(344 days)
No
The device description and performance studies focus on the mechanical and physical properties of the catheter and tubing, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated for "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease," which is a therapeutic intervention aimed at treating a medical condition.
No
The device is indicated for use in the revascularization of patients with acute ischemic stroke by aspirating clots, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components like catheters, tubing, and a delivery tool, and the performance studies focus on bench testing of these physical attributes and an animal study involving physical interaction with vessels. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the revascularization of patients with acute ischemic stroke by physically removing blood clots from large intracranial vessels. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a catheter and associated tubing designed for aspiration within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information about a patient's condition.
- Bench and Animal Testing: The performance studies described are bench testing and an animal study, which are typical for in vivo medical devices, not IVDs.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
NRY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. All testing was conducted per Q'Apel Medical, Inc. Design Control procedures. The bench testing included visual surface requirement, packaging visual inspection, dimensional/visual inspection, liquid leakage under pressure, hub aspiration air leakage, simulated use, flex fatigue, track and advance force, tip deflection, torque, tip elongation and compression, peak tensile, particulates/coating integrity, flow rate, aspiration flow rate, kink resistance, corrosion resistance, radiopacity, burst pressure-static, burst pressure-dynamic, connectors for intravascular or hypodermic applications, lumen collapse, manual syringe injection peak pressure. All samples met predetermined acceptance criteria for these tests. The Aspiration Tubing also met design and performance requirements through dimensional/visual inspection, tensile strength, simulated use test, aspiration tubing resistance to collapse and leakage at maximum aspiration pressures, and flow switch functionality testing; all samples met 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.
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).
Biocompatibility testing on the 072 Aspiration System (072 Aspiration Catheter and Delivery Tool) included: Cytotoxicity - MEM Elution, Sensitization Magnusson-Kligman Method, Irritation: Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, ASTM Hemolysis-Direct, ASTM Hemolysis-Indirect, Hemocompatibility-Complement Activation, Thrombogenicity. All tests showed non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic, non-hemolytic, non-activator of the Complement System, and non-thrombogenic results respectively.
Biocompatibility testing on the Aspiration Tubing included: Cytotoxicity - MEM Elution, Sensitization Magnusson-Kligman Method, Irritation: Intracutaneous Reactivity. All tests showed non-cytotoxic, non-sensitizer, and non-irritant results respectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).
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) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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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.
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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 |
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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. | | |
| | | | | | |
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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 |
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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'.
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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".
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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 |
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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.
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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 |
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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.
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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 ( 10% occurs in three
or more animals from the test
group. | Non-toxic |
| Material Mediated Pyrogenicity
ISO 10993-11:2017, USP 151 | The requirements of the test were
met if no rabbit showed an
individual rise in temperature of
0.5 °C or more above its Non-pyrogenic | |
| | respective baseline temperature
throughout the duration of the test. | |
| ASTM Hemolysis- Direct
(direct blood contact
components only)
ISO 10993-4: 2017
ASTM F756-17 | The positive control's mean
hemolytic index above the
negative control must be ≥ 5% for
the direct method.
The negative control must display
a mean hemolytic index of