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510(k) Data Aggregation
(109 days)
Silk Road Medical, Inc.
The ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty and post-dilatation of self-expanding stents in the carotid arteries.
The Silk Road Medical ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is a standard rapid exchange (RX) 0.014" Percutaneous Transluminal Angioplasty (PTA) catheter with a proximal single lumen and distal coaxial lumen tubing with a dilatation balloon, and an atraumatic, tapered tip. The proximal luer lock hub allows for connection with a balloon inflation device for inflation with diluted contrast medium. The second lumen in the distal shaft permits the use of an 0.014" guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon has two radiopaque marker bands to aid in positioning the balloon in the stenosis, located either 25 or 35 mm apart as indicated on the package label. An external position marker is located 32.5 cm from the distal tip to indicate the relative position of the catheter tip to the guiding catheter/introducer sheath. The total working length of the catheter is 75 cm. The Silk Road Medical ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter will complement the TCAR procedure.
The provided text describes a medical device called the ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter and its substantial equivalence submission to the FDA. The document outlines acceptance criteria and the studies conducted to prove the device meets these criteria.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document details various tests performed and states that the device "met all established requirements" and "all tests passed successfully." While specific quantitative acceptance criteria or exact performance values are not explicitly listed in a comparative table within the provided text, the document indicates that the device met the pre-determined acceptance criteria for each test.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Successfully conducted per BS EN ISO 10993-1, compliant with ISO 10993-1 guidelines for limited exposure ( |
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(98 days)
SILK ROAD MEDICAL, INC.
The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) is intended to provide transcarotid vascular access, introduction of diagnosic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have appropriate anatomy described below:
Adequate femoral venous access;
Common carotid artery reference diameter of at least 6 mm;
Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography.
Silk Road Medical, Inc. is the manufacturer of a single use device intended to provide embolic protection during carotid artery angioplasty and stenting procedures. The ENROUTE Transcarotid NPS is designed to transport emboli away from the carotid artery circulation by reversing blood flow at the treatment site prior to crossing a lesion in the carotid artery and during lesion manipulation. It has an integrated filter used to capture and contain embolic material liberated during the procedure.
Like the predicate device, the ENROUTE Transcarotid NPS consists of three primary components: the ENROUTE Transcarotid Arterial Sheath, the ENROUTE Venous Return Sheath, and the ENROUTE Flow Controller. The Subject Device offers an Angled-Tip configuration and a Straight Tip configuration of the Transcarotid Arterial Sheath. When assembled, the ENROUTE Transcarotid NPS creates an Arteriovenous Shunt. The Transcarotid Arterial Sheath is placed in the carotid artery below the carotid bifurcation. The Venous Return Sheath is placed into the femoral vein. The Arterial and Venous Sheaths are connected by the Flow Controller, thereby completing the Arteriovenous Shunt. When the carotid artery is occluded just proximal to the Transcarotid Arterial Sheath insertion site, the arterial/venous pressure gradient diverts or reverses blood flow in the internal carotid artery (ICA) and external carotid artery (ECA) thereby directing the blood from the cerebral arteries through the Transcarotid Arterial Sheath, through the Flow Controller with integrated filter, and out through the Venous Return Sheath into the venous circulation.
The ENROUTE Transcarotid Arterial Sheath and ENROUTE Venous Return Sheath are constructed of stainless steel reinforced thermoplastic elastomers attached to hemostasis valve adaptors. The Angled-Tip Transcarotid Arterial Sheath configuration has a 15° bend at the distal tip whereas the Straight-Tip Transcarotid Arterial Sheath configuration has no bend at the distal tip. The ENROUTE Flow Controller consists of DEHP free PVC tubing with an integrated polyester filter and polycarbonate housing. A 90cm long 0.035" PTFE coated Nitinol with stainless steel coil J-Tip Guidewire is provided with the ENROUTE Transcarotid NPS. The quidewire is used to facilitate the insertion of the Transcarotid Arterial Sheath into the common carotid artery (CCA) and the Venous Return Sheath into the femoral vein.
The ENROUTE Transcarotid NPS is an ethylene oxide sterilized, non-pyrogenic, singleuse prescription device.
The provided text is a 510(k) Summary for the ENROUTE Transcarotid Neuroprotection System. It details the device, its indications for use, comparison to a predicate device, and supporting data from various tests. However, it does not describe the acceptance criteria for a device's performance, nor does it present a direct study proving the device meets established acceptance criteria in the way typically expected for a medical AI or diagnostic device.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (K143072) based on various performance, biocompatibility, and sterilization tests. The "acceptance criteria" mentioned are broad, such as "All bench testing met the pre-determined acceptance criteria" or "the safety acceptance criteria for the studies were met," without detailing what those criteria are (e.g., a specific sensitivity or specificity threshold, or a specified flow rate range).
