Esperance Aspiration Catheter System

K211697 · Wallaby Medical · NRY · Nov 16, 2021 · Cardiovascular

Device Facts

• Record ID: K211697
• Device Name: Esperance Aspiration Catheter System
• Applicant: Wallaby Medical
• Product Code: NRY · Cardiovascular
• Decision Date: Nov 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Esperance Aspiration Catheter System is a single-use, variable stiffness, composite vascular catheter (5F and 6F sizes). Used in neurointerventional procedures to revascularize occluded intracranial vessels via aspiration. Device is advanced through vasculature to the occlusion site; connected to an external Medela Dominant Flex Surgical Suction Pump via Wallaby Aspiration Tubing. Aspiration removes thrombus, restoring blood flow. Operated by physicians in clinical settings. Distal tip is radiopaque for fluoroscopic visualization; hydrophilic coating reduces friction. System includes shaping mandrel and peelable sheath. Output is the physical removal of the clot, directly impacting clinical decision-making by enabling mechanical thrombectomy in stroke patients.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing (dimensional, aspiration rate, simulated use, tensile, torque, kink resistance, vacuum resistance) and animal studies (porcine model, 3- and 30-day sub-chronic/chronic, gross necropsy, histopathology) comparing 6F Esperance to Penumbra ACE 68.

Technological Characteristics

Single-lumen composite catheter; 5F (0.055" ID) and 6F (0.071" ID). Materials: Tecothane, Pebax, Vestamid, PTFE, Nitinol coil/braid. Hydrophilic coating. Radiopaque Pt/Ir marker band. Sterilized via Ethylene Oxide (ISO 11135). Luer hub per ISO 80369-7. Non-active, surgically invasive.

Indications for Use

Indicated for patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, middle cerebral M1/M2, basilar, vertebral arteries) within 8 hours of symptom onset. Candidates include those ineligible for or failing IV t-PA therapy.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Penumbra Reperfusion Catheter 054, Penumbra Separator 054 (K090752)
• Penumbra System ACE 64 and ACE 68 Reperfusion Catheters (K142458)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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) | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-----------------------------------------------|
| <table><tr><td><b>☑</b> Prescription Use (Part 21 CFR 801 Subpart D) </td></tr><tr><td> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | <b>☑</b> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| <b>☑</b> Prescription Use (Part 21 CFR 801 Subpart D) | | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(k) Number: K211697

