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.

Device Description

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.

AI/ML Overview

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:

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)

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.
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.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was used.
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.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithmic device.
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."
The sample size for the training set: Not applicable. This is not an AI/machine learning device; therefore, no training set was used.
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.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 11, 2024

EUSA Pharma (UK) Limited % Angela Blackwell Senior Consultant Blackwell Device Consulting 3207 SE 156th Ave Portland, Oregon 97236

Re: K234015

Trade/Device Name: Caphosol® Artifical Saliva (32 doses sachet box) Regulatory Class: Unclassified Product Code: LFD Dated: December 14, 2023 Received: December 19, 2023

Dear Angela Blackwell:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

{1}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

{2}------------------------------------------------

Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

Submission Number (if known)

K234015

Device Name

Caphosol® Artifical Saliva (32 doses sachet box)

Indications for Use (Describe)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Caphosol® Artificial Saliva 510(k) Summary December 4, 2023

K234015

Name and Address: EUSA Pharma (UK) Ltd Breakspear Park, Breakspear Way Hemel Hempstead HP2 4TZ United Kingdom

Contact Person: Dr. Sandy Suh Email: suh.s@recordati.com Telephone: (908) 849-4908

Name of device: Caphosol® Artificial Saliva Product Code Name: artificial saliva Primary Product Code: LFD Regulatory Class: unclassified

Submission Contact:

Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com

Device Description: 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.

{5}------------------------------------------------

Ingredients:	% w/w
Dibasic Sodium Phosphate	0.032
Monobasic Sodium Phosphate	0.009
Calcium Chloride	0.052
Sodium Chloride	0.569
Purified Water	99.338

Indications for Use: 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® 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.

Testing Summary: No performance testing was conducted.

Shelf Life: Accelerated shelf life testing equivalent to 3 years was conducted both on the package to make sure its integrity was intact at the end of 3 years equivalent and on the liquids to make sure the solutions did not exhibit microbial growth over the 3 years equivalent. This same type of testing was conducted on the predicate device with the only difference being in the shelf life package testing protocol needing to change slightly to be for a flexible package rather than a rigid one.

Predicate Device: Caphosol® (in vials) K030802

Substantial Equivalence:

Caphosol® has not changed its composition or indications for use. The only difference between the subject device and the predicate device is the subject device is in sachets and the predicate device is in vials.

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

Conclusion: Caphosol® in sachets is substantially equivalent to the predicate device Caphosol® in vials K030802. They have the same indications, similar device description, similar testing, and the same composition. Shelf life testing is similar to the shelf life testing of the predicate device with only minor differences due to the change in packaging. Both packages are tested for shelf life using scientifically valid methods so any differences in methods changing from a rigid to a soft container do not change the substantial equivalence of the devices.

Regulation Number and Section

N/A

	Caphosol® Artificial Saliva in sachetsSubject Device	Caphosol® Artificial Saliva in vialsPredicate Device K030802
Product Code	LFD	LFD
Indications for Use	Caphosol® is indicated for dryness ofthe mouth or throat (hyposalivation,xerostomia), regardless	Caphosol® is indicated for dryness ofthe mouth or throat (hyposalivation,xerostomia), regardless
	of the cause and regardless of	of the cause and regardless of
	whether the conditions are	whether the conditions are
	temporary or permanent. Caphosol®	temporary or permanent. Caphosol®
	is also indicated as an adjunct to	is also indicated as an adjunct to
	standard oral care in treating the	standard oral care in treating the
	mucositis that may be caused by	mucositis that may be caused by
	radiation or high dose chemotherapy.	radiation or high dose chemotherapy.
	Relief of dryness of the oral mucosa	Relief of dryness of the oral mucosa
	in these conditions is	in these conditions is
	associated with an amelioration of	associated with an amelioration of
	pain.	pain.
	Caphosol® may be used for relief of	Caphosol® may be used for relief of
	dryness of the oral mucosa when	dryness of the oral mucosa when
	hyposalivation results from	hyposalivation results from
	the following: surgery, radiotherapy	the following: surgery, radiotherapy
	near the salivary glands,	near the salivary glands,
	chemotherapy, infection or	chemotherapy, infection or
	dysfunction of the salivary glands;	dysfunction of the salivary glands;
	inflammation of the mouth or throat;	inflammation of the mouth or throat;
	fever; emotional	fever; emotional
	factors such as fear or anxiety;	factors such as fear or anxiety;
	obstruction of the salivary ducts;	obstruction of the salivary ducts;
	Sjogren's syndrome; and Bell's	Sjogren's syndrome; and Bell's
	Palsy.	Palsy.
	Caphosol® is also indicated for	Caphosol® is also indicated for
	dryness of the oral mucosa due to	dryness of the oral mucosa due to
	drugs such as antihistamines or	drugs such as antihistamines or
	atropine or other anticholinergic	atropine or other anticholinergic
	agents that suppress salivary	agents that suppress salivary
	secretion.	secretion.
	It may be used as part of an oral	It may be used as part of an oral
	hygiene program for patients with	hygiene program for patients with
	dry mouth. Caphosol®	dry mouth. Caphosol®
	provides intensive hygiene of the oral	provides intensive hygiene of the oral
	cavity, and may be used to help	cavity, and may be used to help
	relieve bad taste and to	relieve bad taste and to
	relieve offensive nasal discharge and	relieve offensive nasal discharge and
	crusting.	crusting.
Device	Caphosol® is an electrolyte solution	Caphosol® is an electrolyte solution
Description	resembling human saliva, designed in	resembling human saliva, designed in
	part to replace the normal ionic and	part to replace the normal ionic and
	pH balance in the oral cavity. It is	pH balance in the oral cavity. It is
	intended as a mouth rinse to	intended as a mouth rinse to
	moisten, lubricate, and clean the oral	moisten, lubricate, and clean the oral
	cavity including the mucosa of the	cavity including the mucosa of the
	mouth, tongue and throat. Caphosol®	mouth, tongue and throat. Caphosol®
	maintains moistness in the oral	maintains moistness in the oral
	cavity.	cavity.

	It relieves diffuse dryness andfissuring of the oral mucosa, as wellas painful tongue conditions due tohyposalivation. Patients having thiscondition are also prone to dentalcaries and candidal infections.Caphosol® is a partial substitute fornatural saliva. Caphosol® facilitateschewing and speaking; loosens toughmucus; prevent mucous membranesfrom sticking together, helps removenasal crust and relieve nasalsoreness; improves adherenceof dentures, and also relieves badtaste. Caphosol® is an adjunct tostandard oral care for treating themucositis that may be caused byradiation or high dose chemotherapy.Relief of dryness of the oral mucosain these conditions is associated withan amelioration ·of pain.Caphosol® is a preparationcomprising two separately packagedaqueous solutions, a phosphatesolution (Caphosol® A) and a calciumsolution (Caphosol® B) which whenboth sachet solutions are combinedin equal volumes form a solutionsupersaturated with respect to bothcalcium and phosphate ions.	It relieves diffuse dryness andfissuring of the oral mucosa, as wellas painful tongue conditions due tohyposalivation. Patients having thiscondition are also prone to dentalcaries and candidal infections.Caphosol® is a partial substitute fornatural saliva. Caphosol® facilitateschewing and speaking; loosens toughmucus; prevent mucous membranesfrom sticking together, helps removenasal crust and relieve nasalsoreness; improves adherenceof dentures, and also relieves badtaste. The purpose of this premarketnotification is to expand the claimsfor Caphosol® to allow Caphosol® tobe marketed as an adjunct tostandard oral care for treating themucositis that may be caused byradiation or high dose chemotherapy.Relief of dryness of the oral mucosain these conditions is associated withan amelioration of pain.Caphosol® is a preparationcomprising two separately packagedaqueous solutions, a phosphatesolution (Caphosol® A) and a calciumsolution (Caphosol® B) which whenboth ampoule solutions whencombined in equal volumes form asolution supersaturated with respectto both calcium and phosphate ions.
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 Lifetesting	Yes	Yes
includes liquidand packagetesting