(62 days)
The Pinnacle® RO11 HiFlow 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 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 radiofrequency (RF) welding is used to fuse the two segments together. The band is completely encapsulated within the tubing wall.
The PINNACLE R/O II HiFlow 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 HiFlow 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 The Mini Guide Wire is then withdrawn from the vessel.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 slightly visible under fluoroscopy.
The provided text describes the regulatory clearance (K062446) for the Pinnacle® ROII HiFlow Introducer Sheath. This is a Special 510(k) submission, which means the device is largely similar to a previously cleared predicate device, with some modifications.
The acceptance criteria for this type of device are primarily focused on demonstrating substantial equivalence to the predicate device in terms of intended use, design, principle of operation/technology, materials, and performance.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a Special 510(k), the acceptance criteria are not explicitly numerical thresholds as one might see for a completely novel device. Instead, the criterion for performance is "substantially equivalent" to the predicate device (K003424).
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | Substantial equivalence to predicate device (K003424) in performance. | Equivalence shown through bench testing. |
| Biocompatibility | Compliance with ISO 10993 for "Externally Communicating Device, Circulating Blood, Prolonged Contact (24hrs to 30 days)". | Blood contacting materials were found to be biocompatible. |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 per ANSI/AAMI/ISO 11135-1994. | Sterilization conditions validated to provide a SAL of 10^-6. |
| Shelf Life | Stability and integrity for a specified duration. | Expiration dating for the device will be 30 months. |
| Physical Dimensions | Sheath Sizes: 6Fr, 7Fr, 8Fr | |
| Sheath Length: 4-110 cm | ||
| Dilator Length: 5-110 cm | ||
| Guide Wire OD: 0.021" - 0.038" | The device specifications meet these dimensions. (Implicitly, as they are listed as device specs rather than performance results against a target, but indicate the manufactured product conforms to these dimensions). |
2. Sample Size Used for the Test Set and Data Provenance
The primary performance evaluation was conducted through bench testing.
- Sample Size: The text does not explicitly state the sample size for the bench testing. In typical medical device bench testing, multiple units would be tested to ensure consistency and reliability, but the specific number is not provided.
- Data Provenance: The data comes from laboratory bench testing conducted by the manufacturer, Terumo Medical Corporation. There is no indication of country of origin of the data beyond the manufacturer's location (Elkton, MD, USA). The testing is prospective in the sense that it was conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of submission. The performance comparison is against a physically existing predicate device using objective bench testing parameters, not against expert interpretation of clinical data or images. "Ground truth" in this context refers to the documented performance characteristics of the predicate device and the objective results of the bench tests on the new device.
4. Adjudication Method for the Test Set
The concept of an adjudication method (e.g., 2+1, 3+1 consensus) is not applicable here. Adjudication methods are typically used in studies where human reviewers interpret data (e.g., medical images) and their agreement needs to be resolved to establish ground truth. For bench testing, the results are typically quantitative and objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers evaluating cases, often with and without AI assistance, to measure diagnostic performance. The Pinnacle® ROII HiFlow Introducer Sheath is a physical medical device (an introducer sheath), not an AI diagnostic tool, so such a study would be irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone performance study in the context of an algorithm or AI was not done. This device is a manual medical instrument.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence was the established performance characteristics and design specifications of the predicate device (Pinnacle® ROII, K003424). The bench testing data for the new device was compared directly against these known characteristics to affirm equivalence.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, there is no "training set" for this physical 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).