(147 days)
The intended use of the electrically powered suction device is to express milk from the breast.
The intended use of the electrically powered suction device is to lactating women.
The pj's comfort jr® Portable Electric Breast Pump is powered by a variable speed DC motor that drives a high vacuum pump similar to that used in the pj's comfort® breast pump that has 510(k) approval # K012275. The vacuum part of the vacuum pump is interconnected with a PIC 16F872 microprocessor controller circuit, and a solenoid valve that provide variable speed vacuum cycling rates, from 16 to 70 cycles per minute, by way of the control panel. A second knob located on the front panel provides for user selection of infinitely variable maximum vacuum levels from 90 to 270 mm Hg. The minimum vacuum is always 40 mm Hg. The vacuum is the same for single and double pumping. When the cycle knob and the vacuum knob are both set at maximum the maximum vacuum is approximately 270 mm Hg. and the cycle speed is 16 cycles per minute. When the cycle knob is set at maximum and the vacuum knob is set at minimum, the maximum vacuum is approximately 90 mm Hg. and the cycle speed is 70 cycles per minute. When the cycle knob is set at minimum, and the vacuum knob is set at maximum, the maximum vacuum is approximately 270 mm Hg. and the cycle speed is 16 cycles per minute. When the cycle knob and the vacuum knob are both set at minimum, the maximum vacuum is approximately 40 mm Hg. and the cycle speed is 36 cycles per minute. The controller contains firmware, loaded at the factory in non-volatile memory, and requires no software to be loaded at each startup. The pj's comfort ® breast pump with 510(k) approval # K012275 uses discrete electronic components to carry out similar control functions. The above controls allow the user of the pj's comfort jr.® to mimic the speed and strength of sucking of their infant, and to maximize their comfort. A maximum vacuum of 270 mm Hg. is applied to one or both breasts by way of flexible tubing to the breast cup(s). The pj's comfort jr® front control panel also has a set of indicator lights that show the time remaining in the pumping session. These lights also indicate a particular pattern in case of pump failure. - Top three lights flashing: Excess vacuum level; not user repairable, return to factory for repair. - Middle three lights flashing: Blocked tubing or replace filter. - Bottom three lights flashing: Pump overheated: turn pump off and allow to cool. If this happens often, return pump to factory for repair. The pj's comfort jr® Portable Electric Breast Pump can be operated by use of either an AC/DC wall converter, a 12-Volt battery pack or a 12 volt motor vehicle adapter. All materials used in the manufacturing of this device that have contact with food or human tissue meet requirements of the FDA and or biocompatability.
The provided text is a 510(k) Premarket Notification for the pj's comfort jr.® Portable Electric Breast Pump. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance as would be expected for a novel, higher-risk device.
Therefore, the document does not contain the acceptance criteria and the detailed study information typically associated with proving device performance through clinical trials, such as:
- A table of acceptance criteria and reported device performance (in terms of clinical outcomes or diagnostic metrics).
- Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. The "testing data" mentioned in the conclusion section is not elaborated upon in a way that allows these details to be extracted.
- The type of ground truth used (e.g., pathology, outcomes data).
Instead, the document focuses on comparison to predicate devices to demonstrate substantial equivalence.
Here's a summary of what is available in the document regarding its comparison to predicate devices, which serves as the basis for its clearance:
1. Table of Comparative Characteristics (acting as a form of "acceptance criteria" for substantial equivalence):
The table below outlines the characteristics of the pj's comfort jr® Portable Electric Breast Pump and its predicate devices. The "reported device performance" in this context refers to the device's specifications and features, which are deemed acceptable because they are similar to or within the range of the legally marketed predicate devices.
| Characteristic | Limerick pj's comfort jr® (Current device) | Predicate Devices (Limerick pj's comfort®, Medela Pump In Style, Ameda Expresse, Ameda Premier) |
|---|---|---|
| Intended Use | As described in 21 CFR 884.5160 (to express milk) | As described in 21 CFR 884.5160 (to express milk) |
| Suction Levels | 40-270 mm Hg. | 20-240 mm Hg (pj's comfort®), 80-240 mm Hg (Medela), |
§ 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).