Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes software that performs image processing and calculations based on user interaction and pre-calibration, but there is no mention of AI, ML, or any learning-based algorithms.

Therapeutic

No.
The "Intended Use / Indications for Use" section explicitly states: "The AccuMeasure™ System provides no therapeutic or diagnostic function."

Diagnostic

No

The "Intended Use / Indications for Use" section explicitly states "The AccuMeasure™ System provides no therapeutic or diagnostic function."

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of two components: a measuring device (through the scope probe and handheld laser source) and a processing unit (video grabber and touch screen PC with software). This includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the AccuMeasure™ System is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the system is an "accessory in conjunction with an endoscope to measure observable anatomy and pathology in the gastrointestinal tract" and "provides no therapeutic or diagnostic function." IVDs are specifically intended for the diagnosis of diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
Device Description: The device measures objects on the mucosal surface using a laser and image processing. This is a measurement function, not a diagnostic test performed on in vitro samples (like blood, urine, or tissue).
Performance Studies: The clinical study focused on safety and usability, not on diagnostic performance metrics like sensitivity, specificity, or AUC, which are typical for IVDs.

The AccuMeasure™ System is a tool for measurement during an endoscopic procedure, which is a clinical procedure performed on a living patient (in vivo). IVDs, by definition, are used to examine specimens taken from the human body (in vitro).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The AccuMeasure™ System is intended to be used as an accessory in conjunction with an endoscope to measure observable anatomy and pathology in the gastrointestinal tract. The AccuMeasure™ System provides no therapeutic or diagnostic function.

Product codes

QTH

Device Description

The device is used in conjunction with an endoscope to measure objects on the mucosal surface of the gastrointestinal (GI) tract. The device consists of two components (1) the measuring device and (2) a processing unit.

The measuring device consists of a through the scope probe that is connected to a handheld laser source. During use, the distal end of the probe extends beyond the endoscope working channel and is positioned to project a red line across the object to be measured. The laser source attaches to the probe via a magnetic connection. The magnetic sensor allows for laser emission only when the probe is connected. The probe is reusable and waterproof.

The processing unit includes a video grabber and a touch screen PC. The medical-grade PC comes with dedicated software for conducting measurements during an endoscopic procedure. The video grabber is an off-the-shelf video grabber model AV.io HD by Epiphan Video. The video grabber is connected to the endoscope video processor video output port, captures the video from the endoscope, and inputs it to a medical grade PC via a standard USB port. The provided medical-grade PC is an off-the shelf component connected with the endoscopic system through the video grabber. The PC has a 22-inch touchscreen with a high-end graphics processing unit and runs Windows 10 64 bit.

The AccuMeasure™ System software allows users to interact with the captured endoscopic images and obtain measurements. The software performs the calculation and provides a measurement of distance using the ruler function or displays a trace between two selected points on the laser line. The software enables recording of sessions for conducting measurements during an endoscopic procedure. The software is pre-calibrated for each endoscope model to find its camera parameters and distortion coefficients. It removes the fisheve and additional artifacts.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

gastrointestinal tract

Indicated Patient Age Range

Adults ages 20 to 75.

Intended User / Care Setting

Physician / healthcare facility

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)

Summary of Nonclinical/Bench Studies:

