(23 days)
MedWorks Urinary Incontinence Surgical Devices are indicated for use in urethropexy surgical procedures for bladder neck suspension to correct female stress urinary incontinence due to urethral hypermobility.
The devices described in this 510(k) are surgical procedure kits intended for use in urethropexy procedures, and include components such as suture placement templates, bone anchors, bone drills, syringes, suture retrievers and suture cutters.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MedWorks Urinary Incontinence Surgical Devices:
Based on the provided text, the device is not a software/AI device and therefore the questions regarding AI-specific studies, ground truth establishment for AI, sample sizes for AI training/test sets, and expert involvement for AI adjudication are not applicable.
The document describes a device modification for surgical kits. The focus is on demonstrating substantial equivalence to predicate devices and adherence to regulatory standards for medical devices, rather than establishing performance through clinical efficacy studies with specific acceptance criteria in the manner one would for a diagnostic or AI-powered device.
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC, as typically seen in AI device submissions, is not present here. Instead, the "acceptance criteria" are implied by compliance with regulatory requirements and demonstration of substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with 21 CFR 820.30 Design Control requirements | "MedWorks has provided certification of compliance to 21 CFR 820.30 Design Control requirements." |
| Description of internal Risk Analysis procedure | "A description of the internal Risk Analysis procedure." |
| Validation testing (Pull testing, Bond integrity testing, Simulated use performance testing) | "Validation testing including pull testing, bond integrity testing and simulated use performance testing is included in Design Validation and Verification planning." (It states the testing is included in planning, implying it was performed as part of design control, but doesn't provide specific results or acceptance criteria for these tests.) |
| Substantial equivalence to predicate devices (K971791, K971796, K971797, K963076, K971801, K971802) | "Based on the indications for use, technological characteristics, and comparison to predicate devices, the MedWorks Urinary Incontinence Surgical Devices have been shown to be safe and effective for its intended use." (The FDA's letter concurs with this finding of substantial equivalence.) |
| Indications for Use (Urethropexy surgical procedures for bladder neck suspension to correct female stress urinary incontinence due to urethral hypermobility) | The FDA's letter states: "we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." |
Study Details (Not Applicable for AI/Software Performance)
Since this is a filing for a physical surgical device modification, the following questions are not applicable in the context of an AI/software performance study:
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of AI performance for this device. The validation mentioned ("pull testing, bond integrity testing, simulated use performance testing") would have its own sample sizes, but these are not for AI performance assessment.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI-assisted device for human interpretation.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, this submission is for a traditional medical device (surgical kits) undergoing a modification, and the "study" demonstrating its acceptability revolves around regulatory compliance, quality system adherence, and benchmarking against predicate devices rather than clinical efficacy studies or AI performance metrics.
§ 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.