(231 days)
Femoral artery Introducer Set: The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through artery while minimizing blood loss during interventional procedures.
Radial Artery Introducer Set. The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into the radial artery while minimizing blood loss during interventional procedures.
This set classifies two types: Femoral Artery and Radial Artery. The Femoral Artery introducer set consist of a sheath introdcuer, dilator, needle, Guidewire. The Radial Artery introducer set consist of a sheath introdcuer lubricated with/without hydrophilic coating, dilator, I.V. cannula /Introducer needle,Guidewire (with/without hydrophilic coating).
The Introducer Set consists of sheath introducer, each packaged in a set to together with a dilator, introdcuer needle, and guidewire. The introducer sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with tubing connected to a 3-way stopcocks is used for injection contrast medium. The dilator is provided to aid in the introduction of sheath to the target vessel. The Introducer needle/I.V. Cannula is provided a conduit for insertion of the guidewire into the vascular system. The guidewire is utilized as a guiding mechanism for the introducer sheath into the vascular system.
The provided document is a 510(k) premarket notification summary for a medical device (KDL Introducer Set). It outlines the device's technical specifications, intended use, and comparison to a predicate device. However, this document describes a Class II medical device (a catheter introducer) and not an AI/ML-driven device. Therefore, the information typically requested in your prompt regarding acceptance criteria and studies for AI/ML device performance (such as sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone algorithm performance, training set details, etc.) is not applicable to this type of traditional medical device.
Instead, the document details non-clinical performance testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the relevant information provided in the document concerning how the device meets acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a single table with "acceptance criteria" and "reported device performance" in the way one might for an AI/ML diagnostic output (e.g., sensitivity, specificity thresholds). Instead, it lists various "Testing item" and "Reference Standard/Guidance" for different components of the Introducer Set. The document then states:
"All sample tested met the standard applicable to each test." and "Base on the result of the performance and biocompatibility testing, the proposed device, Introducer Set, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols."
Here's a re-composition of this information into a table format based on the supplied text:
| Component | Testing Item | Reference Standard/Guidance | Reported Device Performance |
|---|---|---|---|
| Sheath Introducer | Appearance | Section 4.3 of ISO 11070:2014 | Met standard |
| O.D and I.D. | Section 7.2 a) of ISO 11070:2014 | Met standard | |
| Effective Length | Section 7.2 b) of ISO 11070:2014 (detail size see section V in this submission) | Met standard | |
| Luer connector | ISO 594-2 | Met standard | |
| Sheath introducer leakage | Section 7.3 of ISO 11070:2014 | Met standard | |
| Haemostasis valve leakage | Section 7.4 of ISO 11070 | Met standard | |
| Peak tensile force | Section 7.6 of ISO 11070 | Met standard | |
| Coating Integrity (if applicable) | In-house standard | Met standard | |
| Coating Friction force (if applicable) | In-house standard | Met standard | |
| Radio-detectability | ASTM F640-12 | Met standard | |
| Dilator | Appearance | Section 4.3 of ISO 11070:2014 | Met standard |
| O.D. and I.D. | Section 9.2 a), b) of ISO 11070:2014 | Met standard | |
| Effective Length | Section 9.2 c) of ISO 11070:2014 | Met standard | |
| Luer connector | ISO 594-2 | Met standard | |
| Strength of union | Section 9.3.3 of ISO 11070:2014 | Met standard | |
| Coating Friction force (if applicable) | In-house standard TBD (specific to radial artery and guidewire) | Met standard | |
| Coating Integrity (if applicable) | In-house standard TBD (specific to radial artery and guidewire) | Met standard | |
| Radio-detectability | ASTM F640-12 | Met standard | |
| Introducer Needle | Appearance | Section 4.3 of ISO 11070:2014 | Met standard |
| O.D and I.D. | Table 1 of ISO 9626 | Met standard | |
| Effective Length | Section 5.2 of ISO 11070:2014 | Met standard | |
| Luer connector | ISO 594-1:1986 | Met standard | |
| Strength union | Section 5.4.2 of ISO 11070:2014 | Met standard | |
