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K Number
K051112
Device Name
WHITTLESTONE EXPRESSER
Manufacturer
WHITTLESTONE, INC.
Date Cleared
2005-09-07

(128 days)

Product Code
HGX
Regulation Number
884.5160
Type
Traditional
Panel
Obstetrics/Gynecology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Powered Breast Pump used to express milk from lactating women

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a powered breast pump, the Whittlestone Expresser (K051112).

This type of document (510(k) clearance) primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, rather than requiring a device to meet specific acceptance criteria through extensive clinical studies like those needed for a PMA (Premarket Approval) application or for devices with higher risk classifications.

Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document lacks:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set and data provenance.
  3. Number of experts and their qualifications for ground truth.
  4. Adjudication method for the test set.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size.
  6. Standalone (algorithm only) performance study details.
  7. Type of ground truth used.
  8. Training set sample size.
  9. How ground truth for the training set was established.

The FDA letter simply states that the device has been reviewed and determined to be substantially equivalent to predicate devices, allowing it to be marketed under general controls. It does not provide details of any performance studies that would typically include acceptance criteria and proof of meeting them, as would be found in a more rigorous clinical trial report or a PMA.

§ 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).