(140 days)
Not Found
No
The 510(k) summary describes a mechanical reusable tampon applicator and does not mention any AI or ML components or functionalities.
No
The device is described as an applicator for inserting menstrual tampons, not as a device intended to treat or diagnose a medical condition. Its function is purely mechanical assistance in tampon insertion.
No
The device is a reusable tampon applicator intended to assist in the insertion of menstrual tampons, which is a mechanical function related to personal hygiene, not the diagnosis of a medical condition.
No
The device description clearly states it is a "reusable tampon applicator," which is a physical hardware device. The performance studies also focus on physical characteristics and testing of the hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- re.t.a.™ Function: The re.t.a.™ reusable tampon applicator is a device used to physically insert a menstrual tampon into the vagina. It does not analyze any bodily fluids or tissues to provide diagnostic information. Its function is purely mechanical and related to the delivery of a separate medical device (the tampon).
The provided information clearly describes a device for inserting a tampon, not for performing any diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The re.t.a.TM reusable tampon applicator in intended to be used to insert a digital menstrual tampon into the vagina.
Product codes
HEB, HIL
Device Description
The re.t.a.™ Reusable Tampon Applicator is a non-sterile, single user reusable device. It is intended to be sold on its own, without a pre-loaded tampon. The applicator requires the user to insert a legally-marketed digital/non-applicator menstrual tampon into the applicator at the time of use. The use-life of the subject applicator is two years.
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)
The following tests demonstrate that the proposed subject devices met the applicable design and performance requirements:
- Functional evaluation, including assessment of:
- o Weight
- o Physical dimensions
- o Outer cover uncap-force
- o Tampon compatibility testing
- o Ejection force
- Use-life testing
- Biocompatibility including cytotoxicity, vaginal irritation, and sensitization ● testing
- o Cleaning Validation
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
510(k) Summary
| Submitter: | THINX INC
601 W 26th St, Suite 515
New York, NY 10001 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Gillespie (Consultant) Clover Medical LLC
79 Haven St.
Dover, MA 02030
Phone: 1-774-567-0277
Email: jgillespie@clovermedical.com |
Date of Preparation: August 17, 2018
Device Trade Name: re.t.a™ Reusable Tampon Applicator
Common Name: Reusable Tampon Applicator
Classification: Class: Il Panel: Obstetrics/Gynecology Requlation: 884.5470, Unscented Menstrual Tampon Product Code: HEB (Unscented Menstrual Tampon) and HIL (Scented-Deodorized Menstrual Tampon)
Predicate Device: K091749, U by Kotex® Click® Unscented Menstrual Tampons
The predicate device has not been subject to a design-related recall.
Device Description:
The re.t.a.™ Reusable Tampon Applicator is a non-sterile, single user reusable device. It is intended to be sold on its own, without a pre-loaded tampon. The applicator requires the user to insert a legally-marketed digital/non-applicator menstrual tampon into the applicator at the time of use. The use-life of the subject applicator is two years.
Indications for Use Statement:
The re.t.a.™ reusable tampon applicator in intended to be used to insert a digital menstrual tampon into the vagina.
1
Comparison of Technological Characteristics and Indication for Use:
The following table compares the indications for use statement of the subject and predicate device.
| Device & Predicate Device(s): | K180850 | K091749 |
|---|---|---|
| Indication for Use | The re.t.a.TM reusable | |
| tampon applicator in | ||
| intended to be used to | ||
| insert a digital | ||
| menstrual tampon into | ||
| the vagina | Kimberly-clark U by Kotex | |
| is an unscented menstrual | ||
| tampon inserted into the | ||
| vagina to absorb | ||
| menstrual fluid | ||
| Usability | Reusable | Single use |
| Use-life | 2 years | N/A |
| Tampon compatibility | Digital tampons of | |
| various sizes | Kotex Click (applicator | |
| specific tampon) | ||
| Device Design | Sleeve with slit, | |
| pusher, and outer | ||
| cover | Sleeve with compressed | |
| tampon, pusher and outer | ||
| cover |
The Indications for Use statement for the subject device is different from the predicate device. However, they have the same intended use because the subject applicator is an accessory to a class II tampon device.
The subject device differs from the predicate device in technological characteristics. The predicate device is a tampon with applicator whereas the subject device is used for the placement of digital tampons. The subject device is similar in its operating principle (applicator portion of the predicate device). On the other hand, there are several design, usability, and tampon compatibility differences between the subject device and predicate device.
These differences do not raise different questions of safety or effectiveness.
2
Performance Data
The following tests demonstrate that the proposed subject devices met the applicable design and performance requirements:
- Functional evaluation, including assessment of:
- o Weight
- o Physical dimensions
- o Outer cover uncap-force
- o Tampon compatibility testing
- o Ejection force
- Use-life testing
- Biocompatibility including cytotoxicity, vaginal irritation, and sensitization ● testing
- o Cleaning Validation
Conclusion
The subject device is substantially equivalent to the predicate device.
3
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4
August 20, 2018
THINX, Inc. % John Gillespie Consultant Clover Medical, LLC 79 Haven St. Dover, MA 02030
Re: K180850
Trade/Device Name: re.t.a™ Reuseable Tampon Applicator Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB, HIL Dated: July 17, 2018 Received: July 18, 2018
Dear John Gillespie:
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.
5
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure