(132 days)
Not Found
No
The device description and performance studies focus on the physical filtration properties of the device and do not mention any AI or ML components or functionalities.
No.
The device is a non-sterile dialysis fluid filter intended to produce ultrapure dialysate, not to provide direct therapeutic treatment to a patient. Its function is to filter dialysate to remove contaminants for use in hemodialysis.
No
This device is described as a dialysis fluid filter that produces ultrapure dialysate by reducing microbial contaminants and endotoxins, which is a treatment modality, not a diagnostic one.
No
The device description clearly states it is a "non-sterile dialysis fluid filter" and describes its physical components and mechanism of action, indicating it is a hardware device.
Based on the provided information, the DIASAFE®plusUS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the "preparation of ultrapure dialysate from pre-treated water". This is a process related to preparing a fluid for use in a medical procedure (hemodialysis), not for performing a diagnostic test on a biological sample.
- Device Description: The description details a filter that reduces microbial contaminants and endotoxins in dialysate. This is a physical filtration process, not a method for analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
- Performance Studies: The performance studies focus on the filter's ability to remove contaminants from the dialysate and maintain its integrity, not on its ability to accurately measure or detect substances in a biological sample.
The DIASAFE®plusUS is a component used in the process of hemodialysis, which is a treatment for kidney failure. It is a medical device, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The DIASAFE®plusUS is intended for the preparation of ultrapure dialysate from pre-treated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g., RO system, central delivery system).
The microbiological quality (microbial count [CFU/mL] and endotoxin measurement [EU/mL]) of the incoming water should be 300 mL/hr mmHg (3.75 L/min bar) at 37°C.
Results: Pass, results within acceptance criteria.
Dialysis Fluid Composition: Dialysate was passed through the filter at varying flow rates simulating typical in-use conditions. Dialysate composition was measured before and after filtration.
Acceptance Criteria: Dialysate composition shall not be adversely affected after passing through the DIASAFE®plusUS.
Results: Pass, results within acceptance criteria.
Filter Integrity: Filter integrity was evaluated after simulated ship testing.
Acceptance Criteria: The filter connectors, caps, housing, and welding shall not leak at a filtration pressure
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
January 10, 2019
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451
Re: K182367 Trade/Device Name: DIASAFE®plusUS Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water Purification System for Hemodialysis Regulatory Class: II Product Code: FIP Dated: December 4, 2018 Received: December 6, 2018
Dear Denise Oppermann:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carolyn Y. Neuland -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182367
Device Name DIASAFE@plusUS
Indications for Use (Describe)
The DIASAFE®plusUS is intended for the preparation of ultrapure dialysate from pre-treated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g., RO system, central delivery system).
The microbiological quality (microbial count [CFU/mL] and endotoxin measurement [EU/mL]) of the incoming water should be Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font and is also blue.
510(K) SUMMARY 5.
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.
Submitter's Information 5.1.
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| Address: | 920 Winter Street |
| Waltham, MA | |
| 02451-1457 | |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann |
| Senior Director, Regulatory Affairs – Devices | |
| Preparation Date: | 31 August 2018 |
5.2. Device Name
| Trade Name: | DIASAFE® plusUS |
|---|---|
| Common Name: | Subsystem, water purification |
| Regulation Name: | Water purification system for hemodialysis |
| Regulatory Class: | Class II per 21 CFR §876.5665 |
| Product Code: | FIP |
| Classification Panel: | Gastroenterology/Urology |
Legally Marketed Predicate Device 5.3.
The legally marketed predicate device is the Dialysis Machine with Dialysate Ultrafilter (K944767), hereinafter referred to as "Diasafe Dialysate Ultrafilter". This predicate has not been subject to a design-related recall.
Device Description 5.4.
5.4.1. Device Identification
The DIASAFE® plusus (P/N F00007039) is the subject of this Traditional 510(k).
5.4.2. Device Characteristics
The DIASAFE®plusus is a non-sterile dialysis fluid filter that produces ultrapure dialysate as defined in ANSI/AAMI/ISO 11663. The filter reduces microbial contaminants including endotoxins in the dialysate during hemodialysis treatment. The DIASAFE® plusus is installed and exchanged on 2008 Series hemodialysis machines using the DIAFIX™ Lock System. The DIAFIX™ Lock System is a standard feature on 2008 Series hemodialysis machines and is installed during machine production.
