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510(k) Data Aggregation
(256 days)
NAISSANCE HOLDINGS, LC
The GyneFlex is recommended for the strengthening of the perineal pelvic floor muscles by offering resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence.
The GyneFlex is a pelvic floor muscle exerciser. The product has six ranges of resistance. Other than variation in resistance, each exerciser is identical, including identical indications and labeling. It is a "v" sh aped device that provides resistance after insertion into the vagina when the patient contracts her pelvic muscles. The material is made of a polymer plastic specifically formulated to provide specific ranges of resistance for use as an adjunct to Kegel exercises.
The provided text describes a 510(k) premarket notification for a medical device called "GyneFlex," a pelvic floor muscle exerciser. It does not contain information about acceptance criteria, a specific study proving the device meets acceptance criteria, or any of the detailed data requested for such a study (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details).
The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Colonial Medical Supply Pelvic Muscle Therapy) rather than providing a detailed performance study with acceptance criteria.
However, based on the information provided, I can infer and state what is present and what is conspicuously absent.
Acceptance Criteria and Device Performance Study for GyneFlex
Summary of Findings: The provided 510(k) submission for the GyneFlex device (K021115) primarily focuses on demonstrating substantial equivalence to an existing legally marketed device (Colonial Medical Supply Pelvic Muscle Therapy, K002830). It does not present specific acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or a measure of muscle strengthening efficacy). Instead, the "acceptance" implied by this submission is the FDA's determination of substantial equivalence, which is based on similar intended use and technological characteristics to the predicate device.
The "study" referenced in the document is limited to testing for biocompatibility and non-toxicity, which are general safety requirements, rather than a performance efficacy study.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not define explicit "acceptance criteria" in terms of performance metrics or clinical outcomes for the GyneFlex device beyond biocompatibility and substantial equivalence to the predicate. The "reported device performance" is descriptive rather than quantitative.
| Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility, non-toxicity, and mucosal membrane tolerance. | "Testing results indicate that the material is biocompatible, nontoxic and well tolerated by mucosal membranes." (Section F: Testing) |
| Functional Design: Provide resistance to voluntary contractions of pelvic muscles for strengthening. | Described as "a 'v' shaped device that provides resistance after insertion into the vagina when the patient contracts her pelvic muscles. The material is made of a polymer plastic specifically formulated to provide specific ranges of resistance..." (Section B: Device Description) and "provides graduated resistance in specified ranges..." (Section D: Substantial Equivalence Summary). |
| Intended Use Equivalence: Strengthening perineal muscles to correct urinary incontinence. | "The GyneFlex is recommended for the strengthening of the perineal muscles by offering resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence." (Section C: Intended Use). This is stated to be similar to the predicate device. |
| Technological Characteristics Equivalence: Similar materials and design to predicate. | "The GyneFlex is a single, reusable, polymer plastic 'v' shaped exerciser that exceeds the guidelines set forth in ISO 10993." (Section E: Technological Characteristics). This is stated to be similar to the predicate device. |
| Manufacturing Standards: Adherence to relevant standards. | "exceeds the guidelines set forth in ISO 10993." (Section E: Technological Characteristics) |
| Substantial Equivalence: To the predicate device (Colonial Medical Supply Pelvic Muscle Therapy, K002830). | The FDA issued a letter stating, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." (FDA Letter, Page 3). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify any sample size for a test set related to the device's efficacy in strengthening pelvic muscles or correcting urinary incontinence. The only "testing" mentioned is for biocompatibility.
The data provenance for biocompatibility testing is not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. No clinical test set to establish "ground truth" for efficacy is described.
4. Adjudication Method for the Test Set
No test set for clinical performance is described; therefore, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No MRMC comparative effectiveness study was done or mentioned in this 510(k) submission. This type of study is typically performed for AI-based diagnostic devices to assess the impact of AI assistance on human reader performance, which is not relevant to a physical pelvic floor muscle exerciser.
6. If a Standalone Performance Study was Done
No standalone performance study (algorithm only performance, often for AI/software devices) was done or mentioned. The device is a physical exerciser, not a software algorithm. The "testing" mentioned is for material properties (biocompatibility).
7. The Type of Ground Truth Used
For the biocompatibility testing, the ground truth would likely be based on established laboratory standards and protocols for assessing material safety and interaction with biological systems (e.g., ISO 10993 standards mentioned).
For the intended use (muscle strengthening, incontinence correction), the submission relies on the established efficacy of the predicate device and the general understanding that pelvic floor muscle exercises are beneficial. No new clinical ground truth for efficacy of the GyneFlex itself is presented in this document.
8. The Sample Size for the Training Set
Not applicable and not provided. The GyneFlex is a physical medical device, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable and not provided. As the device is not an AI/ML system, there is no training set or corresponding ground truth establishment process described.
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