(28 days)
Not Found
No
The summary describes a physical medical device (a dialyzer) and its function in hemodialysis. There is no mention of software, algorithms, or any technology related to AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as treating chronic and acute renal failure, which is a therapeutic purpose.
No
This device is a dialyzer used for the treatment of renal failure by removing uremic toxins and waste products from the blood. It performs a therapeutic function rather than diagnosing a condition.
No
The device description clearly describes a physical medical device (dialyzer) with a membrane, ports, and hollow fibers, which is used in hemodialysis. It is not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "hemodialysis for the treatment of chronic and acute renal failure." This describes a therapeutic treatment performed directly on the patient's blood outside of the body, not a test performed on a sample of bodily fluid or tissue to diagnose a condition.
- 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 that analyzes a sample for specific markers or substances.
- Lack of Diagnostic Language: The description does not mention analyzing blood for diagnostic purposes, measuring specific analytes, or providing information for diagnosis.
IVDs are typically used to examine specimens (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is a therapeutic device used to treat a condition by filtering the patient's blood.
N/A
Intended Use / Indications for Use
The dialyzer is intended for use in hemodialysis for the treatment of chronic and acute renal failure.
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
This device is intended for use in hemodialysis for the treatment of acute and chronic renal failure.
The intended population of this device is identical to those of the Polyflux HD-C4 (BIG), cleared for marketing in the United States under 510K notification K060195.
The membrane used in this device is a blend of polyarylethersulfone (PAES) and polyviny)pyrrolidone(PVP), which is equivalent to the membrane utilized in the Gambro Polyflux HD-C4 (BIG) single use hemodialyzers cleared for marketing in the United States under 510K Notification (K060195).
Blood enters a blood inlet port where it is distributed to the hollow fibers. 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 membrane, plasma water along with certain lower and middle molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. Uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the membrane and into the countercurrent 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
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)
In vitro testing was conducted to compare the performance of the configurations to the predicate configurations.
Testing performed on the Gambro Polyflux Dialyzers indicates that they are safe, effective and perform as well as the predicate devices, when used in accordance with the instructions for use.
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.”
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Image /page/0/Picture/1 description: The image shows the logo for Gambro, a medical technology company. The logo consists of a stylized "G" symbol on the left, followed by the word "GAMBRO" in bold, sans-serif font. A registered trademark symbol appears to the right of the word "GAMBRO".
SEP -7 2007
510(k) Summary
| Submitter: | Gambro Renal Products, Inc.
14143 Denver West Parkway
Lakewood, Colorado 80401 | |
|----------------------|--------------------------------------------------------------------------------------|---------|
| Contact: | Kae Miller, Manager, Regulatory Affairs
Phone: 303-542-5045
Fax: 303-876-9264 | |
| Date prepared: | August 8, 2007 | |
| Device name: | Gambro Polyflux HD-C4 SMALL Dialyzer for Single Use | |
| Common name: | Hemodialyzer | |
| Classification name: | High Permeability Hemodialysis System Accessory (876.5860) | |
| Predicate Devices: | | |
| Polyflux HD-C4 (BIG) | Hemodialyzer | K060195 |
Device Description:
This device is intended for use in hemodialysis for the treatment of acute and chronic renal failure.
The intended population of this device is identical to those of the Polyflux HD-C4 (BIG), cleared for marketing in the United States under 510K notification K060195.
The membrane used in this device is a blend of polyarylethersulfone (PAES) and polyviny)pyrrolidone(PVP), which is equivalent to the membrane utilized in the Gambro Polyflux HD-C4 (BIG) single use hemodialyzers cleared for marketing in the United States under 510K Notification (K060195).
Blood enters a blood inlet port where it is distributed to the hollow fibers. 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 membrane, plasma water along with certain lower and middle molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. Uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the membrane and into the countercurrent flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.
Indications For Use:
The dialyzer is intended for use in Hemodialysis for the treatments of chronic or acute renal failure.
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K072232 Page 242
Technological Characteristics:
The proposed device configurations have the same technological characteristics and are similar in design, function, composition, and operation, to the currently marketed configurations.
Summary of Non-Clinical Tests:
In vitro testing was conducted to compare the performance of the configurations to the predicate configurations.
Summary of Clinical Tests:
N/A
Conclusion:
Testing performed on the Gambro Polyflux Dialyzers indicates that they are safe, effective and perform as well as the predicate devices, when used in accordance with the instructions for use.
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP -7 2007
Ms. Kae Miller Manager, Regulatory Affairs Gambro@ Renal Products, Inc. 14143 Denver West Parkway LAKEWOOD CO 80401
Re: K072232
Trade/Device Name: Gambro Polyflux HD-C4 SMALL Dialyzer for Single Use Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: August 8 2007 Received: August 10, 2007
Dear Ms. Miller:
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.
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Protecting and Promoting Public Health
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Page 2 -
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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 legally 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), 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 | 240-276-011. |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-011. |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-010- |
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
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Indications for Use Statement 510(k) number: 072232 (if known) Gambro Polyflux HD-C4 SMALL Dialyzer for Single Use Device Name: The dialyzer is intended for use in hemodialysis for the Indications for Use: treatment of chronic and acute renal failure. Over-The-Counter Use Prescription Use X AND / OR (21 CFR 807 Subpart C) (Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Annu Sinha
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K072232