(60 days)
COHITECH Reusable Tampon Applicator is intended to be used to insert a digital menstrual tampon into the vagina.
The COHITECH Reusable Tampon Applicator is a non-sterile, single user, reusable medical device. It is intended to be sold on its own, without a pre-loaded tampon. The applicator requires the user to load the applicator with a legally marketed digital menstrual tampon. The use-life of the subject applicator is 4 years. The applicator requires the user to clean and disinfect the applicator before initial use, before longterm storage and at the end of the menstrual cycle, as well as to clean the device after each use.
The device consists of a polyethylene outer tampon housing and inner pusher, a polypropylene storage case, and a carrying case (optional).
This device is available in two sizes, one size for reqular and super digital tampons and another for super and super plus digital tampons. The total applicator length is 73.3 ± 0.2 mm for both sizes. The overall applicator diameter (outer housing and inner pusher) is 16 ± 0.1 mm for the regular/super digital tampon applicator and 19 ± 0.1 mm for the super/super plus digital tampon applicator. The applicator weight is 5.4 ± 0.2 for the regular/super tampon applicator and 5.7 ± 0.2 g for the super/super plus tampon applicator. The storage case weight is 7.9 ± 0.1 g and carrying case weight is 26.9 ± 0.1 g
The provided text describes a 510(k) premarket notification for the COHITECH Reusable Tampon Applicator. This device is not an AI/ML device, therefore, many of the requested categories in the prompt are not applicable. The document focuses on demonstrating substantial equivalence to a predicate device (re.t.a™ Reusable Tampon Applicator) through non-clinical performance data, rather than clinical studies involving human readers or sophisticated ground truth establishment.
Here's a summary of the acceptance criteria and performance as presented in the document, along with explanations for the inapplicable sections:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic | Non-cytotoxic |
| Non-irritating | Non-irritating | |
| Non-sensitizer | Non-sensitizer | |
| Bench Testing | Device weight met specifications (implied) | 5.4 ± 0.2 g (regular/super), 5.7 ± 0.2 g (super/super plus) |
| Physical dimensions met specifications (implied) | Total applicator length: 73.3 ± 0.2 mm; Overall applicator diameter: 16 ± 0.1 mm (regular/super), 19 ± 0.1 mm (super/super plus) | |
| Functional evaluation (Injection force, Ejection force, Tampon compatibility) met specifications (implied) | Results were acceptable and met established acceptance criteria. | |
| Use-life testing met specifications (implied) | Results were acceptable and met established acceptance criteria. | |
| Reprocessing, Cleaning, and Disinfecting | Cleaning instructions and validated reprocessing met specifications (implied) | Cleaning instructions developed per FDA guidance, demonstrated effective for daily cleaning and end-of-cycle disinfection. |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests, summarized under "SUMMARY DISCUSSION OF NON-CLINICAL PERFORMANCE DATA" on page 5 and 6 of the document.
2. Sample sized 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 specified in the document. For non-clinical bench testing and biocompatibility, sample sizes are typically determined by relevant ISO standards or engineering validation protocols, but the exact numbers are not provided.
- Data Provenance: Not explicitly stated, but the studies were performed in accordance with FDA guidance and ISO standards, suggesting they were conducted in a controlled, prospective manner following established protocols for medical device testing. The submitting company, Cotton High Tech S.L., is located in Spain.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Inapplicable: This is not an AI/ML device or a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this device's acceptance criteria primarily refers to engineering specifications, physical measurements, and biological responses to materials as assessed by standard laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Inapplicable: As this is a physical medical device, not an AI/ML diagnostic, there is no expert adjudication process for image or data interpretation. The test results are based on objective physical and chemical testing.
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
- Inapplicable: This is not an AI/ML device, nor is it a diagnostic tool that would involve human readers or comparative effectiveness studies with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Inapplicable: This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: For biocompatibility, the ground truth is based on the biological response of cells/tissues to the device materials, as defined by international standards (ISO 10993). For bench testing, the ground truth is the engineering specifications, physical dimensions, and functional performance requirements of the device.
8. The sample size for the training set
- Inapplicable: This is not an AI/ML device and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established
- Inapplicable: As there is no AI/ML training set, this question is not relevant.
§ 884.5470 Unscented menstrual tampon.
(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).