K Number
K142369
Date Cleared
2015-06-17

(296 days)

Product Code
Regulation Number
876.5320
Panel
GU
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Urinary Incontinence System with various treatment modalities is intended to be used by males and females for muscle contraction in the treatment of stress incontinence, urge incontinence, and mixed incontinence.

Device Description

The Finecure Urinary Incontinence System is a non-implanted, electrical, pelvic floor muscle stimulator. It is intended to strengthen the pelvic floor muscles by electrical stimulation in the treatment for urinary incontinence. The system has several preset modes that correspond to different conditions associated with urinary incontinence. The Urinary Incontinence System can be used in the clinical setting and the home care environment. The System is composed of enclosure, display screen, PCB, rotary switch, and other electronic components. The system is to be used with pelvic floor probes and anorectal probes.

AI/ML Overview

The provided document is a 510(k) Summary for a Urinary Incontinence System. It describes the device and its equivalence to predicate devices, but it does not contain details of a clinical study with acceptance criteria for device performance related to urinary incontinence treatment efficacy.

The "Testing Summary" section on page 12 focuses entirely on non-clinical tests (biocompatibility, electrical safety, EMC, home healthcare environment, bench testing, and software verification), confirming the device meets safety and design requirements. There is no mention of a study involving human subjects or clinical outcomes for treating incontinence.

Therefore, many of the requested details cannot be extracted from this document as the type of study implied by the request (a study proving the device meets acceptance criteria for its intended use) was not performed or at least not described within this 510(k) summary.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Study Details (Based on available document)

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of clinical performance (e.g., reduction in incontinence episodes) for the Urinary Incontinence System. The acceptance criteria mentioned are related to engineering and safety standards, and the reported "performance" refers to the device passing these tests.

Acceptance Criterion Type (from document)Reported Device Performance (from document)
Biocompatibility SafetyHost shell (ABS) and Membrane Touch Switch (PET) are identical to materials approved in K130691, implying biocompatibility.
Electrical SafetyComplies with IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007).
Electromagnetic Compatibility TestingComplies with IEC 60601-1-2:2007.
Home healthcare environment TestingComplies with IEC 60601-1-11: 2010.
Bench testingDevice meets design requirements.
Software verification and validationMeets the requirements of design.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as the document does not describe a clinical study with a test set of human subjects. The "test set" refers to the hardware and software units tested against engineering standards.

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)

This information is not applicable/provided as there was no clinical study described that would require expert-established ground truth for patient outcomes. The "ground truth" for the engineering tests would be the specifications and standards themselves, assessed by engineers or testing laboratories.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided as there was no clinical study with human readers/assessors described.

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

This information is not applicable/provided. No MRMC or comparative effectiveness study involving human readers or AI assistance is mentioned. The device is a physical therapeutic device, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. The device is a physical medical device for electrical stimulation, not an algorithm, and the safety/performance tests described did not involve evaluating its efficacy in a standalone algorithmic context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is adherence to established international and national engineering standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11) and the manufacturer's own design specifications. There is no ground truth related to clinical outcomes or expert consensus on clinical data mentioned in this document.

8. The sample size for the training set

This information is not applicable/provided as no clinical studydata (training or test) is described.

9. How the ground truth for the training set was established

This information is not applicable/provided as no clinical study data (training or test) is described.


Summary of Document Focus:

This 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices based on:

  1. Similar intended use and indications for use.
  2. Comparison of technological characteristics (e.g., power source, output parameters, waveform, pulse rate).
  3. Non-clinical testing to ensure the device meets safety (electrical, EMC, biocompatibility) and performance standards for its design, especially in the home healthcare environment.

The document does not include details of clinical performance studies demonstrating the effectiveness of the Urinary Incontinence System in treating stress, urge, or mixed incontinence in human subjects, or any associated acceptance criteria for these clinical outcomes. The FDA generally clears Class II devices, like this one, based on substantial equivalence to existing legally marketed devices, often without requiring new clinical efficacy studies if the technological characteristics and safety profiles are similar.

§ 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).