(344 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Q'Apel Medical, Inc. 072 Aspiration System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally phrased as meeting "predetermined acceptance criteria" or specific ISO standards. The reported device performance for all bench tests and animal studies is "Pass," indicating that all samples met the defined criteria.
Note: For bench tests, specific numerical acceptance criteria are not detailed in the provided summary, only the general statement that "All samples met the predetermined acceptance criteria." For biocompatibility, the specific numerical acceptance criteria are listed.
| Test Category | Acceptance Criteria (as stated) | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| Visual Surface Requirement | Device meets visual surface requirements. | Pass |
| Packaging Visual Inspection | Packaging meets visual inspection. | Pass |
| Dimensional/Visual Inspection | Device dimensions conform to specifications. | Pass |
| Liquid Leakage Under Pressure | Catheter joint strength meets freedom from leakage requirements of ISO 10555-1:2013, Annex C. | Pass |
| Hub Aspiration Air Leakage | Device passes hub aspiration air leakage test of ISO 10555-1:2013, Annex D. | Pass |
| Simulated Use | Effectiveness of device at retrieval of soft and firm clots and mechanical integrity after multiple passes. | Pass |
| Flex Fatigue | Meets minimum value per specification for multiple passes in the simulated use model. | Pass |
| Track and Advance Force | Test specimens meet track and advance force criteria. | Pass |
| Tip Deflection | Test specimens meet tip deflection forces criteria and compare favorably to predicate catheters. | Pass |
| Torque | Number of revolutions to failure of the Catheter in simulated anatomy meets criteria. | Pass |
| Tip Elongation and Compression | Test specimens meet tip elongation and compression criteria. | Pass |
| Peak Tensile | Tensile strength of catheter sections and bonds meets criteria after simulated use. | Pass |
| Particulates, Coating Integrity | Integrity of hydrophilic coating evaluated after multiple insertion/withdrawal cycles, and particulates measured during simulated use compared to reference device, meet criteria. | Pass |
| Flow Rate | Flow rate through a catheter meets ISO 10555-1, Annex E. | Pass |
| Aspiration Flow Rate | Aspiration flow rate through the aspiration catheter meets criteria when connected to a constant vacuum source. | Pass |
| Kink Resistance | Test specimen segments formed into a defined bend diameter meet kink resistance criteria. | Pass |
| Corrosion Resistance | No visible corrosion immediately after Corrosion Testing procedure based on ISO 10555-1, Annex A. | Pass |
| Radiopacity | Marker band is fluoroscopically visible. | Pass |
| Burst Pressure-Static | Tested per ISO 10555-1:2013, Annex F, after simulated use, meets criteria. | Pass |
| Burst Pressure-Dynamic | Minimum value per specification. | Pass |
| Connectors for Intravascular | Hubs tested per ISO 80369-7. | Pass |
| Lumen Collapse | Aspiration Catheter samples meet lumen patency under maximum applied vacuum pressures. | Pass |
| Manual Syringe Injection Peak Pressure | Measure peak pressure during manual injection of contrast media with a syringe, meets criteria. | Pass |
| Aspiration Tubing Bench Testing | ||
| Dimensional/Visual Inspection | Aspiration Tubing meets all dimensional and visual specifications. | Pass |
| Tensile Strength | Aspiration Tubing meets existing tensile strength specifications. | Pass |
| Simulated Use Test | Aspiration Tubing passes testing specified in the simulated use test protocol. | Pass |
| Resistance to Collapse and Leakage at Maximum Aspiration Pressures | Aspiration Tubing resistance to collapse at maximum aspiration pressure meets testing specified in the test protocol and does not show signs of leakage at maximum aspiration pressure. | Pass |
| Flow Switch Functionality Testing | Flow Control Switch completely and immediately stops fluid flow after a specified number of ON/OFF cycles. | Pass |
| Biocompatibility Testing (072 Aspiration Catheter and Delivery Tool) | ||
| Cytotoxicity - MEM Elution | The achievement of a numerical grade greater than 2 is considered a cytotoxic effect. (Implicit acceptance: numerical grade ≤ 2) | Non-cytotoxic |
| Sensitization | 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. (Implicit acceptance: no statistically significant sensitization compared to control) | Non-sensitizing |
| Irritation: Intracutaneous Reactivity | The requirements of the test were met if the final test article score was ≤ 1.0. | Non-irritating |
| Acute Systemic Toxicity | If using five animals per group, the test article meets the requirement of the test if: 1. Two or more animals from the test group die. 2. Animal behavior, such as convulsions or prostration, occurs in two or more animals from the test group. 3. A final (end of study) body weight loss > 10% occurs in three or more animals from the test group. (Implicit acceptance: none of these conditions occurred) | Non-toxic |
| Material Mediated Pyrogenicity | The requirements of the test were met if no rabbit showed an individual rise in temperature of 0.5 °C or more above its respective baseline temperature throughout the duration of the test. | Non-pyrogenic |
| ASTM Hemolysis- Direct | 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 < 2% for the direct method. (Implicit acceptance: test article meets non-hemolytic criteria based on these controls) | Non-hemolytic for the Direct Method |
| ASTM Hemolysis- Indirect | The positive control's mean hemolytic index above the negative control must be ≥ 5% for the indirect method. The negative control must display a mean hemolytic index of < 2% for the indirect method. (Implicit acceptance: test article meets non-hemolytic criteria based on these controls) | Non-hemolytic for the Indirect Method |
| Hemocompatibility- Complement Activation | The negative control (HDPE) concentration must not be significantly higher when compared to the NHS at 37 °C concentration or the final concentration must fall within ± 1 standard deviation of the mean in the test facility historical range for HDPE. The positive reference control (Latex) concentration must be statistically significant when compared to the NHS at 37 °C concentration or the final concentration must fall within ± 1 standard deviation of the mean in the test facility historical range for Latex. (Implicit acceptance: test article acts like negative control) | Non-activator of the Complement System |
| Thrombogenicity | The thrombogenic potential of a blood-contacting medical device must be comparable to a predicate device. (Implicit acceptance: comparable to predicate device) | Non-thrombogenic |
| Biocompatibility Testing (Aspiration Tubing) | ||
| Cytotoxicity - MEM Elution | The achievement of a numerical grade greater than 2 is considered a cytotoxic effect. (Implicit acceptance: numerical grade ≤ 2) | Non-cytotoxic |
| Sensitization | Test group shall yield Grade < 1 score on Magnusson and Kligman scale (provided control group yields Grade < 1). (Implicit acceptance: Grade < 1) | Non-sensitizer |
| Irritation: Intracutaneous Reactivity | The test requirements are met if the difference between the test mean score and the control mean score is 1.0 or less and the test does not fail at any observation period. Differences of less than 0 are reported as 0. (Implicit acceptance: difference < 1.0) | Non-irritant |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: The document consistently states "All samples met the predetermined acceptance criteria" for each bench test. However, the exact numerical sample size for each specific bench test is not provided.
- Animal Study: The study involved a "porcine model." The exact number of animals used is not specified. The study was conducted "according to Good Laboratory Practices (GLP) per 21 CFR Part 58," which indicates controlled experimental conditions.
- Data Provenance:
- Bench Testing: In-house testing by Q'Apel Medical, Inc.
- Animal Study: Experimental, prospective study in a porcine (animal) model.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Bench Testing: Not applicable in the context of expert ground truth. These tests likely involved technicians or engineers following standardized protocols.
- Animal Study: The document doesn't specify the number or qualifications of experts (e.g., veterinarians, pathologists) involved in establishing ground truth (e.g., assessing vessel histology or clot aspiration results). It mentions that "Sub-chronic and chronic time points were assessed" and that "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." This implies expert assessment of the outcomes, but details are absent.
4. Adjudication Method for the Test Set
- Bench Testing: Not applicable. Bench tests typically rely on objective measurements against predefined specifications.
- Animal Study: Not specified. While the results were declared "comparable" and "safe," it's not explicitly stated if multiple experts reviewed the outcomes and how any discrepancies were resolved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "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." Therefore, there is no effect size reported for human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. The device is a physical medical instrument (an aspiration catheter system), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance reviewed is the device's physical function.
7. The Type of Ground Truth Used
- Bench Testing: Reference standards (e.g., ISO standards), design specifications, and comparison to a reference device (K211564 for simulated use particulates) were used to establish "ground truth" (i.e., expected performance).
- Animal Study: Angiography and vessel histology were used as ground truth for assessing safety and effectiveness (clot aspiration, wedge assessment, tissue response) in the porcine model. These are objective measures collected during and after the animal procedures.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical instrument, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data used to train an AI model.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As stated above, this is not an AI device, so there is no training set or ground truth for a training set.
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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
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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
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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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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 DriveFremont, CA 94538 |
|---|---|
| Telephone: | 510-738-6255 |
| Contact Person:Title:Telephone: | Kim KyManager, Regulatory Affairs510-828-4757 |
| 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 DeliveryDevice (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 Device1 (K193380) | Reference Device 2(K211654) | Rationale fordifference (ifapplicable) |
| Device Name | 072 AspirationSystem | Penumbra System(JET 7MAX) | CERENOVUSLarge BoreCatheter;CERENOVUSAspiration TubingSet | PenumbraSystem(ReperfusionCatheter 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 |
| ClassificationName | 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 arecandidates fortreatment.Penumbra AspirationTubingAs part of thePenumbra System,the Penumbra SterileAspiration Tubing isindicated to connectthe PenumbraReperfusionCatheters to thePenumbra AspirationPump.Penumbra AspirationPumpThe PenumbraAspiration Pump isindicated as avacuum source forPenumbra AspirationSystems. | (or equivalentvacuum pump)and to allow theuser to controlthe fluid flow. | onset. Patients whoare ineligible forintravenous tissueplasminogenactivator (IV t-PA) orwho fail IV t-PAtherapy arecandidates fortreatment.PenumbraAspiration TubingAs part of thePenumbra System,the PenumbraSterile AspirationTubing is indicatedto connect thePenumbraReperfusionCatheters to thePenumbraAspiration Pump.PenumbraAspiration PumpThe PenumbraAspiration Pump isindicated as avacuum source forPenumbraAspiration Systems. | |||
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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.
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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 Device1 (K193380) | Reference Device 2(K211654) | Rationale fordifference (ifapplicable) |
| AspirationCatheter | 072 AspirationCatheter | Penumbra JET™ 7 | CERENOVUSLarge BoreCatheter | ReperfusionCatheter 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 asK191946 andK211654 |
| Distal OD | 0.0855" | 0.085" Max | 0.081" | 0.085" | Same asK191946 andK211654 |
| Proximal OD | 0.0855" | 0.085" Max | 0.0825" | 0.085" | Same asK191946 andK211654 |
| CatheterCoating | Hydrophilic | Hydrophilic(proprietary) | Hydrophilic | Hydrophilic(proprietary) | Same |
| TipConfiguration | Straight | Straight | Non-shapeabletip | Straight | Same asK191946 andK211654 |
| Coating Length | 28cm +/- 4cm | 30 cm | 30 cm | 30 cm | Similar, thedifferences donot raise newquestionsregardingsafety andeffectiveness. |
| Materials: | |||||
| Hub | Polycarbonate | Grilamid (TR55-LX) | Polyamide (Nylon) | Grilamid (TR55-LX) | Similar, thedifferences donot raise newquestionsregardingsafety andeffectiveness. |
| Liner | PTFE Liner | PTFE Liner | PTFE Liner | PTFE Liner | Same |
| CatheterShaft | |||||
| Extrusions | NylonPebaxPolyurethane | PolyurethanePolyether BlockAmideNylon 12 | PebaxUrethaneNylon | PolyurethanePolyether BlockAmideNylon 12 | Similar, thedifferences donot raise newquestions ofsafety andeffectiveness. |
