(120 days)
SalivaMAX™ is indicated for dryness of the mouth or throat (hyposalivation, xerostomia, mucositis), regardless of the cause and regardless of whether the condition is temporary or permanent. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.
SalivaMAX™ is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by radiation or high dose chemotherapy.
SalivaMAX™ may be used for the relief of dryness of the oral mucosa when hyposalivation results from the following: pre/post surgery, radiotherapy, 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, Bell's Palsy, and Sjogren's syndrome. SalivaMAX™ is also indicated for dryness of the oral mucosa due to drugs such as antihistamines, atropine, or other anticholinergeic agents that suppress salivary secretion.
SalivaMAX™ may be used as part of an oral hygiene program for patients with dry mouth. SalivaMAX™ provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste, relieve offensive nasal discharge, and crusting.
SalivaMAX™ is an artificial saliva that is provided in disposable packets.
SalivaMAX™ is comprised of powdered ingredients that when combined with 30 mL (1 oz.) of water, produces a supersaturated calcium phosphate solution. SalivaMAX™ is packaged in singleuse packets and will be provided non-sterile and is not intended to be sterilized before use.
Because SalivaMAX™ is to be administered several times per day it will primarily be used at home, office or other non-clinical settings. However, SalivaMAXTM may also be used in clinical or healthcare facility settings where patients are receiving inpatient services.
The goal of administering SalivaMAX™ is to relieve chronic and temporary xerostomia and mucositis. SalivaMAX™ is a partial substitute for natural saliva and intended to moisten, lubricate, and clean the oral cavity including the mucosa of the mouth, tongue, and throat. SalivaMAX™ facilitates chewing and speaking; and can relieve bad breath.
SalivaMAX™ is composed of US Pharmacopeia grade calcium, phosphate, bicarbonate, and chloride electrolytes. Each application of SalivaMAX™ is to swish half the solution for 1 minute, expectorate, then repeat for the remaining solution. Given that the rinse is topical with a maximum rinse time of 20 minutes per day (2 minutes per application x maximum 10 times per day), SalivaMAX™ is considered a surface contacting device with a limited duration of contact.
Key performance specifications of SalivaMAX™ are an in solution pH range of 6.25 - 7.5 and solubility in water.
The provided text describes the SalivaMAX™ device, its indications for use, and a comparison with predicate devices to establish substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria for performance.
Therefore, the requested information elements related to a study proving acceptance criteria cannot be fully extracted/answered from this document.
However, based on the Summary of Testing section (page 6), some information can be inferred or directly stated regarding "acceptance criteria" through the lens of establishing substantial equivalence to predicate devices.
Here's what can be extracted, and where information is missing or not applicable, it is noted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (inferred from comparative testing) | Reported Device Performance (SalivaMAX™) | Notes |
|---|---|---|
| Dissolution equivalent to NeutraSal | Equivalent to NeutraSal | The document states "The results were equivalent for SalivaMAX™ and the primary predicate, Neutrasal, providing further evidence of substantial equivalence." This implies that the dissolution profile of SalivaMAX™ met an "acceptance criterion" of being equivalent to NeutraSal. |
| pH between 6.25 - 7.5 (in solution) | 6.69 (in solution) | The "Key performance specifications" (page 4) state a target pH range. Table 1 (page 5) reports the actual pH of SalivaMAX™. The reported pH (6.69) falls within the specified range (6.25 - 7.5). |
| pH equivalent to NeutraSal | Equivalent to NeutraSal | The "Summary of Testing" states "pH evaluation" was conducted and "results were equivalent for SalivaMAX™ and the primary predicate, Neutrasal". The NeutraSal pH is reported as 6.72 in Table 1, very close to SalivaMAX™'s 6.69. |
| Solubility in water | Soluble in water | This is listed as a "Key performance specification" for SalivaMAX™ (page 4) and as a "Comparison Parameter" in Table 1 (page 5) where it is also stated as "Soluble in water" for the subject device and predicates. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to "bench testing" but does not provide details on the number of samples tested for dissolution or pH.
- Data Provenance: Not specified. It's bench testing, likely conducted internally or by a contract lab, but no country of origin or retrospective/prospective nature is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This document describes bench testing (dissolution, pH evaluation) for a liquid solution, not diagnostic performance or a scenario where human experts would establish ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, not for objective bench tests like dissolution and pH.
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 document is for a medical device (artificial saliva solution) that does not involve AI or human "readers" interpreting cases. The testing described is bench testing for physico-chemical properties.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a solution for oral rinse, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For pH and solubility:
- pH: The "ground truth" is established through standard laboratory measurement techniques using a pH meter, yielding an objective value.
- Solubility: The "ground truth" is whether the powder dissolves in water, an objective observation.
- For dissolution:
- The "ground truth" or acceptance standard was equivalence to the predicate device, NeutraSal, which itself would have established its dissolution profile through standard laboratory methods.
