(24 days)
Paragon Trade Brands Digital tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
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.
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.
The provided text describes the 510(k) summary for "Paragon Trade Brand Digital Tampons." However, the device is not an AI/ML device, but rather a traditional medical device (menstrual tampons). Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission.
Here's the relevant information that can be extracted from the provided text, structured according to your request, with "Not Applicable" for AI/ML specific criteria:
Acceptance Criteria and Device Performance for Paragon Trade Brand Digital Tampons
This submission describes a traditional medical device (menstrual tampons), not an AI/ML device. Therefore, the acceptance criteria and study details are focused on traditional medical device safety and performance, primarily demonstrating substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Material Safety | Biocompatibility | "equivalent in terms of safety and effectiveness to legally marketed tampons" |
| Irritation Testing | Not explicitly reported for this device, but "Relevant Studies from the literature include" irritation testing. | |
| Sensitization Testing | Not explicitly reported for this device, but "Relevant Studies from the literature include" sensitization testing. | |
| Acute Oral Toxicity | Not explicitly reported for this device, but "Relevant Studies from the literature include" acute oral toxicity. | |
| Eye Irritation Testing | Not explicitly reported for this device, but "Relevant Studies from the literature include" eye irritation testing. | |
| Gene Toxicology Studies | Not explicitly reported for this device, but "Relevant Studies from the literature include" gene toxicology studies. | |
| Chronic Studies | Not explicitly reported for this device, but "Relevant Studies from the literature include" chronic studies. | |
| Reproductive Studies | Not explicitly reported for this device, but "Relevant Studies from the literature include" reproductive studies. | |
| Cytotoxicity Testing | Conducted for Paragon Trade Brands Components. Implied compliance with safety standards. | |
| Dioxins and Furans Analysis | Conducted for Paragon Trade Brands Components. Implied compliance with safety standards. | |
| Functional Performance | Absorbency (Syngyna Test) | "Standard Syngyna testing confirmed the absorbency of these Tampons." |
| Substantial Equivalence | Comparison to Predicate Device (Tampax) | Deemed "substantially equivalent" to legally marketed Tampax tampons with applicators. Materials and intended use are similar. |
2. Sample size used for the test set and the data provenance
Not Applicable (N/A) for AI/ML test sets. The non-clinical testing involved material characterization and absorbency testing (Syngyna testing). The text does not specify the sample sizes for these tests, nor the "country of origin of the data" in a way relevant to clinical data. The studies performed were non-clinical bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A for AI/ML-style ground truth. The "ground truth" here is based on chemical and physical testing standards for biocompatibility and absorbency, not expert human interpretation of images or other data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. This concept applies to expert consensus in AI/ML performance evaluation, which is not relevant here.
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
N/A. This device is a tampon, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device is a tampon, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established through standardized non-clinical laboratory testing (e.g., biocompatibility assays, Syngyna absorbency testing) and comparison to the known safety and performance of legally marketed predicate devices (Tampax tampons).
8. The sample size for the training set
N/A. This device is not an AI/ML model and does not have a "training set."
9. How the ground truth for the training set was established
N/A. This device is not an AI/ML model and does not have a "training set" with associated ground truth.
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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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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
§ 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).