Hemodialysis with Xenium XPH cialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. Will some of class may be indicated in the treatment of patients intoxicated with poisons or drugs.

Device Description

Xenium XPH dialyzers are Polyethersulfone fiber dialyzers and will be labeled for single use only. The dialyzers are available in six (6) sizes, which differentiate by membrane surface area.

AI/ML Overview

The provided text is a 510(k) summary for the Xenium XPH dialyzer a medical device. The document states that the device is "substantially equivalent" to a predicate device and that "All test results meet the acceptance criteria". However, it does not provide a table of specific acceptance criteria or detailed device performance results.

Specifically, the document states: "Baxter Healthcare Corporation conducts risk analyses, per ISO 14971, and design verification tests based on the result of these analyses. All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use." This is a general statement and does not include the detailed information requested in the prompt.

Therefore, for the requested information, the following can be reported based solely on the provided text:

Acceptance Criteria and Study Details for Xenium XPH Dialyzer

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the provided text.	"All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The testing appears to be internal "design verification tests" conducted by Baxter Healthcare Corporation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable/Not specified, as the testing described is "design verification tests" rather than clinical studies requiring expert ground truth establishment in the traditional sense.
Qualifications of Experts: Not applicable/Not specified.

4. Adjudication method for the test set

Not applicable/Not specified. The document describes "design verification tests," not a study requiring adjudication of interpretations.

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

No, a MRMC comparative effectiveness study was not done. The device is a dialyzer, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical dialyzer, not an algorithm.

7. The type of ground truth used

Not applicable in the context of expert consensus or pathology. The "ground truth" for a dialyzer would relate to its physical and functional performance specifications (e.g., clearance rates, ultrafiltration rates, safety parameters) as measured in design verification tests. The specific "type" is not detailed beyond "design verification tests."

8. The sample size for the training set

Not applicable. The device is a physical dialyzer, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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K083778

Section 5 510(k) Summary

5. 510(k) SUMMARY

December 2, 2008

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Diane Rennpferd Manager, Global Regulatory Affairs 1620 Waukegan Road McGaw Park, IL 60085 Telephone: (847) 473-6293 Fax: (847) 785-5116

DEVICE NAME:

Trade name: Xenium XPH

Product Codes for Xenium XPH
H25601A	Xenium XPH 110
H25602A	Xenium XPH 130
H25603A	Xenium XPH 150
H25604A	Xenium XPH 170
H25605A	Xenium XPH 190
H25606A	Xenium XPH 210

Table 5-1.

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Common name: Dialyzer

Classification name: Dialyzer, high permeability with or without sealed dialysate

PREDICATE DEVICE:

Device	Company	Previous 510(k)	Clearance date
Xenium Dialyzer, Model 110, 130, 150, 170, 190, and 210	BaxterHealthcare	K062079	October 19,2006

Table 5-2. Previous 510(k)s

DESCRIPTION OF THE DEVICE:

Xenium XPH dialyzers are Polyethersulfone fiber dialyzers and will be labeled for single use only. The dialyzers are available in six (6) sizes, which differentiate by membrane surface area.

STATEMENT OF INTENDED USE:

Hemodialysis with Xenium XPH dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The Xenium XPH is substantially equivalent to Baxter's current legally marketed Xenium Dialyzer, Model 110, 130, 150, 170, 190, and 210 cleared October 19, 2006 (K062079).

DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analyses, per ISO 14971, and design verification tests based on the result of these analyses. All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use.

CONCLUSION:

The Xenium XPH is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Diane Rennpferd Manager, Global Regulatory Affairs Baxter Health Care Corporation Renal Division 1620 Waukegan Road MCGAW PARK IL: 60085

and the submit and the same of the same of the states of the states and

FEB 2 0 2009

Re: K083778

Trade/Device Name: Xenium XPH Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: January 20, 2009 Received: January 23, 2009

Dear Ms. Rennpferd:

We have reviewed your Section 510(k) premarket notification of intent to market the device for use stated in the same of 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 provisions of the Federal Pood, Drive, a com/ cantrollers and control subject to the smeral controls provisions of the devices and controls c. the Ast includes . Aquire sentere controls provisions of the devices; good manufacturing practice, labeling, and prohibitions against misoranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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,

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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 requirements, including but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our laveling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrt/industry.suppor/index.html.

Sincerely yours,

Laura B. Morris

anine M. M. N cting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

K083778

Device Name: Xenium XPH

Indications for Use:

Prescription Use ____ X AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulu Hever

and Radiological Devic 510(k) Number

Regulation Number and Section

§ 876.5860 High permeability hemodialysis system.

(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”