Can someone shed light on all the 510K hoopla? I mean, where does it say you need it? RD62? Where did it originate? FDA document from the 90's? Seems like a marketing ploy.

The 510K is from the FDA. This equipment is considered a medical device. This was established to ensure that dialysis providers recieve equipment that is safe for the patient and that meets certain standards. The FDA has strict validation processes for equipment. A manufacturer that has an FDA 510k must also have several internal safety nets for tracking and reporting equipment technical problems.

I do not see this as a marketing ploy. This is a way to ensure that dialysis providers are working with manufacturers, that produce equipment that is safe. The other biggie is that a non FDA manufacturer can get in BIG trouble for selling equipment that is considered a medical device. It would be like a guy producing medication out of his home and then selling it to a pharmacy at a discount to hand out to patients. Is it worth a cost savings. I don't think so. PErsonally if that was my family member on dialysis I would want to know that as minimum the equipment was built to a certain standard, wouldn't you??

Are we talking about "GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR WATER PURIFICATION COMPONENTS AND SYSTEMS FOR HEMODIALYSIS"? May 30 1997. Any updates?

As 'Guest" noted, the 510k is FDA recognition of a specific design with specific parts, as a medical device. This protects from deviation from specs in both design AND in the service of medical water systems. We, biomeds and mech techs, need to be sure that our service providers are using exact replacement parts. (Or that we do if we are maintaining it.) Swapping out pumps for one that looks the same is not a smart as we might think. Sometimes water system mfgs buy the standard motor, and alter parts to handle RO. In medical application a clamp is not just a clamp, and a fitting is not just a fitting. Everything we do has potential consequences. Technically, if we swap out certian parts, it's considered altering a medical device. Better believe it's going to be your responsibility and liability.
The truth isn't always practical, is it?

To expand, It is against federal law to sell/ distribute medical devices/ medications that have not been first approved by the FDA. 510k is that approval.

Use the links below for info from the FDA on Class III Medical Device Pre-Market Approval and 510(K) Premarket Notification

FDA PMA OVERVIEW

FDA PMA DATABASE SEARCH

510K Overview

510K DATABASE SEARCH

Dialysis water treatment systems are considered Class III medical devices and are therefore required to be approved by the FDA for sale in the US. The PMA and 510(K) requirements of the Food Drug and Cosmetic Act apply solely to marketers of medical devices and do not apply to purchasers.

AAMI has included in its recommended practices that dialysis providers utilize only water systems which are FDA approved. And CMS through the "incorporation by reference" of the AAMI recommended practices has now made this part of the Conditions of Coverage for ESRD program participants. While this has completed the circle with respect to regulatory requirements for both sellers and users there remains some middle ground for misunderstandings and misconceptions.

PMA and 510(K) approvals are granted by the FDA and the FDA is the only entity that can “invalidate” a granted PMA or 510(K). Because these approvals are granted to the sellers of medical devices, the only entity that can actually "violate" the FDA approval is the seller.

Now following the logic when a vendor says that your action invalidates or violates their 510K they are misstating the fact. Appropriately what the vendor can tell you, and this should be done in writing, is that your action or use of the device is not in accordance with their specifications or stated intended use and therefore you are liable for any consequences thereof and have voided any warranty. If this is a legitimate circumstance given the CMS requirements you are in violation of the Conditions of Coverage.

With regards to the previous discussion regarding water filters. Nothing in the FDA or CMS requirements compels you to purchase filters or any replacement “part” from the original device vendor. If the replacement part is available from another vendor and is exactly the same part or is equivalent to and meets the original vendor’s specifications for the original part. This generally applies to consumable or generic items such as filters, filter housings, carbon media and other resins, fuses, lamps, tubing and hoses, pipe and fittings, connectors, and cleaners and disinfectants. But can include larger "component" items such as pre-treatment tanks, control heads, storage tanks, membranes and membrane housings.

You should however, as Florian stated, maintain documentation showing the equivalency as “validation” of the replacement part.

Thanks Dennis