Daye Tampon

K223883 · Annes Daye, Ltd. · HEB · Aug 18, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K223883
• Device Name: Daye Tampon
• Applicant: Annes Daye, Ltd.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Aug 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

The Daye Tampons are indicated for insertion into the vagina to absorb menstrual discharge.

Device Story

Daye Tampons are unscented menstrual tampons consisting of an absorbent organic cotton pledget with a W-wadding design and a polyethylene plastic applicator. The device includes a mercerised organic cotton withdrawal cord and a water-soluble cellulose-based wrapper. Available in regular (6-9g) and super (9-12g) absorbencies. The device is gamma-irradiated (10 kGy) in final packaging. Used by patients for self-administration during menstruation to manage menstrual flow. The device functions via physical absorption of fluid; the applicator facilitates insertion. Benefits include effective menstrual fluid management and hygienic disposal via the water-soluble wrapper.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (cytotoxicity, sensitization, vaginal irritation per ISO 10993), physical performance (Syngyna absorbency test per 21 CFR 801.430, withdrawal cord strength, fiber loss, dimensional analysis), and microbiology (Staphylococcus aureus growth and TSST-1 production). Results confirmed the device meets all performance specifications and is equivalent to the predicate.

Technological Characteristics

Materials: 100% organic cotton pledget, mercerised organic cotton withdrawal cord, polyethylene applicator. Additives: MICROCOLOR-Pearl white (coloring) and SICOBATCH AD PE GL (lubricant). Design: W-wadding pledget, full-size applicator. Sterilization: Gamma irradiation (10 kGy). Connectivity: None. Software: None.

Indications for Use

Indicated for menstruating females for insertion into the vagina to absorb menstrual discharge.

Regulatory Classification

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.

Predicate Devices

• W long plastic applicator Tampons by Ontex BVBA (K162746)

Submission Summary (Full Text)

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August 18, 2023

Annes Daye, Ltd. % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002

Re: K223883 Trade/Device Name: Daye Tampon

Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: July 10, 2023 Received: July 10, 2023

Dear Sheila Hemeon-Heyer:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Reginald K. Avery -S

for Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K223883

Device Name Daye Tampon

Indications for Use (Describe)

The Daye Tampons are indicated for insertion into the vagina to absorb menstrual discharge.

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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E.

# 5 10 (k ) Summary

This summary of 510(k) safety and effectiveness inform ation is being submitted in accordance with the requirements of 21 CFR 80 7.92.

A. 5 10 (k ) Applicant : Anne's Daye Ltd. The Biscuit Factory 100 Drummond Road Berm ondsey, London SE16 4DG, UK

Contact: Valentina Milanova, CEO Phone: [phone] Email: [e-mail]

- B. Date Prepared: August 17,2023
#### D. Device Name and Classification Information:

| Trade Name: | Daye Tampon |
|-------------------------------|--------------------------------------------------------------|
| Common Name: | Menstrual Tampon |
| Classification Name: | Tampon, Menstrual, Unscented |
| Classification<br>Regulation: | 21 CFR 884.5470 |
| Product Code: | HEB (Tampon, Menstrual, Unscented) |
| Regulatory Class: | II |
| Predicate Device(s): | (K162746) W long plastic applicator Tampons by Ontex<br>BVBA |

The predicate device has not been subject to a designrelated recall.

- F. The Daye Tampons are unscented menstrual tampons Device Description: consisting of an absorbent cotton pledget and a plastic (polyethylene) full-size applicator. The tampon pledget is made entirely of organic cotton, is fashioned with a W'wadding design and protective sleeve/overwrap. A withdrawal cord, made from mercerised organic cotton, is attached to the pledget. The Daye Tampons are available in regular (6-9 grams) and super (9-12 grams) absorbencies. The Daye Tampons and applicator are gamma irradiated in the finalpackaging. The Daye Tampons and applicators are repackaged together.

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- G. Indications for Use Statement: The Daye Tampons are indicated for insertion into the vagina to absorb menstrualdischarge.
- H. Comparison with Predicate Device: The following table compares the Daye Tampons to the predicate device (Ontex W long plastic applicator Tampons) with respect to indications for use, principles of operation, technological characteristics, materials, and perform ance testing.

