(133 days)
The Pure Water, Inc. Acidified Storage and Distribution system 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.
Pure Water, Inc.'s Acidified Storage and Distribution System 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.
Pure Water, Inc.'s Acidified Storage and Distribution System with optional Remote Fill meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis.
This 510(k) summary describes a medical device, the Pure Water, Inc. Acidified Storage and Distribution System, but it is not an AI/ML powered device. Therefore, most of the requested information regarding AI/ML device studies (such as sample sizes for test and training sets, ground truth establishment methods, expert qualifications, adjudication methods, and MRMC studies) is not applicable to this document.
However, based on the provided text, I can infer the following about the device's acceptance criteria and how it aims to meet them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meeting or exceeding National Standards for Hemodialysis (specifically AAMI standards) | "Pure Water, Inc.'s Acidified Storage and Distribution System with optional Remote Fill meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis." |
| Substantial equivalence to predicate devices (Better Water's K920186 and ZyzaTech Water System, Inc.'s K964539) | The FDA found the device to be "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." |
| Indication for Use: Storage and distribution of acid concentrate in hemodialysis facilities. | The device 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." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This device is an physical medical device (storage and distribution system), not an AI/ML software device that relies on a "test set" of data for performance evaluation. Its performance is demonstrated through adherence to manufacturing standards and functional equivalence to predicate devices.
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):
- Not applicable. Ground truth in the context of AI/ML testing is not relevant for this physical device. The "ground truth" for this device's acceptance is its compliance with established industry standards (AAMI) and functional equivalence to predicate devices, which are assessed through engineering and manufacturing processes, not expert review of a "test set."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept relates to resolving discrepancies in ground truth labeling for AI/ML datasets and is not relevant to the evaluation of this 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:
- Not applicable. This device is not an AI-assisted diagnostic or interpretive tool, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For this physical medical device, the "ground truth" is established by:
- Compliance with recognized national standards: Specifically, the Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis. These standards themselves are developed through expert consensus and industry best practices to ensure safety and efficacy.
- Functional equivalence to predicate devices: The FDA's substantial equivalence determination relies on comparing the new device's technological characteristics and performance to those of legally marketed predicate devices. This implies that the predicate devices' prior approval and safe use serve as a form of "ground truth" for the new device's acceptable performance.
8. The sample size for the training set:
- Not applicable. There is no "training set" for this type of physical device.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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510(k) Summary
Submitter Information:
| Company Name: | Pure Water, Inc. |
|---|---|
| Company Address: | 305 West Market StreetAnderson, South Carolina |
| Company Phone: | (864) 375-0105 |
| Company Fax: | (864) 226-1384 |
| Contact Person: | Rhonda S. McCoy |
| Prepared: | September 10, 1999 |
| Trade Name: | Pure Water, Inc. Acidified Storage and Distribution System withOptional Remote Fill |
| Classification Name: | Acidified Storage and Distribution System with optional RemoteFill for Hemodialysis |
| Equivalancy: | Pure Water, Inc.'s Acidified Storage and Distribution System withOptional Remote Fill is substantially equivalent to Better Water'sWater Purification System for Hemodialysis (510(k) #: K920186)and ZyzaTech Water System, Inc.'s Water Purification Systemsand Components and Portable Reverse Osmosis Systems (510(k)#: K964539) which are currently in commercial distribution. |
| Device Description: | Pure Water, Inc.'s Acidified Storage and Distribution System withOptional Remote Fill uses "one-piece molded seamless tanksconstructed of linear polyethylene" for bulk storage of acidifiedconcentrate.The Optional Remote Fill allows the storage tanks to be filled bythe vendor from outside the building.Pure Water, Inc.'s Acidified Storage and Distribution System withoptional Remote Fill meets or exceeds all Association for theAdvancement of Medical Instrumentation (AAMI) National |
Standards for Hemodialysis.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2000
Ms. Rhonda S. McCoy Office Manager Pure Water, Inc. 305 West Market Street Anderson, South Carolina 29624 Re: K993058 Pure Water, Inc. Acidified Storage and Distribution System Dated: December 29, 1999 Received: December 30, 1999 Regulatory Class: II 21 CFR §876.5820/Procode: 78 FIN 21 CFR §876.5820/Procode: 78 KPO
Dear Ms. McCoy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verily such assumptions. Failure to comply with the GMP regult in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compilance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz. M.D. Acting Director. Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K993058
Device Name: Pure Water, Inc. Acidified Storage and Distribution System
Indications For Use:
The Pure Water, Inc. Acidified Storage and Distribution system 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dinda H.P.
Siti Aisah Dom
(Division Sign Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K993058 510(k) Number
Prescription Use J (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.