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K Number
K974759
Device Name
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
Manufacturer
HYDROX LABORATORIES
Date Cleared
1998-03-09

(80 days)

Product Code
JOL
Regulation Number
880.6740
Type
Traditional
Panel
HO
Reference & Predicate Devices
K943834
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not for injection, for suction catheter procedures. Hydrox Sterile Saline 0.9% Sodium Chloride Solution is intended to be used in device lubrication, moistening and flushing. It is not intended for wound irrigation or IV or IM administration and is labeled as such.

Device Description

Sterile Saline 0.9% Sodium Chloride Solution

AI/ML Overview

In the provided text, the FDA 510(k) letter for "Hydrox Saline Solution 0.9% Sodium Chloride" (K974759) does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The letter focuses on the substantial equivalence determination of the device to pre-existing legally marketed devices, in this case, "Orion 0.9% Sodium Chloride Solution K943834 and Kit Pak Sterile 0.9% Sodium Chloride Solution." The FDA's decision is based on the device's indications for use being the same as the predicate devices, and an assumption of compliance with Good Manufacturing Practice (GMP) requirements.

Therefore, I cannot provide the requested information, including:

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

This type of detailed study information is not typically included in an FDA 510(k) clearance letter for a Class II device like a saline solution, especially when the clearance is based on substantial equivalence to predicate devices, where the focus is on whether the new device is as safe and effective as a legally marketed device.

§ 880.6740 Vacuum-powered body fluid suction apparatus.

(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.