(59 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of a traditional tampon, with no mention of AI or ML.
No
The device is described as absorbing menstrual or other vaginal discharge, not treating or preventing a disease or condition.
No
This device is intended for absorption of menstrual or other vaginal discharge, not for diagnosing any condition.
No
The device description clearly states it is a physical tampon made of cotton with an applicator and withdrawal cord, which are hardware components. There is no mention of any software functionality.
Based on the provided information, the Tempo Natural Tampon 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 within the body, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details a physical device for absorption, not a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting specific substances, or providing diagnostic information.
- Performance Studies: The performance studies focus on physical characteristics, safety (biocompatibility, microbiology), and absorbency, which are relevant to a physical medical device, not an IVD.
IVDs are devices used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. The Tempo Natural Tampon does not fit this description.
N/A
Intended Use / Indications for Use
The Tempo Natural 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 Tempo Natural Tampon will be offered as a traditional unscented menstrual 100% organic 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. It will be offered in two absorbances: Regular and Super.
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)
Performance testing was conducted 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." The assessed characteristics include: Dimensions, Absorbency range, Chemical residues, Withdrawal cord strength, Fiber shedding, and Tampon integrity.
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 2016 and ISO 10993 standards. Specific tests included: Cytotoxicity per ISO 10993-5:2009, Sensitization per ISO 10993-10:2010, Irritation per ISO 10993-10:2010, and Acute Systemic Toxicity per ISO 10993-11:2006. These tests were performed on the subject tampons and applicators, and the results satisfied the ISO standards requirements.
Microbiology testing was conducted per the 2005 FDA guidance document 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), or Alter the growth of normal vaginal microflora.
The results of performance testing demonstrate that the Tempo Natural Tampon is as safe and effective as the predicate device and supports a determination of substantial equivalence.
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
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September 17, 2021
Dong-A Pharmaceutical Co., Ltd. % Joyce Kwon President Provision Consulting Group, Inc. 100 N. Barranca St. Suite 700 West Covina, CA 91791
Re: K212272
Trade/Device Name: Tempo Natural Tampon Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: July 16, 2021 Received: July 20, 2021
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 (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 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,
Jason Roberts -S
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) K212272
Device Name Tempo Natural Tampon
Indications for Use (Describe)
The Tempo Natural Tampon is intended for insertion into the vagina for 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
K212272 Page 1 of 3
510(k) Summary - K212272
Submitter
Hyunjeong Jang Dong-A Pharmaceutical Co., Ltd. 64 Cheonho-daero, Dongdaemun-gu, Seoul, 02587 Republic of Korea
Official Correspondent
Joyce Kwon Provision Consulting Group, Inc. 100 N. Barranca St. Suite 700 West Covina, CA 91791
Date Prepared
Sept 15, 2021
Device Information
Trade Name: Tempo Natural Tampon Common Name: Unscented Menstrual Tampon Classification Name: Tampon, Menstrual, Unscented Product Code: HEB Regulation Number: 21 CFR 884.5470 Regulatory Class: Class II
Predicate Devices
Taebong CottonDay Tampon (K182817)
The predicate device has not been subject to any design-related recalls.
Indication for Use
The Tempo Natural Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Device Description
The Tempo Natural Tampon will be offered as a traditional unscented menstrual 100% organic 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. It will be offered in two absorbances: Regular and Super.
4
| Substantial Equivalent Comparison Chart | ||
|---|---|---|
| Subject Device | Predicate Device (K182817) | |
| Product Name | Tempo Natural Tampon | Taebong CottonDay Tampon |
| Classification | ||
| Regulation | 884.5470 | 884.5470 |
| Product Code | HEB | HEB |
| Indications for Use | The device is intended for | |
| insertion into the vagina for the | ||
| absorption of menstrual or | ||
| other vaginal discharge. | The device is intended for | |
| insertion into the vagina for the | ||
| absorption of menstrual or | ||
| other vaginal discharge. | ||
| Sterile? | No | No |
| 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. | ||
| Syngyna Absorbency | ||
| (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 38 | Regular 38 |
| Super 47 | Super 47 | |
| Pledget Diameter (mm) | Regular 12 | Regular 12 |
| Super 12 | Super 12 | |
| Applicator Inner Length | ||
| (mm) | Regular 73 ± 5% | Regular 73 ± 5% |
| Super 73 ± 5% | Super 73 ± 5% | |
| Applicator Outer Length | ||
| (mm) | Regular 76.5 ± 5% | Regular 76.5 ± 5% |
| Super 76.5 ± 5% | Super 76.5 ± 5% | |
| Applicator Inner | ||
| Diameter (mm) | Regular 11.8 ± 5% | Regular 11.8 ± 5% |
| Super 11.8 ± 5% | Super 11.8 ± 5% | |
| Applicator Outer | ||
| Diameter (mm) | Regular 14.1 ± 5% | Regular 14.1 ± 5% |
| Super 14.1 ± 5% | Super 14.1 ± 5% | |
| Materials | Pledget 100% Organic Cotton | Pledget 100% Organic Cotton |
| Applicator Polyethylene | Applicator Polyethylene |
Substantial Equivalent Comparison Chart
Basis for Substantial Equivalence
The subject device is identical to the predicate device with the same material composition and dimensional characteristics. The subject and predicate device have the same intended use.
5
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 2016 and ISO 10993 standards as follows:
- Cytotoxicity per ISO 10993-5:2009 ●
- Sensitization per ISO 10993-10:2010 ●
- Irritation per ISO 10993-10:2010
- Acute Systemic Toxicity per ISO 10993-11:2006 ●
These tests were performed on the subject tampons and applicators, and the results satisfied the ISO standards requirements.
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 Natural Tampon is as safe and effective as the predicate device and supports a determination of substantial equivalence.