(207 days)
Non-powered Breast Pump to express milk from the breast.
Easy Comfort ™ Deluxe Manual Breast Pump
This document is a 510(k) premarket notification letter from the FDA for a nonpowered breast pump. It does not include information about acceptance criteria or a study proving device performance in the way described in your request (e.g., performance metrics, sample sizes, expert ground truth).
Therefore, I cannot extract the requested information from this document. The document primarily focuses on:
- Device Identification: Easy Comfort™ Deluxe Manual Breast Pump, Regulation Number 21 CFR 884.5150 (Nonpowered breast pump).
- Regulatory Determination: Substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
- General Controls: Reference to general controls provisions of the Act (registration, labeling, good manufacturing practice, etc.).
- FDA Contact Information: For questions regarding labeling, promotion, and general responsibilities.
- Indications for Use: "Non-powered Breast Pump to express milk from the breast."
There is no mention of "acceptance criteria" for performance, specific metrics like sensitivity or specificity, or details of any clinical or performance study conducted to establish these.
§ 884.5150 Nonpowered breast pump.
(a)
Identification. A nonpowered breast pump is a manual suction device used to express milk from the breast.(b)
Classification. Class I. 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, if the device is using either a bulb or telescoping mechanism which does not develop more than 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce cytotoxicity, irritation, or sensitization effects.