(29 days)
Not Found
Yes
The document explicitly states that the SKOUT system utilizes an artificial intelligence-based algorithm.
No.
The device is a computer-aided detection tool that assists in identifying potential colorectal polyps by processing video in real-time. It does not provide therapy or treatment.
Yes
Explanation: The device is designed to "detect potential colorectal polyps" and assist gastroenterologists in "identifying potential colorectal polyps," which are diagnostic functions. While it states it's not intended to "make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment," its primary utility is providing information that directly contributes to a medical diagnosis.
Yes
The device is described as a "software device" and a "software-based computer aided detection (CADe) system." While it processes video from an endoscopic procedure, the description focuses solely on the software's function and user interface, without mentioning any proprietary hardware components included with the device. The software updates mentioned are related to image handling and error handling, further supporting its software-only nature.
Based on the provided information, the SKOUT system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc., outside of the body.
- SKOUT's Function: The SKOUT system analyzes real-time video feed from a colonoscopy procedure. It processes visual information directly from inside the patient's body during the examination. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's a "computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations." This is a real-time visual aid during a procedure, not a diagnostic test performed on a sample.
Therefore, the SKOUT system falls under the category of a medical device that aids in a clinical procedure, but it does not meet the definition of an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The SKOUT system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.
The SKOUT system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT is indicated for white light colonoscopy only.
Product codes
QNP
Device Description
The SKOUT® system is a software-based computer aided detection (CADe) system for the analysis of highdefinition endoscopic video during colonoscopy procedures. The SKOUT system is intended to aid gastroenterologists with the detection of potential colorectal polyps during colonoscopy by providing an informational visual aid on the endoscopic monitor using trained software that processes the endoscopic video in real time.
Users will primarily interact with the SKOUT system by observing the software display, including the polyp detection box and device status indicator signal.
Polyp Detection Notification
The SKOUT system has a main graphical user interface (GUI) feature of the polyp detection notification. The polyp detection notification is a two-dimensional blue rectanqular outline generated around any suspected polyps on the endoscopic video feed. If there is no polyp detected, the bounding box does not appear. SKOUT® system pauses polyp detection when an endoscopic tools are detected in the video feed to ensure that the bounding box does not hinder any surgical procedure, biopsy, or resection or this may also occur when lighting conditions are deemed to be inadequate.
The polyp detection notification enables users to:
- Detect potential colorectal polyps during colonoscopy examinations in adult patients undergoing a . colorectal cancer screeninq or surveillance procedure.
- Utilize a tool that provides additional information for endoscopic observation.
Device Status Indicator
The SKOUT system has an additional GUI feature that notifies users of the current device status (active or error):
- a two-dimensional green box with letter (S) when the device is powered on and actively processing video.
- a two-dimensional grav box with letter (S) when a surgical tool is present.
- a red (X) with an error message: when there is an error with the video processing function of the SKOUT system, the green box will be replaced with a red X and error message to indicate an error has occurred.
Mentions image processing
Yes. "processes the endoscopic video in real time." and "improvements to image handling for image quality performance"
Mentions AI, DNN, or ML
Yes. "The SKOUT system utilizes an artificial intelligence-based algorithm to perform the polyp detection function." and "SKOUT system is on and in use, even when polyp detection notifications are not on the screen to prevent undesired use of the AI."
Input Imaging Modality
endoscopic video (white light colonoscopy)
Anatomical Site
colorectal
Indicated Patient Age Range
adult patients
Intended User / Care Setting
qualified and trained gastroenterologists / Not Specified (implied hospital/clinic setting due to power source)
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)
- Study Type: Non-Clinical Testing
- Sample Size: Not Specified
- AUC: Not Found
- MRMC: Not Found
- Standalone Performance: Not Found
- Key results:
- Software verification and validation was conducted on the SKQUT System software to validate it for its intended use per the design documentation in line with recommendations outlined in General Principles of Software Validation, Guidance for Industry and FDA Staff. The SKOUT software demonstrated passing results on all applicable testing.
- Electrical Safety Electromagnetic Compatibility the SKOUT system was evaluated for compliance to the following FDA-Recognized Consensus Standards: IEC 60601-1:2005, AMD 1:2012, IEC 60601-1-2: 2014, IEC 60601-2-18: 2009.
- Human factors validation was performed following the FDA Guidance document Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and FDA Staff recommendations. The human factors validation demonstrated that the device functioned as intended, use-related risk has been mitigated, and the SKOUT system is safe for its intended use.
