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510(k) Data Aggregation
(277 days)
| 21 CFR 882.4060
| 21 CFR 882.4060
The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.
The Cleveland Multiport Ventricular Catheter contains a main or central lumen for the insertion stylet which is surrounded by four minor lumens (equally spaced) that contain the microcatheters. The catheter includes a ribbed distal tip, a housing for locking the insertion stylet, and proximal male Luer fittings at the end of each micro-catheter. The ribbed distal tip of the main catheter allows the micro-catheters to retract into the main catheter, by stretching the catheter when the insertion stylet is fully inserted and locked. This stretched state allows the catheter tip outside diameter to reduce slightly for atraumatic insertion into the ventricles of the brain. Once the insertion stylet is removed the catheter tip returns to its relaxed state (larger outside diameter) and the micro-catheters deploy. The enlarged tip aids in backflow prevention during injection of fluids. The distal Luer fittings allow for connectivity to a standard syringe or infusion pumps for removal of CSF and/or infusion. The biocompatible metal insertion stylet provides temporary rigidity to the distal portion of the device during catheter insertion and is removed after placement. The Cleveland Multiport Ventricular Catheter has no software, power sources, or radiation emitting components.
The provided text describes a 510(k) premarket notification for a medical device called the "Cleveland Multiport Ventricular Catheter Set." This submission is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. The document refers to various tests performed to support this claim, but it does not describe an AI/ML powered device, an acceptance criteria table with reported device performance in the context of AI/ML, nor does it include information about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/ML models.
The information provided relates to the physical and functional aspects of a traditional medical device (a catheter) and its comparison to existing catheters. Therefore, most of the requested fields are not applicable to the given text.
Here's an attempt to answer the applicable parts of your request based on the provided text, while explicitly stating when information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
The document lists various performance tests and their results, indicating that the device "passed" and "results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices." The specific quantitative acceptance criteria are generally implied rather than explicitly stated as numerical thresholds in this summary, but the results confirm compliance.
| Test | Acceptance Criteria (Implied from "passed") | Reported Device Performance |
|---|---|---|
| Joint and Bond Strength Tests | Withstand minimum pull-off forces; exceed minimum tip loading requirements. | All joints bonds were above the minimum pull-off force requirement. Tip loading exceeded the minimum load requirements. Withstood pull forces based on clinically relevant forces with a safety factor. |
| Viscosity Test | Kinematic viscosity of Cytarabine and saline are comparable (within 2%). | Kinematic viscosity of Cytarabine and saline are similar (within 2%). Bench testing using saline is acceptable. |
| Depth Marking | Depth marks remain legible after swabbing. | Depth gauge marks were not altered. |
| Pressure Testing (Flow Burst, Infusate Pressure, Aspiration Flow Rate) | Withstand pressure spikes; reach specified flow rate within specified time; inject fluid at maximum flow rate; linear pressure profile across all flow rates without leakage or kinking; withstand maximum pressure/spikes; capable of aspirating at clinically acceptable rate. | Reached specified flow rate within specified time; capable of injecting fluid at its maximum flow rate. Reached a linear pressure profile across all flow rates without leakage and no kinking; withstood maximum pressure/spikes. Passed pressure-flow with suture tab attached. Capable of aspirating at its clinically acceptable aspiration rate. |
| Reflux Test | Resists flow in the reverse direction. | Resists flow in the reverse direction. |
| Deployment and Retraction Test | Minimal dimensional changes from deployment/retraction; meet maximum loads for insertion/removal of stylet. | Met specified dimensional and maximum distance insertion and removal forces. |
| Tissue Insertion Test | Withstand insertion and removal from bovine brain tissue. | Passed insertion and removal for bovine tissue. |
| Bend Radius Test | Withstand minimum bend radius without kinking. | Withstands a minimum bend radius without kinking. |
| Dimensional Verification | Manufactured and reproduced to predetermined specifications. | Manufactured and reproduced to predetermined specifications. |
| Micro-Catheter Strength Test | Minimum strength of micro-catheters PTFE material exceeds minimum force requirements. | Micro-catheter material exceeds the minimum force requirements. |
| Syringe Drop Test | Withstand drop without damage to device or operation. | Withstood drop without damage and operation verified. |
| Surface Inspection | Free from voids, cracks, or extraneous matter. | Free from voids, cracks or extraneous matter along the effective length. |
| Particulate Testing | Shedding of particulates below specified limit. | Shedding of particulates are below a specified limit. |
| Leakage under pressure | Free of leaks during infusion and aspiration. | Free of leaks during infusion and aspiration. |
| Cadaver Assessment | Can be placed using conventional techniques and visualized using CT. | Placed using conventional techniques and visualized on axial CT scan with successful infusion of CT dye. |
| Stylet Strength | Withstand excessive loading on stylet handle without fracturing. | Withstood pull forces based on clinically relevant forces with a safety factor. |
| Stylet Corrosion Resistance | Withstand corrosion with extended exposure to sodium chloride. | Withstood corrosion with extended exposure to sodium chloride. |
| Biocompatibility | Compliance with ISO 10993 requirements for tissue contact, limited exposure (<24 hours), non-pyrogenic. | All tissues contacting materials are biocompatible per ISO 10993 (Cytotoxicity, Systemic Toxicity, Intracutaneous Reactivity, Sensitization, Hemocompatibility, Material Mediated Pyrogen tests completed). Non-pyrogenic. |
| Drug Compatibility | Does not leach high concentration levels of identifiable compounds with Cytarabine. | Cytarabine is compatible within the flow path materials with acceptable levels of identifiable compounds. |
| Accelerated Aging | Functions as intended after 1-year equivalent accelerated aging. | Functioned as intended after 1-year equivalent accelerated aging. |
| Sterilization Validation | Minimum sterilization cycle achieves SAL of 10^-6. | Half-cycle EO achieves sterility assurance level (SAL) of 10^-6. |
| LAL Validation | Endotoxin levels <2.15 EU/device per USP guidance. | All devices met an endotoxin level of <2.15 EU/device. |
| Transit Testing - Packaging Qualification | Withstands normal transportation and handling; maintains sterile barrier. | Packaging meets functionality requirements and maintains sterile barrier after exposing to actual and simulated transportation test conditions. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests performed are bench tests and cadaver usability testing, not studies on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is a physical medical instrument, not an AI/ML algorithm requiring expert ground truth for interpretation. The "cadaver usability testing" implies a medical professional would have evaluated the device's placement, but details are not given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the device is a physical medical instrument, not an AI/ML algorithm requiring adjudication of interpretations.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML-powered interpretive devices, which this catheter is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not done. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests was based on engineering specifications, physical measurements, and established medical device testing standards (e.g., ISO standards for biocompatibility, LAL validation). For the cadaver assessment, the "ground truth" was successful placement and visualization on CT, implying a practical assessment against expected physiological outcomes.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device and therefore does not have a "training set."
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device and therefore does not have a "training set" or ground truth for one.
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(34 days)
55313
Re: K150660
Trade/Device Name: Alcyone MEMS Cannula (AMC) System Regulation Number: 21 CFR 882.4060
|
| Product Code andRequlation: | HCD, 21 CFR 882.4060
-----------------------|--------------------------|
| Classification | 21 CFR 882.4060
| 21 CFR 882.4060
The Alcyone MEMS Cannula (AMC) System consisting of the AMC and the AMC Extension Line Set. is intended for iniection of Cytarabine (cytosine arabinoside) or removal of cerebrospinal fluid (CSF) from the ventricles of the brain during intracranial procedures. The AMC System is not intended for implant. The device is intended for "single patient use only."
The AMC System is comprised of the AMC and its Extension Line sets. The AMC is a rigid cannula comprised of two independent channels. The fluid lumens are protected inside a 25cm rigid ceramic cannula. which transitions (steps-down) to a micro-tip. The micro-tip has two independent outlets at the tip that face sideways, designed to prevent plugging during insertion into the brain. The proximal end of the rigid cannula consists of a Y-connector with standard female luers that allow connection to each independent channel. AMC Extension Line Sets with standard male/female luers must be used with the AMC to connect the AMC to an infusion pump. The AMC must be used with a support structure (e.g. a stereotactic quide) to provide support and control during insertion. A safety-sheath, as with the predicate, and depth-stop, for user convenience, are provided on the AMC for this purpose.
