(24 days)
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No
The 510(k) summary describes a standard menstrual tampon and does not mention any AI or ML components or functionalities. The testing described is related to material safety and absorbency, not software or algorithmic performance.
No.
The device is described as a menstrual tampon used to absorb menstrual fluid, which is not a therapeutic function. Therapeutic devices are designed to treat or alleviate a disease or medical condition.
No
The device description clearly states it is a menstrual tampon used to absorb menstrual fluid, and its intended use is for absorption, not diagnosis. The performance studies focus on safety and absorbency, not diagnostic capabilities.
No
The device description clearly states the device is made of physical materials (rayon and cotton) and is a physical object (a tampon) intended for insertion. It does not describe any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to absorb menstrual fluid by insertion into the vagina. This is a physical function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is described as a plug of material for absorption. This aligns with a physical device, not a diagnostic reagent or instrument.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic to diagnose a condition.
- 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 the accuracy of a diagnostic test.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such a function.
N/A
Intended Use / Indications for Use
Paragon Trade Brands Digital Tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Product codes
85 HEB
Device Description
Paragon Trade Brands Digital Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, regular, super and super plus. These Paragon Trade Brands Tampons are made from rayon and cotton and cotton cord. The material used in Paragon Trade Brand tampons are similar to those used in other legally marketed tampons.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
vagina
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: biocompatibility testing of the Paragon Trade Brands Tampons components was carried out. The results of these tests demonstrate that these 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 were conducted relevant to the safety of Paragon Trade Brand Digital tampons. Relevant Studies form the literature include: - irritation testing - sensitization testing - acute oral toxicity - eye irritation testing - gene toxicology studies - chronic studies - reproductive studies Studies carried out specific to Paragon Trade Brands Components include: - cytotoxicity testing - dioxins and furans analysis
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
VII
510K SUMMARY
Device Name: Paragon Trade Brand Digital Tampons
Legally marketed device: These Tampons are substantially equivalent to legally marketed Tampax tampons with applicators.
Device description: Paragon Trade Brands Digital Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, regular, super and super plus.
These Paragon Trade Brands Tampons are made from rayon and cotton and cotton cord.
The material used in Paragon Trade Brand tampons are similar to those used in other legally marketed tampons.
Intended Use: Paragon Trade Brands Digital 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 Paragon Trade Brands Tampons components was carried out. The results of these tests demonstrate that these 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 were conducted relevant to the safety of Paragon Trade Brand Digital tampons.
Relevant Studies form the literature include:
- � irritation testing
- 0 sensitization testing
- 0 acute oral toxicity
- 0 eye irritation testing
- 0 gene toxicology studies
- 0 chronic studies
- 0 reproductive studies
Studies carried out specific to Paragon Trade Brands Components include:
- 0 cytotoxicity testing
- 0 dioxins and furans analysis
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 1998
Paragon Trade Brands c/o Robert J. Staab, Ph.D. Regulatory and Technical Associates 73 Franklin Tpk. Allendale, NJ 07401
Re: K983381
Paragon Trade Brands Tampons Dated: September 23, 1998 Received: September 25, 1998 Regulatory Class: II 21 CFR 884.5470/Procode: 85 HEB
Dear Dr. Staab:
We have reviewed vour Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 probibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 80) and additionally 809,10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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
Lillian Yin, Ph.D.
Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT XI
Page of
510(k) NUMBER (IF KNOWN): K98336)
DEVICE NAME: Various Trade-Tampons-sold under private Label INDICATIONS FOR USE:
Intended Use
As a Class II device, the menstrual tampon is defined as follows: (21 CFR 884.5460 and 21 CFR 884.5470)
Paragon Trade Brands Digital Tampons are made of a plug of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE 4 1 - 1 IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use ( (Optional Format 1-2-96)
Yurid h. Seaymon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number