(107 days)
The water treatment system and its components consisting of; pretreatment, reverse osmosis machine, and the product water distribution components, are designed to remove microbiological, organic, and inorganic contaminants from the tap water to supply dialysis machines for the preparation of dialysate solutions for hemodialysis treatments.
NOTE: Federal Law restricts this device to sale by or on the order of a physician for use as a water treatment device for hemodialysis.
The water treatment system and its components consisting of; pre-treatment, reverse osmosis machine, and the product water distribution components, are designed to remove microbiological, organic, and inorganic contaminants from the tap water to supply dialysis machines for the preparation of dialysate solutions for hemodialysis treatments.
Pretreatment components can include a tap water boosting system, blending valve, sediment filtration, carbon removal system, blomaing vars, and all the necessary interconnecting nlumbing. The purpose of this part of the system is to ensure that properly conditioned water is supplied to the reverse osmosis machine to ensure its safe and trouble free operation. The blending valve ensures that the water is at the proper temperature when entering the reverse osmosis machine. The tap water booster system helps ensure that the reverse osmosis machine has adequate water pressure and volume so it can produce the desired amount of water. The sediment filters can be in the form of an automatic backwashing filter (such as a multi-media depth filter), or as a replaceable filter cartridge. The carbon filters are installed primarily to remove the amount of chlorine and chloramines from the water to meet the necessary water quality standards and can be in the form of automatic backwashing tanks, or portable exchange tanks. The water softener(s) are in place to remove the hardness from the tap water to both meet water quality standards, and to protect the reverse osmosis membranes from scaling and therefore not performing to specifications.
After the tap water has been pre-treated, it then enters the R.O. (reverse osmosis), where total dissolved solids are removed to pertinent water quality standards. This is accomplished by utilizing a membrane separation process, whereby the incoming water is separated into a product stream, and a concentrate stream. The molecular weight cut-off determines what and how many contaminants are passed through into the product stream. R.O.s used for this application typically remove 95-99% of all total dissolved solids and bacteria.
The product water distribution part of the system is in place to store, provide additional purification if needed, and deliver the purified water to wherever needed. These components can include such things as a storage tank, deionization tanks, final filters (for bacteria and endotoxins), and delivery pumps and controls. Some systems can also utilize an ultraviolet light for additional sterilization properties. The distribution piping encompasses the piping and related fittings to deliver the dialysis water from the water treatment system to the use points (dialysis machines) and return the unused portion of water back to the water treatment system.
The provided text describes the Dialysis Services Water Treatment & Distribution System, a water purification system for hemodialysis. This document is a 510(k) premarket notification and primarily focuses on establishing substantial equivalence to a predicate device and demonstrating compliance with relevant standards.
Here's an analysis based on the information provided and the questions you've asked:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the acceptance criterion for the device is:
- "The Dialysis Services Water Treatment System produces product water which is in compliance with the standard issued by the Association for the Advancement of Medical Instrumentation, AAMI RD62-2001."
The reported device performance is:
- "The Dialysis Services Water Treatment System produces product water which is in compliance with the standard issued by the Association for the Advancement of Medical Instrumentation, AAMI RD62-2001."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Product water in compliance with AAMI RD62-2001 standard for water purification. | Product water is in compliance with AAMI RD62-2001 standard. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document only states that "The Dialysis Services Water Treatment System produces product water which is in compliance..." It doesn't detail the testing methodology, number of tests, or amount of water sampled.
- Data provenance: Not specified. It's likely from internal testing by Dialysis Services, Inc., but no details on country of origin or whether it was retrospective/prospective are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The general nature of water quality testing against a standard typically does not involve human experts establishing a "ground truth" in the way a medical image diagnosis might. The ground truth here is the AAMI RD62-2001 standard itself, and measurements are taken against that standard using calibrated instruments.
4. Adjudication method for the test set:
- Not applicable/Not provided. Water quality testing against a standard generally relies on objective measurements rather than adjudication by multiple human experts.
