(74 days)
The Stonebuster Endoscopic System for Stone Removal (SESSR) Catheter for Endoscopy is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as bionsy forceps, cytology brushes, stone retrieval baskets, etc. during endoscopic procedures.
The indications for use of the catheter are in urological applications.
The Stonebuster Endoscopic System for Stone Removal (SESSR) Delivery Catheter is a sterile, single-use device comprised of one main component: a flexible triple lumen delivery catheter with three Luer-Lock delivery ports. This device is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as biopsy forceps, cytology brushes, stone retrieval baskets, etc. during endossopic procedures.
The SESSR Delivery Catheter is introduced into the desired anatomical location through the SESS sheath with a minimum working channel diameter of 4.3mm. The distal tip of the SESSR is straight or benefit at minimum of 6.5 mm from the distal tip of 10 degrees providing the physician with (when using visualization devices) a wider field of view.
The provided document (K083788) describes the Stonebuster Endoscopic System for Stone Removal (SESSR) and its substantial equivalence to predicate devices, but it does not contain details about acceptance criteria, a specific study proving device performance against those criteria, or clinical trial data as requested.
The basis for clearance is demonstrating substantial equivalence to legally marketed predicate devices, not through a study proving predefined acceptance criteria. Therefore, most of the requested fields cannot be directly answered from the provided text.
Here's a breakdown of what can be extracted and explanations for what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or report device performance against such criteria. The "performance" assessment is based on a comparison to predicate devices, focusing on design, materials, and intended use.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The primary "acceptance criterion" was demonstrating substantial equivalence to predicate devices based on design, materials, and intended use rather than specific quantitative performance metrics. | Substantially Equivalent to Bard's Dual Lumen Ureteral Catheter (K032521) and Boston Scientific Ureteral Access Sheath Set (UASS) (K022135) in terms of safety and effectiveness. The document states that "Any differences that have been identified between the devices are believed to be insignificant with respect to safety and effectiveness." |
2. Sample size used for the test set and the data provenance
Not applicable. This was a 510(k) submission based on substantial equivalence, not a clinical study with a "test set" in the context of AI/algorithm performance. The data provenance includes material specifications and sterilization validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" was established by experts for a test set in this 510(k) submission.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication was used.
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
Not applicable. This device is a medical instrument (catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI-related performance metrics are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument (catheter), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of an algorithm's ground truth. The "truth" for this submission was demonstrating that the device's design, materials, and intended use were comparable to existing, legally marketed predicate devices, and that it met relevant standards for sterility.
8. The sample size for the training set
Not applicable. No training set was used, as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
Summary of what the document does provide regarding device evaluation:
- Sterility Testing: A full cycle, single lot batch validation was completed to ensure sterility using ethylene oxide (EtO) gas, contracted with STS Life Sciences Division of Ethox. The reports of these results were included in Section 14.1 of the submission.
- Shelf Life: Currently set at six months, with ongoing monitoring of samples to ensure sterility and functionality, with plans to adjust the shelf life based on these observations.
- Bench Testing: The conclusion mentions "bench test results conducted with the Stonebuster Endoscopic System for Stone Removal (SESSR)." However, the document does not detail these bench tests, their methodologies, or specific quantitative results beyond stating they support substantial equivalence.
- Comparison to Predicate Devices: The primary "proof" of meeting safety and effectiveness is through a detailed comparison (Table 1) to two predicate devices:
- Boston Scientific Corporation UASS Ureteral Access Sheath (K022135)
- Bard Dual Lumen Ureteral Catheter (K032521)
This comparison covers indications for use, shaft material, hub material, sterility, single-use nature, and number of lumens. The sponsor argues that any differences are "insignificant with respect to safety and effectiveness."
In essence, for a traditional 510(k) such as this, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices, supported by foundational tests like sterility validation and general engineering/material specifications, rather than a clinical trial or algorithm performance study.
§ 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.