This document is a 510(k) premarket notification for the Alcyone MEMS Cannula (AMC) System, aiming to demonstrate its substantial equivalence to a predicate device. It is a regulatory submission, not a study report per se, and as such, it focuses on demonstrating equivalence rather than establishing novel acceptance criteria or conducting a traditional clinical study with defined endpoints for performance metrics like sensitivity/specificity.
Therefore, many of the requested categories (acceptance criteria performance, sample size for test set with data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, how ground truth for training set was established) are not directly applicable or explicitly stated in the context of an AI/ML-driven device evaluation. This document is for a medical device (cannula) and its evaluation is based on engineering and preclinical testing.
However, I can extract information related to the device's characteristics and the tests performed to demonstrate its safety and performance equivalence to a predicate device. I will adapt the requested table and sections to best fit the available information.
1. Table of Acceptance Criteria (as implied by equivalence to predicate) and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study (e.g., specific clinical performance thresholds like sensitivity/specificity for a diagnostic AI). Instead, it demonstrates that the AMC System's performance characteristics are equivalent to or meet the requirements for its intended use, similar to the predicate device. The "acceptance criteria" are implied by successful completion of various engineering, biocompatibility, and functional tests, and by demonstrating substantial equivalence to the predicate.
| Characteristic / Test | Implied Acceptance Criteria (Equivalence/Performance Requirement) | Reported Device Performance and Discussion |
|---|---|---|
| Indications for Use / Intended Use | Equivalent to predicate device. Intended for injection of Cytarabine or removal of CSF from ventricles, not for implant, single patient use. | Equivalent to Predicate. The AMC System has the same intended use. |
| Classification & Product Code | Equivalent to predicate device (Class I, HCD, 21 CFR 882.4060). | Equivalent to Predicate. |
| Leak Pressure Testing | Withstand pressure spikes with no leaks. | Passed. AMC and Extension line systems withstood pressure spikes with no leaks. |
| Infusion Flow Testing | Reach specified flow rate within specified time, capable of injecting fluid at maximum flow rate. (Target: 3.0mL/hr. (1.5mL/hr. per channel) at <25psi internal pressure). | Passed. AMC System reached specified flow rate within the specified time and was capable of injecting fluid at its maximum flow rate. (This is different from the predicate's stated range of 0.3ml/hr to 25ml/hr, but the discussion notes this results from different diameters and is within the range of cleared ventricular cannulas, thus considered equivalent in function). |
| Aspiration Rate Testing | Capable of aspirating at maximum aspiration rate. (Target: 2.4mL/hr. (1.2mL/hr. per channel) using an air vacuum of 10mL from a syringe). | Passed. The AMC was capable of aspirating at its maximum aspiration rate. (This is different from the predicate's stated range of 0.1ml/hr to 8.7ml/hr, but similar to infusion, discussion notes this results from different diameters and is considered equivalent). |
| Extension Line Patency Testing | Extension lines remain patent with worst-case expected bend radius. | Passed. Extension lines remained patent with a worst case expected bend radius. |
| Luer Pull-off Testing | All units above maximum luer pull force specification (worst case for clinical use plus safety factor). | Passed. All units were above the maximum luer pull force specification. |
| AMC Brain Insertion & Removal | Withstand insertion and removal into brain tissue without breaking and detaching. | Passed. AMC withstood insertion and removal into a bovine brain without breaking and detaching. |
| AMC Brain Lateral Shift | AMC or AMC tip not break or detach when laterally shifted in brain tissue in any direction from insertion location. | Passed. AMC or AMC tip did not break or detach when laterally shifted in bovine brain tissue in any direction from the insertion location. |
| Axial Tip Compression Force | Withstand acceptance criteria for axial compressive force based on clinically relevant forces with safety factor. | Passed. The AMC or AMC micro-tip withstood the acceptance criteria for axial compressive force based on clinically relevant forces with safety factor. |
| Pull-out strengths of bonds (bullet-nose, y-connector) | Withstand acceptance criteria for minimum pull-out force based on clinically relevant forces with safety factor. | Passed. The AMC withstood the acceptance criteria for minimum pull-out force based on clinically relevant forces with safety factor. |
| Magnetic Resonance (MR) Safety | MR Safe in 1.5T and 3T MRI environment (predicate 1.5T). | MR Safe. The AMC is MR Safe in 1.5 Tesla and 3Tesla magnets. Equivalent to Predicate. |
| Cytarabine Compatibility | Materials compatible with Cytarabine infusion (clinically relevant concentration); no visible degradation or strength reduction; no change in Cytarabine concentration post infusion. | Passed. The materials of the fluid path of the AMC are compatible with Cytarabine infusion of a specified clinically relevant concentration. No visible degradation or reduction in strength below specifications. No change in Cytarabine concentration post infusion. |
| Transit Testing (Packaging Qualification) | Packaging meets functionality requirements; integrity of package as sterile barrier maintained after transportation testing. | Passed. The AMC System packaging meets its functionality requirements and the integrity of the package as a sterile barrier was maintained after conducting actual or simulated Transportation Testing Conditions. |
| Accelerated Aging | Safe for its labeled expiration dating. | Passed. Demonstrates that the AMC System is safe for its labeled expiration dating. |
| Biocompatibility | All tissue-contacting materials biocompatible per ISO 10993 (limited duration, < 24 hours). Tests: Cytotoxicity, Systemic Toxicity, Intracutaneous Reactivity, Sensitization, Hemocompatibility, Material Mediated Pyrogen. | Passed. All tissue contacting materials used are biocompatible per ISO 10993. The specified tests were conducted. |
| Sterilization Validation | Achieve a sterility assurance level (SAL) of 10^-6 with 25 kGy dose. | Passed. Testing substantiates the use of 25 kGy as the minimum sterilization dose to achieve a sterility assurance level, SAL, of 10^-6. |
| LAL Validation (Endotoxin) | Endotoxin levels < 2.15 EU/device. | Passed. All devices met an Endotoxin level of <2.15 EU/device. |
| Animal Testing (Pre-clinical) | Meet specifications for insertion depth, ease of use, independent channel function (infusion/aspiration), minimal/none occlusions, compatible with stereotactic procedures, minimal to no backflow, acceptable infusate distribution. Substantially equivalent to predicate. | Passed. In original concept-development and final design validation animal studies, all results met acceptance criteria per protocol and applicable standards, indicating the AMC System is safe for its intended use and equivalent to the predicate device. In the comparative study, the AMC performed substantially equivalent to the predicate device (SmartFlow). |
| Human Factors and Usability Testing | Safe for intended use and performed as expected by users per instructions for use. | Passed. All results met acceptance criteria per protocol and applicable standards. The AMC performed safely for its intended use and as expected by the users per the AMC System instructions for use. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes several test sets for different types of evaluations, which are primarily engineering and preclinical tests, not clinical performance studies for an AI/ML device.
- AMC System Performance (Leak, Infusion, Aspiration, Patency, Pull-off): Sample sizes are not explicitly stated for individual bench tests but are typically based on engineering validation standards.
- AMC Brain Insertion, Removal, Lateral Shift Testing: Sample sizes for this mechanical testing are not explicitly stated.
- AMC Tip Compression, Pull-out Testing: Sample sizes are not explicitly stated.
- Magnetic Resonance (MR) Safe Testing: Sample sizes for this are not explicitly stated but generally involve testing representative samples.
- Cytarabine Infusion Compatibility: Sample sizes are not explicitly stated.
- Transit Testing (Packaging): Sample sizes are not explicitly stated but would be based on ISTA-2A standards.
- Accelerated Aging: Protocol defines methods and materials; sample size not explicitly stated.
- Biocompatibility: Sample sizes for in vitro and in vivo biocompatibility tests are not explicitly stated but are conducted according to ISO 10993 standards.
- Sterilization Validation: Sample sizes for radiation sterilization validation are not explicitly stated but are determined by ANSI/AAMI/ISO 11137-2.
- LAL Validation: Sample sizes are not explicitly stated but are determined by USP guidance.
