(83 days)
Not Found
No
The device description and intended use focus on the chemical composition and physical properties of the solution, with no mention of AI or ML technologies.
Yes.
The device is indicated for treating mucositis caused by radiation or high-dose chemotherapy, and it ameliorates pain, which are therapeutic actions.
No
Caphosol® is an electrolyte solution intended to relieve symptoms such as dryness of the mouth or throat, and to be an adjunct in treating mucositis. It is a treatment (therapeutic) device, not a diagnostic device, as it does not diagnose medical conditions.
No
The device description clearly states that Caphosol® is an electrolyte solution, a physical substance, and not software.
Based on the provided information, Caphosol® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD is a medical device used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Caphosol®'s Function: Caphosol® is a mouth rinse intended for direct application to the oral cavity to relieve symptoms like dryness and mucositis. It is a topical treatment and a substitute for saliva, not a device used to analyze samples from the body.
- Intended Use: The intended use clearly describes its application for symptom relief and oral hygiene, not for diagnostic testing.
- Device Description: The description details its composition as an electrolyte solution for rinsing, reinforcing its topical nature.
Therefore, Caphosol® falls under the category of a therapeutic or supportive medical device, not an IVD.
N/A
Intended Use / 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; 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.
Product codes (comma separated list FDA assigned to the subject device)
LFD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth or throat, oral mucosa, oral cavity, tongue, nasal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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)
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)
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4
Caphosol® Artificial Saliva 510(k) Summary December 4, 2023
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. |
| | 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 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 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
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. | 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. 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 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 ampoule solutions when
combined in equal volumes form a
solution supersaturated with respect
to 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 Life
testing | Yes | Yes |
| includes liquid
and package
testing | | |
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.