SCKOONCUP

K120107 · Sckoon, Inc. · HHE · Sep 18, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K120107
• Device Name: SCKOONCUP
• Applicant: Sckoon, Inc.
• Product Code: HHE · Obstetrics/Gynecology
• Decision Date: Sep 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5400
• Device Class: Class 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.

Device Story

SckoonCup is a reusable, silicone elastomer menstrual cup designed for internal vaginal use to collect menstrual flow. It is available in two sizes: Size 1 (23ml capacity) for women who have not given birth vaginally, and Size 2 (30ml capacity) for women who have given birth vaginally. The device is inserted by the user and can remain in the body for up to 12 hours. It functions as a passive receptacle rather than an absorbent product. The device is non-sterile and intended for over-the-counter use. It provides a reusable alternative to disposable menstrual products, potentially reducing waste and offering a long-term management solution for menstrual hygiene.

Clinical Evidence

No clinical data. Substantial equivalence is based on material biocompatibility, physical characterization, and comparison of design and technological characteristics to the predicate device.

Technological Characteristics

Material: Silicone elastomer. Form factor: Reusable cup with stem and vent holes. Sizes: Size 1 (40mm diameter, 70mm height, 23ml capacity); Size 2 (45mm diameter, 70mm height, 30ml capacity). Sterilization: Not supplied sterile. Manufacturing: ISO9001:2008 certified facility.

Indications for Use

Indicated for women during menstruation to collect blood and cellular debris. Size 1 is for women who have never given birth vaginally; Size 2 is for women who have given birth vaginally.

Regulatory Classification

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 (K040335)

Submission Summary (Full Text)

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¥120107

## 510(k) Summary

#### Submitter:

SEP 1 8 2012

Sckoon Inc. 2301 Collins Ave 310 Miami Beach FL 33139 USA Tel: [phone] Fax: [phone] 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

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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.

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# 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

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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 [phone] or [phone] or at its Internet address [phone] 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

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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)

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(Division Sign-Off)

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