The Isopure ACDS with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients.

Device Description

The Isopure ACDS (Acidified Concentrate Distribution and Storage) is designed for storage of pre-mixed acidified concentrate in a 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. ISOPURE ACDS (Acidified Concentrate Distribution and Storage) with optional remote fill uses "one-piece molded seamless tanks constructed of linear polyethylene" for bulk storage of acidified concentrate. The optional remote fill allows the storage tanks to be filled by the vendor from outside the building. The Isopure ACDS (Acidified Concentrate Distribution and Storage) with optional remote fill meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis.

AI/ML Overview

The provided text is a 510(k) summary for the Isopure ACDS (Acidified Concentrate Distribution and Storage) device, which is a medical device used in hemodialysis facilities. The summary focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the format typically seen for novel AI/software devices.

Instead, the "acceptance criteria" here refer to the performance and functional equivalence to the previously cleared predicate device (Pure Water Inc.'s Acidified Storage and Distribution System, K993058). The "study" proving this equivalence is the validation protocol VP12-002, which tests the operation of various components of the ACDS system.

Here's an analysis of the provided information, addressing your questions where applicable and noting where information is not present in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) (seeking substantial equivalence for a device that is essentially a re-branded and re-manufactured version of a previously cleared device), the acceptance criteria are implicitly that the new device operates identically or equivalently to the predicate device, especially regarding functional components. The "performance" is the successful testing of those components.

Acceptance Criteria (Implicit from Predicate Device)	Reported Device Performance (Validation Protocol VP12-002)
ACDS Storage Tank:
- Proper assembly of trim kit.	- A 250-gallon storage tank assembled with the trim kit.
- No leaks in trim kit assemblies and connections.	- Tested for leaks in trim kit assemblies and connections to the storage tank. (Implied successful as no failures reported).
- Bottom connection provides acidified concentrate.	- When connected to the bottom, provided acidified concentrate to the distribution pump.
- Valve allows flow termination.	- Valve allowed flow to be terminated to the distribution pump when closed.
Level Floats:
- Low float provides low tank warning.	- Low float tested to ensure proper operation of the remote alarm low-level indicator. (Implied successful).
- Low float turns power on for remote fill station.	- Low float tested to ensure proper operation for the optional remote fill station (turns power on). (Implied successful).
ACDS Control Box:
- Proper operation of control box.	- Connected to storage tank and remote fill box. Power connected. (Implied successful operation of the control box).
- Distribution pump operation.	- Distribution pump tested. (Implied successful).
- Low-level alarm operation.	- Low-level alarm tested. (Implied successful).
- Optional remote fill station operation.	- Optional remote fill station tested. (Implied successful).
Distribution Pump:
- Distribution of acidified concentrate.	- Connected to a 500 ft ½" polyethylene line to test distribution. (Implied successful distribution).
- Pressure and flow measurement.	- Pressure gauge and flow meter used to measure flow and pressure on the distribution line. (Measurements taken, implied within acceptable parameters of the predicate device, though specific numbers are not provided).
- Flow switch operation validation.	- Flow meter used to verify the operation of the flow switch on the ACDS distribution pump. (Implied successful validation).
Remote Fill Station:
- On/off electrical connections to controller.	- Connected to storage tank and controller; tested the on/off electrical connections of the controller in relation to the fill station. (Implied successful).
Regulators:
- Regulates excessive pressure (> 5 psig).	- A 0-25 regulator is supplied to regulate pressure at each individual station in the event of excessive pressure (> 5 psig) at the distribution box. (Implied functional as designed, though a specific test scenario for excessive pressure and its regulation is not detailed, it often falls under design verification testing).
Overall Equivalence:	- "The Isopure ACDS... is the same device that was manufactured by Pure Water, Inc. under 510(k) 993058." "The only change to the device is the name and manufacturing location. All performance data provided in the original 510(k) remains the same." "Performance testing was undertaken to verify that the device is as safe, as effective and performs as well as or better than the earlier versions of the Pure Water Inc's Acidified Concentrate Distribution and Storage system (K993058)."

Information Not Applicable or Provided in this 510(k) Summary:

The following questions are typically relevant for AI/software devices performing diagnostic or interpretive tasks, clinical studies, or novel device performance claims. This 510(k) is for a physical medical device (Acidified Concentrate Distribution and Storage System) and focuses on manufacturing transfer and minor changes, demonstrating substantial equivalence to an existing device. Therefore, these categories are mostly Not Applicable (N/A) to this specific submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

N/A. The "test set" here refers to the actual physical device components and their integrated system. The testing is a validation protocol on a single prototype/production unit or a representative sample, not a data-based test set for an algorithm. The testing was done at the manufacturer's location (Simpsonville, KY, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. "Ground truth" in this context would be engineering specifications and functional requirements outlined in the design and AAMI standards, which are verified by engineers or quality control personnel, not clinical experts establishing diagnostic "ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Adjudication methods are for human interpretation conflicts in clinical studies, not for the functional testing of a physical device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This applies to AI-assisted diagnostic or interpretive devices. The Isopure ACDS is a physical system for storing and distributing hemodialysis concentrate.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

N/A. This applies to AI/software performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A. The "ground truth" for this device's performance is adherence to engineering specifications, functional requirements (e.g., pump distributes fluid, alarm activates), and relevant industry standards (AAMI National Standards for Hemodialysis).

8. The sample size for the training set

N/A. This device does not use a "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on established engineering principles and the predicate device.

9. How the ground truth for the training set was established

N/A. As above, no training set. The "ground truth" for its design and performance expectations is based on the previously cleared predicate device and industry standards for hemodialysis equipment.

Summary

{0}------------------------------------------------

MAR 2 9 2012

OF 3

L. 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.

Isopure Corp 1. Submitter's Name:

141 Citizens Blvd. Simpsonville, KY 40067 Telephone: (502) 722-1000 Kevin C. Gillespie

Contact person: . December 29, 2011 Date of Summary:

1. Device Name: Isopure ACDS (Acidified Concentrate Distribution and Storage) Device Classification Name: Dialysate concentrate for Hemodialysis (liquid or powder) (21 CFR $876.5820, KPO).

Legally Marketed Devices to which Equivalence is Claimed: Isopure Corp purchased the Pure Water Inc's Acidified Storage and Distribution System with Optional Remote Fill (K993058) from Pure Water Inc. Isopure intends to manufacture and market the device at its Simpsonville K Y location. The intended use, functionally of neither the device nor any of the contacting components for the device has changed.

Device Description: The Isopure ACDS (Acidified Concentrate Distribution and Storage) is 4. designed for storage of pre-mixed acidified concentrate in a 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.

ISOPURE ACDS (Acidified Concentrate Distribution and Storage) with optional remote fill uses "one-piece molded seamless tanks constructed of linear polyethylene" for bulk storage of acidified concentrate.

The optional remote fill allows the storage tanks to be filled by the vendor from outside the building. The Isopure ACDS (Acidified Concentrate Distribution and Storage) with optional remote fill meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis.

Indications for use: The Isopure ACDS (Acidified Concentrate Distribution and Storage) with 5. remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients.

Descriptive Summary of Technological Characteristics and Those of Predicate Devices: The 6. technological characteristics of the device are the same as the original submitted device under 501(k) K993058, Pure Water, Inc.'s Acidified Storage and Distribution System cleared January 24, 2000.

Pure Water, Inc K993058	Isopure Corp
The Acidified Tank(s) are designed to store acidified concentrate. The tank(s) are constructed of one piece linear virgin polyethylene. Tanks feature a vented sealed lid to reduce particle contamination. (Pure water acidified storage & distribution 510(k) submission 9/10/99)	The Acidified Tank(s) are designed to store acidified concentrate. The tank(s) are constructed of one piece linear virgin polyethylene. Tanks feature a vented sealed lid to reduce particle contamination.

Summary of Comparisons of Components

{1}------------------------------------------------

OF 3

Acid Fill Controller is a 115 VAC controller that isused to operate the distribution pump when theconcentrate is distributed through a loop to thedialysis stations. The controller will also operatethe remote filling station by providing power to thereceptacle located at the fill station. (Pure wateracidified storage & distribution 510(k) submission9/10/99)	Acid Fill Controller is a 115 VAC controller that isused to operate the distribution pump when theconcentrate is distributed through a loop to thedialysis stations. The controller will also operatethe remote filling station by providing power to thereceptacle located at the fill station.
The filter assembly filters our impurities that maybe present in the Acidified concentrate. The filterassembly is comprised of a clear filter housing anda 5 micron 10 inch filter. (Pure water acidifiedstorage & distribution 510(k) submission 9/10/99)	This filter was eliminated because a filter is locatedon the acidified concentrate mixer for this purpose.Additional filters would serve no purpose and onlyoffers additional opportunities for leakage.
Auxiliary Components A ball valve is placed in thedistribution line to fill jugs of concentrate ifnecessary. (Pure water acidifiedstorage &distribution 510(k) submission 9/10/99)	Auxiliary Components A ball valve is placed in thesupply line or the side of the storage tank to filljugs of concentrate if necessary.
Schedule 80 PVC pipe and fittings: Schedule 80PVC pipe and fittings are used to direct concentrateflow. (Pure water acidified storage & distribution510(k) submission 9/10/99)	Schedule 80 PVC pipe and fittings: Schedule 80PVC pipe and fittings are used to direct concentrateflow.
Polyethylene Flex Tubing: Polyethylene FlexTubing is used to direct concentrate flow. (Purewater acidified storage & distribution 510(k)submission 9/10/99)	Polyethylene Flex Tubing: Polyethylene FlexTubing is used to direct concentrate flow.
Autolock Fittings Autolock fittings are used toconnect tubing. (Pure water acidified storage &distribution 510(k) submission 9/10/99)	Autolock Fittings Autolock fittings are used toconnect tubing.

Performance Data: The Isopure ACDS ( Acidified Concentrate Distribution and Storage) is the same device that was manufactured by Pure Water, Inc. under 510(k) 993058. The applicant is notifying the FDA that the device DMR and 510(k) was sold to Isopure who will begin manufacturing the device at its Simpsonville KY location. The only change to the device is the name and manufacturing location. All performance data provided in the original 510(k) remains the same.

Non Clinical Testing: A validation protocol was performed VP12-002 The following validation test protocol addresses the operation of the ACDS controller, distribution pump, distribution piping, remote fill station, and remote alarm.

ACDS Storage tank:

A 250 gallon storage tank will be assembled with the trim kit to test the operation of all assemblies of the trim kit. This will also test for leaks in the trim kit assemblies and connections to the storage tank. When connected to the bottom connection should provide acidified concentrate to the distribution pump. The valve will also allow flow to be terminated to the distribution pump when closed.

{2}------------------------------------------------

Level floats: The level floats 2 for the remote fill station the low float will have a dual purpose; I- for the low tank warning on the remote alarm, and 2- to turn power on for the optional remote fill station. The floats will be tested to ensure proper operation of the remote alarm low level indicator and for the optional remote fill station.

ACDS Control Box: The ACDS control box will be connected to the storage tank and also to the remote fill box to test the operation of the control box. Power will be connected to the control box and the distribution pump will be tested as well as the low level alarm and the optional remote fill station

Distribution Pump: The distribution pump will be connected to a 500 ft ½" polyethylene line to test the distribution of the acidified concentrate through the distribution line. A pressure gauge and a flow meter will also be connected to this line to measure the amount of flow as well as the pressure on the distribution line. The flow meter will be used to verify the operation of the flow switch on the ACDS distribution pump.

Remote Fill Station: A remote fill station will be connected to the storage tank and also to the controller. This will be used to test the on/off electrical connections of the controller in relation to the fill station.

Regulators: In the event that the pressure is excessive (> 5 psig) at the distribution box, a 0-25 regulator is supplied to regulate the pressure at each individual station.

8. Not Applicable to this application

Conclusion: Upon instituting the above changes, performance testing was undertaken to verify 9. that the device is as safe, as effective and performs as well as or better than the earlier versions of the Pure Water Inc's Acidified Concentrate Distribution and Storage system (K993058) cleared on January 24, 2000.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Kevin Gillespie President/CEO Isopure Corp 141 Citizens Boulevard SIMPSONVILLE KY 40067

MAR 2 9 2012

Re: K120005

Trade/Device Name: Isopure ACDS (Acidified Concentrate Distribution and Storage) Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: February 24, 2012 Received: March 1, 2012

Dear Mr. 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. 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 (reporting of medical

{4}------------------------------------------------

Page 2 -

device-related 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,

Benjamin K. Eicher

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use Statement

December 29, 2011

Page 1 of 1

510(k) Number: K120005

Device Name: Isopure ACDS (Acidified Concentrate Distribution and Storage)

Indications for Use:

The Isopure ACDS with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients.

(Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Di sion of Reproductive, Gastro-Renal, andUrological Devices
510(k) Number	K120005

Prescription Use	X	OR	Over-the-Counter Use
------------------	---	----	----------------------

(Per 21 CFR 801.109)

Regulation Number and Section

§ 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.