PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 18, 2024 PENTAX of America, Inc. Gurvinder Singh Nanda Senior Director Regulatory and Quality 3 Paragon Drive Montvale. New Jersey 07645-1782 Re: K232860 Trade/Device Name: PENTAX Medical Video Processor EPK-i8020c Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: December 20, 2023 Received: December 20, 2023 Dear Gurvinder Singh Nanda: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, # Shuchen Peng -S Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232860 #### Device Name PENTAX Medical EPK-i8020c Video Imaging System Indications for Use (Describe) The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors ancillary equipment for gastrontestinal and pulmonary endoscopic diagnosis, treatment and video observation. The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes. | 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) #### 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." {3}------------------------------------------------ Image /page/3/Picture/2 description: The image contains the logo for Pentax Medical. The word "PENTAX" is written in large, red, bold letters. Below the word "PENTAX" is a gray line, and below the line is the word "MEDICAL" in gray, bold letters. # 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 221 CFR 807.92. All data included in this document is accurate and complete to the best of PENTAX Medical's knowledge. ### 1. SUBMITTER Applicant: PENTAX Medical HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782 Gurvinder Singh Nanda Contact: Senior Director, Regulatory Affairs and Quality PENTAX Medical 3 Paragon Drive Montvale, New Jersey 07645-1782 Telephone: 650-722-4189 FAX: (201)391-4189 Email: gurvinder.nanda@pentaxmedical.com Date Prepared: 1/17/2024 # 2. SUBJECT DEVICE | | PENTAX Medical EPK-i8020c Video Imaging System | | |----------------------|--------------------------------------------------|--| | Device Name | PENTAX Medical Video Processor EPK-i8020c | | | Common Name | Endoscopic Video Processor and Light Source | | | Classification Name | Bronchoscope (flexible or rigid) and accessories | | | Regulation No. | 874.4680 | | | Device Class | II | | | Product Code | EOQ * | | | Classification Panel | Ear Nose & Throat | | * The gastrointestinal use (product code: PEA) of the subject device has been cleared in K231249, and pulmonary use (product code: EOQ) is added through this submission. {4}------------------------------------------------ ## PENTAX Medical EPK-i8020c Video Imaging System Traditional 510(k) Submission Image /page/4/Picture/2 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, and the word "MEDICAL" is in gray. There is a gray line separating the two words. The logo is simple and modern. The PENTAX Medical Video Processor EPK-i8020c is compatible also with the following endoscopes that have been cleared in past Premarket Notifications: | Device Name | Model name | |-------------------------------------------------|---------------------------------| | PENTAX Medical<br>Video Bronchoscope | EB19-J10 (K200678) | | | EB15-J10 (K200678) | | | EB11-J10 (K210928) | | PENTAX Medical<br>Ultrasound Video Bronchoscope | EB19-J10U (K183516 and K203166) | # 3. PREDICATE DEVICE Previously cleared PENTAX Medical Video Processor and Video Scopes have been chosen as a predicate device: | Subject Device | Predicate Device | |----------------------------------------------|-----------------------------------------------------------------------------------| | PENTAX Medical Video Processor<br>EPK-i8020c | PENTAX Medical EPK-i7010 Video<br>Processor with EB Family of Scopes<br>(K173679) | ### 4. REFERENCE DEVICE A previously cleared PENTAX Medical Video Scopes have been chosen as a reference device: ### Reference device for video scopes | Model Name | Model Number | Compatible<br>Video processor | 510(k) Clearance<br>Number | |--------------------------------------|--------------|-------------------------------|----------------------------| | PENTAX Medical<br>Video Bronchoscope | EB19-J10 | EPK-i7010 | K200678 | | | EB15-J10 | | | | | EB11-J10 | K210928 | | {5}------------------------------------------------ ## PENTAX Medical EPK-i8020c Video Imaging System Traditional 510(k) Submission Image /page/5/Picture/2 description: The image contains the logo for Pentax Medical. The word "PENTAX" is in red, and the word "MEDICAL" is in gray. There is a gray line separating the two words. | Model Name | Model Number | Compatible<br>Video<br>processor | Ultrasound<br>Scanner | 510(k)<br>Clearance<br>Number | |----------------------------------------------------|--------------|----------------------------------|-----------------------|-------------------------------| | PENTAX Medical<br>Ultrasound<br>Video Bronchoscope | EB19-J10U | EPK-i7010 | ARIETTA 70 | K183516 | | | | | ARIETTA 850 | K203166 | Reference device for ultrasound video scopes # 5. DEVICE DESCRIPTION # PENTAX Medical Video Processor EPK-i8020c The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment. The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling. The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is found in the instructions for use (IFU) and/or in the commercial materials such as brochures. # 6. INTENDED USE AND INDICATIONS FOR USE # Intended use and Indications for use for PENTAX Medical Video Processor EPKi8020c The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal and pulmonary endoscopic diagnosis, treatment and video observation. The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes and bronchoscopes. {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold, sans-serif font on the top line. Below that is a gray line, and below that is the word "MEDICAL" in gray, bold, sans-serif font. # 7. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE The subject device is functionally equivalent to the predicate device, and the difference between the two devices are minor technological changes such as the application of a CMOS image sensor for the new endoscopes and an LED light source for the new video processor. The changes in the subject device have been evaluated through performance testing including an image quality animal study. This study raised no issues of safety and effectiveness of the device as these differences have no effect on the performance, function or general intended use of the device. The components of the subject device have the same fundamental technology and principle of operation as the predicate device. Both the subject device and the predicate device are intended for illuminating and viewing the inside of the human body. The components of the subject device consist of the same components as the predicate device, including: - . A video processor - . Video Bronchoscope to provide optical visualization of (via a video monitor), and therapeutic access to the trachea and bronchial tube. - Accessories, including but not limited to a keyboard, foot switch, White Balance Adjuster, and Condenser Earth Cable # 8. NON-CLINICAL PERFORMANCE DATA The PENTAX Medical EPK-i8020c Video Imaging System has been successfully tested for their functions, performance, and safety as per FDA recognized consensus standards. The following performance data are provided in support of the substantial equivalence determination. - i. Reprocessing Validation Additional Reprocessing Validation is not required, because the subject device is not reprocessed and provided non-sterile. The reprocessing procedures of the reference devices (video bronchoscopes) have not changed since past Premarket Notifications. - ii. Sterilization and Shelf Life Sterilization and shelf life is not required because the subject device is not {7}------------------------------------------------ Image /page/7/Picture/2 description: The image shows the logo for Pentax Medical. The word "PENTAX" is written in red, bold letters on the top line. A gray line is underneath the word "PENTAX", and the word "MEDICAL" is written in gray, bold letters on the bottom line. reprocessed and is not provided sterile. - iii. Biocompatibility Additional biocompatibility is not required, because the subject device does not contain any direct or indirect patient contact components. Also, the materials of the reference devices (video bronchoscopes) have not changed since past Premarket Notifications. - iv. Software and Cybersecurity Software verification and validation including cybersecurity assessments were conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidance for Industry and Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", and "Postmarket Management of Cybersecurity in Medical Devices". - Electrical Safety and EMC V. The acceptable level of electrical safety (ES) and electromagnetic compatibility (EMC) were confirmed by the following standards: IEC 60601-1-2:2014; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; and IEC 60601-2-18:2009. - vi. System Performance The system performance of the subject device demonstrated the equivalence to the predicate device. - vii. Optical Performance As a part of Design Verification and Validation, optical properties of imaging and illumination performances were measured for the PENTAX Medical EPK-i8020c Video Imaging System. All results show that the optical characteristics of the subject device is equivalent to those of the predicate device and the reference device. - viii. Animal Image Capture Study An animal image capture study was performed as a part of optical and color performance testing. The results indicate that the subject device is able to visualize vascularity and mucosal surface for targeted anatomical areas as well as the predicate device and the reference device. {8}------------------------------------------------ Image /page/8/Picture/2 description: The image displays the logo for PENTAX Medical. The word "PENTAX" is written in large, bold, red letters. Below "PENTAX" is a gray line, and below the line is the word "MEDICAL" in gray letters. The logo is simple and modern. ### Substantial Equivalence Discussion: After analyzing the intended use, indications for use, technological characteristics (including fundamental operating principle, energy source, scientific technology, functional characteristics, design features, performance characteristics, and constituent materials), labeling, reprocessing and sterilization methods, PENTAX Medical concludes that the subject device is as safe and effective as the predicate device. There are no differences in indications for use and intended use between the subject and predicate device and are therefore substantially equivalent. The technological differences in terms of design features, performance characteristics and constituent materials are not substantive. ### 9. CONCLUSION Accordingly, PENTAX Medical believes the PENTAX Medical EPK-i8020c Video Imaging System does not raise any different questions of safety and effectiveness, and that the subject device of the PENTAX Medical Video Processor EPK-i8020c is substantially equivalent to the identified predicate, the PENTAX Medical Video Processor EPK-i7010, cleared by FDA in K173679.