The Esperance 3+ Aspiration Catheter with the Wallaby Aspiration Tubing set and a compatible aspiration pump 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.

Device Description

The Esperance® 3+ Aspiration Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device has a tapered shaft with tapered inner diameter (ID) from 0.054'' (proximal) to 0.041'' (distal) and tapered outer diameter (OD) from 0.066'' (proximal) to 0.050'' (distal). It has five different working lengths: 120 cm, 133 cm, 145 cm, 153 cm, and 160 cm. The device is supplied as a kit with the 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 3+ Aspiration Catheter System is a non-active, surgically invasive device intended for short term use within the neurovasculature.

AI/ML Overview

The document provided is a 510(k) premarket notification decision letter from the FDA for a medical device called the "Esperance 3+ Aspiration Catheter System." It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing and biocompatibility).

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document lists various performance tests and their outcomes, all indicating that the device met the acceptance criteria. The specific numerical acceptance criteria themselves are not detailed in this public FDA letter, but the conclusion for each test is consistently "All samples met the acceptance criteria" or similar.

Test Category	Test Name	Test Method Summary	Reported Device Performance/Conclusion
Biocompatibility	Cytotoxicity (ISO 10993-5)	MTT- L929 Cytotoxicity Study; ISO MEM elution- L929	No cytotoxic effect.
	Skin Irritation (ISO 10993-10)	ISO Intracutaneous Irritation	No sensitization indicated.
	Sensitization (ISO 10993-10)	ISO Guinea Pig Maximization Sensitization	No sensitization indicated.
	Systemic Toxicity (ISO 10993-11)	ISO Acute Systemic Toxicity; ISO Material Mediated Rabbit Pyrogen (GLP); Systemic Toxicity - Acute Systemic Injection	No acute systemic toxicity indicated. Esperance 3+ Aspiration Catheter is deemed non-pyrogenic. Test articles are deemed non-pyrogenic (for Introducer Sheath). RHV is deemed non-pyrogenic (for Rotating Hemostasis Valve).
	Hemocompatibility (ISO 10993-4)	Hemolysis (ASTM method) Indirect Extract; ASTM Hemolysis - Direct Contact and Extract Method (GLP); Complement Activation; Thromboresistance Evaluation; Partial Thromboplastin Time	No hemolysis indicated. Esperance 3+ Aspiration Catheter is deemed comparable to predicate (for Complement Activation, Thromboresistance Evaluation, Partial Thromboplastin Time).
Sterilization	Sterility Assurance Level (SAL)	Sterilization cycle verified to ensure a SAL of 10^-6 per EN ISO 11135:2014 and AAMI TIR28:2009. Validated via the half cycle method.	Met the SAL of 10^-6.
Shelf Life	Accelerated Aging (AA)	Testing on devices subjected to AA process to represent 1 year of aged units. Aging studies for packaging integrity, seal strength, and device functionality.	Design and performance specification requirements were met after one year shelf life. Catheters and packaging remain functional for the labeled use by date. All acceptance criteria met.
Non-Clinical Bench	Dimensional Verification	Dimensions of the catheter and introducer sheath are measured.	All samples met the acceptance criteria.
	Navigability	Device tested for its ability to reach target site in an anatomical model in comparison to the predicate.	All samples met the acceptance criteria.
	Clot Removal	Subject device tested for its ability to aspirate clots in an anatomical model in comparison to the predicate.	All samples met the acceptance criteria.
	Kink Resistance	Catheter tested at different locations for its ability to bend to clinically relevant radii without kinking in comparison to predicate.	All samples met the acceptance criteria.
