Search Results

Caphosol® 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 mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.

Caphosol® may be used 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; Sjogren'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.

Caphosol® is an electrolyte 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 prone to dental caries and candidal infections.

Caphosol® is a partial substitute for natural saliva. Caphosol® facilitates chewing and speaking; loosens tough mucus; prevent mucous membranes from sticking together, helps remove nasal crust and relieve nasal soreness; improves adherence of dentures, and also relieves bad taste. Caphosol® is an adjunct to standard oral care for treating mucositis that may be caused 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 sachet solutions are combined in equal volumes form a solution supersaturated with respect to both calcium and phosphate ions.

This document is a 510(k) Premarket Notification from the FDA regarding Caphosol® Artificial Saliva. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a performance study for new acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, specifically in the context of an AI/human comparative effectiveness study, standalone algorithm performance, or training set details, is not present in this document.

The document states: "No performance testing was conducted." This explicitly indicates that a study demonstrating device performance against acceptance criteria, as typically understood for medical device efficacy or AI performance, was not performed or submitted for this specific 510(k).

The "Substantial Equivalence" section details how the new device (Caphosol® in sachets) is compared to the predicate device (Caphosol® in vials). The core of the submission is that the new device has not changed its composition or indications for use, and the only difference is the packaging (sachets versus vials).

Here's the information that is available in the document, largely pertaining to the comparison with the predicate:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not present a table of new acceptance criteria and corresponding device performance data from a new study. Instead, it compares the characteristics of the subject device (Caphosol® in sachets) to the predicate device (Caphosol® in vials) to establish substantial equivalence.

   Feature	Caphosol® Artificial Saliva in sachets (Subject Device)	Caphosol® Artificial Saliva in vials (Predicate Device K030802)
   Product Code	LFD	LFD
   Indications for Use	Same as Predicate	Same as Subject
   Device Description	Same as Predicate (electrolyte solution resembling human saliva)	Same as Subject
   Composition (% w/w)	Dibasic Sodium Phosphate 0.032	Dibasic Sodium Phosphate 0.032
   	Monobasic Sodium Phosphate 0.009	Monobasic Sodium Phosphate 0.009
   	Calcium Chloride 0.052	Calcium Chloride 0.052
   	Sodium Chloride 0.569	Sodium Chloride 0.569
   	Purified Water 99.338	Purified Water 99.338
   Package	sachets	vials
   Shelf Life	3 years	3 years
   Shelf Life Testing	Yes (includes liquid and package testing)	Yes (includes liquid and package testing)

2. Sample size used for the test set and the data provenance: Not applicable. The document states "No performance testing was conducted." The "testing" mentioned refers to accelerated shelf-life testing, not clinical or performance efficacy trials with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth was used for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an artificial saliva solution, not an AI-powered diagnostic or assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established as "No performance testing was conducted."

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device; therefore, no training set was used.

9. How the ground truth for the training set was established: Not applicable. (See answer to #8).

In essence, this 510(k) submission leverages the substantial equivalence pathway, asserting that because the active ingredients, concentration, and intended use of the Caphosol® product remain identical to the previously cleared predicate, and only the packaging format has changed (from vials to sachets), no new performance data is required to establish safety and effectiveness. Shelf-life testing was conducted to ensure the integrity of the new packaging and the stability of the liquid over time, which is considered "similar" to the predicate's testing, with minor adjustments for the flexible package type.

Ask a specific question about this device