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K Number
K991938
Device Name
CAPHOSOL ARTIFICIAL SALIVA
Manufacturer
INPHARMA A.S.
Date Cleared
1999-08-10

(62 days)

Product Code
LFD
Regulation Number
N/A
Type
Traditional
Panel
DE
Reference & Predicate Devices
K874106
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Caphosol is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the condition is temporary or permanent.

Caphosol is indicated for relief of dryness of the oral mucosa when hyposalivation results from the following: surgery, radiotherapy near the salivary glands, chemotherapy, infection or dysfunction of the salivary glands; inflammation of the mouth or throat; fever; emotional factors such as fear or anxiety, obstruction of the salivary ducts, Sjögren's syndrome; and Bell's Palsy.

Caphosol is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholinergic agents that suppress salivary secretion.

It may be used as part of an oral hygiene program for patients with dry mouth. Caphosol provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste and to relieve offensive nasal discharge and crusting.

Device Description

Caphosol™ Artificial Saliva Consisting of a mixture of two solutions Caphosol™ A -- 15 mL Phosphate Solution and Caphosol™ B - 15 mL Calcium Solution

AI/ML Overview

Based on the provided text, there is no information available to answer the specific questions about the acceptance criteria and the study that proves the device meets them.

The document is a 510(k) summary for "Caphosol™ Artificial Saliva," which primarily focuses on establishing substantial equivalence to a predicate device (GLANDOSANE (SALIVART®)). It outlines the device's name, classification, predicate device, and indications for use.

The document does not contain:

  • Any specific acceptance criteria for the device's performance.
  • Details of a study conducted to demonstrate that the device meets such criteria.
  • Information regarding sample sizes, data provenance, expert involvement, adjudication methods, or MRMC studies.
  • Results of a standalone algorithm performance study (as this is an artificial saliva, not an AI/algorithm-driven device).
  • Details about the ground truth for training or testing sets.

Therefore, I cannot provide the requested table or answer the specific questions based on the provided text.

N/A