(136 days)
R2PTM Destination Slender™ Guiding Sheath is indicated to be used for the introduction of interventional and diagnostic devices in the lower extremities of the peripheral vasculature through an access site, including tut not limited to the radial artery.
The R2PTM Destination Slender™ Guiding Sheath is a low profile guiding sheath designed to perform as a guiding catheter and an introducer sheath. The sheath is coil reinforced, has a radiopaque tip, is hydrophilically coated and is available in 6Fr with a length of 119cm and 149cm. It comes packaged with a dilator and hemostatic valve.
The provided FDA 510(k) summary for the Terumo R2P™ Destination Slender™ Guiding Sheath describes non-clinical performance testing to demonstrate substantial equivalence to predicate devices. It does not include clinical study data or information about AI/ML algorithms. Therefore, many of the requested categories related to clinical studies, expert-derived ground truth, and AI performance metrics cannot be populated from the provided text.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance
The document states that the R2P™ Destination Slender™ Guiding Sheath "met the predetermined acceptance criteria and results support a determination of substantial equivalence." However, the specific quantitative acceptance criteria for each test item are not explicitly listed in the provided tables, only the test items themselves and the reference standards used.
| Test Item | Reference Standard / Test Type | Reported Device Performance |
|---|---|---|
| Three-Point Bend | In-house standard | Met predetermined acceptance criteria |
| Hub Joint Strength | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Tubing Tensile Strength | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Tip Tensile Strength | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Ovalization | In-house standard | Met predetermined acceptance criteria |
| Lubricity and Durability | In-house standard | Met predetermined acceptance criteria |
| Uncoated Length | In-house standard | Met predetermined acceptance criteria |
| Corrosion Resistance | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Gauging | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013, ISO 594-1:1986 | Met predetermined acceptance criteria |
| Liquid Leakage of Luer under Pressure | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013, ISO 594-2:1998 | Met predetermined acceptance criteria |
| Air Leakage | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013, ISO 594-2:1998 | Met predetermined acceptance criteria |
| Separation Force | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013, ISO 594-2:1998 | Met predetermined acceptance criteria |
| Unscrewing Torque | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013, ISO 594-2:1998 | Met predetermined acceptance criteria |
| Ease of Assembly | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013, ISO 594-2:1998 | Met predetermined acceptance criteria |
| Resistance to Overriding | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Stress Cracking | ISO 594-2:1998, ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013, ISO 594-2:1998 | Met predetermined acceptance criteria |
| Simulated Use and Particulate | FDA Guidance Doc 1608 | Met predetermined acceptance criteria |
| Radiodetectability | ISO 11070:2014, ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Visual Inspection of External Surface | ISO 11070:2014, ISO 10555-1:2009, ISO 10555-1:2013 | Met predetermined acceptance criteria |
| Sheath Tip Inner Diameter | In-house standard | Met predetermined acceptance criteria |
| Sheath Hub Inner Diameter | In-house standard | Met predetermined acceptance criteria |
| Dilator Bump Inner Diameter | In-house standard | Met predetermined acceptance criteria |
| Outer Diameter Measurement | In-house standard | Met predetermined acceptance criteria |
| Effective Length | In-house standard | Met predetermined acceptance criteria |
| Coating Integrity | FDA Guidance Doc 1608 | Met predetermined acceptance criteria |
| Liquid Leakage of the Sheath | ISO 11070:2014 | Met predetermined acceptance criteria |
| Liquid Leakage Through Hemostasis Valve | ISO 11070:2014 | Met predetermined acceptance criteria |
| Torque Strength | FDA Guidance Doc 1608 | Met predetermined acceptance criteria |
| Dilator Tip Inner Diameter | In-house standard | Met predetermined acceptance criteria |
| Dilator Tip Penetration | In-house standard | Met predetermined acceptance criteria |
| Biocompatibility | ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity (Acute), Pyrogenicity, Hemocompatibility, Thrombogenicity, Complement Activation, Physiochemical Testing) | Demonstrated biocompatibility of the finished device |
| Sterilization | ISO 11135:2014 (Ethylene Oxide - SAL 10-6) | Sterility assured, residuals meet EN ISO 10993-7:2008 limits |
2. 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.
- Data Provenance: The document describes "non-clinical tests" and "performance testing" conducted. This refers to laboratory testing of the physical device, not patient data. Therefore, questions of country of origin or retrospective/prospective do not apply in the typical sense for clinical data. The manufacturer is Terumo Medical Corporation, located in the USA (Somerset, NJ and Elkton, MD).
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)
This question is not applicable. The testing described is non-clinical performance and biocompatibility testing of a physical medical device. "Ground truth" in the context of expert review for diagnostic AI software is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of clinical data, which is not part of this submission.
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. This submission is for a physical medical device (guiding sheath), not AI software, and no clinical studies, especially MRMC, were conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is not an algorithm or AI software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This question is not applicable in the context of clinical "ground truth." For the non-clinical performance tests, the "ground truth" would be established engineering specifications, industry standards (ISO), and in-house standards against which the device's physical properties are measured.
8. The sample size for the training set
This question is not applicable. This device does not involve a "training set" as it is a physical medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established
This question is not applicable. As explained above, there is no "training set" for this device.
§ 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).