Isopure Dry Acid Dissolution System

K191093 · Isopure, Corp. · KPO · Jan 22, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K191093
• Device Name: Isopure Dry Acid Dissolution System
• Applicant: Isopure, Corp.
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Jan 22, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Intended Use

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.

Device Story

System mixes dry acid powder with purified water to produce hemodialysis acid concentrate. Components include mixing tank, distribution/mixing pump, hopper (with optional automated bag opener), Venturi inductor, hydraulics, sensors, and control circuits. User loads powder into hopper; Venturi inductor and pump draw powder into tank. System measures hydrostatic pressure (HP) inside tank, converts to specific gravity (SG) value, and compares against pre-loaded manufacturer tables to verify solution quality. RFID-tagged connectors ensure transfer to correct storage tank. Used in clinical dialysis water room environments; operated by trained staff. Output is verified acid concentrate. Benefits include automated mixing, electronic record keeping, and automated verification of solution quality, reducing manual error risks compared to manual mixing methods.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including verification of mixing accuracy, hydrostatic pressure sensor linearity/repeatability, disinfection efficacy (3-log reduction non-tuberculous, 6-log reduction tuberculous bacteria), leaching analysis, and usability engineering.

Technological Characteristics

Materials: HDPE, EPDM, 316SS, PP, PE. Sensing: Hydrostatic pressure, temperature, capacitive fill sensors. Mixing: High-flow recirculation. Connectivity: RFID for tank identification. Standards: ISO 23500-3:2019, ISO 23500 (-1, -4):2019, EN 61326-1:2013, IEC 60601-1-2:2014 (4th Ed). Disinfection: Peracetic acid. Software: Control circuits for sensor-based batch verification and automated transfer.

Indications for Use

Indicated for mixing dry acid concentrates with purified water to produce acid concentrate solution for use in 3-stream hemodialysis machines.

Regulatory Classification

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.

Predicate Devices

• Fresenius Medical Care Dry Acid Dissolution Unit (K131611)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# 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)

K191093

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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FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services [phone] EF

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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: [phone] 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 |
| | [phone] 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

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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: [phone] 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<br>to Predicate Device<br>Specifications | Isopure Dry Acid Dissolution<br>System | FMC Granuflo (Dry Acid<br>Dissolution System) |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name And<br>Product Code | | (K131611) |
| Intended Use | The Isopure Dry Acid<br>Dissolution System is designed<br>to mix dry acid concentrates<br>with purified water to produce<br>an acid concentrate solution<br>for hemodialysis for use in 3-<br>Stream (acid concentrate,<br>bicarbonate concentrate, and<br>water) hemodialysis machines. | The Fresenius Medical Care<br>Dry Acid Dissolution Unit<br>mixes Fresenius Medical<br>Care-distributed dry acid<br>concentrate products with<br>hemodialysis quality water.<br>The resulting liquid acid<br>concentrates are intended<br>for use in three-stream<br>hemodialysis machines<br>calibrated for acid and<br>bicarbonate concentrates. |
| Water Requirements:<br>Water Quality | AAMI Quality (RD 62) /<br>ISO 23500-3: 2019 | AAMI Quality (RD 62) |
| Standards | ISO 23500 (-1, -4): 2019<br>(NOTE: ISO 23500- 4 replaces ISO 13958:<br>2014)<br>EN 61326-1:2013 &<br>IEC60601-1-2:2014 (4th<br>Edition)- Emissions<br>(EN55011:2009+A1:2010,<br>IEC 61000-3-2:2014, IEC<br>61000-3-3:2013) | ISO 23500: 2014<br>ISO 13958: 2014<br>EN 61326-1:2013 &<br>IEC60601-1 Emissions<br>IEC60601-1 Immunity |
| Technological Comparison<br>to Predicate Device<br>Specifications | Isopure Dry Acid Dissolution<br>System | FMC Granuflo (Dry Acid<br>Dissolution System) |
| | EN 61326-1:2013 &<br>IEC60601-1-2:2014 (4th<br>Edition)- Immunity (IEC<br>6100-4-2:2008, IEC<br>61000-4-3:2010,<br>IEC61000-4-4:2010, IEC<br>61000-4-4:2012, IEC<br>61000-4-5:2014, IEC<br>61000-4-6:2013,<br>IEC61000-4-8:2009, IEC<br>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<br>information of boxes and bags<br>into the system | Manual record keeping of<br>information of boxes and bags. |
| Mixing method | High Flow Recirculation | High Flow recirculation /<br>Mechanical propeller mixer |
| Powder entry method | Manual entry of powder<br>directly into the Hopper Automated bag opener<br>to transfer powder into<br>Hopper. (accessory) | Manual entry of powder<br>directly into the tank |
| Main Materials in Contact with<br>Fluids | HDPE, EPDM, 316SS, PP, PE | HDPE, EPDM, 316SS, PP, PVC |
| Batch Verification | Measure Hydrostatic Pressure to<br>indirectly calculate Specific<br>Gravity (SG). Use of Powder<br>manufacturer pass / fail SG data | User to manually measure SG<br>and use Powder manufacturer<br>pass / fail SG data to manually<br>verify the solution |
| Technological Comparison<br>to Predicate Device<br>Specifications | Isopure Dry Acid Dissolution<br>System | FMC Granuflo (Dry Acid<br>Dissolution System) |
| | to automatically verify the<br>solution | |
| Transfer Method | RFID connectors on transfer hose<br>and holding tanks to verify that<br>solution is transferred to the<br>proper tank. Decision based on<br>user predefined data. | Manual verification that the<br>solution is transferred to the<br>proper tank. |
| Record Keeping | System to maintain electronic<br>records and print reports as paper<br>back up | Paper Reports manually filled<br>by users. |

