Search Results
Found 102 results
510(k) Data Aggregation
(122 days)
The Zoom System, when used with the Zoom Aspiration Pump (or equivalent vacuum 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 last known well.
Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.
The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (7X, 71, 55, 45, 4S, 35) Catheter and the Zoom 88 Large Distal Platform, the Zoom 88 Large Distal Platform Support, or the TracStar LDP Large Distal Platform to the Zoom Canister or Zoom DuoPort Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.
The Zoom 4S Catheter, a new catheter within the Zoom System, is a single lumen, braid and coil reinforced, variable stiffness catheter with a radiopaque marker and a lubricious hydrophilic coating on the distal portion of the catheter. The Zoom 4S Catheter has a luer hub on the proximal end. The Zoom 4S Catheter is intended to be used in conjunction with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing and Zoom Aspiration Pump (or equivalent vacuum pump) to aspirate thrombus.
Dimensions of the Zoom 4S Catheter are included on the individual device label. The Zoom 4S Catheter is compatible with 0.035" or smaller guidewires. An additional support catheter may be used to assist in accessing the target vasculature. The Zoom 4S Catheter is compatible with guide sheaths having a minimum inner diameter of 0.071".
The Zoom 4S Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is intended to be attached to the proximal hub of the catheter and used to control hemostasis during use with other devices.
The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing (Zoom POD) are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Zoom 4S Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Zoom Aspiration Tubing and Zoom POD are made of common medical grade polymers.
In addition to the accessories discussed above, the adjunctive devices and supplies listed below are intended to be used with the Zoom 4S Catheter.
- Guidewires
- Support/Diagnostic Catheters
- Introducer Sheaths
- Aspiration Pump*
- Capable of achieving pressure between -20inHg to max vacuum (-29 inHg)
- Airflow rating of 0 – 23 LPM
- IEC 60601-1 Compliant
*Imperative Care offers the Zoom Aspiration Pump which meets the indicated criteria. The Zoom Aspiration Pump is used with the Zoom Canister or Zoom DuoPort Canister.
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(132 days)
The Tigertriever 17 Ultra Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Tigertriever 17 Ultra Revascularization Device (TRPP7266) is a line extension of the existing Tigertriever 17 Revascularization Device (TRPP7166) cleared under K203592. The Tigertriever 17 Ultra Revascularization Device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. The Tigertriever 17 Ultra Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neurointerventional procedures and the treatment of ischemic stroke.
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(106 days)
The EMBOTRAP III Revascularization Device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The EMBOTRAP™ III Revascularization Device is composed of a retrievable, self-expanding, Nitinol shaped section at the distal end of a tapered Nitinol shaft. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. The EMBOTRAP™ III Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.
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(29 days)
Millipede70 Aspiration Catheter
The Millipede70 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration 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 thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.
Perfuze Aspiration Tube Set
The Perfuze Aspiration Tube Set is indicated to connect the Millipede70 Aspiration Catheter to a compatible aspiration pump.
The Millipede70 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV).
The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede70 Aspiration Catheter.
The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connector connects to the hub of a Millipede70 Aspiration Catheter. The suction connector connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter.
For the aspiration source, the Millipede70 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters. The aspiration pump is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.
The provided FDA 510(k) clearance letter and summary for the Perfuze Ltd. Millipede70 Aspiration Catheter and Perfuze Aspiration Tube Set do not contain information about an AI/ML-based device or a comparative effectiveness study involving human readers with and without AI assistance.
This submission focuses on demonstrating substantial equivalence of a physical medical device (catheter and aspiration tube set) to a previously cleared predicate device. The primary change is a minor modification to the outer diameter of the distal end of the catheter.
Therefore, many of the requested criteria regarding AI device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone AI performance, and ground truth establishment for AI models are not applicable to this specific 510(k) submission.
However, I can still extract information about the acceptance criteria and the study that proves the physical device meets these criteria based on the provided document.
