(275 days)
Not Found
No
The device description and performance studies focus on traditional tampon characteristics and testing, with no mention of AI or ML.
No.
The device is intended for absorption of menstrual and other vaginal discharge, not for treating a disease or condition.
No
The device is intended for the absorption of menstrual or other vaginal discharge, not for diagnosing any condition.
No
The device description and performance studies clearly indicate a physical, absorbent product (tampon) and do not mention any software component.
Based on the provided information, the Tempo Tampon is not an IVD (In Vitro Diagnostic) device.
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 taken from the body.
- Device Description: The description details a physical absorbent product for insertion into the vagina.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for a health issue.
- Performance Studies: The performance studies focus on physical characteristics (dimensions, absorbency, strength, shedding, integrity), biocompatibility (cytotoxicity, sensitization, irritation, toxicity), and microbiology related to bacterial growth and toxin production in the presence of the device, not on analyzing a biological sample for diagnostic purposes.
- No Mention of IVD-Specific Terms: The document does not use terms commonly associated with IVD devices, such as "assay," "reagent," "analyzer," "diagnostic," "test," or "measurement of analytes."
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Tempo Tampon's function is purely absorbent and physical.
N/A
Intended Use / Indications for Use
The Tempo Tampon is intended for insertion into the absorption of menstrual or other vaginal discharge.
Product codes
HEB
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.
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)
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.
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
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
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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)
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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 | |||||
| Regulation | 884.5470 | 884.5470 | |||
| Product Code | HEB | HEB | |||
| Indications for Use | The Tempo Tampon is | ||||
| intended for insertion into the | |||||
| vagina for theabsorption of | |||||
| menstrual or other vaginal | |||||
| discharge. | The CottonDay Tampon is | ||||
| intended for insertion into the | |||||
| vagina for theabsorption 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 | 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 | |||||
| (mm) | Regular | 73 ± 5% | Regular | 73 ± 5% | |
| Super | 73 ± 5% | Super | 73 ± 5% | ||
| Applicator Outer Length | |||||
| (mm) | Regular | 74.5 ± 5% | Regular | 76.5 ± 5% | |
| Super | 74.5 ± 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 | 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.