(303 days)
No
The document describes a physical medical device (hemodialyzer/filter) and its materials and function, with no mention of software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is explicitly indicated for use in hemodialysis for the treatment of chronic or acute renal failure, which is a medical treatment. It also states its function in removing uremic toxins and waste products from the patient's blood, directly impacting the patient's physiological state.
No
This device is a hemodialyzer/hemofilter, used for treating renal failure by filtering blood, not for diagnosing a condition.
No
The device description clearly details a physical medical device (hemodialyzer/filter) made of materials like polyethersulfone and polycarbonate, with specific dimensions and components. It is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hemodialysis for the treatment of chronic or acute renal failure." This is a therapeutic treatment performed directly on the patient's blood, not a test performed on a sample of the patient's body fluid or tissue in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details how the device filters blood to remove waste products and excess fluid. This is a physical process of separation and removal, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any analysis of samples, detection of substances, or providing diagnostic information about a patient's condition.
Therefore, the POLYFLUX R is a therapeutic medical device used for hemodialysis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
POLYFLUX R is indicated for use in hemodialysis for the treatment of chronic or acute renal failure. The choice of the filter is the responsibility of the physician. Special attention must be paid in connection with pediatric use.
CAUTION! If POLYFLUX R is reused, the procedure and disinfection specified in the RENATRON INSTRUCTION MANUAL must be followed.
The POLYFLUX R may be reprocessed for reuse on the same patient.
Product codes (comma separated list FDA assigned to the subject device)
78 MSF
Device Description
The Gambro Polyflux 17R and 21R, Capillary Dialyzers/Filters labeled for multiple use (reuse) are identical in construction in function to Gambro Polyflux 17S and 21S Hemodialyzers / Hemofilters labeled for single use which are currently marketed in the United States and have been previously cleared by the FDA under 510(k) Notification K981414. Only the product designation "R" has been changed from "S" to designate that they are labeled for multiple use (reuse).
These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure and for certain types of intoxications for both single when reprocessed for reuse for a maximum of 15 reprocessing reuse cycles on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies undertaken by Gambro and presented in the labeling for this device. It may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in these devices is polyethersulfone (PES) which is identical to the membrane utilized in the Gambro Polyflux 17S and 21S Hemodialyzers / Hemofitters for labeled for single use which have been previously approved for marketing in the United States under a 510K Notification (K982414). A copy of this approval letter is included in Appendix I of this Notification.
Blood enters a blood inlet port where it is distributed to polyethersulfone hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of polyethersulfone hollow fibers in each hemodialyzer / hemofilter is 10,000 for the Polyflux 17R and 12,500 for the 21R. These dialyzers have an effective membrane length of 250 mm. The effective membrane surface area is 1.7 square meters for the 17R and 2.1 square meters for the 21R. The housing and end caps of these hemodialyzers / hemofiters are made of polycarbonate. The fibers used in the Gambro Polyflux 17R and 21R are identical in design and materials to the previously approved Gambro Polyflux 17S and 21S Hemodialyzers / Hemofilters for labeled for single use (K982414). The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.
By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the polyethersulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through polyethersulfone membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.
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
Special attention must be paid in connection with pediatric use.
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)
Summary of Non-Clinical Tests:
In vitro data was collected according to the FDA Guidance for Hemodialyzer Reuse Labeling.
Clinical Test Results:
Clinical data was collected according to the FDA Guidance for Hemodialyzer Reuse Labeling.
Conclusions:
Testing performed on the Gambro Polyflux 17R and 21R Capillary Dialyzers/Filters indicates that they are safe, effective, and perform as well as the predicate devices, when used in accordance with the instructions for use. In vitro and in vivo performance data and directions for reuse have been included in the labeling.
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
| OCT 26 2000 | 510(k) Notification Supplement Gambro Polyflux 17R, & 21 R Labeled for Multiple Use July 17th, 2000 510K(k) SUMMARY |
|---|---|
| ------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------- |
| SUBMITTER: | Gambro Healthcare 1185 Oak Street Lakewood, CO 80215 (303) 231-4436 |
|---|---|
| DATE PREPARED: | July 17th, 2000 |
| DEVICE NAME: | Gambro Polyflux 17R & 21R Capillary Dialyzers/Filters Labeled for Multiple Use |
| CLASSIFICATION NAMES: | High Permeability Hemodialyzer / Hemofilters |
| PREDICATE DEVICE: | Gambro Polyflux 17S & Gambro 21S Hemodialyzers/Filters Labeled for Single Use |
Kgq4390
p.113
Device Description:
Gambro Polyflux 17R & 21 R Capillary Dialyzers/Filters Labeled for Multiple Use
The Gambro Polyflux 17R and 21R, Capillary Dialyzers/Filters labeled for multiple use (reuse) are identical in construction in function to Gambro Polyflux 17S and 21S Hemodialyzers / Hemofilters labeled for single use which are currently marketed in the United States and have been previously cleared by the FDA under 510(k) Notification K981414. Only the product designation "R" has been changed from "S" to designate that they are labeled for multiple use (reuse).
