(28 days)
Unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the placement of the tampon correctly into the vagina.
The Opal by Femtex Pull & Snap Unscented Compact Applicator Tampon is an unscented, compact menstrual tampon. It is intended for over-the-counter use for women's personal hygiene with respect to intra-vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the placement of the tampon correctly into the vagina. The tampon itself is made of a strip of viscose rayon fibers in which a cord is inserted. A thin strip of nonwoven fiber covers the tampon, and the tampon is pressed firmly together. The applicator tubes are made of polyethylene (PE) and Polypropylene (PP) and include a barrel and a two-piece plunger. The assembled tampon with applicator is wrapped in a printed PE wrapper. The tampons are marketed in Regular, Super, and Super Plus absorbencies.
The provided document is a 510(k) premarket notification for a medical device: "Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Regular, Super, and Super Plus."
This document describes the regulatory approval process for a menstrual tampon, not an AI/ML powered medical device. Therefore, the questions related to AI/ML specific concepts like test sets, training sets, ground truth, experts, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance are not applicable to this document.
However, I can extract the acceptance criteria and performance data for this device based on the non-clinical testing performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Syngyna Absorbency | Absorbency range requirements defined by 21 CFR 801.430 for Regular, Super, and Super Plus. | It was confirmed that the Regular, Super, and Super Plus absorbencies met the absorbency range requirements defined by 21 CFR 801.430. Specific absorbency ranges: Regular (6.0 - 9.0 g), Super (9.0 - 12.0 g), Super Plus (12.0 - 15.0 g). The "Light" absorbency listed for the predicate device (≤ 6 g) is not applicable to the subject device, which specifies Regular, Super, and Super Plus. |
| Extractables Testing | No safety concerns based on extractables. | Extractables testing was performed on all applicator components per <USP 1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems. Results of Extraction testing did not raise safety concerns. |
| Withdrawal Cord Attachment Strength | Minimum attachment strength of 22.4 Newtons (N) per AS/NZS 2869:1998 for each tampon tested. Each production lot's average value must be ≥ 28 N. | Each tampon tested for every absorbency level met the Australian Standard AS/NZS 2869:1998, Tampons-Menstrual, minimum attachment strength requirement of 22.4 Newtons (N). Each absorbency data set met an average value of ≥ 28N, which is the Standard's requirement for each production lot. |
| Fiber Shedding | Not shedding more fiber than the predicate device. | Fiber shed testing for the subject device demonstrated that it does not exhibit the potential to shed more fiber than the predicate device. (Note: This is a comparative criterion, not an absolute threshold mentioned in this document.) |
Since this is a submission for a physical medical device (tampon), the following points are not relevant to the provided text and would be N/A (Not Applicable):
2. Sample size used for the test set and the data provenance: N/A (Not an AI/ML study)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI/ML study)
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A (Not an AI/ML study)
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 (Not an AI/ML study)
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A (Not an AI/ML study)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (Not an AI/ML study; ground truth for physical device testing typically refers to reference standards or validated measurement methods, which are implicitly covered by the "Acceptance Criteria" column above).
8. The sample size for the training set: N/A (Not an AI/ML study)
9. How the ground truth for the training set was established: N/A (Not an AI/ML study)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2016
First Quality Hygienic, Inc. Melanie Leibowitz Director of Regulatory Affairs 121 North Road McElhattan, PA 17748
Re: K161877
Trade/Device Name: Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Regular, Super, and Super Plus Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: July 6, 2016 Received: July 8, 2016
Dear Melainie Leibowitz,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Douglas Silverstein -S 2016.08.05 10:43:37 -04'00'
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161877
Device Name
Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Regular, Super, and Super Plus
Indications for Use (Describe)
Unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the placement of the tampon correctly into the vagina.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for First Quality Hygienic. The logo features a stylized blue square with a smaller square inside, connected to the text "First Quality" in a bold, blue font. Below "First Quality" is the word "HYGIENIC" in a smaller, gray font.
510(k) Summary K161877
1 Submitter's Information:
Name and Address
First Quality Hygienic, Inc. 121 North Road McElhattan, PA 17748
Establishment Registration Number
2529605
Telephone Number and Fax Number:
+1 (516) 498-3665 Tel: Fax: +1 (516) 829-4949
Contact Person:
Melanie Leibowitz Director of Regulatory Affairs
- 2 Date 510(k) Summary Prepared: 04/08/2016
Regulatory Description: 3
Trade Name: Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Regular, Super, and Super Plus Common Name: Unscented Menstrual Tampon Classification Name: Tampon, Menstrual, Unscented Regulation Description: Unscented Menstrual Tampon 21 CFR 884.5470 Regulation Number: Class: II Product Code: HEB (tampon, menstrual, unscented)
4 Legally Marketed Device to Which Substantial Equivalence is Claimed:
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light, Regular, Super, and Super Plus (K151470)
5 Description of the Device:
The Opal by Femtex Pull & Snap Unscented Compact Applicator Tampon is an unscented, compact menstrual tampon. It is intended for over-the-counter use for women's personal hygiene with respect to intra-vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the placement of the tampon correctly into the vagina. The tampon itself is made of a strip of viscose rayon fibers in which a cord is inserted. A thin strip of nonwoven fiber covers the tampon, and the tampon is pressed firmly together. The applicator tubes are made of polyethylene (PE) and Polypropylene (PP) and include a barrel and a two-piece plunger. The assembled
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Image /page/4/Picture/0 description: The image is a logo for First Quality Hygienic. The logo features a blue square with a white "Q" inside of it. To the right of the square is the text "First Quality" in a bold, blue font. Below that is the word "HYGIENIC" in a smaller, gray font.
tampon with applicator is wrapped in a printed PE wrapper. The tampons are marketed in Regular, Super, and Super Plus absorbencies.
