(30 days)
Not Found
No
The summary describes a dialyzer, a physical device for hemodialysis, and the performance studies focus on physical characteristics and clearance rates. There is no mention of AI or ML terms, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
This device is a dialyzer used for hemodialysis, which is a medical treatment designed to treat kidney failure by removing waste products and excess fluid from the blood, thus serving a therapeutic purpose.
No
The device is a dialyzer used for hemodialysis, which is a treatment process to remove waste products and excess fluid from the blood. It does not diagnose medical conditions.
No
The device is a dialyzer, which is a physical medical device used in hemodialysis, not a software-only device.
Based on the provided information, the Fresenius Ultraflo HPX dialyzer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "single use acute and chronic hemodialysis." Hemodialysis is a process performed on a patient's blood outside the body to remove waste products and excess fluid. This is a therapeutic procedure, not a diagnostic test performed on a sample in vitro (in a test tube or lab setting).
- Device Description: While the description is "Not Found," the function of a dialyzer is to filter blood, which aligns with a therapeutic device.
- Performance Studies: The performance studies listed are related to the physical and functional characteristics of the dialyzer (priming volume, pressure drops, clearance rates), which are relevant to its performance in filtering blood during hemodialysis. There are no studies related to detecting or measuring substances in a sample for diagnostic purposes.
- Lack of IVD Indicators: There are no mentions of analyzing samples, detecting biomarkers, or providing diagnostic information, which are hallmarks of IVD devices.
In summary, the Fresenius Ultraflo HPX dialyzer is a medical device used for a therapeutic procedure (hemodialysis), not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Fresenius Ultraflo HPX dialyzer is designed for single use acute and chronic hemodialysis.
Product codes (comma separated list FDA assigned to the subject device)
78KDI
Device Description
The Ultraflo HPX dialyzers are equivalent in materials, sterilization and indications for use to the currently manufactured Optiflux 200NR and Ultraflux dialyzers. The technological characteristics of the Ultraflo HPX dialyzers are equivalent to those of the Optiflux 200NR and Ultraflux and raise no new types of safety or effectiveness questions.
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
In vitro testing was performed to determine the following: priming volume, bloodside and dialysate-side pressure drops, ultrafiltration coefficient, urea clearance, creatinine clearance, Vitamin B12 clearance, phosphate and lysozyme clearance. No clinical testing was performed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro testing was performed to determine the following: priming volume, bloodside and dialysate-side pressure drops, ultrafiltration coefficient, urea clearance, creatinine clearance, Vitamin B12 clearance, phosphate and lysozyme clearance. No clinical testing was performed.
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
Image /page/0/Picture/1 description: The image shows a geometric shape that resembles a three-tiered funnel or inverted pyramid. Each tier is defined by thick, dark lines, creating a stacked appearance. The tiers decrease in size from top to bottom, converging to a point at the bottom of the shape. The overall design is simple and graphic, with a focus on the geometric form.
KO34064
Fresenius Medical Care
Fresenius Ultraflo HPX Single Use Hemodialyzer "Special" 510(k) Premarket Notification
Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
A. Submitter's Information:
| Name: | Fresenius Medical Care North America |
|---|---|
| Address: | 95 Hayden Ave |
| Lexington, MA 02420 | |
| Phone: | 1-781-402-9068 |
| Fax: | (781) 402-9635 |
| Contact Person: | Arthur Eilinsfeld, Director of Regulatory Affairs |
| Date of Preparation: | 29 December 2003 |
B. Device Name:
| Common Name: | Dialyzer, High Permeability with or without Sealed Dialysate System |
|---|---|
| Product Code/Classification Panel: | 78KDI/Gastroenterology-Urology |
C. Predicate Device
The predicate devices for the Fresenius Ultraflo HPX Hemodialyzer are:
1
Image /page/1/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized funnel shape above the text "Fresenius Medical Care". The funnel is made up of several horizontal lines that decrease in length from top to bottom, creating a perspective effect.
Fresenius Ultraflo HPX Sinqle Use Hemodialyzer "Special" 510(k) Premarket Notification
Summary of Safety and Effectiveness
D. Indications for Use:
The Fresenius Ultraflo HPX dialyzer is designed for single use acute and chronic hemodialysis.
