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.

Device Description

The Opal by Femtex and Private Label Unscented Compact Applicator Tampons is an unscented, compact applicator menstrual tampon. The tampon itself is made of a strip of viscose fibers in which a cord is inserted and pressed firmly together. The viscose tampon is covered with a thin layer of non-woven fiber material which is melted on the strip. The applicator tubes are made from polyethylene (PE). The tampon with applicator is wrapped in printed polypropylene (PP) wrapping. The tampon is marketed in Light, Regular, Super, and Super Plus Absorbencies.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Opal by Femtex and Private Label Unscented Compact Applicator Tampon. It includes information about the device's acceptance criteria, performance studies, and comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test	Specific Requirement / Standard	Reported Device Performance
Absorbency	21 CFR 801.430 for Syngina absorbency testing; 90% population distribution at 90% confidence within specified ranges for Light, Regular, Super, Super Plus	90:90 ranges of Light, Regular, Super, and Super Plus absorbencies met the absorbency range requirements defined by 21 CFR 801.430.
Chemical Residues (TCDD & TCDF)	EC Regulation 589/2014 (food) and 709/2014 (feed)	No TCDD or TCDF was detectable by this method.
Chemical Residues (Pesticides/Herbicides)	Method ASU L00.00-34	No pesticides (including herbicides) were detected.
Extractables (Aqueous)	ISO 10993-12: 2012, ISO 10993-18: 2005 (most closely simulates physiological conditions)	No extractable chemicals were detectable in the aqueous extraction.
Extractables (Organic - "harsh conditions")	ISO 10993-12: 2012, ISO 10993-18: 2005	Very low levels of non-toxic extractables were obtained.
Withdrawal Cord Attachment Strength	Australian Standard AS/NZS 2869:1998, minimum attachment strength of 22.4 Newtons (N) for each tampon, average ≥ 28N for each production lot	Each tampon for every absorbency level met the minimum strength of 22.4 N. Each absorbency data set met an average value of ≥ 28N.
Fiber Shedding	Internal fiber shed test protocol (no recognized standard available)	The new device does not exhibit the potential to shed more fiber than the predicate device.
Biocompatibility (Cytotoxicity)	FDA Blue Book Memorandum #G95-1, ISO 10993-1:2003	Tested as part of the biocompatibility battery.
Biocompatibility (Intracutaneous Irritation)	FDA Blue Book Memorandum #G95-1, ISO 10993-1:2003	Tested as part of the biocompatibility battery.
Biocompatibility (Acute Systemic Toxicity)	FDA Blue Book Memorandum #G95-1, ISO 10993-1:2003	Tested as part of the biocompatibility battery.
Bioburden (Aerobic Bacteria)	European Pharmacopeia 5.1.4, Microbiological Quality of Pharmaceutical Preparations, Category 2	No more than 29 colony forming units (CFU) of aerobic bacteria were identified on any sample.
Bioburden (Yeasts)	European Pharmacopeia 5.1.4, Microbiological Quality of Pharmaceutical Preparations, Category 2	Zero yeasts were found on any sample.
Bioburden (Mold)	European Pharmacopeia 5.1.4, Microbiological Quality of Pharmaceutical Preparations, Category 2	No more than 5 mold CFUs were found on any sample.
Bioburden (Specific Pathogens)	European Pharmacopeia 5.1.4, Microbiological Quality of Pharmaceutical Preparations, Category 2	No Pseudomonas aeruginosa, Staphylococcus aureus, and enterobacteria or other gram-negative bacteria were detected.
Bacteriostatic Effect on S. aureus	USP 30, Chapter 51 (2007): Antimicrobial Effectiveness Testing (adaptation)	The test article did not demonstrate the potential to enhance S. aureus growth.
Effect on Normal Vaginal Microflora Growth	USP 31, Chapter 71 (2008): Sterility Tests	The new device did not demonstrate the potential to inhibit the growth of normal vaginal microflora.
*Effect on Production of S. aureus* TSST-1**	Tampon Sac Method with TSST-1 detected by ELISA and plate counting	The new device does not demonstrate the potential to augment TSST-1 relative to current legally marketed tampons.
Applicator Colorants	Toxics Substance Control Act Inventory (TSCA), 21 CFR 178.3297 and/or EU Resolution (89)1 compliant; extractables testing confirmed no harmful compounds are bioavailable; conforms with 21 CFR 177-178	New colorants (Green, Pink, Blue, Pearl White) met all specified characteristics and regulations.
Applicator Mold Release Agent	Food grade, conforms with 21 CFR 177-178	Conforms with 21 CFR 177-178.
Applicator Antistatic Agent	Food grade, conforms with 21 CFR 177-178	Conforms with 21 CFR 177-178.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the specific "sample sizes" for the test sets beyond mentioning "any sample tested" for bioburden and "each tampon tested for every absorbency level" for withdrawal cord strength. It implies testing was conducted on an adequate number of samples to meet the relevant standards and confidence levels. For example, for absorbency, it states data was "analyzed for 90% population distribution at 90% confidence."

