(56 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological safety of a traditional menstrual tampon, with no mention of AI or ML.
No
The device is a tampon, intended for absorption of menstrual or other vaginal discharge, which is not a therapeutic function.
No
The device is an organic cotton tampon intended for the absorption of menstrual or other vaginal discharge. It does not perform any diagnostic functions.
No
The device description clearly outlines a physical product (tampons with absorbent material, strings, and applicators) and details performance studies related to physical properties and biocompatibility, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "insertion into the vagina for the absorption of menstrual or other vaginal discharge." This is a physical function, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical product designed for absorption. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on physical properties (dimensions, absorbency, strength, integrity), biocompatibility, and microbiological impact (growth of bacteria, toxin production). These are relevant to the safety and function of a physical absorbent device, not a diagnostic test.
- Lack of Diagnostic Metrics: There are no mentions of typical diagnostic metrics like sensitivity, specificity, AUC, etc.
Therefore, this device is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Organic Cotton Tampon and Organic Cotton PESCV cord Tampon are intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Product codes
HEB
Device Description
Organic Cotton Tampon and Organic Cotton PESCVcord Tampon are traditional unscented menstrual tampons. They share the same design and raw materials except the material of the removal strings. Each of them are available in two configurations (i.e., digital tampon and applicator tampon). Each device consists of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion.
Both of Organic Cotton Tampon and Organic Cotton PESCVcord Tampon are provided in 4 absorbency: light (≤6g), regular (6-9g), super (9-12g) and super plus (12-15g). Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and 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)
Non-clinical testing was conducted to verify that the proposed devices can meet all design specifications and perform similarly to the predicate device.
Performance Testing:
The following performance characteristics were assessed on Organic Cotton Tampon and Organic Cotton PESCVcord Tampon respectively 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
- Chemical residues
All samples met the predefined acceptance criteria.
Biocompatibility Testing:
Biocompatibility studies were performed 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 8, 2023.
The following tests were performed on the "tampon" component of Organic Cotton Tampon.
- 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
The results demonstrated that the tampon component of Organic Cotton Tampon is noncytotoxic, 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 final, finished form of Organic Cotton Tampon, and the test results showed that the proposed device does 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
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 and 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 Administration" in blue text.
May 10, 2024
Suzhou Borage Medical Technology Co., Ltd. % Liu Grace Consultant Shenzhen Joyantech Consulting Co. Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 CHINA
Re: K240708
Trade/Device Name: Organic Cotton Tampon; Organic Cotton PESCV cord Tampon Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: March 6, 2024 Received: March 15, 2024
Dear Liu Grace:
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,
Image /page/2/Picture/3 description: The image shows the name Reginald K. Avery -S in a large, clear font. The text is black and stands out against a light background. The name is written in a simple, sans-serif typeface.
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) K240708
Device Name Organic Cotton Tampon; Organic Cotton PESCV cord Tampon
Indications for Use (Describe)
The Organic Cotton Tampon and Organic Cotton PESCV cord Tampon are intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
1. Contact Details
1.1 Applicant information
| Applicant Name | Suzhou Borage Medical Technology Co., Ltd. |
|---|---|
| Address | No.9 Shiheshan Road, Dongshan Town, Wuzhong District, |
| Suzhou City, Jiangsu Province, 215107, China | |
| Contact person | Zhou Nana |
| Phone No. | +86-512-66280008 |
| znn@borage.com.cn | |
| Date Prepared | May 9, 2024 |
1.2 Submission Correspondent
| Image: Logo | Shenzhen Joyantech Consulting Co., Ltd
1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan
District, Shenzhen, Guangdong Province, China |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 卓远天成 | |
| Phone No. | +86-755-86069197 |
| Contact person | Grace Liu |
| Contact person's e-mail | grace@cefda.com |
| Website | http://www.cefda.com |
2. Device Information
| Trade name | Organic Cotton Tampon
Organic Cotton PESCVcord 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 | Unscented Menstrual Tampon |
|---|---|
| 510(k) Number | K222046 |
| Product Code | HEB |
| Manufacturer | Suzhou Borage Medical Technology Co., Ltd. |
The predicate device has not been subject to a design-related recall.
4. Device Description
Organic Cotton Tampon and Organic Cotton PESCVcord Tampon are traditional unscented menstrual tampons. They share the same design and raw materials except the material of the removal strings. Each of them are available in two configurations (i.e., digital tampon and applicator tampon). Each device consists of a tampon,
5
including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion.
Both of Organic Cotton Tampon and Organic Cotton PESCVcord Tampon are provided in 4 absorbency: light (≤6g), regular (6-9g), super (9-12g) and super plus (12-15g). Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.