E. Substantial Equivalence:
1. Is the product a device?
YES - The Ultraflo HPX dialyzers are devices pursuant to 21 CFR §201 [321] (h).
2. Does the new device have the same intended use?
YES - The intended use for the Ultraflo HPX is identical to that for the Optiflux 200NR and Ultraflux and is as follows:
Intended Use for Ultraflux
The Fresenius Ultraflo HPX dialyzer is designed for single use acute and chronic hemodialysis.
Intended Use for Optiflux 200NR
Optiflux 200NR dialyzers are designed for single use acute and chronic hemodialysis.
Intended Use for Ultraflux
The Fresenius Ultraflux dialyzer is designed for single use acute and chronic hemodialysis.
3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?
NO - The Ultraflo HPX dialyzers are equivalent in materials, sterilization and indications for use to the currently manufactured Optiflux 200NR and Ultraflux dialyzers. The technological characteristics of the Ultraflo HPX dialyzers are equivalent to those of the Optiflux 200NR and Ultraflux and raise no new types of safety or effectiveness questions.
2
KO3406A
Fresenius Medical Care
Fresenius Ultraflo HPX Single Use Hemodialyzer "Special" 510(k) Premarket Notification
Summary of Safety and Effectiveness
4. Does descriptive or performance information demonstrate equivalence?
YES - Fresenius Medical Care North America believes that the information provided in this submission clearly describes the Ultraflo HPX dialyzers and demonstrates that it is substantially equivalent to the Optiflux 200NR and Ultraflux.
F. Safety Summary
The Ultraflo HPX dialyzers are substantially equivalent in construction, design, materials, and intended use to the commercially available Fresenius Optiflux and Ultraflux hemodialyzers. In addition, testing of Ultraflo HPX dialyzers indicates that they are safe and effective for their intended use.
In vitro testing was performed to determine the following: priming volume, bloodside and dialysate-side pressure drops, ultrafiltration coefficient, urea clearance, creatinine clearance, Vitamin B12 clearance, phosphate and lysozyme clearance. No clinical testing was performed.
G. General Safety and Effectiveness Concerns
The device labeling contains a Package Insert, which includes indications for use, cautions and warnings, as well as the general operating instructions required for proper use of the device. This information promotes safe and effective use of the dialyzer.
3
Image /page/3/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
JAN 3 0 2004
Ms. Nichole Riek Regulatory Affairs Supervisor Frescnius Medical Care North American Two Ledgemont Center 95 Hayden Avenue LEXINGTON MA 02173
Re: K034064
Trade/Device Name: Fresenius Ultraflo HPX Single Use Hemodialyzer Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: December 29, 2003 Received: December 31, 2003
Dear Ms. Riek:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becare in (a) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encream. 776, 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, de noos that have been require approval of a premarket approval application (PMA). and Cosmote Fee (110) the device, subject to the general controls provisions of the Act. The I ou may, distore, mains of the Act include requirements for annual registration, listing of general controls provision gractice, labeling, and prohibitions against misbranding and adulteration.
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 i lease of advisou that i Dr instian that your device complies with other requirements of the Act that I Dr Has Interes and regulations administered by other Federal agencies. You must of any I edetar statures and regularents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Party) accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rordline and quality by overse (sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mative. 3 > prematication. The PDF intellight 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 labeling regulation (21 CFR Part 801), please If you destle specific advice tor your do to the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the prosse note the regulation entitled, "Misbranding Onlice of Compliance at (501) 57 - 155 (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Obliess http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. I rogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
5
Image /page/5/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a geometric shape resembling an inverted pyramid or funnel, with horizontal lines inside. Below the shape, the text "Fresenius Medical Care" is written in a clear, sans-serif font.
Fresenius Ultraflo HPX Single Use Hemodialyzer "Special" 510(k) Premarket Notification
Indications for Use Statement
Device Name:
Fresenius Ultraflo HPX Hemodialyzers
Indications for Use:
The Fresenius Ultraflo HPX dialyzer is designed for single use acute and chronic hemodialysis.
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K034064
000035