Who is the manufacturer of 072 Aspiration System?

Q'Apel Medical, Inc. filed the 510(k) submission for 072 Aspiration System (K222786).

What is the FDA product code for 072 Aspiration System?

NRY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for 072 Aspiration System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like 072 Aspiration System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

072 Aspiration System

K222786 · Q'Apel Medical, Inc. · NRY · Aug 25, 2023 · Cardiovascular

Device Facts

Record ID	K222786
Device Name	072 Aspiration System
Applicant	Q'Apel Medical, Inc.
Product Code	NRY · Cardiovascular
Decision Date	Aug 25, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

As part of the 072 Aspiration System, the 072 Aspiration Catheter with a compatible suction pump is indicated 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 failed IV t-PA therapy are candidates for treatment. As part of the 072 Aspiration System, the Aspiration Tubing is intended to connect the 072 Aspiration Catheter to a compatible suction pump.

Device Story

072 Aspiration System comprises a single-lumen, variable-stiffness aspiration catheter, aspiration tubing, and accessories (delivery tool, rotating hemostasis valve, flow switch). Used in neurointerventional procedures to revascularize intracranial vessels by removing thrombi. Catheter features hydrophilic coating, radiopaque markers, and luer hub. Operated by physicians in clinical settings; connects to external compatible suction pump via aspiration tubing. Flow switch allows user to control fluid flow/vacuum. Device facilitates clot retrieval; benefits patient by restoring blood flow in acute ischemic stroke. Bench and animal testing confirm mechanical integrity, aspiration performance, and biocompatibility.

Clinical Evidence

No clinical study conducted. Substantial equivalence supported by bench testing (mechanical integrity, flow rates, simulated use in tortuous anatomical models, biocompatibility per ISO 10993) and a GLP-compliant porcine animal study comparing clot aspiration and wedge assessment against predicate/reference devices.

Technological Characteristics

Single-lumen variable-stiffness catheter; hydrophilic coating; PTFE liner; stainless steel/Nitinol reinforcement; platinum/iridium/tantalum marker bands. Hub: polycarbonate. Aspiration tubing: 0.110" ID. Sterilization: 100% Ethylene Oxide (ISO 11135). Connectivity: manual connection to external vacuum pump. No software/AI/ML components.

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 patients ineligible for or who failed 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® [JET™ 7 Reperfusion Catheter with MAX Delivery Device (JET™ 7MAX)] (K191946)

Reference Devices

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set (K193380)
Penumbra System® (Reperfusion Catheter RED™ 72) (K211654)

Submission Summary (Full Text)

{0}------------------------------------------------ August 25, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. Q'Apel Medical, Inc. Kim Ky Manager, Regulatory Affairs 4245 Technology Drive Fremont, California 94538 #### Re: K222786 Trade/Device Name: 072 Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: August 17, 2023 Received: August 17, 2023 #### Dear Kim Ky: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerelv. # 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) K222786 Device Name 072 Aspiration System #### Indications for Use (Describe) #### 072 Aspiration Catheter: As part of the 072 Aspiration System, the 072 Aspiration Catheter with a compatible suction pump is indicated 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 therapy are candidates for treatment. Aspiration Tubing: As part of the 072 Aspiration System, the Aspiration Tubing is intended to connect the 072 Aspiration Catheter to a compatible suction pump. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--------------------------| | <input type="checkbox"/> | <input type="checkbox"/> | 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the word "Q'apel" in blue font. The font is sans-serif and the letters are connected. The apostrophe is placed between the "Q" and the "a". The word is centered and takes up most of the image. #### 510(k) SUMMARY As required by 21 CFR 807.92 | Applicant: Submitter's Name: Address: | Q'Apel Medical, Inc. 4245 Technology Drive Fremont, CA 94538 | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Telephone: | 510-738-6255 | | Contact Person: Title: Telephone: | Kim Ky Manager, Regulatory Affairs 510-828-4757 | | Date Prepared: | August 25, 2023 | | Device Name /Common name: | 072 Aspiration System | | Classification: | Class II | | Product Code(s): | NRY | | Regulation Number(s): | 21 CFR 870.1250 | | Classification Name: | Percutaneous, Catheter | | Predicate Device: | Penumbra System® [JETTM 7 Reperfusion Catheter with MAX Delivery Device (JETTM 7MAX)] (K191946) | | Reference Devices: | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set (K193380) Penumbra System® (Reperfusion Catheter REDTM 72) (K211654) | #### Indications for Use: 072 Aspiration Catheter As part of the 072 Aspiration System, the 072 Aspiration Catheter with a compatible suction pump is indicated 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 failed IV t-PA therapy are candidates for treatment. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Q'apel. The logo is written in a sans-serif font and is a bright blue color. The logo is simple and modern. # Aspiration Tubing As part of the 072 Aspiration System, the Aspiration Tubing is intended to connect the 072 Aspiration Catheter to a compatible suction pump. #### Device Description: The 072 Aspiration Catheter is a single lumen, variable stiffness catheter. The catheter has a hydrophilic coating to reduce friction during use. The catheter includes radiopaque markers on the distal end for angiographic visualization and a Luer hub on the proximal end allowing attachments for flushing and aspiration. The Delivery Tool is an optional accessory for use with the 072 Aspiration Catheter and should be removed prior to aspiration. The 072 Aspiration Catheter, Delivery Tool. Rotating Hemostasis Valve, and Flow Switch are included in the package. The Aspiration Tubing is provided in a separate package. For the aspiration source, the 072 Aspiration Catheter is used in conjunction with a compatible suction pump with prespecified performance parameters that is connected using the Aspiration Tubing. #### Comparison of Technological characteristics with the Predicate Device: O'Apel Medical, Inc. has demonstrated that the 072 Aspiration System is substantially equivalent to the predicate device, Penumbra System® [JET™ 7 Reperfusion Catheter with MAX Delivery Device (JET™ 7MAX)] cleared under K191946, based on the same or similar materials, similar design, and the same fundamental operating principles. A comparison of the subject device with the predicate and reference devices is summarized in the table below. | Comparison of the Subject, Predicate, and Reference Devices | | | | | | |-------------------------------------------------------------|-----------------------------|-------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------| | Feature | Subject Device (K222786) | Predicate Device (K191946) | Reference Device 1 (K193380) | Reference Device 2 (K211654) | Rationale for difference (if applicable) | | Device Name | 072 Aspiration System | Penumbra System (JET 7MAX) | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set | Penumbra System (Reperfusion Catheter RED 72) | N/A | | 510(k) Number | K222786 | K191946 | K193380 | K211654 | N/A | | Classification | Class II | Class II | Class II | Class II | Same | | Product Code | NRY | NRY | NRY | NRY | Same | | Classification Name | 21CFR 870.1250 | 21CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 | Same | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Q'apel. The logo is written in a sans-serif font and is blue. The Q is stylized with a curved tail. The rest of the letters are lowercase. | Indications for Use | 072 Aspiration Catheter | Penumbra Reperfusion Catheters and Separators | The CERENOVUS Large Bore Catheter, with the CERENOVUS Aspiration Tubing Set and NOUVAG Vacuson 60 aspiration pump (or equivalent aspiration pump) | Penumbra Reperfusion Catheters and Separators | Similar, the differences do not raise new questions regarding safety and effectiveness. | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | | As part of the 072 Aspiration System, the 072 Aspiration Catheter with a compatible suction pump is indicated 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 failed IV t-PA therapy are candidates for treatment. | As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated 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. | is indicated 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 failed IV t-PA are candidates for treatment. The CERENOVUS Aspiration Tubing Set is intended to connect the CERENOVUS Large Bore Catheter to the canister of the NOUVAG Vacuson 60 Aspiration Pump | As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated 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. | | | | Aspiration Tubing As part of the 072 Aspiration System, the Aspiration Tubing is intended to connect the 072 Aspiration Catheter to a compatible suction pump. | Penumbra 3D Revascularization Device As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA | | Penumbra 3D Revascularization Device As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated 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) within 8 hours of symptom | | | | | | | | | | | therapy are candidates for treatment. Penumbra Aspiration Tubing As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. | (or equivalent vacuum pump) and to allow the user to control the fluid flow. | onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. Penumbra Aspiration Tubing As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. | | | | | | | | | | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "Q'apel" in blue font. The font is sans-serif and the letters are connected. The apostrophe is slightly raised above the "Q". The background is white. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Q'apel. The logo is written in a sans-serif font and is blue. The Q has a unique design, with a curved tail that extends upwards. The rest of the letters are standard sans-serif letters. | Comparison of the Subject, Predicate, and Reference Devices | | | | | | |-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | Feature | Subject Device (K222786) | Predicate Device (K191946) | Reference Device 1 (K193380) | Reference Device 2 (K211654) | Rationale for difference (if applicable) | | Aspiration Catheter | 072 Aspiration Catheter | Penumbra JET™ 7 | CERENOVUS Large Bore Catheter | Reperfusion Catheter RED 72 | N/A | | Length | 132 cm | 115, 120, 125, 127, 132 cm | 125-135 cm | 115, 120, 125, 127, 132 cm | Same | | ID | 0.072" | 0.072" Min | 0.071" | 0.072" | Same as K191946 and K211654 | | Distal OD | 0.0855" | 0.085" Max | 0.081" | 0.085" | Same as K191946 and K211654 | | Proximal OD | 0.0855" | 0.085" Max | 0.0825" | 0.085" | Same as K191946 and K211654 | | Catheter Coating | Hydrophilic | Hydrophilic (proprietary) | Hydrophilic | Hydrophilic (proprietary) | Same | | Tip Configuration | Straight | Straight | Non-shapeable tip | Straight | Same as K191946 and K211654 | | Coating Length | 28cm +/- 4cm | 30 cm | 30 cm | 30 cm | Similar, the differences do not raise new questions regarding safety and effectiveness. | | Materials: | | | | | | | Hub | Polycarbonate | Grilamid (TR55-LX) | Polyamide (Nylon) | Grilamid (TR55-LX) | Similar, the differences do not raise new questions regarding safety and effectiveness. | | Liner | PTFE Liner | PTFE Liner | PTFE Liner | PTFE Liner | Same | | Catheter Shaft | | | | | | | Extrusions | Nylon Pebax Polyurethane | Polyurethane Polyether Block Amide Nylon 12 | Pebax Urethane Nylon | Polyurethane Polyether Block Amide Nylon 12 | Similar, the differences do not raise new questions of safety and effectiveness. | | Marker Band | Metal Platinum (90%) / Iridium (10%), Tantalum | Platinum (90%) /Iridium (10%) | Metal Platinum (90%) / Iridium (10%) | Platinum (90%) /Iridium (10%) | Similar, the differences do not raise new questions of safety and effectiveness. | | Reinforced Shaft | Stainless Steel (SS), Coil | NiTi wire, SS wire | Stainless Steel, Nitinol, braid | NiTi wire, SS wire | Similar, the differences do not raise new questions of safety and effectiveness. | | Strain Relief | Polyolefin | Polyolefin | Polyamide | Polyolefin | Same as K191946 and K211654 | | Accessories | | | | | | | Peelable Sheath | N/A | PTFE | N/A | PTFE | N/A | | Hemostasis Valve | Silicone O-ring, Polycarbonate, EPDM | Polycarbonate, silicone O-ring | Hemostasis Valve with Side Port Extension Tubing | Polycarbonate, silicone O-ring | Similar to K191946, differences do not raise new questions of safety and effectiveness. | | Flow Switch | Silicone, Polycarbonate, Acetal, ABS | N/A | N/A | N/A | The difference does not raise new questions of safety and effectiveness. | | Shaping Mandrel | N/A | Stainless Steel | N/A | Stainless Steel | N/A | | Delivery Tool | Materials: Pebax, Tecoflex 93A, Tungsten 75% Filler Dimensions: ID: 0.026 in OD: 0.042 in Extension Length: 10 cm | Materials: Nylon 12, Copolyester, Polyolefin, Polyurethane, Polyether Block Amide, PTFE, Platinum/Tungsten, Hydrophilic Coating Dimensions: ID: 0.018 in OD: 0.071 in Extension Length: 1.5 cm | N/A | N/A | Similar, the differences do not raise new questions of safety and effectiveness. | | Aspiration Tubing | Dimensions: ID: 0.110 in Tubing Length: 95 in | Dimensions: Tubing ID: 0.110 in ± 0.005 in Tubing Length: 112.0 in ± 7.0 in | Dimensions: ID: 0.110 in Tubing Length: 112 in | Dimensions: Tubing ID: 0.110 in ± 0.005 in Tubing Length: 112.0 in ± 7.0 in | Similar, the differences do not raise new questions of safety and effectiveness. | | Flow Control Mechanism | Flow Control Switch | Flow Control Switch | Flow Control Switch | Flow Control Switch | Same as K191946, K193380, K211654 | | Packaging Material | | | | | | | | | | | | | | Pouch | Tyvek (polyethylene), Mylar (Polyester) | Polyester / Polyethylene/Tyvek | Polyethylene Hoop and Mounting Card, Pouch, Carton | Polyester / Polyethylene/Tyvek | Similar to K191946, the | | Packaging Tray (Kit Configuration) | PETG (Polyethylene terephthalate glycol) | Polyethylene terephthalate, Polystyrene | | Polyethylene terephthalate, Polystyrene | differences do not raise new questions of safety and | | Display Carton | SBS Paperboard, | SBS Paperboard | | SBS Paperboard | effectiveness. | | Kit Packaging Configuration | Tray/Retainer/Lid /Accessory Pouch/Pouch/Box | Tray/Retainer/Lid/ Aspiration Tubing/Accessory Pouch/Pouch/Box | | Tray/Retainer/Lid/ Aspiration Tubing/Accessory Pouch/Pouch/Box | | | Shelf Life | 6 months | 36 months | 1 year | 36 months | The differences do not raise new questions of safety and effectiveness. | | Sterilization Method | Ethylene oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Same | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Q'apel. The logo is written in a sans-serif font and is blue. The Q has a tail that extends to the left, and the apostrophe is connected to the 'a'. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "Q'apel" in a sans-serif font. The word is written in blue. The apostrophe is placed between the "Q" and the "a". The letters are all lowercase except for the "Q". {10}------------------------------------------------ # Performance Testing – Bench: The necessary testing was identified based on design, risk analysis, and the intended use of the 072 Aspiration System to verify the device performs as intended and to demonstrate that it is substantially equivalent to the predicate device. The following performance data have been provided, supporting the substantial equivalence determination. All testing was conducted per Q'Apel Medical, Inc. Design Control procedures. The bench testing included the following tests: | Test | Test Summary | Result | |------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------| | Visual Surface Requirement | Confirm that the device meets the visual surface requirements. | Pass All samples met the predetermined acceptance criteria | | Packaging Visual Inspection | Confirm that the packaging meets the visual inspection. | Pass All samples met the predetermined acceptance criteria | | Dimensional/Visual Inspection | Device dimensions were measured to confirm conformance to the specifications. | Pass All samples met the predetermined acceptance criteria | | Liquid Leakage Under Pressure | Verify that the catheter joint strength meets the freedom from leakage (liquid leakage during pressurization) requirements of ISO 10555-1:2013, Annex C. | Pass All samples met the predetermined