(351 days)
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 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. 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.
Here's a breakdown of the acceptance criteria and the study information for the AccuMeasure™ System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This table focuses on the "Accuracy Validation" from the Performance Testing - Bench section, as it's the primary quantitative performance claim for the device's main function.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy | Object ≤ 5 mm: +/- 0.5 mm | The device met the acceptance criteria for measuring the diameter of simulated round and flat polyps for all sizes. |
| Validation | Object >5 mm - 10mm: - 0.5 mm - +10% (e.g., for 10 mm, 9.5 mm - 11.0 mm) | |
| Object >10 mm : - 5% - +10% (e.g., for 15 mm, 14.2 mm - 16.5 mm) | ||
| Other Bench Tests (Examples) | Laser Safety: Meet Accessible Emission Limit (AEL) for 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: Power output measurements of straight and bent probes similar with no significant change, less than (b)(4) reduction. | Power measurements for the bent probes were within (b)(4) of the straight probes. | |
| Probe Durability to Reprocessing Cycles: No defects, laser line integrity (clean, straight), water resistance. | All probes remained intact, laser lines were visible, and probes were still water resistant after 500 cycles. | |
| Battery Life: Last at least 5 hours. "Near-empty" indicator allows at least half an hour of remaining operation once color changes to red/orange. | Batteries lasted for at least 5 hours of continuous operation before "near-empty" indication. Emission lasted an additional (b)(4) with "near-empty" indication. |
Note: The clinical study did not assess the accuracy of the device due to limitations in determining the true length of structures in vivo. Its primary endpoints were safety and usability.
Study Details
Here's a breakdown of the specific information requested:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size (for accuracy): The accuracy validation was conducted via bench testing using "phantoms" (simulated round and flat polyps between 5-15 mm in diameter). The exact number of simulated polyps or measurements is not specified, but the text states "for all sizes."
- Test Set Sample Size (for clinical study, usability/safety): The clinical study involved
[redacted]patients from a healthcare facility in Israel.[redacted]patients were excluded for poor preparation.- 100 patients had no polyps.
[redacted]patients were excluded due to an endoscope issue.- The remaining
[redacted]patients had one or more polyps. - A total of
[redacted]polyps were attempted to be measured. [redacted]polyps could not be measured.- Of the remaining, physicians measured
[redacted]polyps.
- Data Provenance:
- Accuracy Test (Bench): Not explicitly stated, but implies internal testing by the manufacturer.
- Clinical Study (Usability/Safety): Prospective; conducted at a healthcare facility in Israel.
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)
- Accuracy Test (Bench): For the bench testing, ground truth was the known, precise dimensions of the simulated polyps in the phantoms. No human experts were required to establish this ground truth, as it was inherent to the phantom design.
- Clinical Study (Usability/Safety): The clinical study focused on physician subjective assessments of usability and safety, not on establishing a ground truth for measurement accuracy. The measurements obtained in the clinical study were not used to assess the accuracy of the device against a "true" measurement.
[redacted]physicians participated in the study; their qualifications are not specified beyond being "physicians."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Accuracy Test (Bench): Not applicable. The ground truth was objective (known dimensions of phantoms).
- Clinical Study (Usability/Safety): The clinical study involved subjective user assessments. No adjudication method for ground truth determination was applicable, as ground truth for accuracy was not assessed in vivo. For adverse events, standard clinical monitoring was performed, but no formal adjudication of disagreements is described.
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
- No MRMC comparative effectiveness study was done. The clinical study was solely for safety and usability, not comparative effectiveness with human readers or other measurement methods.
- The text does state that the device "demonstrated greater accuracy than other methods of assessing length during endoscopy procedures (e.g., visual estimation, biopsy forceps, and snares)" based on bench testing compared to previously published estimates of error ranges for visual estimation and biopsy forceps. This is not an MRMC study with human readers using the AI vs. without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance (Accuracy): Yes, the "Performance Testing - Bench" section describes testing where the device (AccuMeasure™ System software) acquired images and made measurements of simulated polyps in phantoms. This was evaluating the algorithm's performance in a controlled, non-human-in-the-loop setting for its core function of measurement accuracy.
- Standalone Performance (Clinical): No. While the algorithm performs the calculation, it is used "in conjunction with an endoscope" and requires physician interaction to acquire images, position the laser, and
drag target markers. It is not intended to be a standalone diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Accuracy Test (Bench): Objective, precisely known physical dimensions of simulated polyps within custom-built phantoms.
- Clinical Study (Usability/Safety): The "ground truth" for the clinical study was physician subjective assessments via questionnaires for usability and observation for adverse events for safety. There was no ground truth for measurement accuracy in this study.
8. The sample size for the training set
- The provided text does not mention a specific training set sample size. The software is pre-calibrated for each endoscope model, but details about dataset size or how frequently "training" occurs are not given. This product description focuses on verification and validation, not development.
9. How the ground truth for the training set was established
- Given that the text does not mention a specific training set or process (beyond "pre-calibrated for each endoscope model to find its camera parameters and distortion coefficients"), the method for establishing ground truth for any potential training data is not described. It's possible that proprietary internal calibration procedures provided the necessary reference data without a formal "ground truth establishment" process in the context of an AI/ML training paradigm.
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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
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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.
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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:
-
- Cytotoxicity
-
- Sensitization
-
- 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.
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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 todemonstrate theaccuracy of the device. | To simulate thephysiologicalconditions incolonoscopy,phantoms wereconstructed. Thephantoms containedsimulated round andflat polyps.Simulated polypswere between 5- 15mm in diameter.The probe wasinserted through theworking channel ofa colonoscope forimaging. Thesoftware was usedto acquire images ofpolys at variousdistances and anglesusing the phantoms. | Relating to specificobject sizes, therequiredmeasurementaccuracy is:Object ≤ 5 mm: +/-0.5 mm;Object >5 mm -10mm: - 0.5 mm -+10% (e.g., for 10mm, 9.5 mm - 11.0mm); andObject >10 mm : -5% - +10% (e.g., for15 mm, 14.2 mm -16.5 mm) | The device was ableto meet theacceptance criteriafor measuring thediameter of thesimulated round andflat polyps for allsizes. |
| Laser Safety Testing | Tests were conducted todemonstrate the safetyof the laser source. | TheAccuMeasure™laser system wastested for eye safetyand tissue/skinsafety according toIEC 60825-1. | TheAccuMeasure™laser system shouldmeet AccessibleEmission Limit(AEL) forclassifying it asClass II and MPEfor skin safety forduration of exposureabove 10 seconds. | The laser sourcemet therequirements perIEC 60825-1. |
| Laser Bend Loss | The test was to quantifyany loss of laser power | The power wasmeasured while the | The power outputmeasurements of | Powermeasurements for |
| as a result of bendingthe probe. This isimportant because theworking channel of theendoscope is intendedto bend as it ispositioned in the GItract. Therefore, theoptical fiber of thedevice will need tobend without losingpower. | AccuMeasure™probe was straight,and thismeasurement wasused as a reference.TheAccuMeasure™probe was then putin a curved positionwith (b)(4) full turns (b)(4)(b)(4) in diameter and(b)(4) full turn of (b)(4)(b)(4) which was theminimum curvatureof the colonoscope.The powermeasurements of theprobes were takenin the curvedposition. Finally, theprobes werestraightened again,and the power wasmeasured. | straight and bentprobes should besimilar with nosignificant changewith less than (b)(4)reduction for thebent configurationbetweenmeasurements forthe same probe | the bent probeswere within (b)(4) ofthe straight probes. | |
| Pushability | Endoscopic tools aremanually advanced inthe working channel ofan endoscope in smallsegments. If the tool isflexible these segmentsare shorter, as the tooltends to bend moreeasily, increasing thenumber of strokes andmaking the tool lessusable. | The number of thestrokes it takes toadvance the probefully through theworking channelwere compared tothat of forceps andsnares.1. Forceps wereinserted until its tipextended from thedistal end of theworking channeland the number ofstrokes weredocumented.2. Repeat step 1with snare.3. Repeat step 1with AccuMeasureProbe.4. Repeat steps 1-3with endoscoperolled in a(b)(4) diameter | The average numberof strokes requiredto fully insert theAccuMeasure™probe shall becomparable to theforceps and snarestools. It should beless than (b)(4)higher than that ofthe toolwith the highestnumber of strokes. | The number ofstrokes was similarfor the snare,forceps, and theAccuMeasure™probe. |
| Pressure by Probe Tip | This test compares thepressure applied toplastic material by theprobe tip to that offorceps and snare to | Probe initiallyinserted through theholding plastic jigand extends (b)(4)from jig end, | The force requiredto perforate theplastic by the probemust not be lessthan the minimumof open or closed | The recorded forcesindicate that thepressure applied bythe probe tip isgreater than that of aclosed snare and an |
| evaluate the chances ofperforation. | probe's tip pushedagainst the plasticuntil the probe tipperforates theplastic. The requiredforce applied wasdocumented. Thetest was repeatedwith forceps andsnares in the openand closedconfigurations. | forceps and open orclosed snare. | open forceps. Theprobe does notincrease the chancesfor perforation,since the forcesexerted by theprobe'stip are comparableto existing tools. | |
| Battery Life | This test was performedto determine batterylifetime for the lasersource, and to verify theaction of the "weakbattery' indicator lightembedded it its switch | The laser sourcewas connected tothe probe andcontinuously run,snapshots of thelaser line andbattery indicatorwere taken everyminute until thelaser line faded out.Transition time ofthe indicator lightfrom green to redwas also monitored. | Batteries should lastat least 5 hours.Laser Source "near-empty" batteryindicator shall allowat least half an hourof remainingoperation onbatteries once it haschanged colorfrom green tored/orange. | The batteries lastedfor at least5 hours ofcontinuousoperation beforeproviding "near-empty" batteryIndication. Thenwith the "nearempty indication theemission lasted foran additional (b)(4) in all cases. |
| Probe Durability toReprocessing Cycles | The test was conductedto simulate the worst-case simulated exposureto detergent anddisinfectant anddetermine that theprobe is still functionalafter 500 simulated usecycles. | For the cleaning, theprobe was soaked inEndozime PremuimAPA for (b)(4) and(b)(4) in (b)(4)times concentratedas compared toEndozime's IFUmaximalconcertationrecommendation.After soaking, theprobes wereremoved and soakedin a container with(b)(4) of tap waterfor (b)(4) . Theprobes were rinsedunder tap water anddried. Followingrinsing, the probeswere visuallyinspected forintegrity, laser lineemission wasverified, and waterresistance wasverified. | For visualinspection, thereshould be no defectsat the handle ordistal end and theadhesion betweenthe PTFE sheathand the probehandle should beintact.For laser lineintegrity, the laserline should turn onand the line shouldbe clean andstraight.For waterresistance, the probeshould be waterresistant to ensurethe mechanicalintegrity of theprobe. | All probes remainedintact, laser lineswere visible, andprobes were stillwater resistant. |
| For the High-LevelDisinfection (HLD),the probes weresoaked for 60 hoursin Cidex OPASolution in theMinimumEffectiveConcentration(MEC). FollowingHLD, the probeswere rinsed with tapwater according toCidex's IFU anddevice's IFU. Thesame assessmentswere conducted todetermine theintegrity of theprobe. | ||||
| Laser Marking Integrity | Demonstrate that theunique identifier at thetip of the probe remainsintact after reprocessingcycles. | The ID pattern wascaptured andvisually inspected.The probesunderwent (b)(4)cycles of enzymaticcleaning and HLD.At the end of theprocess each one ofthe probes wasplaced into the tipholder jig and theID pattern wascaptured andvisually inspected. | ID pattern integrityat the probe distaltip should remainintact. | The unique IDpattern remainedintact for all probesand were recognizedby the systemfollowingreprocessing. |
| Probe Water Resistance | This test was performedto evaluate the waterresistance of the probe. | The probe sealingcap was removedand (b) pieces ofhumidity detectionstrips were carefullyinserted. One pieceinto the probeconnector the otherpiece into the probesealing cap. Theprobes caps werefirmly placed on theprobe handles. Theprobes wereimmersed in a waterpillar (b)(4)diameter and (b)(4)length, filled withtap water, making | For waterresistance, thehumidity detectionstrips should beblue.No visible fluidresidue inside PTFEsheath, indicatingthe adhesion regionbetween the PTFEsheath and the probehandle is intact.Laser line emissionwas used to verifyintegrity of opticalconnector. | The humidity stripsremained blue forall probes exposedto water. Also, theprobes were able toemit a laser linefollowing exposureto water. All probeswere water resistant. |
