(285 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 technologies.
No
The device is described as a menstrual tampon intended for absorption of menstrual or other vaginal discharge, which is a hygienic product, not one that treats or prevents a disease or condition.
No
The Rael Tampon is intended for absorption of menstrual or other vaginal discharge, not for diagnosing any condition. Its performance studies focus on physical properties, biocompatibility, and microbiology related to its function as an absorbent product.
No
The device description clearly states it is a physical tampon made of cotton with an applicator and withdrawal cord, which are hardware components.
Based on the provided information, the Rael Tampon is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "absorption of menstrual or other vaginal discharge" by insertion into the vagina. This is a physical function, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details a physical absorbent product (tampon) with an applicator and withdrawal cord. It doesn't describe any components or mechanisms for analyzing biological samples.
- Performance Studies: The performance studies focus on physical properties (dimensions, absorbency, strength, integrity), chemical residues, biocompatibility, and microbiological impact on the vaginal environment. These are relevant to a physical medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Rael Tampon does not fit this description.
N/A
Intended Use / Indications for Use
The Rael Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Product codes
HEB
Device Description
Rael 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 for retail sale. It will be offered in two absorbencies: 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
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 (MEM Elution Test) per ISO 10993-5:2009
- Sensitization (Guinea Pig Maximization Test) per ISO 10993-10:2010
- Irritation (Vaginal Irritation Test) 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 met the requirements of the ISO standards.
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 results: The performance data demonstrate that the subject devices are substantially equivalent to the predicate devices.
Key Metrics
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 15, 2019
Rael, Inc. % Joyce Kwun President Provision Consulting Group, Inc. 3350 Shelby St. Ste 200 Ontario, CA 91764
Re: K182814
Trade/Device Name: Rael Tampon Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Received: June 12, 2019 Dated: June 10, 2019
Dear Joyce Kwun:
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
1
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/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 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 medical devices and radiation-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,
Sharon Andrews Assistant Division 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)
Device Name Rael Tampon
Indications for Use (Describe)
The Rael 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 - K182814
1. Submitter Information
| Applicant: | Rael, Inc. |
|---|---|
| Contact: | Binna Won |
| Address: | 6940 Beach Blvd D-608 & |
| 609 Buena Park, CA 90621 |
2. Correspondent Information
| Contact: | Joyce Kwun
Provision Consulting Group, Inc. |
|----------|------------------------------------------------|
| Address: | 3350 Shelby St. Ste 200, Ontario, CA 91764 |
| Phone: | +1-909-493-3276 (O)
+1-909-680-8562 (M) |
| Email: | info@provisionfda.com |
3. Date Prepared: July 12, 2019
4. Device Information
| Device Name: | Rael Tampon |
|---|---|
| Common Name: | Unscented Menstrual Tampon |
| Regulation Number: | 21 CFR 884.5470 |
| Regulation Name: | Tampon, Menstrual, Unscented |
| Regulatory Class: | Class II |
| Product Code: | HEB |
5. Predicate Device Information
Tosama 100% Organic Cotton Menstrual Tampon (K151170). This predicate device has not been subject to a design-related recall.
6. Device Description
Rael 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 for retail sale. It will be offered in two absorbencies: Regular and Super.
7. Indications for Use
The Rael Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
4
| Subject Device (K182814) | Predicate Device (K151170) | ||
|---|---|---|---|
| Product Name | Rael Tampon | Tosama 100% Organic Cotton | |
| Menstrual Tampon | |||
| Classification | |||
| Regulation | 884.5470 | 884.547 | |
| 0 | |||
| Product Code | HEB | HEB | |
| Intended 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 | |
| Super | 9.0 - 12.0 | ||
| Pledget Length (mm) | Regular | 38 | |
| Super | 47 | ||
| Pledget Diameter | |||
| (mm) | Regular | 12 | |
| Super | 12 | ||
| Applicator Inner | |||
| Length (mm) | Regular | 73 ± 5% | |
| Super | 73 ± 5% | ||
| Applicator Outer | |||
| Length (mm) | Regular | 76.5 ± 5% | |
| Super | 76.5 ± 5% | ||
| Applicator Inner | |||
| Diameter (mm) | Regular | 11.8 ± 5% | |
| Super | 11.8 ± 5% | ||
| Applicator Outer | |||
| Diameter (mm) | Regular | 14.1 ± 5% | |
| Super | 14.1 ± 5% | ||
| Materials | Pledget | 100% Organic Cotton | |
| Applicator | Polyethylene | ||
| 100% Organic Cotton | |||
| TPO |
Comparison of Intended Use and Technological Characteristics with the Predicate Device 8.
The subject and predicate devices have the same intended use - to absorb menstrual or other discharge in the vagina. They have the same design and comparable dimensions and absorbencies. The differences in technological characteristics do not raise different questions of safety and effectiveness.
5
9. Summary of Non-Clinical Performance Testing
Performance testing
The following performance characteristics were assessedin 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 standardsas follows:
- . Cytotoxicity (MEM Elution Test) per ISO 10993-5:2009
- Sensitization (Guinea Pig Maximization Test) per ISO 10993-10:2010 ●
- Irritation (Vaginal Irritation Test) 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 met the requirements of the ISO standards.
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
10. Conclusions
The subject and predicate devices have the same intended use. Although there are differences in technological characteristics between the subject and predicate devices, these differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate devices.