SaliPen Human Factors Study for OTC Labeling
Phase: NA
Conditions: Xerostomia
Sponsor: Saliwell Ltd.

 
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SaliPen - Human Factors Study 
for OTC labeling 
 
 
Test Product:
SaliPen
Sponsor's Name: 
Sponsor's Address: 
Saliwell Ltd. 
65 Hatamar St. 
Harutzim 6091700 
Israel 
Sponsor’s Telephone Number:
Sponsor’s Fax Number: 
Tele# (+972).3.534.7592
Fax# (+972).77.353.4338 
Study Number and version:
Version Date: 
1
August 31, 2021 
 

 
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Table Of Content 
1. 
Investigators' Statement _______________________________________________________ 3 
2. 
Study Synopsis _______________________________________________________________ 4 
3. 
Study Objective and Rationale ___________________________________________________ 5 
3.1. 
The study objective ______________________________________________________________ 5 
3.2. 
The study rationale ______________________________________________________________ 6 
4. 
Brief Study Description _________________________________________________________ 6 
5. 
Detailed Study Description ______________________________________________________ 6 
5.1. 
Phase I ________________________________________________________________________ 6 
5.2. 
Phase II ________________________________________________________________________ 7 
6. 
Study Design _________________________________________________________________ 7 
7. 
Arms and Interventions ________________________________________________________ 7 
8. 
Features to be studied _________________________________________________________ 8 
9. 
Outcome Measures ____________________________________________________________ 8 
10. 
Eligibility Criteria ___________________________________________________________ 8 
10.1. 
Inclusion criteria: ________________________________________________________________ 8 
10.2. 
Exclusion criteria: _______________________________________________________________ 8 
11. 
Reportable Events ___________________________________________________________ 9 
12. 
Contacts and Locations _______________________________________________________ 9 
13. 
Task Analysis _______________________________________________________________ 9 
14. 
Ethical and Legal Aspects ____________________________________________________ 10 
14.1. 
Compliance with Regulations Applicable to Clinical Trials ______________________________ 10 
14.2. 
Informed Consent ______________________________________________________________ 10 
14.3. 
Institutional Review Board (IRB) __________________________________________________ 11 
14.4. 
Protocol Amendments __________________________________________________________ 11 
14.5. 
Subject Confidentiality __________________________________________________________ 11 
15. 
Guide for participants _______________________________________________________ 12 
16. 
Evaluation Sheets __________________________________________________________ 14 
 
 

 
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1. 
Investigators' Statement 
 
I have read the protocol: 
  
A Clinical Study Evaluating the SaliPen Usability Engineering Study for OTC labeling  
that contains all the information necessary for the conduct of the study. I agree to conduct the study 
as outlined therein and in accordance with to the Declaration of Helsinki 1964 and all its updates. 
The undersigned confirms that I agree to conduct the study under the conditions described in this 
protocol: 
  
  
________________________________                             |__| |__| / |__| |__| / |__| |__| 
      Principal Investigator (Print Name)                                     Date   (dd / mm / yy) 
  
                                                                   
     Principal Investigator's Signature  

 
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2. 
Study Synopsis 
Protocol Number 
21-D-246 
Study Title:
SaliPen Human Factors Study for OTC labeling
Number of Centers: 
One center  
Countries: 
USA  
Study Duration:
The expected duration of the study for each subject on each Phase 
is about one day.  
Total Study Duration:
TBD
Expected Subject 
Enrollment: 
The total expected enrollment is 16 subjects for Phase I and 16 for 
Phase II.  
Study Population:
Subjects attending an oral health clinic.
Study Objectives: 
The primary objective of this research is to assess the human 
factors in relabeling the SaliPen from a prescription-based device to 
an OTC.  
Primary performance endpoints: 
 
The user can select the device properly. 
 
The user can use the device as instructed in the IFU. 
Study Design:
This will be a single-center, prospective, open-label study.
Screening: Eligible subjects will be included in the study. 
Test Participant 
Recruitment Plan: 
Patients visiting the participating clinic will be asked to participate 
in the study sequentially (by order of recall or arrival at the clinic).  
For Phase I, enrollment will be stopped once the goal of eight (8) 
subjects with xerostomia and eight (8) subjects without xerostomia 
has been reached.  
For Phase II, 16 subjects with xerostomia that are evaluated or 
treated at the clinic will be enrolled sequentially (by order of recall 
or arrival at the clinic). Patients that have participated in Phase I 
and have xerostomia will be invited to participate in Phase II, as 
well. 
Participants will receive $25 cash for participating in either phase of 
this study. Participants in both phases will receive $50 cash. 