- Animal Testing (Design Validation and Performance Evaluation):
- Concept-development phase: N=7 Juvenile Yorkshire Pigs (Acute Study).
- Design-freeze phase: N=4 Juvenile Yorkshire Pigs (Acute Study).
- Comparative study vs. Predicate: N=4 acute animals, N=6 survival animals (survival for 4-weeks post infusion).
- Human Factors and Usability Testing: N=16 Users with repeat uses totaling 28 uses.
Data Provenance: The document does not specify the country of origin for the data for most tests, but they are generally performed in a laboratory setting or by contract research organizations (CROs) adhering to international standards (e.g., ISO, USP, FDA guidance). The animal studies used "Juvenile Yorkshire Pigs." All non-human testing is retrospective from the perspective of the 510(k) submission date.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is largely irrelevant for a device like a ventricular cannula, where "ground truth" is typically established by engineering specifications, physical measurements, and biological responses rather than expert consensus on interpretive data (which is common for AI/ML diagnostic tools).
- Bench and Animal Tests: The "ground truth" or performance standards are established by predefined design requirements, applicable international and national standards (e.g., ISO, USP, FDA guidance), and the performance characteristics of the legally marketed predicate device. This involves engineering and scientific experts, but not in the qualitative assessment sense of a radiologist for image interpretation.
- Human Factors and Usability Testing: Involved N=16 "Users," who would be qualified to interact with the device in a simulated clinical setting. Their feedback on ease of use and adherence to instructions serves as "ground truth" for usability. Specific qualifications (e.g., years of experience as a neurosurgeon or nurse) are not detailed but are implied to be relevant clinical users.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used when subjective expert interpretation is involved in establishing ground truth, such as in reading medical images. This process is not applicable to the engineering, biocompatibility, and functional testing described for the Alcyone MEMS Cannula (AMC) System. The "ground truth" (or compliance) is determined by objective measurements against predefined specifications and regulatory standards.
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
This question is not applicable. The Alcyone MEMS Cannula (AMC) System is a physical medical device (cannula), not an AI-driven software or diagnostic tool that assists human readers with interpretation. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Alcyone MEMS Cannula (AMC) System is a physical medical device. It does not have an algorithm that performs standalone. Its function is to be used by a human healthcare professional for injecting or removing fluids.
7. The Type of Ground Truth Used
For the Alcyone MEMS Cannula (AMC) System, the "ground truth" varies by the type of test:
- Technical/Engineering Tests (Leak, Flow, Mechanical Safety): Ground truth is based on established engineering specifications, physical measurements, performance data from the predicate device, and compliance with relevant industry standards (e.g., pressure ratings, flow rates, material stresses).
- Biocompatibility: Ground truth is based on compliance with ISO 10993 standards and the biological response of materials. This involves specific test methods (e.g., cytotoxicity assays, animal toxicity studies) with predefined acceptance criteria for biological safety.
- Sterility and Endotoxin: Ground truth for sterility is a Sterility Assurance Level (SAL) of 10^-6 per ANSI/AAMI/ISO 11137-2. Ground truth for endotoxin is an endotoxin level < 2.15 EU/device per USP guidance.
- MR Safety: Ground truth is defined by the device being "MR Safe" according to FDA guidance, demonstrated by specific magnetic field interaction tests.
- Animal Testing: Ground truth is derived from the device meeting predefined functional specifications, observed performance in a biological system (e.g., insertion depth, channel function, occlusion, backflow), and qualitative/quantitative comparison to the predicate device in the animal model.
- Human Factors/Usability: Ground truth is based on user feedback and observations of ease of use, adherence to instructions, and overall safety during simulated use by relevant clinical personnel.
8. The Sample Size for the Training Set
This question is not applicable. The Alcyone MEMS Cannula (AMC) System is a physical medical device; it does not involve machine learning or an "algorithm" with a "training set." Its design and performance are based on engineering principles, material science, and preclinical testing, not on data training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for this physical medical device.
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(268 days)
| 21 CFR 882.4060
The SmartFlow™ Flex Ventricular Catheter is intended for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. The device is not intended for implant. This device is intended for "single patient use only."
