(195 days)
The U9000 Plus Ultrafilter is indication of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain standard dialysis fluid in accordance with international standards requirements and local regulations. The risk of exposure to bacteria and endotoxins can thereby be minimized. The U9000 Plus Ultrafilter is intended to be used in conjunction with a water treatment system.
WARNING! The U9000 Plus Ultrafilter can only be used with AK98 dialysis machines equipped with holder for an ultrafilter.
The Ultrafilter product family (U9000 Plus, and its predicate device U9000) are ultrafilters intended for water filtration (removal of pyrogens and microorganisms), and filtration of dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized.
The U9000 Plus is intended to be used in conjunction with an upstream water treatment system. The Ultrafilter U9000 Plus can only be used with AK98 machines equipped with a dedicated holder. This places the U9000 Plus ultrafilter in the pre-dialyzer flow-path to filter the fluid before it reaches the dialyzer.
U9000 Plus Ultrafilter is intended to be used as a required component of the AK 98 Hemodialysis System, to minimize the risk of exposure to bacteria and endotoxins.
After installation, U9000 Plus Ultrafilter becomes an integral part of the dialysis fluid flow path of the dialysis machine; all machine processes that involve the Ultrafilter (e.g., dialysis fluid preparation, disinfection, rinsing) are controlled by the dialysis machine.
The provided document is a 510(k) premarket notification for a medical device (U9000 Plus Ultrafilter) and does not contain the specific information typically found in a study proving a device meets acceptance criteria for an AI/ML or diagnostic imaging device.
This document describes a water purification system for hemodialysis and its substantial equivalence to a predicate device. The "performance testing" mentioned refers to engineering and chemical tests for water filtration, not diagnostic performance with human readers or AI.
Therefore, I cannot extract the requested information (Acceptance Criteria Table, Sample Size, Expert Ground Truth, MRMC, Standalone Performance, Training Set details) as it is not present in the provided text.
The "discussion of nonclinical tests" section lists typical engineering and material compatibility tests for a water filter:
- Biocompatibility
- Pressure drop
- Retention capacity for Bacteria and Endotoxin
- Ultrafiltration rate
- Dialysis fluid composition
- Filter and membrane integrity
- Chemical evaluation
These tests are to confirm the device's physical and functional performance for water purification, not diagnostic accuracy or AI performance.
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October 19, 2021
Baxter Healthcare Corporation Carina Pforr Regulatory Affairs Specialist 25212 W. Illinois Route 120 Round Lake, Illinois 60073
Re: K211035
Trade/Device Name: U9000 Plus Ultrafilter Regulation Number: 21 CFR 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: September 10, 2021 Received: September 17, 2021
Dear Carina Pforr:
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 Act include 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. You must comply with all the Act's
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Glenn B Bell, Ph.D. Director THT3A1: Renal, Gastrointestinal, Obesity and Transplantation Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211035
Device Name U9000 Plus Ultrafilter
Indications for Use (Describe)
The U9000 Plus Ultrafilter is indication of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain standard dialysis fluid in accordance with international standards requirements and local regulations. The risk of exposure to bacteria and endotoxins can thereby be minimized. The U9000 Plus Ultrafilter is intended to be used in conjunction with a water treatment system.
WARNING! The U9000 Plus Ultrafilter can only be used with AK98 dialysis machines equipped with holder for an ultrafilter.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5. 510(k) Summarv
Submission Date: 05 April 2021
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Carina Pforr Regulatory Affairs Specialist 7 Avenue Lionel Terray - BP 126 69883 Meyzieu Cedex, FRANCE Telephone: (0033) 671 686 357 carina pforr@baxter.com
IDENTIFICATION OF THE DEVICE:
Common Name: Ultrafilter/Water Purification Subsystem Trade/Device Name: U9000 Plus Ultrafilter Classification Panel: 78 Gastroenterology and Urology Regulation Number: 21 CFR 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: Class II Product Code: FIP
| Table 1. Product codes in this submission | |||
|---|---|---|---|
| Product code | Name |
|---|---|
| 955825 | U9000 Plus Ultrafilter |
PREDICATE DEVICE:
Table 2. Predicate Device
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| U9000 Ultrafilter | Gambro DialysatorenGmbH | K201809 | March 2020 |
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DESCRIPTION OF THE DEVICE:
The Ultrafilter product family (U9000 Plus, and its predicate device U9000) are ultrafilters intended for water filtration (removal of pyrogens and microorganisms), and filtration of dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized.
The U9000 Plus is intended to be used in conjunction with an upstream water treatment system. The Ultrafilter U9000 Plus can only be used with AK98 machines equipped with a dedicated holder. This places the U9000 Plus ultrafilter in the pre-dialyzer flow-path to filter the fluid before it reaches the dialyzer.
U9000 Plus Ultrafilter is intended to be used as a required component of the AK 98 Hemodialysis System, to minimize the risk of exposure to bacteria and endotoxins.
After installation, U9000 Plus Ultrafilter becomes an integral part of the dialysis fluid flow path of the dialysis machine; all machine processes that involve the Ultrafilter (e.g., dialysis fluid preparation, disinfection, rinsing) are controlled by the dialysis machine.
