(141 days)
Not Found
No
The description focuses on microprocessor control and modular hardware components for managing physical functions of hemodialysis. There is no mention of AI, ML, or related concepts in the provided text.
Yes
The device is intended to provide hemodialysis, hemofiltration, and ultrafiltration, which are medical treatments for patients.
No
The device description indicates that the Phoenix Hemodialysis delivery system provides therapies such as hemodialysis, hemofiltration, and ultrafiltration, which are forms of treatment, not diagnostic procedures.
No
The device description clearly outlines a physical hemodialysis machine with multiple hardware modules (Master Module, Hydraulic Module, Blood Module, Protection Module, Bio Module) and associated components (blood tubing set, dialyzer, syringe, BiCart column, concentrates). While it mentions a new software version and software verification/validation, the core device is a hardware system.
Based on the provided information, the Phoenix® Hemodialysis delivery system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to provide hemodialysis, hemofiltration, and ultrafiltration on patients. These are therapeutic procedures performed directly on the patient's body to filter their blood.
- Device Description: The description details a system that pumps blood from the patient, through a dialyzer, and back to the patient. This is a direct interaction with the patient's circulatory system.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The Phoenix system does not examine specimens in vitro (outside the body) for diagnostic purposes. It performs a therapeutic function in vivo (within the body).
While the system uses components like a dialyzer and interacts with blood, its primary function is to filter the blood within the patient's treatment circuit, not to analyze a sample of blood for diagnostic information.
N/A
Intended Use / Indications for Use
The Phoenix® Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit.
Product codes
78KDI
Device Description
Phoenix is a self-contained, microprocessor-controlled device that provides hemodialysis, hemofiltration and ultrafiltration therapies. The system consists of the Hemodialysis Machine in use with a blood tubing set designed for the machine, a dialyzer, a heparin-filled syringe, a BiCart® column (sodium bicarbonate powder), and other appropriate dialysate concentrates.
The machine has many built-in features which are intended to enhance the ease of providing patient dialysis treatments.
The Phoenix Hemodialysis Machine pumps blood from the patient, in a blood tubing set properly designed for the machine, through the dialyzer where purification takes place, and back to the patient.
In the dialyzer, the blood and the dialysate fluid flow on opposite surfaces of a thin Semipermeable membrane. As the blood passes through the filter, the desired treatment processes take place. Depending upon the therapy in use, the treatment processes can include fluid removal and/or solute clearance.
Phoenix has a modular structure. It is made up of five modules that carry out independent functions: Master Module, Hydraulic Module, Blood Module, Protection Module and Bio Module. The unit consisting of the Master, Hydraulic and Blood Modules is called the Control System. The Control System manages the implementation of the physical functions.
The Phoenix machine can carry out the following therapies:
- Ultrafiltration; the body's excess fluid is removed through the dialyzer membrane by means . of a pressure gradient between the blood and dialysate compartments in the dialyzer.
- Hemofiltration: accumulated metabolic products are removed from blood by the process of . convective transport as a consequence of ultrafiltration of fluid across a dialyzer semipermeable membrane of high-flux type. The volume of filtered fluid that exceeds the desired weight loss is replaced by sterile pyrogen-free infusion solution infused into the blood flowpath.
- Hemodialysis; the chemical composition of blood is corrected by removing accumulated . metabolic products, normalizing ionic content and adding buffer through the process of diffusive transport.
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
patients weighing 15 Kilograms or more.
Intended User / Care Setting
trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit.
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)
The non-clinical testing for this new software version allowed to determine the substantial equivalence with the predicate device and consisted of verification and validation activities for the software and the system, with static tasks (impact analysis, final phase reviews, code inspections, system and software test protocols preparation) and dynamic tasks (baseline verification, system and software test protocols execution, regression testing, Graphical User Interface and Use Cases test execution), verification and validation of the labeling, Usability validation (formative and summative), risk management activities, and compliance with applicable international safety standards for dialysis equipment.
No clinical studies were performed for the software modification.