5. Intended Use/Indication for Use
The organic cotton tampon and the organic cotton PESCVcord tampon are intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
6. Technological Characteristics Comparison
| Comparison item | Proposed Device | Predicate Device (K222046) | ||
|---|---|---|---|---|
| Manufacturer | Suzhou Borage Medical | |||
| Technology Co., Ltd. | Suzhou Borage Medical | |||
| Technology Co., Ltd. | ||||
| Product Name | Organic Cotton Tampon, | |||
| Organic Cotton PESCVcord | ||||
| Tampon | Unscented Menstrual Tampon | |||
| Product Code | HEB | HEB | ||
| Regulation Number | 21 CFR § 884.5470 | 21 CFR § 884.5470 | ||
| Classification | Class II | Class II | ||
| Intended Use/ Indications for Use | The organic cotton tampon and | |||
| the organic cotton PESCVcord | ||||
| tampon are intended for insertion | ||||
| into the vagina for the absorption | ||||
| of menstrual or other vaginal | ||||
| discharge. | The tampon is intended for | |||
| insertion into the vagina for the | ||||
| absorption of menstrual or other | ||||
| vaginal discharge. | ||||
| Single Use | Yes | Yes | ||
| Sterility | Non-sterile | Non-sterile | ||
| 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. | ||||
| Absorbency | Light | ≤6g | ≤6g | |
| Regular | 6~9g | 6~9g | ||
| Super | 9~12g | 9~12g | ||
| Super plus | 12~15g | 12~15g | ||
| Product | ||||
| dimensions | Digital | |||
| tampon | Pledget | |||
| length | Light: 40~50 mm | |||
| Regular: 40~50 mm | ||||
| Super: 45~55 mm | ||||
| Super plus: 45~55 mm | Light: 40~50 mm | |||
| Regular: 40~50 mm | ||||
| Super: 45~55 mm | ||||
| Super plus: 45~55 mm | ||||
| Pledget | ||||
| diameter | Light: 9.5~12.5 mm | |||
| Regular: 10.5~13.5 mm | ||||
| Super: 11.5~14.5 mm | ||||
| Super plus: 12.5~15.5 mm | Light: 9.5~12.5 mm | |||
| Regular: 10.5~13.5 mm | ||||
| Super: 11.5~14.5 mm | ||||
| Super plus: 13.3~16.3 mm | ||||
| Removal | ||||
| string | ||||
| length | 120~170 mm | 125~165 mm | ||
| Applica | ||||
| tor | ||||
| tampon | Pledget | |||
| length | Light: 40~50 mm | |||
| Regular: 40~50 mm | ||||
| Super: 45~55 mm | ||||
| Super plus: 45~55 mm | ||||
| Pledget | ||||
| diameter | Light: 9.5~12.5 mm | |||
| Regular: 10.5~13.5 mm | ||||
| Super: 11.5~14.5 mm | ||||
| Super plus: 12.5~15.5 mm | Light: 9.5~12.5 mm | |||
| Regular: 10.5~13.5 mm | ||||
| Super: 11.5~14.5 mm | ||||
| Super plus: 13.3~16.3 mm | ||||
| Removal | ||||
| string | ||||
| length | 120~170 mm | 125~165 mm | ||
| Applicator | ||||
| length | Light and Regular: 125 mm | |||
| Super and Super plus: 126 mm | Light and Regular: 125 mm | |||
| Super and Super plus: 126 mm | ||||
| Applicator | ||||
| diameter | Light and Regular: 15.0 mm | |||
| Super and Super plus: 16.5 mm | Light and Regular: 15.0 mm | |||
| Super and Super plus: 16.5 mm | ||||
| Component | ||||
| Materials | Pledget | 100% Organic Cotton | 100% Viscose | |
| Overwap | Polyethylene and | |||
| Polyethylene | ||||
| terephthalate | Polyethylene and | |||
| Polyethylene | ||||
| terephthalate | ||||
| Removal string | Organic Cotton Tampon: | |||
| 100% Organic Cotton | ||||
| Organic Cotton PESCVcord | ||||
| Tampon: Polyester and Viscose | Polyester and Viscose | |||
| Applicator | Polyethylene and Polypropylene | Polyethylene and Polypropylene | ||
| Additives and Finishing Agents | Paraffin-based resin | Paraffin-based resin and | ||
| Polyoxyethylene stearate |
Table 1 Technological Characteristics Comparison Table
6
The proposed devices have the same indications for use as the predicate device as well as similar technical characteristics. The subject device has differences in material composition and some dimensions. The differences don't raise any additional questions for safety and effectiveness.
7. Summary of Non-clinical Testing
7
Non-clinical testing was conducted to verify that the proposed devices can meet all design specifications and perform similarly to the predicate device. The following tests were conducted.
Performance Testing
The following performance characteristics were assessed on Organic Cotton Tampon and Organic Cotton PESCVcord Tampon respectively 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
-
Chemical residues
All samples met the predefined acceptance criteria.
Biocompatibility Testing
Biocompatibility studies were performed 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 8, 2023.
The following tests were performed on the "tampon" component of Organic Cotton Tampon.
-
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
The results demonstrated that the tampon component of Organic Cotton Tampon is noncytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.
The only difference between Organic Cotton PESCVcord Tampon and Organic Cotton Tampon is the raw materials of removal strings, while the removal string used in Organic Cotton PESCVcord Tampon is just the same as that used in the predicate device (K222046). So the biocompatibility data of Organic Cotton Tampon and the predicate
8
device was leveraged to demonstrate the safety of the "tampon" component of Organic Cotton PESCVcord Tampon.
The applicator used in the proposed devices is identical to the applicator used in the predicate device (K222046). Therefore, the biocompatibility data from the predicate device was leveraged to demonstrate the safety of the "applicator" component of the proposed devices.
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 final, finished form of Organic Cotton Tampon, and the test results showed that the proposed device does not:
- A enhance the growth of Staphylococcus aureus;
-
increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1);
-
alter the growth of normal vaginal microflora.
The only difference between Organic Cotton PESCVcord Tampon and Organic Cotton Tampon is the raw materials of removal strings, while the removal string used in Organic Cotton PESCVcord Tampon is just the same as that used in the predicate device (K222046). So the microbiology testing data of Organic Cotton Tampon and the predicate device was leveraged to demonstrate the microbiology safety of Organic Cotton PESCVcord Tampon.
8. Clinical Testing
No clinical study is included in this submission.
9. Conclusions
The nonclinical tests demonstrate that the proposed devices are as safe and effective as the legally marketed device (K222046). Therefore, the subject devices are substantially equivalent to the predicate device.