(108 days)
No
The 510(k) summary describes a standard menstrual tampon and its performance and biocompatibility testing, with no mention of AI or ML technology.
No
The device is a tampon, which is used for absorption of menstrual or other discharge. It is not designed to treat a disease, injury, or medical condition, which is the definition of a therapeutic device.
No
Explanation: The device description states it is a menstrual tampon used to absorb fluid, which is a therapeutic function, not diagnostic. There is no information suggesting it identifies or monitors a medical condition.
No
The device description clearly states it is a physical product (tampons made of cotton, cardboard applicator) and the performance studies focus on physical and biological characteristics, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "absorb menstrual or other discharge" by being "inserted into the vagina." This is a physical function within the body, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details the physical components of a tampon designed for absorption. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on physical characteristics (dimensions, absorbency, strength, shedding, integrity), chemical residues, microbiology (impact on bacterial growth and toxin production), and biocompatibility. These are all relevant to a device used internally for absorption, not for in vitro diagnosis.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (like blood, urine, or tissue), detecting specific analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely absorptive and physical.
N/A
Intended Use / Indications for Use
Interlude 100% Cotton Tampons are inserted into the vagina and used to absorb menstrual or other discharge.
Product codes
HEB
Device Description
Interlude 100% Cotton Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are made from cotton absorbing fibers and cotton overwrap to which a cotton cord is sewed with a cotton sewing thread. The applicator tubes are made of cardboard and include a cylindrical barrel and a plunger. The assembled tampon with applicator is wrapped in a printed paper, polyethylene (PE), or polypropylene (PP) wrapper. The subject devices are provided with the following three absorbencies:
Light:
§ 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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 2, 2018
ALBAAD fem % Robert J. Staab, Ph.D. Official Correspondent Regulatory Technical Associates 30 Neck Road Old Lyme, CT 06371
Re: K181911
Trade/Device Name: Interlude 100% Cotton Tampon Regulation Number: 21 CFR& 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: II Product Code: HEB Dated: October 3, 2018 Received: October 4, 2018
Dear Robert J. Staab:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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.
Michael T. Bailey -S
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
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Indications for Use
510(k) Number (if known) K181911
Device Name Interlude 100% Cotton Tampon
Indications for Use (Describe)
Interlude 100% Cotton Tampons are inserted into the vagina and used to absorb menstrual or other 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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510(k) Summary - K181911
1. Submitter Information
| Applicant: | ALBAAD fem |
|---|---|
| Contact: | Shlomo Helvits |
| Address: | 1, Alon Hatavor St. |
| Caesarea Ind. Park 3088900 | |
| Israel | |
| Phone: | +972-4-6223860 |
| Fax: | +972-4-6277022 |
2. Correspondent Information
| Contact: | Robert J. Staab |
|---|---|
| Address: | 30 Neck Road |
| Old Lyme, CT 06370 | |
| Phone: | 860-434-5872 |
| Fax: | 860-434-5892 |
| Email: | rta1ali1@aol.com |
3. Date prepared: October 31, 2018
4. Device Information
| Device Name: | Interlude 100% Cotton Tampon |
|---|---|
| Common Name: | Unscented Menstrual Tampon |
| Regulation Number: | 21 CFR 884.5470 |
| Regulation Name: | Unscented Menstrual Tampon |
| Regulatory Class: | Class II |
| Product Code: | HEB (Tampon, Menstrual, Unscented) |
5. Predicate Device Information
Tampons (K001641) manufactured by, ROSTAM LTD. This predicate device has not been subject to a design-related recall.
6. Device Description
Interlude 100% Cotton Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are made from cotton absorbing fibers and cotton overwrap to which a cotton cord is sewed with a cotton sewing thread. The applicator tubes are made of cardboard and include a cylindrical barrel and a plunger. The assembled tampon with applicator is wrapped in a printed paper, polyethylene (PE), or polypropylene (PP) wrapper. The subject devices are provided with the following three absorbencies:
Light: