(354 days)
The Urinary Incontinence Probe, model PR-51 Vaginal Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
The Urinary Incontinence Probe, model PR-51 Vaginal Probe & PR-52 Anal Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
The Urinary Incontinence Probe, model PR-51 Vaginal Probe & PR-52 Anal Probe are the light weight cylinder consisting of two independent conductive rings that are paired and isolated, physically and electrically. The cylinder is shaped with a handle for comfort positioning in vaginal/anal canal for incontinent treatment as above mentioned and easy for removing after treatment. It is watertight to allow for washing with soap and water between uses. The probe is designed for repeated intermittent use in home or clinic for up to one year by a single user. It does not require sterilization, but does required washing for reuse according to the validated cleaning method as recommended in user manual.
To fit with different type of device connection, the lead wire of device was provided with three different type of wire connection terminals, 2mm pigtail, 3.5mm femelle and 2.35 mm femelle. Either of the PR-51 Vaginal Probe & PR-52 Anal Probe can be connected to any one of three connection terminals.
The provided document describes a 510(k) premarket notification for an "Electrode for Urinary Incontinence" (Models PR-51, PR-52). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a clinical study with acceptance criteria.
Therefore, many sections of your request related to acceptance criteria, sample sizes, ground truth, expert adjudication, and clinical study outcomes cannot be directly extracted from this document, as these types of studies were explicitly stated as "Not applicable" (# 9 Brief discussion of clinical tests: Not applicable).
The document primarily addresses non-clinical performance and biological evaluation.
Here's a breakdown of the information that can be extracted or inferred, and what cannot:
1. Table of acceptance criteria and the reported device performance
This information is not provided in the document. No specific acceptance criteria (e.g., in terms of clinical efficacy, sensitivity, specificity, accuracy) or reported performance metrics are listed because no clinical performance study was conducted or required for this 510(k) submission. The submission focuses on substantial equivalence based on technological characteristics and non-clinical testing.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided. No clinical test set. The non-clinical tests (biological evaluation and standards compliance) do not typically refer to "test sets" in the same way clinical studies do. The manufacturer is Guangzhou Finecure Medical Equipment Co., Ltd. from China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not provided. No clinical test set requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. No clinical test set requiring adjudication.
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 an electrode for urinary incontinence, not an AI diagnostic imaging device. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a medical electrode, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests, the "ground truth" would be compliance with the standards referenced (e.g., biocompatibility testing for ISO 10993).
8. The sample size for the training set
Not applicable/Not provided. No clinical study was conducted.
9. How the ground truth for the training set was established
Not applicable/Not provided. No clinical study was conducted.
Summary of what the document does provide regarding device performance and acceptance:
The device's acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device (Everyway Incontinence Stimulation Electrode, K122194) and compliance with specific non-clinical standards.
Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) submission strategy):
| Acceptance Criteria Category | Specific Criteria (from standard) | Reported Device Performance/Compliance |
|---|---|---|
| Biocompatibility | ISO 10993-1:2009: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process. | The device conforms to ISO 10993-1. (Implies a risk management process led to appropriate biological testing and a favorable outcome). |
| ISO 10993-5:2009: Biological evaluation of medical devices Part 5: Tests for In Vitro cytotoxicity. | The device conforms to ISO 10993-5. (Implies the device material does not exhibit cytotoxicity). | |
| ISO 10993-10:2010: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization. | The device conforms to ISO 10993-10. (Implies the device material does not cause irritation or skin sensitization). | |
| Technological Equivalence | Same intended use, design principle, and similar material composition as predicate device. | "The proposed device and the Predicate device have the same intended use, design principle, and similar material composition. The differences do not exert adverse effect on the proposed device. The proposed device is substantially equivalent to the predicate devices." (Stated in Section 7 of the 510(k) Summary). Key technological features like independent conductive rings, handle for comfort, watertight design, and lead wire connections are described as part of the device description. |
| Cleaning/Reuse | Watertight to allow washing; validated cleaning method for repeated intermittent use up to one year. | "It is watertight to allow for washing with soap and water between uses. The probe is designed for repeated intermittent use in home or clinic for up to one year by a single user. It does not require sterilization, but does required washing for reuse according to the validated cleaning method as recommended in user manual." (Described in Section 4). Implies validated cleaning procedures meet acceptable criteria for reuse. |
Study Proving Device Meets Acceptance Criteria:
The "study" in this context refers to the non-clinical tests and analysis performed to demonstrate substantial equivalence and safety/effectiveness.
- Non-Clinical Testing: The document explicitly states that the "Electrode for Urinary Incontinence conforms to the following standards:" and then lists the three ISO 10993 standards mentioned above. This indicates that appropriate biocompatibility testing was performed and passed, leading to compliance with these standards.
- Comparison to Predicate Device: The 510(k) submission itself is a "study" of comparison, wherein the manufacturer presents arguments and data (including the declaration of compliance with standards) to demonstrate that their device is "substantially equivalent" to an already cleared predicate device. The FDA's review and clearance (K140265) indicate that they agreed with this assessment.
In conclusion, this regulatory document focuses on establishing substantial equivalence for market clearance, rather than reporting on a clinical effectiveness study with defined acceptance criteria for efficacy. The "acceptance criteria" are compliance with relevant safety standards (biocompatibility) and demonstration of similar technological characteristics and intended use as an existing cleared device.
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).