- Assessment of video delay due to marker annotation; SDI 0.0ms (error 1.1ms)
- Assessment of video delay due to device; SDI 0.0ms (error 1.1ms)
- No pixel level degradation is introduced by SKOUT to the Endoscopic System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SKOUT System, Iterative Scopes, K213686
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1520 Gastrointestinal lesion software detection system.
(a)
Identification. A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including detection of gastrointestinal lesions and evaluation of all adverse events.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include:
(i) Standalone algorithm performance testing;
(ii) Pixel-level comparison of degradation of image quality due to the device;
(iii) Assessment of video delay due to marker annotation; and
(iv) Assessment of real-time endoscopic video delay due to the device.
(3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
(4) Performance data must demonstrate electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety testing for any hardware components of the device.
(5) Software verification, validation, and hazard analysis must be provided. Software description must include a detailed, technical description including the impact of any software and hardware on the device's functions, the associated capabilities and limitations of each part, the associated inputs and outputs, mapping of the software architecture, and a description of the video signal pipeline.
(6) Labeling must include:
(i) Instructions for use, including a detailed description of the device and compatibility information;
(ii) Warnings to avoid overreliance on the device, that the device is not intended to be used for diagnosis or characterization of lesions, and that the device does not replace clinical decision making;
(iii) A summary of the clinical performance testing conducted with the device, including detailed definitions of the study endpoints and statistical confidence intervals; and
(iv) A summary of the standalone performance testing and associated statistical analysis.
0
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April 7, 2023
Iterative Scopes Inc. Dennis Francoeur Director of Regulatory Affairs 675 Massachusetts Ave 2nd Floor Cambridge, MA 02139
Re: K230658
Trade/Device Name: SKOUT® system Regulation Number: 21 CFR 876.1520 Regulation Name: Gastrointestinal Lesion Software Detection System Regulatory Class: Class II Product Code: QNP Dated: March 9, 2023 Received: March 9, 2023
Dear Dennis Francoeur:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
Device Name
SKOUT® System
Indications for Use (Describe)
The SKOUT system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.
The SKOUT system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT is indicated for white light colonoscopy only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
VII. 510(K) SUMMARY
510(k) SUMMARY
SKOUT® system
Submitter:
Iterative Health, Inc. (Iterative Scopes)
675 Massachusetts Ave
Cambridge MA 02139
Phone: (603) 819-8387
Contact Person: Dennis Francoeur, Director of Regulatory Affairs
Date Prepared: March 9, 2023
Name of Device: SKOUT® System
Classification Name: Gastrointestinal Lesion Software Detection System
Classification Panel: Gastroenterology and Urology
Regulation Number: 876.1520
Product Code: QNP
Predicate Device: SKOUT System, Iterative Scopes, K213686
Device Description
The SKOUT® system is a software-based computer aided detection (CADe) system for the analysis of highdefinition endoscopic video during colonoscopy procedures. The SKOUT system is intended to aid gastroenterologists with the detection of potential colorectal polyps during colonoscopy by providing an informational visual aid on the endoscopic monitor using trained software that processes the endoscopic video in real time.
Users will primarily interact with the SKOUT system by observing the software display, including the polyp detection box and device status indicator signal.
Polyp Detection Notification
The SKOUT system has a main graphical user interface (GUI) feature of the polyp detection notification. The polyp detection notification is a two-dimensional blue rectanqular outline generated around any suspected polyps on the endoscopic video feed. If there is no polyp detected, the bounding box does not appear. SKOUT® system pauses polyp detection when an endoscopic tools are detected in the video feed to ensure that the bounding box does not hinder any surgical procedure, biopsy, or resection or this may also occur when lighting conditions are deemed to be inadequate.
4
The polyp detection notification enables users to:
- Detect potential colorectal polyps during colonoscopy examinations in adult patients undergoing a . colorectal cancer screeninq or surveillance procedure.
- Utilize a tool that provides additional information for endoscopic observation. ●
Device Status Indicator
The SKOUT system has an additional GUI feature that notifies users of the current device status (active or error):
- a two-dimensional green box with letter (S) when the device is powered on and actively processing ● video.
- o a two-dimensional grav box with letter (S) when a surgical tool is present.
- a red (X) with an error message: when there is an error with the video processing function of the ● SKOUT system, the green box will be replaced with a red X and error message to indicate an error has occurred.
Intended Use / Indications for Use
The SKOUT system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.
