(73 days)
The Coyote MONORAIL PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Sterling Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
The Sterling SL Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Ultra-soft SV Balloon Dilatation Catheter is recommended for the Percutaneous Transluminal Angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Coyote™ Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheters (Coyote MR) are high performance balloon catheters for peripheral vascular indications. The devices feature an ultra low profile, semi-compliant balloon combined with a low profile tip. The catheter is compatible with 0.014 in (0.36 mm) guidewires.
The Sterling™ Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter (Sterling MR) is a Monorail brand rapid exchange catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in / 0.018 in (.36 mm / .46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures.
The Sterling™ SL Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter (Sterling SL) is high performance balloon catheter for peripheral vascular indications featuring a low profile, semi-compliant balloon combined with a low profile tip. They are a line extension to the existing Sterling catheters and include smaller diameter and longer length balloons. The catheters have a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014" (0.36 mm) or 0.018" (0.46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated.
The Ultra-Soft SV™ Monorail™ Balloon Dilatation Catheter 0.018 is a sterile, single use, Monorail catheter with a semi-compliant balloon near the distal tip which inflates to a known diameter and length at a specific pressure. The catheter consists of a double lumen at the distal end and a single lumen catheter at the proximal end. The 0.018 in. guide wire compatible balloon catheter is available in diameters of 4.0 - 7.0 mm in 1.5 and 2.0 cm balloon lengths.
The provided text describes several medical devices, all Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheters from Boston Scientific Corporation. The submission K162350 seeks to declare these devices substantially equivalent to already cleared predicate devices.
Acceptance Criteria and Device Performance (Summary for all listed devices):
The core of the acceptance criteria and device performance evaluation for all listed devices is based on demonstrating substantial equivalence to their respective predicate devices. This is achieved through non-clinical bench and first-article testing.
| Acceptance Criteria Category | Description | Reported Device Performance (Summary) |
|---|---|---|
| Functional Equivalence | The device must function comparably to its predicate device for its intended use. This includes performance characteristics like burst pressure, inflation/deflation times, guidewire compatibility, tip entry profile, etc. | "Bench and first article testing were performed to support a determination of substantial equivalence." (Repeated for all devices). The testing assures conformance to requirements for intended use and did not raise new safety or performance issues. |
| Material Equivalence | The materials used in the device must be safe and perform comparably to the predicate device. | The devices have the "same [...] materials [...] as the applicable predicate device." |
| Design Equivalence | The design of the device, aside from specific modifications being justified, should be substantially similar to the predicate device. | The devices have the "same [...] design (with the exception of the corewire design) [...] as the applicable predicate device." The modified corewire was the specific change being evaluated. |
| Sterilization Equivalence | The sterilization method used for the device must be effective and comparable to the predicate device. | The devices have the "same [...] sterilization method [...] as the applicable predicate device." |
| Packaging Equivalence | The packaging must maintain sterility and protect the device adequately, comparable to the predicate device's packaging. | The devices have the "same [...] packaging materials as the applicable predicate device." |
| Biocompatibility | The materials must be biocompatible. (While not explicitly listed as a test, this is an inherent requirement for medical devices and would be covered under material safety and predicate device comparison). This is implied by the "no new safety or performance issues" statement. | "No new safety or performance issues were raised during the device testing." (Implies biocompatibility was considered and met). |
| Safety | No new safety concerns should be introduced by the device or its modifications. | "No new safety or performance issues were raised during the device testing." |
| Performance | The device's overall performance for its intended use should be equivalent to the predicate. | "The results of these tests provide reasonable assurance that the proposed device with the modified corewire has been designed and tested to assure conformance to the requirements for its intended use." |
Study Details:
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Sample sizes used for the test set and the data provenance:
The document explicitly states that "Bench and first article testing were performed". This indicates that physical samples of the devices were manufactured and subjected to various tests. However, the exact sample sizes (e.g., number of catheters tested for burst pressure, number of inflation/deflation cycles) are not provided in this summary. The data provenance is internal to Boston Scientific Corporation ("Made in USA" is implied by manufacturing and sterilization facilities in the US, but not explicitly stated for the testing data itself). The studies were retrospective in the sense that they were conducted on produced devices to demonstrate equivalence prior to broader market release with the modification. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This submission is for a medical device (catheter) and relies on non-clinical bench testing and first article testing. It is not a clinical study involving human patients or the interpretation of medical images. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense (e.g., radiologists interpreting images) is not applicable. The "ground truth" for these tests would be established by engineering specifications, regulatory standards, and performance characteristics of the predicate device. The experts involved would be engineers, QA/QC personnel, and regulatory affairs specialists who designed, executed, and reviewed these non-clinical tests. Their specific numbers and detailed qualifications are not provided in this summary. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As this is non-clinical bench and first-article testing, the concept of an adjudication method used in clinical trials or diagnostic accuracy studies (e.g., for resolving discrepancies in expert interpretations) is not applicable. Test results are typically compared against pre-defined engineering specifications and performance data of the predicate device. Review and approval of the test results would involve internal quality and regulatory processes, but not "adjudication" in the clinical sense. -
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 MRMC comparative effectiveness study was done. This submission is for a physical medical device (a catheter), not an AI-powered diagnostic tool, and therefore does not involve human readers interpreting cases or AI assistance. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No standalone algorithm performance study was done. This submission is for a physical medical device (a catheter), not an algorithm or software. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this submission is based on:- Engineering specifications and design requirements for the device.
- Performance data and characteristics of the predicate devices, which have already demonstrated safety and effectiveness.
- Relevant industry standards and regulatory guidance for similar medical devices.
- The absence of new safety or performance issues during the "bench and first article testing."
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The sample size for the training set:
Not applicable. This submission is for a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, which are not involved here. -
How the ground truth for the training set was established:
Not applicable. As a "training set" is not relevant for this device, how its ground truth would be established is also not applicable.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).