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Image /page/4/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue abstract symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevron shapes stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
5.4.3. Environment of Use
The DIASAFE® plusus is used in environments where acute and chronic hemodialysis is performed.
5.4.4. Brief Description of the Device
Mixed dialysate is forced through an open filter port across the fibers of DIASAFE® plusus. A bypass valve at the other end is closed which forces the dialysate across the fiber membrane. Dialysate passes through the porous membrane and into the filtrate compartment where it is allowed to flow through the uncapped side ports and into the hemodialyzer. Microorganisms and molecules too large to pass through the membrane are trapped in the fibers until they are flushed out, and/or disinfected during a routine cleaning cycle
5.4.5. Materials of Use
The DIASAFE® plusus is classified as an externally communicating, blood path indirect, prolonged contact (>24 hours to 30 days) duration, Class II (Category B) device in accordance with FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (16 June 2016).
A list of the DIASAFE® plusus components and materials is provided in Table 1.
| Component | Material |
|---|---|
| Capillary fibers (fiber bundle) | Fresenius Polysulfone®, |
| Polyvinylpyrrolidone | |
| Filter housing | Polypropylene |
| PU-Resin (potting mass) | Polyurethane |
| Welded header (caps) | Polypropylene |
| O-ring | Silicone |
| Plastic tabs (tear-off brackets) | Silicone |
| Sealing disc-ring | Silicone |
Table 1: DIASAFE®plusus Components and Materials
Key Performance Specifications/Characteristics 5.4.6.
A description of the key DIASAFE® plusus performance specifications is provided in Table 2.
DIASAFE®plusus Features Table 2:
| Features | Specifications |
|---|---|
| Filtration Rate | ≥ 300 mL/hr·mmHg |
| ≥ 3.75 L/min·bar | |
| Maximum Filtration Pressure | 2 bar |
| Connection System | DIAFIX™ Lock System |
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Image /page/5/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue abstract symbol on the left, resembling three downward-pointing chevrons stacked on top of each other. To the right of the symbol, the text "FRESENIUS MEDICAL CARE" is displayed in a bold, sans-serif font, also in blue. The words "MEDICAL CARE" are stacked below "FRESENIUS".
| Features | Specifications |
|---|---|
| Surface Area | 2.2m² |
| Dialysis Fluid Purity (ultrapure dialysate) | plus US Comparison of Technological Characteristics |
| ---------- | --------------------------------------------------------------------- |
| ---------- | --------------------------------------------------------------------- |
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Image /page/6/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue chevron-like symbol on the left, followed by the text "FRESENIUS" on the first line and "MEDICAL CARE" on the second line, both in blue. The text is bold and sans-serif.
| Feature | Diasafe Dialysate Ultrafilter -
Predicate Device (K944767) | DIASAFE®plusUS - Proposed Device |
|-------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Priming Volume
(outside of
capillaries) | 310 mL | 276 mL |
| Hemodialysis
Machine
Connection
System | Dialyzer connections | DIAFIX™ Lock System |
| Device
Packaging | Plastic overwrap with Tyvek®
sterilized pouch | The filter is sealed with plastic tabs
(tear-off brackets) and is packaged in
a transparent Sealable PA/PE
overwrap |
| Bleach Exposure | ≤15 hours | ≤ 30 hours (≤ 30 chemical
disinfection cycles) |
| Shelf-life | 3 years | 3 years |
| Sterility | Ethylene Oxide sterilized | Non-sterile |
Table 3: DIASAFE®plusus Comparison of Technological Characteristics (Continued)
5.7. Performance Data
Testing conducted to support the determination of substantial equivalence is summarized in Table 4.
