Continued Evaluation of the Preceptis Medical, Inc. Tympanostomy Ear Tube Introducer
Phase: NA
Conditions: Otitis Media
Sponsor: Preceptis Medical, Inc.

 
 
 
 
  
 
 
 
 
 
INVESTIGATIONAL PLAN FOR 
CONTINUED EVALUATION OF THE 
PRECEPTIS MEDICAL INC. 
TYMPANOSTOMY EAR TUBE INTRODUCER  
 
A Non-Significant Risk Investigation 
 
 
Protocol Date: 
30 August 2013 
Revision:  
A1 
 
 
 
 
CONFIDENTIAL: 
DO NOT COPY ANY PORTIONS OF THIS DOCUMENT WITHOUT WRITTEN 
PERMISSION FROM Preceptis Medical, Inc. 
 
 
 
 
__________________________________ 
  
 
 
Preceptis Medical, Inc. 
505 Highway 169 N, Suite #560 
Plymouth, MN  55441 USA 
Telephone:  612-327-4795 

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INVESTIGATIONAL PLAN SUMMARY 
1.0 
BACKGROUND 
1.1 
Device Name 
The Preceptis Tympanostomy Tube Introducer (TTI) 
1.2 
Device Description 
The tympanostomy tube introducer (TTI) is a disposable surgical tool designed to 
deliver a tympanostomy tube (“ear tube”) into the tympanic membrane of patients 
during a tympanostomy tube placement procedure.  
More than 1,000,000 ear tubes are inserted annually in the US, making it one of the 
most common surgical procedures performed in children.  Most ear tubes are 
inserted by ENT surgeons with the patient under either local anesthesia (usually 
adults) or general anesthesia (usually children). 
Preceptis Medical, Inc. has developed the TTI surgical device to reduce trauma, pain, 
and risk to the patient while reducing the overall surgical procedure time.  The TTI 
device integrates the multiple surgical instruments necessary for current surgical 
procedure into a single, one-action device. The TTI device creates an incision in the 
tympanic membrane (“ear drum”) and inserts a tympanostomy tube with the push of a 
lever, all while providing suction and fluid extraction capability. Thus, the TTI device 
allows placement of a tympanostomy tube with a single pass down the ear canal.  
The ear tube used with the TTI device is a standard, commercially available 
tympanostomy tube.   
1.3 
Pre-Clinical Testing 
The TTI device has successfully undergone bench and cadaver tympanic membrane 
tests.   
 
 
1.4 
Summary of Previous Clinical Results 
 
As of 30 August 2013, 60 patients had been enrolled under “Investigational Plan for 
Evaluation of the Preceptis Medical, Inc. Tympanostomy Tube Introducer (TTI)” at the 
University of Minnesota, Amplatz Children’s Hospital and Minneapolis Children’s 
Hospital. 
 
Per procedural outcomes and feedback from the ENT surgeons, the TTI is reducing 
surgical trauma for the patient as designed.  All tubes have been successfully 
delivered across the tympanic membrane.  Safety is being evaluated by an 
independent ENT reviewer, and there have been no safety issues.  There have been 

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three AE’s reported in the study:  one case of otorrhea in an adult patient at the initial 
follow-up visit, a tube extrusion in the same adult patient at the subsequent follow-up 
visit, and a tube extrusion at the follow-up visit in a child.  None of these AE’s were 
unanticipated, and all were non-serious.  The tympanostomy procedures have taken 
place in the operating room, the office, and the sedation unit. 
 