The Catheter has a stepped distal tip with a 30 cm removable rigid ceramic stylet protecting the fluid lumen while providing rigidity to the distal portion of the device. The stylet is removed after insertion to the desired point. Soft tubing protects the lumen in the center portion and at the distal end where it terminates. The fluid containing central lumen is manufactured from PEEK tubing.
The Catheter will be marketed in the following sizes:
Ventricular Catheter .008 x 7.5mm tip
Ventricular Catheter .008 x 15mm tip
Ventricular Cathcter .021 x 7.5mm tip
Ventricular Catheter .021 x 15mm tip
Each unit will provide for an approximate 23 inch tubing extension.
The provided document is a 510(k) summary for a medical device (MRII MR Compatible Ventricular Catheter) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving performance against specific acceptance criteria for a new AI/software device.
Therefore, the information required to populate most sections of the table and answer the subsequent questions is not present in the provided text, as this document describes a traditional medical device submission, not an AI/software device.
However, I can extract information related to the device's technical specifications and the Performance Testing – Bench section, which acts as the "study" proving the device meets certain operational criteria.
Here's a breakdown of what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Flow Rate Testing (constant pressure) | Flow rates at 0.7 psi for the device to be greater than the predicate. (Predicate: .008" ID 0.6 mL/hr, .021" ID 34 mL/hr) | .008" ID Device 4.0 mL/hr.021" ID Device 56 mL/hr |
| High Pressure Flow Testing | Equivalent to or better than the predicate. | Equivalent to or better than the predicate. |
| Aspiration | Better than (higher aspiration rates achievable) the predicate. | Better than the predicate. |
| Leak/Burst Testing | Withstand 70 psi internal pressure without any leaks (same as predicate). | All samples withstood 70 psi internal pressure without any leaks. Equivalent to the predicate. |
| Distal Tip Compressive Strength | No damage to the tip (same as predicate's specification). | All samples met the requirement without damage to the tip. Equivalent to the predicate. |
| Distal Tip Lateral Load | Meet minimum force limit (same as predicate's specification). | All samples met the specification. Substantially equivalent to the predicate. |
| Ceramic Stylet Lateral Load | Device to meet specification (same as predicate's specification). (Note: Predicate has fixed, integrated rigid tube, not removable internal stylet). | Device met the specification. |
| Catheter Axial Tensile Load | Device to meet specification (same as predicate). | All devices met the specification. Equivalent to the predicate. |
| Catheter Insertion into Bone Anchor | Insert without difficulty. | The device was inserted into the Bone Anchor without difficulty. |
| Catheter Retention in Bone Anchor | Retained to the specified limit. | All samples were retained to the specification. |
| Stylet Removal from Bone Anchor | Meet specification of maximum pull force for Stylet removal. | The device met the specification of maximum pull force for Stylet removal. |
| Catheter Tissue Insertion | No tissue in or on the device, no plugging or damage (equivalent to predicate). | There was no tissue in or on the device after insertion and removal. Equivalent to the predicate device. |
| Backflow | No observed backflow (equivalent to predicate). | There was no observed backflow. Equivalent to predicate device. |
| Tip Deflection at Max Pressure | No movement of the tip at 70 psi internal pressure (equivalent to predicate). | There was no movement of the tip at applied internal pressure of 70 psi. Equivalent to the predicate device. |
| Tip Deflection at Max Aspiration | No movement of the tip at 2.0 psi vacuum (equivalent to predicate). | There was no movement of the tip at applied vacuum of 2.0 psi. Equivalent to the predicate device. |
| Bend Radius Withstand | No kinking or damage to the tubing at the specified bend radius (equivalent to predicate). | There was no kinking or damage to the tubing at the specified bend radius. Equivalent to the predicate device. |
| Syringe Dropping Test | No damage sustained by the device after the syringe was dropped with the device connected (equivalent to predicate). | There was no damage sustained by the device after the syringe was dropped with the device connected. Equivalent to the predicate device. |
| Tip Deflection after Stylet Removal | No tip movement upon Stylet removal. | There was no tip movement upon Stylet removal. Device met specification. |
| Bone Anchor Insertion Force | Insert fully with a downward force below the requirement. | All Bone Anchors were all inserted fully with a downward force below the requirement. |
| Bone Anchor Insertion Torque | Insert fully with a torque below the requirement. | All Bone Anchors were all inserted fully with a torque below the requirement. |
| Bone Anchor Side Load Force | Withstand minimum load with no damage or yielding. | All Bone Anchors all withstood the minimum load with no damage or yielding. |
| Bone Anchor Side Impact Force | Withstand minimum energy without damage or yielding. | All Bone Anchors withstood the minimum energy without damage or yielding. |
| Bone Anchor Retention Force | Remain in place under the applied tensile load. | All Bone Anchors remained in place under the applied tensile load. |
| Bone Anchor-Driver Detachment Force | Below the maximum limit for detachment force. | All pairs of Bone Anchors and Drivers were below the maximum limit for detachment force. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each test, but phrases like "All samples" and "All Bone Anchors" suggest that specific, likely small, batches of devices/components were tested. The exact number of units per test is not provided.
