(97 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological compatibility of a traditional menstrual tampon, with no mention of AI or ML capabilities.
No.
The device is a tampon, intended for the absorption of menstrual or other vaginal discharge. Its function is to absorb discharge, not to cure, mitigate, treat, or prevent disease, nor to affect the structure or function of the body as a therapeutic device would.
No
Explanation: The device is a tampon, which is used for absorption of menstrual or other vaginal discharge. Its intended use does not involve diagnosing conditions or diseases.
No
The device description clearly outlines physical components like cotton, viscose, polyethylene, polypropylene, and a removal string, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the absorption of menstrual or other vaginal discharge. This is a physical function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a physical product designed for absorption and insertion into the vagina. There is no mention of reagents, assays, or any components used to analyze a biological sample for diagnostic purposes.
- Performance Studies: The performance studies focus on physical properties (dimensions, absorbency, strength, integrity), biocompatibility, and microbiological impact on vaginal flora and toxin production. These are relevant to the safety and efficacy of a physical absorbent device, not a diagnostic test.
- Lack of Diagnostic Elements: There are no mentions of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue, etc.) to provide information about a person's health status, diagnose diseases, or monitor treatment. This tampon does not fit that description.
N/A
Intended Use / Indications for Use
The tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Product codes (comma separated list FDA assigned to the subject device)
HEB
Device Description
The organic cotton tampon and viscose tampon are traditional unscented menstrual tampons. Except for the raw materials, they share the same design. The organic cotton tampon and viscose tampon, both have two types i.e., digital tampon and applicator tampon. The tampon applicator is available in two colors - milky and pink. Each device consists of a tampon, including an absorbent 100% organic cotton or 100% viscose pledget ("absorbent core") surrounded by polyethylene and polyethylene terephthalate overwrap ("security veil"), a 100% organic cotton or polyester and cotton removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The applicator is made of polyethylene and polypropylene. The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion.
Both, organic cotton tampon and viscose tampon, are provided in 4 absorbencies: light (≤6g), regular (69g), super (912g) and super plus (12~15g). Each device is individually wrapped in a polyethylene/nonwoven laminated film or cellophane film and packaged in sealed multi-unit containers for retail sale. It 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
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)
Non-clinical testing was conducted to verify that the subject devices meet all design and performance specifications similarly to the predicate device. The following tests were conducted:
Performance Testing:
- Dimensions
- Absorbency
- Removal string strength
- Fiber shedding
- Tampon integrity
- Chemical residues
Biocompatibility Testing:
- In vitro cytotoxicity test per ISO 10993-5:2009.
- Skin sensitization test per ISO 10993-10:2021.
- Vaginal irritation test per ISO 10993-23:2021.
- Acute systemic toxicity test per ISO 10993-11:2017 (tampon only).
The results demonstrated that the subject device is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.
Microbiology Testing:
The test results showed that the subject devices do not:
- enhance the growth of Staphylococcus aureus;
- increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1); and do not
- alter the growth of normal vaginal microflora.
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.
