(272 days)
Not Found
No
The device description details a system based on physical processes (mixing, pressure sensing) and control circuits, with verification against a pre-loaded table. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML.
No
The device is designed to prepare an acid concentrate solution for hemodialysis, not directly administer therapy to a patient.
No
Explanation: The device is designed to mix and prepare acid concentrate solutions for hemodialysis, and it verifies the concentration of the prepared solution. It does not diagnose any medical condition or disease in a patient.
No
The device description clearly outlines multiple hardware components including a Mixing Tank, Distribution and Mixing Pump, Hopper, Venturi inductor, hydraulics, control circuits, and sensors. While there is likely software involved in the control circuits and data processing, the device is fundamentally a system of physical components.
Based on the provided information, the Isopure Corp Dry Acid Dissolution System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to prepare an acid concentrate solution for use in hemodialysis machines. This solution is then used in the hemodialysis process, which is a treatment for kidney failure.
- Device Function: The device mixes dry acid with water to create a solution. It verifies the concentration of this solution using physical properties (specific gravity based on hydrostatic pressure).
- Lack of Diagnostic Purpose: The device does not perform any tests on biological samples (blood, urine, etc.) to diagnose a disease, condition, or state of health. It is a system for preparing a reagent used in a medical treatment.
- Comparison to Predicate: The predicate device (K131611) is also a Dry Acid Dissolution Unit, which further supports its classification as a device for preparing a solution for treatment, not for diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Isopure system does not fit this description.
N/A
Intended Use / Indications for Use
The Isopure Dry Acid Dissolution System is designed to mix dry acid concentrates with purified water to produce an acid concentrate solution for hemodialysis for use in 3- Stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines.
Product codes (comma separated list FDA assigned to the subject device)
KPO
Device Description
The Isopure Dry Acid Dissolution System consists mainly of a Mixing Tank, a Distribution and Mixing Pump, a Hopper (with or without an automated opening mechanism), a Venturi inductor, and accompanying hydraulics and control circuits and sensors. The users will enter the dry acid powder mix into the Hopper either manually or by means of the automated bag opening mechanism. The contents of the Hopper will be drawn into the Mixing Tank by means of the Venturi inductor and the Distribution and Mixing Pump. Once all bags have been entered and the solution thoroughly mixed, the reading of the hydrostatic pressure inside the Tank will be converted into a specific gravity value. This in turn will be used to verify that the proper solution has been prepared against a pre-loaded table of values provided by the powder manufacturer. If the solution passes this verification, the system will allow transferring of the solution to the corresponding storage tank in the facility. The tanks will be identified by the use of quick connectors with RFID to prevent the transfer hose from being connected to the wrong tank.
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 Performance Data: Verification and validation protocols were designed to test each function of the Isopure Dry Acid Dissolution System and ensure it performed as intended. Any errors or failures detected during testing were corrected. Materials of construction chosen were the same or even more inert than those of the predicate device. All materials found in water distribution loops have been evaluated for material compatibility with Dry Acid mixed solution. Standard use conditions in the dialysis water room environment were simulated for all testing that was conducted. Performance of control-related filling, pressure, and temperature sensors was tested to verify correct function in each of their respective system processes. Testing provided results that the system was capable of mixing dry acid powder with purified water as intended and is capable to producing an acid concentrate solution consistent with the powder manufacturer's specifications.
Summary of Non-Clinical Performance Data:
- Test: Low and High Ends of Specific Gravity Range Mixing
- Description: Manufacturer pass/fail SG tables has min and max values for each prescription and different temperature points to accommodate variations in the manufacturing process. Bags could have more or less powder due to small variances in the process. The situation was simulated by adding or taking some powder away to come up with SG closer to the ranges provided by the manufacturer. These solutions were analyzed using the nominal SG/HP ratio calculated in the Low / Medium / High SG test to determine if the converted pass/fail table would still pass or reject batches as efficiently as the manufacturer's original pass/fail criteria.
- Test: Prescription Mixing
- Description: The test was used to verify the use of Hydrostatic Pressure (HP) as an indirect method of measuring HP and the use of a ratio between Specific Gravity (SG) and HP to convert SG pass/fail tables provided by the manufacturer to a HP table. Tests performed in low, medium and high end of the SG spectrum. The tests also went on to verify that the use of these ratios could determine that an acid batch that should not meet specifications, i.e. missing a bag, should result in a rejection for that batch. This verified that the method to determine a batch's quality by the mixer is as good as the powder manufacturer's original pass/fall criteria. The tests also verified repeatability of HP readings.
- Test: Small Scale Effects of Acid Powder on Temperature
- Description: This test determined how the water temperature would change once acid powder had been added, independent of the system itself. This was completed on a small scale, using mixing powder with 1 liter of water.
- Test: Large Scale Effects of Acid Powder on Temperature
- Description: This test determined how the water temperature would change when acid powder was added inside the system. It was completed using full sized batches inside the Isopure Dry Acid Dissolution System.
- Test: Effects of temperature on Hydrostatic Pressure (HP) Sensor
- Description: The system was challenged with incoming water pressures at the low and high ends of the manufacturer's recommended working temperatures (20° C and 30°C) to verify if the HP values would remain constant or if a temperature compensation algorithm would be required.
- Test: Self-Calibration
- Description: This test's purpose was to verify that the system could accommodate small variations in sensors over time and among different units in case of field replacements.
- Test: Transfer Process
- Description: The test verified that the transfer process is a repeatable process that results in most of the end product being transferred from the mixer into a separate storage tank. The transfer process relies on the system reading the pressure at different points and estimating the time remaining based on the rate of emptying.
- Test: IFM Pressure sensor
- Description: This test's purpose was to verify linearity, accuracy and repeatability of the HP sensor.
- Test: IFM Temperature sensor
- Description: To verify linearity, accuracy and repeatability of the temperature sensor.
- Test: Fill Sensor
- Description: This test was used to verify the repeatability of the fill sensor (also called Capacitive Sensor).
- Test: Bag Opener Reliability
- Description: This test's purpose was to verify general components reliability and that the contents of the bags are consistently and fully dispensed into the system. The test also identified MTBF values as well as process failure points.
- Test: Disinfection and Rinse
- Description: This test's purpose was to verify the methods used to incorporate Peracetic acid as a disinfectant into the system and the corresponding rinsing methodologies. No disinfection efficacy was tested assuming that the presence of the said agents for the recommended contact times sufficed to prove disinfection.
- Test: Microbiological Disinfection
- Description: This test's purpose was to verify that the disinfection process for the Isopure Dry Acid Dissolution System achieves at least 3-log reduction of non-tuberculous bacteria and at least 6-log reduction of tuberculous bacteria within a maximum disinfection time of 60 minutes.
- Test: Leaching Analysis
- Description: Assuming that the mixed solution could stay inside the Mixing Tank for up to 2 weeks, the system was challenged under this scenario. Samples of the solutions pre and post exposure times were sent to an accredited laboratory for analysis. Generally accepted leaching studies were conducted.
- Test: Usability Engineering
- Description: This test's purpose was to analyze Human Factors normal Use Case scenarios were simulated after conducting a Task Analysis. The main objective of the tests was to assess and mitigate Risks caused by Usability problems associated with the normal use of the device. Usability Goals were met, and Risk Scores associated with Usability Related Risks were acceptable according to Isopure's Risk Management SOP.
- Test: Noise Level
- Description: This test's purpose was to verify that the noise produced by the system is kept below 90dB (excluding alert sounds).
- Test: Effects of Incoming Water Pressure on Fill Level
- Description: This test's purpose was to determine what effects, if any, the incoming water pressure has on the fill level sensor's performance.
Clinical Performance Data: No clinical performance testing was required for determination of substantial equivalence of this type and class of device.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 22, 2020
Isopure, Corp. Kevin Gillespie President & CEO 11851 Plantside Drive Louisville, KY 40299
Re: K191093
Trade/Device Name: Isopure Dry Acid Dissolution System Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis System And Accessories Regulatory Class: II Product Code: KPO Dated: December 20, 2019 Received: December 23, 2019
Dear Kevin Gillespie:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
FORM 3881
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Isopure Dry Acid Dissolution System
Indications for Use (Describe)
The Isopure Corp Dry Acid Dissolution System is designed to mix dry acid concentrates with purified water to produce an acid concentrate solution for hemodialysis for use in 3- Stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
3
Image /page/3/Picture/0 description: The image shows the word "ISOPURE" in large, blue, sans-serif font. Below the text is a graphic of splashing water, also in shades of blue. The water graphic appears to be a stylized representation of water droplets and waves, giving the impression of purity and freshness.
11851 Plantside Drive Louisville, Kentucky 4 502-267-7873 · 800-280-PURE (7873) · Fax: 502-297-5066 www.isopure.com
K191093 Page 1 of 7
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. |
|---|---|
| 11851 Plantside Drive | |
| Louisville, KY 40299 | |
| (502) 267-7873 x6672 |
Kevin Gillespie Contact person:
Date of Summary: January 22, 2020
| Establishment | |
|---|---|
| Registration Number: | 3003768032 |
| Device Name: | Isopure Dry Acid Dissolution System |
| Common Name: | Hemodialysis System and Accessories |
| Product Code: | KPO |
| Device Class: | II |
| Classification Name: | Hemodialysis System and Accessories |
| Regulation Number: | 21 CFR 876.5820 |
Predicate Device for Fresenius Medical Care Dry Acid Dissolution Unit, K131611 Substantial Equivalence:
The Isopure Dry Acid Dissolution System consists mainly of a Device Description: Mixing Tank, a Distribution and Mixing Pump, a Hopper (with or without an automated opening mechanism), a Venturi inductor, and accompanying hydraulics and control circuits and sensors. The users will enter the dry acid powder mix into the Hopper either manually or by means of the automated bag opening mechanism. The contents of the Hopper will be drawn into the Mixing Tank by means of the Venturi inductor and the Distribution and Mixing Pump. Once all bags have been entered and the solution thoroughly mixed, the reading of the hydrostatic pressure inside the Tank will be converted into a specific gravity value. This in turn will be used to verify that the proper solution has been prepared against a pre-loaded table of values provided by the powder manufacturer. If the solution passes this verification, the system will allow transferring of the solution
4
Image /page/4/Picture/0 description: The image shows the word "ISOPURE" in large, blue, sans-serif font above a blue and white image of water splashing. Below the water image is the address "11851 Plantside Drive Louisville, Kentucky 40299" in a smaller, blue, sans-serif font. The address is likely the location of the company associated with the "ISOPURE" brand.
502-267-7873 ● 800-280-PURE (7873) ● Fax: 502-297-5066 www.isopure.com
K191093 Page 2 of 7
to the corresponding storage tank in the facility. The tanks will be identified by the use of quick connectors with RFID to prevent the transfer hose from being connected to the wrong tank.
Intended Use: The Isopure Dry Acid Dissolution System is designed to mix dry acid concentrates with purified water to produce an acid concentrate solution for hemodialysis for use in 3- Stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines.
| Technological Comparison
to Predicate Device
Specifications | Isopure Dry Acid Dissolution
System | FMC Granuflo (Dry Acid
Dissolution System) |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name And
Product Code | | (K131611) |
| Intended Use | The Isopure Dry Acid
Dissolution System is designed
to mix dry acid concentrates
with purified water to produce
an acid concentrate solution
for hemodialysis for use in 3-
Stream (acid concentrate,
bicarbonate concentrate, and
water) hemodialysis machines. | The Fresenius Medical Care
Dry Acid Dissolution Unit
mixes Fresenius Medical
Care-distributed dry acid
concentrate products with
hemodialysis quality water.
The resulting liquid acid
concentrates are intended
for use in three-stream
hemodialysis machines
calibrated for acid and
bicarbonate concentrates. |
| Water Requirements:
Water Quality | AAMI Quality (RD 62) /
ISO 23500-3: 2019 | AAMI Quality (RD 62) |
| Standards | ISO 23500 (-1, -4): 2019
(NOTE: ISO 23500- 4 replaces ISO 13958:
2014)
EN 61326-1:2013 &
IEC60601-1-2:2014 (4th
Edition)- Emissions
(EN55011:2009+A1:2010,
IEC 61000-3-2:2014, IEC
61000-3-3:2013) | ISO 23500: 2014
ISO 13958: 2014
EN 61326-1:2013 &
IEC60601-1 Emissions
IEC60601-1 Immunity |
| Technological Comparison
to Predicate Device
Specifications | Isopure Dry Acid Dissolution
System | FMC Granuflo (Dry Acid
Dissolution System) |
| | EN 61326-1:2013 &
IEC60601-1-2:2014 (4th
Edition)- Immunity (IEC
6100-4-2:2008, IEC
61000-4-3:2010,
IEC61000-4-4:2010, IEC
61000-4-4:2012, IEC
61000-4-5:2014, IEC
61000-4-6:2013,
IEC61000-4-8:2009, IEC
61000-4-11:2010) | |
| Batch size | 99 gallons and 132 gallons | 99 gallons and 132 gallons |
| Disinfection | Peracetic Acid (45 minutes) | Bleach (30 minutes) |
| Mix Preparation Method | Initial Fill Bag Opening Concurrent Mix Final Fill Recirculation and Mix QA Transfer | Initial Fill Add Granules Mix / De-aeration Final Fill Homogenize QA Transfer |
| Data Entry | Scan or manual entry of barcode
information of boxes and bags
into the system | Manual record keeping of
information of boxes and bags. |
| Mixing method | High Flow Recirculation | High Flow recirculation /
Mechanical propeller mixer |
| Powder entry method | Manual entry of powder
directly into the Hopper Automated bag opener
to transfer powder into
Hopper. (accessory) | Manual entry of powder
directly into the tank |
| Main Materials in Contact with
Fluids | HDPE, EPDM, 316SS, PP, PE | HDPE, EPDM, 316SS, PP, PVC |
| Batch Verification | Measure Hydrostatic Pressure to
indirectly calculate Specific
Gravity (SG). Use of Powder
manufacturer pass / fail SG data | User to manually measure SG
and use Powder manufacturer
pass / fail SG data to manually
verify the solution |
| Technological Comparison
to Predicate Device
Specifications | Isopure Dry Acid Dissolution
System | FMC Granuflo (Dry Acid
Dissolution System) |
| | to automatically verify the
solution | |
| Transfer Method | RFID connectors on transfer hose
and holding tanks to verify that
solution is transferred to the
proper tank. Decision based on
user predefined data. | Manual verification that the
solution is transferred to the
proper tank. |
| Record Keeping | System to maintain electronic
records and print reports as paper
back up | Paper Reports manually filled
by users. |
Substantial Equivalence to Predicate Device:
5
Image /page/5/Picture/0 description: The image shows the word "ISOPURE" in blue, with a stylized image of water underneath. The word "ISOPURE" is in all capital letters and is the main focus of the image. The water image is a mix of blues and whites, giving the impression of movement and purity. The overall design is clean and simple, with a focus on the brand name and the association with water.
K191093
Page 3 of 7
6
Image /page/6/Picture/0 description: The image shows the word "ISOPURE" in large, blue, sans-serif font. Below the word is a graphic of water splashing. The water is also blue and appears to be in motion.
11851 Plantside Drive Louisville, Kentucky 40299 502-267-7873 ● 800-280-PURE (7873) ● Fax: 502-297-5066 www.isopure.com
K191093 Page 4 of 7
Non-Clinical Performance Data:
Verification and validation protocols were designed to test each function of the Isopure Dry Acid Dissolution System and ensure it performed as intended. Any errors or failures detected during testing were corrected. Materials of construction chosen were the same or even more inert than those of the predicate device. All materials found in water distribution loops have been evaluated for material compatibility with Dry Acid mixed solution. Standard use conditions in the dialysis water room environment were simulated for all testing that was conducted. Performance of control-related filling, pressure, and temperature sensors was tested to verify correct function in each of their respective system processes. A summary of the Non-Clinical Performance data can be seen in the table below
Testing provided results that the system was capable of mixing dry acid powder with purified water as intended and is capable to producing an acid concentrate solution consistent with the powder manufacturer's specifications.
| Test | Attachment | Description |
|---|---|---|
| Low and High Ends of | ||
| Specific Gravity | ||
| Range Mixing | X | Manufacturer pass/fail SG tables has min and max values for each prescription and different temperature points to accommodate variations in the manufacturing process. Bags could have more or less powder due to small variances in the process. The situation was simulated by adding or taking some powder away to come up with SG closer to the ranges provided by the |
| manufacturer. These solutions were analyzed using the | ||
| nominal SG/HP ratio calculated in the Low / Medium / High SG | ||
| test to determine if the converted pass/fail table would still | ||
| pass or reject batches as efficiently as the manufacturer's | ||
| original pass/fail criteria. | ||
| Prescription Mixing | E | The test was used to verify the use of Hydrostatic Pressure |
| (HP) as an indirect method of measuring HP and the use of a | ||
| ratio between Specific Gravity (SG) and HP to convert SG | ||
| pass/fail tables provided by the manufacturer to a HP table. | ||
| Tests performed in low, medium and high end of the SG | ||
| spectrum. | ||
| The tests also went on to verify that the use of these ratios | ||
| could determine that an acid batch that should not meet | ||
| specifications, i.e. missing a bag, should result in a rejection for | ||
| that batch. This verified that the method to determine a | ||
| batch's quality by the mixer is as good as the powder | ||
| manufacturer's original pass/fall criteria. | ||
| The tests also verified repeatability of HP readings. | ||
| Small Scale Effects of | ||
| Acid Powder on | ||
| Temperature | S | This test determined how the water temperature would |
| change once acid powder had been added, independent of the | ||
| system itself. This was completed on a small scale, using mixing | ||
| powder with 1 liter of water. | ||
| Large Scale Effects of | ||
| Acid Powder on | ||
| Temperature | T | This test determined how the water temperature would |
| change when acid powder was added inside the system. It was | ||
| completed using full sized batches inside the Isopure Dry Acid | ||
| Dissolution System. | ||
| Effects of | ||
| temperature on | ||
| Hydrostatic Pressure | ||
| (HP) Sensor | M | The system was challenged with incoming water pressures at |
| the low and high ends of the manufacturer's recommended | ||
| working temperatures (20° C and 30°C) to verify if the HP | ||
| values would remain constant or if a temperature | ||
| compensation algorithm would be required. | ||
| Self-Calibration | R | This test's purpose was to verify that the system could |
| accommodate small variations in sensors over time and among | ||
| different units in case of field replacements. | ||
| Transfer Process | U | The test verified that the transfer process is a repeatable |
| process that results in most of the end product being | ||
| transferred from the mixer into a separate storage tank. | ||
| The transfer process relies on the system reading the | ||
| pressure at different points and estimating the time | ||
| remaining based on the rate of emptying. | ||
| IFM Pressure sensor | N | This test's purpose was to verify linearity, accuracy and |
| repeatability of the HP sensor. | ||
| IFM Temperature | ||
| sensor | O | To verify linearity, accuracy and repeatability of the |
| temperature sensor. | ||
| Fill Sensor | V | This test was used to verify the repeatability of the fill sensor |
| (also called Capacitive Sensor). | ||
| Bag Opener | ||
| Reliability | Z | This test's purpose was to verify general components reliability |
| and that the contents of the bags are consistently and fully | ||
| dispensed into the system. The test also identified MTBF | ||
| values as well as process failure points. | ||
| Disinfection and | ||
| Rinse | P | This test's purpose was to verify the methods used to |
| incorporate Peracetic acid as a disinfectant into the system | ||
| and the corresponding rinsing methodologies. No disinfection | ||
| efficacy was tested assuming that the presence of the said | ||
| agents for the recommended contact times sufficed to prove | ||
| disinfection. | ||
| Microbiological | ||
| Disinfection | Q | This test's purpose was to verify that the disinfection process |
| for the Isopure Dry Acid Dissolution System achieves at least | ||
| 3-log reduction of non-tuberculous bacteria and at least 6-log | ||
| reduction of tuberculous bacteria within a maximum | ||
| disinfection time of 60 minutes. | ||
| Leaching Analysis | J | Assuming that the mixed solution could stay inside the Mixing |
| Tank for up to 2 weeks, the system was challenged under this | ||
| scenario. Samples of the solutions pre and post exposure times | ||
| were sent to an accredited laboratory for analysis. Generally | ||
| accepted leaching studies were conducted. | ||
| Usability Engineering | L | This test's purpose was to analyze Human Factors normal Use |
| Case scenarios were simulated after conducting a Task | ||
| Analysis. The main objective of the tests was to assess and | ||
| mitigate Risks caused by Usability problems associated | ||
| with the normal use of the device. Usability Goals were | ||
| met, and Risk Scores associated with Usability Related | ||
| Risks were acceptable according to Isopure's Risk | ||
| Management SOP. | ||
| Noise Level | AA | This test's purpose was to verify that the noise produced |
| by the system is kept below 90dB (excluding alert sounds) | ||
| Effects of Incoming | ||
| Water Pressure on | ||
| Fill Level | W | This test's purpose was to determine what effects, if any, |
| the incoming water pressure has on the fill level sensor's | ||
| performance. |
Summary of Non-Clinical Performance Data
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Clinical Performance Data:
No clinical performance testing was required for determination of substantial equivalence of this type and class of device.
Conclusion:
The information and data provided in this 510(k) Notification establish that the Isopure Dry Acid Dissolution System is substantially equivalent to the legally marketed predicate device in relation to intended use, technological characteristics and operational characteristics.