(156 days)
Not Found
No
The description focuses on mechanical and chemical processes controlled by programmable logic (PLC), with no mention of AI or ML algorithms for decision-making or analysis.
No
The device is a system for mixing, storing, and distributing sodium bicarbonate liquid concentrate for hemodialysis patients, but it does not directly treat the patient. It prepares a substance used in treatment.
No
Explanation: The device is designed to mix, store, and distribute sodium bicarbonate liquid concentrate for hemodialysis treatment. It does not perform any diagnostic function.
No
The device description clearly outlines physical components such as tanks, a SOLUBILIZER™, and a distribution loop, indicating it is a hardware system with integrated software (PLC and HMI).
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "mixing, storage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients." This describes a system for preparing and delivering a solution for therapeutic use in a patient, not for performing tests on samples taken from the human body.
- Device Description: The description details a system for dissolving and mixing sodium bicarbonate powder with water and then distributing the resulting solution. This is a preparation and delivery system, not a diagnostic test.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended to prepare a solution for use in a medical treatment (hemodialysis), which falls under the category of a therapeutic device or a device used in conjunction with a therapeutic procedure, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Isopure Sodium Bicarbonate Mixing and Distribution System is intended to be used in Hemodialysis facilities for the mixing, storage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients.
Product codes (comma separated list FDA assigned to the subject device)
FIN
Device Description
The Isopure Sodium Bicarbonate Mixing and Distribution System is designed to mix sodium bicarbonate powder into a liquid solution based on the recommended mixing procedures from the powder manufacturers. Once the powder is mixed into a liquid solution and verified for content accuracy, the solution is transferred to an independent distribution tank for transfer through a loop to the individual dialysis machines or to fill jugs which then can be transported to the individual dialysis machines when no distribution loop exists.
The Isopure Sodium Bicarbonate Mixing and Distribution System features the patented SOLUBILIZER™, which utilizes a large volume of water spinning in a vortex manner to dissolve dry powder into a liquid solution that is drawn into a mix tank. The solution is mixed with AAMI quality water according to specifications outlined by the manufactures for the bicarbonate powder. Once the solution has been dissolved and mixed, the solution can be transferred from the mixing tank to the storage delivery tank for distribution to the loop or jugs. The tanks and the SOLUBILIZER™ are sealed to reduce microbial contamination. The sealed design also facilitates CO2 recovery and gassing off of CO2 during the mixing procedure.
The entire system is controlled by programmable control logic (PLC), which operates the system. The PLC will control the mixing, the delivery and disinfection of the complete system. The system PLC is operated through an HMI touch screen which displays the critical aspects of the system. including the operational stages, real-time indication of various steps, and alarm conditions.
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
Hemodialysis facilities
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 Testing Summary:
The purpose for the Sodium Bicarbonate Mixing and Distribution System, as for the predicate device, is to provide a bicarbonate solution suitable as part of the dialysate mixture which, along with an acid solution and RO water, is used to treat dialysis patients. The system has undergone 100% testing to ensure substantial equivalence to the Pure Water, Inc. predicate device. Both systems are fully capable of meeting the mix requirements specified for a suitable sodium bicarbonate solution.
The testing area consists of all components of a water room that would normally be present at a dialysis clinic, including media tanks, a softener, filtering devices, and a reverse osmosis machine. With pure water provided by the RO system and associated components, the Sodium Bicarbonate Mixing and Distribution System was tested repeatedly for proper operation.
The Mix procedure, which performs the operation of mixing the sodium bicarbonate powder into a solution suitable for delivery to a patient dialysis machine, was run for all selectable volumes of bicarbonate. Using the same brand of bicarbonate typically used in an operating clinic, each mix batch was tested for the target conductivity of the solution to confirm the correct mixture, and then transferred to the Distribution Tank. The distribution function was then tested to ensure that circulation of the solution through the loop occurred as expected.
