QuickClear Mechanical Thrombectomy System

K193197 · Volcano Atheromed, Inc. · QEZ · Apr 20, 2020 · Cardiovascular

Device Facts

• Record ID: K193197
• Device Name: QuickClear Mechanical Thrombectomy System
• Applicant: Volcano Atheromed, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Apr 20, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The QuickClear Mechanical Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

Device Story

System uses continuous vacuum aspiration to remove fresh, soft emboli and thrombi from peripheral vasculature. Components include single-lumen aspiration catheter (6F, 8F, 10F sizes), battery-operated aspiration pump, and waste collection bag. Catheters feature marker bands for fluoroscopic visualization and hydrophilic coating. 8F/10F catheters include obturator for over-the-wire tracking. Physician operates system in clinical setting; catheter introduced over 0.035" guidewire to occlusion site. Pump provides vacuum (≥ 25 inch Hg) via inline flow control. Aspirated material collected in waste bag. System benefits patient by clearing vascular occlusions, restoring blood flow. Pump is identical to Phoenix Aspiration Pump (K181877).

Clinical Evidence

Bench testing included visual/dimensional inspection, leak/vacuum/flow rate tests, tensile/torque strength, lubricity, kink resistance, and guidewire compatibility. Biocompatibility testing per ISO 10993-1 included cytotoxicity, sensitization, irritation, systemic toxicity, PTT, pyrogenicity, hemocompatibility, particulate analysis, and in vivo thrombogenicity. GLP animal study demonstrated safety and performance with no vessel trauma or significant vascular injury.

Technological Characteristics

System components: aspiration catheter (polymeric blends, hydrophilic coating), battery-operated aspiration pump (12V DC), waste collection bag. Catheters: 6F, 8F, 10F sizes; marker bands; 0.035" guidewire compatible. Sterilization: Ethylene Oxide (EO). Biocompatibility: ISO 10993-1. Pump provides ≥ 25 inch Hg vacuum.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from peripheral arterial and venous vessels.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• Penumbra INDIGO Aspiration System (K180939)

Reference Devices

• Teleflex Pronto .035" Extraction Catheter (K070403)
• Phoenix 2.4 mm Atherectomy Plus System (K181877)

Submission Summary (Full Text)

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November 1, 2021

Volcano AtheroMed Inc. Anna Stephen Regulatory Operations Specialist 1530 O'Brien Drive, Suite A Menlo Park, California 94025

Re: K193197

Trade/Device Name: QuickClear Mechanical Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ

Dear Anna Stephen:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 20, 2020. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, [phone], Gregory.Oconnell(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.11.01 15:10:59 -04'00'

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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April 20, 2020

Volcano AtheroMed Inc. Ms. Anna Gloria Stephen Regulatory Operations Specialist 1530 O'Brien Drive, Suite A Menlo Park, California 94025

Re: K193197

Trade/Device Name: QuickClear Mechanical Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: March 20, 2020 Received: March 23, 2020

Dear Ms. Stephen:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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.

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2020.04.20

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K193197

Device Name

QuickClear Mechanical Thrombectomy System

Indications for Use (Describe)

The QuickClear Mechanical Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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### 510(k) Summary 5

Submitter Information: Date of 510(k) Summary Preparation: April 20, 2020 Name and Address of Manufacturer: Volcano AtheroMed, Inc. 1530 O'Brien Drive, Suite A Menlo Park, CA 94025 Establishment Registration Number: 3008847191 Anna Gloria Stephen Contact Person: Phone: [phone] Fax: [phone] Email: [e-mail] Subject Device Information: Device Trade Name: QuickClear Mechanical Thrombectomy System Common Name: Aspiration System Regulation Description: Embolectomy Catheter Regulation Number: 21 CFR 870.5150 Product Code: DXE Device Class: Class II Classification Panel: Cardiovascular

This 510(k) Summary was prepared in accordance with 21 CFR 807.92 (c)

Predicate Device: Primary: Penumbra INDIGO Aspiration System 510(k) Number: K180939, DXE, 870.5150

Reference: Teleflex Pronto .035" Extraction Catheter 510(k) Number: K070403, DXE, 870.5150 serves as a reference predicate with similar indications for use and the same catheter size (10F).

