← Product Code LFD · K234015 # Caphosol® Artifical Saliva (32 doses sachet box) (K234015) _Eusa Pharma (Uk) Limited · LFD · Mar 11, 2024 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K234015 ## Device Facts - **Applicant:** Eusa Pharma (Uk) Limited - **Product Code:** LFD - **Decision Date:** Mar 11, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Intended 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® 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 Story Caphosol® is an electrolyte solution (calcium and phosphate ions) designed to mimic human saliva; functions as a mouth rinse to moisten, lubricate, and clean the oral cavity, tongue, and throat. Comprises two separately packaged aqueous solutions (phosphate solution A and calcium solution B) mixed in equal volumes by the user immediately before use to form a supersaturated solution. Used by patients at home or in clinical settings to facilitate chewing/speaking, loosen mucus, prevent mucosal adhesion, remove nasal crust, and improve denture adherence. Acts as an adjunct to standard oral care for mucositis; provides relief from dryness and associated pain. Benefits include improved oral hygiene, reduced bad taste, and relief of nasal soreness. ## Clinical Evidence No clinical data provided; bench testing only. Accelerated shelf-life testing (3-year equivalent) performed to verify liquid stability and package integrity. ## Technological Characteristics Electrolyte solution containing dibasic sodium phosphate (0.032%), monobasic sodium phosphate (0.009%), calcium chloride (0.052%), sodium chloride (0.569%), and purified water (99.338%). Two-part aqueous system (sachets) mixed to form a supersaturated calcium/phosphate solution. Shelf life: 3 years. ## Predicate Devices - Caphosol® (in vials) ([K030802](/device/K030802.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 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; Siogren'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. 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. 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. The solution after mixing the contents of solutions A and B contains: {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® 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. 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. | | Caphosol® Artificial Saliva in sachets
Subject Device | Caphosol® Artificial Saliva in vials
Predicate Device K030802 | |-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | LFD | LFD | | Indications for Use | Caphosol® is indicated for dryness of
the mouth or throat (hyposalivation,
xerostomia), regardless | Caphosol® is indicated for dryness of
the 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.… --- **Source:** [https://fda.innolitics.com/device/K234015](https://fda.innolitics.com/device/K234015) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com