(234 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, absorbency, biocompatibility, and microbiology of a menstrual tampon, with no mention of AI or ML technology.
No
The device is indicated for insertion into the vagina to absorb menstrual discharge, which is a physical function, not a therapeutic one. It does not treat or prevent any disease or condition.
No
Explanation: The device is a menstrual tampon designed to absorb discharge, not to diagnose a condition.
No
The device description clearly states it is a physical tampon with an applicator, made of cotton and plastic, and undergoes gamma irradiation. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for insertion into the vagina to absorb menstrual discharge." This is a physical function, not a diagnostic one.
- Device Description: The description details the physical components of a tampon and applicator, designed for absorption. There is no mention of reagents, assays, or any components used to analyze biological samples for diagnostic purposes.
- Performance Studies: The performance studies focus on physical characteristics (dimensions, absorbency, strength, integrity), biocompatibility, and microbiology related to the device's interaction with the body and its ability to absorb menstrual fluid. These are not diagnostic performance metrics.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like menstrual fluid) to detect diseases, conditions, or markers.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely absorptive.
N/A
# Intended Use / Indications for Use
The Daye Tampons are indicated for insertion into the vagina to absorb menstrual discharge.
# Product codes (comma separated list FDA assigned to the subject device)
HEB
# Device Description
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.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
vagina
# Indicated Patient Age Range
Menstruating females
# Intended User / Care Setting
Not Found
# 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)
The subject device was assessed for performance characteristics, toxicology (biocompatibility), and microbiology.
Biocompatibility evaluation was performed according to ISO 10993-1, including Cytotoxicity testing per ISO 10993-5:2009, Local Lymph Node Assay Sensitization testing per ISO 10993-10:2010, and Vaginal Irritation testing per ISO 10993-10:2010.
The biocompatibility testing demonstrated the tampon is non-cytotoxic, non-sensitizing, non-irritating, and not acutely systemically toxic. The biocompatibility testing demonstrated the applicator is non-cytotoxic, non-sensitizing, and non-irritating.
Physical and Performance Characteristics tests were conducted on unaged Daye tampons that were gamma irradiated using a dose of 10 kGy. These tests included:
- Dimensional analysis (Applicator Overall Length, Applicator Plunger Length, Applicator Barrel Length, Outer Diameter at top of applicator barrel, Outer diameter at base of barrel of applicator, Tampon overall length, Tampon Diameter).
- Absorbency testing using the Syngyna method (per 21CFR 801.430).
- Withdrawal cord strength testing.
- Fiber loss testing.
- Tampon integrity.
The results demonstrated that:
- Gamma radiation had no effect on any of the measured product dimensions.
- The absorbency for both the regular and super Daye Tampons remained within the required absorbency ranges of 6-9 grams for regular absorbency tampons and 9-12 grams for super absorbency tampons, per 21 CFR 801.430.
- Withdrawal cord strength of the irradiated tampons is similar to non-irradiated tampons.
- Gamma radiation did not increase fiber shedding as compared to non-irradiated tampons.
The conclusion of this testing is that gamma radiation of the Daye regular and super tampons did not impact the tampon’s physical and performance characteristics.
Microbiology Characteristics leveraged testing from the predicate device. The microbiology testing demonstrated that the subject device tampon does not:
- enhance the growth of Staphylococcus aureus.
- increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1).
- alter the growth of normal vaginal microflora.
Wrapper Testing showed that the Daye tampon wrapper, designed to dissolve in water, is not adversely affected when exposed to 90% humidity for 30 minutes, but completely dissolves after approximately 15 seconds when placed in water.
# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
# Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
[K162746](https://510k.innolitics.com/search/K162746)
# Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
# Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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/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.
1
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
2
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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3
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: +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 |
| Classification | |
| 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 |
| 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.
4
- 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
K223883 | Predicate Device
K162746 | Comparis
on |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------|
| Device Trade Name | Daye Tampon | W Long Plastic
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
Statement | The Daye Tampons are
indicated for insertion
into the vagina to absorb
menstrual discharge. | The W long Tampons are
inserted into the vagina
to absorb menstrual
discharge. | Same |
| Intended use
population | Menstruating females | Menstruating females | Same |
| Rx or OTC | OTC | OTC | Same |
| Product design | W wadding with a full
size (long) applicator | W wadding with a full
size (long) applicator | Same |
| Materials:
Tampon and
withdrawal cord | 100% cotton pledget and
withdrawal cord | 100% cotton pledget and
withdrawal cord | Same |
| Applicator | Plastic (polyethylene) | Plastic (polyethylene) | Same |
| Additives and finishing
agents | MICROCOLOR-Pearl
white (coloring
component, 2%)
SICOBATCH AD PE GL
Natural (lubricant) | MICROCOLOR-Pearl
white (coloring
component, 2%)
SICOBATCH AD PE GL
Natural (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 Device
K223883 | Predicate Device
K162746 | Comparison |
| | 115-135 (extended) | 115-135 (extended) | Same |
| Diameter (mm) | 14.9
16.9 | 14.9
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;
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 |
5
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.
-
- 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
6
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.
7
- 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.