(154 days)
Unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the placement of the tampon correctly into the vagina.
The Opal by Femtex and Private Label Unscented Compact Applicator Tampons is an unscented, compact applicator menstrual tampon. The tampon itself is made of a strip of viscose fibers in which a cord is inserted and pressed firmly together. The viscose tampon is covered with a thin layer of non-woven fiber material which is melted on the strip. The applicator tubes are made from polyethylene (PE). The tampon with applicator is wrapped in printed polypropylene (PP) wrapping. The tampon is marketed in Light, Regular, Super, and Super Plus Absorbencies.
This document describes the premarket notification (510(k)) for the Opal by Femtex and Private Label Unscented Compact Applicator Tampon. It includes information about the device's acceptance criteria, performance studies, and comparison to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Specific Requirement / Standard | Reported Device Performance |
|---|---|---|
| Absorbency | 21 CFR 801.430 for Syngina absorbency testing; 90% population distribution at 90% confidence within specified ranges for Light, Regular, Super, Super Plus | 90:90 ranges of Light, Regular, Super, and Super Plus absorbencies met the absorbency range requirements defined by 21 CFR 801.430. |
| Chemical Residues (TCDD & TCDF) | EC Regulation 589/2014 (food) and 709/2014 (feed) | No TCDD or TCDF was detectable by this method. |
| Chemical Residues (Pesticides/Herbicides) | Method ASU L00.00-34 | No pesticides (including herbicides) were detected. |
| Extractables (Aqueous) | ISO 10993-12: 2012, ISO 10993-18: 2005 (most closely simulates physiological conditions) | No extractable chemicals were detectable in the aqueous extraction. |
| Extractables (Organic - "harsh conditions") | ISO 10993-12: 2012, ISO 10993-18: 2005 | Very low levels of non-toxic extractables were obtained. |
| Withdrawal Cord Attachment Strength | Australian Standard AS/NZS 2869:1998, minimum attachment strength of 22.4 Newtons (N) for each tampon, average ≥ 28N for each production lot | Each tampon for every absorbency level met the minimum strength of 22.4 N. Each absorbency data set met an average value of ≥ 28N. |
| Fiber Shedding | Internal fiber shed test protocol (no recognized standard available) | The new device does not exhibit the potential to shed more fiber than the predicate device. |
| Biocompatibility (Cytotoxicity) | FDA Blue Book Memorandum #G95-1, ISO 10993-1:2003 | Tested as part of the biocompatibility battery. |
| Biocompatibility (Intracutaneous Irritation) | FDA Blue Book Memorandum #G95-1, ISO 10993-1:2003 | Tested as part of the biocompatibility battery. |
| Biocompatibility (Acute Systemic Toxicity) | FDA Blue Book Memorandum #G95-1, ISO 10993-1:2003 | Tested as part of the biocompatibility battery. |
| Bioburden (Aerobic Bacteria) | European Pharmacopeia 5.1.4, Microbiological Quality of Pharmaceutical Preparations, Category 2 | No more than 29 colony forming units (CFU) of aerobic bacteria were identified on any sample. |
| Bioburden (Yeasts) | European Pharmacopeia 5.1.4, Microbiological Quality of Pharmaceutical Preparations, Category 2 | Zero yeasts were found on any sample. |
| Bioburden (Mold) | European Pharmacopeia 5.1.4, Microbiological Quality of Pharmaceutical Preparations, Category 2 | No more than 5 mold CFUs were found on any sample. |
| Bioburden (Specific Pathogens) | European Pharmacopeia 5.1.4, Microbiological Quality of Pharmaceutical Preparations, Category 2 | No Pseudomonas aeruginosa, Staphylococcus aureus, and enterobacteria or other gram-negative bacteria were detected. |
| Bacteriostatic Effect on S. aureus | USP 30, Chapter 51 (2007): Antimicrobial Effectiveness Testing (adaptation) | The test article did not demonstrate the potential to enhance S. aureus growth. |
| Effect on Normal Vaginal Microflora Growth | USP 31, Chapter 71 (2008): Sterility Tests | The new device did not demonstrate the potential to inhibit the growth of normal vaginal microflora. |
| Effect on Production of S. aureus TSST-1 | Tampon Sac Method with TSST-1 detected by ELISA and plate counting | The new device does not demonstrate the potential to augment TSST-1 relative to current legally marketed tampons. |
| Applicator Colorants | Toxics Substance Control Act Inventory (TSCA), 21 CFR 178.3297 and/or EU Resolution (89)1 compliant; extractables testing confirmed no harmful compounds are bioavailable; conforms with 21 CFR 177-178 | New colorants (Green, Pink, Blue, Pearl White) met all specified characteristics and regulations. |
| Applicator Mold Release Agent | Food grade, conforms with 21 CFR 177-178 | Conforms with 21 CFR 177-178. |
| Applicator Antistatic Agent | Food grade, conforms with 21 CFR 177-178 | Conforms with 21 CFR 177-178. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample sizes" for the test sets beyond mentioning "any sample tested" for bioburden and "each tampon tested for every absorbency level" for withdrawal cord strength. It implies testing was conducted on an adequate number of samples to meet the relevant standards and confidence levels. For example, for absorbency, it states data was "analyzed for 90% population distribution at 90% confidence."
The data provenance is not explicitly stated in terms of country of origin. The testing references European, Australian, and US Pharmacopeia standards, and FDA guidance, suggesting a mix of internationally recognized testing methodologies. The data appears to be prospective as it was generated specifically for the 510(k) submission to demonstrate the safety and effectiveness of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for the performance tests outlined (e.g., absorbency, chemical residues, biocompatibility) is established by adherence to recognized national and international standards and validated testing methodologies, rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. The tests performed are objective, laboratory-based physical, chemical, and microbiological tests against defined standards, not subjective assessments requiring adjudication.
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
Not applicable. This is a medical device (menstrual tampon), not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI-based device.
7. The Type of Ground Truth Used
The "ground truth" used for this device's performance assessment is based on:
- Established Regulatory Standards: For absorbency (21 CFR 801.430), chemical properties (EC Regulations, 21 CFR), and material safety (21 CFR 177-178).
- International Consensus Standards: For biocompatibility (ISO 10993 series) and withdrawal cord strength (AS/NZS 2869:1998).
- Pharmacopeia Standards: For microbiological evaluations (European Pharmacopeia, United States Pharmacopeia).
- FDA Guidance: For pre-clinical microbiological testing (July 27, 2005 Guidance for Menstrual Tampons and Pads).
These standards and methods define the acceptable performance characteristics and are considered the objective "ground truth" for the device's safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).