ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS by AQUA SCIENCES, INC.

The ASI Deionizer and Carbon Exchange Tank Service for hemodialysis are intended to be used in a hemodialysis facility according to ANSI/AAMI-RD62:2006 standards to supply purified water for use in hemodialysis. These exchange tanks are components of a larger water treatment system employing adequate pretreatment and post treatment sections. These exchange tanks are not to be used alone. Upon exhaustion, these tanks will be replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether, or in the case of Carbon Tanks, with tanks containing virgin carbon. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.

Device Description

Aqua Sciences, Inc. Mixed Bed Deionization Exchange Tanks (DI) are Fiberglass Reinforced Polypropylene (FRP) tanks filled with mixed bed deionizing resin. The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings, PVC heads and tank distributors. The DI Exchange Tanks are dedicated for ion exchange resin only. Our tanks are designed to deliver Association for the Advancement of Medical Instrumentation (AAMI) standard water through an ion exchange process.

Aqua Sciences, Inc. Carbon Exchange Tanks are Fiberglass Reinforced Polypropylene (FRP) tanks filled with new activated carbon. The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings, PVC heads and tank distributors. The Carbon Exchange Tanks are dedicated for carbon only and used to remove chlorine and chloramines.

AI/ML Overview

Based on the provided 510(k) submission for the AQUA Sciences Inc. Deionization (DI) Exchange Tanks and Carbon Exchange Tanks, here's a description of the acceptance criteria and the study that proves the device meets them:

I. Acceptance Criteria and Reported Device Performance

Acceptance Criteria Description	Device Performance
Water Quality Standard Compliance: Supply purified water according to ANSI/AAMI-RD62:2006 for hemodialysis.	"Results verify product complies with AAMI RD:62 Standard." The submission states that "nonclinical tests were conducted on product water from a replicated intended exchange tank configuration. Results verify product complies with AAMI RD:62 Standard." This directly addresses the standard compliance. The specific performance metrics within AAMI RD:62 (e.g., maximum allowable levels of ions, microbes, etc.) are implicitly met by this statement, though not explicitly detailed in the summary provided.
Deionization Efficacy: Effectively remove positive and negative charged dissolved solids and salts from water.	Achieved through "mixed bed deionizing resin." "Deionization Exchange tanks from both Aqua Sciences. Inc. and AmeriWater are utilized to remove positive and negative charged dissolved solids and salts from the water. Both companies utilize mixed bed resins consisting of cation and anion resin." While no numerical performance for removal efficiency is given, the claim is made that the device is utilized for this purpose, aligning with the predicate.
Chlorine/Chloramine Removal Efficacy: Effectively remove chlorine and chloramines from feed water.	Achieved through "new activated carbon" and "granular activated carbon with a minimum iodine number of 900." "Activated Carbon Filtration is utilized by both Aqua Sciences, Inc. and AmeriWater to remove chlorine and chloramines from the feed water. Aqua Sciences, Inc. uses carbon in accordance with AAMI current standards. Both companies use two (2) carbon filters in series configuration. Aqua Sciences, Inc. and AmeriWater both use granular activated carbon with a minimum iodine number of 900." No specific numerical "removal rate" is given, but the method and compliance with AAMI standards are stated.
Compatibility/Integration: Function as components of a larger water treatment system (not used alone).	Implicitly met by design and stated use. "These exchange tanks are components of a larger water treatment system employing adequate pretreatment and post treatment sections. These exchange tanks are not to be used alone." The acceptance is based on the design and intended use as a component.
Tank Integrity/Material: Tanks are Fiberglass Reinforced Polypropylene (FRP).	Directly stated as a design feature. "Aqua Sciences, Inc. Mixed Bed Deionization Exchange Tanks Device Description: (DI) are Fiberglass Reinforced Polypropylene (FRP) tanks filled with mixed bed deionizing resin." and "Aqua Sciences, Inc. Carbon Exchange Tanks are Fiberglass Reinforced Polypropylene (FRP) tanks filled with new activated carbon."
Common Fittings/Heads: Similar inlet and outlet fittings, PVC heads and tank distributors common to the industry.	Directly stated as a design feature. "The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings, PVC heads and tank distributors." and similar phrasing for carbon tanks.

II. Study Details

The provided 510(k) summary describes a comparative study for substantial equivalence rather than a full, de novo clinical trial for a novel device. The study primarily relies on nonclinical tests and a comparison to a predicate device.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "nonclinical tests were conducted on product water from a replicated intended exchange tank configuration." It does not specify the number of tests performed, the volume of water processed, or the number of units tested.
- Data Provenance: The document does not explicitly state the country of origin for the test data, but given the company's address is in New York, USA, and the submission is to the FDA, it is highly probable the testing was conducted in the USA. The tests appear to be prospective in nature, as they were "conducted" for the purpose of this submission to verify compliance.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This criterion is not applicable in the traditional sense for this type of device and study. The "ground truth" for water purification is established by adherence to a predefined standard (ANSI/AAMI-RD62:2006). The "experts" would be the personnel conducting the laboratory analyses and interpreting the results against the AAMI standard. Their qualifications (e.g., trained lab technicians, chemists) are not specified but are implied to be sufficient for water quality testing.
Adjudication Method for the Test Set:
- None specified/Not Applicable: For objective chemical and physical water quality tests, an adjudication method like 2+1 or 3+1 is not typically used. The results are quantitative and compared directly to the specified limits in the AAMI standard.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is relevant for diagnostic imaging AI devices where human readers interpret medical images. The Aqua Sciences device is a water purification component, not an imaging or diagnostic AI device.
Standalone (Algorithm Only Without Human-in-the-Loop Performance):
- Not applicable. This relates to AI/software performance. The device is a physical water purification component. Its "performance" is based on its ability to purify water, not on an algorithm's output.
Type of Ground Truth Used:
- The primary "ground truth" used is established industry standards (ANSI/AAMI-RD62:2006). The water quality parameters (e.g., conductivity, levels of specific ions, contaminants, chlorine/chloramine residual) dictate the "truth" of the water's purity. Analytical laboratory results from the "replicated intended exchange tank configuration" were compared against these predefined standard limits.
Sample Size for the Training Set:
- Not applicable. This device does not involve machine learning or AI models that require a training set.
How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for a machine learning model, this question does not apply.

In summary, the substantial equivalence claim for the Aqua Sciences Inc. Deionization and Carbon Exchange Tanks is based primarily on:

Direct comparison of design, materials, and intended use to a legally marketed predicate device (AmeriWater Purification System for Hemodialysis (K991519)).
Demonstration through nonclinical objective laboratory testing that the product water from their system complies with the established ANSI/AAMI-RD62:2006 standard for purified water used in hemodialysis. This compliance with a recognized standard serves as the "proof" the device meets its core acceptance criteria.

Summary

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AQUA Sciences Inc.
A Pure Splash of Innovation

K.102892, page 1 of 2
510(k) Submission

FEB - 3 2011

510(k) Summary Carbon and Mixed Bed Deionization (DI) Exchange Tanks

Date Prepared:	September 20, 2010
Prepared/Submitted by:	Aqua Sciences, Inc.565 Fillmore AvenueTonawanda, New York 14150
Contact Person:	Mr. Michael J. ToddQuality Manager(716) 695-1200
Device Name:	Deionization Exchange TanksCarbon Exchange Tanks
Device Classifications:	Water Purification ComponentClass II Medical Device21 CFR §876.5665, Product Code -- FIP
Predicate Device:	AmeriWater Purification System for Hemodialysis (K991519)
Model Numbers:	Deionizing Tank Model No.	Carbon Tank Model No.
	AS-618-MB-D	AS-618-GAC
	AS-818-MB-D	AS-818-GAC
	AS-844-MB-D	AS-844-GAC
	AS-1047-MB-D	AS-1047-GAC
	AS-1447-MB-D	AS-1447-GAC

Aqua Sciences, Inc. Mixed Bed Deionization Exchange Tanks Device Description: (DI) are Fiberglass Reinforced Polypropylene (FRP) tanks filled with mixed bed deionizing resin. The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings, PVC heads and tank distributors. The DI Exchange Tanks are dedicated for ion exchange resin only. Our tanks are designed to Medical the Advancement of deliver Association for Instrumentation (AAMI) standard water through an ion exchange process.

