(204 days)
The BeamCath is a positioning device used with external beam conformal radiation therapy for visualizing the prostate position during treatment of prostate cancer. The BeamCath is introduced into the urethra as is a sterile urological catheter and is retained in place by inflating the balloon tip. Its radiopaque markers aid in radiographic visualization of the prostate position for planning, simulation and treatment of prostate cancer using dose escalation radiotherapy.
The BeamCath is a positioning device used with external beam conformal radiation therapy for visualizing the prostate position during treatment of prostate cancer. The BearnCath combines the function of a radiographic positioning device with the configuration of a urological Foley catheter. The BeamCath configuration and material composition are similar to urological catheters with a balloon retention mechanism. The device is disposable, sterile and intended for single use. The BeamCath is approximately 430 mm in length and 14 French diameter with a balloon size of 10 ml. The device consists of a PVC ficitiation in 1 1 renon alaxites in instillation of contrast into the bladder and air-inflation lumen for balloon function; PVC tubing with tantalum radiopaque markers; and a natural latex balloon retention mechanism.
The BeamCath is introduced into the urethra as is a sterile urological catheter and is retained in place by inflating the balloon tip. Its radiopaque markers aid in radiographic visualization of the prostate position for planning, simulation and treatment of prostate cancer using dose escalation radiotherapy. Precise positioning of the prostate allows for more precise dose radiation treatment without excessive side effects to surrounding tissue.
The provided text describes the BeamCath, a urological catheter with radiopaque markers intended for prostate positioning during external beam radiation therapy for prostate cancer. However, the document does not contain specific acceptance criteria, detailed results of a study proving those criteria were met, or most of the information requested in your prompt regarding study design details (sample sizes, expert qualifications, ground truth methods, MRMC studies, etc.).
Instead, the document states:
- "Device performance tests have been conducted and successfully completed."
- "In addition, the Device [BeamCath] has been successfully used in several clinical studies as a prostate positioning aid during dose-escalation radiotherapy."
- "Based upon performance and clinical testing and a comparison to the predicate devices, it is the conclusion of Beampoint that the BeamCath is substantially equivalent to devices already on the marked (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness."
This is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to existing predicate devices rather than providing a detailed report of clinical trials and specific performance metrics and acceptance criteria. For devices cleared through the 510(k) pathway, the primary proof of safety and effectiveness often comes from demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness.
Therefore, many of the specific details you requested cannot be extracted from this document because they are generally not included in a 510(k) summary.
Based on the provided text, here is what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific numeric acceptance criteria for device performance (e.g., accuracy of positioning, displacement limits, or diagnostic performance metrics) are provided in this summary. The document generally states "Device performance tests have been conducted and successfully completed," implying that the device met internal or regulatory performance specifications, but these are not enumerated.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): Not specified. The document mentions "several clinical studies," but no sample sizes for these studies are provided.
- Data Provenance: "Several clinical studies" are mentioned, implying clinical data. The country of origin is not specified, but the applicant (Beampoint AB) is from Sweden. The studies appear to be prospective, as the device was "successfully used" in them.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not specified. The document does not describe how ground truth was established for the clinical studies.
4. Adjudication Method for the Test Set:
Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
Not specified. The document focuses on the device's function as a positioning aid and its substantial equivalence to other positioning systems and catheters. It does not present data from studies comparing human readers with and without AI assistance (as the BeamCath is a physical positioning device, not an AI diagnostic tool).
6. If a Standalone (Algorithm Only) Performance Study Was Done:
Not applicable. The BeamCath is a physical medical device (catheter) with radiopaque markers, not an algorithm. Its "standalone" performance would relate to its physical properties and ability to be visualized, which were covered by "device performance tests."
7. The Type of Ground Truth Used:
Not specified. For a positioning device, ground truth might involve highly accurate imaging modalities or physical measurements from a phantom. The document only mentions the device aids in "radiographic visualization of the prostate position."
8. The Sample Size for the Training Set:
Not applicable or not specified. As a physical device, there isn't a "training set" in the sense of machine learning algorithms. If "training set" refers to data used to refine the device's design or properties, that information is not provided.
9. How the Ground Truth for the Training Set Was Established:
Not applicable or not specified.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. 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 § 876.9.