Reference: Phoenix 2.4 mm Atherectomy Plus System

510(k) Number: K181877, MCW, 870.4875 serves as a reference predicate for the QuickClear Aspiration Pump that was cleared as the Phoenix Aspiration Pump in K181877.

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## Intended Use/ Indication for Use:

The QuickClear Mechanical Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral anterial and venous systems.

## Device Description:

The QuickClear Mechanical Thrombectomy System is an aspiration thrombectomy system designed for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The QuickClear Mechanical Thrombectomy System removes thrombus from the peripheral vasculature using continuous vacuum aspiration, through a single lumen aspiration catheter. The system components are sterile, single-use devices that are sterilized using Ethylene Oxide (EO). The QuickClear Mechanical Thrombectomy System comprises the following devices and accessories:

- . QuickClear Aspiration Pump: The QuickClear Aspiration Pump is identical to the previously cleared Phoenix Aspiration Pump that is part of the Phoenix 2.4 Atherectomy Plus System (K181877) and remains unchanged as part of the QuickClear Mechanical Thrombectomy System. The pump is sterile, single-use, battery-operated, has an ON/OFF button, and serves as a vacuum source for aspirating thrombus from target vessel/s out of the QuickClear Aspiration Catheter via the pump aspiration tubing into a waste collection bag (connected to the pump outlet). Aspiration is controlled via an inline flow control switch. The aspiration pump is non-patient contacting.
- . A 60cc Syringe assists in priming the pump tubing and purging the aspiration system of air. The syringe can also be used to provide additional vacuum by pulling the plunger during active aspiration. The 60cc Syringe is provided with the Aspiration Pump Kit
- QuickClear Aspiration Catheters: Catheters are available in the following sizes: 6F straight tip, 8F straight tip, 8F shaped tip and 10F shaped tip. The QuickClear Aspiration Catheters continuously aspirate and remove thrombus and emboli from the vasculature when connected to the QuickClear Aspiration Pump. The catheters have a marker band tip for enhanced fluoroscopic visualization and are hydrophilic-coated to enhance lubricity. A Hemostasis Valve Y-connector is supplied with the catheter and connects to the proximal catheter hub. The QuickClear Aspiration Pump tubing is attached to the Hemostasis Valve Y-connector port to provide vacuum to the catheter for removal of thrombus.
- . An Obturator is supplied with the 8F and 10F catheters. The Obturator is intended to be used as an over-the-wire (OTW) accessory, positioned within the lumen of the catheter, for tracking over commercially available 0.035" guidewires. The Obturator provides catheter support and atraumatic advancement through the vasculature during catheter placement.
- A Waste Collection Bag is connected to the proximal end of the aspiration pump tubing ● to collect aspirated material.

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# Comparison with Predicate:

The QuickClear Mechanical Thrombectomy System has been assessed for substantial equivalence relative to the currently marketed Penumbra INDIGO Aspiration System (K180939) as the predicate device, along with consideration of two additional reference devices, the Phoenix 2.4mm Atherectomy Plus System (K181877) and the Teleflex Pronto .035" Extraction Catheter (K070403). The indications for QuickClear Mechanical Thrombectomy System are similar to the indications for use of the predicate device Penumbra INDIGO Aspiration System. The QuickClear System and the INDIGO System have similar technological characteristics and operating principles. Both devices consist of two main components Aspiration Catheter and Aspiration Pump. The pump provides continuous vacuum through the single-lumen catheter for the removal of fresh, soft emboli and thrombi from the peripheral vasculature.

The basic operating principle of the Pronto Extraction Catheteris similar to the QuickClear 10F Aspiration Catheter. The Pronto .035" Extraction Catheter serves as a reference predicate with similar indications for use and technological characteristics based on the 10F catheter size to compare with the 10F subject catheter size targeting safe thrombus removal from the larger diameter venous and arterial vessels. Both catheters are designed to be delivered through a 10F or larger introducer sheath over a 0.035" guidewire.

Additionally, the Phoenix 2.4 mm Atherectomy Plus System serves as a direct reference predicate since the QuickClear Aspiration Pump is identical to the Phoenix Aspiration Pump cleared in K181877.

Any differences between the subject and predicate device were evaluated through technological comparison (also taking into account the noted reference devices), design verification and validation testing to demonstrate that the subject QuickClear Mechanical Thrombectomy System is substantially equivalent to the currently marketed predicate device..

