simulated anatomy model by physicians with side by side comparison against the predicate for: preparation/ease of assembly, introducer sheath interaction, introducer peel away, compatibility with guidewire/microcatheter, lubricity and durability of hydrophilic coating, kink resistance, removal/aspiration of clots. Device performs as intended and demonstrates equivalency to its predicate device under simulated use conditions | The device was evaluated in a simulated anatomy model by physicians with side by side comparison against the predicate for: preparation/ease of assembly, introducer sheath interaction, introducer peel away, compatibility with guidewire/microcatheter, lubricity and durability of hydrophilic coating, kink resistance, removal/aspiration of clots. Device performs as intended and demonstrates equivalency to its predicate device under simulated use conditions |
| Delivery and Retrieval Forces (device, retrieval only for guidewire) | The device was subjected to delivery and retrieval forces testing in a vascular model under simulated use conditions and met all pre-defined acceptance criteria.The device results were evaluated and compared to the predicate in the same test conditions and deemed substantially equivalent. | The device was subjected to delivery and retrieval forces testing in a vascular model under simulated use conditions and met all pre-defined acceptance criteria.The device results were evaluated and compared to the predicate in the same test conditions and deemed substantially equivalent. |
Table 3. 5F and 6F Catheter Bench Testing Summary
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| Test | 5F Result | 6F Result |
|---|---|---|
| Tip Stiffness | The device tip deflection force was measured on a universal testing machine and met acceptance criteria. The device results were evaluated and compared to the predicate in the same test conditions and deemed substantially equivalent. | |
| Tip Shaping | The device tip was shaped with the shaping mandrel and steam and met the pre-defined acceptance criteria. | |
| System Tensile (hub, shaft, tip) | The device was evaluated to verify the tensile strength of the full system meets the minimum tensile requirement. The device met all predefined acceptance criteria. | |
| Elongation to Failure | The device elongation was obtained from the shaft tensile testing data. The device met all pre-defined acceptance criteria. | |
| Torque Strength | The device torque response was assessed in a vascular model and met acceptance criteria. | |
| Coating Integrity (after particulate testing) | Utilized results of the 6F catheter testing since the larger size and surface area is worst case in terms of coating coverage, and device and model interaction. | The device coating integrity was inspected pre- and post-insertion and retrieval through a vascular model and met all pre-defined acceptance criteria. |
| Coating Lubricity | The device was evaluated for frictional forces on a universal testing machine and met all pre-defined acceptance criteria. | |
| Catheter Burst (Pressure) | The device was evaluated to verify the device does not leak, burst, and is compatible with accessories per ISO 10555-1 and ISO 594-1 and met acceptance criteria. | |
| Leak (Liquid) | ||
| Leak (Air) | criteria. | |
| Kink Resistance | The device was evaluated for resistance to kinking around bends with clinically relevant radii and met acceptance criteria. | |
| Vacuum Resistance | The device was evaluated for resistance to lumen collapse under vacuum and met all pre-defined acceptance criteria. | |
| Particulate | Utilized results of 6F catheter testing since the larger size and surface area is worst case in terms of coating coverage, and device and model interaction. | The device was evaluated within a simulated anatomy model to verify that any particulate generated is comparable to the predicate. The device met acceptance criteria. |
| Corrosion Resistance | The catheter is corrosion resistant per ISO 10555-1. | |
| Radiopacity | The device was evaluated for marker band visibility under fluoroscopy during the animal study and met the pre-defined acceptance criteria |
Table 4. Tubing Set Bench Testing Summary