1.5 
Clinical and Regulatory Background 
Per 21 CFR 874.4420, the ear tube introducer is defined as a myringotomy tube 
inserter and is classified by the US Food and Drug Administration as Class I (general 
controls).  The device is exempt from the premarket notification procedures (i.e., 
510(k) clearance process) in subpart E of 21 CFR part 807.  
1.6 
Indications for Use and Intended Use 
The TTI device is indicated for patients undergoing a tympanostomy tube procedure.  
The TTI device is intended to deliver a tympanostomy tube through the tympanic 
membrane of a patient during a tympanostomy procedure.  
2.0 
STUDY OBJECTIVES 
The objective of this study is to evaluate the safety and performance of the TTI 
device for the placement of ear tubes in patients undergoing a tympanostomy tube 
placement procedure. 
3.0 
STUDY DESIGN OVERVIEW AND DURATION 
The trial will be a multi-site, prospective, treatment only study of the Preceptis ear 
tube introducer . Patients will already have a scheduled tympanostomy procedure.   
Enrollment in the study at each site will begin after receipt of Institutional Review 
Board (IRB) approval.  Patients will be considered enrolled at the time the informed 
consent document is signed.  A maximum of two hundred fifty (250) subjects will be 
included in the study at up to 5 sites.    
Estimated study start date:  
 
September 2013 (but upon IRB approval) 
Estimated enrollment completion date: May 2014 
Estimated study completion: 
 
Dec 2015 
4.0 
STUDY ENDPOINTS  
4.1 
Safety Endpoint 
The rate of overall AEs, and for each specific type of event, will be estimated.  
4.2 
Efficacy Endpoint 
Efficacy evaluation will consist of determining whether the TTI device successfully 
delivers the tympanostomy tube across the tympanic membrane and whether the 
tube is still in place at the initial follow-up visit and at follow-up visits at 6-month 
intervals until the tube is extruded. 

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5.0 
STATISTICAL METHODS AND DATA ANALYSIS 
5.1 
Data Analysis 
Data from this feasibility study will be analyzed on an As-Treated basis using a 
common closing date.   Standard summary statistics will be calculated for all study 
outcome variables.  Categorical data will be summarized in frequency distributions.  
Detailed summaries of all adverse events will be provided.  The rate of adverse 
events and the delivery success rate will be calculated, along with corresponding 
95% exact confidence intervals.  These data will be compared to published AE rates 
and/or investigator experience with standard tympanostomy procedures. The 
proportions of successfully delivered tubes will be calculated, along with the 
corresponding 95% exact confidence intervals. 
Study success will be determined based on a qualitative clinical analysis of all data.  
5.2 
Enrollment 
5.2.1 A patient will be considered enrolled at the time the informed consent 
document is signed. Inclusion and exclusion evaluation will not require 
baseline testing and will thus be evaluated prior to signing the consent.   
 
5.2.2 Enrollment may begin when the following criteria are met: 
 
• IRB approval of the study protocol and informed consent document. 
• Signed Investigator Agreement-Clinical Study Agreement. 
• Completion of bench training regarding use of the ear tube introducer. This 
is required for each surgeon prior to performing their first case.  
• Investigational site personnel training on the study protocol. 
• Inclusion-exclusion criteria are met for each patient. 
6.0 
SAMPLE SIZE 
Up to 250 enrolled patients will be included in this trial.  Enrollment is expected to be 
approximately 95% children and 5% adults and approximately evenly divided 
between gender.  A total sample size of 250 subjects will provide sufficiently precise 
estimates of adverse event and delivery success rates to assess the feasibility of the 
Preceptis TTI and for publication purposes.  The results from this study may be used 
to support the design and initiation of a larger study of this device.  
7.0 
PATIENT POPULATION 
7.1 
Selection Criteria 

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Patients considered for this trial will meet all of the inclusion criteria in section 7.2 
below.  However, if they meet any of the exclusion criteria in section 7.3, they will not 
be eligible to participate in the trial.   
7.2 
Inclusion Criteria 
Patients must meet all of the following: 
1. Scheduled to undergo tympanostomy tube insertion.   
2. At least 6 months old. 
3. Subject is able and willing to comply with follow-up requirements. 
4. Signed Informed Consent, Parental Consent Form, or Child Assent Form as 
applicable. 
7.3 
Exclusion Criteria 
Patients will be excluded should they meet any of the following: 
1. Any condition that in the opinion of the investigator may place the subject at 
greater risk (e.g., pregnancy)  
2. Significantly atrophic tympanic membrane.  
3. Significantly atelectatic tympanic membrane.  For example, the tympanic 
membrane is in contact with the promontory of the cochlea. 
4. Anatomy precludes sufficient visualization and access to the tympanic membrane.  
 
