(49 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and absorbency of tampons, with no mention of AI or ML.
No.
The device is described as a menstrual tampon used to absorb menstrual fluid, not to treat or diagnose a disease or condition.
No
Explanation: The document describes tampons, which are used for absorbing menstrual fluid, not for diagnosing any medical condition. Their function is purely absorptive.
No
The device is a physical tampon made of cellulosic or synthetic material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to absorb menstrual fluid." This is a physical function within the body, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details the materials and function of a tampon, which is a physical absorbent device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, or tissue), detecting specific markers, or providing diagnostic information about a disease or condition.
- Regulatory Classification: The device is classified under 21 CFR 884.5460 and 21 CFR 884.5470, which are regulations for menstrual tampons, not IVDs.
- Performance Studies: The performance studies focus on biocompatibility and absorbency, which are relevant to the physical function and safety of a tampon, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
85 HIL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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.
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 | (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
3
U.S. Food and Drug Adn
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
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Page __ of_
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