(90 days)
Hemodialysis with Xenium 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 dialyzers are polyethersulfone fiber dialyzers and will be labeled for single use only. The dialyzers are available in six sizes, which differentiate by membrane surface area. The polyethersulfone hollow fiber membrane is the same as that contained in NxStage System One cleared under NxStage Medical's premarket notification K050525. All other components in Xenium are the same as those contained in the Exeltra dialyzer cleared under Baxter's premarket notification K030974.
Here's an analysis of the provided text regarding the Xenium Dialyzer, focusing on the acceptance criteria and the study performed:
This document is a 510(k) premarket notification for a medical device (Xenium Dialyzer), and as such, it primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria and device performance metrics in the way a clinical trial report would.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, training set details) are explicitly listed as "Not Applicable" or are not present in this type of submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (Baxter's Exeltra dialyzer, K030974 & NxStage Medical's NxStage System One, K050525) based on: | The general design and materials of the Xenium dialyzer are the same as Exeltra dialyzer cleared under K030974 and NxStage System One dialyzer cleared under K050525. |
| No new types of safety and effectiveness issues compared to predicate devices. | The polyethersulfone hollow fiber membrane is the same as that contained in NxStage System One (K050525). All other components in Xenium are the same as those contained in the Exeltra dialyzer (K030974). |
| Performance testing in accordance with EN 1283 "Haemodialysers, Haemodiafilters, Haemofilters, Haemoconcentrators and their Extracorporeal Circuits," consistent with FDA guidance. | Performance testing for Xenium dialyzers has been conducted in accordance with EN 1283. (Specific numerical results are not provided in this summary). |
| Indicated uses are the same as predicate devices. | Hemodialysis with Xenium dialyzers is indicated for patients with 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. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not Applicable. This submission relies on demonstrating substantial equivalence through design, materials, and in vitro performance testing according to standards. A separate "test set" in the context of clinical data for performance metrics is not detailed in this submission summary as the device is not expected to produce new safety and effectiveness issues.
- Data Provenance: The in vitro performance testing mentioned follows EN 1283, an international standard. No specific country of origin for in vitro test data is stated, nor is it categorized as retrospective or prospective in this summary.
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 type of regulatory submission for a dialyzer does not typically involve human expert interpretation of a clinical test set to establish ground truth in the way, for example, a diagnostic imaging AI would. The "ground truth" here is the established safety and performance of the predicate devices and the compliance with engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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. This is a physical medical device (dialyzer), not an AI-based diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device. The "performance" assessment is of the device's physical and functional characteristics (e.g., membrane integrity, clearance rates, etc.) as per EN 1283, not an algorithm's output.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the established safety and performance of the predicate devices. For the new device, the "ground truth" for demonstrating equivalence relies on:
- Material Equivalence: The use of the same polyethersulfone membrane as one predicate and the same other components as another predicate.
- Performance Standard Compliance: Adherence to EN 1283 standards for dialyzer performance.
- Intended Use Equivalence: The intended use of the Xenium dialyzer is identical to the predicate devices.
8. The sample size for the training set
- Not Applicable. There is no AI algorithm being trained in this context.
9. How the ground truth for the training set was established
- Not Applicable. There is no AI algorithm and therefore no training set.
{0}------------------------------------------------
| Submitter: | Baxter Healthcare Corporation |
|---|---|
| One Baxter Parkway | |
| Deerfield, Illinois 60015 | |
| OCT 19 2006 | |
| Contact: | David E. Curtin |
| Global Regulatory Affairs | |
| 1620 Waukegan Road, MPGR-AL | |
| McGaw Park, Illinois 60085 | |
| (847) 473-6079 | |
| (847) 785-5116 FAX | |
| Date Prepared: | July 20, 2006 |
| Device Name: | Trade Name: Xenium |
| Common Name: Dialyzer | |
| Classification Name: High Permeability Hemodialysis System | |
| Predicate Devices: | Baxter's Exeltra dialyzer, K030974 |
| NxStage Medical's NxStage System One, K050525 | |
| Device Description: | Xenium dialyzers are polyethersulfone fiber dialyzers and willbe labeled for single use only. The dialyzers are available in sixsizes, which differentiate by membrane surface area. |
| The polyethersulfone hollow fiber membrane is the same as thatcontained in NxStage System One cleared under NxStageMedical's premarket notification K050525. All othercomponents in Xenium are the same as those contained in theExeltra dialyzer cleared under Baxter's premarket notificationK030974. | |
| Intended Use: | Hemodialysis with Xenium dialyzers is indicated for patientswith renal failure when conservative therapy is judged to beinadequate. It also may be indicated in the treatment of patientsintoxicated with poisons or drugs. |
| Summary ofTechnologicalCharacteristicsCompared toPredicate Device: | The general design and materials of the Xenium dialyzer are thesame as Exeltra dialyzer cleared under K030974 and NxStageSystem One dialyzer cleared under K050525, and do not raiseany new types of safety and effectiveness issues when comparedto the predicate devices. |
| Clinical Data: | Not Applicable |
| Performance: | Performance testing for Xenium dialyzers has been conducted inaccordance with EN 1283 "Haemodialysers, Haemodiafilters,Haemofilters, Haemoconcentrators and their ExtracorporealCircuits," consistent with FDA guidance document titled"Guidance for the Content of Premarket Notifications forConventional and High Permeability Hemodialyzers." |
| Conclusion: | The Xenium dialyzers are substantially equivalent to thecurrently cleared Exeltra and NxStage System One dialyzers. |
:
·
{1}------------------------------------------------
:
:
.
:
:
:
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT 1 9 2006
David E. Curtin, R.A.C. Associate Director, Global Regulatory Affairs Baxter Healthcare Corporation Renal Division 1620 Waukegan Road, MPGR-AL MCGAW PARK IL 60085
Re: K062079
Trade/Device Name: Xenium Dialyzer Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: July 20, 2006 Received: July 21, 2006
Dear Mr. Curtin:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below the text is the acronym "FDA" in bold letters. Underneath the acronym is the word "Centennial" in cursive. There are three dots at the bottom of the logo. The logo is surrounded by a dotted border.
ing and Promoting Public St
{3}------------------------------------------------
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 not 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 liating (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 edectronic 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 of substantial equivalence of your device to a logal|y marketed predicate device results in a classification for your device and thus, permits your evice to proceed to the market.
If you desire specific advice for your device on our labeling 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 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K062079
Device Name: Xenium Dialyzer
Indications For Use:
Hemodialysis with Xenium 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use I
OR
Over-The-Counter Use_
(Per 21 CFR 801.109)
David A. Leppert
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev 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.”