(149 days)
No
The device description and performance studies focus on the physical properties, biocompatibility, and absorbency of a menstrual tampon, with no mention of AI or ML technology.
No
The device is described as absorbing menstrual and other vaginal discharge, which implies a supportive or assistive function rather than a therapeutic one aiming to treat or cure a disease or condition.
No
The device is a tampon, which is used for absorbing menstrual and other vaginal discharge, not for diagnosing a condition or disease.
No
The device description clearly states it is composed of physical components: an absorbent pledget (tampon), a withdrawal cord, and an applicator. It also describes physical characteristics and performance testing related to these components.
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, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Youjia unscented tampon is designed to be inserted into the vagina to absorb menstrual and other vaginal discharge. It is a physical device used within the body for absorption, not for analyzing a specimen outside the body.
- Intended Use: The intended use clearly states its purpose is for absorption of discharge, not for diagnostic testing.
Therefore, based on the provided information, the Youjia unscented tampon with plastic applicators 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 Youjia unscented tampon with plastic applicators are inserted into the vagina and used to absorb menstrual and other vaginal discharge.
Product codes (comma separated list FDA assigned to the subject device)
HEB
Device Description
Youjia unscented tampon with plastic applicators are composed of an absorbent pledget (tampon), a withdrawal cord and an applicator. The pledgets have a cylindrical, bullet-like shape and the applicators have a smooth, rounded tip to ease insertion. These tampons are provided in three absorbencies: regular (6-9g), super, (9-12g), and super plus (12-15g). Each tampon is individually wrapped and packaged.
The Youjia unscented tampon with plastic applicators are provided non-sterile and for single use only.
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)
The sponsor completed performance testing consistent with the FDA guidance document: Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) issued on July 27, 2005. As the subject tampon is identical to the tampons cleared under K122603 (Ontex International), the sponsor leveraged testing on the K122603 tampons to support the performance of the proposed Youjia unscented tampon with plastic applicators.
Biocompatibility studies were performed in accordance with the FDA guidance "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 the ISO 10993 standards, as follows:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
The results of these studies demonstrated that the subject device is biocompatible. In addition, biocompatibility data from K190218 was leveraged to support the subject applicator. Extraction testing per USP was completed to evaluate the safety of the colorants used in the applicator.
The following physical assessments were performed on the applicators per in house methods with predefined acceptance criteria:
- Appearance
- Dimensions
- Compatibility of tampon and applicator
- Applicator integrity
- Applicator expulsion force
The results of these tests demonstrated that the subject device meets its pre-defined acceptance criteria.
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.
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.
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
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February 13, 2020
Qingdao Youjia Hygiene Technology Co., Ltd % Emma Xing Official Correspondent Suzhou Jiuzhen Consulting Company Ltd. North Building, A1, 218, Xinghu Str., Suzhou Industrial Park Suzhou, Jiangsu 15123 CHINA
Re: K192557
Trade/Device Name: Youjia unscented tampon with plastic applicators Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: January 9, 2020 Received: January 16, 2020
Dear Emma Xing:
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.
Monica D. Garcia, Ph.D. Acting 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192557
Device Name
Youjia unscented tampon with plastic applicators
Indications for Use (Describe)
The Youjia unscented tampon with plastic applicators are inserted into the vagina and used to absorb menstrual and other vaginal discharge.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary – K192557
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | February 12, 2020 |
|---|---|
| Manufacturer: | Qingdao Youjia Hygiene Technology Co., Ltd. |
| No. 778 Mingyue Road, Huangdao Zone, Qingdao, China | |
| Contact | |
| Person: | Ms. Huiying Zhao |
| Minister of Quality Department Phone: +86-532-86613616 | |
| E-mail: youjia_zhaohy@sina.com | |
| Submission | |
| Correspondent: | Suzhou Jiuzhen Consulting Company Ltd. |
| North Building, A1, 218, Xinghu Str., Suzhou Industrial Park, | |
| China. | |
| Ms. Emma Xing | |
| Phone: +86-512-85665107 | |
| E-mail: Jiuzhenservice@163.com | |
| Trade Name: | Youjia unscented tampon with plastic applicators |
| Common | |
| Name: | Unscented Menstrual Tampon |
Classification Name: Classification Regulation: Classification Panel:
Device Class: Classification Product Code:
Unscented menstrual tampon 21 CFR 884.5470 Obstetrics/Gynecology
Class II HEB (Tampon, Menstrual, Unscented)
4
Predicate Device:
| Trade Name: | BiuBiu Tampon |
|---|---|
| Manufacturer: | Qingdao Youjia Hygiene Technology Co., Ltd. |
| 510(k) Clearance: | K190218 (May 9, 2019) |
The predicate device has not been subject to a design related recall.
