K Number
K211035
Device Name
U9000 Plus Ultrafilter
Date Cleared
2021-10-19

(195 days)

Product Code
Regulation Number
876.5665
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
More Information

Not Found

No
The document describes a physical filter for water and dialysis fluid, with no mention of software, algorithms, or data processing that would indicate AI/ML.

No
The device is an ultrafilter used for purifying water and dialysis fluid, not for directly treating a patient's medical condition. It minimizes exposure to bacteria and endotoxins in the dialysis fluid, thus supporting the dialysis process, but it is not a therapeutic device itself.

No

Explanation: The device is an ultrafilter used for filtering water and dialysis fluid to minimize exposure to bacteria and endotoxins. It is a purification and filtration device, not a diagnostic one.

No

The device description clearly indicates the U9000 Plus Ultrafilter is a physical component (an ultrafilter) intended for water and fluid filtration, not a software program.

Based on the provided text, the U9000 Plus Ultrafilter is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for filtering water and dialysis fluid before it reaches the patient during hemodialysis. It's a component of a dialysis system, not a device used to test samples in vitro (outside the body) to diagnose or monitor a medical condition.
  • Device Description: The description reinforces its role in filtering fluids within the dialysis machine's flow path.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

The device is a component of a medical device (the hemodialysis system) used for treatment, not for in vitro diagnosis.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

FIP

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K201809

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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

2

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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 codeName
955825U9000 Plus Ultrafilter

PREDICATE DEVICE:

Table 2. Predicate Device

DeviceCompanyPredicate 510(k)Clearance Date
U9000 UltrafilterGambro Dialysatoren
GmbHK201809March 2020

4

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

5

Identification of Proposed Device

Trade Name: U9000 Plus Ultrafilter 510(k) Submitter/holder: Baxter Healthcare Corporation Common name: Ultrafilter Clearance: Pending

6

| Features | Predicate Device
U9000 Ultrafilter
Cleared under K201809 | Proposed Device
U9000 Plus Ultrafilter | Assessment of Differences |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Intended Use | The U9000 Ultrafilter is intended to be used
in conjunction with a water treatment system.
WARNING! The U9000 Ultrafilter can only
be used with AK98 dialysis machines
equipped with U9000 filter holder. | 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 ultrafilter. | No significant difference |
| Indications for Use | The U9000 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 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. | 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 |
| Storage
Conditions | Below 30°C (86°F) | Same | Not applicable |
| Pump Compatibility or
Electromechanical device
compatibility | AK98 | Same | Not applicable |

Table 3. Device Comparison

7

| Materials | | | Each Ultrafilter Device has verified
Biocompatibility according to
ISO 10993 | |
|---------------------------|-----------------------------------------------------------|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Membrane | Polyarylethersulfone (PAES)
Polyvinylpyrrolidone (PVP) | Same | Not applicable | |
| Housing
Header
Plug | Polycarbonate (PC) | Polyphenylsulfone (PPSU) | Material is in indirect contact with blood
(contact with fluid)
Biocompatiblity of changed material has
been verified according to
ISO 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 difference
Each Ultrafilter Device is designed and
validated to fulfill the System
Requirements specific to the therapy
system they are used with
Inner diameter of fiber$190 \mu m \pm 10 \mu m$SameNot applicable
Wall thickness of fiber$45 \mu m \pm 3 \mu m$SameNot applicable
Effective surface area$2.40 m^2$SameNot applicable
Maximum
transmembrane pressure$600 (mmHg)$SameNot applicable

8

Operating range: QD300-1200 mL/minSameNot applicable
Inlet pressure (37°C)QF (mL/min)30060090012003006009001200Not applicable
Pressure (mmHg) ±10%59117176235SameSameSameSameNot applicable

9

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.