Key Results:
The basic mixing and distribution of sodium bicarbonate in the Isopure system is equivalent to that of Pure Water, Inc.'s original Bicarbonate Mix, Storage and Distribution System cleared April 10, 2000 under Application number K993272. Changes to the mix portion of the system reflect current recommended mixing procedures outlined by the powder manufacturers such as "Vigorous mixing and propeller style mixers can drive carbon dioxide from the solution''. "Add water for total volume of mixed solution. Mix again for approx. 10 minutes. Ensure that the powder is dissolved in solution". Changes reflected in this submission to the mixing of the sodium bicarbonate were performed to meet the current requirements of the powder manufacturers, such as the removal of the small batch mixer with a propeller and replacement to a hopper and an inductor located in the mix tank.
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
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
JAN 2 6 2012
Isopure Corp
I. 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
| Submitter's Name: | Isopure Corp
141 Citizens Blvd.
Simpsonville, KY 40067
Telephone: (502) 722-1000 |
|-------------------|-------------------------------------------------------------------------------------------|
| Contact person: | Kevin C. Gillespie |
Date of Summary: January 24, 2012
י
Device Name: Isopure Sodium Bicarbonate Mixing and Distribution System
Device Classification Name: Dialysis Holding Tank (876.5820, FIN)
Device Description: The Isopure Sodium Bicarbonate Mixing and Distribution System is designed to mix sodium bicarbonate powder into a liquid solution based on the recommended mixing procedures from the powder manufacturers. Once the powder is mixed into a liquid solution and verified for content accuracy, the solution is transferred to an independent distribution tank for transfer through a loop to the individual dialysis machines or to fill jugs which then can be transported to the individual dialysis machines when no distribution loop exists.
The Isopure Sodium Bicarbonate Mixing and Distribution System features the patented SOLUBILIZER™, which utilizes a large volume of water spinning in a vortex manner to dissolve dry powder into a liquid solution that is drawn into a mix tank. The solution is mixed with AAMI quality water according to specifications outlined by the manufactures for the bicarbonate powder. Once the solution has been dissolved and mixed, the solution can be transferred from the mixing tank to the storage delivery tank for distribution to the loop or jugs. The tanks and the SOLUBILIZER™ are sealed to reduce microbial contamination. The sealed design also facilitates CO2 recovery and gassing off of CO2 during the mixing procedure.
The entire system is controlled by programmable control logic (PLC), which operates the system. The PLC will control the mixing, the delivery and disinfection of the complete system. The system PLC is operated through an HMI touch screen which displays the critical aspects of the system. including the operational stages, real-time indication of various steps, and alarm conditions.
Intended Use: The Isopure Sodium Bicarbonate Mixing and Distribution System is intended to be used in Hemodialysis facilities for the mixing, storage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients.
Legally Marketed Devices to which Equivalence is Claimed: Isopure Corp purchased the Pure Water Inc's Bicarb Mixing, Storage and Distribution System from Pure Water Inc. Isopure intends to manufacture and market the device at its Simpsonville KY location. The intended use of the device has not change, nor have the functionality and any of the contacting components.
Descriptive Summary of Technological Characteristics and Those of Predicate Devices: The technological characteristics of the device are the same as the original submitted device under 501(k) K993272, Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System cleared on April 10, 2000.