| Corrosion resistance | Section 4.4 ISO 11070:2014 | Met standard | |
| Needle point | Section 5.3 of ISO 11070 | Met standard | |
| Patency | Section 13.2 ISO 7864 | Met standard | |
| Stiffness | Section 5.8 of ISO 9626 | Met standard | |
| Breakage resistance | Section 5.9 of ISO 9626 | Met standard | |
| Limits for acidity and alkalinity | Section 5.4 of ISO 9626 | Met standard | |
| Guidewire | Appearance | Section 4.3 of ISO 11070:2014 | Met standard |
| O.D. | Section 8.2 a) of ISO 11070:2014 | Met standard | |
| Length | Section 8.2 b) of ISO 11070:2014 | Met standard | |
| Corrosion resistance | Section 4.4 ISO 11070:2014 | Met standard | |
| Fracture test | Section 8.4 of ISO 11070:2014 | Met standard | |
| Flexing test | Section 8.5 of ISO 11070:2014 | Met standard | |
| Peak tensile force | Section 8.6 of ISO 11070:2014 | Met standard | |
| Torque strength | 3b of FDA Guidance for Coronary and Cervicovascular Guidewire Guidance 1995 | Met standard | |
| Torqueability | 3c of FDA Guidance for Coronary and Cervicovascular Guidewire Guidance 1995 | Met standard | |
| Tip flexibility | 3d of FDA Guidance for Coronary and Cervicovascular Guidewire Guidance 1995 | Met standard | |
| Coating Integrity (if applicable) | In-house standard TBD (specific to radial artery and guidewire) | Met standard | |
| Coating Friction force (if applicable) | In-house standard TBD (specific to radial artery and guidewire) | Met standard | |
| Radio-detectability | ASTM F640-12 | Met standard | |
| Biocompatibility | In Vitro Hemolytic | ASTM F756-13 Standard Practice for assessments of hemolytic properties of material | Met standard |
| In Vitro Cytotoxicity | ISO 10993-5:2009, Biocompatibility Evaluation of Medical Device - Part 5: Tests for In Vitro Cytotoxicity | Met standard | |
| Intracutaneous Reactivity | ISO 10993-10:2010, Biocompatibility Evaluation of Medical Device - Part 10: Tests for Irritation and Skin Sensitization | Met standard | |
| Skin Sensitization | ISO 10993-10:2010, Biocompatibility Evaluation of Medical Device - Part 10: Tests for Irritation and Skin Sensitization | Met standard | |
| Acute Systemic Toxicity | ISO 10993-11:2006, Biocompatibility Evaluation of Medical Device - Part 11: Tests for systemic toxicity | Met standard | |
| Pyrogen | ISO 10993-11:2006, Biocompatibility Evaluation of Medical Device - Part 11: Tests for systemic toxicity | Met standard | |
| In Vivo Thrombogenicity | ISO 10993-4:2002/Amd1:2006, Biocompatibility Evaluation of Medical Device - Part 4: Selection of tests for interactions with blood | Met standard |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample size for each test. It states "The performance tests were performed on the non-aged and ages to 3 years sample." This implies that samples were tested for immediate performance and also after accelerated aging simulating 3 years of shelf life. Specific lot sizes or number of units tested per parameter are not disclosed in this summary.
- Data Provenance: Not explicitly stated, however, the manufacturer is Shanghai Kindly Medical Instruments Co., Ltd. in Shanghai, China. The testing would have been conducted by or for them, likely in China. The study is a non-clinical performance testing and biocompatibility assessment, rather than a clinical study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as this is a traditional medical device undergoing physical and biological performance testing, not an AI/ML device relying on interpretation of medical images or data by experts to establish ground truth. The "ground truth" here is defined by the technical specifications and standards (e.g., ISO, ASTM).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable for the same reason as point 3. Testing involves objective measurements against established engineering and biocompatibility 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 as the device is not an AI-driven product nor does it involve human readers interpreting medical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on engineering specifications, established international standards (ISO, ASTM), and FDA guidance documents for medical devices (specifically catheter introducers and guidewires). For biocompatibility, it's based on standard biological test methods outlined in ISO 10993 and ASTM F756.
8. The sample size for the training set:
- This question is not applicable as this is a manufactured medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- This question is not applicable for the same reason as point 8.
§ 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).