8.0 
SURGICAL PROCEDURE 
The tympanostomy procedure will be identical to a standard tympanostomy 
procedure except for using the TTI device to make the myringotomy incision and 
place the tube rather than using standard, manual surgical instruments.  Accordingly, 
the risks for this study are not expected to be any different than those associated with 
standard tympanostomy procedures.  The tympanostomy procedures will take place 
in the operating room, the pediatric sedation unit or the office. 
 
8.1 
Anesthesia Protocol 
 
Anesthesia for surgical treatment of otitis media ranges from topical anesthesia to 
sedation to general anesthesia.  In a sedation unit or operating room, patients can 
receive sedation to general anesthesia.  In infant to young pediatric populations, 
tympanostomy tube insertion is commonly done in an operating room with a patient 
under general anesthesia or deep sedation.  In cooperative children and adult 
populations, tympanostomy tube placement is typically performed in a physician’s 
office using topical anesthesia and/or sedation if available. 
 
Anesthesia and patient monitoring will be consistent with what is currently done in an 
office, sedation unit, or operating room for tympanostomy tube placement surgery.  
Patients having tympanostomy tube surgery in a physician’s office will receive topical 

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anesthesia on the ear drum.  Patients having surgery in the sedation unit or operating 
room will receive nitrous oxide, sedation, or sevoflurane, depending on the anesthetic 
requirement of the patient. 
 
9.0 
CONSENT 
Patients may be adults or children over the age of 6 months.  As such, a standard 
Informed Consent form will be used for patients 18 years old and above.  A Parental 
Consent form will be used for children who are 17 years old and younger.  A Child 
Assent form will be used for children 8-17 years of age (age range may be dependent 
on the site).  Prior to undergoing enrollment, the study will be explained to the patient 
and/or parents by the investigator and a consent form will be provided in the patient’s 
(or parent’s) native language.  The consent forms must be approved by the IRB.  All 
patients (or parents) will sign a consent form prior to enrollment. 
Additionally, PHI created or received for the purposes of this study is protected under 
the federal regulation known as HIPAA.  Patients will be required to sign a HIPAA 
form authorizing the principal investigator, research staff, and the sponsor access to 
their individual health information.  Some sites may incorporate the HIPAA form 
within the informed consent.  
The Consent forms are located in Attachment A. 
10.0   STUDY PROCEDURES 
 
10.1 Summary of Study Procedures 
The primary investigators are responsible for the quality of all data submitted to the 
Sponsor.  Documentation of patient eligibility, procedural experience, follow-up visit, 
adverse events, protocol deviations, and withdrawal will be reported on the case 
report forms (Attachment B).  For purposes of scheduling follow-up visits, time zero 
is the date of surgery.  Enrolled patients will undergo evaluation at the time of 
procedure, and at a follow-up visit 3-10 weeks days post-surgery and every 6 months 
(+/- 30 days) thereafter until the tube has extruded.  Adverse events will be reported 
for each patient until their enrollment in the study is terminated.   
CRF’s 
Type of Form 
Timing 
#1 
Enrollment 
Prior to surgery  
#2 
Procedure 
Time of surgery 
#3 
Follow-up 
3-10 weeks post-surgery and at 6-month intervals 
#4 
AE 
As applicable 
#5 
Protocol Deviation 
As applicable 
#6 
Patient Withdrawal 
As applicable 

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10.1.1 Baseline Visit 
Patients who are undergoing a tympanostomy tube procedure and meet all 
study inclusion criteria and none of the exclusion criteria will be approached for 
participation in the study by the PI or co-PI.  If the patient agrees to participate, 
an informed consent will be collected.  There are no further baseline tests 
required for the study. 
 
10.1.2 Surgical Visit 
Subjects who sign the informed consent form will proceed to the surgical visit.  
The type of anesthesia, total tympanostomy procedure time and adverse 
events will be documented. 
 
