(279 days)
The Medcomp® Vessel Dilators are designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery.
Medcomp®s Vessel Dilators are designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter into a vein or artery. The Vessel Dilators range in size from 4F to 24F with lengths of either 15cm (6.0 inches) or 20cm (8.0 inches), are either single or dual taper, and can use guidewire sizes .025", .035", and .038". The Medcomp® Vessel dilators are offered in two different tubing materials (polyethylene or polypropylene) attached to an HDPE hub. Vessel dilators are supplied sterile, for use in an aseptic technique and can only be used once.
The provided text is a 510(k) summary for the Medcomp Vessel Dilator, a medical device for percutaneous entry into a vessel to enlarge the opening for catheter placement. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study involving AI.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and training set details for an AI-powered device is not applicable or present in this document.
However, I can extract information related to the bench/performance data/non-clinical testing that demonstrates the device's substantial equivalence to its predicate and reference devices.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present specific acceptance criteria in a table format with corresponding reported performance values for an AI device. Instead, it states that "The proposed device, Vessel Dilators, meets the performance criteria of design verification as specified by ISO standards, guidance documents, and internal test protocols." It also mentions "The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, Medcomp® Vessel Dilator, is equivalent to the reference device, Cook® Dilator, preamendment."
The performance data mentioned includes:
- Compliance with ISO 11070:2014 (Sterile single-use intravascular introducers, dilators and guidewires)
- Compliance with ISO 10555-1:2013 (Sterile, single-use intravascular catheters - part 1: general requirements) - described as "Bench Testing"
- Compliance with AAMI / ANSI / ISO 10993-1:2009/(R) 2013 (Biological evaluation of medical devices -- Part 1: evaluation and testing within a risk management process) - described as "Biocompatibility"
- Compliance with ISO 11135:2014 (Sterilization of health-care products - ethylene oxide - requirements for the development, validation and routine control of a sterilization process for medical devices) - described as "Sterility"
- Compliance with AAMI / ANSI / ISO 10993-7:2008(R) 2012 (Biological evaluation of medical devices - part 7: ethylene oxide sterilization residuals) - described as "Sterility"
- Compliance with ISO 14971:2007 (Medical devices - application of risk management to medical devices)
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document describes non-clinical performance testing and biocompatibility studies, not a test set related to AI performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document is not about an AI device or a study requiring expert ground truth for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable.
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
This information is not applicable. The document is about a physical medical device (vessel dilator) and its substantial equivalence, not an AI-powered image analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing, the "ground truth" would be the established specifications and requirements outlined in the referenced ISO standards and internal test protocols. For biocompatibility, it's the biological response against predefined safety limits. This isn't "ground truth" in the context of an AI diagnostic device.
8. The sample size for the training set
This information is not applicable.
9. How the ground truth for the training set was established
This information is not applicable.
§ 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).