acceptance criteria | | Hub Aspiration Air Leakage | Confirm that the device passes the hub aspiration air leakage test of ISO 10555-1:2013, Annex D. | Pass All samples met the predetermined acceptance criteria | | Simulated Use | Simulated use testing with accessories in an anatomical model which simulated the tortuosity of the neurovasculature. Devices were delivered through the tortuous model to evaluate effectiveness of the device at retrieval of soft and firm clots and mechanical integrity after multiple passes. Testing performed with reference device (K211564) for comparison | Pass All samples met the predetermined acceptance criteria | | Test | Test Summary | Result | | Flex Fatigue | Meets minimum value per specification for multiple passes in the simulated use model. | Pass All samples met the predetermined acceptance criteria | | Track and Advance Force | Test specimens were tested for track and advance force. | Pass All samples met the predetermined acceptance criteria | | Tip Deflection | Test specimens were tested for tip deflection forces and compared to predicate catheters. | Pass All samples met the predetermined acceptance criteria | | Torque | Determine the number of revolutions to failure of the Catheter in simulated anatomy. | Pass All samples met the predetermined acceptance criteria | | Tip Elongation and Compression | Test specimens were tested for tip elongation and compression. | Pass All samples met the predetermined acceptance criteria | | Peak Tensile | The tensile strength of the catheter sections and bonds was tested after simulated use. | Pass All samples met the predetermined acceptance criteria | | Particulates, Coating Integrity | The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles. Particulates were measured during simulated use and compared to the reference device. | Pass All samples met the predetermined acceptance criteria | | Flow Rate | Determine the flow rate through a catheter, based on ISO 10555-1, Annex E. | Pass All samples met the predetermined acceptance criteria | | Aspiration Flow Rate | Determine the aspiration flow rate through the aspiration catheter when the catheter is connected to a constant vacuum source. | Pass All samples met the predetermined acceptance criteria | | Kink Resistance | Test specimen segments were formed into a defined bend diameter to evaluate kink resistance. | Pass All samples met the predetermined acceptance criteria | | Test | Test Summary | Result | | Corrosion Resistance | No visible corrosion immediately after Corrosion Testing procedure based on ISO 10555-1, Annex A. | Pass All samples met the predetermined acceptance criteria | | Radiopacity | The marker band is fluoroscopically visible. | Pass All samples met the predetermined acceptance criteria | | Burst Pressure-Static | Tested per ISO 10555-1:2013, Annex F. Testing conducted after simulated use. | Pass All samples met the predetermined acceptance criteria | | Burst Pressure-Dynamic | Minimum value per specification. | Pass All samples met the predetermined acceptance criteria | | Connectors for Intravascular or Hypodermic Applications | Hubs were tested per ISO 80369-7. | Pass All samples met the predetermined acceptance criteria | | Lumen Collapse | Aspiration Catheter samples were tested for lumen patency under maximum applied vacuum pressures. | Pass All samples met the predetermined acceptance criteria | | Manual Syringe Injection Peak Pressure (psi) | Measure peak pressure during manual injection of contrast media with a syringe. | Pass All samples met the predetermined acceptance criteria | {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the word "Q'apel" in blue font. The font is a sans-serif font, and the letters are all lowercase except for the "Q". The word is slightly italicized, and the apostrophe is placed above the "a". The background is white. {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the word "Q'apel" in blue font. The font is sans-serif and the letters are bold. The apostrophe is placed between the "Q" and the "a". The word is slightly tilted to the right. Q'Apel also confirmed that the Aspiration Tubing meets all design and performance requirements through the following bench testing: | Test | Test Summary | Result | |----------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------| | Dimensional/Visual Inspection | Confirm that the Aspiration Tubing meets all dimensional and visual specifications. | Pass All samples met the predetermined acceptance criteria | | Tensile Strength | Confirm that the Aspiration Tubing meets the existing tensile strength specifications. | Pass All samples met the predetermined acceptance criteria | | Simulated