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510(k) Data Aggregation
K Number
K163609Device Name
Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)
Manufacturer
PALL INTERNATIONAL SARL
Date Cleared
2017-06-01
(161 days)
Product Code
NHV
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
PALL INTERNATIONAL SARL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pall® QPoint™ Water Filter Capsule is intended to be used within the healthcare environment such as hospitals, nursing homes, healthcare facilities or clinical setting where immunecompromised patients may be exposed to waterborne microorganisms originating from the water supply.
The Pall QPoint™ Water Filter Capsule is intended to filter EPA (Environmental Protection Agency in USA) quality drinking water. By retaining bacteria, fungi and protozoa the filters may aid in infection control. The filters produce water that is suitable for washing and drinking, superficial wound cleansing (minor cuts, scrapes or abrasions), cleaning of equipment used in medical procedures and washing of surgeon's hands. The filter is not intended to provide water that can be used as a substitute for USP grade sterile water.
Device Description
The Pall QPoint™ Water Filter Capsule is a disposable filter capsule comprised of polyester, polypropylene, and polyethersulphone. The product is not made with natural rubber latex. The filter does not come into direct contact with patients, but indirect contact occurs as the water flowing through the filter is used by patients and by surgeons operating on patients.
Every device batch is integrity tested prior to release, and the filter capsules are supplied sterile. The Qpoint™ filter is a single-use device, i.e., it should not be removed and then re-used; however, a filter capsule can be used for up to two calendar months (maximum 62 days) following initial connection. A double layer Supor® membrane within the filter capsule is rated and validated at 0.2 µm to remove bacteria, fungi, protozoa and particles in the water supply. The filter membrane also has a high-technology integrated pre-filtration layer to provide extended use with higher dirt capacity for better flow rates.
The Filter Capsule is designed to be used with a fixed reusable Docking Station (i.e., Shower or Faucet Assembly, also called a Filter Capsule holder). The fitter capsule must be connected to a docking station in order to be used, but it can be exchanged when required without discarding the holder, which have separate reorder codes. The Docking Station need only be exchanged if obvious functional damage is found (e.g., a leak) or when aesthetic wear leads the user to prfer replacing this component.
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