Biocompatibility: The AccuMeasure™ probe biocompatibility was supported by cytotoxicity, sensitization, and irritation tests according to ISO 10993-1.
Reprocessing/Cleaning: Reprocessing instructions for the measuring device (manual cleaning and high-level disinfection for the probe, low-level disinfection for the laser source) were validated.
Electromagnetic Compatibility & Electromagnetic Safety: Assessed per ANSI AAMI ES60601-1:2005/(R)2012 and IEC 60601-1-2 Edition 4.0 2014-02.
Software: Reviewed according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005, and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices" dated October 2, 2014.
Performance Testing - Bench:
- Accuracy Validation: Simulated round and flat polyps (5-15 mm) in phantoms. The device met acceptance criteria for measuring polyp diameter across all sizes.
  - Object ≤ 5 mm: +/- 0.5 mm
  - Object >5 mm - 10mm: - 0.5 mm - +10%
  - Object >10 mm: - 5% - +10%
- Laser Safety Testing: Tested for eye and tissue/skin safety according to IEC 60825-1. The laser source met requirements for Class II and MPE for skin safety.
- Laser Bend Loss: Power measurements for bent probes were within (b)(4) of straight probes, demonstrating no significant power loss due to bending.
- Pushability: The number of strokes to advance the probe through the working channel was comparable to forceps and snares.
- Pressure by Probe Tip: The force required to perforate plastic was comparable to existing tools (closed snare, open forceps), indicating the probe does not increase perforation chances.
- Battery Life: Batteries lasted at least 5 hours of continuous operation before "near-empty" indication, allowing for an additional (b)(4) of emission.
- Probe Durability to Reprocessing Cycles: After 500 simulated cycles of enzymatic cleaning and HLD, probes remained intact, laser lines were visible, and water resistance was maintained.
- Laser Marking Integrity: The unique ID pattern at the probe tip remained intact and recognized by the system after (b)(4) cycles of reprocessing.
- Probe Water Resistance: Humidity strips remained blue and probes emitted laser lines after water exposure, confirming water resistance.
- Torque Durability: Laser lines were visible and straight, and no damage to the adhesion region between PTFE sheath and handle after rotation cycles.
- Tension-Compression Fatigue: Laser lines were visible and straight, and no damage to the adhesion region after simulated tension/compression fatigue.
- Probe Drop Test: Probes projected a straight line and remained water resistant after being dropped (b)(4) times from (b)(4) height onto a PVC floor.
- Probe and Laser Source Connector Reliability: Demonstrated to withstand (b)(4) cycles per probe and (b)(4) cycles per laser source without significant power reduction or visual defects.

Summary of Clinical Information:

Study Overview: Patients undergoing routine colonoscopy (20-75 years old) in Israel where polyps were detected. Safety and usability of the AccuMeasure™ System were assessed.
Sample Size: A total of (b)(4) polyps remaining were measured by physicians in (b)(4) patients.
Endpoints:
- Adverse events (AE and SAE) monitored; device defined as safe if no patient damage resulted from its use.
- User experience defined as positive if the average value from the usability questionnaire (1-5 scale) was (b)(4).
Results:
- No adverse events associated with using the AccuMeasure™ System.
- Physicians' subjective assessment of device manipulation (Figure 4) and agreement with statements (Figure 5) showed a mean score of (b)(4) for all questions except "time to obtain a measurable image," which had a mean score of (b)(4). Physicians felt it took longer to obtain a measurable image.
- The study demonstrated the device was safe for use and able to make measurements under conditions where clear images can be obtained.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

DE NOVO CLASSIFICATION REQUEST FOR ACCUMEASURE™ SYSTEM

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Endoscopic light-projecting measuring device. An endoscopic light-projecting measuring device projects light on a mucosal surface and uses software to determine the dimensions of observable features of interest.

NEW REGULATION NUMBER: 21 CFR 876.1530

CLASSIFICATION: Class II

PRODUCT CODE: QTH

BACKGROUND

DEVICE NAME: AccuMeasure™ System

SUBMISSION NUMBER: DEN210032

DATE DE NOVO RECEIVED: August 9, 2021

SPONSOR INFORMATION:

VTM Technologies Ltd. 65 Derech HaAtzmaut Haifa. Israel 3303333

INDICATIONS FOR USE

The AccuMeasure™ System is intended to be used as an accessory in conjunction with an endoscope to measure observable anatomy and pathology in the gastrointestinal tract. The AccuMeasure™ System provides no therapeutic or diagnostic function.

LIMITATIONS

The sale, distribution, and use of the AccuMeasure™ System are restricted to prescription use in accordance with 21 CFR 801.109.

The device is not intended to be used as a stand-alone diagnostic device.

In the clinical study for the AccuMeasure™ System, the usability and safety of the device was assessed while measuring the diameter of colon polyps in patients undergoing routine colonoscopy. Due to limitations in determining the true length of structures in

1

vivo, the clinical study did not assess the accuracy of the device. Clinicians provided subjective assessments regarding the use of the device including ease of use and duration of use.

The device is compatible with forward viewing gastrointestinal endoscopes with working channels ≥ 3.2 mm.

PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.

DEVICE DESCRIPTION

The device is used in conjunction with an endoscope to measure objects on the mucosal surface of the gastrointestinal (GI) tract. The device consists of two components (1) the measuring device and (2) a processing unit. See image of the device in figure 1 below.