The data provenance is not explicitly stated in terms of country of origin. The testing references European, Australian, and US Pharmacopeia standards, and FDA guidance, suggesting a mix of internationally recognized testing methodologies. The data appears to be prospective as it was generated specifically for the 510(k) submission to demonstrate the safety and effectiveness of the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The "ground truth" for the performance tests outlined (e.g., absorbency, chemical residues, biocompatibility) is established by adherence to recognized national and international standards and validated testing methodologies, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. The tests performed are objective, laboratory-based physical, chemical, and microbiological tests against defined standards, not subjective assessments requiring adjudication.

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

Not applicable. This is a medical device (menstrual tampon), not an AI-powered diagnostic or assistive technology for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or AI-based device.

7. The Type of Ground Truth Used

The "ground truth" used for this device's performance assessment is based on:

Established Regulatory Standards: For absorbency (21 CFR 801.430), chemical properties (EC Regulations, 21 CFR), and material safety (21 CFR 177-178).
International Consensus Standards: For biocompatibility (ISO 10993 series) and withdrawal cord strength (AS/NZS 2869:1998).
Pharmacopeia Standards: For microbiological evaluations (European Pharmacopeia, United States Pharmacopeia).
FDA Guidance: For pre-clinical microbiological testing (July 27, 2005 Guidance for Menstrual Tampons and Pads).

These standards and methods define the acceptable performance characteristics and are considered the objective "ground truth" for the device's safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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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 caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 2, 2015

First Quality Hygienic, Inc. % Dave Yungvirt Official Correspondent 45 Rockerfeller Plaza, Suite 2000 New York, NY 10111

Re: K151470

Trade/Device Name: Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: October 14, 2015 Received: October 19, 2015

Dear Dave Yungvirt,

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. Iisting 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.

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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); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours,

Benjamin R. Fisher -S

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) K151470

Device Name

Opal by Femtex and Private Label Unscented Compact Applicator Tampon - Light Absorbency, Super Absorbency, and Super Plus Absorbency

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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5 - 510(k) Summary

1. Submitter's name and address:

First Quality Hygienic, Inc. 121 North Road McElhattan, PA 17748

2. Submitter's telephone number and fax number:

Tel: 516-498-3665 Fax: 516-829-4949

3. Contact person:

Melanie Leibowitz Director of Regulatory Affairs

4. Date this 510(k) summary prepared: 04/23/2015

5. Regulatory Description:

Trade name:	Opal by Femtex and Private Label Unscented CompactApplicator Tampon
Common Name:	Unscented Menstrual Tampon
Classification Name:	Tampon, Menstrual, Unscented
Regulation Description:	Unscented Menstrual Tampon
Regulation Number:	21 CFR 884.5470
Class:	II
Product Code:	HEB

6. Legally marketed device to which substantial equivalence is claimed:

Tosama Hygiene Tampon (Tosama Maxim Compact Plastic Applicator Tampon), K080775

7. Description of the device:

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wrapped in printed polypropylene (PP) wrapping. The tampon is marketed in Light, Regular, Super, and Super Plus Absorbencies.

8. Intended use and indication for use:

For over-the-counter 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.

