(136 days)
The SABERX RADIANZ™ PTA Catheter is intended to dilate stenoral, ilio-femoral, popliteal, infra poplited and renal arteries. The device is also indicated for post-dilation of balloon-expandable and self-expanding stents in the peripheral vasculature.
The SABERX RADIANZ™ Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a single-use sterile device, sterilized by ethylene oxide. The SABERX RADIANZ™ Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (hereafter referred to as "SABERX RADIANZ™") is a Rapid Exchange design, consisting of a single inflation lumen and a distal quidewire lumen. The quidewire lumen permits the use of a quidewire (0.018 in.) to facilitate advancement of the catheter to and through the stenosis to be dilated. It begins at the distal tip and terminates at the guidewire exit port. The guidewire exit-port (hole) is 40 cm from the distal tip. The proximal hub section of the catheter provides a clear, onepiece hub with a single-luer port for inflation of the balloon. The coaxial, concentric dual lumen distal shaft connects proximally at the quidewire exit port and distally to the balloon. The proximal shaft with a supporting stainless-steel core wire connects proximally to the hub and distally to the guidewire exit port. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. A balloon protector is placed over the balloon to maintain a low profile. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. A lubricious hydrophilic coating covers the distal tip. balloon, and a portion of the shaft, to facilitate balloon placement. The SABERX RADIANZ™ catheter will have multiple radiopaque marker bands that provide fluoroscopic visual reference points to facilitate balloon positioning within the vessel. The SABERX RADIANZ™ catheter is compatible with standard 0.018" guidewires and 4F, 5F, or 6F catheter sheath introducers. The usable catheter length is 190 cm and the proximal shaft has two exit markers located at 115 cm and 140 cm from the distal tip. The SABERX RADIANZ™ catheter is available in eighty-two (82) product configurations with balloon diameters of 2.00 - 8.00 mm in 0.50 mm or 1.00 mm increments. The working lengths of the treatment balloon will be offered in lengths from 20 mm to 300 mm. The associated accessories for SABERX RADIANZ™ include: - . Flushing Needle.
This appears to be an FDA 510(k) summary for a medical device called the "SABERX RADIANZ™ Percutaneous Transluminal Angioplasty Dilatation Catheter." This type of document is for demonstrating substantial equivalence to a predicate device, not for proving that a device meets specific acceptance criteria through a comparative study with a "human-in-the-loop AI system" or "standalone AI algorithm."
Therefore, most of the requested information regarding AI acceptance criteria, human reader improvement with AI assistance, sample sizes for training/test sets, expert adjudication, etc., is not applicable to this document.
However, I can extract the acceptance criteria and performance data relevant to this physical medical device and its substantial equivalence determination.
Here's a breakdown of the requested information based on the provided document, noting where the information is not applicable (N/A) to this type of device submission:
Device Name: SABERX RADIANZ™ Percutaneous Transluminal Angioplasty Dilatation Catheter
Type of Study: Substantial Equivalence Determination via Non-Clinical Performance Testing for a Physical Medical Device (Catheter)
Purpose of the Study: To demonstrate that the SABERX RADIANZ™ catheter is substantially equivalent to a legally marketed predicate device (Crosstella RX PTA Balloon Dilatation Catheter cleared under K152873) and thus safe and effective for its intended use.
1. A table of acceptance criteria and the reported device performance
For a physical medical device like this catheter, "acceptance criteria" and "reported performance" refer to the successful completion of specific bench tests and biocompatibility assessments, demonstrating the device's functional integrity and safety. The document states that "passing results for the above tests provide reasonable assurance that the subject device has been designed to meet its intended use."
