(94 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a tampon, with no mention of AI or ML.
No.
The BiuBiu tampon is used to absorb menstrual and other vaginal discharge, which is a supportive function rather than a therapeutic one. Therapeutic devices are typically used to treat or alleviate a disease, injury, or other medical condition.
No
The device is described as a tampon used to absorb menstrual and other vaginal discharge, not to diagnose any condition. Its intended use is purely absorptive.
No
The device description clearly states it is composed of physical components: an absorbent pledget (tampon), a withdrawal cord, and an applicator. It also details physical performance testing.
Based on the provided information, the BiuBiu tampon is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "absorb menstrual and other vaginal discharge." This is a physical function, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details the physical components of a tampon (absorbent pledget, cord, applicator) and its function of absorption. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Lack of Diagnostic Function: IVDs are designed to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The BiuBiu tampon does not perform any such analysis.
- Performance Studies: The performance studies focus on biocompatibility and physical performance (dimensions, integrity, expulsion force), which are relevant to a physical medical device, not a diagnostic one.
Therefore, the BiuBiu tampon is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BiuBiu tampon is inserted into the vagina and used to absorb menstrual and other vaginal discharge.
Product codes
HEB
Device Description
The BiuBiu tampon is composed of an absorbent pledget (tampon), a withdrawal cord, and an applicator. The pledgets (cleared under K090819) have a cylindrical, bullet-like shape and the applicators have a smooth, rounded tip to ease insertion. The barrel of the applicator has a no-slip grip design to help hold the tampon tightly. Each tampon is individually wrapped and packaged. There are three versions of the BiuBiu tampon with different absorbencies: regular, super and super plus. Each version has a different color applicator. The BiuBiu tampon is 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 pledget components of the BiuBiu tampon were cleared under K090819, and remain unchanged. Therefore, data on the performance of the pledgets, consistent with the FDA guidance document: Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s), was leveraged from K090819 to support the performance of the BiuBiu Tampon pledgets.
The following non-clinical performance tests were performed on the applicator component of the BiuBiu tampon:
Biocompatibility testing per ISO 10993-1:2009 and 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."
- Cytotoxicity (ISO 10993-5:2009) .
- Vaginal Irritation (ISO 10993-10:2010)
- Skin Sensitization (ISO 10993-10:2010) .
The applicator was demonstrated to be non-cytotoxic, non-irritating, and non-sensitizing.
Physical performance testing: The following physical assessments were performed on the BiuBiu tampon applicator per in house methods with predefined acceptance criteria:
- Appearance
- Dimensions
- Compatibility of tampon and applicator
- Applicator integrity
- Applicator expulsion force
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
May 9, 2019
Oingdao Youjia Hygiene Technology Co., Ltd % Jessie You Official Correspondent Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District Shenzhen, Guangdong 755 China
K190218 Trade/Device Name: BiuBiu Tampon Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: January 26, 2019 Received: February 4, 2019
Dear Jessie You:
Re:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for 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) K190218
Device Name BiuBiu Tampon
Indications for Use (Describe)
The BiuBiu tampon is 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K190218 - 510(k) Summary
1. Submission Sponsor
| Applicant Name | Qingdao Youjia Hygiene Technology Co., Ltd |
|---|---|
| Address | No. 778 Mingyue Road, Huangdao Zone, Qingdao, |
| China | |
| Phone No. | +86-532-86613616 |
| Contact Person | Ms. Huiying Zhao |
| youjia_zhaohy@sina.com | |
| Date Prepared | May 8, 2019 |
2. Submission correspondent
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | Room 1122, No.55 Shizhou Middle Road, Nanshan |
| District, | |
| Shenzhen, | |
| Guangdong, | |
| P.R.China | |
| Post Code | 518000 |
| Phone No. | 86-755-86069197 |
| Contact Person | Mr. Field Fu; Ms. Jessie You; Ms. Elly Xu |
| Jessie@cefda.com; elly@cefda.com |
3. Device Identification
| Trade name | BiuBiu Tampon |
|---|---|
| Device versions | Regular, Super, and Super Plus |
| Common name | Unscented Menstrual Tampon |
| Device Class | II |
| Classification Number | 21 CFR 884.5470 |
| Classification Name | Unscented menstrual tampon |
| Product code | HEB (Tampon, Menstrual, Unscented) |
4. Predicate Device Information
| Trade name | Ontex Tampon (Unscented) |
|---|---|
| 510(k) number | K090819 |
The predicate device has not been subject to a design related recall.
4
5. Device Description
The BiuBiu tampon is composed of an absorbent pledget (tampon), a withdrawal cord, and an applicator. The pledgets (cleared under K090819) have a cylindrical, bullet-like shape and the applicators have a smooth, rounded tip to ease insertion. The barrel of the applicator has a no-slip grip design to help hold the tampon tightly. Each tampon is individually wrapped and packaged. There are three versions of the BiuBiu tampon with different absorbencies: regular, super and super plus. Each version has a different color applicator. The BiuBiu tampon is provided non-sterile and for single use only.