Therefore, a table of acceptance criteria and reported device performance as requested, with specific quantitative metrics, cannot be fully generated from this document. Similarly, detailed information on sample sizes, ground truth establishment, expert qualifications, and MRMC studies, which are typical for AI/diagnostic device performance evaluations, are not present.
However, I can extract and present the information that is available related to the supporting data and testing.
Summary of Available Information from the Provided Document:
This document summarizes the testing performed to demonstrate substantial equivalence of the ENROUTE Transcarotid Neuroprotection System (Subject Device) to its predicate device (ENROUTE Transcarotid Neuroprotection System with Filter, K143072). The testing focused on functional performance, biocompatibility, and sterilization, rather than clinical performance metrics often associated with AI or diagnostic device acceptance criteria (e.g., sensitivity, specificity).
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that "All bench testing met the pre-determined acceptance criteria" and "the safety acceptance criteria for the studies were met." Specific quantitative acceptance criteria for each test (e.g., a specific tensile strength value, acceptable flow rate range, or specific biological response thresholds) are not provided in this summary.
| Test Category | Specific Test (Examples) | Stated Acceptance Criterion | Reported Device Performance |
|---|---|---|---|
| Performance Testing | - Visual Inspection and Dimensional Verification |
- Disengagement Force Dilator to Hemostasis valve
- Guidewire Advancement
- Dilator Hub Functional Testing (ISO 594-1:1986)
- Sheath Stopper Removal
- Kink Resistance
- Hemostat Clamp and Unclamp
- Air Leakage During Aspiration (ISO 10555-1:2014 and ISO 11070:2014)
- Liquid Leakage Under Pressure (ISO 10555-1:2014 and ISO 11070:2014)
- High/Low Switch Cycling
- Flow Stop Button Cycling
- Tensile Tests (ISO 10555-1:2014 and ISO 11070:2014)
- Flow Rate Characterization
- Air Emboli and Solid Emboli Transportation Simulation
- Small and Large Particle Transport and Capture Efficiency
- System Preparation and Simulated Use
- Packaging Validation (ISO 11607-1:2006[R]2010 and ISO 11607-. 2:2006[R]2010)
- Shelf Life | "pre-determined acceptance criteria" (details not provided) | "All bench testing met the pre-determined acceptance criteria." |
| Guidewire Performance | - Tip Flexibility - Flexing (ISO 11070:2014)
- Fracture (ISO 11070:2014)
- Coating Adhesion
- Tensile Strength (ISO 11070:2014)
- Corrosion (ISO 11070:2014) | "pre-determined acceptance criteria" (details not provided) | "All bench testing met the pre-determined acceptance criteria." |
| Biocompatibility | - Cytotoxicity: MEM Elution L-929 ISO/USP - Sensitization: Maximum Sensitization (Guinea Pig)
- Irritation: ISO Intracutaneous Reactivity Test
- Systemic Toxicity: ISO Acute Systemic Injection
- Hemocompatibility (Thromboresistance, Complement Activation, Platelet/Leukocyte Count, PTT, Hemolysis)
- Genotoxicity (Ames Assay, Mouse Lymphoma Assay, Mouse Micronucleus Assay)
- Pyrogenicity: Material Mediated Pyrogen | Compliance with ISO 10993 standards and FDA guidance | "The Subject Device was determined to be biocompatible." |
| Sterility | Sterility testing | Compliance with ISO 11135-1:20007 and ISO 11135-2:2008 | "Sterility testing demonstrated that the device is compliant..." |
| Animal Testing (GLP) | Safety, performance, and handling evaluation in porcine models | "safety acceptance criteria" (details not provided) | "the safety acceptance criteria for the studies were met." |
| Pre-Clinical Cadaveric | Sheath insertion test on excised cadaveric carotid artery | "acceptability of the Dilator to Sheath transitions" | "All insertions were rated as acceptable by an experienced Vascular Radiologist. There was no evidence of damage to the test samples post insertions." |
2. Sample Size and Data Provenance (for test sets)
- Animal Testing (GLP): Three (3) porcine models were used. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but GLP (Good Laboratory Practice) implies a prospective, controlled study.
