Search Results

The Evenflo Elan Breast Pump and the Evenflo Elan Dual Breast Pump are personal use battery and/or electric powered suction devices used to express milk from the breast (s) of lactating women.

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for the Evenflo Elan Breastpump and Evenflo Elan Dual Breastpump does not contain the specific information requested about acceptance criteria and a study proving the device meets them.

This type of FDA letter primarily focuses on:

• Substantial Equivalence Determination: Declaring that the device is substantially equivalent to a legally marketed predicate device.
• Regulatory Classification: Identifying the device's regulatory class (in this case, Class II and product code HGX).
• Applicable Regulations: Listing general controls and other relevant regulations the manufacturer must comply with.
• Indications for Use: Clearly stating the intended use of the device.

The letter does not include details about:

1. Acceptance criteria table or reported device performance.
2. Sample sizes, data provenance, number of experts, adjudication methods for a test set.
3. MRMC comparative effectiveness study results.
4. Standalone (algorithm only) performance studies.
5. Type of ground truth used.
6. Training set sample size or how its ground truth was established.

These types of details would typically be found in the device's 510(k) submission itself, which is a much more extensive document than the clearance letter. The clearance letter is the FDA's summary decision, not the detailed technical review.

Ask a specific question about this device