(125 days)
No
The summary describes digital and optical image enhancement technologies, but does not mention AI, ML, or related concepts like deep learning or neural networks. The performance studies focus on equivalence to a predicate device and optical characteristics, not on AI/ML performance metrics.
No
The device is described for diagnosis, treatment, and video observation, but the specific mention of "treatment" contextually refers to observing during treatment procedures (e.g., endoscopic treatment) rather than independently providing therapeutic action. The core functionalities highlighted are related to imaging and diagnosis, with imaging enhancement technologies not intended to replace histopathological sampling.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for gastrontestinal and pulmonary endoscopic diagnosis, treatment and video observation." The term "diagnosis" directly indicates its use as a diagnostic device.
No
The device description explicitly states that the video processor consists of a video system, integrated light source, monitor, and ancillary equipment, indicating it includes hardware components beyond just software.
Based on the provided information, the PENTAX Medical Video Processor EPK-i8020c is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "gastrontestinal and pulmonary endoscopic diagnosis, treatment and video observation." This involves visualizing internal structures of the body, which is an in vivo (within a living organism) process, not in vitro (outside of a living organism, typically involving samples like blood or tissue).
- Device Description: The description reinforces its use with endoscopes, monitors, and other peripheral devices for endoscopic procedures.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or any other components typically associated with IVD devices. The imaging enhancement technologies are applied to the video feed from the endoscope, not to a separate sample.
Therefore, the PENTAX Medical Video Processor EPK-i8020c is an endoscopic imaging system used for in vivo procedures, not an IVD device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal, Pulmonary (trachea and bronchial tube)
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)
Non-Clinical Performance Data:
- i. Reprocessing Validation: Not required as the device is not reprocessed and provided non-sterile.
- ii. Sterilization and Shelf Life: Not required as the device is not reprocessed and is not provided sterile.
- iii. Biocompatibility: Not required as the device does not contain any direct or indirect patient contact components.
- iv. Software and Cybersecurity: Verification and validation conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidance for Industry and Staff.
- Electrical Safety and EMC V.: Confirmed by 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: Demonstrated equivalence to the predicate device.
- vii. Optical Performance: Measured for imaging and illumination performances; results show equivalence to predicate and reference devices.
- viii. Animal Image Capture Study: Performed as part of optical and color performance testing. Results indicate 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.
Key results: The subject device passed all performance testing and demonstrated equivalence to the predicate device.
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.
K200678, K210928, K183516, K203166
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.
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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).
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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
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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)
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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.
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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 | |
| Video Bronchoscope | EB19-J10 (K200678) |
| EB15-J10 (K200678) | |
| EB11-J10 (K210928) | |
| PENTAX Medical | |
| 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 | |
| EPK-i8020c | PENTAX Medical EPK-i7010 Video |
| Processor with EB Family of Scopes | |
| (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
Video processor | 510(k) Clearance
Number |
|--------------------------------------|--------------|-------------------------------|----------------------------|
| PENTAX Medical
Video Bronchoscope | EB19-J10 | EPK-i7010 | K200678 |
| | EB15-J10 | | |
| | EB11-J10 | K210928 | |
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PENTAX Medical EPK-i8020c Video Imaging System Traditional 510(k) Submission
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| Model Name | Model Number | Compatible
Video
processor | Ultrasound
Scanner | 510(k)
Clearance
Number |
|----------------------------------------------------|--------------|----------------------------------|-----------------------|-------------------------------|
| PENTAX Medical
Ultrasound
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.
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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
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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.
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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.