The SKOUT system is only intended to assist the aastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT is indicated for white light colonoscopy only.
Design Changes
Hardware architecture changes: The multi piece tethered system of the predicate to a single box containing all of the components. Some of the components included in the subject device have been updated to improve component longevity and image quality performance.
Software architecture changes: To support the updated hardware design the software was updated in addition to improvements to image handling for image quality performance and error handling for improved usability performance.
Non-Clinical Testing
- Software verification and validation was conducted on the SKQUT System software to validate it for its intended use per the design documentation in line with recommendations outlined in General Principles of Software Validation, Guidance for Industry and FDA Staff. The SKOUT software demonstrated passing results on all applicable testing.
- . Electrical Safety Electromagnetic Compatibility the SKOUT system was evaluated for compliance to the following FDA-Recognized Consensus Standards:
- IEC 60601-1:2005, AMD 1:2012 Medical electrical equipment Part 1: General о requirements for basic requirements for basic safety and essential performance
5
- IEC 60601-1-2: 2014 Medical electrical equipment Part 1-2: General requirements for o basic requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility – Requirements and tests
- IEC 60601-2-18: 2009 Medical electrical equipment Part 2-24: Particular requirements o for the basic safety and essential performance of endoscopic equipment
- Human factors validation was performed following the FDA Guidance document Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and FDA Staff recommendations. The human factors validation demonstrated that the device functioned as intended, use-related risk has been mitigated, and the SKOUT system is safe for its intended use.
Summary of Technological Characteristics
The predicate device represents a previous revision of the subject device, SKOUT System FDA cleared via K213686 on August 12, 2022.
| | Subject Device SKOUT System | Predicate Device SKOUT System
(K213686) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A gastrointestinal lesion software
detection system is a computer-
assisted detection device used in
conjunction with endoscopy for the
detection of abnormal lesions in the
gastrointestinal tract. This device with
advanced software algorithms brings
attention to images to aid in the
detection of lesions. The device has
hardware components to support
interfacing with an endoscope. | Same - A gastrointestinal lesion
software detection system is a
computer-assisted detection device
used in conjunction with endoscopy for
the detection of abnormal lesions in the
gastrointestinal tract. This device with
advanced software algorithms brings
attention to images to aid in the
detection of lesions. The device has
hardware components to support
interfacing with an endoscope. |
| Indications for
Use | The SKOUT system is a software
device designed to detect potential
colorectal polyps in real time during
colonoscopy examinations. It is
indicated as a computer-aided
detection tool providing colorectal
polyps location information to assist
qualified and trained
gastroenterologists in identifying
potential colorectal polyps during
colonoscopy examinations in adult
patients undergoing colorectal cancer
screening or surveillance.
The SKOUT system is only intended to
assist the gastroenterologist in
identifying suspected colorectal polyps
and the gastroenterologist is
responsible for reviewing SKOUT
suspected polyp areas and confirming
the presence or absence of a polyp
based on their own medical judgment.
SKOUT is not intended to replace a full
patient evaluation, nor is it intended to
be relied upon to make a primary | Same - The SKOUT system is a
software device designed to detect
potential colorectal polyps in real time
during colonoscopy examinations. It is
indicated as a computer-aided
detection tool providing colorectal
polyps location information to assist
qualified and trained
gastroenterologists in identifying
potential colorectal polyps during
colonoscopy examinations in adult
patients undergoing colorectal cancer
screening or surveillance.
The SKOUT system is only intended to
assist the gastroenterologist in
identifying suspected colorectal polyps
and the gastroenterologist is
responsible for reviewing SKOUT
suspected polyp areas and confirming
the presence or absence of a polyp
based on their own medical judgment.