Image /page/1/Figure/5 description: The image shows a diagram of an endoscopy system. The system includes an endoscope, a light source, a video processor, a video grabber, a medical-grade PC, and a measuring device. The endoscope is connected to the light source and the video processor, which are stacked on top of each other. The video processor is connected to the video grabber, which is connected to the medical-grade PC.

Figure 1. The AccuMeasure™ System

The measuring device consists of a through the scope probe that is connected to a handheld laser source. During use, the distal end of the probe extends beyond the endoscope working channel and is positioned to project a red line across the object to be measured. The laser source attaches to the probe via a magnetic connection. The magnetic sensor allows for laser emission only when the probe is connected. The probe is reusable and waterproof. See image of the measuring device in figure 2 below.

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Image /page/2/Picture/0 description: The image shows a fiber optic visual fault locator and a fiber optic cable. The visual fault locator is a pen-shaped device that emits a red light to help locate breaks or bends in the fiber optic cable. The fiber optic cable is a thin, flexible cable that is used to transmit light signals. The cable is coiled up next to the visual fault locator.

Figure 2. Measuring device

The processing unit includes a video grabber and a touch screen PC. The medical-grade PC comes with dedicated software for conducting measurements during an endoscopic procedure. The video grabber is an off-the-shelf video grabber model AV.io HD by Epiphan Video. The video grabber is connected to the endoscope video processor video output port, captures the video from the endoscope, and inputs it to a medical grade PC via a standard USB port. The provided medical-grade PC is an off-the shelf component connected with the endoscopic system through the video grabber. The PC has a 22-inch touchscreen with a high-end graphics processing unit and runs Windows 10 64 bit.

The AccuMeasure™ System software allows users to interact with the captured endoscopic images and obtain measurements. The software performs the calculation and provides a measurement of distance using the ruler function or displays a trace between two selected points on the laser line. The software enables recording of sessions for conducting measurements during an endoscopic procedure. The software is pre-calibrated for each endoscope model to find its camera parameters and distortion coefficients. It removes the fisheve and additional artifacts.

Principle of operation

Prior to the clinical procedure, the endoscope is checked to make sure it is known to the AccuMeasure™ System by taking a validation image with the endoscope. During the clinical procedure, when the physician wants to make a measurement, the AccuMeasure™ probe is inserted through the instrument channel until the probe tip is seen at the distal end of the endoscope. The physician then attaches the laser source to the proximal end of the AccuMeasure™ probe handle. The laser source is turned on and the laser line is projected over the structure to be measured. The physician can acquire the image using the endoscope's 'Freeze' button or the AccuMeasure™ software's 'Capture' button. The unique identification marking on tip of the probe must be clearly visible in the image. If the identification marking on the tip is not clearly visible, the measurement function will be disabled for that image. If the image is acquired correctly, the triangle overlay can be seen over the image and measurements can be made by dragging the target markers to the edges of the structure to be measured. The AccuMeasure™ software calculates the positioning of the distal tip in 3 dimensions (3D) relative to the endoscope camera, and hence the positioning of the laser plane. Using the triangulation principle, every point along the laser line designated by the operator has 3D coordinates. Several measurements may be taken per image. See image of the measuring sequence in figure 3 below.

3

Image /page/3/Picture/0 description: The image shows four different views of a clear, round object, possibly a lens or a drop of liquid, with a red laser beam passing through it. In the first view, the laser beam is visible as a straight line. In the second and third views, the laser beam appears to be slightly refracted as it passes through the object. In the fourth view, the laser beam is refracted and there are green markings on the object.

Figure 3. Measurement sequence using the ruler mode

SUMMARY OF NONCLINICAL/BENCH STUDIES

Non-clinical studies conducted for the AccuMeasure™ System are summarized below.

BIOCOMPATIBILITY

The AccuMeasure™ probe is classified as mucosal membrane contacting for limited duration (≤ 24 hours). The AccuMeasure™ processing unit is not patient contacting.

To support biocompatibility, appropriate biocompatibility assessments in accordance with ISO 10993-1, Biological evaluation of medical devices, and FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" were provided following simulated reprocessing cycles. The following tests were performed on the AccuMeasure™ probe:

1. Cytotoxicity
1. Sensitization
1. Irritation

Results assessed by FDA support the biocompatibility of the AccuMeasure™ probe.

