(109 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological interactions of a menstrual tampon, with no mention of AI or ML technologies.
No.
The device description and intended use clearly state that the tampon is used to absorb menstrual discharge, not to treat or prevent a disease or condition. While safety testing is performed, its primary function is not therapeutic.
No
The device, an unscented menstrual tampon, is used to absorb menstrual discharge and does not provide information about a patient's health status or condition, which is the function of a diagnostic device.
No
The device description clearly outlines physical components (pledget, overwrap, removal string, applicator tubes, wrapper) and performance studies focus on physical characteristics and biological interactions, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Device Function: The Unscented Menstrual Tampon is a physical device inserted into the body to absorb menstrual fluid. It does not analyze or test any biological sample to provide diagnostic information.
- Intended Use: The intended use is clearly stated as "inserted into the vagina to absorb menstrual discharge." This is a mechanical function, not a diagnostic one.
- Device Description: The description focuses on the materials and construction of the tampon for absorption, not on any components designed for analyzing biological samples.
- Performance Studies: The performance studies listed (absorbency, strength, biocompatibility, microbiology) evaluate the physical and biological safety of the device for its intended use of absorption, not its ability to diagnose or analyze.
Therefore, based on the provided information, the Unscented Menstrual Tampon is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Unscented Menstrual Tampon is inserted into the vagina to absorb menstrual discharge.
Product codes
HEB
Device Description
The Unscented Menstrual Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are provided in 4 absorbencies, light (≤ 6 grams absorbency), regular (6-9 grams), super (9-12 grams) and super plus (12-15 grams). These tampons include a pledget made from viscose and cotton as well as a polyester and polypropylene overwrap. The removal string is made of polypropylene yarn and cotton yarn. The applicator tubes are made of low density polyethylene (LDPE). The assembled tampon with applicator is wrapped in a printed polyethylene wrapper.
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
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)
The following performance characteristics were assessed in accordance with the 2005 FDA guidance document "Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)"
- Dimensional information
- Absorbency range, tested using the Syngyna method (per 21 CFR 801.430)
- Chemical residues
- Withdrawal cord strength
- Fiber shedding
- Tampon integrity
The performance tests were conducted to demonstrate the effectiveness of the subject device; all samples met the predefined acceptance criteria.
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
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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
December 15, 2023
Unibeauty (Hubei) Technology Co.,Ltd. % Helen Nan Official Correpondent New Risen Enterprise Management Consulting Co., Ltd. Room 302, Building 3, Hangqian Mansion, Hangqian Street Lucheng District Wenzhou, Zhejiang 325000 China
Re: K232598
Trade/Device Name: Unscented Menstrual Tampon Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: November 13, 2023 Received: November 13, 2023
Dear Helen Nan:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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
3
Indications for Use
510(k) Number (if known) K232598
Device Name Unscented Menstrual Tampon
Indications for Use (Describe)
The Unscented Menstrual Tampon is inserted 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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4
Image /page/4/Picture/0 description: The image shows a logo for a company called UNI BEAUTY, along with the website address www.unibty.com. The image also contains the text "Page 1 of 6" and the code "K232598". There are Chinese characters below the logo, which translate to "beauty has you, and beauty".
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
1.0 Submitter Information
- · Company: Unibeauty (Hubei) Technology Co.,Ltd.
- · Address: Building A8, nonwoven small and medium-sized enterprise Industrial Park, PENGCHANG Town, Xiantao City, Hubei Province
- Phone: 086-728-8220088
- Contact: Mr. Lin Fongshun, General Manager
- Date Prepared: December 5, 2023
2.0 Device Information
Trade/Device Name: Unscented Menstrual Tampon Common Name: Unscented Menstrual Tampon Classification Name: Tampon, Menstrual, Unscented Classification Regulation: 21 CFR 884.5470 Product Code: HEB (Tampon, Menstrual, Unscented) Device Class: II
3.0 Predicate Device Information
The predicate device is Ontex Unscented Tampons with Colored Plastic Applicator manufactured by ONTEX BVBA.
510K Number: K142786
The predicate device has not been subject to any design-related recall.
4.0 Device Description
The Unscented Menstrual Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are provided in 4 absorbencies,
5
Image /page/5/Picture/0 description: The image shows the logo for UNI BEAUTY, along with the website address www.unibty.com. The image also contains the text "Page 2 of 6" and the code "K232598". There are also Chinese characters that translate to "You, Li, Mei, You, Ni, Er, Mei".
light (≤ 6 grams absorbency), regular (6-9 grams), super (9-12 grams) and super plus (12-15 grams). These tampons include a pledget made from viscose and cotton as well as a polyester and polypropylene overwrap. The removal string is made of polypropylene yarn and cotton yarn. The applicator tubes are made of low density polyethylene (LDPE). The assembled tampon with applicator is wrapped in a printed polyethylene wrapper.
5.0 Indications for Use
The Unscented Menstrual Tampon is inserted into the vagina to absorb menstrual discharge.
6.0 Comparison of Technological Characteristics with the Predicate Device
The following table compares the Unscented Menstrual Tampon to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| 6.1 Comparison Table of Technological Characteristic with the |
|---|
| Predicate Device |
| Characteristics | Subject Device | Predicate Device
(K142786) | Significant
Differences |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Device Name | Unscented Menstrual
Tampon | Ontex Unscented
Tampons with Colored
Plastic Applicators | N/A |
| Regulation
Name | Unscented Menstrual
Tampon | Unscented Menstrual
Tampon | Same |
| Manufacturer | Unibeauty (Hubei)
Technology Co.,Ltd. | ONTEX | N/A |
| Product Code | HEB | HEB | Same |
| Regulation
Number | 21 CFR 884.5470 | 21 CFR 884.5470 | Same |
| Classification | Class II | Class II | Same |
| Indications for
Use | The Unscented
Menstrual Tampons
are inserted into the
vagina to absorb
menstrual discharge. | The Ontex Unscented
Tampons with Colored
Plastic Applicators are
inserted into the vagina to
absorb menstrual
discharge. | Same |
| Overall Design | W wadding tampon
with plastic applicators
of full size (long) | W wadding tampon with
plastic applicators of full
size (long) and compact
size | Different, no
compact size |
| Unscented/Scent
ed | Unscented | Unscented | Same |
| Dimensions
Specifications
(mm) | Total length (in ready
to push position): 106-
122.2
Outside diameter
(outer tube): 14.5- 16.2 | Total length (in ready to
push position): 110 - 135
Outside diameter (outer
tube): 13.5 - 18.2 | Different |
| Weight
Specifications (g)
(single wrapper) | 4.55-6.45 (without | 3.6-8.1 | Different |
| Absorbent
Pledget | Viscose and Cotton | Viscose | Different |
| Withdrawal Cord | Cotton and
Polypropylene | Cotton polyester | Different |
| Applicator | Plastic -polyethylene
including pigments | Plastic -polyethylene
including pigments | Same |
| Absorbencies | ≤6g, 6-9g, 9-12g, 12-
15g |