APRO 70 Catheter and Alembic Aspiration Tubing

K230695 · Alembic, LLC · NRY · Apr 10, 2023 · Cardiovascular

Device Facts

• Record ID: K230695
• Device Name: APRO 70 Catheter and Alembic Aspiration Tubing
• Applicant: Alembic, LLC
• Product Code: NRY · Cardiovascular
• Decision Date: Apr 10, 2023
• Decision: SESE
• Submission Type: Special
• 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 and coil reinforced catheter designed for thrombus removal via aspiration. Device introduced through guide catheter or 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 positioning. Alembic Aspiration Tubing connects catheter to external aspiration pump; flow control valve manages suction. Used in clinical settings by physicians; output is mechanical thrombus removal. Benefits include revascularization of occluded vessels in acute stroke patients.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing, including visual/dimensional inspection, particulate testing, vacuum integrity, kink resistance, hub leakage, torque strength, burst pressure, tensile strength, and simulated use in anatomical neurovascular models.

Technological Characteristics

Single-lumen catheter; 304V stainless steel braid/coil; PTFE/Tecoflex liner; platinum/iridium marker band; thermoplastic polyurethane/elastomer extrusions; hydrophilic coating. Dimensions: 0.070" ID, 0.083" OD. Sterilized via ethylene oxide. Sterile, single-use. No software/algorithm.

Indications for Use

Indicated for revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, M1/M2 middle cerebral, basilar, and vertebral arteries) within 8 hours of symptom onset. Candidates include patients 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

• APRO 70 Catheter and Alembic Aspiration (K223545)

Submission Summary (Full Text)

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

April 10, 2023

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 the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square 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: K230695

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: March 10, 2023 Received: March 13, 2023

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) K230695

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 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.

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

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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: April 7, 2023

#### 2) Device Name and Classification

| Trade/Proprietary Name: | APRO™ 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 Device

| Predicate Device: | K223545 APRO 70 Catheter and Alembic Aspiration |
|-------------------|-------------------------------------------------|
|-------------------|-------------------------------------------------|

#### 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 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

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

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 subject APRO 70 Catheter and Alembic Aspiration Tubing are substantially equivalent to the predicate based on the same materials, same design concept, and the same fundamental operating principles. A comparison of the APRO 70 Catheter with the predicate device is summarized in Table 1 below. There are no changes to the Alembic Aspiration Tubing compared to K223545.

| Category | Subject Device<br>APRO 70 Catheter | Predicate Device<br>APRO 70 Catheter |
|----------------------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K230695 | K223545 |
| Regulatory Class | Identical to predicate | Class II, 21 CFR 870.1250, NRY |
| Indications for<br>Use | Identical to predicate | The APRO 70 Catheter with an aspiration pump and the<br>Alembic Aspiration Tubing is intended for use in the<br>revascularization of patients with acute ischemic stroke<br>secondary to intracranial large vessel occlusive disease<br>(within the internal carotid, middle cerebral – M1 and M2<br>segments, basilar, and vertebral arteries) within 8 hours of<br>symptom onset. Patients who are ineligible for intravenous<br>tissue plasminogen activator (IV t-PA) or who fail IV t-PA<br>therapy are candidates for treatment.<br>The Alembic Aspiration Tubing is intended to connect the<br>APRO 70 Catheter to the aspiration pump. |
| Principles of<br>Operation | Identical to predicate | Using conventional catheterization techniques under<br>fluoroscopic guidance, advance the catheter into the target<br>vessel over an appropriate neurovascular guidewire. Position<br>the catheter proximal to the thrombus to aspirate. |

# Table 1 - Subject APRO 70 Catheter Comparison with the Predicate Device

{5}------------------------------------------------

| Category | Subject Device<br>APRO 70 Catheter | Predicate Device<br>APRO 70 Catheter |
|---------------------------------|------------------------------------|---------------------------------------------------------|
| Accessory Devices<br>Provided | Identical to predicate | Introducer sheath |
| Materials | | |
| Hub | Identical to predicate | Polycarbonate |
| Strain Relief | Identical to predicate | Santoprene (thermoplastic elastomer) |
| Liner | Identical to predicate | Polytetrafluoroethylene/Tecoflex composite |
| Shaft Coil and<br>Braid | Identical to predicate | 304V stainless steel braid<br>304V stainless steel coil |
| Extrusions | Identical to predicate | Thermoplastic polyurethanes, thermoplastic elastomer |
| Marker Band | Identical to predicate | Platinum/ iridium |
| Coating | Identical to predicate | Hydrophilic Coating |
| Dimensions | | |
| Proximal Outer<br>Diameter (OD) | Identical to predicate | 0.083 inch |
| Proximal Inner<br>Diameter (ID) | Identical to predicate | 0.070 inch |
| Distal OD | Identical to predicate | 0.083 inch |
| Distal ID | Identical to predicate | 0.070 inch |
| Effective Lengths | Identical to predicate | 125, 132, 135 cm |
| Coated Length | Identical to predicate | 90, 97, 100 cm |
| Tip Shape | Identical to predicate | Straight |
| Accessories | | |
| Introducer Sheath | Identical to predicate | Pebax |
| Packaging Materials | | |
| Pouch | Identical to predicate | Nylon/polyethylene/Tyvek |
| Packaging Tube | Identical to predicate | High density polyethylene |
| Packaging Card | Identical to predicate | High density polyethylene |
| Shelf Carton | Identical to predicate | Solid bleached sulfate paperboard |
| Other | | |
| Sterilization | Identical to predicate | Ethylene oxide |
| Use Conditions | Identical to predicate | Sterile, single use, disposable |
| Shelf life | 1 year | 6 months |

### 7) Performance Data

Alembic performed non-clinical bench testing in accordance with design controls, protocol, and test methods that were previously reviewed in a relevant prior pre-market submission. Included in Table 2 is the description of each performance test that was conducted to support substantial equivalence determination. The results demonstrate substantial equivalence of the subject APRO 70 Catheter and Alembic Aspiration Tubing to the legally marketed predicate device.

