(60 days)
The Imperative Care Radial 088 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Imperative Care Radial 088 Access System (Radial 088 Access System) consists of a single lumen catheter (Radial 088 Access Catheter) and a 6F Dilator intended to provide ease of access to the peripheral, coronary and neuro vasculature using a transradial access (TRA) approach.
The Radial 088 Access Catheter consists of a single lumen, braid and coil reinforced, variable stiffness catheter constructed using medical grade polymers. The catheter features include a standard luer hub on the proximal end and an atraumatic angled tip on the distal end. The distal section is covered in a lubricious hydrophilic coating for ease of tracking through tortuous vasculature to reach the target location. The distal tip has a radiopaque marker to provide the user with visual confirmation of the distal tip location during tracking and placement under fluoroscopy.
The Radial 088 Access Catheter is offered in working lengths of 95 cm, 105 cm, and 110 cm. The catheter has a proximal and distal inner diameter (ID) of 0.088" and is compatible with ≤ 0.038" diameter guidewires and 6F interventional devices having a minimum device length of 120 cm. The catheter has a distal outer diameter (OD) of 0.107" (2.7 mm) and a proximal OD of 0.110" (2.8 mm): the luer hub on the proximal end is compatible with Rotating Hemostasis Valves (RHVs) having a standard luer connector.
The 6F Dilator is a single lumen dilator with a tapered tip constructed of medical grade polymers. The 6F Dilator includes a standard luer hub on the proximal end which is compatible with standard luer lock devices (e.g., syringes). The 6F Dilator has an ID of 0.039" minimum, an OD of 0.083"-0.086" and is offered in a working length of 130 cm (± 2 cm).
The provided text describes a 510(k) summary for the "Imperative Care Radial 088 Access System." The document extensively outlines the device, its intended use, comparison to a predicate device, and performance data supporting its substantial equivalence. However, it does not describe the acceptance criteria and study that proves the device meets the acceptance criteria in terms of clinical performance measures such as sensitivity, specificity, accuracy, or diagnostic effectiveness.
The document focuses on engineering and material-based performance tests commonly used for medical devices like catheters, ensuring they meet specified physical and material properties. It does not involve a study with a "test set" in the context of diagnostic or AI-driven medical devices (which would typically involve patient data and expert ground truth). Therefore, many of the requested items, particularly those related to diagnostic performance and AI studies, cannot be extracted from this document.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Test Attribute | Specification | Results |
|---|---|---|
| Catheter Tests | ||
| Dimensional Inspection | All defined catheter dimensions are within the specified tolerances. | Pass |
| Delivery, Compatibility, and Retraction (Trackability) | The catheter shall be able to be delivered and retracted per the IFU using radial access in a simulated neurological model without incurring any damage to the catheter. | Pass |
| Flexibility and Kink Resistance | There shall be no kinking of shaft (permanent deformation) after simulated use. Catheter remains patent after removal of the dilator. | Pass |
| Catheter Torque Strength | No separation of any portion of the catheter when rotated at least two (2) full rotations (720 degrees). No damage to the catheter when hand rotated during insertion. | Pass |
| Luer Compatibility | Devices shall be compatible with standard syringe luer fittings per ISO 80369-7. | Pass |
| Guidewire Compatibility | The catheters shall be able to be delivered over the maximum size guidewire indicated in the product labeling. | Pass |
| Dilator Compatibility | The catheter should remain patent after removal of the dilator to allow for the introduction of interventional devices. | Pass |
| Interventional Device Compatibility | The catheters shall be able to accommodate other interventional devices (e.g., support catheter, diagnostic catheter) up to the maximum size indicated in the product labeling. | Pass |
| Direct Puncture | The catheter with dilator can be inserted without incurring any damage to the catheter or causing catheter tip roll back. | Pass |
| Accessory Compatibility | Devices shall be compatible with an RHV. | Pass |
| Stability | The catheter provides enough support to maintain its position when interventional device is advanced to target location. | Pass |