## As required by 21 CFR 807.92:

| Applicant: | Wallaby Medical<br>22901 Mill Creek Drive<br>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<br>(K090752) |
| 6F Predicate Device Name: | Penumbra System ACE 64 and ACE 68 Reperfusion Catheters<br>(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:<br>Penumbra Reperfusion<br>Catheter 054 | Subject Device:<br>Esperance Aspiration<br>Catheter System (5F) | Rationale for Difference (if<br>applicable) |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K090752 | K211697 | |
| Classification | Class II, NRY | SAME | N/A- SAME |
| Intended Use | The Penumbra System is<br>intended for use in the<br>revascularization of patients<br>with acute ischemic stroke<br>secondary to intracranial large<br>vessel occlusive disease (within<br>the internal carotid, middle<br>cerebral – M1 and M2<br>segments, basilar, and vertebral<br>arteries) within 8 hours of<br>symptom onset. | The Esperance Aspiration<br>Catheter with the Medela<br>Dominant Flex Surgical Suction<br>Pump and Wallaby Aspiration<br>Tubing set is intended for use<br>in the revascularization of<br>patients with acute ischemic<br>stroke secondary to<br>intracranial large vessel<br>occlusive disease (within<br>internal carotid, middle<br>cerebral – M1 and M2<br>segments, basilar, and<br>vertebral arteries) within 8<br>hours of symptom onset.<br>Patients who are ineligible for<br>intravenous tissue<br>plasminogen activator (IV t-<br>PA) or who fail IV t-PA therapy<br>are candidates for treatment. | Both devices utilize an<br>aspiration pump as part of the<br>revascularization process |
| Materials | | | |
| Shaft | | | |
| Extrusions | Outer layer:<br>Tecoflex (thermoplastic<br>polyurethane), Pellethane<br>(thermoplastic polyurethane),<br>Pebax (polyether block amide),<br>Vestamid (polyamide)<br>Inner layer:<br>PTFE | Outer layer:<br>Tecothane (polyurethane<br>elastomer), Pebax (polyether<br>block amide), Vestamid<br>(polyamide)<br>Inner layer:<br>PTFE | Both device materials are<br>biocompatible, designed to be<br>used in vasculature |
| Wire<br>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<br>used in vasculature |
| Strain Relief | Stainless Steel 304 | Thermoplastic vulcanizate,<br>polypropylene | |
| Strain Relief<br>[Hub Sleeve] | Grilamid (TR55) | N/A | N/A- subject device has no<br>strain relief hub sleeve |
| ID Band | Polyolefin, PET yellow [black ink] | N/A | N/A- subject device has no ID<br>band |
| Colorant | Clear/Natural or Purple | Natural or Green or Blue | Both device colorants are<br>approved for use in medical<br>device applications |
| Marker Band | C-cut Pt/Ir Band | SAME | N/A- SAME |
| Device Name | Predicate Device:<br>Penumbra Reperfusion<br>Catheter 054 | Subject Device:<br>Esperance Aspiration<br>Catheter System (5F) | Rationale for Difference (if<br>applicable) |
| Tip<br>Configuration | Straight, steam shapeable by<br>user | Straight, steam shapeable by<br>user | N/A- SAME |
| Accessories | | | |
| Shaping<br>Mandrel | Not Reported | Stainless Steel | The shaping mandrel supplied<br>with the Esperance Aspiration<br>Catheter System was<br>considered in biocompatibility<br>assessments |
| Peelable<br>Sheath | PTFE | PTFE | N/A- SAME |
| Rotating<br>Hemostasis<br>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<br>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<br>through the ID of the device |
| Effective<br>Length | 125 – 132 cm | 115 – 131 cm | Both devices are evaluated to<br>achieve proper placement<br>during revascularization |
| Coating Length | 30 cm | 60 cm | Both devices are evaluated to<br>achieve proper placement<br>during revascularization |
| Accessories | | | |
| Peelable<br>Sheath | Not Reported | 0.092 in ID | The peelable sheath ID is<br>designed to be compatible with<br>the 5F Esperance Aspiration<br>Catheter System |
| Shaping<br>Mandrel | 0.038 in OD | 0.035 in OD | Both devices are evaluated for<br>ability to retain shape after<br>shaping with the mandrel |
| Packaging Material | | | |
| Pouch | Polyester/polyethylene/Tyvek | Tyvek to nylon | Packaging materials are similar<br>and common for medical |
| Packaging<br>Hoop | Polyethylene | HDPE | devices. Both packaging<br>configurations maintain<br>sterility of the device through<br>shelf life |
| Packaging Card | Polyethylene | HDPE | |
| Display Carton | SBS Paperboard | SBS Paperboard | N/A- SAME |
| Sterilization<br>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<br>to allow for use of the device |
| Aspiration Pump and Tubing | | | |
| Aspiration<br>Pump | Penumbra System with<br>Penumbra ENGINE Vacuum<br>Pump (cleared under K180008)<br>of -29.2 in Hg with disposable<br>canister | Medela Dominant Flex<br>Surgical Suction Pump<br>Vacuum of -29.2 in Hg with<br>disposable canister | Both pumps are evaluated<br>with their respective system<br>to allow for<br>revascularization |
| Device Name | Predicate Device:<br>Penumbra Reperfusion<br>Catheter 054 | Subject Device:<br>Esperance Aspiration<br>Catheter System (5F) | Rationale for Difference (if<br>applicable) |
| Aspiration<br>Tubing | 112 inch length<br>Tubing ID = 0.110 inch | 112 inch length<br>Tubing ID = 0.110 inch<br>Integrated valve for vacuum<br>control | Both aspiration tubing sets<br>are evaluated with their<br>respective system to allow<br>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:<br>Penumbra System ACE 68<br>Reperfusion Catheter | Subject Device:<br>Esperance Aspiration<br>Catheter System (6F) | Rationale for Difference (if<br>applicable) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K142458 | K211697 | |
| Classification | Class II, NRY | SAME | N/A- SAME<br>Both devices utilize an<br>aspiration pump as part of the<br>revascularization process |
| Intended Use | The Penumbra System is<br>intended for use in the<br>revascularization of patients<br>with acute ischemic stroke<br>secondary to intracranial large<br>vessel occlusive disease (within<br>the internal carotid, middle<br>cerebral - M1 and M2 segments,<br>basilar, and vertebral arteries)<br>within 8 hours of symptom<br>onset. The Reperfusion Catheters<br>ACE 64 and ACE 68 are intended<br>for use in revascularization<br>within the Internal Carotid Artery<br>(ICA) within 8 hours of symptom<br>onset. | The Esperance Aspiration<br>Catheter with the Medela<br>Dominant Flex Surgical Suction<br>Pump and Wallaby Aspiration<br>Tubing set is intended for use<br>in the revascularization of<br>patients with acute ischemic<br>stroke secondary to<br>intracranial large vessel<br>occlusive disease (within<br>internal carotid, middle<br>cerebral – M1 and M2<br>segments, basilar, and<br>vertebral arteries) within 8<br>hours of symptom onset.<br>Patients who are ineligible for<br>intravenous tissue<br>plasminogen activator (IV t-<br>PA) or who fail IV t-PA therapy<br>are candidates for treatment. | |
| Materials | | | |
| Shaft | | | |
| Extrusions | Outer layer:<br>Tecoflex (thermoplastic<br>polyurethane), Pellethane<br>(thermoplastic polyurethane),<br>Pebax (polyether block amide),<br>Vestamid (polyamide)<br><br>Inner layer:<br>PTFE | Outer layer:<br>Tecothane (polyurethane<br>elastomer), Pebax (polyether<br>block amide), Vestamid<br>(polyamide)<br><br>Inner layer:<br>PTFE | Both device materials are<br>biocompatible, designed to be<br>used in vasculature |
| Wire<br>Reinforcement | SS and Nitinol coil | Nitinol coil and braid | |
| Components | | | |
| Hub | Grilamid (TR55) | Nylon | |
| Coating | Hydrophilic Coating | Hydrophilic Coating | Both device materials are<br>biocompatible, designed to be<br>used in vasculature |
| Strain Relief | Stainless Steel 304 | Thermoplastic vulcanizate,<br>polypropylene | |
| Strain Relief<br>[Hub Sleeve] | Grilamid (TR55) | N/A | N/A- subject device has no<br>strain relief hub sleeve |
| Device Name | Predicate Device:<br>Penumbra System ACE 68<br>Reperfusion Catheter…