6. Indications for Use Statement
The BiuBiu tampon is inserted into the vagina and used to absorb menstrual and other vaginal discharge.
7. Substantial Equivalence Discussion
| ltem | Subject Device
(K190218):
BiuBiu Tampon | Predicate Device
(K090819):
Ontex Tampon
(Unscented) | Comments |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Qingdao Youjia
Hygiene Technology
Co., Ltd | Ontex International | None |
| Common
name | Unscented Menstrual
Tampon | Unscented Menstrual
Tampon | Same |
| Indications for
use | The BiuBiu tampon is
inserted into the
vagina and used to
absorb menstrual and
other vaginal
discharge. | Ontex Tampon is a
tampon that is inserted
into the vagina and
used to absorb
menstrual fluid. The
intended use of the
organic cotton tampon
is the same as all other
products that are
legally marketed. | Similar |
| 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. | Similar |
| Components | | | |
| The BiuBiu tampon is composed of an absorbent pledget and an applicator. | The Ontex Tampon consists of an absorbent pledget, with and without an applicator. | Similar. The predicate device comes without an applicator. However, both the subject and predicate device include tampons with applicators. | |
| Specifications | Regular, super, and super plus | Regular, super, and super plus | Same |
| Overwrap | Individual wrapping | Individual wrapping | Same |
| Pledget dimensions | Regular | Regular | Identical |
| | Length (mm):
42-46
Diameter (mm):
11.8-12.2
Withdrawal cord (mm):
130-160
Syngina absorption (g):
6.0-9.0 | Length (mm):
42-46
Diameter (mm):
11.8-12.2
Withdrawal cord (mm):
130-160
Syngina absorption (g):
6.0-9.0 | |
| | Super | Super | Identical |
| | Length (mm):
46-50
Diameter (mm):
12.8-13.2
Withdrawal cord (mm):
130-160
Syngina absorption (g):
9.0-12.0 | Length (mm):
46-50
Diameter (mm):
12.8-13.2
Withdrawal cord (mm):
130-160
Syngina absorption (g):
9.0-12.0 | |
| | Super plus | Super plus | Identical |
| | Diameter (mm): | Diameter (mm): | |
| | 14.8–15.2 | 14.8–15.2 | |
| | Withdrawal cord (mm): | Withdrawal cord (mm): | |
| | 130-160 | 130-160 | |
| | Syngina absorption (g): | Syngina absorption (g): | |
| | 12.0-15.0 | 12.0-15.0 | |
| Materials | -Pledget: 100% organic cotton
-Withdrawal cord:
100% organic cotton
-Applicator:
Polyethylene and Polypropylene | -Pledget: 100% organic cotton
-Withdrawal cord:
100% organic cotton
-Applicator:
Cardboard | Different.
The pledget and cord are identical. However, the subject device utilizes a different material in the applicator. |
| Applicator
Dimensions | Inner tube length (mm) X Diameter (mm):
Regular: 41.60 $\pm$ 0.20 x 9.75 $\pm$ 0.15
Super: 41.60 $\pm$ 0.20 x 9.75 $\pm$ 0.15
Super plus: 41.60 $\pm$ 0.20 x 9.75 $\pm$ 0.15
Outer tube length (mm) X Diameter (mm):
Regular: 76.8 $\pm$ 0.9 x 14.35 $\pm$ 0.15
Super: 77.6 $\pm$ 0.9 x 17.15 $\pm$ 0.15
Super plus: 77.6 $\pm$ 0.9 x 17.15 $\pm$ 0.15 | Length with applicator:
120 – 125 mm
Diameter with applicator:
15.9 – 16.1 mm | Different.
The subject and predicate device have different dimensions. |
5
K190218 Page 3 of 5
6
The subject and predicate device have similar indications for use statements and have the same intended use. The technological characteristics of the subject device are different the subject device contains different applicator materials and dimensions. The different technological characteristics of the subject device do not raise different types of safety
7
and effectiveness questions.
8. Non-Clinical Performance Data
The pledget components of the BiuBiu tampon were cleared under K090819, and remain unchanged. Therefore, data on the performance of the pledgets, consistent with the FDA guidance document: Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s), was leveraged from K090819 to support the performance of the BiuBiu Tampon pledgets.
The following non-clinical performance tests were performed on the applicator component of the BiuBiu tampon:
Biocompatibility
Biocompatibility testing per ISO 10993-1:2009 and 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."
- Cytotoxicity (ISO 10993-5:2009) .
- Vaginal Irritation (ISO 10993-10:2010)
- Skin Sensitization (ISO 10993-10:2010) .
The applicator was demonstrated to be non-cytotoxic, non-irritating, and non-sensitizing.
Physical performance testing
The following physical assessments were performed on the BiuBiu tampon applicator per in house methods with predefined acceptance criteria:
- Appearance
- Dimensions ●
- Compatibility of tampon and applicator ●
- Applicator integrity .
- Applicator expulsion force ●
9. Conclusion
The results of the performance testing described above demonstrate that the BiuBiu Tampon is as safe and effective as the predicate device and supports a determination of substantial equivalence.