(42 days)
First Quality Hygienic, Inc. Femtex and Private Label Scented 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 Scented Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid, with fragrance added for aesthetic purposes. The tampons will be provided in five (5) styles/absorbencies: Light, Slender Regular, 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 provided document is a 510(k) premarket notification for Femtex and Private Label Scented Plastic Applicator Tampons. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for establishing acceptance criteria with a study comparing device performance against those criteria as would be done for novel devices or those undergoing a PMA.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the way a medical diagnostic or therapeutic device might. Instead, it focuses on demonstrating equivalence to an existing product through non-clinical testing.
Here's why the requested information cannot be fully provided from this document:
- Acceptance Criteria & Reported Performance: The document states "Assessment of Performance Standards: Not Applicable." This indicates that there are no specific, quantitative performance metrics with associated acceptance criteria like sensitivity, specificity, accuracy, etc., that are being measured and reported against. The focus is on demonstrating safety and general absorbency equivalence.
- Study Details (Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): These are all elements typically found in clinical studies or performance validation studies designed to quantify a device's effectiveness or accuracy in a diagnostic or therapeutic context. This 510(k) submission, for a tampon, relies on biocompatibility testing and absorbency testing to show equivalence to a predicate device.
However, I can extract the information that is present in the document related to testing, even if it doesn't fit the requested format exactly:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (Sensitization) | "The results of these tests demonstrate that the tampons are equivalent in terms of safety and effectiveness to legally marketed tampons." (Specific Pass/Fail criteria not detailed in this summary) |
| Biocompatibility (Vaginal Irritation) | "The results of these tests demonstrate that the tampons are equivalent in terms of safety and effectiveness to legally marketed tampons." (Specific Pass/Fail criteria not detailed in this summary) |
| Absorbency (Standard Syngyna testing) | "Standard Syngyna testing confirmed the absorbency of these tampons." (Specific absorbency values / equivalency metrics not detailed in this summary) |
Note: The document explicitly states "Assessment of Performance Standards: Not Applicable" as the regulatory pathway is substantial equivalence based on predicate device and non-clinical testing, rather than meeting specific quantifiable performance standards like a diagnostic device. The performance is reported as "equivalent in terms of safety and effectiveness" for biocompatibility and "confirmed" for absorbency, without providing numerical acceptance criteria or results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided summary for any of the non-clinical tests (sensitization, vaginal irritation, Syngyna testing).
- Data Provenance: Not specified. These tests are typically laboratory-based non-clinical studies.
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. This information is relevant for studies involving human interpretation (e.g., diagnostic imaging). The tests performed (biocompatibility, absorbency) are non-clinical laboratory tests, not requiring expert consensus on ground truth in the same manner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This information is relevant for studies involving human interpretation or clinical endpoints.
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 type of study is for diagnostic or AI-assisted devices for human interpretation and is not relevant for a tampon.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This type of study is for AI/algorithm-based devices and is not relevant for a tampon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For biocompatibility testing (sensitization, vaginal irritation): Ground truth/determination of safety and equivalence would be based on established toxicological principles and responses observed in standard biological models (e.g., in vitro, animal models).
- For absorbency testing (Standard Syngyna testing): Ground truth is based on the standardized measurement of fluid absorption under controlled laboratory conditions, as defined by the Syngyna method.
8. The sample size for the training set
- Not applicable. This concept pertains to machine learning models, which are not used here.
9. How the ground truth for the training set was established
- Not applicable. This concept pertains to machine learning models, which are not used here.
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KOS1446
JUL 1 4 2005
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 Other Private label Scented Plastic Applicator tampons (K032173).
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 in five (5) styles/absorbencies: Light, Slender Regular, 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.
- sensitization testing �
- vaginal irritation testing �
Image /page/0/Picture/14 description: The image shows the text "GUDGOT" in a bold, sans-serif font. The letters are closely spaced together, and the overall appearance is somewhat distorted. The text is black against a white background.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
First Quality Hygienic, Inc. % Robert J. Staab, Ph.D. Official Correspondent Regulatory and Technical Associates 73 Franklin TPK. ALLENDALE NJ 07401
Re: K051446
JUL 1 4 2005
Trade/Device Name: Femtex and 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: HIL Dated: May 31, 2005 Received: June 29, 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 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) This letter will anow you'to organization of substantial equivalence of your device to a legally premarket notification: "The PDF mining of Station 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 active for your 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, prease note the regulation enners information on your responsibilities under the Act from the 807.77). Tournal 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/industry/support/index.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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Indications for Use
KOS1446 510(k) Number (if known):_Applied for
Device Name: First Quality Hygienic, Inc. Femtex and Private Label Scented Plastic Applicator Tampons
Indications For Use:
As a Class II Device, the menstrual tampon is defined as follows: (21CFR884.5460 and 21CFR 884 5470).
First Quality Hygienic, Inc. Femtex and Private Label Scented 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR .
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancyc hogdon
(Division Sign-Off)
Division of Reproductive, Abdom and Radiological Devic " (k) Number,
Page 1 of
§ 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).