| Marker Band | Metal Platinum(90%) / Iridium(10%), Tantalum | Platinum (90%) /Iridium(10%) | Metal Platinum(90%) / Iridium(10%) | Platinum (90%)/Iridium (10%) | Similar, thedifferences donot raise newquestions ofsafety andeffectiveness. |
| ReinforcedShaft | Stainless Steel (SS),Coil | NiTi wire, SS wire | Stainless Steel,Nitinol, braid | NiTi wire, SS wire | Similar, thedifferences donot raise newquestions ofsafety andeffectiveness. |
| Strain Relief | Polyolefin | Polyolefin | Polyamide | Polyolefin | Same asK191946 andK211654 |
| Accessories | |||||
| PeelableSheath | N/A | PTFE | N/A | PTFE | N/A |
| HemostasisValve | Silicone O-ring,Polycarbonate,EPDM | Polycarbonate,silicone O-ring | HemostasisValve with SidePort ExtensionTubing | Polycarbonate,silicone O-ring | Similar toK191946,differences donot raise newquestions ofsafety andeffectiveness. |
| Flow Switch | Silicone,Polycarbonate,Acetal, ABS | N/A | N/A | N/A | The differencedoes not raisenew questionsof safety andeffectiveness. |
| ShapingMandrel | N/A | Stainless Steel | N/A | Stainless Steel | N/A |
| Delivery Tool | Materials:Pebax, Tecoflex93A, Tungsten 75%FillerDimensions:ID: 0.026 inOD: 0.042 inExtension Length:10 cm | Materials:Nylon 12,Copolyester,Polyolefin,Polyurethane,Polyether BlockAmide, PTFE,Platinum/Tungsten,Hydrophilic CoatingDimensions:ID: 0.018 inOD: 0.071 inExtension Length:1.5 cm | N/A | N/A | Similar, thedifferences donot raise newquestions ofsafety andeffectiveness. |
| AspirationTubing | Dimensions:ID: 0.110 inTubing Length: 95 in | Dimensions:Tubing ID: 0.110 in ±0.005 inTubing Length: 112.0in ± 7.0 in | Dimensions:ID: 0.110 inTubing Length:112 in | Dimensions:Tubing ID: 0.110 in ±0.005 inTubing Length:112.0 in ± 7.0 in | Similar, thedifferences donot raise newquestions ofsafety andeffectiveness. |
| Flow ControlMechanism | Flow Control Switch | Flow Control Switch | Flow ControlSwitch | Flow Control Switch | Same asK191946,K193380,K211654 |
| PackagingMaterial | |||||
| Pouch | Tyvek(polyethylene), Mylar(Polyester) | Polyester /Polyethylene/Tyvek | PolyethyleneHoop andMounting Card,Pouch, Carton | Polyester /Polyethylene/Tyvek | Similar toK191946,the |
| PackagingTray (KitConfiguration) | PETG (Polyethyleneterephthalate glycol) | Polyethyleneterephthalate,Polystyrene | Polyethyleneterephthalate,Polystyrene | differences donot raise newquestions ofsafety and | |
| Display Carton | SBS Paperboard, | SBS Paperboard | SBS Paperboard | effectiveness. | |
| Kit PackagingConfiguration | Tray/Retainer/Lid/AccessoryPouch/Pouch/Box | Tray/Retainer/Lid/AspirationTubing/AccessoryPouch/Pouch/Box | Tray/Retainer/Lid/AspirationTubing/AccessoryPouch/Pouch/Box | ||
| Shelf Life | 6 months | 36 months | 1 year | 36 months | The differencesdo not raisenew questionsof safety andeffectiveness. |
| SterilizationMethod | Ethylene oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Same |
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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 SurfaceRequirement | Confirm that the devicemeets the visual surfacerequirements. | PassAll samples met thepredetermined acceptancecriteria |
| Packaging VisualInspection | Confirm that the packagingmeets the visual inspection. | PassAll samples met thepredetermined acceptancecriteria |
| Dimensional/VisualInspection | Device dimensions weremeasured to confirmconformance to thespecifications. | PassAll samples met thepredetermined acceptancecriteria |
| Liquid Leakage UnderPressure | Verify that the catheter jointstrength meets thefreedom from leakage(liquid leakage duringpressurization)requirements of ISO10555-1:2013, Annex C. | PassAll samples met thepredetermined acceptancecriteria |
| Hub Aspiration AirLeakage | Confirm that the devicepasses the hub aspirationair leakage test of ISO10555-1:2013, Annex D. | PassAll samples met thepredetermined acceptancecriteria |
| Simulated Use | Simulated use testing withaccessories in ananatomical model whichsimulated the tortuosity ofthe neurovasculature.Devices were deliveredthrough the tortuous modelto evaluate effectiveness ofthe device at retrieval of softand firm clots andmechanical integrity aftermultiple passes. Testingperformed with referencedevice (K211564) forcomparison | PassAll samples met thepredetermined acceptancecriteria |
