(106 days)
The WORRRY-REMOVER™ IRRIGATOR is designed for use as a vaginal douche apparatus for general feminine hygiene applications.
The irrigating-bottle is hand-squeezed to force the cleaning solution to slowly and completely flow into the vaginal cavity. The one-way liquid valve permits the fluid to flow only from the bottle into the vaginal cavity but not back to the bottle, preventing contaminations of the solution and bottle. The one-way air valve permits air to flow into the bottle to prevent production of negative pressure within the bottle. The flow speed of the liquid is controlled by the user's hand. This system makes the process of vaginal irrigation much easier, neater, and more relaxing than using some other types of irrigators.
This document is a 510(k) premarket notification for the WORRY-REMOVER™ IRRIGATOR, a vaginal douche apparatus. The provided text, however, focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or an analytical study proving the device meets those criteria.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert qualifications, and ground truth cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The document does not specify any quantitative or qualitative acceptance criteria for the device beyond its intended use and comparison to predicate devices. It states that the device is "substantially equivalent" to predicate devices, but doesn't define what specific performance metrics constitute this equivalence or how they were measured.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not mentioned.
- Data Provenance: Not mentioned.
Explanation: The document does not describe any specific testing, clinical study, or data collection that would involve a test set. The submission is based on substantial equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable, as no ground truth establishment for a test set is described.
- Qualifications of Experts: Not applicable.
Explanation: There is no indication of human experts being used to establish ground truth because there's no mention of a study involving a test set that would require such expert review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable.
Explanation: No test set or corresponding adjudication process is mentioned in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No.
Explanation: The device is a physical vaginal irrigator, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No.
Explanation: As mentioned, this is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable, as no new ground truth was established for this submission. The basis for approval is substantial equivalence to legally marketed predicate devices.
Explanation: The "proof" for this device meeting its criteria is its substantial equivalence to previously cleared devices (La Joie Vaginal Cleaner Container (K000736) and Peri-Bottle (K902830)). The ground truth, in this context, would implicitly refer to the safety and effectiveness of the predicate devices as established when they were originally cleared.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable.
Explanation: This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
Explanation: As this is not an AI/machine learning device, there is no training set or associated ground truth establishment process.
Summary of the Study (Based on Provided Text):
The "study" described in the 510(k) submission is not a traditional analytical or clinical study with a test set, ground truth, or performance metrics. Instead, it is a substantial equivalence comparison to predicate devices.
- Device Name: WORRY-REMOVER™ IRRIGATOR
- Intended Use: "designed for use as a vaginal douche apparatus for general feminine hygiene applications."
- Predicate Devices Identified: La Joie Vaginal Cleaner Container (K000736) and Peri-Bottle (K902830).
- Conclusion: The submitter asserts, and the FDA agrees, that "WORRRY-REMOVER™ Irrigator is substantially equivalent to the predicate devices" in terms of its indication for use.
The document does not provide any detailed data from performance testing, clinical trials, or user studies that would typically be associated with proving a device meets specific acceptance criteria via a study. The FDA's clearance is based on the argument that because it's similar enough to already-approved devices, it should be equally safe and effective.
§ 884.5900 Therapeutic vaginal douche apparatus.
(a)
Identification. A therapeutic vaginal douche apparatus is a device that is a bag or bottle with tubing and a nozzle. The apparatus does not include douche solutions. The apparatus is intended and labeled for use in the treatment of medical conditions except it is not for contraceptive use. After filling the therapeutic vaginal douche apparatus with a solution, the patient uses the device to direct a stream of solution into the vaginal cavity.(b)
Classification. (1) Class II (performance standards).(2) Class I if the device is operated by gravity feed. Devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.