| Parameter | Proposed Device<br>K223883 | Predicate Device<br>K162746 | Comparis<br>on |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------|
| Device Trade Name | Daye Tampon | W Long Plastic<br>Applicator Tampons | N/A |
| Device Manufacturer | Anne's Daye | Ontex BVBA | N/A |
| Classification regulation | 21CFR 884.5470 | 21CFR 884.5470 | Same |
| Product Code | HEB | HEB | Same |
| Indications for Use<br>Statement | The Daye Tampons are<br>indicated for insertion<br>into the vagina to absorb<br>menstrual discharge. | The W long Tampons are<br>inserted into the vagina<br>to absorb menstrual<br>discharge. | Same |
| Intended use<br>population | Menstruating females | Menstruating females | Same |
| Rx or OTC | OTC | OTC | Same |
| Product design | W wadding with a full<br>size (long) applicator | W wadding with a full<br>size (long) applicator | Same |
| Materials:<br>Tampon and<br>withdrawal cord | 100% cotton pledget and<br>withdrawal cord | 100% cotton pledget and<br>withdrawal cord | Same |
| Applicator | Plastic (polyethylene) | Plastic (polyethylene) | Same |
| Additives and finishing<br>agents | MICROCOLOR-Pearl<br>white (coloring<br>component, 2%)<br>SICOBATCH AD PE GL<br>Natural (lubricant) | MICROCOLOR-Pearl<br>white (coloring<br>component, 2%)<br>SICOBATCH AD PE GL<br>Natural (lubricant) | Same |
| | Regular | Super | |
| Tampon Dimensions:<br>Length (mm) | 45 ± 5 | 45 ± 5 | Same |
| Diameter (mm) | 13.5 ± 0.2 | 15.5 ± 0.2 | Same |
| Weight (g) | 1.9 – 2.3 | 3.0 - 3.4 | Same |
| Absorbency (g) | 6-9 | 9-12 | Same |
| Applicator Dimensions:<br>Length (mm) | 77 (closed) | 77 (closed) | Same |
| Parameter | Proposed Device<br>K223883 | Predicate Device<br>K162746 | Comparison |
| | 115-135 (extended) | 115-135 (extended) | Same |
| Diameter (mm) | 14.9<br>16.9 | 14.9<br>16.9 | Same |
| Withdrawalcord length (mm) | $120 \pm 15$ | $120 \pm 15$ | Same |
| Irradiated | Yes, Gamma, 10 kGy (not labelled sterile) | No | Different |
| Single use | Yes | Yes | Same |
| Tampon wrapper | Cellulose-based;<br>Intended to dissolve in water | Not provided | Different |
| Biocompatibility complies with ISO 10993-1 | Yes | Yes | Same |
| Microbiology complies with FDA Guidance for Tampons | Yes | Yes | Same |

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#### I. Discussion of Differences

Daye Tampons are the same as the Ontex Tampons that were cleared under K162746. The differences are:

- The subject device Daye tampons and applicator are irradiated using gamma 1. radiation after packaging in the wrapper. The predicate device is not irradiated prior to use.
- 2. The Daye Tampon wrapper is designed to dissolve in water.

These differences do not raise different questions of safety and effectiveness.

#### J. Summary of Data Submitted to Support Substantial Equivalence

As outlined in the 2005 FDA guidance document, Menstrual Tampons and Pads: Inform ation for Prem arket Notification Submissions (510(k)s), the subject device was assessed for perform ance characteristics, toxicology (biocom patibility), and m icrobiology, summ arized below.

# Biocom patibility:

Biocom patibility evaluation was performed according to the following requirem ents of the FDA guidance document "Use of International Standard ISO 10993-1, "Biologicalevaluation of medical devices - Part 1: Evaluation and testing within a risk

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m anagement process"" issued September 2020 for the tampon and applicator as fo llo w s :

- Cytotoxicity testing per ISO 10993-5:2009 ●
- Local Lymph Node Assay Sensitization testing per ISO 10993-10:20 10 ●
- Vaginal Irritation testing per ISO 10993-10:20 10 ●

The biocom patibility testing dem onstrated the tam pon is non-cytotoxic, nonsensitizing, non-irritating, and not acutely system ically toxic. The biocom patibility testing dem onstrated the applicator is non-cytotoxic, non-sensitizing, and nonirritating.

# Physicaland Performance Characteristics

Unaged Daye tam pons that were gamma irradiated using a dose of 10 kGy were subjected to the following tests:

- Dimensionalanalysis, including
- Applicator Overall Length o
- Applicator Plunger Length O
- O Applicator Barrel Length
- Outer Diam eter at top of applicator barrel O
- Outer diam eter at base of barrel of applicator o
- Tampon overall length o
- Tampon Diameter O
- Absorbency testing using the Syngyna method (per 21CFR 801.430) ●
- Withdrawalcord strength testing ●
- Fiber loss testing ●
- Tampon integrity

# Chemical Residues testing

The sponsor leveraged chemical resting com pleted on the predicate device to support chemicalresidue testing of the subject device. Given the device is identical to the predicate device except for gam m a irradiation and repackaging, chemical residue testing can be leveraged from the predicate device to support the chem ical residues of the subject device .

The results of these tests dem onstrated that:

- Gam ma radiation had no effect on any of the measured product dimensions. ●
- The absorbency for both the regular and super Daye Tam pons rem ained ● within the required absorbency ranges of 6-9 gram s for regular absorbency tam pons and 9-12 grams for super absorbency tam pons, per 21 CFR 80 1430.

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- Withdrawalcord strength of the irradiated tam pons is sim ilar to nonirradiated tam pons
- Gamma radiation did not increase fiber shedding as compared to non-. radiated tam pons

The conclusion of this testing is that gamma radiation of the Daye regular and super tam pons did not impact the tam pon's physical and perform ance characteristics.

# Microbiology Characteristics

The subject device leveraged microbiology testing completed on the predicate device. Because the subject device is identical to the predicate device except for gamma irradiation and repackaging, microbiology testing for the tampon can be leveraged from the predicate device. The microbiology testing dem onstrated that the subject device tam pon does not:

- . enhance the growth of Staphylococcus aureus,
- increase the poduction of Toxic Shock Syndrom e Toxin-1 (TSST-1), and
- alter the growth of norm al vaginal microflora. .

# Wrapper Testing

The Daye tampon wrapper is designed to dissolve in water. Storage testing demonstrated that the wrapper is not adversely affected when exposed to 90% hum idity for 30 m inutes, but completely dissolves after approxim ately 15 seconds when placed in water.

#### K. Conclusion

The non-clinical data described above demonstrate that the Daye Tampons are as safe and effective as the predicate device and support a determ ination of substantial equivalence.