(49 days)
Femtex and Private label Scented Plastic Applicator Tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
As defined in 21 CFR 884.5460 and 21 CFR 884.5470, First Quality Hygienic Femtex and Other Private Label Scented Plastic Applicator Tampons, a Class II device, are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Femtex and Private label Scented Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid, with fragrance added for aesthetic purposes. The tampons will be provided with 4 absorbencies, Junior, Regular, Super and Super Plus with a plastic applicator.
Femtex and Private label Scented Plastic Applicator Tampons are made from rayon absorbent, cotton cord and cotton sewing thread, and added fragrance
The material used in Femtex and Private label Scented Plastic Applicator Tampons are similar to those used in other legally marketed tampons.
The provided text is a 510(k) summary for "Femtex and Private label Scented Plastic Applicator Tampons." It describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information, addressing the points requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Method) | Reported Device Performance (Result and Conclusion) |
|---|---|---|
| Biocompatibility | No specific criteria quantified, but "equivalent in terms of safety and effectiveness to legally marketed tampons" is the overarching goal. | - Irritation testing: Results not detailed, but stated as "0 irritation testing" (implies none or no irritation found). - Cytotoxicity testing: Results not detailed, but stated as "0 cytotoxicity testing" (implies none or no cytotoxicity found). - Sensitization testing: Results not detailed, but stated as "0 sensitization testing" (implies none or no sensitization found). - Vaginal irritation testing: Results not detailed, but stated as "0 vaginal irritation testing" (implies none or no vaginal irritation found). |
| Absorbency | Standard Syngyna testing to confirm declared absorbencies (Junior, Regular, Super, Super Plus). | "Standard Syngyna testing confirmed the absorbency of these tampons." (Specific absorbency values for each size are not provided in this summary, but the general criteria of confirmation was met). |
| Material Composition | Materials similar to legally marketed tampons. | "The material used in Femtex and Private label Scented Plastic Applicator Tampons are similar to those used in other legally marketed tampons." (Material listed: rayon absorbent, cotton cord, cotton sewing thread, fragrance). |
| Fragrance Safety | Biocompatibility tests imply safety of added fragrance. | Included in the "0 irritation testing," "0 cytotoxicity testing," "0 sensitization testing," and "0 vaginal irritation testing" for the overall tampon, which includes the fragrance. |
2. Sample Size Used for the Test Set and the Data Provenance
The 510(k) summary does not explicitly state the sample sizes for the non-clinical tests (irritation, cytotoxicity, sensitization, vaginal irritation, Syngyna absorbency). It refers to "tests have been conducted" but does not give numerical sample sizes for these tests.
The data provenance is retrospective, as the submission refers to the review of "existing toxicological data in the public literature" in addition to the new tests conducted. The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document does not describe the use of human experts to establish "ground truth" in the way it would for a diagnostic device (e.g., expert radiological review). The tests performed (biocompatibility, Syngyna absorbency) are laboratory-based and rely on established scientific methods and instrumentation rather than expert interpretation of a 'test set' in the context of disease diagnosis. Therefore, this information is not applicable to this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. As explained in point 3, the "test set" here refers to samples of the tampon material undergoing laboratory tests, not a set of cases requiring human expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This is a 510(k) premarket notification for a medical device (tampon), not a diagnostic algorithm. Therefore, an MRMC comparative effectiveness study, which is typically used for assessing reader performance with and without AI assistance in diagnostic imaging, was not performed and is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical product (tampon), not an algorithm or AI system. Its performance is intrinsic to the product itself, not an algorithm's output.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the established scientific methods and accepted safety/performance profiles for tampons.
- Biocompatibility: Absence of irritation, cytotoxicity, or sensitization as determined by standardized laboratory assays. The "ground truth" is that the materials do not elicit adverse biological responses.
- Absorbency: The absorbency capacity as measured by the Syngyna test, which is a standardized method for determining tampon absorbency. The "ground truth" is the measured absorbency value, which is then compared against established ranges for stated absorbencies (Junior, Regular, Super, Super Plus).
- Material Equivalence: The composition of the materials used in the new device must be similar to those in legally marketed predicate devices. "Ground truth" here is the established safety and performance of existing, cleared tampon materials.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI or machine learning model 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 a physical device like a tampon.
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SEP - 3 2003
¥032173 510K SUMMARY
Device Name: Femtex and Private label Scented Plastic Applicator Tampons
Legally marketed device: These Femtex and Private label Scented Plastic Applicator Tampons are substantially equivalent to legally marketed Femtex and Private label Plastic Applicator tampons.
Device description: Femtex and Private label Scented Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid, with fragrance added for aesthetic purposes. The tampons will be provided with 4 absorbencies, Junior, Regular, Super and Super Plus with a plastic applicator.
Femtex and Private label Scented Plastic Applicator Tampons are made from rayon absorbent, cotton cord and cotton sewing thread, and added fragrance
The material used in Femtex and Private label Scented Plastic Applicator Tampons are similar to those used in other legally marketed tampons.
Intended Use: Femtex and Private label Scented Plastic Applicator Tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Assessment of Performance Standards: Not Applicable
Non-Clinical Testing: Biocompatibility testing of the Femtex and Private label Scented Plastic Applicator Tampons was reviewed. The results of these tests demonstrate that the tampons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of these tampons. In addition to the review of existing toxicological data in the public literature, the following tests have been conducted on components relevant to the safety of Femtex scented plastic applicator tampons.
- 0 irritation testing
- 0 cytotoxicity testing
- � sensitization testing
- 0 vaginal irritation testing
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Image /page/1/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings. The logo is black and white and appears to be a seal or emblem.
Food and Drug Administration 00 Corporate Boulevard Rockville MD 20850
SEP - 3 2003
First Quality Hygienic, Inc. % Robert J. Staab, Ph.D. Official Correspondent Regulatory and Technical Associates 73 Franklin TPK ALLENDALE NJ 07401
Re: K032173
Received: July 21, 2003
Trade/Device Name: Femtex and Other Private Label Scented Plastic Applicator Tampons Regulation Number: 21 CFR 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: 85 HIL Dated: July 14, 2003
Dear Dr. Staab:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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U.S. Food and Drug Adn
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
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510(k) Number (if known): Ko3217 3
First Quality Hygienic Femtex and Other Private Label Scented Device Name: Plastic Applicator Tampons_
Indications for Use; Statement of Indications for Use: As defined in 21 CFR 884.5460 and 21 CFR 884.5470, First Quality Hygienic Femtex and Other Private Label Scented Plastic Applicator Tampons, a Class II device, are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
David G. Legmann
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices KA32173
510(k) Number
Over-The-Counter Use
§ 884.5460 Scented or scented deodorized menstrual tampon.
(a)
Identification. A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).