1
112427 OF 7 2 466
Isopure Corp
| Summary of Comparisons of Components | |
|---|---|
| Pure Water, Inc. K993272 | Isopure Corp K112427 |
| Physical and Operational Comparison | |
| Pure Water system features two separate tank | |
| configuration one for mixing the solution and | |
| one for storage of the solution. These tanks are | |
| not connected together allowing the system to | |
| be configured on site. | This was changed to a single system where |
| both tanks are secured on the same | |
| skid/platform. This allows the ease of piping | |
| the two tanks together and reduces the chance | |
| of "dead legs" in the system | |
| Mix tank features a one piece molded open-top | |
| cone bottom high density polyethylene tank with a | |
| welded NDPE stand and hinged bolt-on cover with | |
| a mixer mounted on the cover. | Mix tank features a one piece molded closed top |
| cone bottom high density polyethylene tank with a | |
| welded NDPE stand. A powder hopper consisting | |
| of high density polyethylene mounted between the | |
| tanks to hold powder and a inductor replaces the | |
| mixer | |
| Filling of the mix tank is operator dependent. | |
| The operator must fill the mix tank to markings | |
| on the side of the tank by turning on a valve | |
| then turning off the same valve once the level | |
| is achieved. This same process is required once | |
| the powder is added. | This was changed to an automated process. |
| The operator can adjust the initial fill and the | |
| final fill from a set-up screen, but once set, the | |
| system will fill the exact same level every time | |
| the mix is selected. The initial fill and the final | |
| fill levels are determined by the operator | |
| selecting the desired amount of bicarb to be | |
| mixed i.e. 1 bag, 2 bags, 3 bags, or 4 bags. A | |
| calibrated flow meter will determine the exact | |
| amount of water entering the mix tank. | |
| Mixing the solution is accomplished by small | |
| batch mixer 1750 rpm which is clamped to the | |
| side of the mix tank. | This was changed to an inductor located inside |
| the mix tank. The reason for this change is | |
| recommendation for mixing by the powder | |
| manufacturers as well as AAMI RD52:2004. | |
| The powder is drawn into the system and | |
| mixed with water at the hopper located on the | |
| front of the system. | |
| Mix for 30 minutes and check for correct | |
| mixture by specific gravity method or | |
| conductivity as per your facility requirements. | |
| Once mixing is complete, the mixer switch | |
| must be turned to the off position. | Mix will occur automatically once all of the |
| powder has been dissolved. The mix cycle has | |
| been changed to 10 minutes per the powder | |
| manufacturer's recommendations. | |
| Connect the mix tank hose HM1 to the storage | |
| tank. Operate transfer switch to the "ON" | |
| position to pump liquid concentrate from the | |
| mix tank to the storage tank. Remove hose | |
| HM1 from the storage tank and replace plug | |
| for the tank. | This was changed with the two tanks on the |
| same skid. Once the solution is automatically | |
| mixed, the system will require the operator to | |
| verify that the batch is correctly mixed. Once | |
| the operator passes the batch, the system will | |
| automatically turn on the mix/transfer pump | |
| then rotate AV1 (3-way actuated valve), and | |
| AV2 (3-way actuated valve) to transfer the | |
| solution from the mix tank to the distribution | |
| tank. Once the transfer is complete, the system | |
| will automatically turn off the mix/transfer | |
| pump and rotate AV1 and AV2 back to their | |
| original positions. After complete, the system | |
| will open the drain valve and rinse down the | |
| mix tank, hopper, and associated piping with | |
| RO water in preparation to mix a new batch of | |
| bicarb. If bicarb solution still exists in the | |
| distribution tank, the system will hold the mix | |
| solution in the mix tank until the low level | |
| float is activated in the distribution tank. Once | |
| activated, the system will automatically up to | |
| 75 gallons of mixed solution. If 100 gallons | |
| (380 liters) is in the mix tank, the system will | |
| only transfer over 2/3 of this solution on the | |
| first low tank alarm then the remaining | |
| solution on the next low tank activation. | |
| Centrifugal direct drive transfer pump 25 gpm at 40 | |
| psi to transfer the mixed solution from the mix tank | |
| to the distribution tank. The pump is constructed of | |
| Glass Reinforced Noryl with a stainless steel wear | |
| ring and impeller hub. | Centrifugal magnetic drive transfer pump 40 gpm |
| at 21 psi to mix the solution and transfer the | |
| solution to the distribution tank. The pump is | |
| constructed of Glass Fiber Reinforced | |
| Polypropylene. With a Polypropylene magnetic | |
| capsule and alumina ceramic spindle. | |
| Piping used to supply RO treated water to the mix | |