 
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Participants in Phase II will be given the option to keep the SaliPen 
device they will use in the study. 
Inclusion Criteria: 
Phase I: Any adult person that is 18 years old or older 
Phase II: Subjects with xerostomia that are 18 years old or older 
Exclusion Criteria: 
Phase I:  
 Children and adolescents (persons under 18 years of age) 
 Persons with experience in the use of SaliPen 
 
Phase II:  
• 
Persons with experience in the use of SaliPen 
 
Children and adolescents (persons under 18 years of age) 
• 
Epileptic disorder 
• 
Persons that are allergic to the surface materials of the device 
o Electrodes: coated with gold 
o Body: made of methyl vinyl silicone rubber 
 
Use of a pacemaker 
 
Pregnancy 
 
Psychiatric or psychological disorders 
 
Involuntary muscle movement disorder (such as Parkinson’s) 
 
Neurologic disorder in head and neck area 
Medical Device 
Description:  
Electrical salivary stimulator system. 
Study Endpoints:
Performance Endpoints:
 Correct selection of the product. 
 Product use in accordance with the IFU. 
Statistical Analysis 
A simple descriptive statistical analysis will be utilized to calculate 
the percentage of correct answers and the percentage of subjects 
that passed the evaluation in each phase of the study. 
 
3. 
Study Objective and Rationale 
3.1. 
The study objective 
This is a Summative Evaluation aimed at evaluating the use of SaliPen (the study product) as an Over-
The-Count (OTC) device rather than as a prescription device. 

 
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3.2. 
The study rationale 
• 
Xerostomia (dry mouth) is the subjective feeling of oral dryness. The diagnosis by the practitioner 
is mostly relying on the patient's feeling. 
• 
Most patients are elderly, many of them with limited mobility. 
• 
Nowadays, those patients are at high risk for COVID-19 infection, morbidity and even mortality.  
• 
The fear of exposure at the practitioner's clinic to obtain an Rx inhibits them from treating their 
xerostomia with the SaliPen.  
• 
The cost of getting a prescription is an additional burden. 
• 
The SaliPen is an OTC in other parts of the world for years. 
• 
The performance of potential American users of an OTC SaliPen device will be evaluated in this 
usability study. 
 
As a result, many patients leave their oral dryness untreated, with the well-known consequences of poor 
oral functions, oral health, daily suffering, and more.  
 
4. 
Brief Study Description 
This Human Factors Validation Testing will assess user interactions to verify the capability of potential 
users to assess if the study product fits their needs and if they can use it correctly based on the provided 
Information For User (IFU)?  
More specifically, this is a non-comparative case series study and is subdivided into two major parts. 
Those parts are:  
1- Phase I: aimed at testing if, based on the IFU, the potential subjects can decide whether the 
study product is or is not appropriate to treat their condition and, 
2- Phase II: aimed at assessing whether the users can use the study product correctly without 
counseling by a health care provider. 
 
Condition or disease  
Intervention/treatment  
Xerostomia
SaliPen
 
5. 
Detailed Study Description 
5.1. Phase I  
To simulate an OTC setting, potential subjects will be requested to read the label text on the outside of 
the study product package (external labeling) and determine whether the study product addresses their 
needs, without a provider direction or assistance.  

 
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5.2. Phase II  
The study product will be dispensed only to those subjects who will indicate that they voluntarize to 
participate in this phase of the study.  
At Phase II subjects with xerostomia and that are willing to try the study product, will be requested to 
use it with no training, except for their understanding of the User Manual (internal labeling). Those 
subjects will use the study product in a supervised clinical setting. Subjects who report any discomfort 
will be offered the option to pause and remove the device upon such a request. 
Correct use verification will be performed by the study investigators. Subjects will answer questions 
regarding product use, clarity of the IFU, ease of use, etc.  Subjects will also receive an exam of their oral 
cavity. 
 
6. 
Study Design 
Study Type:
Interventional (Clinical Trial) 
Enrollment:
Phase I: 16 participants, 8 with xerostomia and 8 without 
xerostomia 
Phase II: 16 participants with xerostomia (may include 
participants in Phase I with xerostomia)  
Allocation:
N/A
Intervention Model:
Single Group Assignment 
Masking:
None (Open Label)
Primary Purpose:
Human Factor Validation - Usability Engineering assessment 
for OTC labeling 
Official Title:
SaliPen Usability Engineering Study for OTC labeling
Study Start Date:
TBD 
 
According to the FDA Guidance document “Applying Human Factors and Usability Engineering to Medical 
Devices”, a sample of 15 people to detect most of the problems in a user interface constitutes a practical 
minimum number of participants for human factors validation testing. This sample size theoretically 
provides the best possibility of detecting user interface design flaws while limiting the amount of 
resources required. 
 