	Lubricity	Catheter's hydrophilic coating lubricity tested by applying force to the coated section and measuring frictional force in comparison to the predicate.	All samples met the acceptance criteria.
	Coating Integrity	Coated length of the catheter inspected for defects post simulated use in comparison to the predicate.	All samples met the acceptance criteria.
	Torque Strength	Catheter and predicate evaluated for torque strength by rotating the test sample within an anatomical model until failure while the distal tip was not free to rotate.	All samples met the acceptance criteria.
	Delivery and Retrieval Force	Subject device tested for its ability to reach and be retracted from a target site in an anatomical model with application of force below a specified value. Compared to predicate device.	All samples met the acceptance criteria.
	Vacuum Resistance	Device tested for its ability to withstand a specified vacuum pressure for a specified time without damage, lumen collapse, or kink.	All samples met the acceptance criteria.
	Aspiration Flow Rate	Aspiration flow rate of the subject device at a specified vacuum pressure measured in comparison to the predicate.	All samples met the acceptance criteria.
	Elongation to Failure	Catheter elongation at break obtained from the shaft tensile testing data.	All samples met the acceptance criteria.
	Tip Stiffness	Catheter tip tested by bending in a test fixture and measuring the maximum load that caused deflection. Compared to the predicate.	All samples met the acceptance criteria.
	Atraumatic Distal Tip	Catheter tip inspected for smoothness.	All samples met the acceptance criteria.
	Tip Shaping Ability	Distal tip shaped using the shaping mandrel supplied and assessed for damage and ability to hold tip shape.	All samples met the acceptance criteria.
	Introducer Sheath Compatibility	Supplied introducer sheath tested for compatibility with the Esperance 3+ Aspiration Catheter System.	All samples met the acceptance criteria.
	Device Compatibility	Appropriately sized guidewire delivered and retrieved through the catheter. Catheter delivered and retrieved through an appropriately sized sheath.	All samples met the acceptance criteria.
	Surface Defects	Catheter and introducer sheath examined under magnification for extraneous matter.	All samples met the acceptance criteria.
	Tensile Force	Peak tensile force of the subject catheter measured at different locations in comparison to the predicate.	All samples met the acceptance criteria.
	Liquid Leakage	Subject catheter tested for leakage per ISO 10555-1 and compared to the reference device.	All samples met the acceptance criteria.
	Air Leak	Subject catheter tested for air leakage per ISO 10555-1 and compared to the reference device.	All samples met the acceptance criteria.
	Static Burst	Subject catheter tested to withstand a specified static pressure.	All samples met the acceptance criteria.
	Power Injection	Distal tip of the catheter blocked, and fluid injected into the lumen using a power injector until the catheter burst.	All samples met the acceptance criteria.
	Corrosion	Subject device visually inspected for signs of corrosion post exposure to required conditions per ISO 10555-1.	All samples met the acceptance criteria.
	Particulate Testing	Size and number of particulates generated during simulated use of the device in a neurovascular model were measured and calculated. Particulate generation compared to the reference device.	Particulate generation was similar between the subject and reference device.
	Hub/Luer Fitting	Catheter hub tested as per ISO 80369-7.	All samples met the acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document dedicates a section to "PERFORMANCE TESTING - BENCH" and concludes most tests with "All samples met the acceptance criteria." However, it does not specify the sample size used for each of these non-clinical tests.

