(110 days)
Not Found
No
The description focuses on the physical design, materials, and mechanism of action of a capillary dialyzer, which is a passive filtration device. There is no mention of any computational or algorithmic components that would suggest the use of AI or ML.
Yes
The device is intended for the treatment of chronic and acute renal failure, which is a therapeutic purpose.
No
Explanation: The device is a capillary dialyzer used for the treatment of renal failure by removing waste products from the blood (hemodialysis), which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical capillary dialyzer with a membrane and ports for blood and dialysate, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "hemodialysis and associated modalities for the treatment of chronic and acute renal failure." This describes a therapeutic treatment applied directly to the patient's blood, not a test performed on a sample in vitro (outside the body) to diagnose a condition.
- Device Description: The description details how the device filters blood and removes waste products. This is a process performed on the patient's circulating blood, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.) to detect a substance or characteristic.
- Providing information for diagnosis, monitoring, or screening.
- Using reagents or calibrators.
The device is a therapeutic device used to treat a condition, not a diagnostic device used to identify or characterize a condition.
N/A
Intended Use / Indications for Use
The capillary dialyzer is intended for use in hemodialysis and associated modalities for the treatment of chronic and acute renal failure.
Product codes (comma separated list FDA assigned to the subject device)
78 KDI, 78 FJ1
Device Description
The Gambro Polyflux 14L, 17L, and 21L Capillary Dialyzers/Filters, labeled for single use, have the same design, materials, intended use and function as other hemodialyzers / filters currently marketed in the United States.
These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure. They may also be used in cases of acute fluid overload for the removal of plasma water.
The membrane used in this device is a blend of polyarylethersulfone (PAES), PVP, and Polyamide, which is identical to the membrane used in the Gambro Polyflux H single use hemodialyzers cleared under 510K Notification (K030592) and the Polyflux L dialyzers cleared under 510(k) Notification (K010985).
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)
Non-Clinical Tests: In vitro testing was conducted to compare the performance of the proposed device configurations to the predicate configurations.
Clinical Tests: Clinical studies demonstrated that the proposed Polyflux 14L, 17L and 21L meet the same acceptance criteria as the predicate devices Polyflux 6L, 8L, and 10L.
Conclusion: Testing performed on the Gambro Polyflux 14L, 17L and 21L 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.
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
MAY 2 4 2004
Special 510(k) Modification Gambro Polyflux 14L, 17L, 21L Labeled for Single Use February 1, 2004
510(k) Summary
| Submitter: | Gambro Renal Products
10810 West Collins Avenue
Lakewood, Colorado 80215 | |
|---------------------------|--------------------------------------------------------------------------------|---------------------------|
| Contact: | Jean Willey, Quality Coordinator
Phone: 303-231-4526
Fax: 303-542-5138 | |
| Date prepared: | February 1, 2004 | |
| Device name: | Gambro Polyflux 14L, 17L, 21L Capillary Dialyzer labeled for Single Use | |
| Common name: | Hemodialyzer / Filter | |
| Classification name: | High Permeability Hemodialysis System Accessory (876.5860) | |
| Predicate Devices: | | |
| Polyflux 6L, 8L, 10L | Hemodialyzer / Filter | K010985; October 10, 2001 |
| Polyflux 140K, 170H, 210H | Hemodialyzer / Filter | K030592; May 23, 2003 |
Device Description:
The Gambro Polyflux 14L, 17L, and 21L Capillary Dialyzers/Filters, labeled for single use, have the same design, materials, intended use and function as other hemodialyzers / filters currently marketed in the United States.
These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure. They may also be used in cases of acute fluid overload for the removal of plasma water.
The membrane used in this device is a blend of polyarylethersulfone (PAES), PVP, and Polyamide, which is identical to the membrane used in the Gambro Polyflux H single use hemodialyzers cleared under 510K Notification (K030592) and the Polyflux L dialyzers cleared under 510(k) Notification (K010985).
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.
1
K040255 page
ನಿ ಈ ಎ
Indications For Use:
The capillary dialyzer is intended for use in hemodialysis and associated modalities for the treatment of chronic and acute renal failure.
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:
Clinical studies demonstrated that the proposed Polyflux 14L, 17L and 21L meet the same acceptance criteria as the predicate devices Polyflux 6L, 8L, and 10L.
Conclusion:
Testing performed on the Gambro Polyflux 14L, 17L and 21L 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.
2
Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. In the center of the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2004
Ms. Jean Willey Quality Coordinator GAMBRO® Renal Products 10810 West Collins Avenue LAKEWOOD CO 80215
Re: K040255
Trade/Device Name: Gambro Polyflux 14L, 17L, and 21L Hemodialyzers Regulation Number: 21 CFR $876.5860 Regulation Name: High permeability hemodialysis system Product Code: 78 KDI Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Product Code: 78 FJ1 Regulatory Class: II Dated: May 10, 2004 Received: May 11, 2004
Dear Ms. Willey:
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 cither 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 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.
3
l'age 2
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 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrl/dsma/dsmamain.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
K040255 page 1 of 1
Special 510(k) Modification Gambro Polyflux 14L, 17L, 21L Labeled for Single Use February 1, 2004 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Indications for Use Statement
| 510(k) number: (if known) | K040255 |
|---|---|
| Device Name: | Polyflux 14L, 17L, 21L Hemodialyzer / Filter |
| Indications for Use: | The capillary dialyzer Is intended for use in 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)
David h. Bryson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 640255 510(k) Number _