- Pre-Clinical Cadaveric Testing: The number of cadaveric carotid arteries used is not specified.
3. Number of Experts to Establish Ground Truth and Qualifications
- Pre-Clinical Cadaveric Testing: "an experienced Vascular Radiologist" performed the evaluation. The exact number of radiologists is not specified, but the phrasing "an experienced Vascular Radiologist" suggests one primary expert. Their years of experience are not quantified.
4. Adjudication Method
- The document does not describe a formal adjudication method (like 2+1 or 3+1) for any of its tests. Evaluations appear to be based on direct assessment against criteria or expert opinion without a multi-reader consensus process for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was performed or reported. The study design focuses on testing device function, biocompatibility, and safety, not on comparing human reader performance with and without AI assistance. The device itself is not described as an AI diagnostic tool that assists human readers.
6. Standalone (Algorithm Only) Performance Study
- This device is a physical medical device (Transcarotid Neuroprotection System), not an algorithm or AI. Therefore, the concept of a "standalone algorithm only" performance study is not applicable. The performance studies described evaluate the physical device's function.
7. Type of Ground Truth Used
- Performance Testing: Ground truth is against predefined engineering specifications and international standards (e.g., ISO, FDA guidance).
- Biocompatibility Testing: Ground truth is against established biological response criteria outlined in ISO 10993 and FDA guidance.
- Animal Testing: Ground truth is based on gross pathology, clinical pathology results, and clinical observations of safety, performance, and handling.
- Pre-Clinical Cadaveric Testing: Ground truth is based on the expert assessment by a Vascular Radiologist regarding the acceptability of sheath insertions and absence of damage.
8. Sample Size for Training Set
- This document describes pre-market testing for a physical medical device, not an AI/ML algorithm. Therefore, the concept of a 'training set' in the context of machine learning is not applicable here.
9. How Ground Truth for Training Set was Established
- Not applicable as this is not an AI/ML device.
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(118 days)
SILK ROAD MEDICAL, INC
The Silk Road® Access Catheter is indicated for the introduction of interventional devices into the peripheral vasculature.
The Silk Road Access Catheter is a sterile, non-pyrogenic, single-use access catheter indicated for introduction of interventional devices into the peripheral vasculature. The Silk Road Access Catheter is a single-lumen, coil-reinforced shaft, variable stiffness catheter in a range of diameters and working lengths to accommodate target anatomy. All sizes contain a radiopaque marker on the distal end and a catheter hub on the proximal end. The catheter shaft has a hydrophilic coating on its distal portion to reduce friction during use. The catheter is offered with a dilator. The Silk Road Access Catheter is a limited duration (
This document is a 510(k) Pre-market Notification for a medical device called the Silk Road Access Catheter. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel performance against acceptance criteria for a new type of device.
Therefore, the specific information requested in the prompt about acceptance criteria, detailed study results, sample sizes for test and training sets, expert qualifications, adjudication methods, and standalone/MRMC studies is not directly applicable or available in this document.
This document describes a regulatory submission where the goal is to show the new device (Subject Device) is as safe and effective as an existing, legally marketed device (Predicate Device), not to establish new performance benchmarks.
However, I can extract information regarding the performance testing conducted to support the substantial equivalence claim.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with explicit acceptance criteria and corresponding numerical performance results for the Subject Device. Instead, it lists the types of tests performed and states that these tests demonstrate "substantial equivalence." For biocompatibility, it states "The battery of tests included the following tests," and for animal studies, it mentions "the safety acceptance criteria for the studies were met." This implies the tests were successfully passed, but specific quantitative criteria and results are not detailed.
2. Sample size used for the test set and the data provenance:
- Biocompatibility Tests: The document lists various biocompatibility tests (e.g., Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility, Genotoxicity, Pyrogenicity). However, it does not specify the sample sizes used for these tests.
- Bench Testing: A comprehensive list of bench tests is provided (e.g., Visual Inspection, Coating Particulate, Leakage, Kink Resistance, Burst, Radiopacity, Shelf Life). Again, no sample sizes for these tests are mentioned.
- Animal Studies: A "GLP animal study was previously performed to evaluate the safety, performance and handling of the Predicate Device in the canine model." The sample size for this animal study is not specified.
