(202 days)
The Aqua Pure DI exchange tanks are used according to current AAMI standards (RD 62) and are intended to supply dialysis grade water, for use in dialysis, concentrate preparation systems, dialyzer reuse systems and rinsing of sterilants. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis units. The D.I. exchange tanks for dialysis are only one part of a complete water treatment system and must be used in conjunction within a water treatment system with appropriate pre-treatment and post-treatment.
Aqua Pure's D.I. Exchange Tanks for Dialysis are FRP tanks filled with mixed bed resin. Widget connectors are used in conjunction with a machined PVC schedule 80 head, stand pipe, fill port, and distributor basket. Our tanks are designed to supply AAMI standard water for dialysis through ion exchange. The D.I. exchange tanks are based on the Ameriwater Dialysis Deionizer Exchange Tanks K991519.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Aqua Pure D.I. Exchange Tanks for Dialysis (K072158).
Summary of Findings:
The provided 510(k) relies on substantial equivalence to a predicate device (Ameriwater Dialysis Deionizer Exchange Tanks, K991519) rather than a direct performance study with acceptance criteria. This means the device is deemed acceptable because it is designed to be functionally identical to a previously approved device. Therefore, a traditional "study proving the device meets acceptance criteria" as might be seen for a novel device with new performance claims, is not present.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Equivalence: Tanks, resin, alarm, tubing, connectors, heads, fill plugs, standpipe, and distributor baskets are the same as the predicate device. | All components (Tank type and manufacturer, Resin type and manufacturer, Audio alarm type, Interconnecting tubing, Connectors, Heads and fill plugs, Stand pipe and distributor baskets) are identical to the predicate device, K991519. Both use FRP tanks from Park International, MBD-10 Resin from ResinTech, Resi-Lite 1 megohm audio/visual alarm, high purity PVC tubing, Widget connectors of glass-filled Noryl, PVC schedule 80 machined heads with fill plugs, and PVC schedule standpipe and distributor baskets. |
| Indications for Use Equivalence: Intended to supply dialysis grade water according to AAMI standards (RD 62), for use in dialysis, concentrate preparation systems, dialyzer reuse systems, and rinsing sterilants. Can be used for primary or emergency backup water purification as part of a complete water treatment system. | The device's "Indications for Use" are identical to those of the predicate device, specified as being used "according to current AAMI standards (RD 62) and are intended to supply dialysis grade water, for use in dialysis, concentrate preparation systems, dialyzer reuse systems and rinsing of sterilants." It also notes it can be used for primary or emergency backup and must be part of a complete water treatment system. |
| Fundamental Scientific Technologies Equivalence: No alteration of fundamental scientific technologies from the predicate device. | The submission explicitly states the device has "not altered the fundamental scientific technologies or materials used in the predicate device." |
Study Details (As Per 510(k) Substantial Equivalence Process):
Since this is a substantial equivalence submission, the "study" is effectively a comparative analysis against the predicate, not a performance study in the typical sense.
- Sample size used for the test set and the data provenance: Not applicable. There was no "test set" of performance data in the traditional sense, as the claim is based on identical design and materials to a device already deemed safe and effective. The provenance is the design specifications of the new device compared to the predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for performance was not established via expert review of a test set. Equivalence was established by comparing design specifications and indications for use.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This is a medical device (water purification tanks), not an AI diagnostic or assistance tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used: The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device (Ameriwater Dialysis Deionizer Exchange Tanks, K991519), based on its design, materials, and intended use as assessed by the FDA. The submission demonstrates that the new device shares this "ground truth" by being substantively the same.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
The Aqua Pure D.I. Exchange Tanks for Dialysis gained 510(k) clearance by demonstrating substantial equivalence to a legally marketed predicate device. This means the FDA determined that the new device has the same intended use and the same technological characteristics (or different characteristics that do not raise new questions of safety and effectiveness) as the predicate device. Therefore, no new performance studies, clinical trials, or expert adjudications were required from the applicant to prove that the device meets specific performance acceptance criteria. The "study" was a detailed comparison of its components, materials, and intended use against the predicate device, which the FDA found to be sufficiently similar to allow market entry.
