Tempo Tampon

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & 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 ADMINISTRATION" in blue text. April 21, 2022 Dong-A Pharmaceutical Co., Ltd. % Joyce Kwon President Provision Consulting Group, Inc. 100 N. Barranca St. Suite 700 West Covina, CA 91791 Re: K212277 > Trade/Device Name: Tempo Tampon Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: March 18, 2022 Received: March 22, 2022 Dear Joyce Kwon: 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. 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. {1}------------------------------------------------ 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 (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 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, 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) K212277 Device Name Tempo Tampon Indications for Use (Describe) The Tempo 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary - K212277 #### Submitter Hyunjeong Jang Dong-A Pharmaceutical Co., Ltd. 64 Cheonho-daero, Dongdaemun-gu, Seoul, 02587 Republic of Korea +82-2-920-8289 ### Official Correspondent Joyce Kwon Provision Consulting Group, Inc. 100 N. Barranca St. Suite 700 West Covina, CA 91791 +1-909-493-3276 joyce@provisionfda.com ### Date Prepared April 15, 2022 #### Device Information Trade Name: Tempo Tampon Common Name: Unscented Menstrual Tampon Classification Number: 21 CFR 884.5470 Classification Name: Unscented Menstrual Tampon Product Code: HEB (Tampon, Menstrual, Unscented) Regulatory Class: Class II #### Predicate Devices Taebong CottonDay Tampon (K182817) The predicate has not been subject to a design-related recall. #### Indication for Use The Tempo Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge. #### Device Description The Tempo Tampon will be offered as a traditional unscented menstrual 100% cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbances: Regular and Super. {4}------------------------------------------------ # Substantial Equivalent Comparison Chart | | | Subject Device | Predicate Device | | | |-----------------------------------|------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------|--| | Product Name | | Tempo Tampon | Taebong CottonDay Tampon | | | | 510(k) Number | | K212277 | K182817 | | | | Classification<br>Regulation | | 884.5470 | 884.5470 | | | | Product Code | | HEB | HEB | | | | Indications for Use | | The Tempo Tampon is<br>intended for insertion into the<br>vagina for theabsorption of<br>menstrual or other vaginal<br>discharge. | The CottonDay Tampon is<br>intended for insertion into the<br>vagina for theabsorption of<br>menstrual or other vaginal<br>discharge. | | | | Sterile? | | No | No | | | | Design | | Tampon with cylindrical shape<br>and bullet-like tip. Applicator<br>with smooth, rounded tip. | Tampon with cylindrical shape<br>and bullet-like tip. Applicator<br>with smooth, rounded tip. | | | | Syngyna Absorbency<br>(gram) | Regular | 6.0 - 9.0 | Regular | 6.0 - 9.0 | | | | Super | 9.0 - 12.0 | Super | 9.0 - 12.0 | | | Pledget Length (mm) | Regular | 44-48 | Regular | 38 | | | | Super | 47-51 | Super | 47 | | | Pledget Diameter (mm) | Regular | 13.5 | Regular | 12 | | | | Super | 13.5 | Super | 12 | | | Applicator Inner Length<br>(mm) | Regular | 73 ± 5% | Regular | 73 ± 5% | | | | Super | 73 ± 5% | Super | 73 ± 5% | | | Applicator Outer Length<br>(mm) | Regular | 74.5 ± 5% | Regular | 76.5 ± 5% | | | | Super | 74.5 ± 5% | Super | 76.5 ± 5% | | | Applicator Inner<br>Diameter (mm) | Regular | 11.8 ± 5% | Regular | 11.8 ± 5% | | | | Super | 11.8 ± 5% | Super | 11.8 ± 5% | | | Applicator Outer<br>Diameter (mm) | Regular | 15 ± 5% | Regular | 14.1 ± 5% | | | | Super | 15 ± 5% | Super | 14.1 ± 5% | | | Materials | Pledget | 100% Cotton | | 100% Organic Cotton | | | | Applicator | Polyethylene | | Polyethylene | | {5}------------------------------------------------ The subject device and predicate device have the same design, tampon absorbencies, and applicator material. The subject and predicate device have different pledget and applicator sizes. The predicate device used organic cotton while the subject device does not. The intended use of the subject and predicate devices are identical - absorption of menstrual or other vaginal discharge. The dimensional and material differences between the subject device and predicate device do not raise different questions of safety and effectiveness. ### Non-Clinical Test Data ### Performance Testing The following performance characteristics were assessed in accordance with the 2005 FDA guidance document "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff." - Dimensions - Absorbency range ● - Chemical residues ● - . Withdrawal cord strength - Fiber shedding ● - Tampon integrity ### Biocompatibility Testing Biocompatibility studies were performed in accordance with the 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" issued in 2020 and ISO 10993 standards as follows: - · Cytotoxicity (MEM Elution Test) per ISO 10993-5:2009 - · Sensitization (Guinea Pig Maximization Test) per ISO 10993-10:2010 - · Irritation per ISO 10993-10:2010 - · Acute Systemic Toxicity per ISO 10993-11:2017 Cytotoxicity, sensitization, and irritation testing were performed on the subject applicator and all the above biocompatibility testing was performed on the subject tampons. The results demonstrated the tampon and applicator were non-cytotoxic, non-sensitizers, non-irritating, and that the tampon was not acutely systemically toxic. {6}------------------------------------------------ K212277 Page 4 of 4 ### Microbiology Testing Per the 2005 FDA guidance document mentioned above, microbiology testing was conducted to demonstrate that the subject devices do 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 ## Conclusions The results of performance testing demonstrate that the Tempo Tampon is as safe and effective as the predicate device and supports a determination of substantial equivalence.