Search Results
Found 1 results
510(k) Data Aggregation
(161 days)
Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)
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.
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.
The provided text is a 510(k) summary for the Pall® QPoint™ Water Filter Capsule device. It describes the device's intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the requested information based on the provided text.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a numerical or comparative table format for each performance test as would be typical for an AI/ML device. Instead, it describes various performance tests and states whether the device passed or performed adequately.
Here's an attempt to extract the implied "acceptance criteria" (which appear to be successful completion of the test) and the reported performance:
| Test/Characteristic | Implied Acceptance Criteria (Success Metric) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Achieve a minimum Sterility Assurance Level (SAL) of 10⁻⁶. | Validated and controlled in accordance with ISO 11137-1, ISO11137-2 and 11137-3 to ensure a minimum SAL of 10⁻⁶. |
| Shelf Life/Stability | Maintain performance after accelerated aging representing 5 years of storage. | Shelf life testing on final, finished, sterile devices after accelerated aging performed. All filter capsules tested retained integrity and maintained a safety margin above maximum operating pressure after the equivalent (in accelerated aging) of 5 years in storage. Real-time testing is ongoing. |
| Packaging Integrity | Meet all requirements for transit trials and mechanical seal integrity tests. | Transit trials performed on the filter capsules and their packaging met all requirements. Unit packages are both visually inspected and mechanically tested for seal integrity prior to release. Conducted after accelerated aging. |
| Membrane Integrity | Exhibit no leaks and conform to forward flow specifications. | The filter capsules are 100% in-process tested for forward flow and leaks, confirmed with bacterial challenge testing. |
| Microbial Retention (Brevundimonas diminuta) | Retain ≥ 1 x 10⁷ CFU/cm² of B. diminuta; no detection in filtrate. | Testing per ASTM F838-05 using Brevundimonas diminuta at a challenge level of ≥ 1 x 10⁷ colony forming units (CFU) per cm² of effective filtration area. All analysis membranes were found to be free of the test organism. |
| Microbial Retention (Legionella, Pseudomonas, E. coli, Mycobacterium gordonae) | No detection of challenge organisms in filtered water samples. | No detection of the challenge organism in filtered water samples tested for retention of Legionella pneumophila, Pseudomonas aeruginosa, Escherichia coli, and Mycobacterium gordonae (>1 x 10⁷ CFU/cm² effective filtration area challenge). |
| Microbial Retention in Intermittent Use (B. diminuta, L. pneumophila, Aspergillus fumigatus) | Retain specified microbial challenge organisms during 62 days of intermittent use. | Testing per ASTM F838-05 confirmed that the Pall QPoint™ Water Filter Capsules retain the microbial challenge organisms Brevundimonas diminuta, L. pneumophila, and Aspergillus fumigatus during typical intermittent use for a period of 62 days. All analysis membranes were found to be free of the test organism. |
| Maximum Operating Temperature and Pressure Rating | Maintain integrity at specified temperature and pressure limits. | Tested device operation at a continuous influent temperature of 60°C (140°F) and a maximum influent temperature of 75°C (167°F) for a total cumulative period of 90 minutes over the life of each filter capsule. The filter capsules were also tested to withstand a maximum operating pressure of 5 bar (~75 psi) at continuous 60°C (140°F) influent temperature over the life of the filter. Testing demonstrated that the filters maintain their integrity over their simulated service life. |
| Flow Rate Testing | Achieve specified flow rates at given pressures. | At water pressures reflecting normal use conditions, flow rates through the Filter Capsules ranged from 5.7 L/min at ~15 psi to 18.8 L/min at ~75 psi. |
| Additive Evaluation | Successfully reduce external microbial contamination by >99.5% after 24 hours contact. | The bacteriostatic additive incorporated within the housing polymer was shown to successfully reduce external microbial contamination by >99.5% after 24 hours contact. |
| Biocompatibility | Conformance to ISO 10993-1 for listed tests. | All tests were passing, demonstrating conformance to ISO 10993-1. Specific tests: Cytotoxicity (L929 MEM elution) per ISO 10993-5:2009; Sensitization and intracutaneous injection per ISO 10993-10:2010; Systemic injection and material-mediated rabbit pyrogen per ISO 10993-11:2006. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify exact "sample sizes" for the test sets in terms of number of filters or specific data points for each performance test. It refers to "testing" or "per ASTM F838-05," which would imply adherence to the standard's recommended sample sizes.
- Sample Size: Not explicitly stated as a number of devices for each test. Phrases like "All analysis membranes" or "All filter capsules tested" suggest that a sufficient number was used to meet the requirements of the standards cited (e.g., ASTM F838-05, ISO 11137, ISO 10993).
- Data Provenance: Not explicitly stated. The manufacturer is Pall International Sàrl, Fribourg, Switzerland, with a U.S. contact. The testing appears to be laboratory-based performance validation, likely conducted internally or by contract labs following international standards. It's not clinical data (retrospective or prospective) from specific countries, but rather engineering/microbiological performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. This device is a water filter, and its performance is evaluated through physical, chemical, and microbiological testing (e.g., bacterial retention, flow rates, integrity tests). It does not involve human expert interpretation of medical images or other data that would require "ground truth" established by human experts like radiologists.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As the device is a physical water filter and the studies are performance tests (e.g., microbial challenges, material integrity), there is no "adjudication method" in the context of human interpretation or disagreement resolution for a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This pertains to AI/ML software devices that assist human readers (e.g., radiologists interpreting images). The Pall® QPoint™ Water Filter Capsule is a physical medical device, and its approval involves demonstrating its physical and biological performance against established standards, not a comparative effectiveness study involving human interpretation.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This also pertains to AI/ML algorithms. The performance studies described are for the physical filter itself, operating as a standalone filtration device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of this device is established through:
- Standardized Microbiological Challenge Testing: Using well-characterized reference organisms (e.g., Brevundimonas diminuta, Legionella pneumophila, Aspergillus fumigatus) at specified concentrations to challenge the filter and then quantitatively measuring the presence or absence of these organisms in the filtrate. This is a direct measurement based on established scientific principles.
- Physical and Chemical Measurement Standards: For flow rates, pressure ratings, temperature tolerances, and material integrity, the "ground truth" is based on precise measurements against design specifications and existing industry standards.
- ISO and ASTM Standards: Compliance with relevant International Organization for Standardization (ISO) and American Society for Testing and Materials (ASTM) standards (e.g., ASTM F838-05 for microbial retention, ISO 11137 for sterilization, ISO 10993 for biocompatibility) serves as the basis for "ground truth" for these tests.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the context of machine learning. The term "training set" refers to data used to train a statistical or machine learning model. This is a physical product.
9. How the ground truth for the training set was established
Not applicable. As there is no AI/ML component or "training set," this question does not apply. The "ground truth" for the device's design and manufacturing is derived from engineering principles, material science, and microbiology, validated through the performance tests mentioned above.
Ask a specific question about this device
Page 1 of 1