(304 days)
No
The description focuses on digital filter-based image enhancement techniques (RGB component manipulation) and does not mention AI, ML, or related concepts like training data or algorithms.
No.
The device is described as a video processor used for bronchoscopic diagnosis, treatment, and video observation, and it employs imaging enhancement technology (i-Scan) to provide an enhanced view of mucosal surfaces and blood vessels to aid in diagnosis. It does not exert a direct therapeutic effect on the patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for bronchoscopic diagnosis, treatment and video observation." The "Device Description" also reiterates its intention for "endoscopic diagnostic, treatment and video observation." The mention of "i-Scan™ technology" for "enhanced view of the texture of the mucosal surface and blood vessels" further supports its role in aiding diagnosis.
No
The device description explicitly states that the PENTAX EPK-i5010 video processor consists of hardware components including a video system, integrated light source, monitor, and ancillary equipment. While it includes software (i-Scan), it is not a software-only device.
Based on the provided text, the PENTAX Medical EPK-i5010 Video Processor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Intended Use: The intended use of the PENTAX Medical EPK-i5010 is for "bronchoscopic diagnosis, treatment and video observation" using an endoscope inserted into the body. It processes images captured in vivo (within the living body).
- Device Description: The device description confirms it's a video processor for use with endoscopes, light sources, and monitors for endoscopic procedures. The i-Scan technology enhances images captured during these procedures.
- Lack of Specimen Analysis: There is no mention of the device analyzing any specimens derived from the human body. The image processing is applied to images captured directly from the internal anatomy.
Therefore, the PENTAX Medical EPK-i5010 Video Processor falls under the category of an endoscopic imaging system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PENTAX Medical EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipments for bronchoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i5010 includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan is compatible with PENTAX k-series and i-series video bronchoscopes.
Product codes (comma separated list FDA assigned to the subject device)
EOQ, PEA
Device Description
The PENTAX EPK-i5010 video processor consists of a video system, integrated light source, monitor, and ancillary equipment. This processor when connected to a compatible EB family bronchoscope is intended for endoscopic diagnostic, treatment and video observation.
The PENTAX i-Scan technology is a digital filter-based image enhancement technique with three modes, i-Scan 1, 2 and 3. i-Scan 1 enhances image topography and edges and i-Scan 2 and 3 enhances the color tone of the image by dissecting and recombining the individual red, green and blue (RGB) components of a white light image.
PENTAX i-Scan™ modes 1, 2, and 3, are intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels. i-Scan 1 provides the user with a view that sharpens surface vessels and enhances surface texture of the mucosa. i-Scan 2 provides the user with increased visibility of blood vessels while also providing the same enhancements to the mucosa achieved in i-Scan 3 provides the user with increased visibility of blood vessels including dimly illuminated far-field regions while also providing the same enhancement to the mucosa achieved in i-Scan 1. The user can select either white light image or i-Scan modes by pressing a pre-programmed button on the scope, by using a pre-programmed foot pedal or by pressing a keyboard button. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.
White light is captured from a 300 Watt xenon lamp housed in the EPK-i5010 video processor. All visualization is done with the white light mode first. White light (BGR) illuminates the tissue and transfers the captured light through the video scope or a charged coupled device (CCD). Note that the white light visualization mode is always used first by the physician. The modification of the combination of RGB components for each pixel occurs when the i-Scan function is turned on in the EPK-i5010 video processor. The resulting i-Scan image is then displayed on the observation monitor.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
White light endoscopy
Anatomical Site
Pulmonary anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Electrical Safety and electromagnetic compatibility (EMC)
The acceptable level of Electromagnetic Compatibility (EMC) and Electrical Safety (ES) for the PENTAX Medical EPK-i5010 Video Processor with EB Family was confirmed by testing in accordance with the following standards:
- IEC 60601-1:2005+A1:2012. Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:Edition 3:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-6 Edition 3.0:2010. Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-2-18 Edition 3.0:2009: , Medical electrical equipment- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software is classified as CLASS B under the Software Safety Classification per IEC 62304:2006, Medical device software life cycle processes) and the software level of concern is "Moderate" based on the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
All testing of the software was conducted in compliance with the following standards:
- ISO 14971 Second Edition:2007, Medical devices -Application of risk management to medical devices
- IEC 62304 First Edition:2006, Medical device software- Software life cycle processes
- IEC 62471 First Edition:2006, Photobiological safety of lamps and lamp systems
Optical Performance Testing (Bench and Animal non-clinical testing)
Animal Study: A library of images [white light endoscopic (WLE), PENTAX i-Scan™, and Olympus Narrow Band Imaging (NBI)] were obtained from the porcine pulmonary mucosa. The images were used for image evaluation and quantitative data analysis.