8. The sample size for the training set
- Not Applicable. This refers to bench testing of a medical device solution; there is no "training set" in the context of machine learning or algorithms.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for this type of device and testing.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2015
Forward Science LLC Mr. Brian Pikkula President 3944 Bluebonnet Dr. Stafford, Texas 77477
Re: K152406
Trade/Device Name: SalivaMAXTM Regulation Number: N/A Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LFD Dated: November 12, 2015 Received: November 13, 2015
Dear Mr. Pikkula:
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.
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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 yours,
Tina Kiang -
for Erin I. Keith, M.S. 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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K152406/S002
4. Indications for Use
| Applicant: | Forward Science LLC |
|---|---|
| 3944 Bluebonnet Dr | |
| Stafford, TX 77477 | |
| Ph: 855-696-725 | |
| Fax: 855-329-6725 |
K152406 510(k) Number:
Device Name: SalivaMAXTM
Indications For Use:
SalivaMAX™ is indicated for dryness of the mouth or throat (hyposalivation, xerostomia, mucositis), regardless of the cause and regardless of whether the condition is temporary or permanent. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.
SalivaMAX™ is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by radiation or high dose chemotherapy.
SalivaMAX™ may be used for the relief of dryness of the oral mucosa when hyposalivation results from the following: pre/post surgery, radiotherapy, 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, Bell's Palsy, and Sjogren's syndrome. SalivaMAX™ is also indicated for dryness of the oral mucosa due to drugs such as antihistamines, atropine, or other anticholinergeic agents that suppress salivary secretion.
SalivaMAX™ may be used as part of an oral hygiene program for patients with dry mouth. SalivaMAX™ provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste, relieve offensive nasal discharge, and crusting.
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Forward Science LLC
3944 Bluebonnet Stafford, TX 77477 USA Ph: 855-696-7254
5. 510(k) SUMMARY
| Submitted by: | Forward Science LLC3944 Bluebonnet DrStafford, TX 77477Ph: 855-696-7254Fax: 855-329-6725 |
|---|---|
| Contact Person: | Brian Pikkula, PhD |
| Date Prepared: | December 16, 2015 |
| Proprietary Name: | SalivaMAX™ |
| Common Name: | Artificial Salvia |
| Classification Name: | Unclassified |
| Device Class: | Unclassified (Pre-Amendment) |
| Panel: | Dental |
| Product Code: | LFD |
| Predicate Devices: | Primary PredicateNeutrasal (K093642)Invado Pharmaceuticals25 Ravenna DrivePomona, NY, 10970 |
| Reference PredicateCaphosol (K030802) |
New England Biomedical Research, Incorporated 96 West Main Street. P.O. Box 809 Northborough, MA 01532
Device Description:
SalivaMAX™ is an artificial saliva that is provided in disposable packets.
SalivaMAX™ is comprised of powdered ingredients that when combined with 30 mL (1 oz.) of water, produces a supersaturated calcium phosphate solution. SalivaMAX™ is packaged in singleuse packets and will be provided non-sterile and is not intended to be sterilized before use.
Because SalivaMAX™ is to be administered several times per day it will primarily be used at home, office or other non-clinical settings. However, SalivaMAXTM may also be used in clinical or healthcare facility settings where patients are receiving inpatient services.
The goal of administering SalivaMAX™ is to relieve chronic and temporary xerostomia and mucositis. SalivaMAX™ is a partial substitute for natural saliva and intended to moisten, lubricate,
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Forward Science LLC
and clean the oral cavity including the mucosa of the mouth, tongue, and throat. SalivaMAX™ facilitates chewing and speaking; and can relieve bad breath.
SalivaMAX™ is composed of US Pharmacopeia grade calcium, phosphate, bicarbonate, and chloride electrolytes. Each application of SalivaMAX™ is to swish half the solution for 1 minute, expectorate, then repeat for the remaining solution. Given that the rinse is topical with a maximum rinse time of 20 minutes per day (2 minutes per application x maximum 10 times per day), SalivaMAX™ is considered a surface contacting device with a limited duration of contact.
Key performance specifications of SalivaMAX™ are an in solution pH range of 6.25 - 7.5 and solubility in water.
Intended Use:
SalivaMAX™ is indicated for dryness of the mouth or throat (hyposalivation, xerostomia, mucositis), regardless of the cause and regardless of whether the condition is temporary or permanent. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.
SalivaMAX™ is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by radiation or high dose chemotherapy.
SalivaMAX™ may be used for the relief of dryness of the oral mucosa when hyposalivation results from the following: pre/post surgery, radiotherapy, chemotherapy, infection of the salivary glands, inflammation of the mouth or throat, fever, emotional factors such as fear or anxiety, obstruction of the salivary ducts, Bell's Palsy, and Sjogren's syndrome. SalivaMAX™ is also indicated for dryness of the oral mucosa due to drugs such as antihistamines, atropine, or other anticholinergeic agents that suppress salivary secretion.
SalivaMAX™ may be used as part of an oral hygiene program for patients with dry mouth. SalivaMAX™ provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste, relieve offensive nasal discharge, and crusting.
Substantial Equivalence
Between the subject device to the primary predicate, NeutraSal (K093642), there are no technological differences.
Comparing the subject device to the reference predicate, Caphosol (K030802), there are two technological differences. First, Caphosol is provided in a two vial, liquid package. This difference does not change its substantial equivalence because both the subject device and the reference predicate are a supersaturated calcium phosphate rinse when applied. The other technological difference from the reference predicate is the addition of sodium bicarbonate and silicon dioxide in the subject device.
Note, however, that sodium bicarbonate and silicon dioxide are ingredients in the primary predicate, NeutraSal. Therefore, the subject device is substantially equivalent to the primary predicate Neutrasal as the ingredients in the subject device and the primary predicate are the same.
SalivaMAX™ and the predicates, Neutrasal (primary predicate K093642) and Caphosol (reference predicate K030802) share the same labeling and intended uses, operation principles, and technical characteristics. Each uses supersaturated calcium phosphate as a partial substitute for natural saliva to relieve dry mouth. Therefore, SalivaMAXTM and the predicates, Neutrasal and Caphosol are substantially equivalent.
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Forward Science LLC
| Subject Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| ComparisonParameters | SALIVAMAXTM | NeutraSal(K093642) | Caphosol(K030802) |
| IntendedUse | SalivaMAXTM is indicated for dryness of the mouth or throat (hyposalivation, xerostomia, mucositis), regardless of the cause and regardless of whether the condition is temporary or permanent. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.SalivaMAXTM is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by radiation or high dose chemotherapy.SalivaMAXTM may be used for the relief of dryness of the oral mucosa when hyposalivation results from the following: pre/post surgery, radiotherapy, 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, Bell's Palsy, and Sjogren's syndrome. SalivaMAXTM is also indicated for dryness of the oral mucosa due to drugs such as antihistamines, atropine, or other anticholinergeic agents that suppress salivary secretion.SalivaMAXTM may be used as part of an oral hygiene program for patients with dry mouth. SalivaMAXTM provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste, relieve offensive nasal discharge, and crusting. | (OTC) Neutrasal is indicated for the dryness of the mouth (hyposalivation, xerostomia).(OTC) Neutrasal 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.(OTC): Neutrasal may be used as part of an oral hygiene program for patients with dry mouth. Neutrasal also provides intensive hygiene of the oral cavity.(Rx): Neutrasal is also indicated as an adjunct to standard oral care in relieving the discomfort associated with oral 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.(Rx): Neutrasal 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; fever; emotional factors such as fear or anxiety; obstruction of the salivary ducts; Sjogren's syndrome. | Caphosol is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the conditions is temporary or permanent. Caphosol is also indicated as an adjunct to standard oral care in 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 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. |
| ComparisonParameters(cont.) | Subject Device | Primary Predicate | Reference Predicate |
| SALIVAMAXTM | NeutraSal(K093642) | Caphosol(K030802) | |
| Area of Use | Oral cavity | Oral cavity | Oral cavity |
| Formulationin Solution | Supersaturated CalciumPhosphate | Supersaturated CalciumPhosphate | Supersaturated CalciumPhosphate |
| DiseaseState | Xerostomia and mucositis | Xerostomia and mucositis | Xerostomia and mucositis |
| Applications/Day | 2 - 10 as directed by physicianand severity | 2 - 10 as directed byphysician and severity | 2 - 10 as directed byphysician and severity |
| pH | 6.69 (in solution) | 6.72 (in solution) | unknown |
| Solubility | Soluble in water | Soluble in water | Soluble in water (alreadyin solution) |
| Prescription/OTC | Prescription | Prescription/OTC | Prescription |
| Packaging | Powder in sealed packet | Powder in sealed packet | Liquid in 2 sealed vials |
| Shelf life | 2 years | 2 years | unknown |
| Environmentof Use | Home and Clinic | Home and Clinic | Home and Clinic |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
Table 1. Comparison of Subject Device and Predicates
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Summary of Testing
Bench testing comparing SalivaMAX™ and Neutrasal were performed. The results were equivalent for SalivaMAX™ and the primary predicate, Neutrasal, providing further evidence of substantial equivalence. The testing consisted of:
- Dissolution Tests
- . pH evaluation
Conclusion
SalivaMAX™ is substantially equivalent to the primary predicate, NeutraSal, and the reference predicate, Caphosol, in that they share a principal technological characteristic; a supersaturated calcium phosphate rinse. They also possess a similar intended use of which the primary indication is the treatment of xerostomia and mucositis.
Additionally, the subject device, SalivaMAX™, obtained similar results in bench testing (dissolution and pH evaluation) as the primary predicate, NeutraSal, giving further credence to its substantial equivalence.
N/A