(89 days)
No
The description focuses on the physical components and function of a hemodialyzer, a device for filtering blood. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for hemodialysis, which is a treatment for renal failure, directly aiding in the management of a medical condition.
No
Explanation: The device description clearly states its purpose is for hemodialysis, which is a treatment for renal failure, not for diagnosing conditions.
No
The device description clearly describes a physical medical device (capillary dialyzer) with a membrane, ports, and hollow fibers, not a software-only product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "hemodialysis for the treatment of chronic and acute renal failure." This is a therapeutic treatment, not a diagnostic test performed on samples outside the body.
- Device Description: The description details how the device filters blood to remove waste products and excess fluid directly from the patient's bloodstream. This is a direct treatment of the patient's condition.
- Lack of IVD Characteristics: The description does not mention analyzing samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or determine compatibility.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used to treat a condition by directly interacting with the patient's blood.
N/A
Intended Use / Indications for Use
The capillary dialyzer is intended for hemodialysis for the treatment of chronic and acute renal failure.
Product codes
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 210H, cleared for marketing in the United States under 510K notification K030592.
The membrane used in this device is a blend of polyarylethersulfone (PAES) and polyvinylpyrrolidone(PVP), which is equivalent to the membrane utilized in the Gambro Polyflux H single use hemodialyzers cleared for marketing in the United States under 510K Notification (K030592).
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
In vitro testing was conducted to compare the performance of the proposed device configurations to the predicate configurations.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AFR 2 4 2006
Image /page/0/Picture/1 description: The image shows the logo for GAMBRO Renal Products. The logo consists of a stylized "G" symbol on the left, followed by the word "GAMBRO" in a larger, bold font. To the right of "GAMBRO" is the phrase "Renal Products" in a smaller, less bold font. The overall design is simple and professional, suggesting a company that specializes in renal-related products.
510(k) Summary
Gambro Renal Products Submitter: 10810 West Collins Avenue Lakewood, Colorado 80215 Thomas B. Dowell, Manager, Regulatory Affairs Contact: Phone: 303-231-4094 Fax: 303-542-5138 January 24, 2006 Date prepared: Gambro Polyflux HD-C4 Capillary Dialyzer for Single Use Device name: Common name: Capillary Dialyzer High Permeability Hemodialysis System Accessory (876.5860) Classification name: Predicate Devices: Polyflux 210H Hemodialyzer / Filter K030592
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 210H, cleared for marketing in the United States under 510K notification K030592.
The membrane used in this device is a blend of polyarylethersulfone (PAES) and polyvinylpyrrolidone(PVP), which is equivalent to the membrane utilized in the Gambro Polyflux H single use hemodialyzers cleared for marketing in the United States under 510K Notification (K030592).
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 capillary dialyzer is intended for hemodialysis for the treatment of chronic and acute renal failure.
1
CONC 15 page Ext 2
Image /page/1/Picture/1 description: The image shows the logo for GAMBRO Renal Products. The logo consists of a stylized "G" symbol followed by the text "GAMBRO Renal Products". The text is in a simple, sans-serif font and is black. The logo is clean and professional.
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 proposed device 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Blvd., Rockville MD 20850. The text is in a simple, sans-serif font and is left-aligned.
APR 2 4 2006
Mr. Thomas B. Dowell Manager Regulatory Affairs Gambro Renal Products 10810 West Collins Avenue LAKEWOOD CO 80215
Re: K060195
Trade/Device Name: Gambro Polyflux HD-C4 Capillary Dialyzer for Single Use Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: March 27, 2006 Received: March 28, 2006
Dear Mr. Dowell:
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 Americants, 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 mass 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. [Special Dontrols) or class Iff i Finance 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/9 description: The image shows a circular logo for the FDA Centennial from 1906-2006. The letters FDA are in large bold font in the center of the circle. The word Centennial is written in cursive below the letters FDA. Three stars are below the word Centennial.
romoting Public .
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 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology). | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KU60145 page 10
"GAMBRO Renal Products
Indications for Use Statement
| 510(k) number: (if known) | K060195 |
|---|---|
| Device Name: | Gambro Polyflux HD-C4 Capillary Dialyzer for Single Use |
| Indications for Use: | The capillary dialyzer is intended for hemodialysis for the treatment of chronic and acute renal failure. |
| Prescription Use (Per 21 CFR 801 Subpart D) | X |
| AND / OR | |
| Over-The-Counter Use (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Gordon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _