(292 days)
No
The 510(k) summary describes a traditional menstrual tampon and does not mention any AI or ML components or capabilities.
No.
The device, a tampon, is intended for absorption of menstrual or other vaginal discharge, which is a supportive or maintenance function, not a therapeutic treatment for a disease or condition.
No
The device is described as a tampon intended for the absorption of menstrual or other vaginal discharge, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a traditional physical tampon made of cotton with an applicator and withdrawal cord, and the performance studies focus on physical and biological characteristics of the material and device.
Based on the provided information, the CottonDay Tampon is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the absorption of menstrual or other vaginal discharge. This is a physical function within the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a physical absorbent product for internal use.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample, detecting a substance, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on physical characteristics, safety, and biological compatibility, not diagnostic accuracy.
- Anatomical Site: While the anatomical site is the vagina, the device's function is absorption, not diagnosis.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The CottonDay Tampon does not perform this function.
N/A
Intended Use / Indications for Use
The CottonDay Tampon is intended for insertion into the absorption of menstrual or other vaginal discharge.
Product codes
HEB
Device Description
CottonDay Tampon will be offered as a traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbencies: Regular and Super.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vagina
Indicated Patient Age Range
Not Found
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)
Performance testing was conducted in accordance with the 2005 FDA guidance document "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff". The following characteristics were assessed:
- Dimensions
- Absorbency range
- Chemical residues
- Withdrawal cord strength
- Fiber shedding
- Tampon integrity
Biocompatibility studies were performed in accordance with the FDA guidance document "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" issued in 2016 and ISO 10993 standards as follows:
- Cytotoxicity (MEM Elution Test) per ISO 10993-5:2009
- Sensitization (Guinea Pig Maximization Test) per ISO 10993-10:2010
- Irritation (Vaginal Irritation Test) per ISO 10993-10:2010
- Acute Systemic Toxicity per ISO 10993-11:2006
These tests were performed on the subject tampons and applicators, and the results met the requirements of the ISO standards.
Microbiology testing was conducted per the 2005 FDA guidance document to demonstrate that the subject devices do 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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July 22, 2019
Taebong Co., Ltd Joyce Kwun President Provision Consulting Group, Inc. 3350 Shelby St., Ste 200 Ontario, CA 91764
Re: K182817
Trade/Device Name: CottonDay Tampon Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: June 10, 2019 Received: June 12, 2019
Dear Joyce Kwun:
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.
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 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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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.
Sharon M. Andrews Assistant Division 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)
Device Name CottonDay Tampon
Indications for Use (Describe)
The CottonDay Tampon is intended for insertion into the absorption of menstrual or other vaginal 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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510(k) Summary - K182817
1. Submitter Information
| Applicant: | Taebong Co., Ltd. |
|---|---|
| Contact: | Ha Neul Jeong |
| Address: | 684-2 Illgok-Dong, Buk-Gu |
| Gwangju Gwangyeogsi, KOREA, | |
| REPUBLIC OF 500-866 |
2. Correspondent Information
| Contact: | Joyce Kwun |
|---|---|
| Provision Consulting Group, Inc. | |
| Address: | 3350 Shelby St. Ste 200, Ontario, CA 91764 |
| Phone: | +1-909-493-3276 (O) |
| +1-909-680-8562 (M) | |
| Email: | info@provisionfda.com |
Date Prepared: July 18, 2019 3.
4. Device Information
| Device Name: | CottonDay Tampon |
|---|---|
| Common Name: | Unscented Menstrual Tampon |
| Regulation Number: | 21 CFR 884.5470 |
| Regulation Name: | Tampon, Menstrual, Unscented |
| Regulatory Class: | Class II |
| Product Code: | HEB |
5. Predicate Device Information
Tosama 100% Organic Cotton Menstrual Tampon (K151170). This predicate device has not been subject to a design-related recall.
6. Device Description
CottonDay Tampon will be offered as a traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbencies: Regular and Super.
7. Indications for Use
The CottonDay Tampon is intended for insertion into the absorption of menstrual or other vaginal discharge.
4
| | | Subject Device (K182817) | Predicate Device
(K151170) |
|-----------------------------------|------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Product Name | | CottonDay Tampon | Tosama 100% Organic Cotton
Menstrual Tampon |
| Classification
Regulation | | 884.5470 | 884.5470 |
| Product Code | | HEB | HEB |
| Intended Use | | The device is intended for
insertion into the vagina
for the absorption of
menstrual or other vaginal
discharge. | The device is
intended for insertion
into the vagina for the
absorption of
menstrual or other
vaginal discharge. |
| Sterile? | | No | No |
| Design | | Tampon with cylindrical
shape and bullet-like tip.
Applicator with smooth,
rounded tip. | Tampon with
cylindrical shape and
bullet-like tip.
Applicator with
smooth, rounded tip. |
| Syngyna Absorbency
(gram) | | Regular 6.0 - 9.0 | Regular 6.0 |
| | | Super 9.0 - 12.0 | Super 9.0 - 12.0 |
| Pledget Length (mm) | | Regular 38 | Regular 43.0 - 46.0 |
| | | Super 47 | Super 48.0 - 51.0 |
| Pledget Diameter
(mm) | | Regular 12 | Regular 11.0 - 12.0 |
| | | Super 12 | Super 12.0 - 13.0 |
| Applicator Inner
Length (mm) | | Regular 73 ± 5% | Regular 120 ± 5% |
| | | Super 73 ± 5% | Super 120 ± 5% |
| Applicator Outer
Length (mm) | | Regular 76.5 ± 5% | Regular 120 ± 5% |
| | | Super 76.5 ± 5% | Super 120 ± 5% |
| Applicator Inner
Diameter (mm) | | Regular 11.8 ± 5% | Regular 13 |
| | | Super 11.8 ± 5% | Super 16 |
| Applicator Outer
Diameter (mm) | | Regular 14.1 ± 5% | Regular 13 |
| | | Super 14.1 ± 5% | Super 16 |
| Materials | Pledget | 100% Organic Cotton | 100% Organic Cotton |
| | Applicator | Polyethylene | TPO |
Comparison of Intended Use and Technological Characteristics with the Predicate Device 8.
The subject and predicate devices have the same intended use - to absorb menstrual or other discharge in the vagina. They have the same design and comparable dimensions and absorbencies. The differences in technological characteristics do not raise different questions of safety and effectiveness.
5
9. Summary of Non-Clinical Performance Testing
Performance testing
The following performance characteristics were assessed in accordance with the 2005 FDA guidance document "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff".
- Dimensions
- Absorbency range
- Chemical residues
- Withdrawal cord strength
- Fiber shedding
- Tampon integrity
Biocompatibility Testing
Biocompatibility studies were performed in accordance with the FDA guidance document "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" issued in 2016 and ISO 10993 standards as follows:
- . Cytotoxicity (MEM Elution Test) per ISO 10993-5:2009
- Sensitization (Guinea Pig Maximization Test) per ISO 10993-10:2010 ●
- Irritation (Vaginal Irritation Test) per ISO 10993-10:2010 ●
- . Acute Systemic Toxicity per ISO 10993-11:2006
These tests were performed on the subject tampons and applicators, and the results met the requirements of the ISO standards.
Microbiology Testing
Per the 2005 FDA guidance document mentioned above, microbiology testing was conducted to demonstrate that the subject devices do 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
10. Conclusions
The subject and predicate devices have the same intended use. Although there are differences in technological characteristics between the subject and predicate devices, these differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate devices.