The data provenance is through non-clinical bench testing performed by the manufacturer, Wallaby Medical. There's no information about the country of origin of the data within the document, beyond the sterilization facility being in "Suzhou) Ltd., Jiangsu, China." The nature of the tests (bench testing, biocompatibility, sterilization, shelf life) indicates these are prospective tests performed specifically 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 the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the document describes non-clinical bench performance testing, not a clinical study involving human or image-based data that would require expert ground truth labeling. The "ground truth" for these tests is based on objective measurements and established engineering standards (e.g., ISO, ASTM).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the document describes non-clinical bench performance testing where adjudication methods typical for clinical or image-based studies are not relevant.

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

No MRMC comparative effectiveness study was done or reported. The device is a medical catheter and not an AI/imaging algorithm that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical medical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests described, the "ground truth" is based on:

Engineering specifications and standards: Adherence to ISO standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 10555-1 and 80369 for bench tests) and relevant FDA guidance documents.
Objective measurements: Dimensional verification, force measurements, flow rates, visual inspections for defects, etc.
Comparison to predicate/reference device: Many tests involved comparing the subject device's performance (e.g., navigability, clot removal, lubricity, particulate generation) to the predicate or reference device to establish similarity and ensure similar safety and effectiveness profiles.

8. The sample size for the training set

This is not applicable. The document describes the testing of a physical medical device, not an AI or machine learning model that would require a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

October 1, 2024

Wallaby Medical Rachel McDaid Senior Regulatory Affairs Specialist 22901 Mill Creek Drive Laguna Hills, California 92653

Re: K240917

Trade/Device Name: Esperance 3+ Aspiration Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: August 30, 2024 Received: August 30, 2024

Dear Rachel McDaid:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Naira Muradyan -S

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K240917

Device Name Esperance 3+ Aspiration Catheter System

Indications for Use (Describe)

The Esperance 3+ Aspiration Catheter with the Wallaby Aspiration Tubing set and a compatible aspiration pump 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.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/1 description: The image shows the logo for Wallaby Medical. The logo consists of a green and blue circle with a white design inside, followed by the text "沃比医疗" in Chinese characters, with "Wallaby Medical" written below in English. The text is also in green and blue, matching the colors of the circle.

K240917 510(k) Summary (21 CFR 807.92)

I. SUBMITTER

Wallaby Medical 22901 Mill Creek Drive Laguna Hills, California 92653

Contact Person: Rachel McDaid Phone: +353 (0)91 740128 Date Prepared: September 30, 2024

II. DEVICE

Device Trade Name: Esperance 3+ Aspiration Catheter System Common or Usual Name: Catheter, Thrombus Retriever Classification: Class II Regulation Number: 21 CFR 870.1250 Product Code: NRY

III. PREDICATE DEVICE

Name: Penumbra System MAX Manufacturer: Penumbra, Inc. 510(k) number: K113163

IV. DEVICE DESCRIPTION

Device Description:

The Esperance 3+ Aspiration Catheter System is a non-active, surgically invasive device intended for short term use within the neurovasculature.

Environment of Use:

The Esperance 3+ Aspiration Catheter System is solely intended for use by trained physicians in a healthcare facility/hospital.

V. INDICATIONS FOR USE

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Image /page/5/Picture/1 description: The image shows the logo for Wallaby Medical. The logo features a green and blue gradient circle with a white abstract design inside. To the right of the circle is the company name in both Chinese and English. The English name, "Wallaby Medical," is written in a green and blue gradient font.

The Indications for Use statement of the subject device is similar to the predicate device. The differences do not raise new or different questions of safety or effectiveness.

Table 1: Comparison of Indications for Use of the Esperance 3+ Aspiration Catheter System with the predicate and reference devices

