THE DIVACUP MENSTRUAL SOLUTION

• K Number: K021356
• Device Name: THE DIVACUP MENSTRUAL SOLUTION
• Manufacturer: DIVA INTERNATIONAL INC
• Date Cleared: 2002-07-16 ( 78 days)
• Product Code: HHE
• Regulation Number: 884.5400
• Type: Traditional
• Panel: OB
• Reference & Predicate Devices: N/A

Intended Use

This menstrual cup has the same intended use as the predicate menstrual cup. The DivaCup™ is intended to be used as a receptacle, which is placed in the vagina to collect menstrual flow.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA letter to a company, Diva International, Inc., regarding the 510(k) premarket notification for "The DivaCup Menstrual Solution."

The letter primarily discusses:

• The FDA's determination of substantial equivalence for the device.
• Classification of the device (Class II, Menstrual cup).
• Applicable regulations and general controls.
• Contact information for various FDA offices.
• An "Indications For Use" statement for The DivaCup, which states it "has the same intended use as the predicate menstrual cup" and "is intended to be used as a receptacle, which is placed in the vagina to collect menstrual flow."

There is no mention of specific performance metrics, acceptance criteria, study methodologies, sample sizes for training or test sets, expert qualifications, ground truth establishment, or any comparative effectiveness studies (e.g., MRMC studies).

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.