| Test | Test Summary | Result |
| Flex Fatigue | Meets minimum value per specification for multiple passes in the simulated use model. | PassAll samples met the predetermined acceptance criteria |
| Track and Advance Force | Test specimens were tested for track and advance force. | PassAll samples met the predetermined acceptance criteria |
| Tip Deflection | Test specimens were tested for tip deflection forces and compared to predicate catheters. | PassAll samples met the predetermined acceptance criteria |
| Torque | Determine the number of revolutions to failure of the Catheter in simulated anatomy. | PassAll samples met the predetermined acceptance criteria |
| Tip Elongation and Compression | Test specimens were tested for tip elongation and compression. | PassAll samples met the predetermined acceptance criteria |
| Peak Tensile | The tensile strength of the catheter sections and bonds was tested after simulated use. | PassAll 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. | PassAll samples met the predetermined acceptance criteria |
| Flow Rate | Determine the flow rate through a catheter, based on ISO 10555-1, Annex E. | PassAll 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. | PassAll samples met the predetermined acceptance criteria |
| Kink Resistance | Test specimen segments were formed into a defined bend diameter to evaluate kink resistance. | PassAll 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. | PassAll samples met thepredetermined acceptancecriteria |
| Radiopacity | The marker band is fluoroscopically visible. | PassAll samples met thepredetermined acceptancecriteria |
| Burst Pressure-Static | Tested per ISO 10555-1:2013, Annex F. Testing conducted after simulated use. | PassAll samples met thepredetermined acceptancecriteria |
| Burst Pressure-Dynamic | Minimum value per specification. | PassAll samples met thepredetermined acceptancecriteria |
| Connectors forIntravascular orHypodermicApplications | Hubs were tested per ISO 80369-7. | PassAll samples met thepredetermined acceptancecriteria |
| Lumen Collapse | Aspiration Catheter samples were tested for lumen patency under maximum applied vacuum pressures. | PassAll samples met thepredetermined acceptancecriteria |
| Manual Syringe InjectionPeak Pressure (psi) | Measure peak pressure during manual injection of contrast media with a syringe. | PassAll samples met thepredetermined acceptancecriteria |
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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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Q'Apel also confirmed that the Aspiration Tubing meets all design and performance requirements through the following bench testing:
| Test | Test Summary | Result |
|---|---|---|
| Dimensional/VisualInspection | Confirm that the AspirationTubing meets all dimensionaland visual specifications. | PassAll samples met thepredeterminedacceptance criteria |
| Tensile Strength | Confirm that the AspirationTubing meets the existingtensile strength specifications. | PassAll samples met thepredeterminedacceptance criteria |
| Simulated Use Test | Confirm that the AspirationTubing passes testing specifiedin the simulated use testprotocol. | PassAll samples met thepredeterminedacceptance 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 TubingResistance to Collapseand Leakage atMaximum AspirationPressures | Confirm that the AspirationTubing resistance to collapse atmaximum aspiration pressuretesting is as specified in the testprotocol. Confirm that theAspiration Tubing does not showsigns of leakage at maximumaspiration pressure. | PassAll samples met thepredeterminedacceptance criteria |
|---|---|---|
| Flow SwitchFunctionality Testing | The Flow Control Switchcompletely and immediatelystops fluid flow after a specifiednumber of ON/OFF cycles. | PassAll samples met thepredeterminedacceptance 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 (< 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 ElutionISO 10993-5:2009 | The achievement of a numericalgrade greater than 2 is considereda cytotoxic effect. | Non-cytotoxic |