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 0 2011
Special 510(k)
510(k) SUMMARY
| Submitter's Name | Gambro Renal Products, Inc |
|---|---|
| Address | 14143 Denver West Parkway, Suite 400 |
| Lakewood, Colorado 80401 | |
| Establishment | |
| Registration Number | 2087532 |
| Contact Person | Kae Miller, Regulatory Affairs Manager |
| Telephone Number | (303) 222.6724 |
| Fax Number | (303) 222.6914 |
| Date of Summary | December 27, 2010 |
| Subject Device | |
|---|---|
| Name of the Device | Phoenix® Hemodialysis Delivery System - version 3.40 |
| Catalogue Number | 6023006700 |
| Common or Usual Name | Hemodialysis Delivery System |
| Classification Name | High Permeability Hemodialysis System |
| Device Class | II |
| Product Code | 78KDI |
| Regulation Number | 876.5860 |
| Legally Marketed Device (Predicate Device) | |
|---|---|
| Name of the Device | Phoenix® Hemodialysis Delivery System – version 3.35 |
| Catalogue Number | 6023006700 |
| Common or Usual Name | Hemodialysis Delivery System |
| Classification Name | High Permeability Hemodialysis System |
| Device Class | II |
| Product Code | 78KDI |
| Regulation Number | 876.5860 |
| 510(k) number | K070643 |
.
1
Special 510(k) Phoenix® System
page 2 of 6
510(k) SUMMARY, continued
Device Description
Gambro Renal Products, Inc.
Lakewood, Colorado 80401
14143 Denver West Parkway, Suite 400
Image /page/1/Picture/5 description: The image shows a dialysis machine. The machine is white and has a screen on the top half of the machine. There are tubes and other attachments on the side of the machine. The machine is on a stand with wheels.
FIGURE 1: Phoenix Hemodialysis Machine Phoenix is a self-contained, microprocessor-controlled device that provides hemodialysis, hemofiltration and ultrafiltration therapies. The system consists of the Hemodialysis Machine in use with a blood tubing set designed for the machine, a dialyzer, a heparin-filled syringe, a BiCart® column (sodium bicarbonate powder), and other appropriate dialysate concentrates.
The machine has many built-in features which are intended to enhance the ease of providing patient dialysis treatments.
The Phoenix Hemodialysis Machine pumps blood from the patient, in a blood tubing set properly designed for the machine, through the dialyzer where purification takes place, and back to the patient.
In the dialyzer, the blood and the dialysate fluid flow on opposite surfaces of a thin Semipermeable membrane. As the blood passes through the filter, the desired treatment processes take place. Depending upon the therapy in use, the treatment processes can include fluid removal and/or solute clearance.
Phoenix has a modular structure. It is made up of five modules that carry out independent functions: Master Module, Hydraulic Module, Blood Module, Protection Module and Bio Module. The unit consisting of the Master, Hydraulic and Blood Modules is called the Control System. The Control System manages the implementation of the physical functions.
The Phoenix machine can carry out the following therapies:
- Ultrafiltration; the body's excess fluid is removed through the dialyzer membrane by means . of a pressure gradient between the blood and dialysate compartments in the dialyzer.
- Hemofiltration: accumulated metabolic products are removed from blood by the process of . convective transport as a consequence of ultrafiltration of fluid across a dialyzer semipermeable membrane of high-flux type. The volume of filtered fluid that exceeds the desired weight loss is replaced by sterile pyrogen-free infusion solution infused into the blood flowpath.
- Hemodialysis; the chemical composition of blood is corrected by removing accumulated . metabolic products, normalizing ionic content and adding buffer through the process of diffusive transport.
2
Physical Characteristics
Special 510(k)
Phoenix
® System 3.40
page 3 of 6
| Parameter | Dimension |
|---|---|
| Height | 1440 mm (56.7 in) |
| 1970 mm (77.4 in) with "IV Pole" | |
| Width | 610 mm (24.0 in) with "Dialyzer |
| holder" in working position | |
| Depth of base | 710 mm (27.9 in) |
| 930 mm (36.5 in) with "Chemical | |
| Container Shelf" | |
| Total floor surface covered by base | 433100 mm² (671.3 in²) |
| 567300 mm² (879.3 in²) | |
| Dry weight | 120 kg (264.5 lb) |
510(k) SUMMARY, continued
Indications For Use of the predicate device: Phoenix version 3.35
The Phoenix® Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit.