| Test | Tubing Set Results |
|---|---|
| Leak (Liquid) | The tubing set was evaluated for liquid leak under simulated use conditions and met acceptance criteria. |
| Leak (Air) | The tubing set was evaluated for air leak under simulated use conditions and met acceptance criteria. |
| Set Tensile (Luer connector, suction connector) | The Luer and suction connectors were evaluated to verify the tensile strength supports the minimum tensile requirement. The tubing set connectors met all predefined acceptance criteria. |
| Dimensions (ID, length) | The tubing set was evaluated to verify the dimensional requirements were met. The device met all pre-defined acceptance criteria. |
| Tubing Vacuum Resistance | The tubing set was evaluated for resistance to lumen collapse during vacuum and met all pre-defined acceptance criteria. |
| Tubing Set Functionality | Tubing set functionality was evaluated during simulated use testing and met all pre-defined acceptance criteria. |
| Tubing Label Verification | Tubing set labeling was evaluated during simulated use testing and met all pre-defined acceptance criteria. |
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Table 5. Luer Hub Bench Testing Summary
| Test | Luer Hub Results |
|---|---|
| ISO 80369-7 Section 5Dimension | The device Luer hub dimensions were verified against standard requirements andmet the pre-defined specifications. |
| ISO 80369-7, Section 6.1.3 &80369-20 Annex CFalling Drop PositivePressure Liquid Leakage | The device Luer hub resistance to liquid leakage was verified against standardrequirements and met the pre-defined specifications. |
| ISO 80369-7, Section 6.2 &80369-20 Annex DSub-atmospheric-pressureAir Leakage | The device Luer hub resistance to air leakage was verified against standardrequirements and met the pre-defined specifications. |
| ISO 80369-7, Section 6.3 &80369-20 Annex EStress Cracking | The device Luer hub resistance to liquid leakage after being subjected to stress wasverified against standard requirements and met the pre-defined specifications. |
| ISO 80369-7, Section 6.4 &80369-20 Annex FResistance to Separationform Axial Load | The device Luer hub resistance to separation while under axial load was verifiedagainst standard requirements and met the pre-defined specifications. |
| ISO 80369-7. Section 6.6 &80369-20 Annex HResistance to Overriding | The device Luer hub resistance to overriding a reference connector when under anapplied torque was verified against standard requirements and met the pre-defined specifications. |
| ISO 80369-7, Section 6.5 &80369-20 Annex G & J.2.5Resistance to Separationfrom Unscrewing | The device Luer hub resistance force to unscrewing when under an applied torquewas verified against standard requirements and met the pre-definedspecifications. |
Design Verification Testing - Animal
Non-clinical testing comparing the safety, usability, and performance of the 6F Esperance Aspiration Catheter to the Penumbra System ACE 68 Reperfusion Catheter was conducted on a porcine model. Sub-chronic and chronic (3- and 30-day, respectively) time points were assessed. The 6F Esperance Aspiration Catheter was considered worst case for tracking, vessel interaction and particulate generation due to larger dimensions and surface area.
An interventionalist assessed the safety and usability of the subject and predicate devices after each pass, which included preparation and ease of assembly, introducer sheath interaction, introducer peel away, compatibility with guidewire and microcatheter, lubricity of hydrophilic coating, kink resistance, and device condition, the safety of the device was evaluated by gross necropsy and histopathology of the treated vessels and their downstream tissues and organs.
Sterilization and Shelf Life
The 6F and 5F Esperance Aspiration Catheters are sterilized using an Ethylene Oxide (EO) 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.
Aging studies for the 5F and 6F Esperance Aspiration Catheters have established that the catheters and packaging remain functional for the labeled use by date. Aging studies for packaging integrity, seal strength, and device functionality were performed and met all acceptance criteria.
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Biocompatibility
Biocompatibility data for the Esperance Aspiration Catheter System was collected 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 included:
| TestCatheter | Standard | Results | Conclusion |
|---|---|---|---|
| MTT – L-929Cytotoxicity Study | Cytotoxicity10993-5 | 1XMEM test extract showed no cytotoxic potential to L-929 mouse fibroblast cells undiluted or at any dilution. | Non-cytotoxic |
| ISO IntracutaneousIrritation (GLP - 2Extracts) | Irritation orIntracutaneousReactivity10993-10 | The delta between the average scores of the extract of the test article and the vehicle control are 0.0; 0.2. | Non-irritant |
| ISO Guinea PigMaximizationSensitization (GLP - 2Extracts) | Sensitization10993-10 | Test and control animal's response not greater than "0". | Did not elicitsensitization response |
| ISO Acute SystemicToxicity (GLP - 2Extracts) | Systemic Toxicity10993-11 | 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 within acceptable parameters. | Non-toxic |
| ISO MaterialMediated RabbitPyrogen (GLP) | Pyrogen10993-11 | No rabbit temp rise >= 0.5°C. | Non-pyrogenic |
| ComplementActivation - SC5b-9Assays with Sponsor-Supplied Comparator(GLP) | Results with acceptable range as compared to Control Device. | Test articlecomplement activationhas similarperformance as thecontrol | |
| ASTM Hemolysis -Direct Contact andExtract Method (GLP) | Blank corrected Hemolytic index: 0.1. | Test device is non-hemolytic | |
| Platelet andLeukocyte counts(GLP) | Hemocompatibility10993-4 | No ranges or levels outside an acceptable range and comparable to Control Device. | Counts of test deviceare withinacceptable rangesand similar tocontrol |
| PartialThromboplastin Time(PTT) GLP | Test and predicate device have similar performance. | Test and control articlesare not considered anactivator of the intrinsiccoagulation pathway | |
| ThromboresistanceEvaluation (GLP - 4Hour - 3 Dog) | No adverse effects or clinical signs during test period and no thrombus score >3 for either test or control device | Thromboresistance oftest device is similarto control | |
| Peelable Introducer | |||
| MTT – L-929Cytotoxicity Study | 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 the extract of the test article and the vehicle control are 0.0; 0.1. | Non-irritant |
| ISO Guinea PigMaximization | Sensitization | Test and control animal's response notgreater than "0" | Did not elicitsensitization response |
| Table 6. 510(k) Summary - Biocompatibility Testing | ||
|---|---|---|
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| Sensitization (GLP - 2Extracts) | |||
|---|---|---|---|
| ISO Acute SystemicToxicity (GLP - 2Extracts) | Systemic Toxicity10993-11 | None of the animals were observed withabnormal clinical signs indicative oftoxicity for 72 hours. All were alive atthe end of 72 hours and body weightchanges within acceptable parameters. | Non-toxic |
| ISO MaterialMediated RabbitPyrogen (GLP) | Pyrogen10993-11 | No rabbit temp rise >= 0.5°C. | Non-pyrogenic |
| ASTM Hemolysis -Direct Contact andExtract Method (GLP) | Hemocompatibility10993-4 | Blank corrected Hemolytic index: 0.6. | Non-hemolytic |
| Wallaby AspirationTubing Set | |||
| MTT - L-929Cytotoxicity Study | Cytotoxicity10993-5 | Percent Cell Lysis: 0%Cytotoxic Score: 0 | 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 0.0; 0.1. | Non-irritant |
| ISO Guinea PigMaximizationSensitization (GLP - 2Extracts) | Sensitization10993-10 | Test and control animal's response notgreater than "0". | Did not elicitsensitization response |
Clinical Testing
None. The substantial equivalence was established based on non-clinical performance data. The safety and usability results from the animal studies with both the 6F Esperance Aspiration Catheter and the Penumbra System ACE 68 Reperfusion Catheter were used to demonstrate the subject device is safe, usable, and is substantially equivalent to the predicate device.
Conclusion
The 5F and 6F Esperance Aspiration Catheter Systems are substantially equivalent to the Penumbra Reperfusion Catheter 054 and Penumbra System ACE 68 Reperfusion Catheter, respectively, based on the successful completion of non-clinical testing as well as similar principles of operation, materials of construction, packaging, usability, and the same intended 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).