APRO 70 Catheter and Alembic Aspiration Tubing

K223545 · Alembic, LLC · NRY · Feb 17, 2023 · Cardiovascular

Device Facts

• Record ID: K223545
• Device Name: APRO 70 Catheter and Alembic Aspiration Tubing
• Applicant: Alembic, LLC
• Product Code: NRY · Cardiovascular
• Decision Date: Feb 17, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The APRO 70 Catheter with an aspiration pump and the Alembic Aspiration Tubing 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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Alembic Aspiration Tubing is intended to connect the APRO 70 Catheter to the aspiration pump.

Device Story

Single-lumen, braid/coil-reinforced catheter designed for thrombus removal via aspiration; used in conjunction with aspiration pump and tubing. Introduced through guide catheter/femoral sheath into intracranial vasculature; navigated over neurovascular guidewire under fluoroscopic visualization to occlusion site. Distal shaft features hydrophilic coating; radiopaque marker at distal end for visualization. Aspiration pump connected via Alembic Aspiration Tubing with flow control valve. Used in clinical setting by physicians; output is mechanical suction at catheter tip to remove thrombus. Benefits include revascularization of occluded vessels in acute ischemic stroke patients.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing (visual/dimensional, vacuum integrity, kink resistance, leakage, torque, burst pressure, tensile strength, simulated use, usability, corrosion resistance, delivery/retrieval force, tip buckling) and GLP-compliant animal study (porcine model, 3-day and 30-day assessments) comparing safety and performance to predicate.

Technological Characteristics

Single-lumen catheter; 304V stainless steel braid/coil; PTFE/Tecoflex liner; polycarbonate hub; Santoprene strain relief; platinum/iridium marker band; hydrophilic coating. Dimensions: 0.083" OD, 0.070" ID. Sterilization: Ethylene oxide (ISO 11135). Biocompatibility: ISO 10993-1 compliant. Mechanical aspiration principle.

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 System ACE 68 Reperfusion Catheter (K142458)

Reference Devices

• SOFIA Plus Aspiration Catheter (K173200)

Submission Summary (Full Text)

{0}------------------------------------------------

February 17, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Alembic, LLC Lisa Yen Director of Regulatory and Quality 627 National Avenue Mountain View, California 94043

#### Re: K223545

Trade/Device Name: APRO 70 Catheter and Alembic Aspiration Tubing Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: November 23, 2022 Received: November 25, 2022

#### Dear Lisa Yen:

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 -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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K223545

Device Name

APRO 70 Catheter and Alembic Aspiration Tubing

#### Indications for Use (Describe)

The APRO 70 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute 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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Alembic Aspiration Tubing is intended to connect the APRO 70 Catheter to the aspiration pump.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X 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) Summary

#### 510(k) Number:

This 510(k) Summary is provided in accordance with the requirements of 21 CFR §807.92.

#### 1) Submitter information

| Submitter: | Alembic, LLC<br>627 National Ave.<br>Mountain View, CA 94043 |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Lisa Yen<br>Director of Regulatory and Quality<br>Telephone Number: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

#### Date Prepared: February 16, 2023

#### 2) Device Name and Classification

| Trade/Proprietary Name: | APRO TM 70 Catheter and Alembic Aspiration Tubing |
|-------------------------|---------------------------------------------------|
| Common Name: | Catheter, Thrombus Retriever |
| Classification Name: | Percutaneous Catheter, 21 CFR 870.1250 |
| Regulatory Class: | Class II |
| Product Code: | NRY |
| Review Panel: | Neurology |

#### 3) Legally Marketed Predicate and Reference Devices

| Primary Predicate Device: | K142458 Penumbra System ACE 68 Reperfusion Catheter |
|---------------------------|-----------------------------------------------------|
| Reference Device: | K173200 SOFIA Plus Aspiration Catheter |

#### 4) Device Description

The APRO 70 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO

{4}------------------------------------------------

70 Catheter targets aspiration from the suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 70 Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 70 Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 70 Catheter is available in lengths of 125 cm, and 135 cm and is provided with an introducer sheath.

The Alembic Aspiration Tubing connects the APRO 70 Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.

#### 5) Indications for Use

The APRO 70 Catheter with an aspiration pump and the Alembic Aspiration Tubing 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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Alembic Aspiration Tubing is intended to connect the APRO 70 Catheter to the aspiration pump.

#### 6) Technological Characteristics Comparison

Alembic has demonstrated the APRO 70 Catheter and Alembic Aspiration Tubing are substantially equivalent to the predicate device based on the similarity in materials, similarity in design concept, and the same fundamental operating principles. A comparison of the APRO 70 Catheter and Alembic Aspiration Tubing with the predicate device is summarized in Table 1 below.