REPROCESSING/CLEANING

The AccuMeasure™ System is provided non-sterile and multi patient use. The AccuMeasure™ System is reprocessed before the first use and following each clinical use. The reprocessing instructions for the measuring device were validated per FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling dated March 17, 2015.The reprocessing validation included manual cleaning and high-level disinfection for the probe and low-level disinfection for the non-patient contacting laser source.

ELECTROMAGNETIC COMPATIBILITY & ELECTROMAGNETIC SAFETY

The electrical and electromagnetic safety for the AccuMeasure™ System were assessed per ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) (19-4) and IEC 60601-1-2 Edition 4.0 2014-02 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

4

SOFTWARE

The software was reviewed according to the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. Appropriate software documentation consistent with a "Moderate" level of software concern were provided.

Cybersecurity was reviewed according to FDA guidance document "Content of Premarket Submission for Management of Cybersecurity in Medical Devices" dated October 2, 2014.

PERFORMANCE TESTING - BENCH

The integrity and performance of the AccuMeasure™ System was evaluated with the nonclinical bench testing summarized in Table 1.

Test	Purpose	Method	Acceptance Criteria	Results
Accuracy Validation	The test was to
demonstrate the
accuracy of the device.	To simulate the
physiological
conditions in
colonoscopy,
phantoms were
constructed. The
phantoms contained
simulated round and
flat polyps.
Simulated polyps
were between 5- 15
mm in diameter.
The probe was
inserted through the
working channel of
a colonoscope for
imaging. The
software was used
to acquire images of
polys at various
distances and angles
using the phantoms.	Relating to specific
object sizes, the
required
measurement
accuracy is:
Object ≤ 5 mm: +/-
0.5 mm;
Object >5 mm -
10mm: - 0.5 mm -
+10% (e.g., for 10
mm, 9.5 mm - 11.0
mm); and
Object >10 mm : -
5% - +10% (e.g., for
15 mm, 14.2 mm -
16.5 mm)	The device was able
to meet the
acceptance criteria
for measuring the
diameter of the
simulated round and
flat polyps for all
sizes.
Laser Safety Testing	Tests were conducted to
demonstrate the safety
of the laser source.	The
AccuMeasure™
laser system was
tested for eye safety
and tissue/skin
safety according to
IEC 60825-1.	The
AccuMeasure™
laser system should
meet Accessible
Emission Limit
(AEL) for
classifying it as
Class II and MPE
for skin safety for
duration of exposure
above 10 seconds.	The laser source
met the
requirements per
IEC 60825-1.
Laser Bend Loss	The test was to quantify
any loss of laser power	The power was
measured while the	The power output
measurements of	Power
measurements for
	as a result of bending
the probe. This is
important because the
working channel of the
endoscope is intended
to bend as it is
positioned in the GI
tract. Therefore, the
optical fiber of the
device will need to
bend without losing
power.	AccuMeasure™
probe was straight,
and this
measurement was
used as a reference.
The
AccuMeasure™
probe was then put
in a curved position
with (b)(4) full turns (b)(4)
(b)(4) in diameter and
(b)(4) full turn of (b)(4)
(b)(4) which was the
minimum curvature
of the colonoscope.
The power
measurements of the
probes were taken
in the curved
position. Finally, the
probes were
straightened again,
and the power was
measured.	straight and bent
probes should be
similar with no
significant change
with less than (b)(4)
reduction for the
bent configuration
between
measurements for
the same probe	the bent probes
were within (b)(4) of
the straight probes.
Pushability	Endoscopic tools are
manually advanced in
the working channel of
an endoscope in small
segments. If the tool is
flexible these segments
are shorter, as the tool
tends to bend more
easily, increasing the
number of strokes and
making the tool less
usable.	The number of the
strokes it takes to
advance the probe
fully through the
working channel
were compared to
that of forceps and
snares.