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:
- No. This device is a water treatment system, not an AI-assisted diagnostic tool or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/No. This is a physical water treatment system, not a software algorithm.
7. The type of ground truth used:
- The "ground truth" used is the AAMI RD62-2001 standard for water purification systems for hemodialysis. Device performance is measured against the specifications outlined in this standard.
8. The sample size for the training set:
- Not applicable/Not provided. This is a hardware device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As there is no training set, this question is not relevant.
Summary of the Study:
The "study" referenced in the document is a non-clinical performance evaluation to demonstrate that the Dialysis Services Water Treatment System produces product water that complies with the AAMI RD62-2001 standard. This type of evaluation typically involves testing the system's output water against various chemical, physical, and microbiological parameters specified in the standard (e.g., levels of total dissolved solids, chlorine, chloramines, hardness, bacteria, endotoxins). The document does not provide specifics about the experimental design, sample sizes, or the individual results of these tests, only a summary statement of compliance. The FDA reviewed this claim of compliance as part of the 510(k) submission to determine substantial equivalence to a predicate device.
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Kop3344
Fage 1(3)
MAR 2 1 2005
510(k) Summary of Safety and Effectiveness
| Submitter: | Dialysis Services, Inc.3620 Kelto Jackson Rd.Springfield, TN 37172 | |
|---|---|---|
| Establishment Registration Number: | 9061060 | |
| Phone: | (615) 384-4810 | |
| Fax: | (615) 384-4847 | |
| Date Prepared: | 12-01-04 | |
| Contact Person: | Mike Sterling | |
| Device Names: | Trade Name: | Dialysis Services Water Treatment& Distribution System |
| Common Name: | Complete Water TreatmentSystem with Pre-treatment andProduct Water Distribution &Piping | |
| Classification Name: | Water purification system forHemodialysis(21 CFR 876.5665)Class II Critical Medical Device | |
| Product Code: | 78 FIP | |
| Predicate Device: | Better Water, Inc. Water Purification System forHemodialysis, K#920186/C | |
| Device Description: | The water treatment system and its components consistingof; pre-treatment, reverse osmosis machine, and theproduct water distribution components, are designed toremove microbiological, organic, and inorganiccontaminants from the tap water to supply dialysis machinesfor the preparation of dialysate solutions for hemodialysistreatments. |
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Pretreatment components can include a tap water boosting system, blending valve, sediment filtration, carbon removal system, blomaing vars, and all the necessary interconnecting nlumbing. The purpose of this part of the system is to ensure that properly conditioned water is supplied to the reverse osmosis machine to ensure its safe and trouble free operation. The blending valve ensures that the water is at the proper temperature when entering the reverse osmosis machine. The tap water booster system helps ensure that the reverse osmosis machine has adequate water pressure and volume so it can produce the desired amount of water. The sediment filters can be in the form of an automatic backwashing filter (such as a multi-media depth filter), or as a replaceable filter cartridge. The carbon filters are installed primarily to remove the amount of chlorine and chloramines from the water to meet the necessary water quality standards and can be in the form of automatic backwashing tanks, or portable exchange tanks. The water softener(s) are in place to remove the hardness from the tap water to both meet water quality standards, and to protect the reverse osmosis membranes from scaling and therefore not performing to specifications.
After the tap water has been pre-treated, it then enters the R.O. (reverse osmosis), where total dissolved solids are removed to pertinent water quality standards. This is accomplished by utilizing a membrane separation process, whereby the incoming water is separated into a product stream, and a concentrate stream. The molecular weight cut-off determines what and how many contaminants are passed through into the product stream. R.O.s used for this application typically remove 95-99% of all total dissolved solids and bacteria.