- Data Provenance: The studies were internal testing, likely conducted by the manufacturer or contracted labs, as part of the regulatory submission process. The document does not specify country of origin for the data or whether the data was retrospective or prospective, though regulatory testing like this is typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The document refers to "acceptance criteria" being met for the animal study, but does not detail how ground truth for any of the non-clinical tests was established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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 comparative effectiveness study was not done. This is a non-clinical device that does not involve "human readers" or "AI assistance" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not an AI/algorithm-based device. Therefore, this type of standalone performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For Biocompatibility, ground truth is typically assessed against established ISO standards and biological responses (e.g., cell viability, immune reaction indicators, blood compatibility parameters).
- For Bench Testing, ground truth is based on engineering specifications and performance limits defined by relevant standards (e.g., ISO 10555-1) and internal design requirements.
- For Animal Studies, ground truth for safety and performance was based on "pathology and histopathology results" and "performance and handling observations" by a clinician in the canine model.
8. The sample size for the training set:
- This information is not applicable as this is not an AI/machine learning device that requires 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/machine learning device that requires a training set.
Summary of Device and Performance Testing:
The Silk Road Access Catheter is a sterile, single-use percutaneous catheter. The regulatory submission (K143459) aims to demonstrate its substantial equivalence to a previously cleared predicate device (K130649).
The performance data to support this claim includes:
- Biocompatibility Testing: Conducted according to FDA Blue Book Memorandum #G-95-1 and ISO 10993-1, covering Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility, Genotoxicity, and Pyrogenicity. The document states that the device is considered an externally communicating medical device with circulating blood contact for less than 24 hours. No specific quantitative results or sample sizes are provided for these tests, only that an evaluation was conducted.
- Bench Testing: A comprehensive set of engineering tests were performed, including Visual Inspection, Dimensional Verification, Coating Particulate, Coating Integrity, Liquid Leakage, Air Leakage, Kink Resistance, Torsion, Guidewire Advancement and Withdrawal Force, Burst, Bending Stiffness, Aspiration Rate, Flush Rate, Tensile Test, Corrosion, Radiopacity, Simulated Preparation and Use, and Shelf Life. These tests aim to verify the physical and mechanical properties of the device. No specific quantitative results or sample sizes are provided.
- Animal Studies: A GLP animal study was "previously performed to evaluate the safety, performance and handling of the Predicate Device in the canine model." The document states that based on pathology and histopathology results, "the safety acceptance criteria for the studies were met," and "No untoward observations were found by the clinician." The rationale is that since the subject device has the same basic design and fundamental technology as the predicate, the predicate's animal study results are applicable. No specific sample size for the animal study is mentioned.
- Clinical Performance Testing: The document explicitly states, "The Predicate Device was cleared based on the results of only non-clinical testing, therefore, only non-clinical testing was required to support substantial equivalence." No clinical performance testing was conducted or required for this 510(k) submission.
In conclusion, this regulatory document focuses on establishing substantial equivalence through non-clinical testing (biocompatibility, bench testing, and reliance on previous animal studies for the predicate device). It does not provide the detailed acceptance criteria and performance data in a format suitable for the requested table, nor does it involve the types of studies (MRMC, standalone AI) or expert-based ground truth establishment typically associated with diagnostic AI/software devices.
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(105 days)
SILK ROAD MEDICAL, INC
ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have the appropriate anatomy described below:
- Adequate femoral venous access
- Common carotid artery reference diameter of at least 6 mm.
- Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography
Silk Road Medical, Inc. is the manufacturer of a single use device intended to provide embolic protection during carotid artery angioplasty and stenting procedures. The ENROUTE Transcarotid NPS is designed to transport emboli away from the carotid artery circulation by reversing blood flow at the treatment site prior to crossing a lesion in the carotid artery and during lesion manipulation. It has an in-line filter used to capture and contain embolic material liberated during the procedure.
The ENROUTE Transcarotid NPS consist of three primary components: the ENROUTE Transcarotid Arterial Sheath (Model #1016), the ENROUTE Venous Return Sheath (Model #1026), and the ENROUTE Flow Controller (Model #2031). When assembled, the ENROUTE Transcarotid NPS creates an Arteriovenous Shunt. The Transcarotid Arterial Sheath is placed in the carotid artery below the carotid bifurcation. The Venous Return Sheath is placed into the femoral vein. The Arterial and Venous Sheaths are connected by the Flow Controller, thereby completing the Arteriovenous Shunt. When the carotid artery is occluded just proximal to the Transcarotid Arterial Sheath insertion site, the arterial/venous pressure gradient diverts or reverses the internal carotid artery (ICA) and external carotid artery (ECA) blood flow thereby directing the blood from the cerebral arteries through the Transcarotid Arterial Sheath, through the Flow Controller, and out through the through the Venous Return Sheath into the venous circulation. The ENROUTE Transcarotid NPS is an ethylene oxide sterilized, non-pyrogenic, single-use prescription device.