Parameter	Reference DeviceEsperance AspirationCatheter System (K211697)	Predicate DevicePenumbra System MAX(K113163)	Subject DeviceEsperance 3+ AspirationCatheter System(K240917)
Indications forUse	The Esperance AspirationCatheter with the MedelaDominant Flex SurgicalSuction Pump andWallaby Aspiration Tubingset is intended for use intherevascularization ofpatients with acuteischemic stroke secondaryto intracranial 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-tPA) or who fail IV t-PAtherapy are candidates fortreatment.	The Penumbra Systemis intended for use inthe revascularization ofpatients with acuteischemic strokesecondary tointracranial large vesselocclusive disease (inthe internal carotid,middle cerebral – M1and M2 segments,basilar, and vertebralarteries) within 8 hoursof symptom onset.	The Esperance 3+Aspiration Catheter withthe Wallaby AspirationTubing set and acompatible aspirationpump is intended for usein the revascularizationof patients with acuteischemic strokesecondary to intracraniallarge vessel occlusivedisease (within internalcarotid, middle cerebral– M1 and M2 segments,basilar, and vertebralarteries) within 8 hours ofsymptom onset. Patientswho are ineligible forintravenous tissueplasminogen activator (IVt-PA) or who fail IV t-PAtherapy are candidates fortreatment.
Parameter	Reference Device(K211697)	Predicate Device(K113163)	Subject Device(K240917)
Device Name	Esperance AspirationCatheter System	Penumbra SystemMAX	Esperance 3+ AspirationCatheter System
Model #	ASP6F131KITASP6F125KITASP6F115KITASP6F131ASP6F125ASP6F115	6F3MAXC	ASP3F160KITASP3F153KITASP3F145KITASP3F133KITASP3F120KIT
	ASP5F131KITASP5F125KITASP5F115KITASP5F131ASP5F125ASP5F115	5F
510(k) Number	K211697	K113163	K240917
Classification	Class II	Class II	Class II
Product Code	NRY	NRY	NRY
DeviceDesign/Materials	Nitinol braided shaft,nitinol coil, polymericexterior	Stainless steel andNitinol coiled shaft,polymeric exterior	Inner shaft:Stainless steel braidedshaft, Nitinol coilOuter layer:Polymeric exterior Tecoflex(thermoplasticpolyurethane), Pellethane(thermoplasticpolyurethane), Pebax(polyether block amide),Vestamid (polyamide)Inner layer: PTFEHub: Polyamide
WireReinforcement	Nitinol coil and braid	Stainless steel andNitinol coiled shaft	Stainless steelbraided shaft,Nitinol coil
Strain Relief	Thermoplasticvulcanizate,polypropylene	Unknown	Silicone
Colorant	Natural or Green orBlue	Unknown	Green/Blue/White
	Tip Configuration
	Straight, steam shapeable by user	Straight, steam shapeable by user	Straight, steam shapeable by user
Marker Band Material/ Radiopacity	Radiopaque C-cut Platinum/Iridium	Radiopaque	Radiopaque Platinum/Iridium
Hub Material	Nylon	Unknown	Polyamide
Coating and Length	Hydrophilic coating Length: 60 cm	Hydrophilic coating Length: 95 cm	Hydrophilic coating Length: 100 cm
Working Length	115 cm125 cm131 cm	153 cm	120 cm133 cm145 cm153 cm160 cm
Outer Diameter	6F 0.084" Distal0.084" Proximal5F 0.065" Distal0.069" Proximal	0.050" Distal0.062" Proximal	0.050" Distal0.066" Proximal
Inner Diameter	6F 0.070"5F 0.054"	0.035" min	0.041" Distal0.054" Proximal
Use	Single Use Device	Single Use Device	Single Use Device
Sterilization	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
Shelf Life	12 months	Unknown	12 months
Accessory Devices	Aspiration TubingIntroducer SheathShaping MandrelRotating Haemostasis Valve	Aspiration TubingIntroducer SheathShaping MandrelRotating Haemostasis Valve	Aspiration TubingIntroducer SheathShaping MandrelRotating Haemostasis Valve
Aspiration Tubing Dimensions	112 inch lengthTubing ID = 0.110 inchIntegrated valve for vacuum control	112 inch lengthTubing ID = 0.110 inch	112 inch lengthTubing ID = 0.110 inchIntegrated valve for vacuum control
Aspiration Tubing Materials	Polyurethane & Nylon	Polyurethane & Nylon	Polyurethane & Nylon
Packaging Components/ Configuration	Device is stored within a HDPE packaging hoopPackaging hoop is contained within a sterile barrier Tyvek to nylon pouchPackaged within a shipping carton	Supplied within a dispenser hoopDispenser hoop is contained within a sterile barrier pouchPackaged within a shipping carton	Device is stored within a HDPE packaging hoopPackaging hoop is contained within a sterile barrier Tyvek to nylon pouchPackaged within a shipping carton

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Image /page/6/Picture/1 description: The image shows the logo for Wallaby Medical. The logo consists of a green and blue circle with a white design inside, followed by the text "Wallaby Medical" in green and blue. Above the text are Chinese characters in blue and green.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Table 2: Comparison of technological characteristics of the Esperance 3+ Aspiration Catheter System with predicate and reference devices

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Image /page/7/Picture/0 description: The image shows the logo for Wallaby Medical. The logo features a green and blue color scheme. To the left is a green circular graphic with a white design inside. To the right of the graphic is the company name, with the Chinese characters above the English name.