Aqua Sciences, Inc. Carbon Exchange Tanks are Fiberglass Reinforced Polypropylene (FRP) tanks filled with new activated carbon. The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings, PVC heads and tank distributors. The Carbon Exchange Tanks are dedicated for carbon only and used to remove chlorine and chloramines.

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Image /page/1/Picture/0 description: The image shows the logo for Aqua Sciences Inc. The logo features the company name in a simple, sans-serif font. Below the company name is the tagline "A Pure Splash of Innovation" in a smaller font. To the left of the tagline is a graphic of a water splash.

K102892, page 2 of 2
510(k) Submission

[510(k) summary continued]

Indication of Use: The ASI Deionizer and Carbon Exchange Tank Service for hemodialysis are intended to be used in a hemodialysis facility according to ANSI/AAMI-RD62:2006 standards to supply purified water for use in hemodialysis. These exchange tanks are components of a larger water treatment system employing adequate pretreatment and post treatment sections. These exchange tanks are not to be used alone. Upon exhaustion, these tanks will be replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether, or in the case of Carbon Tanks with tanks containing new virgin carbon. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.

Comparison to Predicate: AmeriWater Exchange Tanks (K991519)

Deionization Exchange tanks from both Aqua Sciences. Inc. and AmeriWater are utilized to remove positive and negative charged dissolved solids and salts from the water. Both companies utilize mixed bed resins consisting of cation and anion resin.

Activated Carbon Filtration is utilized by both Aqua Sciences, Inc. and AmeriWater to remove chlorine and chloramines from the feed water. Aqua Sciences, Inc. uses carbon in accordance with AAMI current standards. Both companies use two (2) carbon filters in series configuration. Aqua Sciences, Inc. and AmeriWater both use granular activated carbon with a minimum iodine number of 900. Both companies recommend a chlorine and chloramines water test before each patient shift.

The Aqua Sciences. Inc. water purification components and the Summary: AmeriWater predicate device components are substantially equivalent to one another. All the water purification components and technology in this submission are comparable. In addition, nonclinical tests were conducted on product water from a replicated intended exchange tank configuration. Results verify product complies with AAMI RD:62 Standard.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The logo is black and white.

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

Mr. Michael J. Todd Ouality Manager AOUA Sciences, Inc. 565 Fillmore Avenue TONAWANDA NY 14150

FEB - 3 201

Re: K102892

Trade/Device Name: Aqua Sciences, Inc. (ASI) Deionizer and Carbon Exchange Tank Service for Hemodialysis Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: 11 Product Code: FIP Dated: January 12, 2011 Received: January 21, 2011

Dear Mr. Todd:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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Page 2

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 0, 000-0050.

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/vcm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Alo, 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Huker Lemur MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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A Pure Splash of Innovation

510(k) Submission

Statement of Indications for Use (revised)

510 (k) Number: K102892

AQUA Sciences Inc.

Aqua Sciences, Inc. (ASI) Deionizer and Carbon Exchange Tank Device Name: Service for Hemodialysis

The ASI Deionizer and Carbon Exchange Tank Service for Indications for Use: hemodialysis are intended to be used in a hemodialysis facility according to ANSI/AAMI-RD62:2006 standards to supply purified water for use in hemodialysis. These exchange tanks are components of a larger water treatment system employing adequate pretreatment and post treatment sections. These exchange tanks are not to be used alone. Upon exhaustion, these tanks will be replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether, or in the case of Carbon Tanks, with tanks containing virgin carbon. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.

Prescription Use X (Part 21 CFR 801 Subpart D) And/Or

Over-The-Counter Use (21 CFR 801 Subpart C)

(Please do not write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

loughn Whay

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K102892

Regulation Number and Section

§ 876.5665 Water purification system for hemodialysis.

(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.