(154 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of a tampon, with no mention of AI or ML.
No
The device is described as an "unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge," indicating it is for hygiene, not for treating or diagnosing a disease or condition.
No
Explanation: The device is an unscented tampon for menstrual absorption, which is a personal hygiene product and not intended for diagnosing any medical condition.
No
The device description clearly outlines physical components made of viscose fibers, polyethylene, and polypropylene, and the performance studies focus on physical and chemical properties of these materials, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge." This is a physical function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical components of a tampon and applicator, designed for absorption. It does not describe any components or mechanisms for detecting or measuring substances or conditions in vitro.
- Performance Studies: The performance studies focus on physical properties (absorbency, cord strength, fiber shedding), chemical residues, biocompatibility, and microbiological aspects related to safety and hygiene. None of the studies describe a diagnostic test or the measurement of biological markers for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, or tissue) in vitro to provide diagnostic information. The device's function is purely absorptive and related to personal hygiene.
Therefore, this device is a medical device, but it falls under the category of a personal hygiene product and not an In Vitro Diagnostic device.
N/A
Intended 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.
Product codes (comma separated list FDA assigned to the subject device)
HEB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
Absorbency testing was performed per 21 CFR 801.430 for Syngina absorbency testing. Data for each absorbency were analyzed for 90% population distribution at 90% confidence, confirming 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 testing (TCDD and TCDF) was performed per EC Regulation 589/2014 and EC Regulation 709/2014. No TCDD or TCDF was detectable. Pesticide testing was performed per method ASU L00.00-34. No pesticides were detected. Extractables testing was performed according to ISO 10993-12: 2012 and ISO 10993-18: 2005. No extractable chemicals were detectable in aqueous extraction; very low levels of non-toxic extractables were obtained in harsh organic extraction conditions.
Withdrawal cord attachment strength testing was performed per Australian Standard AS/NZS 2869:1998. Each tampon tested met the minimum attachment strength requirement of 22.4 Newtons (N), and each absorbency data set met an average value of >= 28N.
Fiber shed testing was evaluated using an internal fiber shed test protocol. The new device does not exhibit the potential to shed more fiber than the predicate device.
Biocompatibility assessment was evaluated in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1:2003, for "limited contact" (
§ 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
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.
1
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)
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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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 Compact
Applicator 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:
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
4
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 Compact
Applicator Tampon | Tosama Hygiene Tampon
K080775 |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Regulation | 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 $\leq$ 6.0
Regular 6.0 - 9.0
Super 9.0 - 12.0
Super Plus 12.0 - 15.0 | N/A
Regular 6.0 - 9.0
Super 9.0 - 12.0
Super Plus 12.0 - 15.0 |
| Pledget Length
Dimensions (mm) | Light 40.0 - 45.0
Regular 40.0 - 45.0
Super 43.0 - 46.0
Super Plus 43.0 - 46.0 | N/A
Regular 45.0 - 49.0
Super 45.0 - 49.0
Super Plus 46.0 - 50.0 |
| Pledget Diameter
Dimensions (mm) | Light 8.7 – 9.7
Regular 8.7 – 9.7
Super 11.0 – 13.0
Super Plus 13.0 - 15.0 | N/A
Regular 11.0 - 13.0
Super 11.0 - 13.0
Super Plus 13.0 - 15.0 |
| Applicator Inner Tube
Length x Diameter | Light 66.0 - 68.0 x
10.5 - 11.5 | N/A |
5
| Dimensions (mm) | | Regular | 66.0 - 68.0 x
10.5 - 11.5 | Regular | 66.5 x 18.0 |
|--------------------------------------------------------------|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| | | Super | 64.0 - 66.0 x
13.5 - 14.5 | Super | 66.5 x 18.0 |
| | | Super Plus | 65.5 - 68.5 x
15.5 - 16.5 | Super Plus | 66.5 x 21.4 |
| Applicator OuterTube
Length x Diameter
Dimensions (mm) | | Light | 58.0 x 60.0 x
13.0 - 14-0 | N/A | |
| | | Regular | 58.0 x 60.0 x
13.0 - 14-0 | Regular | 59.5 x 18.9 |
| | | Super | 59.0 x 61.0 x
15.0 - 16.0 | Super | 59.5 x 18.9 |
| | | Super Plus | 60.0 x 62.0 x
17.0 - 18.0 | Super Plus | 59.5 x 22.7 |
| Cotton Cord | | 100% Hydrophobic Cotton | | 100% Hydrophobic Cotton | |
| Nonwoven | PET/PE - conforms with 21
CFR 177-178 | | PET/PE - conforms with 21
CFR 177-178 | | |
| | Plastic | Low Density Polyethylene | | Low Density Polyethylene | |
| Applicator
Tube | Colorant | Four new colorants, for Green,
Pink, Blue, and Pearl White
applicator tubes; New colorants
have the following
characteristics:
• Meets Toxics Substance Control Act
Inventory (TSCA)
• 21 CFR 178.3297 and/or EU
Resolution (89)1 compliant;
Extractables testing confirmed that
no harmful compounds are
bioavailable
• conforms with 21 CFR 177-178 | | Pearl White colorant with the
following characteristics:
• Meets Toxics Substance Control Act
Inventory (TSCA)
• 21 CFR 178.3297 and/or EU
Resolution (89)1 compliant;
Extractables testing confirmed that
no harmful compounds are
bioavailable
• 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 | |
| | Antistatic
Agent | Food grade antistatic agent—
conforms with 21 CFR 177-178 | | N/A | |
| Wrapper (Primary
Packaging) | | 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
7
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.,