7. 
Arms and Interventions 
Arm  
Intervention/treatment  
Experimental: Use of SaliPen medical device 
Use according to self-decision. 
 

 
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8. 
Features to be studied 
 
The points of interaction between the user and the device (User Interface) will be evaluated, including: 
- 
the elements of the device with which the user interacts (i.e., those parts of the device that users 
see and touch), and 
- 
the IFU (including packaging, labeling, User Manual, etc.). 
The following parameters will be studied: 
- 
Hazard: Potential source of harm, if any. 
- 
Use error: User action or lack of action that was different from that expected by the 
manufacturer. 
 
9. 
Outcome Measures 
1. Percentage of participants who appropriately will self-select the study product for use under 
simulated OTC conditions [Phase I]. Following the standard norms for the Rx-to-OTC 
switch process, this outcome is a validation of potential consumers' ability to self-diagnose the 
condition and to decide that treatment with the product is appropriate for them. 
2. Percentage of participants who correctly will use the study product when dispensed under 
simulated OTC conditions [Phase II]. Correct use means that the participants will demonstrate the 
use of the study product according to the guidelines outlined in the User Manual.  
Following the standard norms for the therapy of Rx-to-OTC switch process, this outcome is a 
validation of potential consumers' ability to self-treat with the product according to the product's 
supplied IFU.   
 
10. 
Eligibility Criteria 
Ages Eligible for Study:   
18 years of age and older for Phase I and Phase II 
Genders Eligible for Study:   
Female and male 
10.1. Inclusion criteria: 
1- For Phase I: 8 subjects with xerostomia and 8 without that are 18 years old or older 
 
2- For Phase II: Subjects with xerostomia that are 18 years old or older  
10.2. Exclusion criteria: 
1- For Phase I:  
 
Children and adolescents (persons under 18 years of age) 
 
Persons with experience in the use of SaliPen 

 
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2- For Phase II: Subjects for them the study product is not indicated and/or do not agree to 
participate in Phase II. For the avoidance of doubt, the following conditions are exclusion criteria: 
 
Persons with experience in the use of SaliPen 
 
Children and adolescents (persons under 18 years of age) 
 
Epileptic disorder 
 
Persons that are allergic to the surface materials of the device 
o Electrodes: coated with gold 
o Body: made of methyl vinyl silicone rubber 
 
Use of a pacemaker 
 
Pregnancy 
 
Psychiatric or psychological disorders 
 
Involuntary muscle movement disorder (such as Parkinson’s) 
 
Neurologic disorder in head and neck area 
 
11. 
Reportable Events 
An adverse event (AE) is defined as any untoward medical occurrence in a subject during the 
investigation.  Any findings will be documented on the AE CRF.   
 Serious AEs include any events resulting in death, decreased life expectancy, life-threatening situations, 
persistent or permanent disability/incapacity, hospitalization, or congenital anomaly/birth defect or 
other important medical event. Within 24 hours, the Investigator will submit a written report 
documenting the circumstances of the serious AE. 
While AE’s and SAE’s are not anticipated, should an incident occur during the visit or a subject report an 
event following the visit, the AE will be recorded in the subject’s study records and followed to 
resolution. 
 
12. 
Contacts and Locations 
The subjects will randomly be recruited at clinical settings that deal with oral health, like dental or head 
and neck clinics. The outcome measure will be performed in this setting. Data will be collected on-site by 
the clinical staff. 
 
13. 
Task Analysis 
The Task Analysis breaks down the device use process into discrete sequences of tasks. The tasks will be 
analyzed to identify the user interface components involved, the use errors that users could make and 
the potential results of all use errors. The following task analysis is planned: 

 
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Phase
# 
Task 
I
1
Potential user knows the intended use of the study product.
 
2 
Potential user assesses correctly whether the study product is indicated for 
him/her. 
3
Potential user assesses correctly whether he/she can use the study product or
not or conditioned to a medical advice. 
II 
1 
User knows the maximum amount of times and the maximum length of time 
he/she can use the study product. 
 
2 
User knows how to switch the study product ON and OFF. 
3
User knows how to place the study product into his/her mouth.
 
