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510(k) Data Aggregation
(319 days)
The Cope Nephroureterostomy Stent is delivered percutaneously and is intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent. The Cope Nephroureterostomy Stents are not intended to remain indwelling more than 90 days.
The Amplatz Ureteral Stent Set is delivered percutaneously and is intended to establish drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally. The Amplatz Ureteral Stents are not intended to remain indwelling more than 180 days.
The Cope Nephroureterostomy Stent is an internal/external draining stent consisting of double pigtails (proximal pigtail in the renal pelvis and distal pigtail in the bladder). The Cope nephroureterostomy stent is designed with a Mac-Loc locking mechanism. This locking mechanism consists of an ABS body, stainless steel pin, and valox lever with a 30 to 40 cm nylon filament (suture). The nylon monofilament runs between the Mac Loc cap and extends through a 6.5 cm segment in the stent shaft corresponding with the positioning of the proximal loop and enters and exits through two puncture holes in the stent. The Cope Nephroureterostomy stents are manufactured using polyether-urethane material and are designed with sideports. The stents are available in diameters ranging from 8.5 Fr to 14.0 Fr and working lengths ranging from 10 to 32 cm. The device includes a stiffening cannula that aids in the placement of the stent and also includes a catheter securement device. All proposed devices are supplied sterile for single use.
The Amplatz Ureteral Stent Set is an internal draining stent that consists of double pigtails, with the proximal pigtail forming in the renal pelvis and the distal pigtail forming in the bladder. The set also includes a stent positioner with stent introducer catheter and loading stylet. The Amplatz Stent is composed of polyether-urethane material and designed with sideports that are located on the proximal and distal pigtails. The stents are available in diameters of 8.5 Fr or 10.2 Fr and length ranging from 10 to 30 cm. The distal end of the Amplatz Stent has a hydrophilic coating. A suture is looped through the most proximal drainage hole which allows for stent adjustment or removal during placement, and the suture is removed once placement is complete. All proposed devices are supplied sterile for single use.
The provided text describes pre-market notification (510(k)) for two medical devices: the Cope Nephroureterostomy Stent and the Amplatz Ureteral Stent Set. This type of submission focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than conducting new clinical trials to establish novel performance criteria. Therefore, the information provided does not contain a study that "proves the device meets the acceptance criteria" in the sense of a clinical trial with specific performance metrics like sensitivity, specificity, or reader improvement.
Instead, the document details technological characteristics testing to ensure reliable design and performance, and demonstrates that these characteristics are substantially equivalent to predicate devices. The "acceptance criteria" here refer to the pre-determined thresholds for these engineering and material tests.
Here's the breakdown of the information as requested, largely based on the technological characteristics section:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a single table directly mapping specific acceptance criteria to reported device performance outcomes for a clinical or diagnostic measure (like sensitivity/specificity). Instead, it lists various engineering and material tests with a general statement that "all pre-determined acceptance criteria were met."
| Test Category | Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|---|
| Dimensional and Compatibility | Adequate for clinical use (based on JIS T 3270) | Dimensions and component compatibility was adequate for clinical use. |
| Tensile Testing | Peak load value ≥ predetermined acceptance criterion (based on BS EN 1617) | Peak load value was greater than or equal to the predetermined acceptance criterion. |
| Curl Retention Strength Testing | Retention force ≥ predetermined acceptance criterion (based on ASTM F 1828-97) | Retention force greater than or equal to the predetermined acceptance criterion. |
| Liquid leakage (Nephroureterostomy stent) | Connection should not leak (based on BS EN 1615) | The connection did not leak. |
| Flow rate Testing | Minimum average flow rate ≥ predetermined acceptance criterion (based on BS EN 1618) | Minimum average flow rate greater than or equal to the predetermined acceptance criterion. |
| Radiopacity Testing | Radiopacity non-inferior to selected comparative device (based on ASTM F6540-12) | Radiopacity of the Nephroureterostomy Stent was determined to be noninferior to the radiopacity of the selected comparative device. |
| Kink Radius Testing | (For characterization only – no specific acceptance criterion stated) | Testing was performed for characterization only. |
| Lubricity Testing | Met predetermined peak force acceptance criterion | Testing met predetermined peak force acceptance criterion. |
| MRI Testing | MR Conditional (based on ASTM F2503) | The Cope Nephroureterostomy Stent and the Amplatz Ureteral Stent Set are MR Conditional. |
| Biocompatibility Testing | Biocompatible (based on ISO 10993-1 and FDA guidance for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, subchronic toxicity, material mediated pyrogenicity, implantation, and genotoxicity) | Testing demonstrated that the devices are biocompatible. |
2. Sample Size Used for the Test Set and the Data Provenance
The document describes device testing (engineering and material) rather than clinical studies on a "test set" of patients or data. Therefore:
- Sample size: Not applicable in the context of patient data. The sample sizes for the various engineering tests are not specified.
- Data provenance: Not applicable. These are laboratory/bench tests of the physical devices, not clinical data from patients or a country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth for these types of engineering and material tests is defined by established international standards (JIS, BS EN, ASTM, ISO) and internal design requirements. There is no mention of human experts establishing "ground truth" in this context.
4. Adjudication Method for the Test Set
Not applicable. This concept applies to human review of clinical data, not the objective results of engineering tests against pre-defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices to assess clinical performance and reader impact. The devices described are physical stents.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. These are physical medical devices, not algorithms.
7. The Type of Ground Truth Used
The "ground truth" for the device's characteristics and performance is based on established engineering and material standards (e.g., JIS T 3270, BS EN 1617, ASTM F 1828-97, BS EN 1615, BS EN 1618, ASTM F6540-12, ASTM F2503, ISO 10993-1) and internal product design specifications.
8. The Sample Size for the Training Set
Not applicable. Training sets are associated with machine learning algorithms. The reported submission is for physical medical devices where performance is verified through physical testing, not machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for these physical devices.
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