Forceps were
inserted until its tip
extended from the
distal end of the
working channel
and the number of
strokes were
documented.
Repeat step 1
with snare.
Repeat step 1
with AccuMeasure
Probe.
Repeat steps 1-3
with endoscope
rolled in a
(b)(4) diameter | The average number
of strokes required
to fully insert the
AccuMeasure™
probe shall be
comparable to the
forceps and snares
tools. It should be
less than (b)(4)
higher than that of
the tool
with the highest
number of strokes. | The number of
strokes was similar
for the snare,
forceps, and the
AccuMeasure™
probe. |
| Pressure by Probe Tip | This test compares the
pressure applied to
plastic material by the
probe tip to that of
forceps and snare to | Probe initially
inserted through the
holding plastic jig
and extends (b)(4)
from jig end, | The force required
to perforate the
plastic by the probe
must not be less
than the minimum
of open or closed | The recorded forces
indicate that the
pressure applied by
the probe tip is
greater than that of a
closed snare and an |
| | evaluate the chances of
perforation. | probe's tip pushed
against the plastic
until the probe tip
perforates the
plastic. The required
force applied was
documented. The
test was repeated
with forceps and
snares in the open
and closed
configurations. | forceps and open or
closed snare. | open forceps. The
probe does not
increase the chances
for perforation,
since the forces
exerted by the
probe's
tip are comparable
to existing tools. |
| Battery Life | This test was performed
to determine battery
lifetime for the laser
source, and to verify the
action of the "weak
battery' indicator light
embedded it its switch | The laser source
was connected to
the probe and
continuously run,
snapshots of the
laser line and
battery indicator
were taken every
minute until the
laser line faded out.
Transition time of
the indicator light
from green to red
was also monitored. | Batteries should last
at least 5 hours.
Laser Source "near-
empty" battery
indicator shall allow
at least half an hour
of remaining
operation on
batteries once it has
changed color
from green to
red/orange. | The batteries lasted
for at least
5 hours of
continuous
operation before
providing "near-
empty" battery
Indication. Then
with the "near
empty indication the
emission lasted for
an additional (b)(4) in all cases. |
| Probe Durability to
Reprocessing Cycles | The test was conducted
to simulate the worst-
case simulated exposure
to detergent and
disinfectant and
determine that the
probe is still functional
after 500 simulated use
cycles. | For the cleaning, the
probe was soaked in
Endozime Premuim
APA for (b)(4) and
(b)(4) in (b)(4)
times concentrated
as compared to
Endozime's IFU
maximal
concertation
recommendation.
After soaking, the
probes were
removed and soaked
in a container with
(b)(4) of tap water
for (b)(4) . The
probes were rinsed
under tap water and
dried. Following
rinsing, the probes
were visually
inspected for
integrity, laser line
emission was
verified, and water
resistance was
verified. | For visual
inspection, there
should be no defects
at the handle or
distal end and the
adhesion between
the PTFE sheath
and the probe
handle should be
intact.
For laser line
integrity, the laser
line should turn on
and the line should
be clean and
straight.
For water
resistance, the probe
should be water
resistant to ensure
the mechanical
integrity of the
probe. | All probes remained
intact, laser lines
were visible, and
probes were still
water resistant. |
| | | For the High-Level
Disinfection (HLD),
the probes were
soaked for 60 hours
in Cidex OPA
Solution in the
Minimum
Effective
Concentration
(MEC). Following
HLD, the probes
were rinsed with tap
water according to
Cidex's IFU and
device's IFU. The
same assessments
were conducted to
determine the
integrity of the
probe. | | |
| Laser Marking Integrity | Demonstrate that the
unique identifier at the
tip of the probe remains
intact after reprocessing
cycles. | The ID pattern was
captured and
visually inspected.
The probes
underwent (b)(4)
cycles of enzymatic
cleaning and HLD.
At the end of the
process each one of
the probes was
placed into the tip
holder jig and the
ID pattern was
