Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical aspiration catheter system and associated components. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are focused on mechanical and physical properties, not algorithmic performance.

Therapeutic

Yes
The device is described as an "Aspiration Catheter" used for "revascularization of patients with acute ischemic stroke" by removing occlusions in blood vessels, which directly treats a medical condition.

Diagnostic

No

The device is intended for revascularization and clot retrieval, which are therapeutic interventions, not diagnostic procedures.

SaMD (Software as a Medical Device)

No

The device description explicitly details a physical catheter system, tubing set, and associated hardware components. It is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used in vivo (within the body) for a surgical procedure (revascularization of patients with acute ischemic stroke). IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Device Description: The description details a vascular catheter designed to be inserted into blood vessels. This is consistent with an in vivo medical device, not an in vitro diagnostic device.
Anatomical Site: The specified anatomical site is within the intracranial arteries, which is an in vivo location.
Performance Studies: The performance studies described are bench testing and animal testing, which are typical for in vivo medical devices. IVD performance studies typically involve testing with human specimens.

In summary, the Esperance Aspiration Catheter System is a surgical device used directly on the patient's body for treatment, not a device used to analyze samples from the body for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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 - 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.

Product codes (comma separated list FDA assigned to the subject device)

NRY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intracranial large vessel occlusive disease (within internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Design Verification Testing - Bench: Performance testing was conducted to support the Esperance Aspiration Catheter System submission. Tests included Visual Inspection, Dimensional Inspection, Aspiration Rate, Simulated Use, Physician Validation (simulated clot retrieval), Delivery and Retrieval Forces, Tip Stiffness, Tip Shaping, System Tensile, Elongation to Failure, Torque Strength, Coating Integrity, Coating Lubricity, Catheter Burst, Leak (Liquid), Leak (Air), Kink Resistance, Vacuum Resistance, Particulate, Corrosion Resistance, and Radiopacity. All tests met pre-defined acceptance criteria and demonstrated substantial equivalence to predicate devices under simulated use conditions.

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. An interventionalist assessed the safety and usability of the subject and predicate devices 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.

Biocompatibility: Biocompatibility data was collected in accordance with ISO 10993-1:2018. Tests included MTT – L-929 Cytotoxicity Study, ISO Intracutaneous Irritation, ISO Guinea Pig Maximization Sensitization, ISO Acute Systemic Toxicity, ISO Material Mediated Rabbit Pyrogen, Complement Activation - SC5b-9 Assays, ASTM Hemolysis, Platelet and Leukocyte counts, Partial Thromboplastin Time (PTT), and Thromboresistance Evaluation. All tests showed non-cytotoxic, non-irritant, non-sensitizing, non-toxic, non-pyrogenic, non-hemolytic results, and similar performance to control devices, indicating biocompatibility.

Clinical Testing: None conducted. Substantial equivalence was established based on non-clinical performance data and animal studies results.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K090752, K142458

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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

1

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

2

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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3

510(k) Number: K211697

As required by 21 CFR 807.92:

| Applicant: | Wallaby Medical
22901 Mill Creek Drive
Laguna 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:

4

| Device Name | Predicate Device:
Penumbra Reperfusion
Catheter 054 | Subject Device:
Esperance Aspiration
Catheter System (5F) | Rationale for Difference (if
applicable) |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K090752 | K211697 | |
| Classification | Class II, NRY | SAME | N/A- SAME |
| Intended Use | The Penumbra System is
intended for use in the
revascularization of patients
with acute ischemic stroke
secondary to intracranial large
vessel occlusive disease (within
the internal carotid, middle
cerebral – M1 and M2
segments, basilar, and vertebral
arteries) within 8 hours of
symptom onset. | 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. | Both devices utilize an
aspiration pump as part of the
revascularization process |
| Materials | | | |
| Shaft | | | |
| Extrusions | Outer layer:
Tecoflex (thermoplastic
polyurethane), Pellethane
(thermoplastic polyurethane),
Pebax (polyether block amide),
Vestamid (polyamide)
Inner layer:
PTFE | Outer layer:
Tecothane (polyurethane
elastomer), Pebax (polyether
block amide), Vestamid
(polyamide)
Inner layer:
PTFE | Both device materials are
biocompatible, designed to be
used in vasculature |
| Wire
Reinforcement | SS flat coil | Nitinol coil and braid | |
| Components | | | |
| Hub | Grilamid (TR55) | Nylon | Both device materials are |
| Coating | Hydrophilic Coating | Hydrophilic Coating | biocompatible, designed to be
used in vasculature |
| Strain Relief | Stainless Steel 304 | Thermoplastic vulcanizate,
polypropylene | |
| Strain Relief
[Hub Sleeve] | Grilamid (TR55) | N/A | N/A- subject device has no
strain relief hub sleeve |
| ID Band | Polyolefin, PET yellow [black ink] | N/A | N/A- subject device has no ID
band |
| Colorant | Clear/Natural or Purple | Natural or Green or Blue | Both device colorants are
approved for use in medical
device applications |
| Marker Band | C-cut Pt/Ir Band | SAME | N/A- SAME |
| Device Name | Predicate Device:
Penumbra Reperfusion
Catheter 054 | Subject Device:
Esperance Aspiration
Catheter System (5F) | Rationale for Difference (if
applicable) |
| Tip
Configuration | Straight, steam shapeable by
user | Straight, steam shapeable by
user | N/A- SAME |
| Accessories | | | |
| Shaping
Mandrel | Not Reported | Stainless Steel | The shaping mandrel supplied
with the Esperance Aspiration
Catheter System was
considered in biocompatibility
assessments |
| Peelable
Sheath | PTFE | PTFE | N/A- SAME |
| Rotating
Hemostasis
Valve | 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 placement
during 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 revascularization
through the ID of the device |
| Effective
Length | 125 – 132 cm | 115 – 131 cm | Both devices are evaluated to
achieve proper placement
during revascularization |
| Coating Length | 30 cm | 60 cm | Both devices are evaluated to
achieve proper placement
during revascularization |
| Accessories | | | |
| Peelable
Sheath | Not Reported | 0.092 in ID | The peelable sheath ID is
designed to be compatible with
the 5F Esperance Aspiration
Catheter System |
| Shaping
Mandrel | 0.038 in OD | 0.035 in OD | Both devices are evaluated for
ability to retain shape after
shaping with the mandrel |
| Packaging Material | | | |
| Pouch | Polyester/polyethylene/Tyvek | Tyvek to nylon | Packaging materials are similar
and common for medical |
| Packaging
Hoop | Polyethylene | HDPE | devices. Both packaging
configurations maintain
sterility of the device through
shelf life |
| Packaging Card | Polyethylene | HDPE | |
| Display Carton | SBS Paperboard | SBS Paperboard | N/A- SAME |
| Sterilization
Method | 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 sufficient
to allow for use of the device |
| Aspiration Pump and Tubing | | | |
| Aspiration
Pump | Penumbra System with
Penumbra ENGINE Vacuum
Pump (cleared under K180008)
of -29.2 in Hg with disposable
canister | Medela Dominant Flex
Surgical Suction Pump
Vacuum of -29.2 in Hg with
disposable canister | Both pumps are evaluated
with their respective system
to allow for
revascularization |
| Device Name | Predicate Device:
Penumbra Reperfusion
Catheter 054 | Subject Device:
Esperance Aspiration
Catheter System (5F) | Rationale for Difference (if
applicable) |
| Aspiration
Tubing | 112 inch length
Tubing ID = 0.110 inch | 112 inch length
Tubing ID = 0.110 inch
Integrated valve for vacuum
control | Both aspiration tubing sets
are evaluated with their
respective system to allow
for revascularization |

Table 1 5F Esperance Aspiration Catheter System Technological Comparison to Predicate Penumbra Reperfusion Catheter 054

5

6

Table 2 6F Esperance Aspiration Catheter System Technological Comparison to Predicate Penumbra System ACE 68 Reperfusion Catheter

| Device Name | Predicate Device:
Penumbra System ACE 68
Reperfusion Catheter | Subject Device:
Esperance Aspiration
Catheter System (6F) | Rationale for Difference (if
applicable) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K142458 | K211697 | |
| Classification | Class II, NRY | SAME | N/A- SAME
Both devices utilize an
aspiration pump as part of the
revascularization process |
| Intended Use | The Penumbra System is
intended for use in the
revascularization of patients
with acute ischemic stroke
secondary to intracranial large
vessel occlusive disease (within
the internal carotid, middle
cerebral - M1 and M2 segments,
basilar, and vertebral arteries)
within 8 hours of symptom
onset. The Reperfusion Catheters
ACE 64 and ACE 68 are intended
for use in revascularization
within the Internal Carotid Artery
(ICA) within 8 hours of symptom
onset. | 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. | |
| Materials | | | |
| Shaft | | | |
| Extrusions | Outer layer:
Tecoflex (thermoplastic
polyurethane), Pellethane
(thermoplastic polyurethane),
Pebax (polyether block amide),
Vestamid (polyamide)

Inner layer:
PTFE | Outer layer:
Tecothane (polyurethane
elastomer), Pebax (polyether
block amide), Vestamid
(polyamide)

7

8

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

9

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.