INDICATIONS FOR USE OF PROPOSED DEVICE:
The U9000 Plus Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain standard dialysis fluid in accordance with international standards requirements and local regulations. The risk of exposure to bacteria and endotoxins can thereby be minimized. The U9000 Plus Ultrafilter is intended to be used in conjunction with a water treatment system.
WARNING! The U9000 Plus Ultrafilter can only be used with AK98 dialysis machines equipped with holder for an ultrafilter.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The differences between the predicate U9000 Ultrafilter and the proposed device U9000 Plus Ultrafilter as reflected in the Substantial Equivalence (SE) Table are considered substantially equivalent. See the comparison in Table 3.
Identification of Predicate Device
Trade Name: U9000 Ultrafilter 510(k) Submitter/holder: Baxter Healthcare Corporation Common name: Ultrafilter Clearance: K201809
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Identification of Proposed Device
Trade Name: U9000 Plus Ultrafilter 510(k) Submitter/holder: Baxter Healthcare Corporation Common name: Ultrafilter Clearance: Pending
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| Features | Predicate DeviceU9000 UltrafilterCleared under K201809 | Proposed DeviceU9000 Plus Ultrafilter | Assessment of Differences |
|---|---|---|---|
| Intended Use | The U9000 Ultrafilter is intended to be usedin conjunction with a water treatment system.WARNING! The U9000 Ultrafilter can onlybe used with AK98 dialysis machinesequipped with U9000 filter holder. | The U9000 Plus Ultrafilter is intended to beused in conjunction with a water treatmentsystem.WARNING! The U9000 Plus Ultrafilter canonly be used with AK98 dialysis machinesequipped with holder for ultrafilter. | No significant difference |
| Indications for Use | The U9000 Ultrafilter is indicated forpurification of incoming water for dialysisfluid as well as purification of dialysis fluidto obtain standard dialysis fluid inaccordance with international standardsrequirements and local regulations. The riskof exposure to bacteria and endotoxins canthereby be minimized. | The U9000 Plus Ultrafilter is indicated forpurification of incoming water for dialysisfluid as well as purification of dialysis fluidto obtain standard dialysis fluid inaccordance with international standardsrequirements and local regulations. The riskof exposure to bacteria and endotoxins canthereby be minimized. | No significant difference |
| Sterile | No(Unsterile Device) | Same | Not applicable |
| Non-Pyrogenic | No | Same | Not applicable |
| Expiration | 2 years | Same | Not applicable |
| Single Use | No | Same | Not applicable |
| StorageConditions | Below 30°C (86°F) | Same | Not applicable |
| Pump Compatibility orElectromechanical devicecompatibility | AK98 | Same | Not applicable |
Table 3. Device Comparison
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| Materials | Each Ultrafilter Device has verifiedBiocompatibility according toISO 10993 | |||
|---|---|---|---|---|
| Membrane | Polyarylethersulfone (PAES)Polyvinylpyrrolidone (PVP) | Same | Not applicable | |
| HousingHeaderPlug | Polycarbonate (PC) | Polyphenylsulfone (PPSU) | Material is in indirect contact with blood(contact with fluid)Biocompatiblity of changed material hasbeen verified according toISO 10993 | |
| Supporting ring | Polypropylene (PP) | Same | Not applicable | |
| Gasket material | Silicone rubber (SIR) | Same | Not applicable | |
| Potting material | Polyurethane (PUR) | Same | Not applicable | |
| Filtrate Protection cap | Low Density Polyethylene(LDPE) | Same | Not applicable | |
| Protection cap | Polypropylene (PP) | Same | Not applicable |
| Specification | |||
|---|---|---|---|
| No differenceEach Ultrafilter Device is designed andvalidated to fulfill the SystemRequirements specific to the therapysystem they are used with | |||
| Inner diameter of fiber | $190 \mu m \pm 10 \mu m$ | Same | Not applicable |
| Wall thickness of fiber | $45 \mu m \pm 3 \mu m$ | Same | Not applicable |
| Effective surface area | $2.40 m^2$ | Same | Not applicable |
| Maximumtransmembrane pressure | $600 (mmHg)$ | Same | Not applicable |
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| Operating range: QD | 300-1200 mL/min | Same | Not applicable | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Inlet pressure (37°C) | QF (mL/min) | 300 | 600 | 900 | 1200 | 300 | 600 | 900 | 1200 | Not applicable | |
| Pressure (mmHg) ±10% | 59 | 117 | 176 | 235 | Same | Same | Same | Same | Not applicable |
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DISCUSSION OF NONCLINICAL TESTS:
U9000 Plus Ultrafilter
Performance testing in accordance with FDA guidance document: Guidance for Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis was performed on the U9000 Plus Ultrafilter. The performance testing confirms that the device is safe, effective and is substantially equivalent to the predicate device when used in accordance with the instructions for use.
The following performance testing was conducted to verify the performance of the proposed device:
- Biocompatibility
- Pressure drop
- Retention capacity for Bacteria and Endotoxin. ●
- Ultrafiltration rate
- Dialysis fluid composition
- Filter and membrane integrity
- Chemical evaluation .
The specifications of the U9000 Plus Ultrafilter are provided in accordance with FDA Guidance.
§ 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.