9. Summary of technological characteristics compared to the predicate device:

	Opal by Femtex and Private Label Unscented CompactApplicator Tampon	Tosama Hygiene TamponK080775
ClassificationRegulation	884.5470	884.5470
Product Code	HEB	HEB
Intended 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 tampon correctly into the vagina.	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 tampon correctly into the vagina.
Sterile?	No	No
Design	Compact tampon with mushroom-shaped tip and straight grooves	Compact tampon with mushroom-shaped tip and straight grooves
Absorbency, grams	Light $\leq$ 6.0Regular 6.0 - 9.0Super 9.0 - 12.0Super Plus 12.0 - 15.0	N/ARegular 6.0 - 9.0Super 9.0 - 12.0Super Plus 12.0 - 15.0
Pledget LengthDimensions (mm)	Light 40.0 - 45.0Regular 40.0 - 45.0Super 43.0 - 46.0Super Plus 43.0 - 46.0	N/ARegular 45.0 - 49.0Super 45.0 - 49.0Super Plus 46.0 - 50.0
Pledget DiameterDimensions (mm)	Light 8.7 – 9.7Regular 8.7 – 9.7Super 11.0 – 13.0Super Plus 13.0 - 15.0	N/ARegular 11.0 - 13.0Super 11.0 - 13.0Super Plus 13.0 - 15.0
Applicator Inner TubeLength x Diameter	Light 66.0 - 68.0 x10.5 - 11.5	N/A

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Dimensions (mm)		Regular	66.0 - 68.0 x10.5 - 11.5	Regular	66.5 x 18.0
		Super	64.0 - 66.0 x13.5 - 14.5	Super	66.5 x 18.0
		Super Plus	65.5 - 68.5 x15.5 - 16.5	Super Plus	66.5 x 21.4
Applicator OuterTubeLength x DiameterDimensions (mm)		Light	58.0 x 60.0 x13.0 - 14-0	N/A
		Regular	58.0 x 60.0 x13.0 - 14-0	Regular	59.5 x 18.9
		Super	59.0 x 61.0 x15.0 - 16.0	Super	59.5 x 18.9
		Super Plus	60.0 x 62.0 x17.0 - 18.0	Super Plus	59.5 x 22.7
Cotton Cord		100% Hydrophobic Cotton		100% Hydrophobic Cotton
Nonwoven	PET/PE - conforms with 21CFR 177-178		PET/PE - conforms with 21CFR 177-178
	Plastic	Low Density Polyethylene		Low Density Polyethylene
ApplicatorTube	Colorant	Four new colorants, for Green,Pink, Blue, and Pearl Whiteapplicator tubes; New colorantshave the followingcharacteristics:• Meets Toxics Substance Control ActInventory (TSCA)• 21 CFR 178.3297 and/or EUResolution (89)1 compliant;Extractables testing confirmed thatno harmful compounds arebioavailable• conforms with 21 CFR 177-178		Pearl White colorant with thefollowing characteristics:• Meets Toxics Substance Control ActInventory (TSCA)• 21 CFR 178.3297 and/or EUResolution (89)1 compliant;Extractables testing confirmed thatno harmful compounds arebioavailable• conforms with 21 CFR 177-178
	Mold	Food grade mold release		Food grade mold release
	Release	agent—conforms with 21 CFR		agent—conforms with 21 CFR
	Agent	177-178		177-178
	AntistaticAgent	Food grade antistatic agent—conforms with 21 CFR 177-178		N/A
Wrapper (PrimaryPackaging)		Polypropylene		Polypropylene

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10. Non-Clinical Performance Data

The following testing was performed:

Absorbency

Absorbency testing for the new device was performed per the 21 CFR 801.430 for Syngina absorbency testing. Data for each absorbency were then analyzed for 90% population distribution at 90% confidence, as the regulation directs, and it was confirmed that 90:90 ranges of Light, Regular, Super, and Super Plus absorbencies met the absorbency range requirements defined by 21 CFR 801.430.

Chemical residues

2.3.7.8-tetrachlorodibenzo-p-dioxin (TCDD) and 2.3.7.8-tetrachlorofuran dioxin (TCDF) testing was performed on the new device per European Community (EC) Regulation 589/2014 (for food) and EC Regulation 709/2014 (for feed). No TCDD or TCDF was detectable by this method.

