(257 days)
Caph sol is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the conditions are temporary or permanent. Caphosol is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by and increating or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is assoc iated with an amelioration of pain.
Capt osol may be used for relief of dryness of the oral mucosa when hyposalivation results from the f )llowing: surgery, radiotherapy near the salivary glands, chemotherapy; infection of dysf inction of the salivary glands; inflammation of the mouth or throat; fever; emotional fact rs such as fear or anxiety; obstruction of the salivary ducts; Sjögren's syndrome; and Bell's Pals /.
Cap 10sol is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atro ine 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.
Caphosol is an clectrolyte solution resembling human saliva, designed in part to replace the normal ionic and pH balance in the oral cavity. It is intended as a mouth rinse to moisten, lubricate, and clean the oral cavity including the mucosa of the mouth, tongue and throat. Caphosol maintains moistness in the oral cavity. It relieves diffuse dryness and fissuring of the oral mucosa, as well as painful tongue conditions due to hyposalivation. Patients having this condition are also prome to dental caries and candidal infections.
Caphosol is a partial substitute for natural saliva. Caphosol facilitates chewing and speaking; loosens tough mucus; prevent mucous membrancs from sticking together; helps remove nasal crust and relieve nasal soreness; improves adherence of dentures, and also relieves bad taste. The purpose of this premarket notification is to expand the claims for Caphosol to allow Caphosol to be marketed as an adjunct to standard oral care for treating the mucositis that may be mansed by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.
Caphosol is a preparation comprising two separately packaged aqueous solutions, a phosphate solution (Caphosol A) and a calcium solution (Caphosol B) which when both ampoule solutions are combined in equal volumes form a solution supersaturated with respect to both calcium and phosphate ions. The solution after mixing the contents of solutions A and B contains:
| Ingredient: | % w/w |
|---|---|
| Dibasic Sodium Phosphate | 0.032 |
| Monobasic Sodium Phosphate | 0.009 |
| Calcium Chloride | 0.052 |
| Sodium Chloride | 0.569 |
| Purified Water | qs ad |
The provided text is for a 510(k) premarket notification for a medical device (Caphosol Artificial Saliva) and describes its intended use, comparison to a predicate device, and the FDA's substantial equivalence determination. It does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a regulatory submission for a device, which typically focuses on demonstrating substantial equivalence to a previously cleared device, rather than presenting new clinical study data with performance criteria. The FDA letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the clearance is based on similarity to an existing device, not on new clinical performance data against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text. All the fields regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth are not present in the provided document.
N/A