Device Description:
Youjia unscented tampon with plastic applicators are composed of an absorbent pledget (tampon), a withdrawal cord and an applicator. The pledgets have a cylindrical, bullet-like shape and the applicators have a smooth, rounded tip to ease insertion. These tampons are provided in three absorbencies: regular (6-9g), super, (9-12g), and super plus (12-15g). Each tampon is individually wrapped and packaged.
The Youjia unscented tampon with plastic applicators are provided non-sterile and for single use only.
Indications for Use Statement:
The Youjia unscented tampon with plastic applicators are inserted into the vagina and used to absorb menstrual and other vaginal discharge.
Substantial Equivalence Discussion:
| | Currently Marketed
Predicate BiuBiu Tampon
(K190218) | Proposed Youjia
unscented tampon with
plastic
applicators | Comment |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Manufacturer | Qingdao Youjia Hygiene
Technology Co.,
Ltd. | Qingdao Youjia Hygiene
Technology Co.,
Ltd. | - |
| Regulation
name | Unscented menstrual tampon | Unscented menstrual
tampon | No difference |
| Indications
for use | The BiuBiu tampon is
inserted into the vagina and
used to absorb menstrual and
other vaginal discharge. | The Youjia unscented
tampon with plastic
applicators are inserted
into the vagina and used to
absorb menstrual and
other vaginal discharge. | No difference |
| Design | Tampon with cylindrical
shape and bullet-like tip.
Applicator with smooth and
rounded tip. | Tampon with cylindrical
shape and bullet-like tip.
Applicator with smooth
and rounded tip. | No difference |
| Components | The BiuBiu tampon is
composed of an absorbent
pledget and an applicator. | The tampon is composed
of an absorbent pledget
and an applicator. | No difference |
| Materials | -Pledget: 100% organic
cotton.
-Withdrawal cord: 100%
organic cotton
-Applicator with telescope:
Polyethylene and
Polypropylene | -Pledget: 100% Rayon.
-Withdrawal cord: 67%
polyester and 33% cotton.
-Applicator with
telescope: Polyethylene
and Polypropylene
-Applicator without
Telescope:
Polyethylene | Different |
| Applicator
color | Orange, Green, Yellow | Applicator with telescope:
Green, Red, Blue
Applicator without
telescope: white | Different |
| Specifications | Regular, super, and super
plus | Regular, super and super
plus. | No difference |
| Applicator Dimensions | | | |
| Applicator Dimensions | Length with applicator: 120 – 125 mm
Diameter with applicator:
14.2 – 17.9 mm | Applicator with telescope:
Length:
120 – 125 mm
Diameter:
14.2 – 17.3 mm
Applicator without
telescope: Length:
113 – 120 mm
Diameter: 14.05 – 17.15
mm | Different |
5
6
The Youjia unscented tampon with plastic applicators and predicate devices have similar indications for use statements and have the same intended use. The differences in technological characteristics between the Youjia unscented tampon with plastic applicators and predicate devices do not raise different safety and effectiveness questions.
Summary of Performance Testing:
The sponsor completed performance testing consistent with the FDA guidance document: Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) issued on July 27, 2005. As the subject tampon is identical to the tampons cleared under K122603 (Ontex International), the sponsor leveraged testing on the K122603 tampons to support the performance of the proposed Youjia unscented tampon with plastic applicators.
Biocompatibility
Biocompatibility studies were performed in accordance with the FDA guidance "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 the ISO 10993 standards, as follows:
- Cytotoxicity
- Sensitization ●
- Irritation ●
- Acute Systemic Toxicity ●
The results of these studies demonstrated that the subject device is biocompatible. In addition, biocompatibility data from K190218 was leveraged to support the subject applicator. Extraction testing per USP was completed to evaluate the safety of the colorants used in the applicator.
Physical performance testing
The following physical assessments were performed on the applicators per in house
7
methods with predefined acceptance criteria:
- Appearance ●
- . Dimensions
- Compatibility of tampon and applicator .
- . Applicator integrity
- . Applicator expulsion force
The results of these tests demonstrated that the subject device meets its pre-defined acceptance criteria.
Conclusion:
The Youjia unscented tampon with plastic applicators are substantially equivalent to the proposed predicate device.