(136 days)
No
The summary describes a standard video bronchoscope and video processor. While the processor includes "digital, post-processing imaging enhancement technology" (PENTAX i-Scan), this is not explicitly stated or implied to be AI/ML. There is no mention of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML algorithms.
Yes
The device description states that the EB-J10 series endoscopes provide "therapeutic access to, the airways and tracheobronchial tree" and have a "working channel through which biopsy devices, or other devices, may be introduced." This indicates that it facilitates therapeutic interventions.
Yes
The device provides visualization of the airways and tracheobronchial tree, allowing medical professionals to observe the internal structures for diagnosis. The mention of "therapeutic access" suggests it can also be used for treatment, but its primary function as described involves visualization, which is a key aspect of diagnosis.
No
The device description clearly outlines physical hardware components including a flexible insertion tube, control body, PVE connector, light carrying bundles, CCD, and a working channel. While it is used with a software-controlled video processor, the bronchoscope itself is a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "endoscopic surgery within the airways and tracheobronchial tree" and for "visualization of, and therapeutic access to, the airways and tracheobronchial tree." This describes a device used in vivo (within the living body) for direct visualization and intervention.
- Device Description: The description details a flexible insertion tube, control body, and connections for light, video signals, air/water, and suction. It also mentions a working channel for introducing biopsy devices or other devices. These are all characteristics of an endoscopic device used for direct examination and procedures within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. This device does not collect or analyze specimens in vitro. It provides direct visualization and access in vivo.
While the device does involve image processing and visualization, this is for the purpose of guiding the endoscopic procedure in vivo, not for analyzing specimens in vitro.
N/A
Intended Use / Indications for Use
The PENTAX Medical Video Bronchoscopes EB-J10 Series have been designed to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopic surgery within the airways and tracheobronchial tree.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
The EB-J10 series endoscopes are used to provide visualization of, and therapeutic access to, the airways and tracheobronchial tree. There are two models of EB-J10 series: EB15-J10 and EB19-J10. These models are identical in all parameters and only differ in French size: 15 and 19.
The bronchoscopes are used with cleared PENTAX Video Processors (a softwarecontrolled device). The endoscopes have a flexible insertion tube, a control body, and PVE connector. The PVE connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water and suction.
The control body includes controls for up/ down angulation, air/ water delivery, and an accessory inlet port. The endoscope contains light carrying bundles (LCB) to illuminate the body cavity, and a charge coupled device (CCD) to collect endoscopic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced.
The video processor contains a lamp that provides white light and is focused at the PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
The instrument is immersible (with the use of supplied cleaning accessories) as described in the endoscope reprocessing instructions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic image data
Anatomical Site
airways and tracheobronchial tree
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
The PENTAX Medical Video Bronchoscopes EB-J10 Series have 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.
Reprocessing Validation
Simulated use testing, soil accumulation analysis, cleaning, high-level disinfection, and rinsing validation studies of the Video Bronchoscopes EB-J10 Series and accessories were conducted and confirmed the effectiveness of reprocessing procedures.
Sterilization and Shelf Life
PENTAX Medical coordinated with Advanced Sterilization Products, Inc. to validate the use of STERRAD NX/100NX for the sterilization of the EB-J10 series Video Bronchoscopes and accessories. The devices are not provided sterile.
PENTAX Medical conducted Electron Beam Sterilization for packaging and for PENTAX Medical OF-B205 single-use disposable Suction Control Valve. A shelf-life of 3 years after sterilization was verified.
Software
Software verification and validation tests 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. The software level of concern is "Moderate" based on FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Cybersecurity risks have been assessed and mitigated according to the FDA Guidances for Industry and Staff "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued October 2, 2014 and "Postmarket Management of Cybersecurity in Medical Devices." issued December 28, 2016.
EMC and Electrical Safety
The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX Medical Video Bronchoscopes EB-J10 Series 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.
Optical Testing
As a part of Design Verification and Validation, optical properties including signal to noise, color, limiting spatial resolution transfer function (MTF), distortion, light distribution, spectral distribution, total luminous flux and photobiological safety were measured for the EB15-J10 and EB19-J10 in conjunction with the EPK-3000, EPKi7010 and EPK-i5010 Video Processors. All results show that the optical characteristics of the subject device is equivalent to those of the predicate device.
