(212 days)
The Brilliant Introducer Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.
The Brilliant™ Introducer Kit classifies into four types (Type I, II, III, and IV). Type I consists of a sheath introducer and a dilator. Type II consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator and a puncture needle. Type III consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator. Type IV consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator, an Intravascular catheter (with needle) and a syringe. The puncture needle or an intravascular catheter incorporates a lumen, which provides a conduit for the insertion of the guide wire into the vascular system. The various types of guide wires, model dependent, are utilized as a guiding mechanism for the insertion of the introduction sheath into the vascular system. The guide wire contains a wire collimator, which assists in funneling the wire through the lumen of the puncture needle or the intravascular catheter. The guide wire is radio- detective under fluoroscopy. The sheath introducer provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vasculature. The main components of the sheath introducer assembly are a hydrophilic coated sheath introducer, hemostasis valve housing, and a side port tubing with a 3-way stopcock/valve. The hydrophilic coated dilator is used to provide support and stability to the sheath introducer during deployment into the vascular system. The proximal end of the dilator includes a luer port and has a tapered, atraumatic distal tip. The sheath introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy. There is no radiocontrast agent in the dilator.
The provided text is a 510(k) premarket notification for a medical device called the "Brilliant Introducer Kit." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria for a novel AI/software component within the device.
Therefore, many of the requested points regarding AI/algorithm performance studies cannot be answered from this document.
However, I can extract information related to the device's biocompatibility and performance testing, which are critical acceptance criteria for this type of medical device.
Here's the information that can be extracted and a clear indication of what cannot be derived from the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are demonstrated through biocompatibility testing and general performance testing. The text does not provide quantitative acceptance criteria targets in the way one might for a software algorithm's accuracy, but rather indicates that the device "met the requirements" or "successfully passed" various tests based on established standards.
Table 1: Acceptance Criteria (as implied by successful testing) and Reported Device Performance
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance (Results) |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | No cytotoxicity potential (as per ISO 10993-5) | Under the conditions of this study, the Mem test extracts would be considered no cytotoxicity potential. The negative controls, blank controls, and the positive controls performed as anticipated. |
| ISO Intracutaneous Study | Met requirements, with no significant difference between test extract and control overall mean scores (as per ISO 10993-10) | Under the conditions of this study, the test article met the requirements of the test since the difference between each test extract overall mean score and corresponding control overall mean score was 0.0 and 0.0 for the SC and CSO test extracts, respectively. |
| ISO Guinea Pig Maximum Sensitization | No evidence of causing delayed dermal contact sensitization (as per ISO 10993-10) | Under the conditions of this study, the test article extracts showed no evidence of causing delayed dermal contract sensitization in the Guinea pig. The test article was not considered a sensitizer in the Guinea pig maximization test. |
| ISO Systemic Toxicity | No mortality or evidence of systemic toxicity (as per ISO 10993-11) | Under the conditions of this study, there was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. |
| Complement Activation Assay | Not significantly different from negative control (P>0.05) (as per ISO 10993-4) | Under the conditions of this study, the Sc5b-9 concentration from the test article were not significantly different from that of negative control sample and Control article (P>0.05). |
| ASTM Hemolysis | Non-hemolytic (as per ISO 10993-4, ASTM F756) | Under the conditions of this study, the Hemolytic Index for the test article in direct contact with blood was 1.9% and that for the test article extract was 0.6%. Both the test article in direct contact with blood and test article were non-hemolytic. |
| USP Pyrogen Study | Non-pyrogenic (maximum rise of rabbit temperatures not showing a rise of 0.5 °C or more above baseline) (as per ISO 10993-11, USP ) | Under the conditions of this study, the maximum rise of each rabbit temperatures did not show a rise of 0.5 °C or more above its baseline temperature during 3 hour observation period. The test article was judged as nonpyrogenic. |
| Partial Thromboplastin Time | Mild thrombogenicity response considered acceptable (as per ISO 10993-4) | Under the conditions of this study, the % negative control is 72.32%, the test article would be considered mild thrombogenicity response. |
| In Vivo Thromboresistance | Thromboresistant (no thrombosis, similar to control) (as per ISO 10993-4) | Under the conditions of this study, the test article showed no thrombosis which was similar with the control article. The test article would be considered as thromboresistant. |
| Performance Testing | Successfully passed all listed performance tests. Specific quantitative acceptance criteria are not provided, but passing indicates meeting internal or standard specifications for these parameters. | The Brilliant™ Introducer Kit successfully passed all of the following performance tests: Radio-detectability (Sheath Introducer), Peak Tensile Force between Side Port Tubing and Hemostasis Valve, Dilator internal diameter, Radio-detectability (Dilator), Guidewire accessibility, Coating integrity, Coating efficacy, Particulate evaluation, Residual EO and ECH, Sterile, Bacterial endotoxin. |
| Sterilization | Sterility Assurance Level (SAL) of 10-6 (as per AAMI / ANSI / ISO 11135:2014) | The method used is based on practices recommended by AAMI / ANSI / ISO 11135:2014 and provides a Sterility Assurance Level (SAL) of 10-6. |
Additional Information Requests:
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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 specified in the document for the biocompatibility or performance tests.
- Data Provenance: The document does not specify the country of origin for the test data, nor whether the studies were retrospective or prospective. The applicant is Lepu Medical Technology (Beijing) Co., Ltd., which is located in P.R. China, implying the studies were likely conducted there or overseen by them.
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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 question is not applicable to the type of device and testing described. The "ground truth" here is established by standardized laboratory testing procedures (e.g., ISO, ASTM, USP standards) for biocompatibility and engineering performance, not by expert interpretation of clinical images or data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods are typically for subjective clinical assessments or image interpretations, not for objective laboratory test results.
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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 that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/software device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For biocompatibility: Ground truth is established by the specific endpoints and methodologies defined in the referenced international standards (e.g., cell viability for cytotoxicity, skin irritation scores for intracutaneous reactivity, sensitization response for maximization tests, mortality/organ effects for systemic toxicity, complement activation markers for complement assay, hemolytic index for hemolysis, temperature rise for pyrogenicity, clotting times for thromboplastin, and visual/histological assessment for in vivo thromboresistance).
- For performance testing: Ground truth is established by engineering specifications and measurements (e.g., tensile force measurements, diameter measurements, visual inspection for coating integrity, particulate counts, chemical residue analysis, microbial culture for sterility, endotoxin assays).
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The sample size for the training set
- Not applicable. This is not a machine learning/AI device, so there is no "training set."
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How the ground truth for the training set was established
- Not applicable (no training set).
In summary, the provided document is a 510(k) premarket notification for a conventional introducer kit, primarily demonstrating substantial equivalence through adherence to existing medical device standards for biocompatibility and performance. It does not involve AI/machine learning components, and thus, metrics pertinent to AI/software validation are not present.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).