Acceptance Criteria and Device Performance for the Physical Device
The acceptance criteria for this physical device are primarily demonstrated through performance testing (bench testing), confirming its mechanical properties and functionality meet defined specifications and are comparable to the predicate device.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Test Method (Acceptance Criteria) | Reported Device Performance (Conclusion) |
|---|---|
| Dimensional Verification: Conformance to specifications (specifically the outer diameter of the distal end) | The device met established specifications. (Outer diameter increased from 0.0835" to 0.0837"). |
| Simulated Use Testing: Deliverability and compatibility with accessory devices in a neurovascular model | The device performs as intended under simulated use conditions. |
| Visual Inspection: Device surface characteristics assessed after simulated use testing for freedom from defects | The device surface characteristics are suitable for its intended use. |
| Hydrophilic Coating Integrity: Evaluated after multiple insertion and withdrawal cycles | The hydrophilic coating integrity is suitable for its intended use. |
| Kink Resistance: Specimen segments formed into a defined bend diameter to evaluate kink resistance | The device met established specifications. |
| Tip Stiffness: Bending stiffness of the tip measured to confirm conformance to specification | The device met established specifications. |
| Torque Strength: Test specimens rotated with distal end constrained to evaluate integrity post-rotation | The device met established specifications. |
| Biocompatibility: Materials, formulation, and suppliers identical to predicate. | No biocompatibility testing required. |
| Sterilization: EO process with 1x10-6 sterility assurance level, identical to predicate. | No new sterilization testing required; method is identical and validated. |
| Shelf Life and Packaging: Identical to predicate. | No shelf-life testing or packaging validation required. |
2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify exact sample sizes (N-values) for each bench test (e.g., how many catheters were subjected to kink resistance or torque strength testing). It broadly states "test specimen segments" or "test specimens."
- Data Provenance: The studies are bench (laboratory) tests conducted by the manufacturer, Perfuze Ltd., in Ireland. They are inherently prospective in the sense that they are designed and executed specifically for this regulatory submission. Country of origin of the data would be Ireland (where Perfuze Ltd. is based).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not an AI/ML device where expert consensus would establish ground truth for image interpretation or diagnosis. The "ground truth" for this physical device's performance is established by engineering specifications and physical measurements, and its functionality evaluated against predefined criteria in simulated environments.
4. Adjudication method for the test set:
- Not Applicable. As this is not a study involving human-in-the-loop assessment or expert review of clinical cases. Bench testing results are typically evaluated against pre-defined engineering specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not conducted as this is a physical medical device (catheter) and not an AI/ML diagnostic or assistive software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not a standalone algorithm.
7. The type of ground truth used:
- For the physical device, the "ground truth" is defined by engineering specifications, performance standards, and functional demonstration in controlled laboratory environments (e.g., neurovascular models). The goal is to demonstrate that the device performs according to its design, is safe, and is substantially equivalent to a previously cleared device.
8. The sample size for the training set:
- Not Applicable. This is a physical device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. There is no training set. The device's design and manufacturing are based on established engineering principles and material science, verified through the bench testing described.
Summary of the Device and Study:
The Millipede70 Aspiration Catheter and Perfuze Aspiration Tube Set are physical devices indicated for the revascularization of patients with acute ischemic stroke. The 510(k) submission seeks to demonstrate substantial equivalence to a predicate device (Millipede 070 Aspiration Catheter; K250012) due to a minor change in the distal outer diameter (from 0.0835" to 0.0837").
The study to prove the device meets acceptance criteria was non-clinical bench (laboratory) testing. This testing confirmed that the slightly modified device still met all relevant engineering specifications for dimensions, simulated use performance, coating integrity, kink resistance, tip stiffness, and torque strength. No new biocompatibility, sterilization, shelf-life, animal, or clinical studies were deemed necessary because the materials, fundamental design, indications for use, and operating principle remained the same as the predicate device. The change was determined not to raise different questions of safety or effectiveness.
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(70 days)
Product code NRY:
The CEREGLIDE 71 Catheter System, with the Cerenovus Aspiration Tubing Set and a compatible aspiration 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE 71, 57, or 42 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
Product code QJP:
The CEREGLIDE 71 Catheter System is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CEREGLIDE 71 Catheter System is also indicated for use as a conduit for retrieval devices.
The CEREGLIDE™ 71 Catheter System consists of the CEREGLIDE™ 71 Intermediate Catheter and associated accessories including the INNERGLIDE™ 7 Delivery Aid, Rotating Hemostasis Valve, and Slit Introducers.
The CEREGLIDE™ 71 Intermediate Catheter is a single lumen, variable stiffness catheter designed to be introduced over a steerable guidewire along with a microcatheter and/or compatible support device into the neuro vasculature. The catheter consists of a lubricious PTFE inner lumen liner to facilitate movement of the guidewires and other devices, variable pitch stainless steel and tungsten braid, and various durometer polymer jackets.