Clinical Image Capture Study
A clinical image capture study was performed as a part of optical and color performance testing. The results indicate that the subject device demonstrates equivalent or better capabilities in visualization of vascularity and mucosal surface for each anatomical area.
Operational and Reprocessing Instructions for Use are provided for the scopes
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.
K172156, K182846, K143727, K173679
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
Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 30, 2020
PENTAX of America, Inc. William Goeller Vice President, Quality Assurance and Regulatory Affairs 3 Paragon Drive Montvale, New Jersey 07645-1782
Re: K200678
Trade/Device Name: PENTAX Medical Video Bronchoscope EB-J10 Series Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOQ Dated: June 30, 2020 Received: July 2, 2020
Dear William Goeller:
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 Actinclude 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.
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
1
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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200678
Device Name
PENTAX Medical Video Bronchoscopes EB-J10 Series
Indications for Use (Describe)
The PENTAX Medical Video Bronchoscopes EB-J10 Series have been designed to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopic surgery within the airways and tracheobronchial tree.
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."
3
Image /page/3/Picture/1 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.
K200678
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.
Applicant: PENTAX Medical HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782
Contact: William Goeller Vice President, Quality and Regulatory Affairs PENTAX Medical 3 Paragon Drive Montvale, New Jersey 07645-1782 Telephone: (201)571-2300 ext. 2318 FAX: (201)391-4189 Email: william.goeller@pentaxmedical.com
Date Prepared: 03/13/2020
Common Name: Bronchoscope
Name of the System: PENTAX Medical Video Bronchoscopes EB-J10 Series EB15-J10 Video Bronchoscope, EB19-J10 Video Bronchoscope
Regulation Number:
21 CFR Part 874.4680
Regulation Names:
Bronchoscope (flexible or rigid) and accessories
Regulatory Class: Class II
Product Code: EOQ
Predicate Device: PENTAX Video Bronchoscopes (EB Family) (K131028)
PENTAX Medical is seeking clearance of a new line of Video Bronchoscopes EB-J10 Series with the compatible PENTAX Video Processors EPK-3000 (K172156, K182846), EPK-i5010 (K143727), and EPK-i7010 with EB Family (K173679).
This 510(k) also captures some minor design changes that have occurred during the evolution of the product line. Although the changes are believed to be minor, the 510(k) is being submitted to account for technological advances in associated compatible devices and to ensure that FDA has the most current information concerning the PENTAX Medical Video Bronchoscopes EB-J10 Series.
4
Image /page/4/Picture/0 description: The image contains the logo for Pentax Medical. The word "PENTAX" is written in large, bold, red letters. Below the word "PENTAX" is a gray line. Below the gray line, the word "MEDICAL" is written in gray, bold letters.
The subject device has virtually the same indications for use, viewing directions, and image size as the predicate.
The main differences between the subject device and predicate device are as follows:
- Introduction of a new line of Video Bronchoscopes, EB-J10 series, which includes ● EB15-J10, and EB19-J10 as compatible Video Bronchoscopes in the EB family.
- The EB-J10 series have a new control body design with a sterile single-use suction control valve, OF-B205.
- Due to technological advances, the optical design of the subject device EB-J10 Series has been modified. Specifically, its sensor module assembly, and glass rod are different with respect to the predicate device. The optical performance of the subject and predicate devices has been confirmed to be substantially equivalent through bench testing and clinical imaging study results.
- Device firmware and CCD has been updated to reflect technological ● modernization with higher resolution CCD.
Device Description:
The EB-J10 series endoscopes are used to provide visualization of, and therapeutic access to, the airways and tracheobronchial tree. There are two models of EB-J10 series: EB15-J10 and EB19-J10. These models are identical in all parameters and only differ in French size: 15 and 19.
The bronchoscopes are used with cleared PENTAX Video Processors (a softwarecontrolled device). The endoscopes have a flexible insertion tube, a control body, and PVE connector. The PVE connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water and suction.
The control body includes controls for up/ down angulation, air/ water delivery, and an accessory inlet port. The endoscope contains light carrying bundles (LCB) to illuminate the body cavity, and a charge coupled device (CCD) to collect endoscopic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced.
The video processor contains a lamp that provides white light and is focused at the PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
The instrument is immersible (with the use of supplied cleaning accessories) as described in the endoscope reprocessing instructions.
5
Image /page/5/Picture/1 description: The image contains the logo for Pentax Medical. The word "PENTAX" is written in large, red, bold letters on the top line. Below that is a gray line, and below that is the word "MEDICAL" in gray, bold letters. The logo is simple and professional.
