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This document serves as a summary of the 510(k) premarket notification submitted to the FDA, providing details about the Spectra Series Breast Pump, including devices classification, intended use,
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How to fill out 510k summary of safety
How to fill out 510(k) Summary of Safety and Effectiveness for Spectra Series Breast Pump
01
Gather product information, including model details and intended use.
02
Conduct necessary tests to demonstrate safety and effectiveness of the breast pump.
03
Compile a summary of the testing results, including any clinical data, literature references, and risk analysis.
04
Clearly outline the predicate devices you are comparing your product to.
05
Provide a detailed description of the device's design, technology, and components.
06
Clearly articulate how the device meets standards set by the FDA.
07
Include labeling information, explaining how to use the breast pump correctly.
08
Review and revise the summary for clarity and compliance with FDA regulations.
09
Submit the 510(k) summary and relevant documentation to the FDA for review.
Who needs 510(k) Summary of Safety and Effectiveness for Spectra Series Breast Pump?
01
Manufacturers of the Spectra Series Breast Pump seeking to market their device in the U.S.
02
Healthcare professionals who require information for evaluating the safety and effectiveness of the breast pump.
03
Regulatory consultants assisting manufacturers in the FDA submission process.
04
Distributors and retailers wanting compliance information for marketing the product.
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People Also Ask about
How do you use a Spectra pump effectively?
Pump both simultaneously for 15-20 min using a cyclic pumping rhythm. Start on massage mode and when milk slows, switch to expression. Set the vacuum for comfort to optimize your pumping session.
What is considered a hospital grade pump?
In expression mode, you will be able to adjust the cycles every minute, up or down, going between 38 and 54 cycles/minute. You can adjust the suction strength from level 1 to 12 which is measured in mmHg: level 12 will reach 250mmHg.
What is the lifespan of a spectra pump?
How Many Hours Do Spectra Pumps Last? The longevity of Spectra pumps can vary depending on factors such as usage frequency, maintenance, and care. That said, Spectra pumps have a motor life of 1500 hours. This is not to say your Spectra motor will stop working after 1500 hours, but it may not work as efficiently.
Is Spectra considered a hospital grade pump?
In addition to providing all the standard features that Spectra's been recognized for in the past including its true closed system, soothing night light, and unique natural nursing technology; the S3 Pro is a multiuser pump and is hospital grade.
How do you use Spectra for best results?
Most moms start pumping in the massage mode to encourage milk to release or “let down”. During the massage mode, adjust the vacuum pressure (suction) to what is most comfortable for you. Increase the vacuum pressure to the point of minor discomfort, and then decrease it until the pressure (suction) is comfortable.
How good is the Spectra pump?
To this is I'm going to say, the Spectra S1 and S2 are quality pumps, they have a motor life of 1500 hours, which is fabulous. They're basically on everyone's list of covered pumps and nowadays that list can be long and full of options.
How do I get the most milk out of my Spectra pump?
0:00 1:06 And three vacuum until your milk starts flowing. Again. Now you're going to go back down to 38 cycleMoreAnd three vacuum until your milk starts flowing. Again. Now you're going to go back down to 38 cycle. But up to 5 to 8 vacuum. However you're comfortable here so listen to your body.
What level is Spectra pump?
The Dual Compact allows setting the Left and Right suction differently for each of your . More silent than a kitten's purr, this amazing hospital-grade rechargeable pump is recommended for active moms who are seeking portability and performance.
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What is 510(k) Summary of Safety and Effectiveness for Spectra Series Breast Pump?
The 510(k) Summary of Safety and Effectiveness for the Spectra Series Breast Pump is a document submitted to the FDA to demonstrate that the device is safe and effective for its intended use, and is substantially equivalent to a legally marketed device.
Who is required to file 510(k) Summary of Safety and Effectiveness for Spectra Series Breast Pump?
Manufacturers of the Spectra Series Breast Pump or any entity seeking to market a new version or modification of this device are required to file a 510(k) Summary of Safety and Effectiveness with the FDA.
How to fill out 510(k) Summary of Safety and Effectiveness for Spectra Series Breast Pump?
To fill out the 510(k) Summary, one must include details such as device name, intended use, device description, performance data, labeling information, and any substantial equivalence claims.
What is the purpose of 510(k) Summary of Safety and Effectiveness for Spectra Series Breast Pump?
The purpose of the 510(k) Summary is to provide the FDA with sufficient information to assess the safety and effectiveness of the device, ensuring it meets regulatory standards before being marketed.
What information must be reported on 510(k) Summary of Safety and Effectiveness for Spectra Series Breast Pump?
The report must include the device's name, identification of the predicate device, description of the device, intended use, labeling, and results of non-clinical and clinical testing that support safety and effectiveness.
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