Caphosol Dispersible is indicated for dryness of the mouth and throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the condition is temporary or permanent. Caphosol Dispersible is also indicated as an adjunct to standard oral care in the treatment of the mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with amelioration of pain.

Device Description

Caphosol is a supersaturated calcium phosphate, electrolyte mouth rinse used as artificial saliva, designed in part to replace ionic and pH balance in the oral cavity, and formulated as a tablet to be dissolved in water prior to use.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Caphosol Artificial Saliva Tablets." It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or a study proving that the device meets such criteria in the context of an AI/ML device.

However, I can extract the information that is present and indicate what is not available for your specific request on AI/ML device acceptance criteria and study details.

Here's a breakdown based on the provided document and your request:

Device: Caphosol Artificial Saliva Tablets.
Device Type (relevance to AI/ML): This is a pharmaceutical-like product (artificial saliva) and not an AI/ML device. Therefore, the questions related to AI/ML specific performance, such as human reader improvement with AI assistance or standalone algorithm performance, are not applicable.

1. Table of acceptance criteria and the reported device performance

The document does not specify formal "acceptance criteria" for performance in the way an AI/ML device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Caphosol liquid artificial saliva) based on:

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance (Caphosol Artificial Saliva Tablets)
Intended Use	Caphosol Dispersible is indicated for dryness of the mouth and throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the condition is temporary or permanent. Also indicated as an adjunct to standard oral care in the treatment of mucositis caused by radiation or high dose chemotherapy. Relief of dryness is associated with amelioration of pain. (Identical to predicate in core function, slight difference in specificity not raising concerns).
Technology/Operating Principle	Supersaturated calcium phosphate, electrolyte mouth rinse designed to replace ionic and pH balance in the oral cavity. Active chemical components (Calcium and Phosphate) are identical to the predicate. The final solution prepared after dissolution of a tablet or after mixing 2 ampules (predicate) are identical in quantity of the active ingredients. Substantially equivalent to predicate regarding operating principle and function.
Formulation (Active Ingredients)	Contains: Sodium phosphate dibasic anhydrous, Sodium phosphate monobasic anhydrous, Calcium chloride. (Identical active components to predicate).
Biocompatibility	Assessed in accordance with ISO - 10993-1. (Implies compliance with standard).
Safety (Adverse Effects)	"A literature search has not shown any clinically significant adverse effects being reported."

Regarding the study that proves the device meets the acceptance criteria (as requested for an AI/ML device):

The document explicitly states: "Clinical performance testing was not conducted for the subject device."

Therefore, the following points which are highly relevant for AI/ML device studies are not applicable or not present in this document:

Sample size used for the test set and the data provenance: Not applicable as no clinical performance testing was done.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary for this specific document:

This document describes a 510(k) submission for a non-AI/ML medical device. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a legally marketed predicate device, focusing on intended use, technological characteristics, active ingredients, and biocompatibility. No clinical performance study, in the typical sense of showing efficacy or safety for novel AI/ML devices, was reported to have been conducted for this submission, as it relied on the established safety and efficacy of the predicate and the similar nature of the product.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 31, 2017

Eusa Pharma (UK) Limited % Mr. J. Harvey Knauss Consultant Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071-3404

Re: K162167

Trade/Device Name: Caphosol Artificial Saliva Tablets Regulatory Class: Unclassified Product Code: LFD Dated: March 7, 2017 Received: March 7, 2017

Dear Mr. Knauss:

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 marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known). K162167

Device Name CAPHOSOL Artificial Saliva

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

× Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary, K162167, GENERAL INFORMATION:

Sponsor/Submitter:	EUSA PharmaBreakspear Park, Breakspear WayHemel HempsteadHP2 4TZ United-Kingdom011 44 1732 832 317 voiceRegistration # 10049906Mr. Paul Davisson
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Common/Usual Name	None
Proprietary Name	Caphosol Artificial Saliva
Regulation Number	Unclassified
Product Code	LFD
Predicate Devices	K030802 Primary

Description of the device and its intended application:

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The following table lists the Caphosol components:

List of components	Function inCaphosolDispersible	Function in Caphosol
Sodium phosphate dibasicanhydrous	Active component	Active component
Sodium phosphatemonobasic anhydrous	Active component	Active component
Calcium chloride	Active component	Active component
Sodium hydrogen carbonate	Effervescent Agent	Stabilizer
Sodium carbonateanhydrous	Effervescent Agent	none
Maltodextrin	Diluent	none
Granulate Citric acidanhydrous/sorbitol	Effervescent Agent	none
Water		Active component

Caphosol Statement of Intended Use:

Comparison of Device Technology:

COMPARING	CAPHOSOL® DispersibleK162167	CAPHOSOL®PredicateK030802
Product Code	LFD	LFD
Regulation Number	Unclassified	Unclassified
Indication for Use	Caphosol Dispersible is indicated for dryness of the mouth and throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the condition is temporary or permanent. Caphosol Dispersible is also indicated as an adjunct to standard oral care in the treatment of the mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with amelioration of pain.	Caphosol is indicated for dryness of the mouth or throat (hypo salivation, 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 hypo salivation 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.
COMPARING	CAPHOSOL® DispersibleK162167	CAPHOSOL®PredicateK030802
		Caphosol is also indicated fordryness of the oral mucosa due todrugs such as antihistamines oratropine or other anticholinergicagents that suppress salivarysecretion. It may be used as part ofan oral hygiene program for patientswith dry mouth. Caphosol providesintensive hygiene of the oral cavity,and may be used to help relieve badtaste and to relieve offensive nasaldischarge and crusting.
Packaging	Tablet solid form, 1.75 MMdiameter.Image: Tablet	• Two 15 ml solutions plastid (LDPE)ampules• Solution A (blue ampule) –(phosphate solution)
		Solution B (clear ampule) - (calciumsolution)Image: Ampules
Method of use	Ready to use, mix with water.	Mix solutions A & B
Area of use	Oral cavity.	Oral cavity.
Presentation	Non-Sterile.	Non-Sterile.
Interaction with othermedicinal products	There are no known interactionswith medicinal or other products.	There are no known interactions withmedicinal or other products.

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Indication for Use Differences:

The indication for use statement of the predicate device is more specific than the indication for use statement of the subject device. The differences do not raise concerns as the intended use is the same.

Technology Differences:

The CAPHOSOL® Artificial Saliva Tablets and Caphosol® Liguid Artificial Saliva active chemical components are identical, however the CAPHOSOL® Artificial Saliva Tablets formulation includes a diluent and effervescent agents, and does not contain water. The available physical form of the subject device is a dry tablet, whereas the predicate device is composed of two ampules containing different solutions to be mixed prior to use. The

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excipients in the subject device formulation result in effervescence and complete dissolution of the table to obtain the final solution prepared after dissolution of a tablet or after mixing 2 ampules are identical in quantity of the active ingredients (Calcium and Phosphate).

The CAPHOSOL® Artificial Saliva Tablets is substantially equivalent to the predicate devices with regard to operating principle and function.

Performance Testing:

Biocompatibility assessment conducted in accordance with ISO - 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process.

Non-Clinical and Clinical Studies:

Clinical performance testing was not conducted for the subject device.

A literature search has not shown any clinically significant adverse effects being reported.

Conclusion:

Based on the similarities in intended use, technology, and performance testing, the CAPHOSOL Artificial Saliva Effervescent Tablets is substantially equivalent to the predicate device.

Regulation Number and Section

N/A