(208 days)
INTENDED USE STATEMENT: The Perineometer (Biofeedback monitor) and vaginal probe are intended to be used to assist the patient in exercising her pelvic muscles (referred to Kegal exercises) which may lead to increased bladder control.
The PERINEOMETER & VAGINAL PROBE , is a passive device which will allow the patient to visually monitor their Kegal exercise progress.
The Vaginal probe is a Single patient use only device comprised of a medical grade Silicone shaft with a silicone balloon (Inflatable to enlarge to accomodate various vaginal sizes.) and a oolvurethane connector tube. The silicone balloon is mounted in such a way that when pressure is applied to it, air will be displaced through it's connector tubing. This air displacement is being monitored by the biofeedback monitor will cause the LED lights to turn on in proportion to the pressure exerted. This probe is similar to the legally marketed probe via 510(k) numbers (K902843) and (K913736) except that in this case we are inflating the balloon to provide gentle pressure to the vaginal wall. This will allow the probe to be customized for the patients individual vaqinal size.
The Perineometer (Biofeedback Monitor) is powered by rechargeable batteries. To prevent a potential shock hazard this unit will not function while it is being recharged. The Perineometer is identical to the biofeedback monitor which had been 510(k) approved for use in fecal incontinence (K902843). Thus, in the case of this 510(k) submission, we only seek to expand its use for general Kegal exercises.
SYSTEM DESCRIPTION: The patient inserts the vaginal probe which is connected to the Perineometer. Once the probe is inflated until it provides gentle pressure to the vaginal wall. As the pelvic muscles expand and contract (Kegal exercises) the pressure in the probe changes and these pressure changes are converted into a visual signal on the Perineometer (biofeedback monitor). The visual signal on the Perineometer is a series of LEDs (lights) which provide the patient with a real time representation of pelvic muscle activity.
This submission describes the Biosearch Medical Products, Inc. "PERINEOMETER & VAGINAL PROBE" for assisting patients with pelvic muscle exercises to improve bladder control. The device consists of a Perineometer (biofeedback monitor) and a vaginal probe.
Here's an analysis of the acceptance criteria and supporting studies based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define quantitative acceptance criteria for the "PERINEOMETER & VAGINAL PROBE" in terms of performance metrics like sensitivity, specificity, or accuracy. Instead, the focus is on demonstrating substantial equivalence to legally marketed predicate devices through material biocompatibility and functional similarity.
Therefore, the "acceptance criteria" can be inferred as meeting the safety and material requirements of similar devices and demonstrating comparable functionality.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility: Materials in patient contact are safe. | Vaginal Probe Components: |
| - Silicone Probe & Silicone Marker Ring: USP Class VI Silicone (Meets requirements). | |
| - Anorectal Probe Assembly (entire device): Tested for Cytotoxicity (MEM Elution), reported as Nontoxic. | |
| - Glue used to assemble Anorectal probe: Vendor Provided (FDA Master File), reported as Nontoxic. | |
| - Polyurethane Tubing: USP Class VI Plastics tests (Cytotoxicity Agarose overlay, Hemolysis, Intracutaneous Toxicity, Implantation Test), reported as Meets the requirements. | |
| Components Not Inserted into Body Cavity (Luer Lock Connector, Medical Grade Tubing, Molded Tube Adapter, Luer Connector & Dual Port Adapter, Balloon Inflation Valve/Port): Made of Medical grade plastic, assumed safe due to no direct patient contact. Some were also tested against USP Class VI Plastics (e.g., Luer Connectors, Molded Tube Adapter). | |
| Functional Equivalence: Device functions similarly to legally marketed devices for its intended use. | Perineometer (Biofeedback Monitor): Identical to Biosearch Biofeedback monitor #5 (K902843), already 510(k) approved for fecal incontinence. |
| Vaginal Probe: Similar to legally marketed probes (K902843, K913736) but with an inflatable balloon to customize to patient's vaginal size. Demonstrates comparable operation by converting pressure changes from pelvic muscle activity into a visual LED signal. | |
| Equivalence Matrix: The "Equivalence Matrix" table (page 7) shows the "BIOSEARCH "PERINOMETER & VAGINAL PROBE" (This Submission) has similar features (Balloon Type Probe, EMG Exercising, Can be used with Sensor Stimulator, Used for Female Bladder Control, Probe Inserted in the Vagina) to predicate devices like "MILEX "PERINEAL EXERCISER" (K862410) and "CARDIO DESIGN "PERITRON" (K945611). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific clinical "test set" in the way typically expected for performance claims (e.g., a cohort of patients randomized to use the device). The device's performance is primarily established through:
- Substantial Equivalence: Comparison to existing, legally marketed predicate devices.
- Material Biocompatibility Testing: Conducted on components (e.g., Anorectal Probe Assembly, Silicone, Polyurethane Tubing). The "sample size" for these tests would refer to the number of material samples tested, but this detail is not provided.
- Data Provenance: The biocompatibility tests are listed with "Test Date" (e.g., 11/11/91 for Anorectal Probe Assembly) or "Vendor Provided." This indicates the data is from laboratory testing of materials and components, likely retrospective given the dates. There is no information about the country of origin for the data or whether it was prospective or retrospective in a clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts establishing a "ground truth" in a clinical context for a test set. The submission relies on:
- Regulatory Standards: USP Class VI for plastics, ANSI/HIMA MD 70.1, British BS 5081,176 for check valve.
- Previous Approvals: The Perineometer's equivalence to existing 510(k)-approved devices (K902843, K913736).
- Expertise in Biocompatibility: The "Nontoxic" and "Meets requirements" results imply assessment by experts in material science and biocompatibility testing, but their specific qualifications or number are not detailed.
4. Adjudication Method for the Test Set
As there is no described clinical "test set" or human assessment of device performance for the purpose of establishing clinical efficacy or accuracy in this submission, there is no adjudication method mentioned. The primary "adjudication" is the FDA's review of the substantial equivalence claim based on the provided material and functional comparisons.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No MRMC comparative effectiveness study was done or reported in this submission. The effectiveness of the device is inferred from its similarity to predicate devices already on the market and the general understanding that pelvic muscle exercises improve bladder control. There is no mention of human readers or AI assistance, let alone an effect size.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This device, the "PERINEOMETER & VAGINAL PROBE," is a biofeedback system that provides a visual signal (LED lights) in proportion to pressure exerted by pelvic muscles. It is an interactive device used by the patient (human-in-the-loop) to guide their exercises. Therefore, the concept of a "standalone (algorithm only)" performance assessment does not apply to this type of medical device. Its function is to facilitate human action, not to perform an automated diagnostic or therapeutic task independently.
7. The Type of Ground Truth Used
The "ground truth" in this submission is primarily based on:
- Established Biocompatibility Standards: USP Class VI, ISO standards, and previous FDA approvals for material safety.
- Functional Similarity to Legally Marketed Predicate Devices: The reference to previous 510(k) clearances (K902843, K913736, K945611, K862410, K891774) indicates that the performance of these devices in assisting pelvic muscle exercises and improving bladder control is the benchmark.
- Scientific Consensus: The statement "Presently many Orologists of the country are recommending pelvic muscle exercises to their female patients since the exercises improve urinary continence" implies a general medical consensus on the efficacy of the underlying therapy (Kegal exercises).
8. The Sample Size for the Training Set
There is no "training set" in the context of machine learning or AI models described in this document. The device is a mechanical/electronic biofeedback tool, not an AI or algorithm-based system that requires training data.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
§ 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).