(30 days)
The Pinnacle® ROII Introducer Sheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or 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 after removal of a catheter.
The PINNACLE R/O II Introducer Sheath is comprised of an introducer sheath and a dilator. The introducer sheath has a radiopaque marker that is highly visible under fluoroscopy. The marker is a band that is located approximately 5 mm from the sheath's distal tip. The introducer sheath consists of 2 pieces of ETFE tubing -- a long segment and a short tip segment. The band is sandwiched between the two segments and fused together. The band is completely encapsulated within the tubing wall. The PINNACLE R/O II Introducer Sheath is used to facilitate placement of a catheter through the skin into a vein or artery. A Mini Guide Wire (with Inserter) may be included with the device. The Inserter does not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer. The Mini Guide Wire is inserted through a cannula placed in the patient's blood vessel. The PINNACLE R/O II Introducer Sheath 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 The Mini Guide Wire is then withdrawn from the vessel.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 Introducer Sheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted. The RADIFOCUS Obturator is an accessory device which creates an occlusion when inserted into the Sheath. The Obturator also provides support to the indwelling Sheath after the catheter is removed. The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.
The KOR2847 document describes the "Pinnacle® ROII Introducer Sheath," a medical device designed to facilitate placing catheters into veins or arteries.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the performance of the Pinnacle® ROII Introducer Sheath is substantially equivalent to the performance of its predicate device (K003424). It doesn't list specific quantitative acceptance criteria for this device (like tensile strength values or flow rates) but rather relies on the equivalence to the predicate.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Facilitate placing a catheter through the skin into a vein or artery. | The device has the same intended use as the predicate device (K003424). |
| Design Equivalence: Similar design, materials, and components. | Uses the same materials and design as the predicate device. |
| Principle of Operation / Technology Equivalence: Manual operation. | Operates manually, same as the predicate. |
| Material Biocompatibility: Non-toxic and safe for blood contact. | Blood contacting materials were tested and found to be biocompatible, following FDA and ISO 10993 guidelines. |
| Sterility: Achieve a certain sterility assurance level. | Sterilization conditions validated to achieve a Sterility Assurance Level of 10⁻⁶ (ANSI/AAMI/ISO 11135-1994). |
| Shelf Life/Expiration Dating: Stable over a specified period. | Expiration dating for 30 months. |
| Physical Dimensions/Specifications (Matching Predicate) | Sheath Sizes: 4Fr., 5Fr., 9Fr. (nominal lumen sizes: 0.055", 0.068", 0.122") |
| Sheath Length: 4-110 cm | |
| Dilator Length: 5-110 cm | |
| Guide Wire OD: 0.021"-0.038" | |
| Overall Performance Equivalence: No new issues of safety and effectiveness. | Performance shown to be substantially equivalent to the predicate device (K003424) through bench testing. Differences do not raise any issues of safety or effectiveness. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample size used for the bench testing.
- Data Provenance: The testing was conducted as "bench testing" by the manufacturer, Terumo Medical Corporation. The country of origin of this data is not specified, but the manufacturer is based in Elkton, MD, USA. The testing is considered prospective as it's part of the pre-market notification process for the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study involved bench testing rather than clinical performance evaluation that would typically involve expert assessment against ground truth. The "ground truth" here is adherence to engineering specifications and performance parameters set to achieve substantial equivalence.
4. Adjudication method for the test set:
This information is not provided. As it was bench testing, there was likely no "adjudication" in the sense of expert consensus on clinical outcomes.
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:
No. This study is not a multi-reader multi-case comparative effectiveness study. It's a 510(k) submission for a non-AI medical device, focusing on substantial equivalence to a predicate device through bench testing. There is no AI component involved.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This device is a manual introducer sheath, not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this submission is based on engineering specifications, regulatory standards (e.g., ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11135-1994 for sterilization), and the established performance characteristics of the predicate device (K003424). The testing aims to demonstrate that the new device meets these specifications and performs equivalently to the predicate.
8. The sample size for the training set:
Not applicable. This submission is for a physical medical device (introducer sheath), not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, no training set is relevant 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).