(335 days)
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.
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.
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.
The Alicia™ menstrual cup is manufactured from a soft silicone elastomer.
This 510(k) summary (K070965) for the Alicia™ Menstrual Cup does not contain the kind of detailed performance study data typically found in submissions for AI/ML-based medical devices. The device described is a physical menstrual cup, and the submission focuses on demonstrating substantial equivalence to a predicate device based on manufacturing materials, intended use, and general safety standards (biocompatibility).
Therefore, I cannot provide information on acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. These concepts are not applicable to the type of device and submission provided.
The document states:
"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." This implies that such tests were performed, but the details are not included in the provided 510(k) summary. These details would typically be found in the full 510(k) submission, not the public summary.
Here's what can be extracted based on the provided text, heavily indicating that the prompt's requirements for AI/ML device testing are not met by this document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The provided document is for a physical medical device (menstrual cup) and does not include performance metrics or acceptance criteria in the context of an AI/ML algorithm. The "performance" assessment is based on demonstrating substantial equivalence to a predicate device, primarily through material biocompatibility and intended use.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a "test set" in the context of evaluating an algorithm's performance on data. The evaluation appears to be based on compliance with standards (e.g., ISO 10993) for the device's materials.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. There is no mention of establishing ground truth for data review, as this is not an AI/ML device.
4. Adjudication Method
Not applicable. No adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a physical menstrual cup, not an AI/ML diagnostic or assistive tool, so an MRMC study is not relevant.
6. Standalone (Algorithm Only) Performance Study
Not applicable. There is no algorithm to test in a standalone manner.
7. Type of Ground Truth Used
Not applicable. There is no clinical "ground truth" established from data, as typically seen in AI/ML submissions. The "truth" for this device likely revolves around material safety and functional design.
8. Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set or ground truth in the context of AI/ML.
{0}------------------------------------------------
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:
- 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.
-
- Name of the Device: Alicia110 Menstrual Cup / 99ALXS, 100ALSM, 101ALMD, 102ALLG
-
- 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)
-
- 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.
-
- 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.
- Conclusions
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
§ 884.5400 Menstrual cup.
(a)
Identification. A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.(b)
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.