captured and
visually inspected. | ID pattern integrity
at the probe distal
tip should remain
intact. | The unique ID
pattern remained
intact for all probes
and were recognized
by the system
following
reprocessing. |
| Probe Water Resistance | This test was performed
to evaluate the water
resistance of the probe. | The probe sealing
cap was removed
and (b) pieces of
humidity detection
strips were carefully
inserted. One piece
into the probe
connector the other
piece into the probe
sealing cap. The
probes caps were
firmly placed on the
probe handles. The
probes were
immersed in a water
pillar (b)(4)
diameter and (b)(4)
length, filled with
tap water, making | For water
resistance, the
humidity detection
strips should be
blue.
No visible fluid
residue inside PTFE
sheath, indicating
the adhesion region
between the PTFE
sheath and the probe
handle is intact.
Laser line emission
was used to verify
integrity of optical
connector. | The humidity strips
remained blue for
all probes exposed
to water. Also, the
probes were able to
emit a laser line
following exposure
to water. All probes
were water resistant. |
| Torque Durability | The test was to verify
mechanical integrity of
the stainless-steel coil
that composes the body
of the probe the PTFE
sheath and the strain
point of adhesion
between the PTFE and
probe handle during
probe rotation. | The probe handle
was connected via
an adapter to a
stepper motor while
the distal end of the
probe is fixed in a
collet, the distance
between the collet
and the handle is (b)(4) . The
stepper motor
controller script was
as follows:
(b)(4) turn CCW (b)(4)
sec wait (b)(4) turn
CW, (b)(4) sec wait
Duration @ (b)(4)
RPM: [] sec / cycle
Total duration for
(b)(4) cycles: (b)(4)
minutes. | Laser line should be
visible and straight.
The adhesion region
between the PTFE
sheath and the probe
handle was visibly
inspected and
should be intact.
Also, the probe
should be water
resistant. | The laser lines were
all visible and
straight. Also, there
was no damage to
the adhesion region
between the PTFE
sheath and the probe
handle. |
| Tension-Compression
Fatigue | The probe is inserted
through the working
channel of a curved
endoscope and is
required to rotate
around its axis. As a
result, tension and
compression occurs.
This test was to
simulate
tension/compression
fatigue that exceed the
expected cycles during
the lifetime of the
probe. | The probe was
placed in a vise.
The handle was
connected to the
stepper motor via an
adaptor. The vise
and the motor were
positioned on the
same plane and the
probe is rotated CW
and then CCW for a
total of (b)(4)
revolutions at (b)(4)
RPM (duration is
approximately 1 | The devices were
checked for laser
line emission,
visually inspected
under a microscope
(adhesion region
between the PTFE
sheath and the probe
handle, PTFE
integrity at the point
of fatigue, and water
resistance was
confirmed. | The laser lines were
all visible and
straight. Also. there
was no damage to
the adhesion region
between the PTFE
sheath and the probe
handle. |
| | | hour and 15
minutes). | | |
| Probe drop test | This test is intended to
examine the robustness
of probe construction
and its resistance to
accidental drops. | The probe was held
in one hand at
height of (b)(4)
and dropped on a
PVC floor (b)(4) times.
After each drop, the
laser line integrity
was verified. | Laser line emission
should remain intact
and the probe
should be water
resistant. | The probes
projected a straight
line, and the probes
were still water
resistant following
the test. |
| Probe and Laser Source
Connector Reliability | The probe and laser
source are routinely
connected and
disconnected. The
connection between
them is secured by two
ring magnets, one at the
probe handle and the
other at the laser
source. This test is to
verify the reliability of
the connection. | (b)(4) cycles of
connection and
disconnection of the
probe from the laser
source were
performed
manually.
Repeat the previous
step with another
laser source,
conducting (b)(4)
connect-disconnect
cycles with each
probe, for a total of
(b)(4) cycles per
laser source. | Laser source
connector shall
withstand (b)(4)
connection/disconne
ction cycles

Visual inspection
Direct power
output shall not
reduce below
(b)(4) at the end of
the cycles
Probe connector
shall withstand
(b)(4) connection/
disconnection
cycles.
Visual inspection
The probe shall
produce no less than
(b)(4) when
connected to the
same laser source at
the end of their
cycles | The probe/laser-
source connector
reliability was
demonstrated to
withstand (b)(4)
cycles per probe and
(b)(4) cycles
per laser source. |

Table 1. Summary of non-clinical bench testing for the AccuMeasure™ System

5

De Novo Summary (DEN210032/S001)

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7

8

9

SUMMARY OF CLINICAL INFORMATION

Study Overview

The sponsor conducted a clinical study that included " patients who were undergoing routine colonoscopy procedures at a healthcare facility in Israel. All patients were adults ages 20 to 75. During procedures where polyps were detected, the AccuMeasure™ System was used to obtain measurements. The physicians also made qualitative assessments based on the use of the device. There were partil physicians that participated in the study. The colonoscopes used in the study (2014) endoscopy system, @ma were CONDY colonoscopes. Each colonoscope

colonoscopes, and (D)(4) ======================================================================================================================================================================= was calibrated to the system. The purpose of the study was to determine the safety and usability of the AccuMeasure™ System.

The following data was collected during the study:

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. AccuMeasure™ session data that included still images and measurement results. Each measurable image contained the tip of the probe used, with a unique identification marker. Patient data was not included in the saved session.
. Specific colonoscope used including the model and serial number
. User experience with the device
. Adverse event monitoring

Study Endpoints

Adverse events (both AE and SAE) were analyzed at the end of the study. The . AccuMeasureTM System was defined as safe only if no damage caused to the patient was found to be as a result of using the AccuMeasure™ System.
. User experience was defined as positive if the average value obtained from the user's answers to the usability questionnaire was 1611 The scale was 1 to 5 for the questionnaire, 1 is very poor; 2 is poor; 3 is satisfactory; 4 is good; and 5 is excellent.

Results

Of the patients that were enrolled in the study, patients were excluded due to poor preparation. 100 patients had no polyps detected during the procedure, and patients were excluded due to an issue with the endoscope that was unrelated to the AccuMeasure™ System. The remaining patients had at least or or more polyps detected. The physicians attempted to measure a total of polyps in these " patients. " (of the " polyps could not be measured due the following reasons; polyps were in regions of suboptimal preparation, cases of partial visibility of the polyp, or exaggerated peristalsis. There were polyps remaining that could be measured. Of these polyps, the physicians measured polyps. The remaining (on polyps that were not measured in the study were due to device-related errors for woolyps and an endoscope related error for polyp.

The results presented in Figure 4 show the score that was obtained by the participating physicians regarding their subjective assessment to different aspects of device manipulation.

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Image /page/11/Picture/0 description: The image is a gray rectangle with a red border. The text '(b)(4)' is located in the top center of the rectangle. The rectangle takes up most of the image.

Figure 4. Device operation- User Assessment

The results presented in Figure 5 show the score that was obtain by the participating physicians regarding their agreement with each of the provided statements.

Image /page/11/Picture/3 description: The image is a gray rectangle with a red border. At the top of the rectangle is the text "(b)(4)". At the bottom of the rectangle is the text "Figure 5. Device operation- Agreement with statements".

Figure 5. Device operation- Agreement with statements

The assessment included questions about pushability, manually advancing the device through the working channel of the endoscope, maneuverability of the probe, use of the software and the touchscreen, and clarity of the laser line. The mean score was 1014 for all questions except for

De Novo Summary (DEN210032/S001)

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the time to obtain a measurable image (mean score was m). Physicians felt that it took a longer time to obtain an image that could be used for making measurements.

Adverse Events

There were no adverse events associated with using the AccuMeasure™ System during the procedures where polyps were detected.

Summary

In summary, the study supporting the AccuMeasure™ System demonstrated that the device was safe for use and able to make measurements under conditions where clear images can be obtained.

Pediatric Extrapolation

In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population.

LABELING

The Sponsor provided labeling that included a user manual for the AccuMeasure™ System. The user manual addresses the known hazards and risks of the device for the intended use and incorporates safety statements to mitigate these risks. The labeling includes:

Instructions intended to minimize the risk of improper use of the AccuMeasure™ System . including a summary of how to navigate the software.
. The AccuMeasure™ System is compatible with commercially available flexible colonoscopes and gastroscopes having working channels of ≥ 3.2 mm in diameter, and both Standard-Definition and High-Definition endoscopy systems are supported. A specific warning indicates potential damage to endoscopes with narrower working channels.
. The user manual includes the accuracy of the device and states that the accuracy was determined using bench testing.

RISKS TO HEALTH

The table below identifies the risks to health that may be associated with use of the endoscopic light-projecting measuring device, and the measures necessary to mitigate these risks.

Identified Risks to Health	Mitigation Measures
Ineffective treatment due to the
device providing inaccurate
measurements	Non-clinical performance testing
Labeling
Device failure/malfunction leading to
injury	Non-clinical performance testing
Electrical, thermal, and mechanical safety testing
Software validation, verification, and hazard analysis

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Identified Risks to Health	Mitigation Measures
	Labeling
Device failure due to interference
with other devices	Electromagnetic compatibility testing
Adverse tissue reaction	Biocompatibility evaluation
Extended procedure time leading to
increased adverse events	In vivo performance testing
Infection	Reprocessing validation
	Labeling

SPECIAL CONTROLS

In combination with the general controls of the FD&C Act, the endoscopic light-projecting measuring device is subject to the following special controls:

(1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate:
- (i) Visualization during the procedure:
- (ii) Ease of procedure as reported by the intended user; and
- (iii)User acceptability of imaging time.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
- (i) Accuracy validation;
- (ii) Endoscope compatibility testing;
- (iii)Battery life testing;
- (iv) Durability testing; and
- (v) Light safety testing.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Electrical, thermal, and mechanical safety testing must be performed.
(6) Performance testing must demonstrate electromagnetic compatibility (EMC) of the device in the intended use environment.
(7) Methods and instructions for reprocessing reusable components must be validated.
(8) Labeling must include:
- (i) Device technical parameters, including a description of the accuracy of the device:
- (ii) Information regarding endoscope compatibility;

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(iii)Warning for light hazards and protection for patient and operator; and (iv) Validated reprocessing instructions.

BENEFIT-RISK DETERMINATION

The risks of the device are based on nonclinical laboratory testing as well as data collected in a clinical study described above.

During the clinical study, there were no device related adverse events. However, in the user questionnaire, physicians felt it took more time to obtain a usable image for making measurements. The additional time that it takes to obtain a usable image in the device can prolong the procedure time and put patients at risk for adverse events. Also, if a clear image cannot be taken due to movement in the GI tract, poor bowel preparation, or exaggerated peristalsis the device cannot be utilized.

The probable benefits of the device are based on nonclinical laboratory data.

The AccuMeasure™ System provides accurate measurements of round and flat structures when images are taken from a variety of angles and distances between the distal end of the probe and the structure. The AccuMeasure™ System demonstrated greater accuracy than other methods of assessing length during endoscopy procedures (e.g., visual estimation, biopsy forceps, and snares). Also, these other endoscopy tools are not intended for measurement. The assessment of polyp size is important for determining which polyps are removed and the follow up care for patients, Larger polyps tend to have more advanced histological features. Therefore, polyps ≥ 10 mm are typically removed during colonoscopy. Most endoscopists measure polyp size by visualization or they may use an endoscope tool like a snare or biopsy forceps that are available during the procedure. In a study comparing the accuracy of measurements made with biopsy forceps and by visual estimation1, the error range for visual estimation was greater than | |014 for polyps 6-9 mm and greater than | for polyps ≥ 10 mm. Similar error ranges were found using biopsy forceps. The bench testing demonstrated that the accuracy of the AccuMeasure™ System according to the polyp size was significantly greater than that of the visual estimation and forceps (polyps > 5 mm- 10 mm the accuracy is -0.5 mm - 10% (e.g., for 10 mm, 9.5 mm -11.0 mm). The bench testing results indicate that the method using the AccuMeasure™ System can increase the accuracy of polyp size measurement regardless of polyp size, compared to previously published estimates of polyp size using visual estimation or endoscopic accessories like biopsy forceps.

Patient Perspectives

This submission did not include specific information on patient perspectives for this device.

Benefit/Risk Conclusion

1 Kim JH, Park SJ, Lee JH, Kim HJ, Kim HW, Lee SH, Back DH, Bigs BU. Is forceps more useful than visualization for measurement of colon polyp size? World J Gastroenterol. 2016 Mar 21;22(11):3220-6. doi: 10.3748/wjg.v22.i11.3220. PMID: 27003999; PMCID: PMC4789997.

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In conclusion, given the available information above, for the following indication statement:

The AccuMeasure™ System is intended to be used as an accessory in conjunction with an endoscope to measure observable anatomy and pathology in the gastrointestinal tract. The AccuMeasure™ System provides no therapeutic or diagnostic function.

The probable benefits outweigh the probable risks for the AccuMeasure™ System. The device provides benefits, and the risks can be mitigated by the use of general controls and the identified special controls.

CONCLUSION

The De Novo request for the AccuMeasure™ System is granted and the device is classified as follows:

Product Code: OTH Device Type: Endoscopic light-projecting measuring device Regulation Number: 21 CFR 876.1530 Class: II