← Product Code [HHE](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE) · K070965 # ALICIA MENSTRUAL CUP (K070965) _Alicia International Pty , Ltd. · HHE · Mar 5, 2008 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K070965 ## Device Facts - **Applicant:** Alicia International Pty , Ltd. - **Product Code:** [HHE](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE.md) - **Decision Date:** Mar 5, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.5400 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for Use The Alicia™ Menstrual Cup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation. The Alicia'10 Menstrual Cup is placed low enough in the vagina to be retrieved readily and to prevent it's toughing the cervix or interfering with menstrual flow through it. ## Device Story The Alicia™ Menstrual Cup is a reusable, internally worn silicone receptacle designed to collect menstrual flow. It is inserted into the vagina, positioned to avoid contact with the cervix, and can be worn for up to 12 hours. The device features a stem for retrieval. It is available in four sizes (XS, S, M, L) to accommodate different anatomical needs. The device is intended for over-the-counter use by women. It functions as a passive collection vessel, requiring no external power or complex operation. Users manually insert and remove the device, cleaning it between uses. By collecting rather than absorbing fluid, it provides a non-absorbent alternative for menstrual hygiene management. ## Clinical Evidence Bench testing only. Biocompatibility testing was performed in accordance with ISO 10993-1, ISO 10993-5, and ISO 10993-10 standards to ensure safety of the silicone elastomer material. ## Technological Characteristics Material: Silicone elastomer. Form factor: Reusable, internally worn cup with retrieval stem. Available in four sizes (XS, S, M, L). Biocompatibility: Compliant with ISO 10993-1, ISO 10993-5, and ISO 10993-10. Non-powered, passive mechanical device. ## Regulatory Identification A menstrual cup is a receptacle placed in the vagina to collect menstrual flow. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. ## Predicate Devices - MoonCup® Menstrual Cup ([K040335](/device/K040335.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K070965 ## 510(k) SUMMARY MAR - 5 2011 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is: 1. Submitter's Identifications: Establishment: Alicia™ International Pty, Ltd. 84A Skyline Dr, Burleigh Heads, Gold Coast, Queensland, Australia 4220 Operations: Foreigner importer #### Owner/Operator: Alicia™ International Pty, Ltd. 84A Skyline Dr, Burleigh Heads, Gold Coast, Queensland, Australia 4220 Date of Summary Preparation: April 2, 2007. - 2. Name of the Device: Alicia110 Menstrual Cup / 99ALXS, 100ALSM, 101ALMD, 102ALLG - 3. Information of device classification. | Device | Cup, Menstrual | |------------------------------|-----------------------| | Regulation Description | Menstrual cup | | Regulation Medical Specialty | Obstetrics/Gynecology | | Review Panel | Obstetrics/Gynecology | | Product Code | HHE | | Regulation Number | 884.5400 | | Device Class | II | ### 4. Device Description: The Alicia™ menstrual cup is a soft, small internally worn reusable silicone menstrual cup that holds (instead of absorbing) monthly menstrual flow. It may remain in the body for up to 12 hours. It holds an ounce of fluid. It is available four sizes: - · L size: 102ALLG; for larger built women that have had children. - · M size: 101ALMD; for women who have had vaginal childbirth or C-Section; and for women who are over 30 years old and never had childbirth. - S size: 100ALSM; for women under 30 years old who have never had childbirth or C-Section. - · XS size: 99ALXS; for teenagers and very small framed women. ned women. Eonch Eouch The cup remains entirely within the vagina and does not tough the cervix but the stem remains outside the body to ensure retrieval of the cup. See the user's manual for information about how to use and care for the Alicia™ menstrual cup. The Alicia™ menstrual cup is manufactured from a soft silicone elastomer. The properties of the silicone are described in a master file at FDA. The master file provides data on all of the biocompatibility or toxicity testing required according to FDA's memorandum to guidance G95-1. shich Page 1 of 2 {1}------------------------------------------------ Alicia™ International Pty., Ltd. - · 5. Intended Use: The Alicia™ Menstrual Cup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation. The Alicia'10 Menstrual Cup is placed low enough in the vagina to be retrieved readily and to prevent it's toughing the cervix or interfering with menstrual flow through it. - 6. Comparison to the 510(k) Cleared Device (Predicate Device): MoonCup® Menstrual Cup (K040335) - 7. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows: Compliance to applicable voluntary standards includes ISO 10993-1 for biocompatibility as well as the specified testing standard of ISO 10993-5 and ISO 10993-10. - 8. Conclusions The Alicia™ Menstrual Cup / Model: 99ALXS, 100ALSM, 101ALMD and 102ALLG have the same intended use and technological characteristics as the cleared devices, Menstrual Cup (K040338). Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device. In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device. Therefore, the new device Alicia Menstrual Cup / Model: 99ALXS, 100ALSM. 101ALMD and 102ALLG is considered substantial equivalent to the chosen 510(k) cleared device MoonCup® Menstrual Cup (K040335). {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of an abstract symbol, possibly representing a human figure or a flame. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR - 5 2008 Alicia International PTY LTD c/o Mr. Tom Stone Official Correspondent PO Box 1471 Oxenford 4210 OLD AUSTRALIA Re: K070965 > Trade/Device Name: Alicia™ Menstrual Cup / Models 99ALXS, 100ALSM 101ALMD, 102ALLG Regulation Number: 21 CFR 8884.5400 Regulation Name: Menstrual cup Regulatory Class: II Product Code: HHE Dated: February 21, 2008 Received: February 21, 2008 Dear Mr. Stone: 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. 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. {3}------------------------------------------------ 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter. | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): Device Name: Alicia™ Menstrual Cup / Models 99ALXS, 100ALSM, 101ALMD, 102ALLG Indications For Use: The Alicia 100 Menstrual Cup / Models 99ALXS, 100ALSM, 101ALMD, 102ALLG is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation. Prescription Use (Part 21 CFR 801 Subpart D) OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Hushin Leun sion of Reproductive, Abdon Radiological Devices 510(k) Number Page 1 of _ 1 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K070965](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K070965) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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