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K Number
K061013
Device Name
PLAYTEX EMBRACE PETITE BREAST PUMP
Manufacturer
PLAYTEX PRODUCTS, INC.
Date Cleared
2006-08-15

(124 days)

Product Code
HGX
Regulation Number
884.5160
Type
Traditional
Panel
OB
Reference & Predicate Devices
K022594,K950750,K950531
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

An electrically powered breast pump used to express milk from the breast of a lactating woman.

Device Description

The Playtex electric breast pump is a small, quiet, safe and effective system for expressing milk from a lactating mother's breast(s). This device is comprised of 3 major assemblies: a pump assembly, a breast cup assembly, and some commercially available items (i.e., bottles, bottle liners, etc). The device is designed with 1 pre-set speed level and 3 pre-set suction setings, which are selectable by the user via a rotating dial. The device is powered by a 12V DC power supply, which is included with the package.

AI/ML Overview

The provided document is a 510(k) summary for the Playtex Embrace Petite Double Electric Breast Pump. It focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria, a study proving device performance against those criteria, or details regarding algorithm-based device performance.

Therefore, I cannot provide the requested information from the given text. The document explicitly states:

  • "No clinical tests have been conducted on this device." This directly addresses and negates the possibility of finding information related to clinical studies, acceptance criteria for such studies, sample sizes, ground truth establishment, or expert evaluations.
  • The "Discussion of Non-Clinical Tests" section only states that "Testing of the device has demonstrated that the Playtex breast pump meets established requirements when used in the manner and environment specified in product labeling." It does not provide details about what those "established requirements" (acceptance criteria) are, nor the specific results of those tests. The only performance data given are vacuum settings and cycle speeds, which are presented as a comparison to predicate devices, not as criteria against which the device was tested.

In summary, the provided text does not contain the information needed to answer your request regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/algorithm-based device as implied by your questions 2-9.

§ 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).