These jackets provide distal flexibility and gradually transition to a stiffer proximal shaft to facilitate the advancement of the catheter in the anatomy. The outer surface of the catheter is hydrophilic coated in order to reduce friction during manipulation in the vessel. A radiopaque marker at the distal end of the catheter provides fluoroscopic visualization of the catheter tip. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories, a hub, and an ID band.
The CEREGLIDE™ 71 Catheter System is packaged with an INNERGLIDE™ 7 Delivery Aid, a Rotating Hemostasis Valve (RHV) with a side port and two Slit Introducer accessories. The INNERGLIDE™ 7 Delivery Aid is a compatible support device comprising of a single lumen catheter with a tapered tip, hydrophilic coating for increased lubricity, radiopaque tip for fluoroscopic visualization, and a proximal luer hub that is designed to be used as part of the CEREGLIDE™ 71 Catheter System to facilitate delivery of the CEREGLIDE™ 71 Intermediate Catheter to select blood vessels in the neurovasculature. The RHV with side port is used for flushing and insertion of catheters. The Slit Introducers are designed to introduce the CEREGLIDE™ 71 Intermediate Catheter into the base catheter and protect the distal tip of the CEREGLIDE™ 71 Intermediate Catheter during insertion into the hemostasis valve of the base catheter.
Product code NRY: The CEREGLIDE™ 71 Intermediate Catheter can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set.
This document is a 510(k) clearance letter for a medical device (CEREGLIDE 71 Catheter System), and does not contain the information requested about acceptance criteria and a study proving a device meets these criteria for an AI/software medical device.
The 510(k) summary explicitly states:
- "No animal studies were required as appropriate verification and validation of the subject device design were achieved based on the similarities of the proposed device and the predicate devices, and from results of bench testing."
- "Clinical studies were not required as appropriate verification and validation of the subject device design were achieved based on the similarities of the proposed device and the predicate devices, and from results of bench testing."
The document details the device's technical specifications, indications for use, and a comparison to predicate devices, along with non-clinical (bench) performance testing. These bench tests are primarily focused on the physical characteristics and performance of the catheter system, such as dimensions, material properties, durability, and a simple in vitro usability study.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or MRMC studies, as these aspects are not present in the provided document. The device in question is a physical medical catheter system, not an AI/software medical device that would typically involve such studies for regulatory submission.
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(162 days)
Raptor Aspiration Catheter:
The Raptor Aspiration Catheter with a compatible aspiration pump and Balt Aspiration Tubing Set 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
Balt Aspiration Tubing Set:
The Balt Aspiration Tubing Set is intended to connect the Raptor Aspiration Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered in various sizes that facilitates removal of thrombus from the neurovasculature when connected to a compatible aspiration pump and the Balt Aspiration Tubing Set. The distal tip of the catheter shaft includes a markerband and the proximal end of the catheter has a luer fitting to allow for the attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter. The Raptor Aspiration Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Raptor Aspiration Catheters are compatible with 0.014" – 0.018" guidewires.
A peelable split Introducer Sheath is provided in the package to provide support and facilitate the introduction of the distal tip of the Raptor Aspiration Catheter into an appropriate vascular sheath. The catheter and Introducer Sheath are provided sterile, non-pyrogenic, and intended for single use only.
The Balt Aspiration Tubing Set consists of one 100" HPF proximal tubing with a suction connector on one end and male rotator on the other, one 1-way Large Bore Stopcock, and one 10" HPF distal tubing with a female luer connector on one end and a male rotator on the other.
The Balt Aspiration Tubing Set facilitates the supply of vacuum from a compatible aspiration pump to the distal tip of the Raptor Aspiration Catheter. Balt Aspiration Tubing Set is provided sterile, non-pyrogenic and it is intended for single use only.
The provided FDA 510(k) clearance letter pertains to the Raptor Aspiration Catheter and Balt Aspiration Tubing Set, medical devices used for revascularization in acute ischemic stroke patients. The document describes various performance tests conducted to demonstrate substantial equivalence to predicate devices.
However, it's crucial to note that this document does not describe the acceptance criteria and study for a software/AI device. The tests listed are for the physical catheter and tubing set. There is no mention of an algorithm, AI, or any software component that would require the specific information requested in the prompt (e.g., test set, ground truth, expert adjudication, MRMC study, standalone performance).
Therefore, I cannot provide information for points 1 through 9 of your request, as they are not applicable to the content of this FDA clearance letter. The device described is a physical medical instrument, not an AI/software-based diagnostic or assistive tool.