- Data Provenance: The studies are described as "Bench testing" performed by "MRII, Inc." This indicates the data is from in-vitro (lab/bench) testing of the physical device, not patient data. No country of origin for data is specified beyond the company's location (Irvine, CA, USA). It's prospective in the sense that the tests were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a traditional device submission focused on physical and material properties, not an AI/software device requiring expert ground truth for classification or detection tasks. The "ground truth" for these tests is based on objective physical measurements and adherence to engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments, often for AI performance evaluation. The tests described here are objective bench tests.
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
Not applicable. This is not an AI/software device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/software device. The device's "performance" is its physical function, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests is derived from:
- Pre-defined engineering specifications and limits (e.g., specific flow rates, pressure limits, force thresholds).
- Comparative performance against the legally marketed predicate device.
- Objective physical measurements (e.g., fluid volume, pressure, force, visual inspection for damage/leaks).
- Compliance with recognized standards (e.g., ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11137-2 for sterility).
8. The sample size for the training set
Not applicable. This is not an AI/software device and does not involve training data.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/software device.
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(183 days)
Ventricular Cannula |
| Classification: | Class I |
| Regulation Number: | 882.4060
--------------------------------|
| Classification | 21 CFR 882.4060
| 21 CFR 882.4060
K102101
Trade/Device Name: SurgiVision MR Compatible Ventricular Cannula Regulation Number: 21 CFR 882.4060
The MR Compatible Ventricular Cannula is intended for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. The device is not intended for implant. The device is intended for "single patient use only."
The Cannula has a stepped distal tip with a 30 cm rigid ceramic stylet protecting the fluid lumen while providing rigidity to the distal portion of the device. Soft this in areets the lumen in the center portion and at the distal end where it terminates at a female luer fitting. The fluid containing central lumen is manufactured from non-reactive silica. The cannula will be marketed in the following sizes: 16 ga Ventricular Cannula, .008" ID x 4ft; 16 ga Ventricular Cannula. .008" ID x 10ft; 14 ga Ventricular Cannula, .021" ID x 4ft; 14 ga Ventricular Cannula, .021" ID x 10ft.
The provided text describes the SurgiVision MR Compatible Ventricular Cannula and its substantial equivalence to a predicate device (Adson Cannula), but it does not contain information about the acceptance criteria or a study designed to prove the device meets those criteria in the context of typical AI/ML device evaluations. This document describes a traditional medical device submission (a cannula), not a diagnostic AI/ML device.
Therefore, many of the requested details about acceptance criteria, specific performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert consensus, MRMC studies, or standalone performance are not present because they are not applicable to this type of device submission.
However, I can extract the information relevant to the device's technical validation and comparison to the predicate device.