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Image /page/8/Picture/1 description: The image contains the logo for Wallaby Medical. The logo consists of a circular graphic on the left, with a stylized image inside. To the right of the graphic is the company name in both Chinese and English. The English name, "Wallaby Medical", is written in a smaller font size below the Chinese characters.

VII. PERFORMANCE DATA

Biocompatibility

Biocompatibility testing for the Esperance 3+ Aspiration Catheter System was conducted based on International Organization for Standardization (ISO) 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process," and the FDA guidance document "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process"" (2020).

Table 3 below summarizes biocompatibility testing performed on the Esperance 3+ Aspiration Catheter System and accessories to be marketed with the device.

Test	Test Description	Conclusion
	Esperance 3+ Aspiration Catheter Test Results
CytotoxicityISO 10993-5	MTT- L929 Cytotoxicity Study	No cytotoxic effect.
Skin IrritationISO 10993-10	ISO Intracutaneous Irritation	No sensitization indicated.
SensitizationISO 10993-10	ISO Guinea Pig MaximizationSensitization	No sensitization indicated.
Systemic ToxicityISO 10993-11	ISO Acute Systemic Toxicity	No acute systemic toxicity indicated.
	ISO Material Mediated RabbitPyrogen (GLP)	Esperance 3+ Aspiration Catheter isdeemed non-pyrogenic.
HemocompatibilityISO 10993-4	Hemolysis (ASTM method) IndirectExtract	No hemolysis indicated.
	ASTM Hemolysis - Direct Contactand Extract Method (GLP)	No hemolysis indicated.
	Complement Activation	Esperance 3+ AspirationCatheter is deemed comparableto predicate.
	Thromboresistance Evaluation	Esperance 3+ Aspiration Catheter isdeemed comparable to predicate.
	Partial Thromboplastin Time	Esperance 3+ Aspiration Catheter isdeemed comparable to predicate.
Accessory Test Results - Introducer Sheath
CytotoxicityISO 10993-5	ISO MEM elution- L929	No cytotoxic effect.
SensitizationISO 10993-10	ISO Guinea Pig MaximizationSensitization	No sensitization indicated.
Skin IrritationISO 10993-10	ISO Intracutaneous Irritation	No sensitization indicated.
Systemic ToxicityISO 10993-11	Systemic Toxicity - AcuteSystemic Injection	No acute systemic toxicity indicated.

Table 3: Biocompatibility Testing Results for the Esperance 3+ Aspiration Catheter System

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Image /page/9/Picture/0 description: The image shows the logo for Wallaby Medical. The logo consists of a green and blue gradient design. On the left is a green circle with a white design inside. To the right of the circle is the company name in both Chinese and English. The Chinese characters are in blue, and the English name "Wallaby Medical" is in green.

	Material Mediated PyrogenicityTest	Test articles are deemed non-pyrogenic.
HemocompatibilityISO 10993-4	ASTM Hemolysis -Extract Method	No hemolysis indicated.
Accessory Test Results - Wallaby Aspiration Tubing
CytotoxicityISO 10993-5	MTT- L929 Cytotoxicity Study	No cytotoxic effect.
Skin IrritationISO 10993-10	ISO Intracutaneous Irritation	No sensitization indicated.
SensitizationISO 10993-10	ISO Guinea Pig MaximizationSensitization	No sensitization indicated.
Accessory Test Results - Rotating Hemostasis Valve
CytotoxicityISO 10993-5	ISO MEM elution- L929	No cytotoxic effect.
Skin IrritationISO 10993-10	ISO Intracutaneous Irritation	No sensitization indicated.
SensitizationISO 10993-10	ISO Guinea Pig MaximizationSensitization	No sensitization indicated.
Systemic ToxicityISO 10993-11	ISO Acute Systemic Toxicity	No acute systemic toxicity indicated.
	ISO Material Mediated RabbitPyrogen (GLP)	RHV is deemed non- pyrogenic.
HemocompatibilityISO 10993-4	ASTM Hemolysis -Extract Method	No hemolysis indicated.