Key takeaway: The provided text is for a physical medical device (catheter and tubing) and does not involve AI or software-based performance. Therefore, the specific criteria requested for AI/software devices (like sample size, ground truth, expert adjudication, MRMC studies) are not present in this document.
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(243 days)
The Zoom 7X Catheter, with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing, and the Zoom Aspiration Pump (or equivalent vacuum 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 last known well.
Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.
The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (7X, 71, 55, 45, 35) Catheter and the TracStar LDP Large Distal Platform, the Zoom 88 Large Distal Platform, or the Zoom 88 Large Distal Platform Support to the Zoom Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.
The Zoom™ 7X Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source, such as the Zoom Aspiration Pump, using the Zoom Aspiration Tubing or the Zoom POD Aspiration Tubing.
The Zoom 7X Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.
The distal section of the Zoom 7X Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.
The Zoom 7X Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is intended to be attached to the proximal hub of the catheter and used to control hemostasis during use with other devices. The Zoom 7X Catheter is also packaged with two (2) introducer sheath accessories. The introducer is intended to assist with insertion of the Zoom 7X Catheter into the RHV or the guide catheter.
The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Zoom 7X Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Zoom Aspiration Tubing is made of common medical grade polymers.
Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) clearance letter:
1. Acceptance Criteria and Reported Device Performance:
| Test Attribute | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Zoom 7X Catheter | ||
| Delivery, Compatibility, and Retraction (Trackability) | The catheter shall be able to be delivered, deployed, and retracted per the IFU within a simulated neurological model without incurring any damage to the catheter. | Pass |
| Compatibility with Other Devices (External) | The catheter shall be able to be delivered through the minimum introducer sheath or guide catheter size indicated in the product labeling. | Pass |
| Guidewire Compatibility | The catheter shall be able to be delivered over the maximum size guidewire indicated in the product labeling. | Pass |
| Microcatheter / Intermediate Catheter Compatibility | The catheter shall be able to accommodate a microcatheter/intermediate catheter up to the maximum size indicated in the product labeling. | Pass |
| Tip Flexibility | The catheter distal tip flexibility shall be comparable to the predicate. | Pass |
| Visual Inspection | The catheter shall meet visual inspection criteria. The printing on the strain relief must be legible. | Pass |
| Dimensional (ID, Distal OD, Tip Length) | All defined catheter dimensions are within the specified tolerances. | Pass |
| Catheter Bond Strength | The catheter shall have sufficient bond strength to remain intact throughout a procedure. | Pass |
| Dynamic Burst | The catheter must withstand pressure testing under dynamic flow conditions. | Pass |
| Static Burst | The catheter shall meet criteria for static burst pressure testing. | Pass |
| Catheter Torque Strength | The catheter shall not be damaged when rotated at least two (2) full rotations (720 degrees) with the tip constrained. | Pass |
| Kink Resistance | There shall be no kinking of the catheter shaft around respective clinically relevant minimum bend radii in distal tip, medial and proximal locations. | Pass |
| Flexibility | The catheter needs to have acceptable flexure values for tracking in the vasculature. | Pass |
| Luer Compatibility | Device and accessories shall be compatible with standard syringe luer fittings per ISO 80369-7. | Pass |
| Accessory Compatibility | Device shall be compatible with an RHV. | Pass |
| Coating - Particulate | The amount of particulate matter generated during simulated use testing shall be determined and comparable to competitive products. | Pass |
| Coating – Lubricity, Durability, and Integrity | Coating must be lubricious with a specified average pull force. There were no coating anomalies or significant wear observed post simulated use. | Pass |
| Clot Retrieval | The device shall be able to aspirate a variety of clot types in a range of vessel diameters. | Pass |
| Zoom POD Aspiration Tubing (new component) | ||
| Visual Inspection | The Zoom POD Aspiration Tubing shall meet visual inspection criteria. | Pass |
| Dimensional (Working Length) | The working length is within the specified tolerances. | Pass |
| Vacuum Force at Catheter Tip | The vacuum force delivered by the aspiration tubing to the tip of the catheter should be comparable to the vacuum force delivered by the predicate aspiration tubing. | Pass |
| Connector Compatibility | The aspiration tubing connectors shall securely connect to the pump canister lid and standard luer fittings. | Pass |
| Lumen Collapse Test | The tubing lumen shall not collapse under vacuum. | Pass |
| Flow Control Functionality | The flow control mechanism shall allow users to start and stop flow multiple times when the connected pump is running at maximum vacuum. | Pass |
| Freedom From Leakage | The vacuum pressure delivered at the tip of the aspiration tubing shall be consistent with the pressure generated by the pump. | Pass |
