(293 days)
The PelvicFlexer is intended to assist women in performing Kegel Exercises which may help control stress urinary incontinence.
Treatment of stress and /or Urge incontinence in women
The PelvicFlexer is a comprehensive, behaviorally based program designed for independent use by incontinence people at home. The program includes a PelvicFlexer device, instructional manual and direct support via phone and internet. The PelvicFlexer is hand-held and inserted into the vagina. The strength of the muscle contraction is reflected by the stainless steel springs.
Acceptance Criteria and Device Performance Study for the PelvicFlexer Exercise Device
This submission describes the PelvicFlexer Exercise Device and establishes its substantial equivalence to the predicate device, Pelvic Muscle Therapy (K# 002830). The assessment is based on non-clinical tests rather than clinical studies to demonstrate safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in quantitative metrics within the provided document for device performance. Instead, the "acceptance criteria" appear to revolve around demonstrating biocompatibility, safety, and functional equivalence to the predicate device through non-clinical testing.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (PelvicFlexer) |
|---|---|---|
| Biocompatibility | Meet ISO 10993 standards for medical devices. | Extensive testing performed by NAMSA against ISO 10993 standards: Cytotoxicity (ISO Elution Method), Muscle Implantation Test (7 day), Acute Systemic Toxicity, Delayed Contact Sensitization (Maximization Method), Hemolysis Test (USP - direct and extraction methods). Results indicated material is biocompatible, nontoxic, and well tolerated by mucosal membranes. |
| Material Safety | Materials used must be safe for patient contact. | Addressed by biocompatibility testing (ISO 10993). |
| Functional Safety (Spring Load) | Assure safety and effectiveness of the spring mechanism. | Safety Testing (spring load testing) performed. (Specific performance metrics not detailed, but states assurance of safety and effectiveness). |
| Intended Use | To assist women in performing Kegel Exercises which may help control stress urinary incontinence. | Identical intended use as the predicate device. |
| Target Population | Women with mild incontinence. | Identical to the predicate device. |
| Reusable/Single Patient Use | Must be reusable and for single patient use. | Reusable, single patient device. |
2. Sample Size Used for the Test Set and Data Provenance
The submission explicitly states, "Discussion of Clinical Tests Performed: Not applicable."
Therefore, there was no human "test set" in the context of clinical performance evaluation. The "test set" for the non-clinical tests would refer to the samples of materials and device components subjected to the biocompatibility and safety testing. The document does not specify the exact number of samples used for these non-clinical tests.
The data provenance for the non-clinical tests would be the testing laboratories (e.g., NAMSA) where the biocompatibility and safety tests were conducted. The country of origin is not specified for these tests. The nature of these tests is laboratory-based (bench testing), not retrospective or prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable, as no clinical test set was used to evaluate device performance against a medical ground truth (e.g., disease diagnosis, treatment efficacy). The "ground truth" for the non-clinical tests was established by adherence to ISO 10993 standards and general engineering safety principles.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done, as no clinical studies involving human readers or AI assistance were conducted.
6. Standalone (Algorithm Only) Performance Study
Not applicable, as this device is a physical medical device, not an algorithm or AI software. Therefore, no standalone algorithm performance study was relevant or performed.
7. Type of Ground Truth Used
The "ground truth" for demonstrating the safety and biochemical compatibility of the device's materials was based on internationally recognized standards and guidelines for medical device biocompatibility, specifically ISO 10993. For the functional safety (spring load testing), the "ground truth" was internal engineering specifications and generally accepted safety parameters for mechanical components, aiming to assure safety and effectiveness.
8. Sample Size for the Training Set
Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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).