The product water distribution part of the system is in place to store, provide additional purification if needed, and deliver the purified water to wherever needed. These components can include such things as a storage tank, deionization tanks, final filters (for bacteria and endotoxins), and delivery pumps and controls. Some systems can also utilize an ultraviolet light for additional sterilization properties. The distribution piping encompasses the piping and related fittings to deliver the dialysis water from the water treatment system to the use points (dialysis machines) and return the unused portion of water back to the water treatment system.
1 - V
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- The Dialysis Services Water Treatment System is intended to Intended Use: be used to remove organic and inorganic contaminants from a tap water supply to dilute a dialysate concentrate for hemodialysis treatments, as well as for use for dialyzer reprocessing and dialysis equipment disinfecting and rinsing.
- The Dialysis Services Water Treatment System and its Predicate Device: components are substantially equivalent to the Better Water, Inc. Water Purification System for Hemodialysis, K#920186/C. Both the predicate device systems and the Dialysis Services Water Treatment System utilize reverse osmosis technology as the primary means of purification, and all utilize an R.O. which has 510(k) clearance from the FDA.
Non-Clinical Performance Data:
The Dialysis Services Water Treatment System produces product water which is in compliance with the standard issued by the Association for the Advancement of Medical Instrumentation, AAMI RD62-2001.
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Image /page/3/Picture/1 description: The image shows a logo with a stylized bird in flight. The bird is composed of three curved lines that suggest movement and feathers. Encircling the bird is text that appears to be part of the logo, though the letters are small and difficult to read. The overall design is simple and abstract, giving the logo a modern and professional look.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2005
Mr. Mike Sterling Vice President/COO Dialysis Services, Inc. 3620 Kelton Jackson Road SPRINGFIELD TN 37172
Re: K043344
K 043344
Trade/Device Name: Dialysis Services Water Treatment & Distribution System Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: December 1, 2004 Received: December 6, 2004
Dear Mr. Sterling:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your becasin 910(ts) prohostantially equivalent (for the indications for use stated in above and have decemined the aboved icate devices marketed in interstate commerce prior to the enclosure) to legally manected prodisate deal Device Amendments, or to devices that have been May 26, 1970, the elacultion date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accondatics with the proval application (PMA). You may, therefore, market the do not require approval of a premance approva approvations of the Act. The general controls provisions of the Act device, subject to the general connois provisions of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classince (see aoove) income controls. Existing major regulations affecting your Approval), it thay of Subject to SecrateReal Regulations, Title 21, Parts 800 to 898. In addition, FDA uevice can be tound in the concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that 1 DA 3 issualled of accessful other requirements of the Act of any FDA has made a delemination mad your dones Federal agencies. You must comply with all the Federal Statues and regulations administer to registration and listing (21 CFR Part 807); labeling Act's requirements, including, but not intitled to regurements as set forth in the quality systems (QS) (ZI CFR Part 801), good nammacturing proctices treation control product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k)
. The supportune and comments of aling of sourcence of your device to a legal This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA finding of substantial couivalence of yo premarket notification. The FDA finding of substantial equivalities of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r many and and on the many of the following numbers, hased on the regulat If you desire specific advice for your device on our labeling regulation (1) is a desires of the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, " Misoration on your responsibilities under the Act from the 807.97). You may obtain other general information on your responsive at its toll-free number (800)
Division of Small Manufacturers, International address that/com/dsmamain. Division of Small Manufacturers, International and Consumer Assistanter of the Press.
638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmama
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1_of_1_
510(k) Number (if known): Not Yet Assigned K043344
Device Name: Dialysis Services Water Treatment & Distribution System
Indications for Use:
The water treatment system and its components consisting of; pretreatment, reverse osmosis machine, and the product water distribution components, are designed to remove microbiological, organic, and inorganic contaminants from the tap water to supply dialysis machines for the preparation of dialysate solutions for hemodialysis treatments.
NOTE: Federal Law restricts this device to sale by or on the order of a physician for use as a water treatment device for hemodialysis.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) ED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _/ (Per 21 CFR 801.109)
Harrey C. Braden
Division Sign Off
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043344
§ 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.