{6}------------------------------------------------

# A. Design Verification Testing – Non-Clinical Bench

| Table 2 – Summary of Non-Clinical Bench Test Results | | |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test | Acceptance Criteria | Conclusion |
| Visual and Dimensional<br>Characteristics | Catheter meets the visual and<br>dimensional specifications.<br>Introducer Sheath meets the visual and<br>dimensional specifications.<br>Aspiration Tubing meets the visual and<br>dimensional specifications. | The APRO 70 Catheter met the<br>acceptance criteria.<br>The Introducer Sheath met the<br>acceptance criteria.<br>The Alembic Aspiration Tubing<br>met the acceptance criteria. |
| Particulate | Catheter meets the acceptance criteria.<br>Subject device was evaluated with a<br>predicate device under the same test<br>conditions. | The APRO 70 Catheter met the<br>acceptance criteria. |
| Vacuum Integrity | Catheter with Aspiration Tubing is free<br>from collapse and loss of vacuum between<br>aspiration source and catheter tip. | The APRO 70 Catheter and<br>Alembic Aspiration Tubing met<br>the acceptance criteria. |
| Kink Resistance | Catheter distal shaft shall not kink. | The APRO 70 Catheter met the<br>acceptance criteria. |
| Catheter Hub Leakage | Catheter does not leak into hub assembly<br>during aspiration, with methods specified<br>in ISO 10555-1, Annex D. | The APRO 70 Catheter met the<br>acceptance criteria. |
| Catheter Torque Strength | Catheter must withstand the minimum<br>required number of rotations without<br>breakage. | The APRO 70 Catheter met the<br>acceptance criteria. |
| Dynamic Burst Pressure | No damage to catheter with dynamic<br>pressure. | The APRO 70 Catheter met the<br>acceptance criteria. |
| Fluid Leakage | Catheter must withstand pressure<br>with methods specified in ISO 10555-<br>1, Annex C. | The APRO 70 Catheter met the<br>acceptance criteria. |
| Static Burst | Catheter must withstand pressures<br>anticipated for clinical use. | The APRO 70 Catheter met the<br>acceptance criteria. |
| Tensile Strength of<br>Catheter Hub and Shaft | Catheter hub and shaft must meet tensile<br>strength specification. | The APRO 70 Catheter met the<br>acceptance criteria. |
| Tensile Strength of<br>Catheter Tip | Catheter tip must meet tip tensile strength<br>specification. | The APRO 70 Catheter met the<br>acceptance criteria. |
| Delivery and Retrieval<br>Force | Catheter delivery and retrieval force must<br>be acceptable. Forces were compared to a<br>predicate. | The APRO 70 Catheter met the<br>acceptance criteria. |
| Tip Buckling Force | Catheter tip buckling force must be<br>acceptable. Forces were compared to a<br>predicate. | The APRO 70 Catheter met the<br>acceptance criteria. |
| Simulated Use | When used per the Instructions for Use<br>with accessory devices in an anatomical<br>neurovascular model, the Catheter and<br>Aspiration Tubing must meet<br>functionality specifications. | The APRO 70 Catheter and<br>Alembic Aspiration Tubing met<br>the acceptance criteria. |

## Table 2 – Summary of Non-Clinical Bench Test Results

{7}------------------------------------------------

#### B. Design Verification Testing - Animal

Substantial equivalence was established based on non-clinical bench performance data. Animal testing data were not deemed necessary.

#### C. Sterilization and Shelf-Life

Sterilization studies for the subject APRO 70 Catheter have established that the subject device remains sterile for the labeled expiration date. Additional sterilization data were not deemed necessary.

Aging studies for the subject APRO 70 Catheter have established that the subject device and packaging remains functional for the labeled expiration date. Aging studies for the subject device functionality were performed and met the acceptance criteria.

#### D. Biocompatibility

Biocompatibility studies for the predicate APRO 70 Catheter and Alembic Aspiration Tubing (K223545) have previously established that the subject device is biocompatible. Additional biocompatibility data were not deemed necessary because there are no changes to the design, material, or manufacturing of the APRO 70 Catheter and Alembic Aspiration Tubing compared to the predicate (K223545).

#### E. Clinical Testing

Substantial equivalence was established based on non-clinical performance data. Human clinical data were not deemed necessary.

#### 8) Conclusion

Based on the comparison of the technological characteristics and the non-clinical testing, the subject device is found to be substantially equivalent to the predicate device. The revised Instructions for Use and the extended shelf-life do not raise new questions of safety and effectiveness. Testing was conducted to demonstrate that the subject device meets the specifications and performs as intended.