K200678
Intended Use /Indications for Use (EB-J10 Series)
The PENTAX Medical Video Bronchoscopes EB-J10 Series have been designed to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Compatible Video Processors
In addition to compatibility with EPK-i5010, EPK-i7010 previously cleared with other PENTAX bronchoscopes (K143727; K173679), EB-J10 series is compatible with a new processor EPK-3000 that has been previously cleared to be used with other PENTAX Medical endoscopes, in particular nasopharyngo/laryngoscopes (K172156, K182846). EPK-3000 labeling has been revised to reflect compatibility of the processor with EB-J10 series.
Please see below the proposed Intended Use/ Indications for Use for EPK-3000 video processor:
Intended Use /Indications for Use (EPK-3000)
For Bronchoscopes
The PENTAX VIDEO PROCESSOR EPK-3000 is intended to be used with the PENTAX Medical EB19-J10U, EB15-J10, and EB19-J10 endoscopes, video monitors and other ancillary equipment for bronchoscopic diagnosis, treatment and video observation.
The PENTAX Medical VIDEO PROCESSOR EPK- 3000 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.
Summary of Technology Characteristics:
The PENTAX Medical Video Bronchoscopes EB-J10 Series are functionally equivalent to the predicate device, the PENTAX Medical Video Bronchoscopes (EB Family) cleared by FDA in 2014 (K131028). The only difference between the two devices are minor technological changes.
The changes in the subject device have been evaluated through performance testing and raise no issue of safety and effectiveness of the device as these differences have no effect on the performance, function or general intended use of the device.
Non-Clinical Performance Data
The PENTAX Medical Video Bronchoscopes EB-J10 Series have 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.
6
Image /page/6/Picture/1 description: The image contains the logo for Pentax Medical. The word "PENTAX" is in red, bold, uppercase letters. Below "PENTAX" is a gray line. Below the line, the word "MEDICAL" is in gray, bold, uppercase letters.
K200678
Reprocessing Validation
Simulated use testing, soil accumulation analysis, cleaning, high-level disinfection, and rinsing validation studies of the Video Bronchoscopes EB-J10 Series and accessories were conducted and confirmed the effectiveness of reprocessing procedures.
Sterilization and Shelf Life
PENTAX Medical coordinated with Advanced Sterilization Products, Inc. to validate the use of STERRAD NX/100NX for the sterilization of the EB-J10 series Video Bronchoscopes and accessories. The devices are not provided sterile.
PENTAX Medical conducted Electron Beam Sterilization for packaging and for PENTAX Medical OF-B205 single-use disposable Suction Control Valve. A shelf-life of 3 years after sterilization was verified.
Software
Software verification and validation tests 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. The software level of concern is "Moderate" based on FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Cybersecurity risks have been assessed and mitigated according to the FDA Guidances for Industry and Staff "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued October 2, 2014 and "Postmarket Management of Cybersecurity in Medical Devices." issued December 28, 2016.
EMC and Electrical Safety
The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX Medical Video Bronchoscopes EB-J10 Series 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.
Optical Testing
As a part of Design Verification and Validation, optical properties including signal to noise, color, limiting spatial resolution transfer function (MTF), distortion, light distribution, spectral distribution, total luminous flux and photobiological safety were measured for the EB15-J10 and EB19-J10 in conjunction with the EPK-3000, EPKi7010 and EPK-i5010 Video Processors. All results show that the optical characteristics of the subject device is equivalent to those of the predicate device.
7
Image /page/7/Picture/1 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold letters on the top line. A gray line is underneath the word "PENTAX". The word "MEDICAL" is in gray, bold letters on the bottom line.
Clinical Image Capture Study
A clinical image capture study was performed as a part of optical and color performance testing. The results indicate that the subject device demonstrates equivalent or better capabilities in visualization of vascularity and mucosal surface for each anatomical area.
Operational and Reprocessing Instructions for Use are provided for the scopes
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, and sterilization method, we conclude that the subject device PENTAX Medical Video Bronchoscopes EB-J10 Series are 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.
Conclusion:
Accordingly, PENTAX Medical believes the PENTAX Medical Video Bronchoscopes EB-J10 Series are substantially equivalent to the identified predicate, the PENTAX Medical Video Bronchoscopes (EB Family), cleared by FDA in 2014 (K131028).