(138 days)
Hemodialysis with Xenium XPM 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.
Xenium XPM dialyzers are Polyethersulfone fiber dialyzers and will be labeled for single use only. The dialyzers are available in six (6) sizes, which are differentiated by membrane surface area.
The provided document is a 510(k) Premarket Notification for the Xenium XPM hemodialyzer. It focuses on demonstrating substantial equivalence to a predicate device and does not contain the detailed information typically found in studies for AI/ML-based devices regarding acceptance criteria, performance metrics, ground truth establishment, or sample sizes in the manner requested.
Here's an analysis of the information that is available in the document, and where the requested details are missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document states, "All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use." However, it does not specify what these quantitative acceptance criteria are (e.g., specific thresholds for clearance rates, ultrafiltration rates, etc.).
- Reported Device Performance: No specific performance metrics or results are reported in this summary. The manufacturer conducted "design verification tests" but the outputs of these tests are not provided. The demonstration of substantial equivalence suggests the performance is similar to the predicate, but no direct performance data is given.
Conclusion for Point 1: No specific acceptance criteria or quantitative device performance data are provided in this 510(k) summary.
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 mentions "design verification tests" and "risk analyses per ISO 14971." These are non-clinical tests.
- Sample Size: No sample size for any test set is mentioned.
- Data Provenance: Not applicable, as this refers to non-clinical, in-vitro testing/design verification, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a hemodialyzer, a physical medical device, not an AI/ML diagnostic or measurement tool. There is no concept of "ground truth" derived from expert consensus in the context of its performance verification as described here. Physical and chemical tests are likely used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This term refers to the process of resolving discrepancies in expert interpretations, which is not relevant for the type of device and verification described.
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. The Xenium XPM is a hemodialyzer, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the AI/ML sense. For a hemodialyzer, "ground truth" for performance would be established by validated physical and chemical measurement methods (e.g., measuring solute clearance, ultrafiltration, pressure drops according to established standards).
8. The sample size for the training set
- Not applicable. This device does not involve an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve an AI/ML algorithm.
Summary of what the study provided in the document focuses on:
The document describes a "Special 510(k) Premarket Notification" for a hemodialyzer, the Xenium XPM. The primary objective of this type of submission is to demonstrate substantial equivalence to an already legally marketed predicate device (in this case, the Baxter Xenium XPH dialyzer, K083778).
The "study" or testing mentioned is non-clinical: "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 indicates that standard engineering and regulatory verification tests were performed to ensure the device met its design specifications and safety requirements, likely comparing its physical characteristics and functional performance (e.g., membrane surface area, materials, in-vitro clearance, and ultrafiltration rates) against the predicate device to demonstrate equivalence. The details of these tests, including specific acceptance criteria and detailed quantitative results, are not included in this 510(k) summary, which is typical for such submissions where the focus is on the conclusion of substantial equivalence rather than a full study report.
{0}------------------------------------------------
K093120
PAGE 1 OF 2
Special 510(k) Premarket Notification Xenium XPM
Section 5 510(k) Summary
5. 510(k) SUMMARY
September 24, 2009
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 XPM
Table 5-1. Product Codes for Xenium XPM
| M25649A | Xenium XPM 110 |
|---|---|
| M25650A | Xenium XPM 130 |
| M25651A | Xenium XPM 150 |
| M25652A | Xenium XPM 170 |
| M25653A | Xenium XPM 190 |
| M25654A | Xenium XPM 210 |
FEB 1 7 2010
{1}------------------------------------------------
Special 510(k) Premarket Notification Xenium XPM
K093120
PAGE 2 OF 2
Section 5 510(k) Summary
Common name: Hemodialyzer
Classification name: Dialyzer, high permeability with or without sealed dialysate system
PREDICATE DEVICE:
| Table 5-2. |
|---|
| Previous 510(k)s |
| Device | Company | Previous 510(k) | Clearance date |
|---|---|---|---|
| Xenium XPH | BaxterHealthcareCorporation | K083778 | February 20,2009 |
DESCRIPTION OF THE DEVICE:
Xenium XPM dialyzers are Polyethersulfone fiber dialyzers and will be labeled for single use only. The dialyzers are available in six (6) sizes, which are differentiated by membrane surface area.
STATEMENT OF INTENDED USE:
Hemodialysis with Xenium XPM 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 XPM is substantially equivalent to Baxter's current legally marketed Xenium XPH dialyzer cleared February 20, 2009 (K083778).
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 XPM is substantially equivalent to the predicate device.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, topped by a pair of wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002
Ms. Diane Rennpferd Manager, Global Regulatory Affairs Baxter Health Care Corporation Renal Division 1620 Waukegan Road MCGAW PARK IL 60085
FEB 1 7 2010
Re: K093120
Trade/Device Name: Xenium XPM
Regulation Number: 21 CFR §876.5860
Regulation Name: High permeability hemodialysis system Regulatory Class: II
Product Code: KDI
Dated: January 11, 2010
Received: January 19, 2010
Dear Ms. Rennpferd:
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. 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 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
{3}------------------------------------------------
Page 2 -
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
{4}------------------------------------------------
INDICATIONS FOR USE
KO93120 510(k) Number (if known):
Device Name: Xenium XPM
Indications for Use:
Hemodialysis with Xenium XPM 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.
AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
9
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal and Division oral Devices 510(k) Number
§ 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.”