(90 days)
Not Found
No
The summary describes a physical medical device (hemodialyzer) and its components, with no mention of software, algorithms, or AI/ML terms. The performance studies are based on physical testing standards.
Yes
The device is used for hemodialysis in patients with renal failure or intoxication, directly treating a medical condition.
No
The device is a hemodialyzer, used for treating renal failure and intoxications, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states that the device is a physical dialyzer made of polyethersulfone fibers, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a treatment for patients with renal failure or intoxication. This is a therapeutic intervention performed directly on the patient's blood, not a test performed on a sample in vitro (outside the body) to diagnose a condition.
- Device Description: The device is a dialyzer, which is a component used in hemodialysis to filter blood. This is a medical device used for treatment, not for diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, or analysis of biological samples for diagnostic purposes.
Therefore, the Xenium dialyzer is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
KDI
Device Description
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.
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 for Xenium dialyzers has been conducted in accordance with EN 1283 "Haemodialysers, Haemodiafilters, Haemofilters, Haemoconcentrators and their Extracorporeal Circuits," consistent with FDA guidance document titled "Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers."
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.
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
§ 876.5860 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.”
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 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. | |
| Intended Use: | 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. | |
| Summary of | |
| Technological | |
| Characteristics | |
| Compared to | |
| Predicate Device: | 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, and do not raise | |
| any new types of safety and effectiveness issues when compared | |
| to the predicate devices. | |
| Clinical Data: | Not Applicable |
| Performance: | Performance testing for Xenium dialyzers has been conducted in |
| accordance with EN 1283 "Haemodialysers, Haemodiafilters, | |
| Haemofilters, Haemoconcentrators and their Extracorporeal | |
| Circuits," consistent with FDA guidance document titled | |
| "Guidance for the Content of Premarket Notifications for | |
| Conventional and High Permeability Hemodialyzers." | |
| Conclusion: | The Xenium dialyzers are substantially equivalent to the |
| currently cleared Exeltra and NxStage System One dialyzers. |
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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