(78 days)
The Laser Fiber Delivery/Cleaning Catheter is used to protect the delivery of a laser ablation fiber, for periodic, intraoperative cleaning of charred, thermally degraded tissue from the laser fiber and for irrigation of the surgical site.
The Laser Fiber Delivery/Cleaning Catheter is used to protect the delivery of a laser ablation fiber, for periodic, intraoperative cleaning of charred, thermally degraded tissue from the laser fiber and for irrigation of the surgical site. The 5.7Fr Laser Fiber Delivery/Cleaning Catheter will accept laser fibers up to 1250 inch). The 8.0Fr Laser Fiber Delivery/Cleaning Catheter will accept laser fibers up to 1500 microns (0.060 inch). The naterials used in this device are polyethylene, nylon, acetal, polyvinylchloride and polycarbonate. Biocompatibility testing has been performed on the polyethylene and results show the materials to meet the requirements of these tests. The nylon, acetal, polyvinylchloride and polycarbonate do not come into contact with body tissue.
This document is a 510(k) Premarket Notification for a Laser Fiber Delivery/Cleaning Catheter from Cook Urological, Incorporated, dated May 14, 1996.
Based on the provided text, there is no information available about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like sensitivity, specificity, or other quantitative measures.
The document discusses substantial equivalence to predicate devices based on:
- Indications for use
- Design
- Construction
- Materials equivalence
It also mentions biocompatibility testing on polyethylene, stating that "results show the materials to meet the requirements of these tests." However, it does not detail:
- The specific acceptance criteria for these biocompatibility tests.
- The study design, sample sizes, or outcomes of those biocompatibility tests.
Therefore, for all the specific questions you've asked (1-9), the answer based solely on this document is that the information is not provided or not applicable as the document describes a traditional medical device (catheter) and not an AI/ML-driven device with performance metrics typically associated with your questions.
Here's why each of your points cannot be addressed:
- A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence to predicate devices rather than quantitative performance metrics.
- Sample size used for the test set and the data provenance: Not applicable/Not provided. There's no performance "test set" described for the device's function.
- Number of experts used to establish the ground truth... and qualifications: Not applicable/Not provided. Ground truth in the context of AI/ML is not relevant here.
- Adjudication method: Not applicable/Not provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating human performance, often with AI assistance, which is not relevant to this device's description.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) summary focuses on the physical characteristics, materials, and intended use of a conventional medical device (catheter) and its substantial equivalence to existing devices, not on performance metrics typically associated with AI or diagnostic systems.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.