Pesticide (including herbicides) testing was performed on the new device per method ASU L00.00-34. No pesticides (including herbicides) were detected.

Extractables testing was performed on the new device according to ISO 10993-12: 2012, Biological evaluation of medical devices – Part 12: Sample preparation and reference materials, and ISO 10993-18: 2005, Biological evaluation of medical devices - Part 18: Chemical characterization of materials. No extractable chemicals were detectable in the aqueous extraction, which most closely simulated physiological conditions. Very low levels of non-toxic extractables were obtained in harsh, non-physiologically relevant organic extraction conditions.

Withdrawal cord attachment test

Withdrawal cord attachment strength testing for the new device was performed per 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 Shed Testing

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Fiber shed testing for the new device was evaluated using an internal fiber shed test protocol, since no recognized standard is available. The new device does not exhibit the potential to shed more fiber than the predicate device.

Biocompatibility Testing

Biocompatibility assessment for the new device was evaluated in accordance with the May 1, 1995 FDA Blue Book Memorandum #G95-1, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, ' and ISO 10993-1:2003, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process. Biocompatibility requirements were assessed for the tampon as having "limited contact" (i.e., < 24 hrs) and as a surface device, contacting the skin and mucous membrane. The battery of testing included the following tests:

. Cytotoxicity
Intracutaneous irritation ●
. Acute systemic toxicity

Pre-clinical microbiological testing

Preclinical microbiology evaluation was performed for the new device in as recommended by the July 27, 2005 Guidance, Guidance for Industry and FDA Staff, Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s). The following pre-clinical microbiology tests were considered:

. Bioburden
Bioburden was evaluated for the new device per European Pharmacopeia 5.1.4, Microbiological Quality of Pharmaceutical Preparations, Category 2. No more than 29 colony forming units (CFU) of aerobic bacteria were identified on any sample tested. Furthermore, zero yeasts and no more than 5 mold CFUs were found on any sample tested. Finally, no Pseudomonas aeruginosa, Staphylococcus aureus, and enterobacteria or other gram negative bacteria were detected.
Bacteriostatic effect on Staphylococcus aureus
Effect of the new device on growth of Staphylococcus aureus was evaluated using adaption of method United States Pharmacopeia (USP) 30, Chapter 51 (2007): Antimicrobial Effectiveness Testing. The test article did not demonstrate the potential to enhance S. aureus growth.

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Effect on normal vaginal microflora growth
Effect of the new device on the growth of normal vaginal microflora was evaluated per USP 31, Chapter 71(2008): Sterility Tests. The new device did not demonstrate the potential to inhibit the growth of normal vaginal microflora.
Effect on production of S. aureus Toxic Shock Syndrome Toxin-1 (TSST-1)
The new device was evaluated to determine its impact on the production of TSST-1 by S. aureus. Evaluation was performed using a Tampon Sac Method with TSST-1 production detected by enzyme-linked immunosorbant assay (ELISA) and subsequent plate counting to enumerate CFUs. The new device does not demonstrate the potential to augment TSST-1 relative to current legally marketed tampons.

11. Conclusion

The Opal by Femtex and Private Label Unscented Compact Applicator Tampon characteristics and comparisons detailed above demonstrate that the new device has the same fundamental design, Indications for Use, technology, and performance specifications as the predicate device. Non-Clinical Performance Testing demonstrates that the new device meets the absorbency requirements defined by 21 CFR 801.430, which confirms the device's effectiveness for the Indications for Use. Biocompatibility testing, Pre-Clinical Microbiology testing, and Withdrawal Cord Attachment Strength and Fiber Shed testing demonstrate that the new device has a safe biocompatibility profile, does not increase the potential to promote TSS relative to the predicate device, and has a tampon integrity profile that is equivalent to the predicate device. Furthermore, Extractables testing demonstrates that the applicator and tampons do not have the potential to expose the user to harmful chemicals. Altogether, then, the data support the conclusion that the Opal by Femtex and Private Label Unscented Compact Applicator Tampon is substantially equivalent to the predicate device and is safe and effective for its Indications for Use.

Regulation Number and Section

§ 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).