The Daye Tampons are unscented menstrual tampons 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.

AI/ML Overview

The provided document is a 510(k) summary for the Daye Tampon, which is a medical device, not an AI/ML powered diagnostic device. Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving a device meets acceptance criteria using AI/ML specific methods is largely not present. The document focuses on demonstrating substantial equivalence to a predicate menstrual tampon based on performance characteristics, biocompatibility, and microbiology.

However, I can extract and restructure the available information to fit the spirit of the request, interpreting "device performance" in the context of a tampon and its established safety and effectiveness. I will explicitly state where the requested information is not applicable or not provided in the document.

Acceptance Criteria and Study for Daye Tampon (based on 510(k) Summary)

The Daye Tampon is a menstrual tampon, and its performance and safety are assessed against established regulatory standards and comparison to a legally marketed predicate device (Ontex W long plastic applicator Tampons, K162746). The "acceptance criteria" here are essentially the demonstration of substantial equivalence, ensuring the device is as safe and effective as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type	Specific Acceptance Criterion (Standard or Predicate Equivalence)	Reported Device Performance and Confirmation
Biocompatibility	Non-cytotoxic, non-sensitizing, non-irritating, and not acutely systemically toxic (for tampon). Non-cytotoxic, non-sensitizing, and non-irritating (for applicator). (Complies with ISO 10993-1, -5, -10)	Tampon: Demonstrated to be non-cytotoxic, non-sensitizing, non-irritating, and not acutely systemically toxic. Applicator: Demonstrated to be non-cytotoxic, non-sensitizing, and non-irritating.
Physical & Performance Characteristics
Dimensional Analysis	Gamma radiation should have no adverse effect on measured product dimensions (e.g., tampon length/diameter, applicator length/diameter, withdrawal cord length).	Gamma radiation had no effect on any of the measured product dimensions (tampon: Length 45±5mm, Diameter 13.5±0.2mm (Reg) / 15.5±0.2mm (Super), Weight 1.9-2.3g (Reg) / 3.0-3.4g (Super); applicator: Closed 77mm, Extended 115-135mm, Diameter 14.9/16.9mm; withdrawal cord: 120±15mm).
Absorbency (Syngyna Method)	Regular: 6-9 grams; Super: 9-12 grams (per 21 CFR 801.430).	Regular Daye Tampons: Remained within 6-9 grams absorbency range. Super Daye Tampons: Remained within 9-12 grams absorbency range.
Withdrawal Cord Strength	Should maintain adequate strength after irradiation, similar to non-irradiated tampons.	Withdrawal cord strength of irradiated tampons is similar to non-irradiated tampons.
Fiber Loss	Gamma radiation should not increase fiber shedding compared to non-irradiated tampons.	Gamma radiation did not increase fiber shedding as compared to non-irradiated tampons.
Tampon Integrity	Maintain integrity (details not specified, but implied to be acceptable).	(Results confirmed acceptable for substantial equivalence, specific metrics not detailed in summary).
Chemical Residues	Acceptable chemical residue profile, leveraged from predicate.	Chemical residue testing leveraged from the predicate device due to identical composition, demonstrating acceptable profile.
Microbiology Characteristics	Does not enhance Staphylococcus aureus growth, increase TSST-1 production, or alter normal vaginal microflora (Complies with FDA Guidance).	Does not enhance the growth of Staphylococcus aureus, increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1), or alter the growth of normal vaginal microflora. (Leveraged from predicate device).
Wrapper Testing	Not adversely affected by humidity, dissolves in water as designed.	Wrapper not adversely affected by 90% humidity for 30 minutes; dissolves completely in approximately 15 seconds when placed in water.
Overall Equivalence	As safe and effective as the predicate device.	Non-clinical data demonstrate the Daye Tampons are as safe and effective as the predicate device, supporting a determination of substantial equivalence.

