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 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
Material: SckoonCup menstrual cup is manufactured from a soft silicone elastomer.

AI/ML Overview

The provided 510(k) summary for the "SckoonCup, Size 1 and 2" is for a menstrual cup, which is a Class II medical device. The submission focuses on demonstrating substantial equivalence to a predicate device (MoonCup, K040335) rather than providing extensive clinical study data related to acceptance criteria. Therefore, several of the requested sections below are not applicable to this type of submission.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device (MoonCup, K040335) rather than establishing specific performance acceptance criteria for a novel device. The "acceptance criteria" here are implicitly related to conforming to the characteristics of the predicate device and relevant regulations.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred/Stated)	Reported Device Performance (SckoonCup)
Material Composition	Manufactured from a soft silicone elastomer.	Manufactured from a soft silicone elastomer. Properties described in FDA master file and MDSS.
Biocompatibility	Silicone elastomer is well-characterized, physically & chemically suitable, with a history of safe use in medical devices. Complies with FDA G95-1 guidance.	Silicone elastomer is well characterized chemically and physically and has a long history of safe use in medical devices with human body contact. Master file and MDSS provide data on biocompatibility or toxicity testing required by G95-1.
Physical Characteristics (Shape, Dimensions, Capacity)	Substantially equivalent in shape, dimensions, and capacity to the predicate device.	SckoonCup (Size 1: 23ml, top dia 40mm, height 70mm, stem 30mm, vent 1mm; Size 2: 30ml, top dia 45mm, height 70mm, stem 20mm, vent 1.5mm) is presented as substantially equivalent to the predicate (MoonCup K040335).
Technological Characteristics	Substantially equivalent technological characteristics to the predicate device.	Presented as substantially equivalent in technological characteristics to the MoonCup (K040335).
Indications for Use	"Receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation."	Identical 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."
Manufacturing Standards	Manufactured under recognized quality systems.	Manufactured in the USA with similar manufacturing methods to the predicate device, in an ISO9001:2008 BSI America Certified facility.
Sterility	Not supplied sterile.	Not supplied sterile.
Duration of Patient Contact	Same duration of patient contact as the predicate. (Up to 12 hours)	Identical use to the predicate device MoonCup (K040335) and same duration of patient contact.

The Study that Proves the Device Meets Acceptance Criteria

The provided document describes a 510(k) Premarket Notification submission, which is a regulatory pathway for demonstrating "substantial equivalence" to a legally marketed predicate device. This process typically relies on non-clinical testing and comparison to the predicate, rather than an extensive clinical study with human subjects, especially for a well-understood device type like a menstrual cup.

Type of Study: This is not a clinical study or a comparative effectiveness study in the traditional sense. It is a design verification and product comparison exercise to demonstrate substantial equivalence. The "study" involves:

Material Characterization: Reviewing material properties, biocompatibility data, and manufacturing processes.
Dimensional Comparison: Presenting and comparing physical dimensions (shape, diameter, height, capacity) to the predicate device.
Intended Use Comparison: Clearly stating identical indications for use and duration of patient contact.
Manufacturing Process Comparison: Highlighting similar manufacturing methods and a certified quality system.

The "proof" stems from the detailed justifications provided in the submission that the SckoonCup is "substantially equivalent in shape, dimensions, material, technological characteristics, and Indications for Use" to the MoonCup (K040335). The FDA's issuance of the 510(k) clearance (K120107) signifies their agreement with this substantial equivalence claim.

Additional Information on Study Parameters:

Given that this is a 510(k) for a menstrual cup based on substantial equivalence, many of the typical clinical study parameters (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable or are not detailed in this type of regulatory submission. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate.

Sample Size Used for the Test Set and Data Provenance:
- N/A. There isn't a "test set" in the context of human subjects or data classification for this type of submission. The comparison is made against the specifications and regulatory clearance of the predicate device itself.
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- N/A. Ground truth, in the sense of expert consensus on disease or image interpretation, is not applicable here. The "ground truth" for this submission is the established safety and effectiveness of the predicate device as determined by its prior FDA clearance.
Adjudication Method for the Test Set:
- N/A. Not applicable, as there's no clinical "test set" requiring expert adjudication.
If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This is not an AI-enabled diagnostic device.
If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This is not an algorithm-only device.
The type of ground truth used:
- The "ground truth" for this 510(k) submission is the documented characteristics and safety/efficacy profile of the predicate device (MoonCup, K040335), as previously cleared by the FDA. The SckoonCup's safety and effectiveness are inferred from its substantial equivalence to this predicate.
The sample size for the training set:
- N/A. There is no "training set" as this is not an AI/machine learning device. The "data" used is the engineering specifications, material data, and regulatory history of both the SckoonCup and the predicate.
How the ground truth for the training set was established:
- N/A. Not applicable for this type of device and submission.

Summary

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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: 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

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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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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

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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)

tonu m Whay
(Division Sign-Off)

Gastro-R

Regulation Number and Section

§ 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.