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" for performance metrics like those seen in AI/ML diagnostic devices (e.g., sensitivity, specificity). Instead, it describes performance and material characteristics that are either equivalent to the predicate or designed for specific needs (like MR compatibility). The "reported device performance" is essentially that it functions as intended and is safe and effective.
| Characteristic Category | Acceptance Criteria (Implied) | Reported Device Performance | Discussion/Evidence (from the document) |
|---|---|---|---|
| Intended Use | Equivalent to predicate (injection/aspiration of fluids in ventricles). | Injection of Cytarabine or removal of CSF from ventricles. | Equivalent to predicate, validated using Cytarabine and primate CSF. |
| MR Compatibility | Safe in 1.5T MRI environment. | Safe in 1.5T MRI environment. Device is MR Compatible/MR Safe. | Designed for MR environment; not restricted to non-MRI environment. Predicate is not indicated for MR environments. |
| Material/Rigidity | Sufficiently rigid to pass through brain tissue. | Sufficiently rigid to pass through brain tissue. | Uses ceramic (VC) vs stainless steel (predicate); both rigid. |
| Fluid Movement | Contains a channel for fluid removal/placement. | Contains a channel for fluid removal/placement. | Equivalent to predicate. |
| Flow Rate | Capability to move fluids (differs due to diameter) | Flow rate of 0.3 ml/hr (0.008" I.D.) to 25.0 ml/hr (0.021" I.D.) at 0.7 PSI. | Both devices moving fluids; different flow rates result from different diameters. VC provides flow vs. pressure tables (additional information). |
| Biocompatibility | Meet ISO 10993 for tissue contact. | Tissue contact tested per ISO 10993: Biological Evaluation of Medical Devices with acceptable results. | Equivalent to predicate (presumed). |
| Sterility | Sterilized. | Yes, per ANSI/AAMI/ISO 11137-2. | Supplied sterile. Predicate is provided non-sterile and sterilized on-site, but both achieve sterility. |
| Mechanical Safety | Safe for intended use. | Performance Testing Bench, including design verification testing, comparison testing with the predicate Adson Cannula, pressure withstand testing and injection/aspiration testing, lateral tip deflection testing, transit testing in conformance to D4169 and accelerated aging testing. acceptable results. | Equivalent to predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is bench testing, not a clinical study on human subjects where patient data provenance would be relevant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a medical device, not an AI/ML diagnostic algorithm requiring expert-established ground truth from images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.
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
Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, "ground truth" is established through engineering and materials testing, demonstrating that the device physically performs as intended and meets safety standards. For example:
- Biocompatibility: In vitro and in vivo (animal) studies to confirm material safety, assessed against ISO 10993 standards.
- Performance (flow rates, rigidity): Bench testing using simulated conditions and fluids (e.g., Cytarabine, primate CSF).
- MR Compatibility: Physical testing of the device in an MRI environment to confirm safety (e.g., no excessive heating, no significant image artifact).
8. The sample size for the training set
Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.
Summary of the Study/Testing that Proves the Device Meets Acceptance Criteria:
The document describes several types of testing performed to demonstrate the device's safety, effectiveness, and substantial equivalence to the predicate device:
- Sterilization and Shelf Life Testing: Validation using the VDmax25 procedure of ISO 11137-2 to ensure the device remains sterile and functional over its shelf life.
- Biocompatibility Testing: Conducted per ISO 10993 (Biological Evaluation of Medical Devices), including cytotoxicity, material mediated pyrogen, ISO maximization study, intracutaneous toxicity, and systemic toxicity. All tests yielded acceptable results.
- Performance Testing Bench:
- Design verification testing.
- Comparison testing with the predicate Adson Cannula.
- Pressure withstand testing.
- Injection/aspiration testing.
- Lateral tip deflection testing.
- Transit testing in conformance to D4169.
- Accelerated aging testing.
- Cytarabine Injection and Primate CSF Aspiration Testing: Completed with acceptable results, validating the device's intended use with specific fluids.
- MR Compatibility Testing: The device is stated to be "Safe in a 1.5T MRI environment" and "MRI Safe. All brain contacting components tested safe in a 1.5T environment."
The conclusion from these tests was that the "MR Compatible Ventricular Cannula functions as intended and is substantially equivalent to legally marketed predicate device." The differences in design (e.g., single-patient use, MR compatibility, different materials, longer rigid section, no stylet, integral extension) are noted to "meet the needs of the MR work environment and do not represent changes that effect the safety or effectiveness of the device."
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