{0}------------------------------------------------
K072158 - 510(k) Pre-market Notification D.I. Exchange Tanks for Dialysis
1. Submitter: Aqua Pure Staubach Barror Water systems Inc. FEB 21 2008 495 Rotterdam Ind. Park Schenectady, NY 12306 Contact Person: Jarrod Staubach V.P. / Quality Manager Tel:(518)355-4390 November 26, 2007 Date prepared: 2. Device name: D.I. Exchange Tanks for Dialysis. 3. Device Classification: Class II Medical Device under 21 CFR $876.5665 4. Predicate Device: Ameriwater Dialysis Deionizer Exchange Tanks
510(k) Summary
-
- Device Description: Aqua Pure's D.I. Exchange Tanks for Dialysis are FRP tanks filled with mixed bed resin. Widget connectors are used in conjunction with a machined PVC schedule 80 head, stand pipe, fill port, and distributor basket. Our tanks are designed to supply AAMI standard water for dialysis through ion exchange. The D.I. exchange tanks are based on the Ameriwater Dialysis Deionizer Exchange Tanks K991519.
-
- Indications for use: The Aqua Pure DI exchange tanks are used according to current AAMI standards (RD 62) and are intended to supply dialysis grade water, for use in dialysis, concentrate preparation systems, dialyzer reuse systems and rinsing of sterilants. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis units. The D.I. exchange tanks for dialysis are only one part of a complete water treatment system and must be used in conjunction within a water treatment system with appropriate pretreatment and post-treatment.
{1}------------------------------------------------
K472158
PAGE 2 OF 2
-
- Comparison with predicate device: Aqua Pure's D.I. Exchange Tanks for Dialysis are substantially equivalent to the currently marketed Ameriwater Dialysis Deionizer Tanks, and have not altered the fundamental scientific technologies or materials used in the predicate device. The intended use of the D.I. Exchange Tanks for Dialysis is the same as the intended use of the predicate device K991519.
| Tank parts andmanufacturers. | Ameriwater DialysisDeionizer ExchangeService | Aqua Pure D.I. ExchangeTanks for Dialysis |
|---|---|---|
| Tank type and manufacturer | FRP tanks manufactured fromPark International | FRP tanks manufactured from ParkInternational |
| Resin type and manufacturer | MBD-10 Resin manufactured byResinTech | MBD-10 Resin manufactured byResinTech |
| Audio alarm type | Resi-Lite 1 megohm audio/visualalarm positioned between workerand polisher | Resi-Lite 1 megohm audio/visualalarm positioned between workerand polisher |
| Interconnecting tubing | High purity PVC interconnectingtubing | High purity PVC interconnectingtubing |
| Connectors | Widget connectors made ofglass filled Noryl | Widget connectors made ofglass filled Noryl |
| Heads and fill plugs | PVC schedule 80 machined headwith PVC schedule 80 fill plug. | PVC schedule 80 machined headwith PVC schedule 80 fill plug. |
| Stand pipe and distributorbaskets | PVC schedule stand pipe anddistributor basket. | PVC schedule stand pipe anddistributor basket. |
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boylevard Rockville MD 20850
Mr. Jarrod J. Staubach Vice President/Quality Manager Staubach Barror Water Systems, Inc. (DBA: Aqua Pure) 495 Rotterdam Industrial Park SCHENECTADY NY 12306
K072158 Re:
Trade/Device Name: D.I. Exchange Tanks for Dialysis Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: January 2, 2008 Received: February 5, 2008
Dear Mr. Staubach:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Rederal Register.
{3}------------------------------------------------
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 fisting (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
{4}------------------------------------------------
Indications for Use
510(k) Number: K072158
Device Name: D.I. Exchange Tanks for Dialysis
Indications for Use: The Aqua Pure DI exchange tanks are used according to current AAMI standards (RD 62) and are intended to supply dialysis grade water, for use in dialysis, concentrate preparation systems, dialyzer reuse systems and rinsing of sterilants. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis units. The D.I. exchange tanks for dialysis are only one part of a complete water treatment system and must be used in conjunction within a water treatment system with appropriate pre-treatment and post-treatment.
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)
(vers 6/25/05)
Halut Reiner
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 1 of
§ 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.