(355 days)
The EndoVascular Instrument Peripheral Vascular Dilator is intended to be used to enlarge or calibrate a vessel as an adjunctive procedure to other interventional procedures such as catheterization.
The vascular dilator is a catheter with smooth stainless steel tip(s) that enlarges the lumen of the artery and/or measures the caliber via the tip of the vessel. Access is either percutaneous (interventional through a sheath) or cut down (surgical, through an ateriotomy) procedure. The vascular dilator is used over a guidewire and has tip(s) of increasing size to enlarge the lumen with each repeated pass or to measure the vessel size. Only an appropriately trained physician using sterile techniques uses the sterile device.
Acceptance Criteria and Device Performance Study for EndoVascular Instruments Inc.'s Peripheral Vascular Dilator
1. Table of Acceptance Criteria and Reported Device Performance
The provided documentation does not explicitly detail a list of quantitative "acceptance criteria" in the format of a modern performance study. Instead, the evaluation focuses on demonstrating "substantial equivalence" to predicate devices through qualitative and comparative assessments of physical characteristics and performance.
However, based on the submission, we can infer the implied acceptance criteria to be alignment with the performance and characteristics of the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Physical Characteristics: | |
| Materials | EVI's Peripheral Vascular Dilator is substantially equivalent to Pilling Weck's Amato Dilator in materials. |
| Construction | EVI's Peripheral Vascular Dilator is substantially equivalent to Pilling Weck's Amato Dilator in construction. |
| Diameter and Length Dimensions | EVI's Peripheral Vascular Dilator is substantially equivalent to Pilling Weck's Amato Dilator in diameter and length dimensions. |
| Configuration | EVI's Peripheral Vascular Dilator is substantially equivalent to Pilling Weck's Amato Dilator in configuration. |
| Strength of Joints/Connections | The strength of the Vascular Dilator's joints and connections is reported to be equal to or greater than the Amato dilator. |
| Intended Use/Performance: | |
| Functionality (Vessel Dilation) | EVI's Vascular Dilator is substantially equivalent to Cook Inc.'s Dottering Set in intended use ("Both dilators are used to dilate atheromas and to calibrate vessels."). "Results of tests indicated that the Vascular Dilator effectively enlarged the vessels." This implies successful dilation of vessels as a primary functional criterion. |
| Safety & Efficacy | "posed no new safety or efficacy issue in any of the tests." This serves as a critical, albeit qualitative, acceptance criterion for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not specify a sample size for any test set. The submission focuses on a comparative analysis of the device's characteristics and performance against predicate devices. The phrase "Results of tests indicated that the Vascular Dilator effectively enlarged the vessels and posed no new safety or efficacy issue in any of the tests" suggests that some testing was performed, but the details of these tests (e.g., number of units tested, conditions, or methodology) are not provided.
The data provenance is internal to the manufacturer, EndoVascular Instruments Inc., and appears to be based on retrospective comparison to existing predicate devices and internal testing to confirm performance and safety. There is no mention of external or geographically specific data provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The documentation does not mention the use of external experts to establish ground truth for a test set. The assessment of substantial equivalence appears to be based on the manufacturer's internal comparisons and testing, as reviewed by the FDA. There is no indication of a panel of experts or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
Since there is no mention of a formal test set with ground truth established by experts, an adjudication method is not applicable and not described in the provided document. The primary assessment method is a comparison against predicate devices by the manufacturer as part of the 510(k) submission process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. This type of study, evaluating human reader performance with and without AI assistance, is not relevant to this device submission, which is for a physical medical instrument (a vascular dilator) rather than a diagnostic imaging or AI-driven decision support system.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study of an algorithm was mentioned or performed. This device is a physical instrument, not an algorithm or software. Therefore, an algorithm-only performance study is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this submission is implicitly established by the performance and characteristics of the legally marketed predicate devices (Cook, Inc.'s Dotter Transluminal Dilator and Pilling Weck's Amato Dilators). The new device is deemed acceptable because it is substantially equivalent to these existing, approved devices. The "results of tests" performed internally by the manufacturer served to confirm that the device effectively enlarged vessels and posed no new safety or efficacy issues, aligning with the expected performance of the predicate devices.
8. Sample Size for the Training Set
No training set is applicable or mentioned. This submission is for a physical medical device, not a machine learning model or algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, the establishment of ground truth for a training set is not applicable to this device submission.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).