(58 days)
Femtex and Private Label Plastic Applicator Tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Femtex and Private Label Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. The tampons will be provided in Regular absorbency within a slender plastic applicator.
Femtex and Private Label Slender Regular Plastic Applicator Tampons are made from rayon absorbent, cotton cord and cotton sewing thread.
The material used in Femtex and Private Label Slender Regular Plastic Applicator Tampons are similar to those used in other legally marketed tampons.
The provided text is for a 510(k) premarket notification for Femtex and Private Label Slender Regular Plastic Applicator Tampons. This document focuses on demonstrating substantial equivalence to a previously marketed device (K023479), rather than establishing new acceptance criteria or proving performance through a study against specific criteria. Therefore, much of the requested information regarding acceptance criteria, specific study design, and performance metrics is not explicitly stated or applicable in this type of regulatory submission.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the 510(k) summary. The document does not define specific quantitative acceptance criteria (e.g., minimum absorbency in Syngyna testing) that the new device must meet. Instead, it relies on the predicate device's established safety and effectiveness.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as quantitative criteria for this submission. | No specific performance values were reported for the new device as compared to explicitly defined acceptance criteria. |
| Biocompatibility (Cytotoxicity, Sensitization, Vaginal Irritation) | "The results of these tests demonstrate that the tampons are equivalent in terms of safety and effectiveness to legally marketed tampons." (Implicitly, the new device met the same standards as the predicate). |
| Absorbency (Syngyna testing) | "Standard Syngyna testing confirmed the absorbency of these tampons." (Implies absorbency is within an acceptable range, likely comparable to the predicate, but specific values or criteria are not given). |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated.
- Data Provenance: The document states "review of existing toxicological data in the public literature" and that "the following tests have been previously conducted on components relevant to the safety of Femtex plastic applicator tampons." This suggests that some of the data might be retrospective or historical, potentially from previous testing on similar components or the predicate device. However, it also mentions "Standard Syngyna testing confirmed the absorbency of these tampons," which implies some current testing was performed on the new device, but the details of the test set are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable and therefore not provided. The 510(k) submission for tampons does not involve expert-based ground truth establishment in the way medical diagnostic devices do. The assessments are based on laboratory testing (biocompatibility, absorbency) against defined standards or equivalency to a predicate.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. Given the nature of the non-clinical tests (biocompatibility, Syngyna absorbency), no expert adjudication method (like 2+1, 3+1) would be employed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. It is not applicable to a menstrual tampon.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone study was not done. This concept is relevant for AI algorithms without human intervention. A menstrual tampon is a physical device, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for the non-clinical testing appears to be based on:
- Established Biocompatibility Standards: The results of cytotoxicity, sensitization, and vaginal irritation testing would be compared against recognized biological safety standards for medical devices and/or data from the predicate device to establish safety.
- Standard Absorbency Measurement (Syngyna Test): The absorbency of the tampons is measured quantitatively using a standardized laboratory method (Syngyna test), which provides an objective ground truth for absorbency.
8. Sample Size for the Training Set:
This information is not applicable and therefore not provided. Training sets are relevant for machine learning algorithms. The provided document concerns a physical medical device.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and therefore not provided. (See point 8).
{0}------------------------------------------------
MAY 1 2 2005
510K SUMMARY
Device Name: Femtex and Private Label Slender Regular Plastic Applicator Tampons
Legally marketed device: These Femtex and Private Label Slender Regular Plastic Applicator Tampons are substantially equivalent to legally marketed Femtex and other Private Label Plastic Applicator tampons (K023479).
Device description: Femtex and Private Label Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. The tampons will be provided in Regular absorbency within a slender plastic applicator.
Femtex and Private Label Slender Regular Plastic Applicator Tampons are made from rayon absorbent, cotton cord and cotton sewing thread.
The material used in Femtex and Private Label Slender Regular Plastic Applicator Tampons are similar to those used in other legally marketed tampons.
Intended Use: Femtex and Private Label 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 Slender Regular 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 previously conducted on components relevant to the safety of Femtex plastic applicator tampons.
- cytotoxicity testing �
- sensitization testing �
- vaginal irritation testing �
6000007
{1}------------------------------------------------
Image /page/1/Picture/2 description: The image shows a logo with a stylized bird in the center. The bird is facing left and has three lines representing its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the bird. The text is in uppercase letters and is evenly spaced around the circle.
MAY 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
First Quality Hygienic, Inc. c/o Robert J. Staab, Ph.D. Official Correspondent Regulatory & Technical Associates 73 Franklin Tpk. ALLENDALE NJ 07401
Re: K050660
Trade/Device Name: First Quality Hygienic Femtex and Other Private Label Unscented Slender Regular Plastic Applicator Tampons Regulation Number: 21 CFR §884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: March 14, 2005 Received: April 7, 2005
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 (Premarket Approval), it may be subject to such 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 I reaso or arrison that your device complies with other requirements of the Act or any I Dri mas mass and regulations administered by other Federal agencies. You must comply with all the I ou'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) (2) CFR Part 800); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{2}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin manceing your and equivalence of your device to a legally premarket nothication. The PDA mainly of bassification 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 If you desire specific advice for your device of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entition, "Thisoranana on your responsibilities under the Act from the 807.97). You may odiali other general massass and Consumer Assistance at its toll-free number (800) DYNSIon of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmam.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
{3}------------------------------------------------
KOSO660 Indications for Use
Device Name:
- e Name:
A. Device Name: Unscented Slender Regular Plastic Applicator Tampons Device Name: Unscented Siehoer Regular Pregular Plastic Applicator Tampons
Indications For Use:
As a Class II Device, the menstrual tampon is defined as follows: (21CFR884.5460 and 21CFR 884 5470).
21CFR 884 5470).
Femtex and Private I abel Plastic Applicator Tampons are a plug of Cellulosic or Femtex and Private Tabel Plastic Applicator Tampons and upg of Collusion
synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Page 1 of
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdo and Radiological Device 510(k) Number.
Over-the-Counter Use.
§ 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).