| Pushability | The proximal shaft of the catheters shall have sufficient stiffness that the user can easily push the catheter to the target anatomy without buckling. | Pass |
| Access Force | Catheters shall not require excessive force to safely navigate and track to the target anatomy. | Pass |
| Coating Integrity/Particulate | The amount of particulate matter that comes off the hydrophilic coated shaft during simulated use testing shall be determined and compared to competitive products and techniques. | Pass |
| Dilator Tests | ||
| Dimensional Inspection | All defined dilator dimensions are within the specified tolerances. | Pass |
| Radiopacity | The distal tip of dilator can be seen under fluoroscopy during use. | Pass |
| Dilator Bond Strength | The dilator shall have sufficient bond strength to remain intact throughout a procedure. | Pass |
| Luer Compatibility | The dilator shall be compatible with standard luer lock fittings per ISO 80369-7. | Pass |
| Guidewire Compatibility | The dilator shall be able to be delivered over the maximum size guidewire indicated in the product labeling. | Pass |
| Direct Puncture | The dilator can be inserted without incurring any damage. | Pass |
| Biocompatibility Testing (6F Dilator) | ||
| Cytotoxicity (ISO MEM Elution) | No reactivity. (Conclusion: Non-cytotoxic) | Non-cytotoxic |
| Sensitization (Magnusson-Klingman Method) | Extracts elicited no reaction at the challenge following the induction phase. (Conclusion: Non-sensitizer) | Non-sensitizer |
| Irritation/Intracutaneous Reactivity | Test article sites did not show any significantly greater biological reaction than control sites. Differences in mean test and control scores were less than 1.0. (Conclusion: Non-irritant) | Non-irritant |
| Acute Systemic Toxicity | None of the animals treated with sample extracts showed a significantly greater biological reaction than animals treated with control extracts. (Conclusion: Non-toxic) | Non-toxic |
| Hemocompatibility (Complement Activation) | Statistically similar SC5b-9 concentrations when compared to the predicate device and negative controls. (Conclusion: Pass) | Pass |
| Hemocompatibility (ASTM Hemolysis, Direct Contact) | Difference between hemolytic indexes of test sample and negative control equals 0 percent. (Conclusion: Non-hemolytic) | Non-hemolytic |
| Hemocompatibility (ASTM Hemolysis, Extract Method) | Difference between hemolytic indexes of test sample and negative control equals 0.15 percent. (Conclusion: Non-hemolytic) | Non-hemolytic |
| Hemocompatibility (in-vitro Blood Loop Assay) | Acceptable thrombus formation scores. (Conclusion: Thromboresistant) | Thromboresistant |
| Material Mediated Pyrogenicity | No individual temperature rise of ≥ 0.5°C at observed time points. (Conclusion: Non-pyrogenic) | Non-pyrogenic |
| Shelf Life & Packaging | ||
| Packaging Visual Inspection | Pass (T=0) / Pass (T=1 year) | Pass |
| Pouch Integrity Test - Gross Leak Detection | Pass (T=0) / Pass (T=1 year) | Pass |
| Pouch Seal Strength - Peel Strength | Pass (T=0) / Pass (T=1 year) | Pass |
| Label Integrity | Pass (T=0) / Pass (T=1 year) | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes bench and laboratory (in-vitro) testing. It does not involve a "test set" of patient data in the sense of a clinical or AI diagnostic study. The testing was conducted in a simulated neurological model for trackability. No specific sample sizes for these bench tests are provided, nor is the country of origin or whether it was retrospective/prospective in a clinical sense.
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 device is a catheter, and its performance evaluation involves engineering and biocompatibility testing, not expert-adjudicated ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is a catheter, and its performance evaluation involves engineering and biocompatibility testing, not expert adjudication on patient data.
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 device is a catheter, not an AI-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a catheter, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on established engineering standards (e.g., ISO 10555-1 for catheter performance, ISO 80369-7 for luer compatibility, ASTM F1980-16 for accelerated aging) and biocompatibility testing guidelines. It's about meeting physical, chemical, and biological specifications rather than a diagnostic 'truth.'
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI algorithm that would have a "training set."
9. How the ground truth for the training set was established
Not applicable. This document describes a physical medical device, not an AI algorithm.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).