| Test Conducted | Test Method Description | Acceptance Criteria | Results / Conclusion |
|---|---|---|---|
| Bacteria | |||
| Retention | Dialysis fluid spiked with | ||
| bacteria that exceeded the | |||
| allowable limit per | |||
| ANSI/AAMI RD52 was | |||
| filtered through the | |||
| DIASAFE®plusus | The filter shall retain | ||
| bacteria to produce | |||
| ultrapure dialysate | |||
| with a microbial | |||
| count plus US filter | |||
| samples were evaluated for | |||
| aqueous KUF | The aqueous | ||
| ultrafiltration rate | |||
| shall be >300 mL/hr | |||
| mmHg (3.75 L/min | |||
| bar) at 37°C | Pass, results within | ||
| acceptance criteria | |||
| Dialysis Fluid | |||
| Composition | Dialysate was passed | ||
| through the filter at | |||
| varying flow rates | |||
| simulating typical in-use | |||
| conditions. Dialysate | |||
| composition was measured | |||
| before and after filtration | Dialysate | ||
| composition shall not | |||
| be adversely affected | |||
| after passing through | |||
| the DIASAFE® plus US | Pass, results within | ||
| acceptance criteria | |||
| Filter Integrity | Filter integrity was | ||
| evaluated after simulated | |||
| ship testing | The filter connectors, | ||
| caps, housing, and | |||
| welding shall not leak | |||
| at a filtration pressure | |||
| plus US | |||
| was evaluated for | |||
| elemental and ionic | |||
| chemical contaminants | |||
| listed in ANSI/AAMI/ISO | |||
| 13959:2014 | The | ||
| DIASAFE® plus US | |||
| should not contribute | |||
| unacceptable levels | |||
| of chemical | |||
| contaminants | Pass, results within | ||
| acceptance criteria | |||
| for each defined | |||
| element/ion |
Table 4: Performance Data Testing
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Image /page/7/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons.
Table 4: Performance Data Testing (Continued)
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Image /page/8/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue abstract symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The abstract symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
Biocompatibility Testing 5.7.1.
The following testing was performed to support the biological safety of the DIASAFE®plusus.
- Chemical characterization
- Cytotoxicity, ISO Elution Method with MEM
- Sensitization, Guinea Pig Maximization
- Intracutaneous Irritation
- Material Mediated Pyrogenicity
- Hemocompatibility, ASTM Hemolysis (Indirect) Contact ●
- Subchronic Intravenous Toxicity
- Risk assessment of potential toxicity ●
- o PVP Testing
5.7.2. Stability Design Verification
The DIASAFE® plusus is provided non-sterile and will be labeled with a 36 months (3-year) product shelf life. The shelf life is supported by accelerated aging equivalent to 3-year realtime and 24 months real-time.
5.7.3. Shipping Verification
Shipping verification was conducted to support that the DIASAFE® plusys can withstand the distribution environments it is subjected to during actual use. Initial shipping verification was performed to evaluate pallet shipping configurations according to ASTM D4169-14 using an assurance level II with distribution cycle 6. A subsequent gap assessment between the ASTM D4169-14 and ASTM D4169-16 confirmed that the previous requirements of ASTM D4169-14 satisfied the requirements of ASTM D4169-16.
Additional shipping verification was then performed to evaluate single packaging shipping configurations according to ASTM D4169-16 using an assurance level II with distribution cvcles 3 and 13.
Membrane and filter integrity testing were performed after ship testing to evaluate gross mechanical damage to the fiber/filter.
5.7.4. Human Factors Testing
Formative and validation studies were conducted to address both labeling comprehension and user interaction with the DIASAFE® plusus. Execution of the human factors process is consistent with the requirements of ANSI/AAMI/IEC 62366-1:2015 and FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).
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Image /page/9/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue emblem on the left and the company name on the right. The emblem is made up of three downward-pointing chevrons stacked on top of each other. The text "FRESENIUS MEDICAL CARE" is in bold, blue letters.
Software Verification and Validation Testing 5.7.5.
This section is not applicable. The DIASAFE® plusus does not contain software.
5.7.6. Animal Studies
No animal studies were performed.
5.7.7. Clinical Studies
No clinical studies were performed.
5.8. Conclusion
The intended use, principle of operation, environment of use, and design of the DIASAFE®plusus are substantially equivalent to those of the predicate device. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the DIASAFE®plusus is safe and effective for its intended use