| Tensile Strength | The bonds between the tubing and connectors shall be sufficiently strong to ensure the tubing remains intact during use. | Pass |
| Clot Filter Functionality (Zoom POD only) | The clot filter should be able to be opened and closed without causing leak. | Pass |
| Introducer Sheath Accessory (new component biocompatibility tests) | ||
| Cytotoxicity | Test article extracts must yield grade 2 or lower. | Pass, Non-cytotoxic |
| Sensitization | Test article extracts must yield grade 0. | Pass, Non-sensitizing |
| Intracutaneous Reactivity | Test article extracts must yield a difference between the test extract overall mean score and corresponding control overall mean score of 1.0 or less. | Pass, Non-irritating |
| Acute Systemic Toxicity | None of the animals treated with the test article extracts must show a significantly greater reactivity than animals treated with the control article. | Pass, Non-toxic (acute systemic) |
| Material-Mediated Pyrogenicity | Test article extract must yield <0.5°C rise in individual animal temperature. | Pass, Non-pyrogenic |
| Indirect Hemolysis | Test article extract must result in a hemolytic index of <2%. | Pass, Non-hemolytic |
2. Sample Size Used for the Test Set and Data Provenance:
The document primarily refers to non-clinical bench testing to demonstrate substantial equivalence. It does not provide specific numerical sample sizes for each bench test conducted on the subject devices (Zoom 7X Catheter, Zoom Aspiration Tubing, Zoom POD Aspiration Tubing, and the Introducer Sheath accessories). The tests were conducted on physical devices in simulated environments.
The data provenance is from bench testing and laboratory testing performed by the manufacturer, Imperative Care, Inc. There is no indication of country of origin for the data beyond the manufacturer's location in Campbell, California. The study is a pre-market regulatory submission, and the data is generated for this specific purpose rather than being retrospective or prospective patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The clearance letter describes bench testing for physical device performance and biocompatibility testing. This type of evaluation does not involve establishing ground truth from human expert interpretations of medical images or patient outcomes. The "ground truth" for these tests is defined by established engineering and biological safety standards (e.g., ISO, ASTM).
4. Adjudication Method for the Test Set:
Not applicable. As described above, no human expert adjudication of a test set (e.g., for image interpretation or clinical diagnosis) was performed. The "adjudication" in this context refers to the comparison of test results against predefined acceptance criteria for physical, mechanical, and biological properties.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document explicitly states:
- "Substantial equivalence was established based on non-clinical testing presented above."
- "Clinical Study: Substantial equivalence was established based on non-clinical testing presented above."
- "Animal Study: Substantial equivalence was established based on non-clinical testing presented above."
This indicates that no MRMC study or any clinical study was conducted. Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance. The device is a physical medical device (catheter and aspiration tubing system), not an AI-powered diagnostic or assistive tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No. This question applies to AI/software as a medical device. The Zoom 7X Catheter and its associated aspiration tubing are physical medical devices. There is no mention of an algorithm or AI component in the device's function.
7. Type of Ground Truth Used:
For the device performance tests (Tables 3 and 4), the "ground truth" is defined by:
- Established engineering standards: e.g., ISO 10555-1 for catheter performance, ISO 80369-7 for Luer compatibility.
- Manufacturer's internal specifications: The acceptance criteria (e.g., specific dimensions, torque strength, burst pressure) are derived from the device's design requirements and comparison to the predicate device.
- Simulated neurological models: Used for trackability and clot retrieval tests.
For the biocompatibility tests (Table 5), the "ground truth" is based on:
- International standards for biological evaluation: e.g., ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23.
- ASTM standards: e.g., ASTM F756-17 for indirect hemolysis.
- FDA guidance documents.
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical device cleared based on substantial equivalence to a predicate through bench and biocompatibility testing, not through machine learning or AI model development that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set was used for this device.
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(179 days)
The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, when used with a compatible vacuum 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 artery and middle cerebral artery M1 segment within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Aspiration Catheter, Delivery Catheter, and Base Camp Sheath comprise the Route 92 Medical HiPoint Reperfusion System. The Route 92 Medical HiPoint Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set and the Route 92 Medical Base Camp Sheath System.
The Aspiration Catheter has a single-lumen, coil-reinforced polymer distal shaft section connected to a proximal control wire. The Delivery Catheter is a single-lumen variable stiffness catheter. Both catheters have hydrophilic coating. The devices are provided sterile and non-pyrogenic and are intended for single use only.
The Route 92 Medical Aspiration Tubing Set is made from high-pressure tubing. An on/off switch is provided to control fluid flow. A suction connector allows connection to an aspiration pump canister and a Luer fitting allows connection to the aspiration catheter.
For the aspiration source, the Aspiration Catheter is used in conjunction with an aspiration pump with prespecified performance parameters that is connected using the Route 92 Medical Aspiration Tubing Set.
The Route 92 Medical Base Camp Sheath System is comprised of a Sheath, a Dilator, a Navigating Catheter, and an RHV (rotating hemostasis valve). The Sheath is a single-lumen, variable stiffness catheter with a radiopaque marker on the distal end. The inner lumen of the catheter is compatible with 8 French (F) or smaller catheters. The Dilator may be placed within the Sheath to facilitate percutaneous introduction of the Sheath into a femoral artery. The Dilator has a radiopaque marker at the distal tip. The Navigating Catheter is a single-lumen, variable stiffness catheter with a radiopaque marker at the distal tip. The Navigating Catheter is compatible with the Sheath and has a shaped distal end to facilitate placement. All of the catheters are coated with hydrophilic coating.
The provided text describes a 510(k) clearance for the Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set. This is a medical device for treating acute ischemic stroke, not an AI/software device. Therefore, the requested information regarding AI acceptance criteria, data provenance, expert ground truth, MRMC studies, standalone performance, and training set details for an AI model cannot be extracted from this document, as it does not pertain to an AI device.
The document focuses on non-clinical and clinical studies (SUMMIT MAX trial) to demonstrate the safety and effectiveness and substantial equivalence of the mechanical device to a predicate device.
However, I can provide the acceptance criteria and performance data for the mechanical device as presented in the document:
Device: Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
Study: SUMMIT MAX, a prospective, multi-center, randomized, controlled, interventional, open-label clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Primary Endpoint) | Target/Threshold for Non-Inferiority | Reported Device Performance (Route 92 Medical) | Reported Predicate Performance (AXS Vecta) | Result (Difference, 95% CI) | P-value |
|---|---|---|---|---|---|
| Primary Effectiveness Endpoint: Successful arterial revascularization (mTICI ≥ 2b) using only the assigned study device (adjunctive therapy considered a failure). | Non-inferiority margin of 12.5% vs. predicate | 77.5% (69/89) | 50.6% (39/77) | 26.9% (12.7%, 41.0%) | < 0.0001 (one-sided) |
| Primary Safety Endpoint: Symptomatic intracranial hemorrhage (sICH) within 24 hours post-procedure (Heidelberg bleeding classification). | Non-inferiority margin of 12.5% vs. predicate | 3.6% (3/84) | 2.7% (2/75) | 0.9% (-4.5%, 6.3%) | < 0.0001 (one-sided) |
Note: The efficacy endpoint was met with superiority (implied by p-value < 0.0001 in superiority context and the large positive difference outside the non-inferiority margin), and the safety endpoint met non-inferiority.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Effectiveness Endpoint (primary):
- Route 92 arm: N=89
- Vecta arm: N=77
- Safety Endpoint (primary):
- Route 92 arm: N=84 (denominator for sICH, based on sICH calculation out of 89 total patients in Route 92 arm and 77 in Vecta arm)
- Vecta arm: N=75 (denominator for sICH, based on sICH calculation out of 89 total patients in Route 92 arm and 77 in Vecta arm)
- The "mITT" (Modified Intent to Treat) cohort comprised 166 participants (N=89 Route 92 arm, N=77 Vecta arm), which was used for primary endpoint analysis.
- Effectiveness Endpoint (primary):
- Data Provenance: Prospective, multi-center clinical trial. Country of origin not explicitly stated but implied to be multinational given "applicable country regulations" and "IRB / Ethics Committee" implies regulatory approval beyond a single nation. The medical history table includes "Maori" as a race category, suggesting participation from New Zealand.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- For mTICI (Effectiveness Endpoint): Adjudicated by an "independent blinded core lab." Specific number and qualifications of experts not detailed.
- For sICH (Safety Endpoint): Identified by the "core lab" and adjudicated by the "clinical events committee." Specific number and qualifications of experts not detailed beyond being "independent" and "blinded."
4. Adjudication Method for the Test Set
- Effectiveness (mTICI): "Adjudicated by an independent blinded core lab."
- Safety (sICH): "Identified by the core lab and adjudicated by the clinical events committee."
- The specific structure of the adjudication (e.g., 2+1, 3+1) is not provided. It simply states "core lab" and "clinical events committee" for adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This was a clinical trial comparing two mechanical devices (reperfusion systems), not an AI device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical medical device, not an algorithm or AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Effectiveness: Angiographic outcome (modified Thrombolysis in Cerebrovascular Infarction (mTICI) score ≥ 2b), adjudicated by an independent blinded core lab. This can be considered a form of expert consensus/adjudicated imaging outcome.
- Safety: Clinical outcome (symptomatic intracranial hemorrhage), identified by an independent blinded core lab and adjudicated by an independent blinded clinical events committee. This is based on clinical events and imaging findings interpreted by experts.
- Other Outcomes: Modified Rankin Scale (mRS) at 90 days (patient-reported outcome/clinical assessment), time from groin puncture to final angiogram, etc., all based on clinical trial data collection.
8. The Sample Size for the Training Set
- Not applicable. This is a mechanical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is a mechanical device, not an AI model.
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(28 days)
The APRO 45 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Alembic Aspiration Tubing is intended to connect the APRO 45 Catheter to the aspiration pump.
The APRO 45 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 45 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 45 Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 45 Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 45 Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 45 Catheter is available in lengths of 115, 125, 146, and 160 cm and is provided with an introducer sheath. The APRO 45 Catheter contains animal derived materials made from tallow derivatives.
The Alembic Aspiration Tubing connects the APRO 45 Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.
The provided document is a 510(k) clearance letter and summary for the APRO 45 Catheter and Alembic Aspiration Tubing. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. As such, it does not contain information typically found in studies proving a device meets acceptance criteria related to clinical performance, such as sample sizes for test sets, data provenance, expert ground truth establishment, or multi-reader multi-case studies.
Therefore, many of the requested sections will state that the information is not available or not applicable based on the provided document.
Acceptance Criteria and Reported Device Performance
The study supporting this 510(k) clearance relied on non-clinical bench testing to demonstrate that the APRO 45 Catheter and Alembic Aspiration Tubing meet predefined specifications and perform as intended. The acceptance criteria and reported device performance are detailed in Table 2 (Summary of Non-Clinical Bench Test Results) of the 510(k) Summary.
Table of Acceptance Criteria and Reported Device Performance (from Table 2):
| Test | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| Visual and Dimensional Characteristics | Catheter meets the visual and dimensional specifications.Introducer Sheath meets the visual and dimensional specifications. | The APRO 45 Catheter met the acceptance criteria.The Introducer Sheath met the acceptance criteria. |
| Particulate | Catheter meets the acceptance criteria. Subject device was evaluated with a predicate device under the same test conditions. | The APRO 45 Catheter met the acceptance criteria. |
| Vacuum Integrity | Catheter is free from collapse and loss of vacuum between aspiration source and catheter tip. | The APRO 45 Catheter met the acceptance criteria. |
| Kink Resistance | Catheter shaft shall not kink at clinically relevant radii. | The APRO 45 Catheter met the acceptance criteria. |
| Catheter Hub Leakage | Catheter does not leak air into hub assembly with methods specified in ISO 10555-1, Annex D. | The APRO 45 Catheter met the acceptance criteria. |
| Hub Compatibility | Catheter meets the requirements specified in ISO 80369-7. | The APRO 45 Catheter met the acceptance criteria. |
| Catheter Torque Strength | Catheter must withstand the minimum required number of rotations without breakage and without kinking compared to legally marketed devices. | The APRO 45 Catheter met the acceptance criteria. |
| Dynamic Burst Pressure | No damage to catheter with dynamic pressure. | The APRO 45 Catheter met the acceptance criteria. |
| Liquid Leakage | Catheter must withstand pressure with methods specified in ISO 10555-1, Annex C. | The APRO 45 Catheter met the acceptance criteria. |
| Static Burst | Catheter must withstand pressures anticipated for clinical use. | The APRO 45 Catheter met the acceptance criteria. |
| Tensile Strength of Catheter Hub and Shaft | Catheter hub and shaft must meet tensile strength specification. | The APRO 45 Catheter met the acceptance criteria. |
| Tensile Strength of Catheter Tip | Catheter tip must meet tip tensile strength specification. | The APRO 45 Catheter met the acceptance criteria. |
| Delivery and Retrieval Force | Catheter delivery and retrieval force must be acceptable. Forces were compared to a predicate. | The APRO 45 Catheter met the acceptance criteria. |
| 3-Point Bend | Catheter 3-Point Bend force must be acceptable. Forces were compared to a predicate. | The APRO 45 Catheter met the acceptance criteria. |
| Simulated Use including Clot Retrieval | When used per the Instructions for Use with accessory devices in an anatomical neurovascular model, the Catheter and Aspiration Tubing must meet functionality specifications. Clot retrieval from various locations of the anatomical model was performed using the subject device system. | The APRO 45 Catheter and Alembic Aspiration Tubing met the acceptance criteria. |
| Corrosion Resistance | Catheter shall show no signs of corrosion when tested in accordance with ISO 10555-1, Annex A. | The APRO 45 Catheter met the acceptance criteria. |
Additional Requested Information:
-
Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each bench test conducted. It refers to "the subject device and predicate device" for comparisons, implying relevant samples were used for laboratory testing.