| Test Category | Specific Test | Acceptance Criteria (Implied/Standard) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity MEM Elution | Pass/Biocompatible | Successfully passed |
| Sensitization - Guinea Pig Maximization | Pass/Biocompatible | Successfully passed | |
| Intracutaneous Irritation Reactivity | Pass/Biocompatible | Successfully passed | |
| Acute Systemic Toxicity | Pass/Biocompatible | Successfully passed | |
| Materials Mediated Rabbit Pyrogen | Pass/Non-pyrogenic | Successfully passed | |
| Hemolysis - Extract / Direct Contact | Pass/Biocompatible | Successfully passed | |
| Partial Thromboplastin Time (PTT) | Pass/Biocompatible | Successfully passed | |
| Platelet & Leukocyte Counts | Pass/Biocompatible | Successfully passed | |
| Complement Activation Assay | Pass/Biocompatible | Successfully passed | |
| Bacterial Mutagenicity - Ames Assay | Pass/Non-mutagenic | Successfully passed | |
| In Vitro Mouse Lymphoma | Pass/Non-genotoxic | Successfully passed | |
| In Vivo Mouse Micronucleus | Pass/Non-genotoxic | Successfully passed | |
| In Vivo Thrombogenicity | Pass/Non-thrombogenic | Successfully passed | |
| USP Physicochemical Aqueous Extract Test | Pass | Successfully passed | |
| Chemical Characterization | Characterized, within acceptable limits | Successfully characterized | |
| Sterilization | Ethylene Oxide Sterilization Cycle Validation | Sterility Assurance Level (SAL) of 10⁻⁶ per ISO 11135:2014+A1:2019 | Achieved SAL of 10⁻⁶; residuals met ISO 10993-7:2008/Cor:2009 |
| Bench Testing | Dimensional verification | Meets design specifications | Successfully completed |
| Balloon Preparation | Proper balloon folding/preparation | Successfully completed | |
| Balloon Rated Burst Pressure (with and without stent) | Withstands specified pressure without bursting | Successfully completed | |
| Balloon Fatigue (Repeat Balloon Inflations with and without stent) | Maintains integrity over multiple inflations | Successfully completed | |
| Balloon Compliance | Meets specified compliance profile | Successfully completed | |
| Balloon Inflation Time | Meets specified inflation time | Successfully completed | |
| Balloon Deflation Time | Meets specified deflation time | Successfully completed | |
| Catheter Bond Strength | Withstands specified forces | Successfully completed | |
| Flexibility and Kink Test | Maintains functionality without kinking under typical use | Successfully completed | |
| Torque Strength | Withstands specified torque without failure | Successfully completed | |
| Particulate Evaluation / Coating Uniformity-Integrity | Meets cleanliness and coating integrity standards | Successfully completed | |
| Packaging Testing | Visual inspection | Meets visual quality standards | Successfully completed |
| Component position | Correct component placement | Successfully completed | |
| Peel strength | Meets peel strength specifications | Successfully completed | |
| Bubble test | Pass | Successfully completed | |
| Particulate | Meets particulate cleanliness standards | Successfully completed |
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the exact number of units/samples tested for each bench test or biocompatibility test. It only states that "passing results for the above tests provide reasonable assurance." For physical devices, this typically involves a statistically relevant number of samples for each specific test, but the exact N is not disclosed in this summary.
- Data Provenance: The data comes from "non-clinical design verification testing" and "biocompatibility testing" performed for the SABERX RADIANZ™ device. The specific country of origin for the testing labs is not mentioned, but the submitter is Cordis Corporation in Miami Lakes, Florida, USA. The testing is retrospective in the sense that it was completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This device submission does not involve human readers evaluating images or a dataset that requires "ground truth" established by medical experts in the way an AI diagnostic device would. The "ground truth" for this catheter is its adherence to engineering specifications, biocompatibility standards, and functional performance as determined by laboratory testing.
4. Adjudication method for the test set
- N/A. See explanation for #3. Adjudication is not applicable as there are no discrepant expert interpretations to resolve.
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
- N/A. This document describes a physical medical device (catheter), not an AI-assisted diagnostic system. No MRMC study was conducted, nor is it relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device does not have a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on established engineering standards, international consensus standards (e.g., ISO, USP), and validated internal test methods that define acceptable limits for device functionality, material properties, and biological safety. For example, for "Balloon Rated Burst Pressure," the ground truth is simply whether the balloon bursts or not at a specified pressure, according to a defined test method. For biocompatibility, it's whether the biological response falls within accepted safe limits as defined by ISO standards.
8. The sample size for the training set
- N/A. This is a physical medical device, not an AI algorithm, so there is no training set in the AI sense. The device design and manufacturing processes are "trained" through iterative R&D and validation, but this doesn't correspond to an "AI training set."
9. How the ground truth for the training set was established
- N/A. See explanation for #8.
§ 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).