Use Test | Confirm that the Aspiration Tubing passes testing specified in the simulated use test protocol. | Pass All samples met the predetermined acceptance criteria | {13}------------------------------------------------ Image /page/13/Picture/1 description: The image shows the word "Q'apel" in blue font. The font is a sans-serif font, and the letters are all lowercase except for the "Q". The word is slightly italicized, and the apostrophe is placed between the "Q" and the "a". The background is white. | Aspiration Tubing Resistance to Collapse and Leakage at Maximum Aspiration Pressures | Confirm that the Aspiration Tubing resistance to collapse at maximum aspiration pressure testing is as specified in the test protocol. Confirm that the Aspiration Tubing does not show signs of leakage at maximum aspiration pressure. | Pass All samples met the predetermined acceptance criteria | |--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------| | Flow Switch Functionality Testing | The Flow Control Switch completely and immediately stops fluid flow after a specified number of ON/OFF cycles. | Pass All samples met the predetermined acceptance criteria | #### Performance Testing - Animal: An animal study was conducted to evaluate the safety, effectiveness, and usability of the 072 Aspiration System in comparison to cleared control devices, the CERENOVUS Large Bore Catheter (K193380) and the Penumbra System (Reperfusion Catheter RED 72) (K211654), in a porcine model according to Good Laboratory Practices (GLP) per 21 CFR Part 58. Sub-chronic and chronic time points were assessed. The study included aspiration of experimental clots and a worst-case wedge assessment. Clot aspiration and wedge assessment were comparable between the test and control catheters, and both were shown to be safe in porcine vessels via angiography and vessel histology. #### Performance Data - Clinical: No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes and to support the substantial equivalence of the 072 Aspiration System. #### Sterilization: The 072 Aspiration System, which includes the Aspiration Tubing, is sterilized using a validated 100% Ethylene Oxide sterilization process to ensure sterility assurance level (SAL) of 10 6 in accordance with AAMI TIR 28:2016 "Product Adoption and Process Equivalence for Ethylene Oxide Sterilization" and per the requirements of ISO 11135:2014 "Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices." The 072 Aspiration System, accessories, and Aspiration Tubing are for single use only. #### Shelf-Life Testing: The 072 Aspiration System, which includes the Aspiration Tubing, has a shelf life of six months based on the successful completion of stability testing. Shelf-life testing was performed using standard test methods and acceptance criteria. All samples were exposed to standard transportation conditioning and distribution before aging. Results of testing on the subject device met the established acceptance criteria. {14}------------------------------------------------ ### Biocompatibility Testing: The 072 Aspiration System was assessed for biocompatibility in accordance with ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process," and the FDA Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process"," (issued September 4, 2020). The 072 Aspiration Catheter and the Delivery Tool are considered externally communicating medical devices with direct contact with circulating blood for a limited (≤ 24 hours) duration. The Rotating Hemostasis Valve (RHV), Flow Switch, and Hub are considered external communicating devices contacting blood indirectly for a limited (< 24 hours) duration. The Aspiration Tubing is considered to have contact with intact skin for a limited (≤ 24 hours) duration. Biocompatibility testing on the 072 Aspiration System (072 Aspiration Catheter and Delivery Tool) included: | Test Name | Acceptance Criteria | Conclusion | |---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------| | Cytotoxicity - MEM Elution ISO 10993-5:2009 | The achievement of a numerical grade greater than 2 is considered a cytotoxic effect. | Non-cytotoxic | | Sensitization Magnusson- Kligman Method ISO 10993-10:2010 | Magnusson and Kligman grades of 1 or greater in the test group generally indicate sensitization, provided grades of less than 1 are seen in control animals. If grades of 1 or greater are noted in control animals, then the reactions of test animals which exceed the most severe reaction in control animals are presumed to be due to sensitization.…

072 Aspiration System

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072 Aspiration System

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