(20 days)
First Quality Hygienic, Inc. Femtex and Private Label Scented Plastic Applicator tampons are a menstrual tampon 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Femtex and Private Label Scented Plastic Applicator Tampons:
It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study for novel device performance. As such, many of the typical clinical study elements you've requested (like sample sizes for test sets, expert ground truth, MRMC studies, etc.) are not applicable or not present in these types of submissions.
The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing performed to show the device's safety and performance equivalence to existing tampons.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments / Context from Document |
|---|---|---|
| Biocompatibility: Device materials are safe for human contact (non-irritating, non-cytotoxic, non-sensitizing). | All tested components demonstrated acceptable biocompatibility. Results "demonstrate that the tampons are equivalent in terms of safety and effectiveness to legally marketed tampons." | Specific tests performed: irritation testing, cytotoxicity testing, sensitization testing, vaginal irritation testing. These tests confirm the materials used in the tampon (rayon, cotton, fragrance) are suitable for their intended use and do not pose undue biological risks. |
| Absorbency: Tampons meet "Standard Syngyna" absorbency requirements for stated absorbency levels (Light, Regular, Super, Super Plus). | "Standard Syngyna testing confirmed the absorbency of these tampons." | This is a standard in vitro test method for tampon absorbency. The document implies that the absorbency of the various tampon styles/absorbencies met the established limits or were comparable to predicate devices. |
| Substantial Equivalence: The device is as safe and effective as a legally marketed predicate device (K032173). | The FDA determined the device is "substantially equivalent" to the predicate device. | This is the overarching "acceptance criterion" for a 510(k) submission. The non-clinical tests (biocompatibility, absorbency) are submitted as evidence to support this claim. |
Further Details on the "Study" (Non-Clinical Testing)
The document refers to non-clinical testing rather than a traditional clinical study.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the non-clinical tests. These tests typically use laboratory samples of materials or finished products, not human subjects.
- Data Provenance: Not explicitly stated, but it would be laboratory testing data, presumably conducted in the United States or by a qualified lab following international standards. It is retrospective in the sense that the testing was performed on manufactured components/products, not on prospective human cohorts.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For non-clinical tests like biocompatibility and Syngyna absorbency, "ground truth" is established by standard laboratory protocols and measurements, not by expert consensus on individual cases. The interpretation of the results would be done by qualified toxicologists or laboratory personnel.
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Adjudication method for the test set:
- Not Applicable. This concept applies to human reader studies or clinical trials where discordant interpretations might need resolution. Non-clinical lab tests have defined pass/fail criteria.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is a non-clinical device, not an imaging or diagnostic AI device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
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The type of ground truth used:
- Laboratory Standard Results/Measurements: For biocompatibility, the ground truth is established by the outcome of standard toxicology assays (e.g., cell viability in cytotoxicity, animal skin reactions in irritation/sensitization). For absorbency, it's the measured fluid uptake compared to established Syngyna test standards.
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The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an artificial intelligence/machine learning device. The non-clinical tests are performed on the device or its components directly.
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How the ground truth for the training set was established:
- Not Applicable. (As above, no training set).
In summary: The provided 510(k) summary focuses on demonstrating that Femtex and Private Label Scented Plastic Applicator Tampons are substantially equivalent to existing, legally marketed tampons based on standard non-clinical safety (biocompatibility) and performance (absorbency) testing. It explicitly states "Assessment of Performance Standards: Not Applicable" in the summary because it's a predicate-based submission, not a novel device requiring new performance standards to be met. The "study" here is rigorous laboratory testing to confirm material safety and functional absorbency according to established industry and regulatory norms, rather than a clinical trial with human subjects.
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KOSOO67
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.
- irritation testing �
- cytotoxicity testing 0
- sensitization testing 0
- vaginal irritation testing 0
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Image /page/1/Picture/13 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle or other bird with its wings spread. The image is in black and white and appears to be a logo or emblem.
Image /page/1/Picture/3 description: The image shows the text 'FEB - 1 2005' in a simple, sans-serif font. The text is arranged horizontally, with 'FEB' on the left, followed by a hyphen, the number '1', and the year '2005'. The text appears to be a date, indicating February 1, 2005.
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: K050067
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: 85 HIL Dated: January 10, 2005 Received: January 12, 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 the enerosale) to regally manned ate of the Medical Device Amendments, or to devices that have been rear 20, 1770, the clarians 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 do not require approvince of a 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 If your de rio is classino controls. Existing major regulations affecting major regulations affecting your Approval), It may of cashes to and Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA as roo ban of round 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 loase be advisod that i breat your device complies with other requirements of the Act or any I DA has made a decemination and your evel by other Federal agencies. You must comply with all the I cacal statues and regalding, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, metaling practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); 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'lo orgin mating of substantial equivalence of your device to a legally premarked nothleation: "The PDF mailing sification 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 act 100 for your as on 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 on your responsibilities under the Act from the 807.77). Tou may obtain varers, International and Consumer Assistance at its toll-free number (800) DVISION of Offair Manakatarers, ins Internet address http://www.fda.gov/cdrh/dsmadsmamain.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
510(k) Number (if known): Applied for K O 5 0 06 7
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 plasted into the the the First Quality Hyglenic, Inc. I Cintox and that is inserted into the vagina tampons are a play 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)
Nancy Bridgon
(Division Sign-Off) (Division of Reproductive, Abdom and Radiological Device 510(k) Number .
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§ 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).