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Image /page/10/Picture/0 description: The image contains the logo for Wallaby Medical. The logo consists of a green and blue gradient circle with a white abstract design inside. To the right of the circle is the company name in both Chinese characters and English. The English name "Wallaby Medical" is written in a smaller font size below the Chinese characters.

Sterilization

The Esperance 3+ Aspiration Catheter System is sterilized by Ethylene Oxide. Sterilization takes place in Steris Sterilization Technologies (Suzhou) Ltd., Jiangsu, China. The sterilization cycle was verified to ensure a sterility assurance level (SAL) of 10-6.

The Esperance 3+ Aspiration Catheter System has been adopted into an existing validated cycle per EN ISO 11135:2014 and AAMI TIR28:2009.

Standards utilized in regards to sterilization:

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."

FDA guidance documents utilized in regards to sterilization:

"Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labelled as Sterile" (2016).

The sterilization cycle has been validated via the half cycle method.

Shelf Life

Shelf life conditioning has been completed and testing has been performed on devices subjected to an accelerated aging (AA) process to represent 1 year of aged units. Devices subjected to 1 year AA were tested to ensure design and performance specification requirements were met after the one year shelf life that the Esperance 3+ Aspiration Catheter System will have at commercialization. Aging studies for the Esperance 3+ Aspiration Catheter System 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.

FDA guidance documents utilized in regards to shelf life:

"Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019).

Non-Clinical Performance Data

The following non-clinical performance tests were performed to support the substantial equivalence determination as summarized below.

PERFORMANCE TESTING - BENCH

A full suite of bench performance testing was carried out on the Esperance 3+ Aspiration Catheter System. The results of this testing demonstrated compliance to all the design attributes and that the device performs as intended. Table 4 below summarizes the bench performance tests and results.

Test	Test Method Summary	Results
DimensionalVerification (WorkingLength, CoatingLength, ID, OD)	The dimensions of the catheter and theintroducer sheath are measured.	All samples met theacceptance criteria.
Test	Test Method Summary	Results
Navigability	The device is tested for its ability to reach targetsite in an anatomical model in comparison to thepredicate.	All samples met theacceptance criteria.
Clot Removal	The subject device is tested for its ability toaspirate clots in an anatomical model incomparison to the predicate.	All samples met theacceptance criteria.
Kink Resistance	The catheter is tested at different locationsfor its ability to bend to clinically relevantradii without kinking in comparison topredicate.	All samples met theacceptance criteria.
Lubricity	The catheter's hydrophilic coating lubricity istested by applying force to the coatedsection of the catheter and measuring thefrictional force in comparison to thepredicate.	All samples met theacceptance criteria.
Coating Integrity	The coated length of the catheter isinspected for defects post simulated use incomparison to the predicate.	All samples met theacceptance criteria.
Torque Strength	The catheter and predicate were evaluatedfor torque strength by rotating the testsample within an anatomical model untilfailure while the distal tip was not free torotate.	All samples met theacceptance criteria.
Delivery and RetrievalForce	The subject device is tested for its ability toreach and be retracted from a target site inan anatomical model with application offorce below a specified value. Delivery andretrieval forces were also compared to thepredicate device.	All samples met theacceptance criteria.
Vacuum Resistance	The device is tested for its ability towithstand a specified vacuum pressure for aspecified time without damage, lumencollapse, or kink.	All samples met theacceptance criteria.
Aspiration Flow Rate	The aspiration flow rate of the subject deviceat a specified vacuum pressure wasmeasured in comparison to the predicate.	All samples met theacceptance criteria.
ElongationtoFailure	The catheter elongation at break wasobtained from the shaft tensile testing data.	All samples met theacceptance criteria.
Test	Test Method Summary	Results
Tip Stiffness	The catheter tip is tested by bending in a testfixture and measuring the maximum loadthat caused deflection. Tip stiffness was alsocompared to the predicate.	All samples met theacceptance criteria.
Atraumatic Distal Tip	The catheter tip is inspected for smoothness.	All samples met theacceptance criteria.
Tip Shaping Ability	The distal tip of the catheter is shaped usingthe shaping mandrel supplied with theEsperance 3+ Aspiration Catheter System andthe distal tip is assessed for damage and theability to hold the tip shape.	All samples met theacceptance criteria.
Introducer SheathCompatibility	The supplied introducer sheath is tested forcompatibility with the Esperance 3+Aspiration Catheter System.	All samples met theacceptance criteria.
Device Compatibility	An appropriately sized guidewire is deliveredand retrieved through the catheter. Thecatheter is delivered and retrieved throughan appropriately sized sheath.	All samples met theacceptance criteria.
Surface Defects	The catheter and introducer sheath areexamined under magnification forextraneous matter.	All samples met theacceptance criteria.
Tensile Force	The peak tensile force of the subject catheteris measured at different locations incomparison to the predicate.	All samples met theacceptance criteria.
Liquid Leakage	The subject catheter is tested for leakage perISO 10555-1 and compared to the referencedevice.	All samples met theacceptance criteria.
Air Leak	The subject catheter is tested for air leakageper ISO 10555-1 and compared to thereference device.	All samples met theacceptance criteria.
Static Burst	The subject catheter is tested to withstand aspecified static pressure.	All samples met theacceptance criteria.
Test	Test Method Summary	Results
Power Injection	The distal tip of the catheter was blocked,and fluid was injected into the lumen using apower injector until the catheter burst.	All samples met theacceptance criteria.
Corrosion	The subject device is visually inspected forsigns of corrosion post exposure to requiredconditions per ISO 10555-1.	All samples met theacceptance criteria.
Particulate Testing	The size and number of particulatesgenerated during simulated use of the devicein a neurovascular model were measured andcalculated. Particulate generation wascompared to the reference device.	Particulate generation wassimilar between the subjectand reference device.
Hub/Luer Fitting	The catheter hub is tested as per ISO 80369-7.	All samples met theacceptance criteria.

