(7 days)
The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.
The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery.
The Radifocus Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery, including but not limited to the radial artery, after removal of a catheter.
The Glidesheath is comprised of an introducer sheath and a dilator. The Glidesheath is coated with a hydrophilic coating to reduce the frictional resistance of the sheath when inserting or removing the sheath from the patient's blood vessel. The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.
The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery. The Mini Guide Wire is inserted through a cannula placed in the patient's blood vessel. The Glidesheath is then inserted over the Mini Guide Wire and into the blood vessel. The Mini Guide Wire is then withdrawn from the vessel. The Dilator maintains the integrity of the Sheath and dilates the blood vessel while the Glidesheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted.
The Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery, including but not limited to the radial artery, after removal of a catheter. The Obturator is sold separately.
The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.
Accessories to the Glidesheath are the mini guide wire, Surflo IV catheter, Syringe, and Scalpel, and the RADIFOCUS Obturator. Depending on the product code, these accessories may or may not be contained within the kit. All of the accessories are packaged with the Glidesheath in a pouch prior to sterilization.
The provided text is a 510(k) summary for the Glidesheath, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with performance metrics in the way, for example, an AI/ML algorithm would be evaluated for accuracy.
Therefore, many of the requested categories (e.g., sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth) are not applicable to this type of device submission based on the provided information.
Here's an analysis based on the information provided, highlighting what is included and what is not:
Acceptance Criteria and Device Performance Summary
Since this is a 510(k) submission for substantial equivalence for a medical device (introducer sheath, dilator, guide wire, obturator), the "acceptance criteria" and "device performance" are primarily focused on meeting regulatory requirements for safety and effectiveness through comparison to already marketed predicate devices, rather than quantitative performance metrics like sensitivity, specificity, or accuracy for a diagnostic or AI device.
The "study" that proves the device meets the "acceptance criteria" is essentially the comparison to predicate devices and adherence to relevant standards/tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Implied from 510(k) goals) | Reported Device Performance (as demonstrated by comparison/testing) |
|---|---|---|
| Intended Use | Substantially equivalent to predicate devices (Glidesheath K062858, Cordis Avanti K962746) | Used to facilitate catheter placement into veins/arteries, including radial artery. Mini Guide Wire and Obturator as accessories. |
| Design / Materials | No new issues of safety and effectiveness compared to predicate devices | Differences in materials between modified and predicate device raise no new safety/effectiveness issues. Includes hydrophilic coating. |
| Biological Safety (Biocompatibility) | Biocompatible for prolonged contact (24 hrs to 30 days) with circulating blood. | Blood contacting materials tested per ISO 10993-1, results demonstrate biocompatibility. |
| Sterilization | Sterilized to a Sterility Assurance Level (SAL) of 10^-6. | Validated according to EN ISO 11135-1, device sterilized to SAL of 10^-6. |
| Risk Management | Conducted according to EN ISO 14971. | A risk/hazard analysis was conducted according to EN ISO 14971. |
| Manufacturing Controls | Includes visual, functional, dimensional, and sterility tests. | Manufacturing controls include visual, functional, dimensional and sterility tests. |
| Overall Safety and Effectiveness (SE) | Substantially equivalent to predicate devices. | "Differences between the devices do not raise any significant issues of safety or effectiveness." |
| Physical Specifications | Meet specified ranges for sheath sizes, lengths, guide wire OD, and Surflo IV catheter. | Ranges: Sheath 4, 5, 6 Fr; Sheath Length 10-25 cm; Dilator Length 15.5-30.5 cm; Guide Wire OD 0.021"-0.038", 10-180cm; Surflo IV Catheter 16G-22G, 1"-2.5" length. |
2. Sample Size used for the test set and the data provenance
- Not Applicable. This is a 510(k) submission for a physical medical device, not a data-driven device (like an AI/ML algorithm) that typically relies on a "test set" in the conventional sense of machine learning. The "testing" involves biocompatibility tests, sterilization validations, and performance characteristic determinations based on engineering principles and comparisons to predicate devices, not data sets of patient information.
- The provenance of data is not specified in terms of country of origin or retrospective/prospective, as typical for clinical data studies. The testing is laboratory and bench-top oriented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth in the context of diagnostic performance metrics is not established for this type of device. The verification and validation activities are based on engineering standards, material science, and regulatory compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or expert consensus for ground truth. This is not the type of evaluation described.
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
- Not Applicable. An MRMC study is relevant for diagnostic imaging devices, particularly with AI assistance. This device is an introducer sheath for facilitating catheter placement, not an imaging or diagnostic interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable in the sense of clinical ground truth for diagnostic accuracy. For physical device testing, "ground truth" equates to established engineering specifications, validated test methods (e.g., ISO standards for biocompatibility and sterilization), and objective measurements.
8. The sample size for the training set
- Not Applicable. This device does not involve a "training set" like an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not Applicable. This device does not involve a "training set" or "ground truth" in the context of data-driven learning.
§ 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).