4 
User knows how to remove the study product from his/her mouth. 
5
Patient knows how to separate the intraoral and the extraoral units.
 
6 
Patients reports any significant discomfort felt with SaliPen 
 
7 
Patients reports any significant difficultis in using SaliPen 
 
Each task will be evaluated by the binary grading scheme satisfactory/unsatisfactory. The evaluator will 
be a member of the study team.  
For Phase I - 100% success is needed to pass the evaluation for every subject. 
For Phase II - 85% success rate is needed to pass the evaluation for every subject. 
The Human Factor Study will be considered successful if 85% of the participants passed each Phase of 
the test.  
 
14. 
Ethical and Legal Aspects 
14.1. 
Compliance with Regulations Applicable to Clinical Trials 
The study will be conducted according to the laws, regulations and administrative provisions relating to 
the implementation of Good Clinical Practice in the conduct of clinical trials. 
14.2. 
Informed Consent 
The principles of Informed Consent, according to the Declaration of Helsinki 1964 and all its updates, will 
be followed. A subject should not enter a clinical study until he/she has been properly informed, has 
been given time to contemplate participation, and has freely given his/her consent by signing and dating 
the IRB-approved informed consent form. This must be done prior to performing any study-related 
procedures. 
The proposed consent form and any other documents relevant to the consent process must be 
submitted to the Institutional Review Board (IRB), together with the protocol, and must be approved 
prior to the study start. 

 
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A copy of the fully signed and dated Informed Consent and any other documents relevant to the consent 
process will be given to the subject and the original will be maintained at the site. 
14.3. 
Institutional Review Board (IRB) 
The study must have approval, in writing, by an appropriate Institutional Review Board (IRB).  
Records of the IRB review and approval of all documents pertaining to this study must be kept on file by 
the investigator.  
Serious or unanticipated adverse events (SAEs) must also be reported to the IRB by the Investigator. 
14.4. 
Protocol Amendments 
Protocol amendments must be approved by the IRB prior to implementation. 
14.5. 
Subject Confidentiality 
All subject data will be identified only by a subject identification number and date of birth.  
 
 
 
 
 

 
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15. 
Guide for participants 
Phase I - Self-Administered Questionnaire 
I.D.: __________________________DATE: ____________ 
 
Please read the cover and the back cover of the device and 
answer the following questions: 
 
 
1. Is the device for Dry Mouth Relief?  
 Yes 
 No 
 
2. Does the device fit your needs? 
 Yes 
 No 
 
3. If the device fits your needs, please check a box (only one): 
 
 I can use the device.  
 
 I cannot use the device because, either: 
 I'm under 18 years of age. 
 I suffer from epileptic disorder. 
 I'm allergic to gold or silicone rubber. 
 
 I need a professional consultation before buying the device 
because, either: 
 I use a pacemaker. 
 I’m pregnant. 
 I suffer from a psychiatric or psychological disorder. 
 I suffer from an involuntary movement disorder (for example 
Parkinson’s disease). 
 I have a neurologic disorder in the head and neck area (for 
example trigeminal neuralgia). 
 
 

 
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Phase II - Interviewer-administered questionnaire 
I.D.: __________________________DATE: ____________ 
 
Please read the user manual and hold the device.  
 
Firstly, your oral cavity will be examined. 
 
Next, you will be asked the following questions and to 
perform the following tasks: 
 
1. How many times can you use the device in a day and how many minutes 
(maximum time) you can use the device in one session? (See page 2)  
 
2. How do you turn ON and OFF the device? (See page 6) 
 
3. How do you insert the device in your mouth? (See pages 7, 8 and 9 and watch 
the video “How to use the SaliPen device to stop dry mouth”) 
 
4. How do you take the device out of your mouth? (See pages 7, 8 and 9) 
 
5. How do you detach and reattach the white extraoral command unit from the 
blue intraoral stimulating unit? (See page 6) 
 
6. Did you experience discomfort with the SaliPen in your mouth? 
 
7. Did you experience difficulties in using the SaliPen? 
 
Finally, your oral cavity will be examined again. 
 
 
 
 
 

 
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16. 
Evaluation Sheets 
 
Phase I 
Subject I.D.: __________________________ 
EVALUATOR NAME: _______________________ 
Date: ______________ 
 
Step 1: Anamnesis taken by the evaluator 
 
Ruling 
Parameters 
yes 
no 
Indication 
Xerostomia 
 
 
Contraindications 
Under 18 years old 
 
 
Epileptic disorder 
 
 
Allergy to gold 
 
 
Allergy to silicone
Precautions – 
medical advice 
recommended 
before purchase 
Pacemaker
Pregnant
 
 
Psychiatric or psychological disorder
Involuntary movement disorder (e.g., Parkinson’s disease) 
 
 
Neurologic disorder in the head and neck area (e.g., trigeminal 
neuralgia) 
 
 
 
 
Step 2: Self-Administered Questionnaire - Subject pre-purchase selection of the study 
product  
 
Subjects will be asked to read the cover and the back cover of the device package and 
answer the following questions: 
 
Question / Statement 
Participant’s 
answer
Correct 
answer
Success (1) / 
Failure (0)
1. Is the device for Dry Mouth 
Relief?  
 Yes
 No 
 Yes
 No 
2. Does the device fit your needs?
 Yes
 No 
 Yes
 No 
3. If the device fits your needs, please check a box (only one):
 
I can use the device
 Yes
 No 
 
 Yes
 No 

 
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Question / Statement 
Participant’s 
answer 
Correct 
answer 
Success (1) / 
Failure (0) 
I cannot use the device because, either:
 
I'm under 18 years of age. 
 
I suffer from epileptic disorder. 
 
I'm allergic to gold or silicone rubber. 
 Yes
 No 
 Yes
 No 
I need professional advice before using 
the device because, either: 
 I use a pacemaker. 
 I’m pregnant. 
 I suffer from a psychiatric or 
psychological disorder. 
 I suffer from an involuntary movement 
disorder (for example Parkinson’s 
disease). 
 I have a neurologic disorder in the head 
and neck area (for example trigeminal 
neuralgia). 
 Yes 
 No 
 Yes 
 No 
 
 
Step 3: Summary evaluation (to be completed by the evaluator) 
 
Total questions/statements for those with dry mouth: 5 
Number of correct answers: _____ 
Total questions/statements for those without dry mouth: 2 
Number of correct answers: _____ 
Passed? (all answers/statements should be correct):  
 Yes 
 No 
 
 
 
 
 
 

 
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Phase II 
Subject I.D.: __________________________ 
 
Step 1: Oral soft tissue examination 
 
EVALUATOR NAME: _______________________ 
DATE: ____________________ 
 
 
Normal
Abnormal
If Abnormal, please specify findings 
Labial Mucosa (including lips) 
 
 
 
Buccal Mucosa 
 
 
 
Mucogingival Folds 
 
 
 
Gingival Mucosa 
 
 
 
Edentulous Ridge/Retromolar 
area 
 
 
 
Tongue 
 
 
 
Sublingual Area/floor of mouth 
 
 
 
Submandibular area 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Step 2: Assessment of subject performance 
 
EVALUATOR NAME: _______________________ 
DATE: ____________________ 
 
Please evaluate how the participant addresses the following questions/tasks: 
Questions 
Participant’s 
answer 
Correct 
answer 
Success (1) / 
Failure (0) 
1. How many times in a day and
how many minutes (maximum 
time) you can use the device in 
one session? 
Tasks 
 
Evaluation 
Success (1) / 
Failure (0) 
2. How do you turn on ON and 
OFF the device? 
3. How do you insert the device 
in your mouth? 
4. How do you take the device
out of your mouth? 
5. How do you detach and 
reattach the white extraoral 
command unit from the blue 
intraoral stimulating unit? 
 
 
Subject assessment (place an x where relevant for you) 
Note: Success (1) is meant if options 2 or 3 were chosen 
Failure (0) is meant if option 1 was chosen
Success (1) / 
Failure (0)  
6. Did you experience discomfort 
with the SaliPen in your 
mouth? 
1- Severe discomfort 
 
2- Moderater discomfort
3- No discomfort
7. Did you experience difficulties 
in using the SaliPen? 
1- Severe discomfort
2- Moderater discomfort
3- No discomfort 
Summary evaluation: 
Total questions/tasks/self-assessments: 7 
Number of points: _____ 
Passed? (minimum 6 points):  
 Yes 
 No 

 
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Step 3: Oral soft tissue examination 
 
EVALUATOR NAME: _______________________ 
DATE: ____________________ 
 
 
Normal
Abnormal
If Abnormal, please specify findings 
Labial Mucosa (including lips) 
 
 
 
Buccal Mucosa 
 
 
 
Mucogingival Folds 
 
 
 
Gingival Mucosa 
 
 
 
Edentulous Ridge/Retromolar 
area 
 
 
 
Tongue 
 
 
 
Sublingual Area/floor of mouth 
 
 
 
Submandibular area