(194 days)
This device is made out of silicone, and it is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia. It is available with different sizes of the following models: CUBE (with and without drain), OVAL. (with and without support), HODGE (with and without support), SHAATZ , GELLHORN (with and without drains), RING (with and without support), DONUT , GEHRUNG, DISH (with and without support), & MAR-LAND (with and without support).
CUBE: indicated for use for the support of a third-degree prolapse. OVAL: indicated for use for the support of a first or mild second-degree prolapse. HODGE: indicated for use for the support of a uterine retroversion. SHAATZ; indicated for use for the support of a first or mild second-degree prolapse. GELLHORN: indicated for use for the support of a third-degree prolapse or procidentia. RING: indicated for use for the support of a first or mild second-degree prolapse. DONUT: indicated for use for the support of a third-degree prolapse. GEHRUNG: indicated for use for the support of cystocele or rectocele. DISH: indicated for use for the control of stress urinary incontinence or a first or mild seconddegree prolapse. It restores continence by applying gentle pressure to the urethra. MAR-LAND: indicated for use for the control of stress urinary incontinence or a first or mild second-degree prolapse. It restores continence by applying gentle pressure to the urethra.
This device is made out of silicone, and it is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia. It is available with different sizes of the following models: CUBE (with and without drain), OVAL (with and without support). HODGE (with and without support), SHAATZ , GELLHORN (with and without drains), RING (with and without support), DONUT , GEHRUNG, DISH (with and without support), & MAR-LAND (with and without support).
All models with their dimensions are detailed within the labeling section of this submission.
The provided text describes a 510(k) summary for the "MARINA MEDICAL SILICONE PESSARY" and the FDA's clearance letter. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance studies with acceptance criteria for the new device as a standalone product.
Therefore, many of the requested elements regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth are not applicable or not explicitly stated in this type of submission. The safety and effectiveness are claimed based on the similarity to a previously cleared device.
Here's an analysis of the provided text in relation to your request:
1. Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable metrics. The primary "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to a legally marketed predicate device. | The device is deemed "substantially equivalent" to the predicate device (Bioteque Vaginal pessary, K013289) for its stated indications for use. This implies the device is considered as safe and effective as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set with patient data for performance evaluation is mentioned.
- Data Provenance: Not applicable. The submission relies on a comparison to a predicate device, not new clinical data from a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. No ground truth establishment for a test set is described. The clearance is based on comparison to an existing predicate device and its known safety/effectiveness profile, as well as material specifications and intended use.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document does not describe any MRMC comparative effectiveness study, which would typically involve human readers (e.g., clinicians) evaluating cases with and without the device's assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: No. This device is a physical medical device (vaginal pessary), not an algorithm or software. Therefore, the concept of a "standalone" algorithmic performance study does not apply.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of device performance data. The "truth" in this submission relates to the intended use, material composition, and design principles being similar to those of a legally marketed predicate device. The ground truth for the predicate device would have been established historically through its own clearance process, clinical experience, and regulatory standards.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set. The "training" in the context of a 510(k) for a physical device usually refers to product development, materials testing, and manufacturing processes, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. See point 8.
Summary of 510(k) Process (as demonstrated here):
This 510(k) submission is for a Class II medical device. The primary method for clearance is to demonstrate substantial equivalence to a predicate device. This typically involves:
- Comparison Table: A detailed comparison of the new device to the predicate device, highlighting similarities in intended use, technological characteristics (materials, design, performance), and safety/effectiveness profiles. (Paragraph 14, mentioned but not included, would likely contain this table).
- Performance Data (often bench testing): For physical devices like pessaries, this usually involves material biocompatibility, mechanical strength, and dimensional integrity testing to ensure it meets established standards and is comparable to the predicate. The provided text doesn't detail these study results but implies they were part of the rationale for equivalence.
- Labeling and Indications for Use: Ensuring the proposed indications for use are consistent with those of the predicate device.
The FDA's letter confirms that they have reviewed the submission and determined that the device is "substantially equivalent" to legally marketed predicate devices, thereby allowing the company to market it. This process does not typically involve the type of detailed clinical performance studies with explicit acceptance criteria, expert adjudication, or AI-specific terminology (like test sets, training sets, MRMC studies) that would be seen for novel devices, high-risk devices, or AI/ML-enabled devices.
§ 884.3575 Vaginal pessary.
(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).