DOUBLE UP BREAST PUMP

• K Number: K964396
• Device Name: DOUBLE UP BREAST PUMP
• Manufacturer: THE NATURAL CHOICE CO., INC.
• Date Cleared: 1997-06-06 ( 214 days)
• Product Code: HGX
• Regulation Number: 884.5160
• Type: Traditional
• Panel: Obstetrics/Gynecology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Double Up Breast Pump is indicated to facilitate expression of milk from the breasts of lactating women

Device Description

Double Up Breast Pump

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification letter from the FDA regarding the "Double Up Breast Pump." This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

However, this document does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth, or adjudication methods. The 510(k) clearance process sometimes relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies that would typically include the details you've requested.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them based solely on the provided text. The document is primarily a regulatory approval letter.

Regulation Number and Section

§ 884.5160 Powered breast pump.

(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).