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 14, 2023
Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. % Grace Liu Consultant Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China
K231341 Re:
Trade/Device Name: Organic cotton tampon. Viscose tampon Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: August 3, 2023 Received: August 3, 2023
Dear Grace Liu:
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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
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) K231341
Device Name
Organic cotton tampon, Viscose tampon
Indications for Use (Describe)
The 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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3
510(k) Summary - K231341
1. Contact Details
1.1 Applicant information
| Applicant Name | Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. |
|---|---|
| Address | Lianshi Industrial Park, Nanxun District, Huzhou City, Zhejiang |
| Province, China | |
| Website | www.tianqingglobal.com |
| Contact person | Roy Du |
| Phone No. | +86-13817862379 |
| roy.d@tianqingglobal.com | |
| Date Prepared | August 8, 2023 |
1.2 Submission Correspondent
| Shenzhen Joyantech Consulting Co., Ltd | ||
|---|---|---|
| 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan | ||
| 早远大成 | District, Shenzhen, Guangdong Province, China | |
| Phone No. | +86-755-86069197 | |
| Contact person | Grace Liu, Field Fu | |
| Contact person's e-mail | grace@cefda.com, field@cefda.com | |
| Website | http://www.cefda.com |
2. Device Information
| Trade name | Organic cotton tampon, Viscose tampon |
|---|---|
| Common name | Unscented Menstrual Tampon |
| Classification | II |
| Classification name | Tampon, Menstrual, Unscented |
| Product code | HEB |
| Regulation No. | 21 CFR 884.5470 |
3. Legally Marketed Predicate Device
| Trade Name | Tosama 100% Organic Cotton Menstrual Tampon |
|---|---|
| 510(k) Number | K151170 |
| Product Code | HEB |
| Manufacturer | TOSAMA, d.o.o. |
| Design Related Recall | None |
4. Device Description
The organic cotton tampon and viscose tampon are traditional unscented menstrual tampons. Except for the raw materials, they share the same design. The organic cotton tampon and viscose tampon, both have two types i.e., digital tampon and applicator tampon. The tampon applicator is available in two colors - milky and pink. Each device consists of a tampon, including an absorbent 100% organic cotton or 100% viscose pledget ("absorbent core") surrounded by polyethylene and polyethylene terephthalate
4
overwrap ("security veil"), a 100% organic cotton or polyester and cotton removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The applicator is made of polyethylene and polypropylene. The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion.
Both, organic cotton tampon and viscose tampon, are provided in 4 absorbencies: light (≤6g), regular (69g), super (912g) and super plus (12~15g). Each device is individually wrapped in a polyethylene/nonwoven laminated film or cellophane film and packaged in sealed multi-unit containers for retail sale. It is provided non-sterile and for single use only.
5. Intended Use/Indication for Use
The tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
6. Technological Characteristics Comparison
| Comparison item | Subject Device (K231341) | | Predicate Device
(K151170) | Comment | |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------|
| Manufacturer | Zhejiang Tianqing Manufacturing
Technology Group Co., Ltd. | | TOSAMA, d.o.o. | None | |
| Product Name | Organic cotton
tampon | Viscose
tampon | Tosama 100%
Organic Cotton
Menstrual
Tampon | None | |
| Product Code | HEB | | HEB | Same | |
| Regulation Number | 21 CFR § 884.5470 | | 21 CFR § 884.5470 | Same | |
| Classification | Class II | | Class II | Same | |
| Intended Use / Indications for
Use | The tampon is intended for insertion
into the vagina for the absorption of
menstrual or other vaginal discharge. | | The Tosoma 100%
Organic Cotton
Menstrual Tampon is
intended for insertion
into the vagina for
the absorption of
menstrual or other
vaginal discharge. | Same | |
| Single Use | Yes | | Yes | Same | |
| Sterility | Non-sterile | | Non-sterile | Same | |
| 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. | Same | |
| Absorbency | | | | | |
| Light | ≤6g | | N/A | | |
| Regular | 69g | | 69g | Different | |
| Super | 912g | | 912g | | |
| Super plus | 1215g | | 1215g | | |
| Product dimensions | | | | | |
| Digital tampon | | | | | |
| Light | Pledget length | (4349) mm | | N/A | |12.5) mm | N/A | | |
| | Pledget diameter | (9.5
| | Removal string
length | (120160) mm | | | |50) mm | (43.0
| Regular | Pledget length | (4446.0) mm | | |13.5) mm | (11.0
| | Pledget diameter | (10.512.0) mm | | |160) mm | (130
| | Removal string
length | (120160) mm | | |51) mm | (48.0