These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure and for certain types of intoxications for both single when reprocessed for reuse for a maximum of 15 reprocessing reuse cycles on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies undertaken by Gambro and presented in the labeling for this device. It may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in these devices is polyethersulfone (PES) which is identical to the membrane utilized in the Gambro Polyflux 17S and 21S Hemodialyzers / Hemofitters for labeled for single use which have been previously approved for marketing in the United States under a 510K Notification (K982414). A copy of this approval letter is included in Appendix I of this Notification.
Blood enters a blood inlet port where it is distributed to polyethersulfone hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of polyethersulfone hollow fibers in each hemodialyzer / hemofilter is 10,000 for the Polyflux 17R and 12,500 for the 21R. These dialyzers have an effective membrane length of 250 mm. The effective membrane surface area is 1.7 square meters for the 17R and 2.1 square meters for the
000263
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510K Notification Gambro Polyflux 17R Labeled for Multiple Use December 2nd , 1999
21R. The housing and end caps of these hemodialyzers / hemofiters are made of polycarbonate. The fibers used in the Gambro Polyflux 17R and 21R are identical in design and materials to the previously approved Gambro Polyflux 17S and 21S Hemodialyzers / Hemofilters for labeled for single use (K982414). The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.
By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the polyethersulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through polyethersulfone membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.
Predicate Devices:
The Gambro Polyflux 17R and 21R Capillary Dialyzers / Filters labeled for multiple use (reuse) is identical in design and construction to the currently marketed Gambro Polyflux 17S and 21S, Hemodialyzers / Filters, respectively, labeled for single use which have been approved for marketing / sale in the United States under a 510K Notification (K982414). Both the predicate and the proposed devices, incorporate an identical polyethersulfone membrane and other blood contact materials. They are the same device with the exception of the labeling. The intended use for the proposed and predicate devices is also the same; hemodialyzer/ filter.
PREDICATE DEVICE
| DEVICE NAMES | Gambro Polyflux 17S & 21S, Hemodialyzers / Filters
labeled for Single use |
|---------------|------------------------------------------------------------------------------|
| INTENDED USE | Hemodialyzer/Filter |
| 510K NUMBER | K982414 |
| APPROVAL DATE | 3/26/99 |
With respect to performance, these hemodialyzers/filters perform in a manner substantially We therefore consider the predicate devices substantially equivalent to each other. equivalent to existing products in commercial distribution in the United States
Intended Use:
POLYFLUX R is indicated for use in hemodialysis for the treatment of chronic or acute renal failure. The choice of the filter is the responsibility of the physician. Special attention must be paid in connection with pediatric use.
CAUTION! If POLYFLUX R is reused, the procedure and disinfection specified in the RENATRON INSTRUCTION MANUAL must be followed.
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The POLYFLUX R may be reprocessed for reuse on the same patient.
This indication statement is essentially the same as the indication statement for the predicate device.
Technological Characteristics:
Comparing the proposed devices to the predicate devices, they are identical with the exception that one is labeled for single use (Gambro Polyflux 17S & 21S Hemodialyzer/Filters and the other is labeled for multiple use (reuse) (Gambro Polyflux 17R & 21R Hemodialyzer/Filter. Both the proposed and predicate devices use the same polyethersulfone, hollow fiber membrane. Both the proposed and predicate devices use polycarbonate for the housing and header material and polyurethane for the membrane potting material.
Summary of Non-Clinical Tests:
In vitro data was collected according to the FDA Guidance for Hemodialyzer Reuse Labeling.
Clinical Test Results:
Clinical data was collected according to the FDA Guidance for Hemodialyzer Reuse Labeling.
Conclusions:
Testing performed on the Gambro Polyflux 17R and 21R Capillary Dialyzers/Filters indicates that they are safe, effective, and perform as well as the predicate devices, when used in accordance with the instructions for use. In vitro and in vivo performance data and directions for reuse have been included in the labeling.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2000
Jeffrey R. Shideman, Ph.D. Gambro Healthcare 225 Union Boulevard Suite 600 Lakewood, CO 80228
Re: K994390
Multiple Use Labeling for Gambro Polyflux 17R and 21R Hemodialyzers Dated: July 17, 2000 Received: July 28, 2000 Regulatory Class: II 21 CFR §876.5860/Procode: 78 MSF
Dear Dr. Shideman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have we nave tevice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate comment for the more in the mactment 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the may, uculone, market the do not of the gisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject If your device is dassinod (oo acon of any regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Fride requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (2) CFR Part 1 raches requirements, to sol tour mare Quand the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation regulatory action. In addition, FDA may publish further announcements to comply with the Federal Register. Please note: this response to your premarket notification submission does not comeching you device in allo reast to sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding I fills letter will and you to obgally 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 labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro If you don't devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers-Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
4
510 (k) NUMBER (IF KNOWN): K994390
DEVICE NAME: Gambro Polyflux 17R & 21R
INDICATIONS FOR USE:
Indications for Use Statement
POLYFLUX R is indicated for use in hemodialysis for the treatment of chronic or acute renal failure. The I OLITLOA It is thatea you use in not the physician. Special attention must be paid in connection with pediatric use.
CAUTION! If POLYFLUX R is reused, the procedure and disinfection specified in the RENATRON INSTRUCTION MANUAL must be followed.
The POLYFLUX R may be reprocessed for reuse on the same patient.
(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 (Optional Format 1-2-96)
David A. Berman
(Division Sign-Off) Division of Reproductive, Abdominal. EN and Radiological De 510(k) Number