(58 days)
RAIN Sheath™ Transradial is indicated to facilitate placing a catheter through the skin into a radial artery.
RAIN Sheath™ Transradial is indicated to facilitate placing a catheter through the skin into a radial artery. Each RAIN Sheath™ device consists of a sheath introducer, a vessel dilator (0.021" guidewire compatible), an IV cannula needle and/or a bare access needle, and a 45 cm 0.021" guidewire (either bare or hydrophilic). The device configurations with the hydrophilic guidewire contain only the IV cannula needle whereas device configurations with the bare wire contain only the bare needle. The sheath introducer has a lubricious hydrophilic coating, a smooth shoulder transition to the dilator and low-profile outer diameters (OD). To provide an atraumatic transition between the dilator tip and the 0.021" mini guide wire, the RAIN Sheath™ dilator is tapered at the distal end and the inner diameter (ID) of the dilator has been optimized. The hub is overmolded to the dilator and includes a locking mechanism between the hub of the vessel dilator and the hub of the sheath cannula to facilitate insertion of the product while preventing the vessel dilator from backing out of the cannula. RAIN Sheath™ device is available in sixteen (16) product configurations which differ based on French size and length, and the specific wire and needle included in the system, as indicated in the table below. It is offered in French sizes of 4F, 5F, 6F and 7F, with lengths of 10 cm and 16 cm. RAIN Sheath™ device is a single-use sterile device, sterilized by ethylene oxide.
This document pertains to a 510(k) premarket notification for the RAIN Sheath™ Transradial device. As such, it does not describe a study involving device performance against predefined acceptance criteria in the manner an AI/ML clinical study would. The document focuses on demonstrating substantial equivalence to a predicate device, not on proving de novo performance criteria in a clinical setting with human subjects.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" (especially those related to AI/ML or clinical efficacy studies) are not applicable or cannot be extracted from this regulatory document.
However, I can extract information regarding the bench testing which serves as the "study" demonstrating the device's technical specifications and safety through comparison with standards and for substantial equivalence.
Here's a breakdown of what can be inferred or directly stated from the provided text, and where specific requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly defined by the referenced ISO standards and internal test methods. The "reported device performance" is the statement that the testing was "successfully performed" and yielded "passing results."
| Acceptance Criteria Category (Implied) | Specific Tests / Standards | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1:2009/Cor 1:2010 | "biocompatible for its intended use" (based on cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility) |
| Sterilization | ISO 11135:2014 | "Sterility Assurance Level (SAL) of 10-6" (validated per standard) |
| Residuals (EO & ECH) | ISO 10993-7:2008 | "meet requirements for limited exposure devices" (levels will not exceed 4 mg EO /device or 9 mg ECH/device) |
| Sheath Introducer Functionality | ISO 11070:2014, USP 788, internal test methods | "successfully performed" / "passing results" |
| Dilator Functionality | ISO 11070:2014, internal test methods | "successfully performed" / "passing results" |
| IV Cannula Needle Functionality | ISO 10555-1:2013, ISO 10555-5:2013 | "successfully performed" / "passing results" |
| Stainless Steel Needle Functionality | ISO 11070:2014 | "successfully performed" / "passing results" |
| Hydrophilic Coated Wire Functionality | ISO 11070:2014 | "successfully performed" / "passing results" |
| Stainless Steel Wire Functionality | ISO 11070:2014 | "successfully performed" / "passing results" |
| Packaging integrity | ISO 11607-1:2009/A1:2014, ISO 11607-2:2006 | "successfully performed" / "passing results" |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated in the document. For bench testing, sample sizes are typically determined by statistical rationale for each specific test (e.g., number of units tested for tensile strength, burst pressure, etc.).
- Data Provenance: The tests were conducted internally by Cordis Corporation or outsourced to testing facilities following international standards (ISO, USP) and FDA guidance for medical device evaluation. This does not represent patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. For this type of device (catheter introducer) and submission (510(k) for substantial equivalence based on bench testing), "ground truth" established by human experts in the context of diagnostic interpretation or clinical outcomes is not a component of the evaluation. The "ground truth" is defined by the objective performance criteria set by the engineering and material standards.
4. Adjudication method for the test set
This is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used in clinical studies, often for diagnostic accuracy, where there is subjective interpretation by experts. Bench testing results are typically objective measurements against predefined limits.
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 is not applicable. This document is for a physical medical device (catheter introducer), not an AI/ML diagnostic or assistive software. No human reader or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. As above, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" is based on objective measurements against established engineering and material standards (e.g., ISO, USP) and internal test methods. For example, a "ground truth" for tensile strength would be the measured force at which the material breaks, compared to a predefined acceptance limit according to a standard.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/ML algorithm.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set."
§ 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).