FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS

• K Number: K031067
• Device Name: FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS
• Manufacturer: FIRST QUALITY HYGIENIC, INC.
• Date Cleared: 2003-07-14 ( 101 days)
• Product Code: HEB
• Regulation Number: 884.5470
• Type: Traditional
• Panel: Obstetrics/Gynecology
• Reference & Predicate Devices: K060417 , K113426 , K954848 , K931267 , K042079 , K073280 , K002361 , K960906 , K011158 , K021303 , K142475 , K940562 , K040292 , K100494 , K172288
• Predicate For: N/A

Intended Use

First Quality Hygienic slender regular and Junior tampons are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge

Device Description

Femtex Junior and Slender Regular Tampons are menstrual tampons used to absorb menstrual fluid. These Femtex Open-End Tampons will be provided with 2 absorbencies: Slender Regular and Junior.

Femtex Open-End Junior and Slender Regular Tampons are made from rayon absorbent, cotton cord and cotton sewing thread.

The material used in Femtex Open-End Junior and Slender Regular Tampons are similar to those used in other legally marketed tampons.

AI/ML Overview

The provided text is for a 510(k) premarket notification for Femtex Open-End Tampons. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way medical AI/imaging devices typically do.

Therefore, the requested information elements related to acceptance criteria, specific performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in this context.

Here's why and what information can be extracted:

• Type of Device: Menstrual Tampons. These are Class II medical devices, and their regulatory pathway (510(k)) primarily requires demonstrating substantial equivalence, especially in terms of materials, absorbency, and safety (biocompatibility), rather than demonstrating diagnostic accuracy or efficacy through clinical studies with complex statistical endpoints.
• Performance Standards: The document explicitly states "Assessment of Performance Standards: Not Applicable" under "Non-Clinical Testing."
• "Study" Conducted: The non-clinical testing performed involves biocompatibility testing and Syngyna testing for absorbency. These are standard tests for tampons to ensure safety and function, but they don't generate the kind of data typically requested for AI device studies.

Information that can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria/Standards: The criteria are implicitly tied to the performance of the legally marketed predicate device and general safety standards for similar devices. Specifically mentioned are:
     • Biocompatibility (irritation, oral toxicity, cytotoxicity).
     • Absorbency (confirmed by Standard Syngyna testing).
   • Reported Device Performance:
     • Biocompatibility testing "demonstrate that the Femtex Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons."
     • Standard Syngyna testing "confirmed the absorbency of the Femtex Tampons."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not specified. The document mentions "review of existing toxicological data in the public literature" and "tests have been conducted on components relevant to the safety of Femtex tampons." The sample sizes for these specific component tests are not detailed.
   • Provenance is not mentioned for the testing itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. The "ground truth" for tampon performance is established by standardized physical/chemical tests (e.g., Syngyna for absorbency, lab tests for cytotoxicity), not expert clinical review in the sense of diagnostic imaging.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable.

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 not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For biocompatibility: Laboratory assays for irritation, oral toxicity, and cytotoxicity, likely compared against established safety thresholds.
   • For absorbency: Results from the "Standard Syngyna testing," which is a standardized laboratory method for measuring menstrual tampon absorbency.

8. The sample size for the training set:

   • Not applicable. This is not an AI device, so there is no concept of a "training set" in this context.

9. How the ground truth for the training set was established:

   • Not applicable.

Summary

{0}------------------------------------------------

JUL 1 4 2003

K031067 510K SUMMARY

Device Name: Private Label and Femtex Open-End Tampons

Legally marketed device: These Femtex Junior and Slender Regular Tampons are substantially equivalent to legally marketed Femtex tampons with open-end applicators.

Device description: Femtex Junior and Slender Regular Tampons are menstrual tampons used to absorb menstrual fluid. These Femtex Open-End Tampons will be provided with 2 absorbencies: Slender Regular and Junior.

Femtex Open-End Junior and Slender Regular Tampons are made from rayon absorbent, cotton cord and cotton sewing thread.

The material used in Femtex Open-End Junior and Slender Regular Tampons are similar to those used in other legally marketed tampons.

Intended Use: Femtex Open-End Junior and Slender Regular 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: Biocompatability testing of the Femtex Junior and Slender Regular Tampons' components was reviewed. The results of these tests demonstrate that the Femtex Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of the Femtex 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 tampons.

• ◇ irritation testing
• 0 oral toxicity testing
• cytotoxicity testing �

---

Image /page/0/Picture/14 description: The image shows a series of zeros, specifically six zeros in a row. The zeros are written in a slightly irregular font, giving them a somewhat handwritten appearance. The image is in black and white, with the zeros appearing as dark shapes against a light background.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2003

First Quality Hygienic, Inc. % Robert J. Stabb. Ph.D. Official Correspondent Regulatory and Technical Associates 73 Franklin TPK. ALLENDALE NJ 07401

Re: K031067

Trade/Device Name: First Quality Hygienic and Other Private Label Slender Regular and Junior Tampons Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampons Regulatory Class: II Product Code: 85 HEB Dated: April 2, 2003 Received: May 30, 2003

Dear Dr. Stabb:

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.

{2}------------------------------------------------

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	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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}------------------------------------------------

Ver/ 3 - 4/24/96	K031067
Applicant:	First Quality Hygienic
510(k) Number (if known):	applied for
Device Name:	First Quality Hygienic and other Private LabelSlender Regular and Junior tampons
Indications For Use:

As a Class II device, the menstrual tampon is defined as follows
(21CFR884.5460 and 21CFR884.5470)

First Quality Hygienic slender regular and Junior tampons
are a plug made of cellulosic or synthetic material that is
inserted into the vagina and used to absorb menstrual or other v
vaginal discharge

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

David A. Symm

(Division Sig ar 510k

Over-The-Counter Use

Regulation Number and Section

§ 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).