10.1.3 Follow-up Visit  
 
Subjects will return to the clinic between 3-10 weeks post-surgery and then at 
6-month intervals (+/- 30 days) until the tube is extruded (standard of care).  At 
these visits, the physician will assess the subject to determine if the tube is still 
in place and will document any adverse events.  If standard of care at that 
institution, an audiogram will be performed post-surgically, and the ENT 
surgeon will provide commentary on the comparison of the pre and post-
surgical audiograms for any evidence of hearing loss.  
10.2 Study Termination 
The safety and efficacy phases for each patient will begin at the implant procedure 
and end when their tympanostomy tube has extruded and enrollment in the study has 
been completed.  After the last patient enrolled has completed their last follow-up 
visit, the study will be terminated.  Once monitoring has been completed, the 
database will be frozen and a clinical report will be prepared and submitted to the 
IRB. 
 
10.3 Stopping Rules/Safety Monitoring 
The sponsor will appoint an independent ENT physician to review 100% of 
unanticipated adverse device effects.  If any perceived safety issues arise, the trial 
may be suspended, and safety data will be analyzed.  Additionally, the independent 
ENT will review all safety results at each interval of 20 patients whose surgery used 
the TTI.  If any perceived safety issues arise per this review, the trial may be 
suspended, and safety data will be analyzed.  If the Sponsor, the PI, and the 
independent reviewer agree that the study is safe to continue, the study may be re-
started. 
11.0 ADVERSE EVENTS  
11.1 Reporting Criteria 
Adverse events are reported as they occur during the course of the study, with the 
starting point being anesthetic administration during the tympanostomy procedure  All 
adverse events, including the date, outcome management, and assessed relationship 

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of the event to the study device, must be recorded on the appropriate case report 
form.  Adverse events may be anticipated or unanticipated.  
Device related events are defined as follows:  events that are likely related to the ear 
tube introducer as it relates to the act of placing the tympanostomy tube in the 
tympanic membrane and cause an adverse event.  They result from a malfunction 
(operation not according to design specification) of the TTI or from interaction 
between the TTI and the patient. 
11.2 Anticipated Adverse Events 
Anticipated adverse events include those that are expected to occur in this study 
because they are typically associated with tympanostomy tube procedures.  
Conditions existing at the time of enrollment should not be reported as adverse 
events.  Anticipated adverse events may be non-serious or serious.   
Serious Adverse Events are defined as those which require an in-patient 
hospitalization (> 24 hours), prolonged hospitalization, resulted in permanent hearing 
loss, resulted in death or required medical and surgical intervention to prevent life-
threatening illness or injury or permanent impairment to body structure or body 
function.   
Adverse events, which resolve and recur, should be reported as separate events.  
Anticipated adverse events are defined in Attachment C.   
11.3 Unanticipated Adverse Events 
Unanticipated adverse events are events that are not considered anticipated, as 
defined in the previous section.   
 
There are additional reporting requirements for the subset of unanticipated adverse 
events which are likely device related (UADE).  Any adverse event that is 
unanticipated and likely device-related must be reported as a UADE to Preceptis as 
soon as possible, (but no later than 5 working days after the investigator first learns of 
the problem).  In addition, the investigator may be required to submit a written report 
to the IRB in accordance with the IRB’s specific reporting requirements. 
 
12.0 BENEFIT-RISK ANALYSIS 
The potential design benefits of the Preceptis TTI device are as follows: 
• Device is designed to make incision and place tube with one pass into the 
tympanic membrane and ear canal.  This is a significant reduction in patient 
trauma resulting from the 4-6 passes currently required for a standard 
tympanostomy procedure. 
• Device is designed to make an incision that is smaller than those made 
manually with a standard myringotomy blade and to optimally match the outer 
diameter of the tympanostomy tube, thereby potentially reducing the extrusion 
rate of the tube. 

