(249 days)
Not Found
No
The device description and intended use clearly describe a physical menstrual cup with no mention of any computational or data-driven features.
No
The device is a menstrual cup intended to collect menstrual blood and cellular debris, which is a collection function rather than a therapeutic one. It does not treat or prevent any condition.
No
Explanation: The SckoonCup collects menstrual flow and does not claim to diagnose any medical conditions or provide information about the physiological state of the anatomical site.
No
The device description clearly states it is a physical silicone menstrual cup, which is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- The SckoonCup is a device placed inside the body (in the vagina) to collect menstrual flow. It does not perform any analysis or testing on the collected material.
The intended use and device description clearly indicate that the SckoonCup is a menstrual collection device, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The SckoonCup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
Product codes (comma separated list FDA assigned to the subject device)
HHE
Device Description
SckoonCup is a soft, small silicone menstrual cup that is placed internally in the vagina. The SckoonCup is reusable and it holds menstrual flow instead of absorbing. It may remain in the body up to 12 hours. It is available in two sizes:
- Size 1: Small-Women who have never given birth vaginally; Capacity 23ml
- Size 2: Large-Women who have given birth vaginally; Capacity 30 ml
SckoonCup menstrual cup is manufactured from a soft silicone elastomer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vagina, Uterus, Cervix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
¥120107
510(k) Summary
Submitter:
SEP 1 8 2012
Sckoon Inc. 2301 Collins Ave 310 Miami Beach FL 33139 USA Tel: 212-228-6903 Fax: 631-787-6286 Establishment Registration Number 253046
Contact: Satoko Asai Title: Owner
Date prepared: January 9, 2012 Revision prepared: September 14, 2012
New Device:
| Trade Name: | SckoonCup, Size 1 and 2 |
|---|---|
| Common Name: | Menstrual Cup |
| Classification Name: | Menstrual Cup |
| Review Panel: | Obstetrics/Gynecology |
| Regulation Number | 21 CFR 884.5400 |
| Product Code: | HHE |
| Device Class: | II |
MoonCup (K040335) Predicate Device:
Predicate Device Information:
MoonCup Mooncup LLC One East Main Street, Madison, WI 53701 510(k) Number: K040335
Device Description:
General: SckoonCup is a soft, small silicone menstrual cup that is placed internally in the vagina. The SckoonCup is reusable and it holds menstrual flow instead of absorbing. It may remain in the body up to 12 hours. It is available in two sizes:
-
- Size 1: Small-Women who have never given birth vaginally; Capacity 23ml
-
- Size 2: Large-Women who have given birth vaginally; Capacity 30 ml
Material: SckoonCup menstrual cup is manufactured from a soft silicone elastomer. The properties of the silicone elastomer are described in a master file at FDA. The Materials
1
Data Safe Sheet (MDSS) and the Product Specifications Sheet for the silicone were submitted.
Biocompatibility: The silicone elastomer is well characterized chemically and physically and has a long history of safe use in medical devices with human body contact. The master file and the MDSS provide data on the biocompatibility or toxicity testing required according to FDA's memorandum to guidance G95-1. SckoonCup is manufactured in the USA with similar manufacturing methods to the predicate device, in an ISO9001:2008 BSI America Certifiet facilities. SckoonCup has identical use to the predicate device MoonCup (K040335) and same duration of patient contact.
Sterility: SckoonCup is not supplied sterile.
Indications for Use: SckoonCup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
Device Drawings:
Image /page/1/Figure/5 description: The image shows a diagram of two menstrual cups, labeled SCKOONCUP 1 and SCKOONCUP 2, with measurements. SCKOONCUP 1 has a total volume of 23 ml, a top diameter of 40.00 mm, a height of 70.00 mm, a stem length of 30 mm, and vent holes with a diameter of 1.0 mm. SCKOONCUP 2 has a total volume of 30 ml, a top diameter of 45.00 mm, a height of 70.00 mm, a stem length of 20 mm, and vent holes with a diameter of 1.5 mm.
Comparison to Predicate Devices:
SckoonCup and MoonCup (K040335) are both made of silicone elastomer and the two devices are substantially equivalent in shape, dimensions, material, technological characteristics, and Indications for Use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 1 8 2012
Mr. Mohamed Elgayar President Sckoon, Inc. 2301 Collins Ave #310 MIAMI BEACH FL 33139
Re: K120107
Trade/Device Name: SckoonCup, Size 1 and 2 Regulation Number: 21 CFR§ 884.5400 Regulation Name: Menstrual cup Regulatory Class: II Product Code: HHE Dated: August 24, 2012 Received: September 4, 2012
Dear Mr. Elgayar:
We have reviewed your Section 5.10(k) premarket notification of intent to market the device We have reviewed your Section 210(x) prematics is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to tegarly manators provice Amendments, or to commerce prior to May 26, 1976, the chance with the provisions of the Federal Frod, Drug, devices that have been reclassince in accordantes with as premarket application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application and Cosment Act (Act) that do not require apple for the general controls provisions of the Act. The Act. The You may, dereible, market the device, subject to une grourements for annual registration, listing of
general controls provisions of the Act include requirements for annual r general controls provisions of the rice necessary on a prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Please note. CDNT does not Cranato missumation in the truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) in Extisting major regulations affecting your device can be
it may be subject to additional controls. Extransmano and en addition, E if may be subject to additional controls. DATS: 11. Parts 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to Sederal Register found in the Code of I ederal Regarations, Four device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA S issuality of a suosanian requirements of the Act
that FDA has made a determination that your device of the Feguirements of the Act that FDA has made a decertimation that your arrant of other Federal agencies. You must or any Federal statules and regulations administration of the not limited to: registration and listing of media comply with all the Act STEquilements, merading, consistence reporting (reporting of medical
3
Page 2 -
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-leated adverse events) (21 CFR Part 820); and if applicable, the electronic a forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your do recessor offices/CDRHOffices/ucm15809.html for go to hip.7/www.lua.gow/roouth Dr. CoHealth's (CDRH's) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance (21 the Celler for Devices and reading by reference to premarket notification" (21CFR Pat
note the regulation entitled, "Misbranding by reference to premarket potification (21 note the regulation onlined, Timoraname of Collection of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain other general mormational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (600) 030-2011 or (304) MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher, Ph.D.
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
4
510(k) Premarket Notification - SckoonCup
Indications for Use
510(k) Number (if known):
Device Name: SckoonCup, Size 1 and 2
Indications for Use:
The SckoonCup 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) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tonu m Whay
(Division Sign-Off)
Gastro-R