Table 4: Summary of Non-Clinical Bench Testing

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Image /page/12/Picture/1 description: The image is a logo for Wallaby Medical. The logo features a green and blue gradient circle with a white kangaroo-like figure inside. To the right of the circle is the text "沃比医疗" in Chinese characters, followed by "Wallaby Medical" in English.

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Image /page/13/Picture/1 description: The image is a logo for Wallaby Medical. The logo features a green and blue gradient circle with a white abstract design inside. To the right of the circle is the text "沃天比医疗" in blue and green, followed by "Wallaby Medical" in a smaller font size.

Standards utilized in regards to bench testing:

ISO 10555-1:2013/A1:2017 "Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements."

ISO 80369-20 "Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods."

ISO 80369-7:2016 "Small-bore connectors for liquids and gases in healthcare application - Part 7: Connectors for intravascular or hypodermic applications.

ISO 62366-1: 2015 + AC:2015 & A1 2020 "Medical Devices- Part 1: Application of Usability Engineering to Medical Devices."

FDA quidance documents utilized in regards to bench testing:

"Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019).

"Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters - Class II Special Controls Guidance for Industry and FDA" (2010).

"Applying Human Factors and Usability Engineering to Medical Devices" (2016).

Clinical Testing

Clinical testing was not performed on the Esperance 3+ Aspiration Catheter System as clinical data were not deemed necessary to establish substantial equivalence.

Animal Testing

Animal data were not deemed necessary as substantial equivalence was established based upon successful completion of non-clinical performance testing presented above.

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Image /page/14/Picture/1 description: The image contains a logo for Wallaby Medical. The logo features a green and blue gradient circle with a white kangaroo-like figure inside. To the right of the circle, the text "沃比医疗" is written in blue and green, followed by "Wallaby Medical" in a smaller font size.

VIII. CONCLUSIONS

Wallaby Medical has demonstrated that the Esperance 3+ Aspiration Catheter System is substantially equivalent to the predicate device Penumbra System MAX (K113163). The subject device has the same intended use, similar technological characteristics, similar materials, and the same operating principle as the predicate device. The differences do not raise new questions of safety or effectiveness. The subject device has been demonstrated to perform as intended through successful non-clinical performance testing.

Regulation Number and Section

§ 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).