Some of the similarities and differences between the subject device and the predicate devices are outlined in Table 5-1 below

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| Table 5-1:Comparative Summary of QuickClear Mechanical Thrombectomy System and Predicate Devices | | | | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | Subject Device | Predicate Device | Reference Device | Direct Reference Device |
| Trade Name | QuickClear Mechanical | Penumbra INDIGO Aspiration | Teleflex Pronto .035" | Philips Volcano AtheroMed |
| (510(k) #) | Thrombectomy System | System | Extraction Catheter | Phoenix 2.4mm Atherectomy |
| | (K193197) | (K180939) | (M20650400) | Plus System |
| | | | (K070403) | (K181877) |
| Classification | Class II, DXE | Class II, DXE | Class II, DXE | Class II, MCW |
| Regulation Description | Embolectomy Catheter | Embolectomy Catheter | Embolectomy Catheter | Catheter, Peripheral, Atherectomy |
| Regulation Number | 870.5150 - Embolectomy | 870.5150 - Embolectomy | 870.5150 - Embolectomy | 870.4875, Intraluminal Artery |
| | Catheter | Catheter | Catheter | Stripper |
| Classification Panel | Cardiovascular | Cardiovascular | Cardiovascular | Cardiovascular |
| Indications For Use | The QuickClear Mechanical<br>Thrombectomy System is<br>intended for removal of<br>fresh, soft emboli and<br>thrombi from vessels of the<br>peripheral arterial and<br>venous systems. | INDIGO Aspiration Catheters and<br>Separators:<br>As part of the INDIGO Aspiration<br>System, the INDIGO Aspiration<br>Catheters and Separators are<br>indicated for the removal of fresh,<br>soft emboli and thrombi from<br>vessels of the peripheral arterial<br>and venous systems.<br><br>INDIGO Aspiration Tubing:<br>As part of the INDIGO Aspiration<br>System, the INDIGO Sterile<br>Aspiration Tubing is indicated to<br>connect the INDIGO Aspiration<br>Catheters to the Penumbra<br>Aspiration Pump. | The Pronto .035"extraction<br>catheter is indicated for:<br>● The removal/aspiration<br>of embolic material<br>(Thrombus/Debris)<br>from vessels of the<br>arterial system.<br>● The removal/aspiration<br>of embolic material<br>(Thrombus/Debris)<br>from vessels of the<br>deep venous system.<br>● To infuse/deliver<br>diagnostic or<br>therapeutic agents. | The Phoenix Atherectomy System is<br>intended for use in atherectomy of the<br>peripheral vasculature. The system is<br>not intended for use in the coronary,<br>carotid, iliac, pulmonary, or renal<br>vasculature.<br><br>Phoenix Atherectomy Plus System:<br>When used with the Phoenix<br>Aspiration Pump as the vacuum<br>source, the Phoenix 2.4 Deflecting<br>Atherectomy System is indicated for<br>the removal of thrombus from vessels<br>of the peripheral arterial vasculature. |
| | | Penumbra Aspiration Pump: The<br>Penumbra Aspiration Pump is<br>indicated as a vacuum source for<br>Penumbra Aspiration Systems. | | |
| Thrombus<br>Collection and Removal | Continuous aspiration and<br>removal of emboli and<br>thrombus via a vacuum<br>aspiration source with the | Continuous aspiration and<br>removal of emboli and thrombus<br>via a vacuum aspiration source<br>with the catheter targeted at | Removal of emboli and<br>thrombus mechanically via a 60<br>cc syringe based aspiration<br>through the extension line and | Continuous collection and removal of<br>emboli and thrombus via mechanical<br>conveyance of |
| Table 5-1:Comparative Summary of QuickClear Mechanical Thrombectomy System and Predicate Devices | | | | |
| Attribute | Subject Device | Predicate Device | Reference Device | Direct Reference Device |
| Trade Name<br>(510(k) #) | QuickClear Mechanical<br>Thrombectomy System<br>(K193197) | Penumbra INDIGO Aspiration<br>System<br>(K180939) | Teleflex Pronto .035"<br>Extraction Catheter<br>(M20650400)<br>(K070403) | Philips Volcano AtheroMed<br>Phoenix 2.4mm Atherectomy<br>Plus System<br>(K181877) |
| | catheter targeted at<br>thrombus in the peripheral<br>vasculature. | thrombus in the peripheral<br>vasculature. | stopcock source with the<br>catheter targeted at thrombus in<br>the peripheral vasculature. | Catheter assisted by a vacuum<br>aspiration source. |