| Torque Durability | The test was to verifymechanical integrity ofthe stainless-steel coilthat composes the bodyof the probe the PTFEsheath and the strainpoint of adhesionbetween the PTFE andprobe handle duringprobe rotation. | The probe handlewas connected viaan adapter to astepper motor whilethe distal end of theprobe is fixed in acollet, the distancebetween the colletand the handle is (b)(4) . Thestepper motorcontroller script wasas follows:(b)(4) turn CCW (b)(4)sec wait (b)(4) turnCW, (b)(4) sec waitDuration @ (b)(4)RPM: [] sec / cycleTotal duration for(b)(4) cycles: (b)(4)minutes. | Laser line should bevisible and straight.The adhesion regionbetween the PTFEsheath and the probehandle was visiblyinspected andshould be intact.Also, the probeshould be waterresistant. | The laser lines wereall visible andstraight. Also, therewas no damage tothe adhesion regionbetween the PTFEsheath and the probehandle. |
| Tension-CompressionFatigue | The probe is insertedthrough the workingchannel of a curvedendoscope and isrequired to rotatearound its axis. As aresult, tension andcompression occurs.This test was tosimulatetension/compressionfatigue that exceed theexpected cycles duringthe lifetime of theprobe. | The probe wasplaced in a vise.The handle wasconnected to thestepper motor via anadaptor. The viseand the motor werepositioned on thesame plane and theprobe is rotated CWand then CCW for atotal of (b)(4)revolutions at (b)(4)RPM (duration isapproximately 1 | The devices werechecked for laserline emission,visually inspectedunder a microscope(adhesion regionbetween the PTFEsheath and the probehandle, PTFEintegrity at the pointof fatigue, and waterresistance wasconfirmed. | The laser lines wereall visible andstraight. Also. therewas no damage tothe adhesion regionbetween the PTFEsheath and the probehandle. |
| hour and 15minutes). | ||||
| Probe drop test | This test is intended toexamine the robustnessof probe constructionand its resistance toaccidental drops. | The probe was heldin one hand atheight of (b)(4)and dropped on aPVC floor (b)(4) times.After each drop, thelaser line integritywas verified. | Laser line emissionshould remain intactand the probeshould be waterresistant. | The probesprojected a straightline, and the probeswere still waterresistant followingthe test. |
| Probe and Laser SourceConnector Reliability | The probe and lasersource are routinelyconnected anddisconnected. Theconnection betweenthem is secured by tworing magnets, one at theprobe handle and theother at the lasersource. This test is toverify the reliability ofthe connection. | (b)(4) cycles ofconnection anddisconnection of theprobe from the lasersource wereperformedmanually.Repeat the previousstep with anotherlaser source,conducting (b)(4)connect-disconnectcycles with eachprobe, for a total of(b)(4) cycles perlaser source. | Laser sourceconnector shallwithstand (b)(4)connection/disconnection cycles- Visual inspection- Direct poweroutput shall notreduce below(b)(4) at the end ofthe cyclesProbe connectorshall withstand(b)(4) connection/disconnectioncycles.- Visual inspection- The probe shallproduce no less than(b)(4) whenconnected to thesame laser source atthe end of theircycles | The probe/laser-source connectorreliability wasdemonstrated towithstand (b)(4)cycles per probe and(b)(4) cyclesper laser source. |
Table 1. Summary of non-clinical bench testing for the AccuMeasure™ System
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De Novo Summary (DEN210032/S001)
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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 thedevice providing inaccuratemeasurements | Non-clinical performance testingLabeling |
| Device failure/malfunction leading toinjury | Non-clinical performance testingElectrical, thermal, and mechanical safety testingSoftware validation, verification, and hazard analysis |
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| Identified Risks to Health | Mitigation Measures |
|---|---|
| Labeling | |
| Device failure due to interferencewith other devices | Electromagnetic compatibility testing |
| Adverse tissue reaction | Biocompatibility evaluation |
| Extended procedure time leading toincreased 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
N/A