(108 days)
Interlude 100% Cotton Tampons are inserted into the vagina and used to absorb menstrual or other discharge.
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: <6 grams Regular: 6-9 grams Super: 9-12 grams
This document does not contain information about an AI/ML medical device. Instead, it is a 510(k) premarket notification for a menstrual tampon (Interlude 100% Cotton Tampon).
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, ground truth establishment, or sample sizes related to an AI/ML device. The document details the assessment of the tampon based on physical characteristics, absorbency, chemical residues, microbiology, and biocompatibility, as per FDA guidance for menstrual tampons.
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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.
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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 3088900Israel |
| Phone: | +972-4-6223860 |
| Fax: | +972-4-6277022 |
2. Correspondent Information
| Contact: | Robert J. Staab |
|---|---|
| Address: | 30 Neck RoadOld 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: <6 grams Regular: 6-9 grams Super: 9-12 grams
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6. Indications for Use
Interlude 100% Cotton Tampons are inserted into the vagina and used to absorb menstrual or other discharge.
| Devices | K181911 (subject device) | K001641 (predicate device) |
|---|---|---|
| Intended use | Same as the predicate device | The device is inserted into the vagina andused to absorb menstrual or other discharge. |
| Design (pledget) | Same as the predicate device | A cotton absorbing pledge with overwrapand withdrawal cord |
| Absorbency | Same as the predicate device | Multiple absorbencies |
| Material | Cotton | Cotton, polyethylene, polypropylene, andother material(s) |
| Assemblydimension | • Length: 110-140 mm• Applicator barrel diameter:Light – 11.3-12.7 mmRegular – 13.3-14.7 mmSuper – 15.3-16.7 mm | • Length: 115-145 mm• Applicator barrel diameter: N/A |
| Applicator | Same as the predicate | Cardboard |
| 7. Comparison of Intended Use and Technological Characteristics with the Predicate Device | ||||
|---|---|---|---|---|
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 predicate device uses multiple materials, whereas the subject device uses single material. The differences in technological characteristics do not raise different questions of safety or effectiveness.
8. Summary of Non-Clinical Performance Testing
Performance testing
The following performance characteristics were assessed in accordance with the 2005 FDA guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)":
- Dimensions .
- Absorbency range ●
- Chemical residues ●
- . Withdrawal cord strength
- Fiber shedding ●
- Tampon integrity .
Microbiology testing
Per the 2005 FDA guidance mentioned above, microbiology testing was conducted to demonstrate that the subject devices do not:
- . Enhance the growth of Staphylococcus aureus
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- Increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1) ●
- . Alter the growth of normal vaginal microflora
Biocompatibility testing
Biocompatibility studies were performed in accordance with FDA guidance "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 the 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 the results met the requirements of the ISO standards. In addition, biocompatibility data in K001641 and K173225 are leveraged to support the subject applicators.
9. Conclusion
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.
§ 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).