## Substantial Equivalence to Predicate Device:

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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.

www.isopure.com

K191093
Page 3 of 7

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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: [phone] 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<br>Specific Gravity<br>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<br>nominal SG/HP ratio calculated in the Low / Medium / High SG<br>test to determine if the converted pass/fail table would still<br>pass or reject batches as efficiently as the manufacturer's<br>original pass/fail criteria. |
| Prescription Mixing | E | The test was used to verify the use of Hydrostatic Pressure<br>(HP) as an indirect method of measuring HP and the use of a<br>ratio between Specific Gravity (SG) and HP to convert SG<br>pass/fail tables provided by the manufacturer to a HP table.<br>Tests performed in low, medium and high end of the SG<br>spectrum. |
| | | The tests also went on to verify that the use of these ratios<br>could determine that an acid batch that should not meet<br>specifications, i.e. missing a bag, should result in a rejection for<br>that batch. This verified that the method to determine a<br>batch's quality by the mixer is as good as the powder<br>manufacturer's original pass/fall criteria. |
| | | The tests also verified repeatability of HP readings. |
| Small Scale Effects of<br>Acid Powder on<br>Temperature | S | This test determined how the water temperature would<br>change once acid powder had been added, independent of the<br>system itself. This was completed on a small scale, using mixing<br>powder with 1 liter of water. |
| Large Scale Effects of<br>Acid Powder on<br>Temperature | T | This test determined how the water temperature would<br>change when acid powder was added inside the system. It was<br>completed using full sized batches inside the Isopure Dry Acid<br>Dissolution System. |
| Effects of<br>temperature on<br>Hydrostatic Pressure<br>(HP) Sensor | M | The system was challenged with incoming water pressures at<br>the low and high ends of the manufacturer's recommended<br>working temperatures (20° C and 30°C) to verify if the HP<br>values would remain constant or if a temperature<br>compensation algorithm would be required. |
| Self-Calibration | R | This test's purpose was to verify that the system could<br>accommodate small variations in sensors over time and among<br>different units in case of field replacements. |
| | | |
| Transfer Process | U | The test verified that the transfer process is a repeatable<br>process that results in most of the end product being<br>transferred from the mixer into a separate storage tank.<br>The transfer process relies on the system reading the<br>pressure at different points and estimating the time<br>remaining based on the rate of emptying. |
| IFM Pressure sensor | N | This test's purpose was to verify linearity, accuracy and<br>repeatability of the HP sensor. |
| IFM Temperature<br>sensor | O | To verify linearity, accuracy and repeatability of the<br>temperature sensor. |
| Fill Sensor | V | This test was used to verify the repeatability of the fill sensor<br>(also called Capacitive Sensor). |
| Bag Opener<br>Reliability | Z | This test's purpose was to verify general components reliability<br>and that the contents of the bags are consistently and fully<br>dispensed into the system. The test also identified MTBF<br>values as well as process failure points. |
| Disinfection and<br>Rinse | P | This test's purpose was to verify the methods used to<br>incorporate Peracetic acid as a disinfectant into the system<br>and the corresponding rinsing methodologies. No disinfection<br>efficacy was tested assuming that the presence of the said<br>agents for the recommended contact times sufficed to prove<br>disinfection. |
| Microbiological<br>Disinfection | Q | This test's purpose was to verify that the disinfection process<br>for the Isopure Dry Acid Dissolution System achieves at least<br>3-log reduction of non-tuberculous bacteria and at least 6-log<br>reduction of tuberculous bacteria within a maximum<br>disinfection time of 60 minutes. |
| Leaching Analysis | J | Assuming that the mixed solution could stay inside the Mixing<br>Tank for up to 2 weeks, the system was challenged under this<br>scenario. Samples of the solutions pre and post exposure times<br>were sent to an accredited laboratory for analysis. Generally<br>accepted leaching studies were conducted. |
| Usability Engineering | L | This test's purpose was to analyze Human Factors normal Use<br>Case scenarios were simulated after conducting a Task |
| | | Analysis. The main objective of the tests was to assess and<br>mitigate Risks caused by Usability problems associated<br>with the normal use of the device. Usability Goals were<br>met, and Risk Scores associated with Usability Related<br>Risks were acceptable according to Isopure's Risk<br>Management SOP. |
| Noise Level | AA | This test's purpose was to verify that the noise produced<br>by the system is kept below 90dB (excluding alert sounds) |
| Effects of Incoming<br>Water Pressure on<br>Fill Level | W | This test's purpose was to determine what effects, if any,<br>the incoming water pressure has on the fill level sensor's<br>performance. |

Summary of Non-Clinical Performance Data

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Image /page/7/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 blue and white, and it appears to be moving quickly.

www.isopure.com

K191093
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Image /page/8/Picture/0 description: The image shows the word "ISOPURE" in large, blue, sans-serif font. Below the text is a graphic of splashing water. The water is blue and white, and it appears to be moving quickly.

www.isopure.com

K191093
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Image /page/9/Picture/0 description: The image shows the word "ISOPURE" in blue, with a water graphic underneath. The water graphic is a close-up of water with bubbles and ripples. The word "ISOPURE" is in a sans-serif font and is slightly italicized. The overall effect is clean and refreshing.

11851 Plantside Drive Louisville, Kentucky 40299 502-267-7873 • 800-280-PURE (7873) • Fax: [phone] www.isopure.com

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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.