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

Sample Size: The document does not explicitly state the specific sample sizes for each test (e.g., number of tampons tested for absorbency, dimensions, etc.). It refers to "tests" being performed.
Data Provenance: The study was conducted by Anne's Daye Ltd. The country of origin for the data is not specified, but the applicant's address is in London, UK. The studies are implicitly prospective in the sense that they are specifically performed for the purpose of this 510(k) submission to demonstrate compliance and substantial equivalence to the predicate where comparative testing was done (e.g., post-irradiation effects). For chemical residues and microbiology, leverage from the predicate device implies reliance on data previously generated for the predicate, which could have been retrospective for that predicate, but for the Daye Tampon submission, it's a forward-looking use of existing data.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

Not Applicable. This device is a menstrual tampon, not an AI/ML diagnostic system requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" here is defined by established regulatory standards (e.g., 21 CFR 801.430 for absorbency, ISO standards for biocompatibility) and direct physical/chemical measurements.

4. Adjudication Method for the Test Set

Not Applicable. As this is not an AI/ML diagnostic study involving human readers and interpretations, an adjudication method for a test set is not relevant. Tests are performed according to established methods (e.g., Syngyna method, ISO 10993).

5. MRMC Comparative Effectiveness Study

Not Applicable. This is not an AI/ML diagnostic device, and thus, no Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. There are no human readers assisting with an AI to improve performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. This is not an AI or algorithm-based device. Its performance is inherent to its physical and chemical properties.

7. Type of Ground Truth Used

The "ground truth" for this device is based on:
- Regulatory Standards: Specific performance requirements defined by FDA regulations (e.g., 21 CFR 801.430 for absorbency ranges).
- International Standards: Biological evaluation standards (ISO 10993 series) for biocompatibility.
- Direct Measurement & Empirical Testing: Objective measurements of physical dimensions, strength, and laboratory tests for fiber loss, absorbency, and dissolution.
- Comparison to Predicate: Establishing equivalence to the performance and safety characteristics of a legally marketed predicate device.

8. Sample Size for the Training Set

Not Applicable. As this is not an AI/ML device, there is no "training set."

9. How Ground Truth for the Training Set Was Established

Not Applicable. There is no training set as it's not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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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: +44 73 66 45 6294 Email: Valentina@yourdaye.com

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
ClassificationRegulation:	21 CFR 884.5470
Product Code:	HEB (Tampon, Menstrual, Unscented)
Regulatory Class:	II
Predicate Device(s):	(K162746) W long plastic applicator Tampons by OntexBVBA

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 DeviceK223883	Predicate DeviceK162746	Comparison
Device Trade Name	Daye Tampon	W Long PlasticApplicator 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 UseStatement	The Daye Tampons areindicated for insertioninto the vagina to absorbmenstrual discharge.	The W long Tampons areinserted into the vaginato absorb menstrualdischarge.	Same
Intended usepopulation	Menstruating females	Menstruating females	Same
Rx or OTC	OTC	OTC	Same
Product design	W wadding with a fullsize (long) applicator	W wadding with a fullsize (long) applicator	Same
Materials:Tampon andwithdrawal cord	100% cotton pledget andwithdrawal cord	100% cotton pledget andwithdrawal cord	Same
Applicator	Plastic (polyethylene)	Plastic (polyethylene)	Same
Additives and finishingagents	MICROCOLOR-Pearlwhite (coloringcomponent, 2%)SICOBATCH AD PE GLNatural (lubricant)	MICROCOLOR-Pearlwhite (coloringcomponent, 2%)SICOBATCH AD PE GLNatural (lubricant)	Same
	Regular	Super
Tampon Dimensions: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:Length (mm)	77 (closed)	77 (closed)	Same
Parameter	Proposed DeviceK223883	Predicate DeviceK162746	Comparison
	115-135 (extended)	115-135 (extended)	Same
Diameter (mm)	14.916.9	14.916.9	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;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.
1. 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.

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).