The associated accessory for use with the ENROUTE Transcarotid NPS is an FDA cleared 0.038" quidewire (K890959). The quidewire is used to facilitate the insertion of the Transcarotid Arterial Sheath into the common carotid artery (CCA) and the Venous Return Sheath into the femoral vein.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document focuses on the ROADSTER study's primary endpoint as the key acceptance criterion for effectiveness.
| Acceptance Criteria (Performance Goal) | Reported Device Performance (Upper 95% CI) | Result |
|---|---|---|
| Primary Endpoint |
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(235 days)
SILK ROAD MEDICAL, INC
The Silk Road™ Access Catheter is indicated for the introduction of interventional devices into the peripheral vasculature.
The Silk Road Access Catheter is a sterile, non-pyrogenic, single-use access catheter indicated for introduction of interventional devices into the peripheral vasculature. The Silk Road Access Catheter is a single-lumen, coil-reinforced shaft, variable stiffness catheter in a range of diameters and working lengths to accommodate target anatomy. All sizes contain a radiopaque marker on the distal end and a catheter hub on the proximal end. The catheter shaft has a hydrophilic coating on its distal portion to reduce friction during use. The catheter is offered with a dilator in all but the smallest size (SR-045-AC). The Silk Road Access Catheter is a limited duration (
The Silk Road™ Access Catheter underwent a series of non-clinical tests to demonstrate its safety and effectiveness. The acceptance criteria and reported device performance are summarized below:
1. Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection and Dimensional Verification | All samples must pass visual and dimensional inspection specifications. | Pass |
| Simulated Prep and Use | All samples must be able to be prepped and used per the IFU. | Pass |
| Coating Particulate | All samples must track through the track fixture and meet USP 788 microscopy method. | Pass |
| Coating Integrity | All samples must easily track through the track fixture. | Pass |
| Guidewire-Microcatheter Advance/Withdrawal Force | All samples must pass advancement and withdrawal force. | Pass |
| Bonding Stiffness | Characterize Bend Stiffness. | All samples are acceptable. |
| Aspiration Rate | Characterize Aspiration Rate. | All samples are acceptable. |
| Flush Rate | Characterization Flush Rate. | All samples are acceptable. |
| Tensile Test | All bonds must withstand a set force dictated by the device outer diameter for all samples. | Pass |
| Shaft Kink Resistance | The distal and proximal shaft must not kink around the bend for all samples. | Pass |
| Torsion Test | All samples shall show no evidence of damage (kinking, flattening, separation) to any joints or bonds. | Pass |
| Liquid Leakage | All samples shall show no water leaks large enough to form a falling drop over the entire device. | Pass |
| Air Leakage | All samples shall show no bubbles are present. | Pass |
| Luer Functional Testing | All samples shall meet the requirements of ISO 594-2 (gauging, separation force). | Pass |
| Biocompatibility | ||
| Cytotoxicity (MEM Elution L-929) | The test article passes if the mouse fibroblast cells do not display signs of toxicity after examination at 24, 48, and 72 hours. | The test article scored '0' at 24, 48, and 72 ± 4 hours, considered non-cytotoxic. |
| Sensitization (Maximum Sensitization, Guinea Pig) | The test article passes if the animals do not have signs of a delayed allergic response after being exposed to the test extract when compared to a control group. | No sensitization response greater than '0' was observed in animals challenged with test article extracts, considered non-sensitizing. |
| Irritation (ISO Intracutaneous Reactivity Test) | The test article passes if the difference between the mean scores for the test article extract and control are less than or equal to 1.0. | Differences in mean test and control scores of dermal observations were less than 1.0, meeting test requirements. |
| Systemic Toxicity (ISO Acute Systemic Injection) | The test article passes if the animals exposed to the test article extract do not show signs of toxicity greater than the concurrent control groups over a 72 hour period. | No clinical signs of toxicity were observed in treated animals, and body weight changes were acceptable. |
| Systemic Toxicity (Material Mediated Pyrogen) | The test article passes if the animals exposed to the test article extract do not show a significant increase in body temperature over a 3 hour period. | No temperature rise of 0.5 °C at required observation times, determined to be non-pyrogenic. |
| Hemocompatibility (Four Hour Thromboresistance Evaluation in Dogs) | 1) Test animals survive general anesthesia and study observation interval without test article complications; and 2) blood test results, pre/post weight differences, and patency and thrombus scores are not subjectively different between the test and control articles. | Implantation in two canines resulted in no adverse effects or significant thrombus formation; blood tests and clinical observations indicated no compromise in clotting abilities. Similar thromboresistance characteristics to control devices. |
