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K Number
K971278
Device Name
PURE COMPANY FLUID DELIVERY SYSTEM
Manufacturer
PURE CO.
Date Cleared
1997-07-03

(87 days)

Product Code
EIA
Regulation Number
872.6640
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Pure Fluid Delivery System is a dual reservoir system that isolates a dental operatory from municipal or rural water supplies. It can also be used to introduce bottled solutions that are commonly used in dental procedures through the dental unit. The Pure Fluid Delivery System also has a .01 Micron air filter that permits air purging of the dental unit with higher quality air.

Device Description

The Pure Fluid Delivery System is a dual reservoir system that isolates a dental operatory from municipal or rural water supplies. It can also be used to introduce bottled solutions that are commonly used in dental procedures through the dental unit. The Pure Fluid Delivery System also has a .01 Micron air filter that permits air purging of the dental unit with higher quality air.

The operation of the the Fluid Delivery System is facilitated by a rotary switch on the control face that permits switching between the contents of the two bottles being used. There is a built-in pressure relief valve that limits pressure in the bottles to 40psi as a safety feature.

The control face panel also has a quick disconnect that allows the solutions in the bottle selected to be used in an external dental device.

AI/ML Overview

I am sorry, but based on the provided document, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for the "Pure Fluid Delivery System" and primarily covers the regulatory approval for marketing the device. It focuses on substantial equivalence to a predicate device and general controls.

Therefore, I cannot fulfill your request to provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set and data provenance.
  3. Number of experts used to establish ground truth and their qualifications.
  4. Adjudication method.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
  6. If a standalone study was done.
  7. The type of ground truth used.
  8. The sample size for the training set.
  9. How the ground truth for the training set was established.

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.