SKOUT is not intended to replace a full
patient evaluation, nor is it intended to
be relied upon to make a primary |
| | Subject Device SKOUT System | Predicate Device SKOUT System
(K213686) |
| | interpretation of endoscopic
procedures, medical diagnosis, or
recommendations of treatment/course
of action for patients. SKOUT is
indicated for white light colonoscopy
only. | interpretation of endoscopic
procedures, medical diagnosis, or
recommendations of treatment/course
of action for patients. SKOUT is
indicated for white light colonoscopy
only. |
| User Population | Adult patients undergoing colorectal
cancer screening or surveillance
colonoscopy. | Same - Adult patients undergoing
colorectal cancer screening or
surveillance colonoscopy. |
| Technological
Characteristics | The SKOUT system is composed of a
single piece hardware design and
software designed to highlight portions
of the colon where the device detects
potential colorectal polyps. | Similar - The SKOUT system is
composed of a multi piece hardware
design and software designed to
highlight portions of the colon where
the device detects potential colorectal
polyps. |
| Software
Algorithm | The SKOUT system utilizes an artificial
intelligence-based algorithm to perform
the polyp detection function. | Same - The SKOUT system utilizes an
artificial intelligence-based algorithm to
perform the polyp detection function. |
| Power Source | Hospital mains power | Same - Hospital mains power |
| Safety Features | The Mode Selection Button allows for
instantaneous toggling between the
SKOUT video feed and the bypass
video feed in the event of software
error that affects video quality. | Similar - The Video Display Switch
allows for instantaneous toggling
between the SKOUT video feed and
the standard video feed in the event of
software error that affects video quality. |
| | The polyp detection marker is disabled
if a biopsy tool enters the field of view
to prevent obstruction of the area of
interest during intervention. | The polyp detection marker is disabled
if a biopsy tool enters the field of view
to prevent obstruction of the area of
interest during intervention. |
| | SKOUT system GUI also has a device
status indicator, the subject device has
an additional GUI feature that notifies
users of the current device status
(active or error):
a two-dimensional green box
with letter (S) when the device
is powered on and actively
processing video. a two-dimensional gray box
with letter (S) when a surgical
tool is present. a red (X) with an error
message; when there is an
error with the video processing
function of the SKOUT®
system, the green box will be
replaced with a red X and error
message to indicate an error | SKOUT system GUI also has a device
status indicator, a green square,
located in the top left corner of the
SKOUT video feed. This GUI feature is
an additional check to the user that the
SKOUT system is on and in use, even
when polyp detection notifications are
not on the screen to prevent undesired
use of the AI. |
| | Subject Device SKOUT System | Predicate Device SKOUT System
(K213686) |
| Device Output | SKOUT system generates markers in
the form of blue rectangles
superimposed on the endoscopic video
when potential colorectal polyps are
identified. SKOUT markers are not
accompanied by a sound. | Same - SKOUT system generates
markers in the form of blue rectangles
superimposed on the endoscopic video
when potential colorectal polyps are
identified. SKOUT markers are not
accompanied by a sound. |
| | The polyp detection marker is disabled
if a biopsy tool enters the field of view
to prevent obstruction of the area of
interest during intervention. | The polyp detection marker is disabled
if a biopsy tool enters the field of view
to prevent obstruction of the area of
interest during intervention. |
| Compatible
Endoscopes | Olympus EVIS EXERA III and FUJI
EC760 series | Same - Olympus EVIS EXERA III and
FUJI EC760 series |
| Video Delay | Assessment of video delay due to
marker annotation; SDI 0.0ms (error
1.1ms )
Assessment of video delay due to
device; SDI 0.0ms (error 1.1ms)
Subject device does not have DVI
input. | Similar - Assessment of video delay due to marker annotation; 56.00ms
(95% CI: 50.54,
61.46) and 3.25 (95% CI: 2.93, 3.56)
frame delay for Serial Digital Interface
(SDI) and 62.33ms (95% CI: 60.76,
63.90) and 3.74 (95% CI: 3.65, 3.83)
frame delay for Digital Visual Interface
(DVI).
Assessment of real-time endoscopic
video delay due to the device; 56.67ms
(95% CI: 51.01, 62.33) and 3.28 (95%
CI: 2.96, 3.62) frame delay for SDI and
60.67ms (95% CI: 57.72, 63.61) and
3.64 (95% CI: 3.46, 3.81) frame delay
for DVI. |
| Pixel Level
Degradation | No pixel level degradation is introduced
by SKOUT to the Endoscopic System. | Similar - No visually detectable
differences between images were
found with the introduction of the
SKOUT system @ |
Table 1: Technological Characteristics Comparison
6
7
The hardware and software differences to the subject device that result in improved performance, these differences do not introduce new questions of safety or effectiveness.
Conclusions
The SKOUT system has the same intended use, indications for use, technological characteristics, and principles of operation as its predicate device. The minor differences in hardware design and software do not affect its safety and effectiveness when used as labeled. The algorithm between the two devices remains the same, therefore clinical performance remains unchanged. Performance data demonstrates that the SKOUT system is as safe and effective as the predicate device. Thus, the SKOUT system can be considered substantially equivalent.