| Hemocompatibility (Complement Activation C3a and SC5b-9) | The test article passes if complement activation in human plasma (C3a Assay and SC5b-9) is not induced significantly when compared with the comparison article. | All biomaterials have the potential to affect complement components; no established acceptable ranges. Test article and comparison article showed similar activation levels. |
| Hemocompatibility (Platelet and Leukocyte Count) | The test article passes if the counts are not statistically and adversely significant compared to the reference material and comparison article. | Test article groups and comparison article showed platelet and leukocyte counts within a reasonable percentage of reference material. All biomaterials have the potential to affect blood components; no established acceptable ranges. |
| Hemocompatibility (Partial Thromboplastin Time (PTT)) | The test article passes if the PTT is not significantly shortened following contact with a material under standardized conditions. | Both test article groups and the comparison article had an average clotting time of 300.0 seconds (100% of negative control), indicating non-activation of the intrinsic coagulation pathway. |
| Hemocompatibility (Hemolysis - Direct Contact and Extract (ASTM F 756)) | The test samples are rated per the hemolytic index above the negative control. If 0 – 2%, classified as non-hemolytic, if 2.1-5%, classified as slightly hemolytic, and if ≥5.1%, classified as hemolytic. | Test article returned hemolytic index values equal to or lower than the negative control, falling within the non-hemolytic range for both direct contact and extract tests. |
| Genotoxicity | ||
| Bacterial Mutagenicity Test (Ames Assay) | The test article passes if the criteria for positive mutagen are not met. | The test article did not induce substantial increases in reversion rates associated with mutagenesis; no substantial toxicity noted. Considered non-mutagenic. |
| In Vitro Mouse Lymphoma Assay | The test article passes if the mutant frequency is less than 1.8 fold higher than that of the concurrent negative control groups. | Mutant frequencies and cloning efficiencies were within limits for a negative response. Considered non-mutagenic (non-genotoxic and non-clastogenic). |
| In Vivo Mouse Micronucleus Assay | The test article passes if it does not show a significant increase in the number of micronucleated polychromatic erythrocytes. | No apparent gross manifestations of toxicity nor biologically significant erythropoietic disturbances. No biologically significant increases in mPCE production. Considered non-mutagenic. |
| Packaging Validation | Packaging must maintain product sterility and protect the product during shipment and storage. | Pass |
| Sterilization Validation | Silk Road Access Catheter must be validated ISO 11135-1:2007. | Pass |
| Shelf Life | Silk Road Access Catheter must perform to specification and the package must maintain a sterile barrier during the shelf-life period as labeled on the product label. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each non-clinical test beyond phrases like "all samples" or mentioning "replicates" for certain biocompatibility tests. For the animal study, it mentions "two canines" for the Hemocompatibility (Four Hour Thromboresistance Evaluation) test.
The data provenance is not explicitly stated. These appear to be laboratory test results conducted by the manufacturer or contracted labs for the purpose of regulatory submission. The studies are non-clinical, meaning they were performed in a lab or animal setting, not on human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the studies are non-clinical (laboratory and animal studies) and do not involve human interpretation of medical images or data requiring expert consensus or clinical evaluation of ground truth. The "ground truth" for these tests is based on established scientific and regulatory standards in material science, engineering, and toxicology.
4. Adjudication Method for the Test Set
This is not applicable as the studies performed are non-clinical and do not involve human diagnostic decisions or require adjudication for consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (access catheter) and focuses on non-clinical performance, safety, and biocompatibility, not on diagnostic accuracy or reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical medical instrument (an access catheter), not a software algorithm, so "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for these non-clinical tests is based on:
- Established specifications and standards: e.g., "All samples must pass visual and dimensional inspection specifications," "meet USP 788 microscopy method," "meet the requirements of ISO 594-2," "validated ISO 11135-1:2007."
- Biological responses as defined by assays and protocols: e.g., "mouse fibroblast cells do not display signs of toxicity," "animals do not have signs of a delayed allergic response," "no significant increase in body temperature."
- Physical and mechanical measurements: e.g., "advancement and withdrawal force," "bend stiffness," "aspiration rate."
- Pathology and histopathology results: from the GLP animal study.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical instrument, not an AI or machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
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