6 Indications for Use:
Indications for Use
Unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the placement of the tampon correctly into the vagina.
These are the same Indications for Use as the Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light, Regular, Super, and Super Plus (K151470) predicate device.
7 Summary of Technological Characteristics Compared to the Predicate Device:
The Opal by Femtex Pull & Snap Compact Applicator Tampon is a modification of the Opal by Femtex and Private Label Unscented Compact Applicator Tampon K151470 device. The modifications do not change the technological characteristics of the predicate device in that they do not change the tampon pledget design, the tampon pledget materials or chemical composition, or the way the tampon pledget is physically constructed (i.e., formation of fiber, method of nonwoven application, and method of compression). The modifications include material and physical design changes to the applicator and minor modifications to the pledget weights and dimensions. The table below provides a detailed comparison.
| Characteristic | Opal by Femtex Pull & Snap andPrivate Brand UnscentedCompact Applicator Tampon | Opal by Femtex and PrivateBrand Unscented CompactApplicator Tampon 510(k)K151470 |
|---|---|---|
| Classification Regulation | 884.5470 | 884.5470 |
| Product Code | HEB | HEB |
| Indications for Use | For Over-The-Counter Use:Unscented tampon for women'spersonal hygiene with respect tointra vaginal absorption ofmenstrual or other vaginaldischarge. The plastic applicator isfor easing the placement of thetampon correctly into the vagina. | For Over-The-Counter Use:Unscented tampon for women'spersonal hygiene with respect tointra vaginal absorption ofmenstrual or other vaginaldischarge. The plastic applicator isfor easing the placement of thetampon correctly into the vagina. |
| Sterile? | No | No |
Subject and Predicate Device Technological Characteristic Comparisons
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Image /page/5/Picture/0 description: The image is a logo for First Quality Hygienic. The logo features a blue square with a smaller square inside of it. To the right of the square is the text "First Quality" in a stylized font, with the word "Hygienic" underneath in a smaller font. The colors used in the logo are blue and white.
| Tampon Design | Digital tampon with round tip andstraight grooves | Digital tampon with mushroomshape tip and straight grooves | |
|---|---|---|---|
| Applicator Design | Compact style applicator withcylindrical barrel with finger gripand two-piece plunger | Compact style applicator withcylindrical barrel and one-pieceplunger | |
| Absorbency | Light | N/A | ≤ 6 g |
| Regular | 6.0 - 9.0 g | 6.0 - 9.0 g | |
| Super | 9.0 - 12.0 g | 9.0 - 12.0 g | |
| Super Plus | 12.0 - 15.0 g | 12.0 - 15.0 g | |
| Absorbent Material | Viscose Rayon | Viscose Rayon | |
| Nonwoven Overwrap Material | PE/PET Nonwoven—Conformswith 21 CFR 177-178 | ||
| Withdrawal Cord | 100% Cotton | 100% Cotton | |
| Applicator Tube | Toxic Substance Control Act Inventory (TSCA) Listed Resins and additives are 21 CFR 177-178 compliant Colorants are 21 CFR 178.3297 compliant USP 1663 Extraction testing confirmed that no harmful compounds are bioavailable | Toxic Substance Control Act Inventory (TSCA) Listed Resins and additives are 21 CFR 177-178 compliant Colorants are 21 CFR 178.3297 and/or EU Resolution (89)1 compliant | |
| Primary Packaging (i.e.wrapper) | Printed PE Toxic Substance Control Act Inventory (TSCA) Listed Resins and additives are 21 CFR 177-178 compliant Colorants are 21 CFR 178.3297 compliant | Printed PP Toxic Substance Control Act Inventory (TSCA) Listed Resins and additives are 21 CFR 177-178 compliant Colorants are 21 CFR 178.3297 compliant |
8 Non-Clinical Performance Data:
The following testing was performed:
Syngyna Absorbency
Absorbency testing for the new device was performed per the 21 CFR 801.430 for Syngina absorbency testing, and it was confirmed that the Regular, Super, and Super Plus absorbencies met the absorbency range requirements defined by 21 CFR 801.430.
Extractables Testing and Biocompatibility Review
Extractables testing was performed on all applicator components per <USP 1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems. Results of Extraction testing did not raise safety concerns.
Withdrawal cord attachment per AS 2869-2008, Tampons-Menstrual
Withdrawal cord attachment strength testing for the new device was performed per
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Image /page/6/Picture/0 description: The image is a logo for First Quality Hygienic. The logo features a blue square with a white "Q" inside of it. To the right of the square is the text "First Quality" in a bold, blue font. Below the text "First Quality" is the word "HYGIENIC" in a smaller, gray font.
Australian Standard AS/NZS 2869:1998, Tampons-Menstrual. Each tampon tested for every absorbency level met the Standard's minimum attachment strength requirement of 22.4 Newtons (N). Each absorbency data set met an average value of ≥ 28N, which is the Standard's requirement for each production lot.
Fiber shedding
Fiber shed testing for the subject device demonstrate that it does not exhibit the potential to shed more fiber than the predicate device.
9 Conclusion:
The performance testing demonstrate that the Opal by Femtex Pull & Snap Unscented Compact Applicator Tampon is substantially equivalent to the Opal by Femtex and Private Brand Unscented Compact Applicator Tampon.
§ 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).