| Device Characteristic | Subject Device | Predicate Device | Reference Device |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | APRO 70 Catheter and<br>Alembic Aspiration Tubing | Penumbra System ACE<br>68 Reperfusion Catheter<br>(K142458) | SOFIA Plus Aspiration<br>Catheter (K173200) |
| Regulatory Class | II, 21 CFR 870.1250 | Same as subject device | Same as subject device |
| Product Code | NRY | Same as subject device | Same as subject device |
| Device<br>Characteristic | Subject Device<br>APRO 70 Catheter and<br>Alembic Aspiration Tubing | Predicate Device<br>Penumbra System ACE<br>68 Reperfusion Catheter<br>(K142458) | Reference Device<br>SOFIA Plus Aspiration<br>Catheter (K173200) |
| Indication for Use | The APRO 70 Catheter with<br>an aspiration pump and the<br>Alembic Aspiration Tubing 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<br>(within the internal carotid,<br>middle 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<br>therapy are candidates for<br>treatment.<br>The Alembic Aspiration<br>Tubing is intended to connect<br>the APRO 70 Catheter to the<br>aspiration pump. | The Penumbra System is<br>intended for use in the<br>revascularization of<br>patients with acute<br>ischemic stroke secondary<br>to intracranial large vessel<br>occlusive disease (within<br>the internal carotid, middle<br>cerebral - M1 and M2<br>segments, basilar, and<br>vertebral arteries) within 8<br>hours of symptom onset.<br>The Reperfusion Catheters<br>ACE 64 and ACE 68 are<br>intended for use in<br>revascularization within<br>the Internal Carotid Artery<br>(ICA) within 8 hours of<br>symptom onset. | The SOFIA Plus Aspiration<br>Catheter with the Gomco 405<br>Aspiration Pump and<br>MicroVention Tubing Kit is<br>intended for use in the<br>revascularization of patients<br>with acute ischemic stroke<br>secondary to intracranial<br>large vessel occlusive disease<br>(within the internal carotid,<br>middle cerebral - M1 and M2<br>segments, basilar, and<br>vertebral arteries) within 8<br>hours of symptom onset.<br>Patients who are ineligible<br>for intravenous tissue<br>plasminogen activator (IV t-<br>PA) or who fail IV t-PA<br>therapy are candidates for<br>treatment. |
| Principles of<br>Operation | Using conventional<br>catheterization techniques<br>under fluoroscopic guidance,<br>advance the catheter into the<br>target vessel over an<br>appropriate neurovascular<br>guidewire. Position the<br>catheter proximal to the<br>thrombus to aspirate. | Same as subject device | Same as subject device |
| Accessory Devices<br>Provided | Introducer sheath | Peelable sheath, rotating<br>hemostasis valve, shaping<br>mandrel | Introducer sheath,<br>shaping mandrel |
| Materials | | | |
| Hub | Polycarbonate | Nylon (Grilamid) | Nylon (Grilamid) |
| Strain Relief | Santoprene (thermoplastic<br>elastomer) | Nylon (Grilamid) / 304<br>stainless steel | Polyurethane |
| Liner | Polytetrafluoroethylene<br>(PTFE)/Tecoflex composite | Not described | Polytetrafluoroethylene/<br>polyolefin elastomer |
| Shaft Coil and<br>Braid | 304V stainless steel braid<br>304V stainless steel coil | 304V stainless steel braid<br>nitinol coil | Stainless steel braid<br>Stainless steel coil |
| Device | Subject Device | Predicate Device | Reference Device |
| Characteristic | APRO 70 Catheter and | Penumbra System ACE | SOFIA Plus Aspiration |
| | Alembic Aspiration Tubing | 68 Reperfusion Catheter<br>(K142458) | Catheter (K173200) |
| Extrusions | Thermoplastic polyurethanes,<br>thermoplastic elastomer | Thermoplastic<br>polyurethane (Pellethane<br>and Tecoflex), polyether<br>block amide (Pebax),<br>polyamide (Vestamid) | Polyurethane elastomer<br>(polyblend and Pellethane),<br>polyether block amide<br>(Pebax), polyamide<br>(Grilamid) |
| Marker band | Platinum/ iridium | Same as subject device | Same as subject device |
| Coating | Hydrophilic coating | Same as subject device | Same as subject device |
| Dimensions | | | |
| Proximal Outer<br>Diameter (OD) | 0.083 inch | 0.084 inch max | Same as subject device |
| Proximal Inner<br>Diameter (ID) | 0.070 inch | 0.068 inch min | Same as subject device |
| Distal OD | 0.083 inch | 0.084 inch max | 0.082 inch |
| Distal ID | 0.070 inch | 0.068 inch min | Same as subject device |
| Effective Lengths | 125, 132, 135 cm | 115, 120, 125, 127, 132<br>cm | 125 - 131 cm |
| Coated Length | 90, 97, 100 cm | 30 cm | Unknown |
| Tip Shape | Straight | Same as subject device | Same as subject device |
| Accessories | | | |
| Peelable Sheath | Pebax | PTFE | Same as subject device |
| Packaging Materials | | | |
| Pouch | Nylon/polyethylene/Tyvek | Polyester/polyethylene/<br>Tyvek | Polyester/polyethylene/<br>Tyvek |
| Packaging Tube | High density polyethylene | Polyethylene | Polyethylene |
| Packaging Card | High density polyethylene | Polyethylene | Polyethylene |
| Display Carton | Solid bleached sulfate<br>paperboard | Same as subject device | Same as subject device |
| Other | | | |
| Sterilization | Ethylene oxide | Same as subject device | Same as subject device |
| Shelf-Life | 6 months | 36 months | 36 months |
| Use | Single use, disposable | Same as subject device | Same as subject device…