- Data Provenance: The data is from non-clinical bench testing and simulated use in anatomical neurovascular models, conducted by Alembic, LLC. It is by nature prospective experimental data, not patient-derived.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This was a non-clinical bench study. The "ground truth" was established by predefined engineering specifications and international standards (e.g., ISO), not by expert human interpretation of medical data.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As a non-clinical bench study, expert adjudication of medical results was not performed. Test results were assessed against predetermined engineering acceptance criteria.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC comparative effectiveness study was not performed. This is a medical device (catheter and tubing), not an AI diagnostic algorithm, and its clearance was based on non-clinical performance and substantial equivalence to a predicate device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant. The device's performance was evaluated through bench testing.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For bench tests, the "ground truth" was defined by established engineering and material specifications, international standards (e.g., ISO 10555-1, ISO 80369-7, ISO 11135, ISO 10993-1), and acceptable performance in simulated models (e.g., clot retrieval from an anatomical neurovascular model). This is analogous to a "reference standard" from engineering specifications rather than clinical ground truth like pathology or outcomes.
-
The sample size for the training set:
- Not Applicable. This submission is for a physical medical device. There is no "training set" in the context of machine learning. The device development process involves design, prototyping, and iterative testing, not AI model training.
-
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI algorithm mentioned, the establishment of ground truth for such a set is not relevant.
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(28 days)
The APRO 55 Swift Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Alembic Aspiration Tubing is intended to connect the APRO 55 Swift Catheter to the aspiration pump.
The APRO 55 Swift Catheter is a single-lumen, braid and coil reinforced catheter designed to remove thrombus from the vasculature using aspiration. It targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature, guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation, and a radiopaque marker is at the distal end for fluoroscopic visualization. It is used with an aspiration pump connected via the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The catheter is available in lengths of 125 cm and 137 cm and is supplied with an introducer sheath.
The Alembic Aspiration Tubing connects the APRO 55 Swift Catheter to the aspiration pump and features a flow control valve with an ON/OFF switch. It is available in a single size.
This FDA 510(k) clearance letter details a device called the "APRO 55 Swift Catheter and Alembic Aspiration Tubing." However, this document does not describe a study that uses a test set, ground truth established by experts, or any of the elements typically found in a study demonstrating AI/ML device performance.
Instead, the submission for the APRO 55 Swift Catheter and Alembic Aspiration Tubing focuses on demonstrating substantial equivalence to a predicate device (K232971 APRO 55 Catheter and Alembic Aspiration Tubing) based on non-clinical performance data and a comparison of technological characteristics.
The core of this 510(k) is that the only difference between the subject device (APRO 55 Swift Catheter) and its predicate (APRO 55 Catheter) is the packaging configuration. The "Swift" designation appears to indicate a change in how the catheter is packaged (coiled in a dispenser tube) rather than a fundamental change in the device itself or its functionality.
Therefore, the requested information about acceptance criteria, test set, ground truth, expert consensus, MRMC studies, or standalone algorithm performance for this specific device cannot be extracted from the provided text because such studies were not conducted or deemed necessary for this particular submission.
The document explicitly states:
- "Performance bench testing was not conducted as sterility and shelf-life testing was sufficient for verification and validation of the change in packaging configuration."
- "An animal study was deemed not necessary to support the substantial equivalence of the subject device."
- "Substantial equivalence was established based on non-clinical performance data. Human clinical data were not deemed necessary."
In summary, the provided document does not contain the information required to answer your prompt, as it relates to a physical medical device (catheter) whose clearance was based on demonstrating equivalence through non-clinical bench testing for packaging changes, not on the performance of a diagnostic AI/ML algorithm.
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