(134 days)
The electrical stimulation component of the InCare Pelvic Floor Therapy System provides stimulation capabilities that are intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.
The biofeedback components of the InCare Pelvic Floor Therapy System are intended to provide electromyography or pressure biofeedback from the pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.
The InCare Pelvic Floor Therapy System is an office based instrument that is intended to be used by physicians, nurses, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital for the purpose of providing electromyography or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and the restoration of neuromuscular control for the treatment of urinary incontinence.
The InCare Pelvic Floor Therapy System also provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.
The proposed InCare Pelvic Floor Therapy System is comprised of a combination of an instrumentation unit and a personal computer. Other peripheral devices such as monitors and printers can be added for convenience or ease of use. The personal computer and instrumentation unit are physically separate devices "linked" to each other by a communication pathway. Features or functions that are "data manipulation and presentation" activities are properly associated with the personal computer. Features or functions that are" patient therapy" actions are controlled by the instrumentation unit.
The provided text is a 510(k) premarket notification for the Hollister Incorporated InCare Pelvic Floor Therapy System. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a standalone study with detailed performance metrics.
Therefore, the document does not contain the information requested in the prompt regarding:
- A table of acceptance criteria and reported device performance: This is not a study assessing performance against pre-defined criteria.
- Sample size used for the test set and data provenance: No new clinical study data is presented.
- Number of experts used to establish ground truth and their qualifications: Not applicable, as no new ground truth was established for a test set.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide:
The core of this document is a statement of "substantial equivalence" to predicate devices, which means that the device has the same intended use and similar technological characteristics to devices already legally marketed.
Here's a summary of the relevant details from the provided text:
- Device Name: InCare Pelvic Floor Therapy System
- Intended Use:
- Electrical stimulation component: To provide electrical stimulation for the rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.
- Biofeedback components: To provide electromyography or pressure biofeedback from pelvic musculature for the rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.
- Predicate Devices:
- Technological Characteristics (briefly described as justification for equivalence): The proposed system is an office-based instrument combining an instrumentation unit and a personal computer, with separate functions for "data manipulation and presentation" (PC) and "patient therapy" (instrumentation unit). The key update in this 510(k) is an "expanded stimulation parameter of 10 Hz and updated clinician application software."
- Conclusion of the 510(k): "Based upon the information presented within this pre-market notification it is concluded that the proposed InCare Pelvic Floor Therapy System with expanded stimulation parameter of 10 Hz and updated clinician application software is substantially equivalent to the predicate devices."
In essence, this document is a regulatory submission for market clearance based on similarity to existing devices, not a scientific study proving performance against specific acceptance criteria.
§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).