| SensitizationMagnusson- Kligman MethodISO 10993-10:2010 | Magnusson and Kligman gradesof 1 or greater in the test groupgenerally indicate sensitization,provided grades of less than 1 areseen in control animals. If gradesof 1 or greater are noted in controlanimals, then the reactions of testanimals which exceed the mostsevere reaction in control animalsare presumed to be due tosensitization. | Non-sensitizing |
| Irritation: IntracutaneousReactivityISO 10993-23:2021 | The requirements of the test weremet if the final test article scorewas ≤ 1.0. | Non-irritating |
| Acute Systemic ToxicityISO 10993-11:2017 | If using five animals per group, thetest article meets the requirementof the test if none of the followingcircumstances occur:1. Two or more animals from thetest group die.2. Animal behavior, such asconvulsions or prostration, occursin two or more animals from thetest group.3. A final (end of study) bodyweight loss > 10% occurs in threeor more animals from the testgroup. | Non-toxic |
| Material Mediated PyrogenicityISO 10993-11:2017, USP 151 | The requirements of the test weremet if no rabbit showed anindividual rise in temperature of0.5 °C or more above its Non-pyrogenic | |
| respective baseline temperaturethroughout the duration of the test. | ||
| ASTM Hemolysis- Direct(direct blood contactcomponents only)ISO 10993-4: 2017ASTM F756-17 | The positive control's meanhemolytic index above thenegative control must be ≥ 5% forthe direct method.The negative control must displaya mean hemolytic index of < 2 %for the direct method. | Non-hemolytic for the Direct Method |
| ASTM Hemolysis- Indirect(indirect blood contactcomponents only)ISO 10993-4: 2017ASTM F756-17 | The positive control's meanhemolytic index above thenegative control must be ≥ 5% forthe indirect method.The negative control must displaya mean hemolytic index of < 2 %for the indirect method. | Non-hemolytic for the IndirectMethod |
| Hemocompatibility-Complement Activation(direct blood contactcomponents only)ISO 10993-4: 2017 | The negative control (HDPE)concentration must not besignificantly higher whencompared to the NHS at 37 °Cconcentration or the finalconcentration must fall within ± 1standard deviation of the mean inthe test facility historical rangefor HDPE.The positive reference control(Latex) concentration must bestatistically significant whencompared to the NHS at 37 °Cconcentration or the finalconcentration must fall within ± 1standard deviation of the mean inthe test facility historical rangefor Latex. | Non-activator of the ComplementSystem |
| ThrombogenicityISO 10993-4: 2017 | The thrombogenic potential of ablood-contacting medical devicemust be comparable to apredicate device. | Non-thrombogenic |
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Image /page/16/Picture/1 description: The image shows the logo for Q'apel. The logo is written in a sans-serif font and is blue. The logo is simple and modern.
Biocompatibility testing on the Aspiration Tubing included:
| Test Name | Acceptance Criteria | Conclusion |
|---|---|---|
| Cytotoxicity - MEM ElutionISO 10993-5:2009 | The achievement of a numericalgrade greater than 2 isconsidered a cytotoxic effect. | Non-cytotoxic |
| Sensitization Magnusson-Kligman MethodISO 10993-10:2010 | Test group shall yield Grade < 1score on Magnusson andKligman scale (provided controlgroup yields Grade < 1) | Non-sensitizer |
| Irritation: IntracutaneousReactivityISO 10993-23:2021 | The test requirements are met ifthe difference between the testmean score and the controlmean score is 1.0 or less andthe test does not fail at anyobservation period. Differencesof less than 0 are reported as 0. | Non-irritant |
Conclusion:
The performance characteristics and the test results demonstrate that the 072 Aspiration System meets the test acceptance criteria, performs as well as, and is substantially equivalent to the predicate device, Penumbra System® [JET™ 7 Reperfusion Catheter with MAX Delivery Device (JET™ 7MAX)] (K191946), and reference devices.
§ 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).