10

Table 5. Luer Hub Bench Testing Summary

Test	Luer Hub Results
ISO 80369-7 Section 5
Dimension	The device Luer hub dimensions were verified against standard requirements and
met the pre-defined specifications.
ISO 80369-7, Section 6.1.3 &
80369-20 Annex C
Falling Drop Positive
Pressure Liquid Leakage	The device Luer hub resistance to liquid leakage was verified against standard
requirements and met the pre-defined specifications.
ISO 80369-7, Section 6.2 &
80369-20 Annex D
Sub-atmospheric-pressure
Air Leakage	The device Luer hub resistance to air leakage was verified against standard
requirements and met the pre-defined specifications.
ISO 80369-7, Section 6.3 &
80369-20 Annex E
Stress Cracking	The device Luer hub resistance to liquid leakage after being subjected to stress was
verified against standard requirements and met the pre-defined specifications.
ISO 80369-7, Section 6.4 &
80369-20 Annex F
Resistance to Separation
form Axial Load	The device Luer hub resistance to separation while under axial load was verified
against standard requirements and met the pre-defined specifications.
ISO 80369-7. Section 6.6 &
80369-20 Annex H
Resistance to Overriding	The device Luer hub resistance to overriding a reference connector when under an
applied torque was verified against standard requirements and met the pre-
defined specifications.
ISO 80369-7, Section 6.5 &
80369-20 Annex G & J.2.5
Resistance to Separation
from Unscrewing	The device Luer hub resistance force to unscrewing when under an applied torque
was verified against standard requirements and met the pre-defined
specifications.

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:

| Test

Catheter	Standard	Results	Conclusion
MTT – L-929
Cytotoxicity Study	Cytotoxicity
10993-5	1XMEM test extract showed no cytotoxic potential to L-929 mouse fibroblast cells undiluted or at any dilution.	Non-cytotoxic
ISO Intracutaneous
Irritation (GLP - 2
Extracts)	Irritation or
Intracutaneous
Reactivity
10993-10	The delta between the average scores of the extract of the test article and the vehicle control are 0.0; 0.2.	Non-irritant
ISO Guinea Pig
Maximization
Sensitization (GLP - 2
Extracts)	Sensitization
10993-10	Test and control animal's response not greater than "0".	Did not elicit
sensitization response
ISO Acute Systemic
Toxicity (GLP - 2
Extracts)	Systemic Toxicity
10993-11	None of the animals were observed with abnormal clinical signs indicative of toxicity for 72 hours. All were alive at the end of 72 hours and body weight changes within acceptable parameters.	Non-toxic
ISO Material
Mediated Rabbit
Pyrogen (GLP)	Pyrogen
10993-11	No rabbit temp rise >= 0.5°C.	Non-pyrogenic
Complement
Activation - SC5b-9
Assays with Sponsor-
Supplied Comparator
(GLP)		Results with acceptable range as compared to Control Device.	Test article
complement activation
has similar
performance as the
control
ASTM Hemolysis -
Direct Contact and
Extract Method (GLP)		Blank corrected Hemolytic index: 0.1.	Test device is non-
hemolytic
Platelet and
Leukocyte counts
(GLP)	Hemocompatibility
10993-4	No ranges or levels outside an acceptable range and comparable to Control Device.	Counts of test device
are within
acceptable ranges
and similar to
control
Partial
Thromboplastin Time
(PTT) GLP		Test and predicate device have similar performance.	Test and control articles
are not considered an
activator of the intrinsic
coagulation pathway
Thromboresistance
Evaluation (GLP - 4
Hour - 3 Dog)		No adverse effects or clinical signs during test period and no thrombus score >3 for either test or control device	Thromboresistance of
test device is similar
to control
Peelable Introducer
MTT – L-929
Cytotoxicity Study	Cytotoxicity
10993-5	Percent Cell Lysis: 0%
Cytotoxic Score: 0	Non-cytotoxic
ISO Intracutaneous
Irritation (GLP - 2
Extracts)	Irritation or
Intracutaneous
Reactivity
10993-10	The delta between the average scores of the extract of the test article and the vehicle control are 0.0; 0.1.	Non-irritant
ISO Guinea Pig
Maximization	Sensitization	Test and control animal's response not
greater than "0"	Did not elicit
sensitization response

Table 6. 510(k) Summary - Biocompatibility Testing

12

| Sensitization (GLP - 2

Extracts)
ISO Acute Systemic
Toxicity (GLP - 2
Extracts)	Systemic Toxicity
10993-11	None of the animals were observed with
abnormal clinical signs indicative of
toxicity for 72 hours. All were alive at
the end of 72 hours and body weight
changes within acceptable parameters.	Non-toxic
ISO Material
Mediated Rabbit
Pyrogen (GLP)	Pyrogen
10993-11	No rabbit temp rise >= 0.5°C.	Non-pyrogenic
ASTM Hemolysis -
Direct Contact and
Extract Method (GLP)	Hemocompatibility
10993-4	Blank corrected Hemolytic index: 0.6.	Non-hemolytic
Wallaby Aspiration
Tubing Set
MTT - L-929
Cytotoxicity Study	Cytotoxicity
10993-5	Percent Cell Lysis: 0%
Cytotoxic Score: 0	Non-cytotoxic
ISO Intracutaneous
Irritation (GLP - 2
Extracts)	Irritation or
Intracutaneous
Reactivity
10993-10	The delta between the average scores of
the extract of the test article and the
vehicle control are 0.0; 0.1.	Non-irritant
ISO Guinea Pig
Maximization
Sensitization (GLP - 2
Extracts)	Sensitization
10993-10	Test and control animal's response not
greater than "0".	Did not elicit
sensitization response

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.