| Super | Pledget length | (4551.0) mm | | |14.5) mm | (12.0
| | Pledget diameter | (11.513.0) mm | | |160) mm | (130
| | Removal string
length | (120160) mm | | |51) mm | (48.0
| Super plus | Pledget length | (4551.0) mm | | |15.5) mm | (14.0
| | Pledget diameter | (12.515.0) mm | | |160) mm | (130
| | Removal string
length | (120160) mm | Different | |49) mm | | | |
| Applicator tampon | | | | | |
| | Pledget length | (43
| | Pledget diameter | (9.512.5) mm | | | |160) mm | | | |
| | Removal string
length | (120
| Light | Applicator length | 130.1 mm | N/A | | |
| | Applicator
diameter | 15.2 mm | | | |
| | Pledget length | (4450) mm | (43.046.0) mm | | |
| | Pledget diameter | (10.513.5) mm | (11.012.0) mm | | |
| | Removal string
length | (120160) mm | (130160) mm | | |
| Regular | Applicator length | 130.1 mm | 120 mm | | |
| | Applicator
diameter | 15.2 mm | 13 mm | | |
| | Pledget length | (4551) mm | (43.046.0) mm | | |
| | Pledget diameter | (11.514.5) mm | (12.013.0) mm | | |
| | Removal string
length | (120160) mm | (130160) mm | | |
| Super | Applicator length | 131.0 mm | 120 mm | | |
| | Applicator
diameter | 16.7 mm | 16 mm | | |
| Super plus | Pledget length | (4551) mm | (43.046.0) mm | | |
| | Pledget diameter | (12.515.5) mm | (14.015.0) mm | | |
| | Removal string
length | (120160) mm | (130160) mm | | |
| | Applicator length | 131.0 mm | 120 mm | | |
| | Applicator
diameter | 16.7 mm | 18 mm | | |
| Component
Materials | Pledget | 100% Organic
Cotton | 100% Viscose | 100% Organic
Cotton | Different |
| | Overwrap | Polyethylene and
Polyethylene
terephthalate | Polyethylene and
Polyethylene
terephthalate | 100% Organic
Cotton | |
| | Removal string | 100% Organic
Cotton | PolyesterAnd
Cotton | 100% Organic Cotton | |
| | Applicator | Polyethylene
and
Polypropylene | Polyethylene
and
Polypropylene | TPO | |
| | Additives
and
Finishing
Agents | Anti-wicking agent
of removal string | Repellan T | Repellan T | |
| | | Finishing agent of
pledget | Fiber finishes | Fiber finishes | Not available |
| | Complies with ISO 10993-1 | | Yes | | Yes |
| | Compliance with microbiology
requirements of FDA Guidance
for Tampons | | Yes | | Yes |
| Labeling | | Complied with 21 CFR part 801 and
FDA Menstrual Tampons and Pad
guidance | | Complied with 21
CFR part 801 and
FDA Menstrual
Tampons and Pads
guidance | Same |
Table 1 Technological Characteristics Comparison Table
5
6
The subject devices have the same indication for use as the predicate device; therefore, the subject device has the same intended use as the predicate device. The differences in technological characteristics between the subject and predicate devices, outlined in Table 1, do not raise different questions for safety and effectiveness.
7. Summary of Non-clinical Testing
Non-clinical testing was conducted to verify that the subject devices meet all design and performance specifications similarly to the predicate device. The following tests were conducted.
Performance Testing
The following performance characteristics were assessed on the organic cotton tampon and the viscose tampon in accordance with the FDA guidance document "Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)" issued on July 27, 2005.
-
Dimensions
-
Absorbency
-
Removal string strength
-
Fiber shedding
-
Tampon integrity
7
-
Chemical residues
Biocompatibility Testing
Biocompatibility studies were performed on the organic cotton tampon and the viscose tampon in accordance with the FDA guidance document "Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" issued on September 4, 2020 as follows:
- A In vitro cytotoxicity test per ISO 10993-5:2009
-
Skin sensitization test per ISO 10993-10:2021
-
Vaginal irritation test per ISO 10993-23:2021
- A Acute systemic toxicity test per ISO 10993-11:2017 (tampon only)
All the above tests, except acute systemic toxicity, were performed on the applicator. The tampon and applicator were tested separately. The results demonstrated that the subject device is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.
Microbiology Testing
Per the FDA guidance document "Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)" issued on July 27, 2005, the following microbiology testing was conducted on the highest absorbency of the final, finished form of the subject devices (i.e., the organic cotton tampon and the viscose tampon), and the test results showed that the subject devices do not:
-
enhance the growth of Staphylococcus aureus;
-
increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1); and do not
-
alter the growth of normal vaginal microflora.
8. Clinical Testing
No clinical study is included in this submission.
9. Conclusions
The nonclinical tests demonstrate that the proposed device is as safe and effective as the legally marketed device (K151170). Therefore, the subject device is substantially equivalent to the predicate device.