| tank and to transfer the mixed solution from the | |
| mix tank to the distribution tank is schedule 80 | |
| PVC pipe and fittings. | Piping used to supply RO treated water to the mix |
| tank and to transfer the mixed solution from the | |
| mix tank to the distribution tank is schedule 80 | |
| PVC pipe and fittings. | |
| Two-way ball valve is used to drain the mix tank as | |
| well as a container filling valve located on the front | |
| of the tank. The two way valve is constructed of | |
| schedule 80 PVC with Teflon seats and EPDM "O" | |
| rings. | Two-way ball valve is used to drain the mix tank as |
| well as a container filling valve located on the front | |
| of the tank. The two way valve is constructed of | |
| schedule 80 PVC with Teflon seats and EPDM "O" | |
| rings. A 24 VDC actuated ball valve is connected | |
| to the valve which will allow automatic actuation | |
| of the valve during operation | |
| Three way true union ball valves are used to direct | |
| the mixed solution from the mix tank to the | |
| distribution tank. The valve is schedule 80 PVC | |
| with Teflon seats and EPDM "O" rings. | Three way true union ball valves are used to direct |
| the mixed solution from the mix tank to the | |
| distribution tank. The valve is schedule 80 PVC | |
| with Teflon seats and EPDM "O" rings. | |
| Auto lock fittings are used to connect lines from | |
| the mix tank to the distribution tank. Auto lock | |
| fittings are constructed of food grade Acetal and | |
| Nitrite. | The Auto lock fittings and hose have been removed |
| from the system as a potential source of | |
| contamination. | |
| A conductivity meter has independent high/low set | |
| points that control to SPDT relays. The controller | |
| features a 1 mV per digit ± 0.5% ± 1 mV recorder | |
| output interface with a recorder or data logger to | |
| make permanent records. Automatic temperature | |
| compensation is provided. By a 10KΩ thermistor | |
| built in to the conductivity cell. | The Signet 8860 Dual Channel |
| Conductivity/Resistivity Controller is a two- | |
| channel input device equipped with three saleable 4 | |
| to 20 mA outputs and four programmable relays. A | |
| selector switch activates two open collector outputs | |
| in place of two of the relays for extraordinary | |
| output versatility. Dual input and advanced control | |
| capability, including percent rejection, difference | |
| The 27500 Teflon rotary tank cleaning nozzle | |
| features a spray head that is rotated by the | |
| pressurized flow of the spray solution. The | |
| compact nozzle produces effective solid stream | |
| sprays and can be operated at pressures of 10 - 50 | |
| psi. | |
| 3/8" Solenoid valve consisting of glass filled | |
| polypropylene and a viton is used to administer RO | |
| water to the mix tank. | and ratio calculations, together with Signet |
| Conductivity Sensors. Conductivity/Resistivity | |
| electrodes are designed to provide versatile | |
| installation and accurate sensing across a very | |
| broad dynamic range. These electrodes are built | |
| with a controlled surface finish to ensure accuracy | |
| and repeatability. The standard electrode is | |
| constructed 316 SS or Titanium, but there are other | |
| materials available for maximum chemical | |
| compatibility. Reversible threads or sanitary | |
| flanges allow for maximum installation versatility. | |
| The 27500 Teflon rotary tank cleaning nozzle | |
| features a spray head that is rotated by the | |
| pressurized flow of the spray solution. The | |
| compact nozzle produces effective solid stream | |
| sprays and can be operated at pressures of 10 - 50 | |
| psi. | |
| 3/8" Solenoid valve consisting of glass filled | |
| polypropylene and a viton is used to administer RO | |
| water to the mix tank. This valve is also used to | |
| administer RO water to the hopper and used for | |
| Storage tank is a high density cone bottom tank | |
| with a sealed cap. A 0.2 uS vent filter provides | |
| filtration of the replacement air in the tank. The | |
| distribution tank is mounted to a NDPE tank stand. | |
| Distribution of bicarb solution; verify Loop | |
| Pump switch on the Bicarb Controller is in the | |
| "ON" position. Automatic operation – ensure | |
| that the power switch on AUTOCHEM 1000 is | |
| in the "OFF" position and all indicator lamps | |
| are extinguished. Verify LOOP PUMP switch | |
| on the RELAY CONTROLLER is in the "ON" | |
| position | disinfection. |
| Storage tank is a high density cone bottom tank | |
| with a sealed cap. A 0.2 uS vent filter provides | |
| filtration of the replacement air in the tank. The | |
| distribution tank is mounted to a NDPE tank stand | |
| Distribution is automated so when the | |
| Distribute button is pushed, the distribution of | |
| the bicarb will begin to purge the distribution | |
| line with bicarb. The return loop valve will | |
| divert the return loop to drain until the | |
| conductivity of the return loop solution is |