Bench Testing: i-Scan and Artifact Analysis were performed with the images from the porcine pulmonary location that were gathered using two PENTAX bronchoscopes, one high definition and one standard definition, along with an Olympus bronchoscope. In addition, PENTAX and Olympus bronchoscopes were compared and optical bench testing was conducted to evaluate the effects of processing features and demonstrate the equivalence of the distortion, resolution and color performance of the subject compared to the predicate.
Key Results: The animal and optical bench test image data gathered with bronchoscopes establish the equivalence of the subject and predicate device. The data submitted support the safety of the device and the hardware and software verification and validation demonstrate that the PENTAX Medical EPK-5010 Video Processor performs as intended in the specified use conditions. The optical data analysis demonstrate that the PENTAX Medical EPK-i5010 Video Processor performs comparably to the predicate device that is currently marketed for the same indication for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2015
Pentax of America, Inc. Mr. Krishna Govindarajan Senior Manager, Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645
Re: K143727
Trade/Device Name: Pentax Medical EKP-i5010 Video Processor With EB Family Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ, PEA Dated: September 28, 2015 Received: September 29, 2015
Dear Mr. Govindarajan,
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | K143727 |
| Device Name | PENTAX Medical EPK-i5010 Video Processor with EB Family |
| Indications for Use (Describe) | The PENTAX Medical EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes,
light sources, monitors and other ancillary equipments for bronchoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i5010 includes PENTAX i-Scan™, a digital, post-processing imaging enhancement
technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not
intended to replace histopathological sampling. i-Scan is compatible with PENTAX k-series and i-series video
bronchoscopes. |
| Type of Use (Select one or both, as applicable) | |
| | Prescription Use (Part 21 CFR 801 Subpart D) |
| | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| PSC Publishing Services (301) 443-6740 EF |
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510(k) Summary
The following summary is provided in accordance with 21 CFR 807.92:
I. SUBMITTER
PENTAX of America, Inc., HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782
Phone: 201-251-2300 x 2125 201-799-4117 Fax:
Contact Person: Krishna Govindarajan Date Prepared: October 28, 2015
II. DEVICE
| Name of Device: | PENTAX Medical EPK-i5010 Video Processor with EB Family |
|---|---|
| Common or Usual Name: | Endoscopic Video Processor and Light Source |
| Classification Name: | Endoscopic video imaging system/component, |
| Classification Name: | Bronchoscopes (Flexible or rigid) and accessories (21 CFR |
| Part 874.4680) | |
| Regulatory Class: | Class II |
| Product Code: | EOQ and PEA |
III. PREDICATE DEVICE
The OLYMPUS EVIS EXERA III Video System CV - 190 Video System Center and CLV -190, Xenon Light Source (K121959) is the primary predicate for this submission.
The PENTAX EPK-i5010 Video Processor (K122470; dated April 22, 2013) is the reference device for this submission.
This reference device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The PENTAX EPK-i5010 video processor consists of a video system, integrated light source, monitor, and ancillary equipment. This processor when connected to a compatible EB family bronchoscope is intended for endoscopic diagnostic, treatment and video observation.
The PENTAX i-Scan technology is a digital filter-based image enhancement technique with three modes, i-Scan 1, 2 and 3. i-Scan 1 enhances image topography and edges and i-Scan 2 and 3 enhances the color tone of the image by dissecting and recombining the individual red, green and blue (RGB) components of a white light image.
PENTAX Medical EPK-i5010 Video Processor with EB Family 510(k) Summary
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PENTAX i-Scan™ modes 1, 2, and 3, are intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels. i-Scan 1 provides the user with a view that sharpens surface vessels and enhances surface texture of the mucosa. i-Scan 2 provides the user with increased visibility of blood vessels while also providing the same enhancements to the mucosa achieved in i-Scan 3 provides the user with increased visibility of blood vessels including dimly illuminated far-field regions while also providing the same enhancement to the mucosa achieved in i-Scan 1. The user can select either white light image or i-Scan modes by pressing a pre-programmed button on the scope, by using a pre-programmed foot pedal or by pressing a keyboard button. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.
White light is captured from a 300 Watt xenon lamp housed in the EPK-i5010 video processor. All visualization is done with the white light mode first. White light (BGR) illuminates the tissue and transfers the captured light through the video scope or a charged coupled device (CCD). Note that the white light visualization mode is always used first by the physician. The modification of the combination of RGB components for each pixel occurs when the i-Scan function is turned on in the EPK-i5010 video processor. The resulting i-Scan image is then displayed on the observation monitor.
The table below are the list of accessories and compatible devices that are used with the EPK-i5010 Video Processor.
| Accessories Name | Intended Use | Model Number |
|---|---|---|
| PENTAX Condenser Earth | ||
| Cable | Condenser earth cable OL-Z4 is intended to reduce high- frequency noise which is generated during high- frequency electro cautery device use together with Pentax endoscopes. | OL-Z4 |
| PENTAX Foot Switch | Foot Switch OS-A61 is used to remotely control processor functions. | OS-A61 |
| PENTAX Keyboard | Keyboard OS-A79 is used as an input device for the video processor. | OS-A79 |
| PENTAX White Balance | ||
| Adjuster | White Balance Adjuster OS- A43H is a white tube used as the object of white balance feature. | OS-A43H |
Table 1: List of Accessories
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| Compatible Devices | Manufacturer | Model Name |
|---|---|---|
| Printer | Sony Corporation | UP-55MD |
| Sony Corporation | UP-21MD | |
| Sony Corporation | UP-D23MD | |
| Sony Corporation | UP-D23MDA | |
| USB Flash Memory | SanDisk | SDCZ6-1024-A10 |
| LCD Monitor | NDS Surgical Imaging | Radiance 19 |
Table 2: List of Compatible Devices
The EPKi-5010 is compatible with PENTAX k-series video bronchoscopes.
V. INDICATIONS FOR USE
The PENTAX Medical EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for bronchoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i5010 includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan is compatible with PENTAX k-series video bronchoscopes.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The PENTAX Medical EPK-i5010 Video Processor with EB Family (subject device) has the same intended use and fundamental operating principle as the OLYMPUS EVIS EXERA III Video System CV - 190 Video System Center and CLV - 190, Xenon Light Source (K121959) (primary predicate device). Both devices also have the same indications for use; namely, for use in bronchoscopic diagnosis, treatment and video observation in the pulmonary anatomy. The devices differ slightly with regard to design and technological characteristics. Performance data, specifically optical bench and animal testing, is provided to support substantial equivalence of the devices.
The PENTAX Medical EPK-i5010 Video Processor with EB Family (subject device) has the same intended use, design, fundamental operating principle, and scientific technology, including the PENTAX i-Scan image enhancement technology, compared to the commercially available PENTAX EPK-i5010 Video Processor (reference device). There were minor changes made to the EPK-i5010 Video Processor with EB Family to address the requirements of the 3rd edition of IEC 60601. However, these changes did not affect the
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final product specification and did not raise any questions of safety or effectiveness. The only substantive difference between the subject and primary predicate device is in use of the device in different anatomical locations. The subject device is used for bronchoscopic diagnosis, treatment and video observation in the pulmonary anatomy and the predicate device is used for gastrointestinal endoscopic diagnosis, treatment and video observation in the upper and lower gastrointestinal anatomical location.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Electrical Safety and electromagnetic compatibility (EMC)
The acceptable level of Electromagnetic Compatibility (EMC) and Electrical Safety (ES) for the PENTAX Medical EPK-i5010 Video Processor with EB Family was confirmed by testing in accordance with the following standards:
-
- IEC 60601-1:2005+A1:2012. Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
- IEC 60601-1-2:Edition 3:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
-
- IEC 60601-1-6 Edition 3.0:2010. Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
-
- IEC 60601-2-18 Edition 3.0:2009: , Medical electrical equipment- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software is classified as CLASS B under the Software Safety Classification per IEC 62304:2006, Medical device software life cycle processes) and the software level of concern is "Moderate" based on the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
All testing of the software was conducted in compliance with the following standards:
-
- ISO 14971 Second Edition:2007, Medical devices -Application of risk management to medical devices
-
- IEC 62304 First Edition:2006, Medical device software- Software life cycle processes
-
- IEC 62471 First Edition:2006, Photobiological safety of lamps and lamp systems
PENTAX Medical EPK-i5010 Video Processor with EB Family 510(k) Summary
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Optical Performance Testing (Bench and Animal non-clinical testing)
Animal Study
A library of images [white light endoscopic (WLE), PENTAX i-Scan™, and Olympus Narrow Band Imaging (NBI)] were obtained from the porcine pulmonary mucosa. The images were used for image evaluation and quantitative data analysis.
Bench Testing
i-Scan and Artifact Analysis were performed with the images from the porcine pulmonary location that were gathered using two PENTAX bronchoscopes, one high definition and one standard definition, along with an Olympus bronchoscope. In addition, PENTAX and Olympus bronchoscopes were compared and optical bench testing was conducted to evaluate the effects of processing features and demonstrate the equivalence of the distortion, resolution and color performance of the subject compared to the predicate.
The animal and optical bench test image data gathered with bronchoscopes establish the equivalence of the subject and predicate device.
VIII. CONCLUSIONS
The data submitted support the safety of the device and the hardware and software verification and validation demonstrate that the PENTAX Medical EPK-5010 Video Processor performs as intended in the specified use conditions. The optical data analysis demonstrate that the PENTAX Medical EPK-i5010 Video Processor performs comparably to the predicate device that is currently marketed for the same indication for use.