Indications For Use of the subject device: Phoenix version 3.40
The Phoenix® Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit.
Note:
The Indications For Use of the proposed device and of the predicate device are identical. There is no change of the indications for use, intended use of hemodialysis system, or affect on the fundamental scientific technology. Due to the physical characteristics of the low weight - low volume set, the user must currently divide the following displayed parameter values by 4 to determine the actual parameter values: blood flow, liters processed, and pump speed. With the 3.40 version of the software, there is no need to perform any mathematical calculations; all displayed values are the actual for the low weight - low volume set.
3
K103832 Special 510(k)
510(k) SUMMARY, continued
Device Comparison Table
In the following table the proposed device Phoenix® Hemodialysis Delivery System – version 3.35 (K070643).
| Subject device – Phoenix sw 3.40 | Predicate device – Phoenix sw 3.35 | |
|---|---|---|
| The Phoenix® Hemodialysis delivery | ||
| system is intended to be used to | ||
| provide high flux and low flux | ||
| hemodialysis, hemofiltration and | ||
| ultrafiltration on patients weighing 15 | ||
| Kilograms or more. The Phoenix | ||
| system is to be used with either high | ||
| or low permeability dialyzers. The | ||
| device is intended to be used by | ||
| trained operators when prescribed by | ||
| a physician, in a chronic care dialysis | ||
| facility or acute care unit. | The Phoenix® Hemodialysis delivery | |
| system is intended to be used to | ||
| provide high flux and low flux | ||
| hemodialysis, hemofiltration and | ||
| ultrafiltration on patients weighing 15 | ||
| Kilograms or more. The Phoenix | ||
| system is to be used with either high | ||
| or low permeability dialyzers. The | ||
| device is intended to be used by | ||
| trained operators when prescribed by | ||
| a physician, in a chronic care dialysis | ||
| facility or acute care unit. | ||
| Indications for Use | ||
| Gambro Cartridge™ Blood Set: | ||
| 003410-510 Double Needle | ||
| 003410-710 Double Needle | ||
| 003414-500 Double Needle | ||
| 003414-510 Double Needle | Gambro Cartridge™ Blood Set: | |
| 003410-510 Double Needle | ||
| 003410-710 Double Needle | ||
| 003414-500 Double Needle | ||
| 003414-510 Double Needle | ||
| Dedicated Disposable | ||
| Sets | 003409-410 Single Needle | |
| 003429-500 Single Needle | ||
| Conversion Kit | 003409-410 Single Needle | |
| 003429-500 Single Needle | ||
| Conversion Kit | ||
| 003412-500 Double Needle | ||
| (75 ml VOLUME) | 003412-500 Double Needle | |
| (20-40 Kg weight) | ||
| 003422-520 Double Needle | ||
| (LOW WEIGHT - LOW VOLUME) | ||
| Anticoagulation | Heparin Syringe Pump | |
| 0/0.5 - 9.9 ml/hr | Heparin Syringe Pump | |
| 0/0.5 - 9.9* ml/hr | ||
| Accuracy: | ||
| $\pm$ 5% or $\pm$ 0.2 ml/h | Accuracy: | |
| $\pm$ 5% or $\pm$ 0.2 ml/h | ||
| Blood Flow Rate | 10 - 580 ml/min | |
| (10 - 140 ml/min in LW-LV mode) | 10 - 580 ml/min | |
| Accuracy $\pm$ 10% if pressure before the | ||
| pump is not lower (more negative) | ||
| than - 150 mmHg | Accuracy $\pm$ 10% if pressure before the | |
| pump is not lower (more negative) | ||
| than - 150 mmHg | ||
| Proposed device - Phoenix sw 3.40 | Predicate device - Phoenix sw 3.35 | |
| Fluid Removal Rate | ||
| from Patient | 0 – 4 Kg/h | 0 – 4 Kg/h |
| Dialysate flow rate at 350 ml/min: | ||
| Accuracy (on total Weight removed): | ||
| ±(2% UF rate + 35 g/hr) | Dialysate flow rate at 350 ml/min: | |
| Accuracy (on total Weight removed): | ||
| ±(2% UF rate + 35 g/hr) | ||
| Dialysate flow rate at 500 ml/min: | ||
| Accuracy (on total Weight removed): | ||