| Basic Operating Principle/<br>General Technological<br>Design | Continuous aspiration and<br>removal of emboli and<br>thrombus via a vacuum<br>aspiration source with the<br>catheter targeted at thrombus<br>in the peripheral vasculature. | Continuous aspiration and removal<br>of emboli and thrombus via a<br>vacuum aspiration source with the<br>catheter targeted at thrombus in the<br>peripheral vasculature. | The Pronto .035" extraction<br>catheter is a dual lumen, over-<br>the-wire (OTW) catheter with<br>related accessories. The catheter<br>is designed to be delivered<br>through a 10F or larger<br>introducer sheath over a 0.035"<br>guidewire. The larger lumen<br>allows for the removal of<br>thrombus by use of the included<br>syringe through the extension<br>line and stopcock. The catheter<br>has a rounded distal tip with a<br>protected, extraction lumen to<br>facilitate advancement of the<br>catheter into the blood vessel<br>and maximize extraction of<br>thrombus through the extraction<br>lumen. | Phoenix Aspiration System Pump -<br>handheld<br>battery powered pump<br>capable of providing a<br>vacuum source of ≥ 25inches<br>Mercury (Hg) to aspirate<br>blood and thrombus related<br>materials. |
| | The aspiration catheter<br>accesses the thrombotic<br>occlusions within the<br>vasculature and is used to<br>aspirate material directly<br>through the catheter lumen.<br>The catheter is introduced<br>over a guidewire (0.035") to<br>the site of the target<br>occlusion to perform<br>aspiration when connected<br>to the aspiration pump that<br>serves as a vacuum source.<br>An obturator, supplied with<br>the catheter (8F & 10F<br>only), may be used to<br>facilitate access through the<br>vessel while providing an<br>atraumatic transition to the<br>front edge of the catheter.<br>The catheter connects to the | The aspiration catheter accesses the<br>thrombotic occlusions within the<br>vasculature and is used to aspirate<br>material directly through the<br>catheter lumen.<br>The catheter is introduced over a<br>guidewire (0.035") to the site of the<br>target occlusion to perform<br>aspiration when connected to the<br>aspiration pump that serves as a<br>vacuum source.<br>A separator may be deployed<br>within the Aspiration Catheter to<br>assist with thrombus removal by<br>clearing the lumen of the<br>Aspiration Catheter should it<br>become blocked with thrombus.<br>The separator is manually<br>advanced and retracted through<br>the Aspiration Catheter at the<br>proximal margin of the primary<br>occlusion to facilitate clearing of<br>the thrombus from the Aspiration<br>Catheter tip. | The catheter has a radiopaque<br>marker band located<br>approximately 4mm from the<br>distal tip. The proximal end of<br>the catheter incorporates a<br>hemostatic Y-junction that<br>allows for the attachment of the<br>catheter to the included<br>extension line, stopcock and<br>syringe; and can be tightened<br>down on the guidewire to<br>prevent blood leakage. | |
| | distal end of a vacuum pump<br>through hemostasis and<br>inline ON/OFF valve. The<br>male luer on the exit port of<br>the vacuum pump tubing<br>connects to the female luer | A separator may not be necessary<br>when using an Aspiration Catheter<br>with an ID of 0.054" (4Fr) or<br>larger. | | |
| Volcano Aheromed, Inc. Traditional 510(k) Premarket Notification for QuickClear Mechanical Thrombectomy System K19319 pg. 6 of 9 | | | | |
| | on the waste collection bag<br>tubing.<br><br>Aspirated material is<br>collected in a waste<br>collection bag.<br><br>Aspiration Pump - handheld<br>battery powered pump<br>capable of providing a<br>vacuum source of ≥ 25inch<br>Mercury (Hg) to aspirate<br>blood and thrombus related<br>materials. | Aspirated material is collected in a<br>suction canister. | | |
| Power Source | 12V DC Battery for<br>Aspiration Pump | 100-115V AC/230V AC, 50/60<br>HZ AC Power supply for<br>Penumbra Max Pump | N/A (manual aspiration) | 12V DC Battery for Phoenix<br>Aspiration System Pump…