(116 days)
The ROCAMED RocaUS Platinum is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.
The ROCAMED RocaUS Platinum is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopague and have hydrophilic coating. This device is sold in two sizes, 10/12 and 12/14 FR.
The provided documentation is a 510(k) summary for the ROCAMED RocaUS Platinum, a ureteral access sheath. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria in the same way a new AI/ML-driven diagnostic device might.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable or not present in this document because it is not a clinical study report for a diagnostic or treatment outcome device. The "performance data" referred to in this document relates to physical and functional testing, not clinical performance measures like accuracy or sensitivity.
Here's an attempt to fill in the table and address the questions based on the provided text, indicating where information is not applicable (N/A) or not provided (NP):
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a medical device (ureteral access sheath) demonstrating substantial equivalence, the "acceptance criteria" are primarily met through comparison to predicate devices across technological characteristics and intended use, supported by physical and functional testing. There are no explicit performance metrics like sensitivity, specificity, or accuracy derived from a clinical study with a test set that would have numerical acceptance criteria.
| Acceptance Criteria Category | Reported Device Performance (ROCAMED RocaUS Platinum) |
|---|---|
| Intended Use | Conduit for passage of endoscopes and other urological devices for performing ureteroscopy procedures. Dual working lumen dilator allows guidewire and fluid insertion. |
| Technological Characteristics | - Disposable, sterile, X-ray opaque, coil reinforced, atraumatic tip, tapered dilator, radiopaque marks, hydrophilic coating, injection of contrast media, proximal end funnel. |
- 2 lumens
- Dilator Material: LDPE+BaSO4
- Sheath Material: Pebax-SST-PTFE
- Fr Size: 10/12, 12/14
- Length: 35 cm
- Guidewire compatibility: 0.032", 0.035" |
| Safety | Implied by substantial equivalence to legally marketed predicate devices and successful physical/functional testing. Changes in dilator material (LDPE instead of PTFE) stated to "ease insertion into the patient and reduce trauma." |
| Performance (Functional) | Results of physical and functional testing support substantial equivalence. (Specific reported performance values for these tests are not detailed in this summary). |
| Materials | Materials chosen are considered substantially equivalent or improved (e.g., LDPE for dilator) compared to predicate devices, based on physical and functional testing. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This document refers to physical and functional testing, not a clinical test set of patient data. The specifics of samples used for these engineering tests (e.g., number of devices tested for tensile strength or burst pressure) are not provided in this summary.
- Data Provenance: Not applicable for clinical test data. The physical and functional testing would have been conducted by Promepla SAM.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for diagnostic device performance (e.g., pathology, expert consensus on images) is not relevant for this type of medical device submission, which relies on physical and mechanical properties and comparison to predicates.
4. Adjudication method for the test set
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
Not applicable. This device is not an AI-assisted diagnostic tool and therefore did not undergo an MRMC study related to AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of clinical "ground truth." The "ground truth" for this device's performance would be against engineering specifications and predicate device characteristics, verified through physical and functional testing.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm.
§ 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.