(275 days)
The Tempo Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
The Tempo Tampon will be offered as a traditional unscented menstrual 100% cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbances: Regular and Super.
This document is a 510(k) Premarket Notification for the "Tempo Tampon". It aims to demonstrate substantial equivalence to a legally marketed predicate device, the "Taebong CottonDay Tampon" (K182817).
Based on the provided text, here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Performance Testing (per 2005 FDA Guidance) | Dimensions | Not explicitly stated, implied to be within acceptable variance for equivalence with predicate | Pledget Length: Regular 44-48mm, Super 47-51mm; Pledget Diameter: Regular 13.5mm, Super 13.5mm; Applicator Inner Length: Regular/Super 73 ± 5%; Applicator Outer Length: Regular/Super 74.5 ± 5%; Applicator Inner Diameter: Regular/Super 11.8 ± 5%; Applicator Outer Diameter: Regular/Super 15 ± 5%. (These generally align with predicate but have some dimensional differences which are considered not to raise new questions of safety/effectiveness). |
| Absorbency range (Syngyna Absorbency) | Regular: 6.0 - 9.0 gram; Super: 9.0 - 12.0 gram | Regular: 6.0 - 9.0 gram; Super: 9.0 - 12.0 gram (Matches predicate) | |
| Chemical residues | Not explicitly stated, implied to meet safety standards. | Not explicitly stated as a value, but testing was performed. | |
| Withdrawal cord strength | Not explicitly stated, implied to meet safety standards. | Not explicitly stated as a value, but testing was performed. | |
| Fiber shedding | Not explicitly stated, implied to meet safety standards. | Not explicitly stated as a value, but testing was performed. | |
| Tampon integrity | Not explicitly stated, implied to meet safety standards. | Not explicitly stated as a value, but testing was performed. | |
| Biocompatibility Testing (per ISO 10993) | Cytotoxicity (MEM Elution Test) | Non-cytotoxic | Non-cytotoxic (for tampon and applicator) |
| Sensitization (Guinea Pig Maximization Test) | Non-sensitizers | Non-sensitizers (for tampon and applicator) | |
| Irritation | Non-irritating | Non-irritating (for tampon and applicator) | |
| Acute Systemic Toxicity | Not acutely systemically toxic | Not acutely systemically toxic (for tampon) | |
| Microbiology Testing (per 2005 FDA Guidance) | Enhance S. aureus growth | Does not enhance | Does not enhance |
| Increase TSST-1 production | Does not increase | Does not increase | |
| Alter normal vaginal microflora | Does not alter | Does not alter |
2. Sample Size Used for the Test Set and Data Provenance
Since this is a submission for a physical medical device (tampon) and not an AI/software device, the concept of "test set" in the context of AI models (e.g., training/test/validation split) does not directly apply. The "studies" described are in vitro and in vivo tests on the device itself.
- Sample Size: The document does not specify the exact number of samples (e.g., individual tampons) used for each performance, biocompatibility, and microbiology test. It only states that the tests were performed.
- Data Provenance: The tests are implicit to have been conducted under controlled laboratory conditions to assess the device properties. There is no mention of "country of origin of the data" in terms of patient data or "retrospective/prospective" as relevant to clinical trial data. These are laboratory studies on the manufactured product.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable to this type of device submission. The "ground truth" for the performance characteristics (e.g., absorbency, dimensions, biocompatibility) is established through standardized laboratory testing methods and accepted scientific protocols (e.g., specific FDA guidance documents, ISO standards). There isn't a "human expert" interpretation of images or symptoms involved in establishing these facts.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or interpretation of complex data that would require an adjudication process. The tests performed yield objective, measurable results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No. An MRMC study is relevant for AI or diagnostic imaging devices where human readers interpret medical images. This submission is for a menstrual tampon, and no such study was conducted or is required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This concept is relevant for AI algorithms. The "device" here is a physical product (tampon), not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by:
- Standardized Test Methods: Adherence to established FDA guidance documents ("Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff") for performance characteristics.
- International Standards (ISO): Compliance with specific ISO 10993 standards for biocompatibility testing.
- Predicate Device Comparison: Direct comparison of key performance metrics (like absorbency) against the legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI/machine learning model for this medical device submission. The device is manufactured, and its properties are tested.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set in the AI/ML sense.
§ 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).