(126 days)
Not Found
No
The device description and performance studies focus on the physical components and chemical process of water purification, with no mention of AI or ML technologies.
No
The device is a component of a larger water treatment system that supplies purified water for hemodialysis, but it does not directly treat a patient or disease itself. It purifies water, which is then used in a therapeutic context.
No
The device is a component of a water treatment system used to supply purified water for hemodialysis, which is a therapeutic process. It is described as a "Deionizer and Carbon Exchange Tank Service" and its function is to purify water, not to diagnose a condition or disease.
No
The device description clearly states the device is comprised of physical tanks made of Fiberglass Reinforced Polypropylene (FRP) filled with resin or activated carbon. This indicates a hardware component, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to supply purified water for use in hemodialysis. This is a process that treats water before it is used in a medical procedure, not a test performed on a biological sample to diagnose or monitor a condition.
- Device Description: The device description details tanks filled with resin or carbon for water purification. This aligns with water treatment equipment, not diagnostic devices.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Measuring analytes or biomarkers
- Providing diagnostic information
- Using reagents or assays
The device is a component of a water treatment system used in a hemodialysis facility, which is a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FIP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hemodialysis facility
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)
nonclinical tests were conducted on product water from a replicated intended exchange tank configuration. Results verify product complies with AAMI RD:62 Standard.
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
§ 876.5665 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.
0
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 Avenue | ||
| Tonawanda, New York 14150 | ||
| Contact Person: | Mr. Michael J. Todd | |
| Quality Manager | ||
| (716) 695-1200 | ||
| Device Name: | Deionization Exchange Tanks | |
| Carbon Exchange Tanks | ||
| Device Classifications: | Water Purification Component | |
| Class II Medical Device | ||
| 21 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.
1
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.
2
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
3
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
4
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