| ±(2% UF rate + 50 g/hr) | Dialysate flow rate at 500 ml/min: | |
| Accuracy (on total Weight removed): | ||
| ±(2% UF rate + 50 g/hr) | ||
| Dialysate flow rate at 800 ml/min: | ||
| Accuracy (on total Weight removed): | ||
| ±(2% UF rate + 80 g/hr) | Dialysate flow rate at 800 ml/min: | |
| Accuracy (on total Weight removed): | ||
| ±(2% UF rate + 80 g/hr) | ||
| Dialysate Flow Rate | 350 - 800 ml/min | |
| Accuracy: ± 5% | ||
| Transmembrane | ||
| Pressure | -100 to +450 mmHg | |
| Ultrafiltration Rate | 0 - 4 Kg/h | |
| Accuracy: | ||
| ±2 % of actual value | 0 - 4 Kg/h | |
| Accuracy: | ||
| ±2 % of actual value | ||
| Dialysate | ||
| Temperature | 34 - 39.5 °C | |
| Dialysate | ||
| Conductivity | 13-17 mS/cm | |
| Arterial and Venous | ||
| Pressure | Arterial: -400 to +150 mmHg | |
| Venous: 0 to +450 mmHg | Arterial: -400 to +150 mmHg | |
| Venous: 0 to +450 mmHg |
*Note: submission (K070643) noted this as 10 ml/hr in summary, but actual value without rounding is 9.9 as reflected in Operator's Manual. This value has not changed between software versions.
4
K103832
Special 510(k)
Phoenix® System 3.40
Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, Colorado 80401
510(k) SUMMARY, continued
Non-clinical performance data
The non-clinical testing for this new software version allowed to determine the substantial equivalence with the predicate device and consisted of verification and validation activities for the software and the system, with static tasks (impact analysis, final phase reviews, code inspections, system and software test protocols preparation) and dynamic tasks (baseline verification, system and software test protocols execution, regression testing, Graphical User Interface and Use Cases test execution), verification and validation of the labeling, Usability validation (formative and summative), risk management activities, and compliance with applicable international safety standards for dialysis equipment.
Clinical performance data
No clinical studies were performed for the software modification.
5
K103832
Special 510(k)
Phoenix® System 3.40
510(k) SUMMARY, continued
Conclusion of Safety and Effectiveness
The successful completion of the following verification and validation activities:
- . Static activities code reviews;
- System and software functional tests; .
- Labeling evaluations as part of usability testing; .
- . Standards compliance to IEC standards 60601-1-2, 60601-2-16, 60601-1-4, 60601-1-6, 62366; and
- Usability validation, .
demonstrates the safety and effectiveness of the Gambro Phoenix® Hemodialysis Delivery System - version 3.40 when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device.
6
Image /page/6/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Kae Miller Regulatory Affairs Manager Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 LAKEWOOD CO 80401
MAY 2 0 2011
K103832 Re:
Trade/Device Name: Phoenix® Hemodialysis Delivery System - version 3.40 Regulation Number: 21 CFR §876.5860 . . . Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: April 19, 2011 Received: April 21, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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); medical device reporting of medical device-related
7
Page 2
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Herbert Lemon MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
page 1 of 1
Special 510(k) Phoenix® System 3.40
Indications for Use
510(k) Number (if known): K103832
Device Name: Phoenix® Hemodialysis Delivery System - version 3.40
Indications for Use:
The Phoenix® Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
Aonf. An. Wtz
(Division Sign-Off)
RA 10-068
(Division Bign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K103832
Page 19 of 125