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• The reduction of trauma and pain to the patient due to reduced passes into 
the ear canal and manipulation of the ear drum may potentially allow a 
reduction in the type and amount of anesthesia required for the procedure. 
The potential risks or discomforts that may be expected include any of the standard 
risks of a patient undergoing standard tympanostomy tube surgery. These risks 
include, but are not limited to, the following: 
• Otorrhea,  
• Acute tube extrusion, 
• Chronic tube extrusion,  
• Tube dislocating into the middle ear, 
• Tube clogging, 
• Bleeding, 
• Vertigo,  
• Nausea, 
• Infection, 
• Hearing loss,  
• Facial nerve injury. 
Other risks may exist.  Any additional risks for participation in this study have been 
minimized by careful patient selection, center selection, and training, as well as by 
implementing monitoring procedures to ensure proper conduct and management of 
the study.   
14.0 PROTOCOL MODIFICATIONS AND DEVIATIONS 
The investigator may not modify this protocol without obtaining written concurrence 
from the sponsor.  The investigator in conjunction with Preceptis will submit protocol 
modifications to the IRB as necessary. 
Any deviations from this protocol intended to protect the physical well-being of a 
patient are to be reported to Preceptis and the IRB as soon as possible and no later 
than five (5) working days after the deviation occurred.  Other deviations to the 
protocol must also be reported to Preceptis using the applicable CRF. 
15.0 STUDY MATERIALS 
Study materials will be provided by the sponsor, Preceptis. Sites will be responsible 
for the securing, storage, and handling of study materials according to site-specific 
institutional processes.  
16.0 MONITORING PROCEDURES 

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An employee of the study sponsor, Preceptis Medical, Inc., or its designee, will serve 
as study monitor.  Study monitoring activities will include verification of study data to 
source documents.  Monitors may also assume responsibility for communications 
between the investigator and the sponsor. 
 
Site visits are performed to ensure that the proper medical records are reviewed and 
that study data is complete and accurate.  Database downloads and study 
documentation will be compared to source documentation and reviewed for accuracy, 
completeness, and protocol compliance.  The following documents will also be 
monitored: 
• Informed Consent Forms:  Informed consent must be signed by each patient.  
These documents will be monitored 100% to ensure they are in compliance. 
• IRB:  All approvals, adverse events reports, unanticipated adverse device 
effect reports, protocol deviations, annual reports and other correspondence 
with the center’s IRB must be up to date and on file.  These documents will be 
monitored 100% to ensure they are in compliance. 
Site visits will also be used to verify source data, assess the maintenance of records 
and reports, assess progress toward meeting study objectives, and identify any 
concerns that stem from observations of study management documents.  Resolution 
of concerns and completion of corrective actions will be documented by the study 
monitor in monitoring reports.  At the conclusion of the study, a final monitoring visit 
will occur to appropriately close out the study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ATTACHMENT A (consent forms) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ATTACHMENT B 
CASE REPORT FORMS 
 
 
 
 

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ATTACHMENT C REPORTABLE ANTICIPATED ADVERSE EVENTS 
 
Anticipated AE 
Definition 
Otorrhea 
Fluid discharge from the middle ear. 
Acute tube extrusion 
During the surgical procedure, a myringotomy incision is completed but the 
tympanostomy tube will not stay in the tympanic membrane. 
Chronic tube extrusion 
At the initial follow-up visit, the tube is no longer in place in the tympanic 
membrane. 
Tube dislocating into middle ear 
space 
Tube passes completely through the tympanic membrane and falls into the 
middle ear cavity. 
Tube clogging 
Tube becomes clogged and fails to provide ventilation and drainage. 
Bleeding 
Bleeding in the ear canal, tympanic membrane, or the middle ear. 
Vertigo 
The patient experiences dizziness beyond 72 hours post-surgically. 
Nausea 
The patient experiences nausea and/or vomiting beyond 72 hours post-
surgically. 
Infection 
Patient has fever > 101 F beyond 24 hours post-surgically. 
Hearing loss 
Hearing loss > 15 dB compared to baseline result in Pure Tone Average 
(PTA). 
Facial nerve injury 
Any weakness in face or altered perception of taste beyond 24 hours post-
surgically.