(206 days)
Not Used
No
The summary describes a standard video bronchoscope and video processor system, focusing on visualization and therapeutic access. There is no mention of AI, ML, or any advanced image analysis beyond basic formatting and display. The performance studies focus on device function, safety, and equivalence to a predicate device, not on algorithmic performance metrics.
Yes
The "Intended Use" states the device is used with "endo-therapy accessories (such as biopsy forceps)" and for "endoscopic surgery within the airways and tracheobronchial tree," indicating its use in therapeutic procedures. The "Device Description" also notes a "working channel through which biopsy devices, or other devices, may be introduced," supporting its role in facilitating therapeutic access.
Yes
Explanation: The device is used to provide visualization of the airways and tracheobronchial tree to aid in diagnosing conditions and informing therapeutic access. The "Intended Use/Indications for Use" states its use for endoscopy and endoscopic surgery, which inherently involves examining the internal body for diagnostic purposes.
No
The device description clearly outlines hardware components such as a flexible insertion tube, control body, PVE connector, light carrying bundles, and a CCD. While it interacts with a software-controlled video processor, the device itself is a physical bronchoscope.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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 observation and intervention.
- Device Description: The description details a flexible insertion tube, control body, and connections for light, video, air/water, and suction. It also mentions a working channel for introducing instruments like biopsy forceps. 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 (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. The description of the PENTAX Medical Video Bronchoscope EB11-J10 does not mention any such use or the analysis of biological specimens.
The device is a medical device used for endoscopy, which is a procedure performed directly on a patient.
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 subject device is used to provide visualization of, and therapeutic access to, the airways and tracheobronchial tree. There are three models of EB-J10 series: the subject device, and the previously cleared models: EB15-J10 and EB19-J10 (K200678). These models are identical in all parameters and only differ in French size: 11, 15 and 19, respectively.
The subject device is used with cleared PENTAX Video Processors (a software- controlled device). The subject device has 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 subject device contains light carrying bundles (LCB) to illuminate the body cavity, and a 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 subject device is immersible (with the use of supplied cleaning accessories) as described in the endoscope reprocessing instructions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 subject device has been successfully tested for their functions, performance and safety as per FDA recognized consensus standards.
Reprocessing Validation: Simulated use testing, soil accumulation analysis, cleaning, high-level disinfection, and rinsing validation studies of the subject device 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 subject device and accessories. The subject device is not provided sterile.
Biocompatibility: Biocompatibility of the EB11-J10 scope on direct and indirect contact materials was confirmed by assessing the cytotoxicity, sensitization, and intracutaneous reactivity. The risk levels of local toxicity were determined as "Acceptable" as a result of applying the risk level of local toxicity to the risk evaluation criteria.
Software: Software verification and validation including cybersecurity assessments were conducted according to IEC 62304: 2006 and FDA Guidances for Industory 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."
EMC and Electrical Safety: The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX Medical Video Bronchoscope EB11-J10 was 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, and IEC 60601-1-2:2014.
Optical Testing: As a part of Design Verification and Validation, optical properties of imaging and illumination performances were measured for subject device in conjunction with the EPK-3000, EPK-i7010, and EPK-i5010 Video Processors. All results show that the optical characteristics of the subject device is equivalent to those of the predicate device.
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 each anatomical area as well or better than 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.
PENTAX Video Bronchoscope EB-1170K (K131028)
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.
Not Found
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
October 21, 2021
PENTAX of America, Inc. William Goeller Vice President, Ouality Assurance and Regulatory Affairs 3 Paragon Drive Montvale, New Jersey 07645-1782
Re: K210928
Trade/Device Name: PENTAX Medical Video Bronchoscope EB11-J10 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: September 20, 2021 Received: September 22, 2021
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 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.
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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Shu-Chen Peng 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
Enclosure
2
Indications for Use
510(k) Number (if known) K210928
Device Name PENTAX Medical Video Bronchoscope EB11-J10
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
PENTAX Medical Video Bronchoscope EB11-J10 Traditional 510(k) Submission
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.
Applicant: PENTAX Medical HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782
Contact: William Goeller Vice President, Quality/Regulatory Affairs PENTAX of America. Inc. 3 Paragon Drive Montvale, New Jersey 07645-1782 Email: william.goeller@pentaxmedical.com Phoner: 800-431-5880 Ext 2318 Fax: 201-571-2340
Date Prepared: 3/22/2021
Common Name: Bronchoscope Name of the System: PENTAX Medical Video Bronchoscope EB11-J10
Regulation Number: 21 CFR Part 874.4680 Regulation Names: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOO Predicate Device: PENTAX Video Bronchoscope EB-1170K (K131028)
PENTAX Medical is seeking clearance of EB11-J10 Video Bronchoscope (Hereinafter "the subject device" which is a new line of Video Bronchoscopes EB-J10 Series (K200678) with the compatible PENTAX Medical Video Processors EPK-3000, EPK-i5010 (K143727), and EPKi7010 with EB Family (K173679).
This premarket notification 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 subject device.
The subject device has virtually the same indications for use, viewing directions, and image size as the PENTAX Medical Video Bronchoscope EB-1170K (Hereinafter "the predicate device").
The main differences between the subject device and predicate device are as follows:
- Introducing the subject device as a new video bronchoscope to the Video Bronchoscopes ● EB-J10 series.
- The subject device has a new control body design with a sterile single-use suction control ● valve, OF-B205.
4
PENTAX Medical Video Bronchoscope EB11-J10 Traditional 510(k) Submission
- . Due to technological advances, the optical design of the subject device 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 animal imaging study results.
- Device firmware and a charge coupled device (CCD) has been updated to reflect technological modernization with higher resolution CCD.
- The subject device is compatible with the video processor EPK-3000 in addition to compatibility with EPK-i5010, EPK-i7010.
- . The subject device can be sterilized using the STERRAD 100NX® system in addition to STERRAD NX® system.
Device Description:
The subject device is used to provide visualization of, and therapeutic access to, the airways and tracheobronchial tree. There are three models of EB-J10 series: the subject device, and the previously cleared models: EB15-J10 and EB19-J10 (K200678). These models are identical in all parameters and only differ in French size: 11, 15 and 19, respectively.
The subject device is used with cleared PENTAX Video Processors (a software- controlled device). The subject device has 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 subject device contains light carrying bundles (LCB) to illuminate the body cavity, and a 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 subject device is immersible (with the use of supplied cleaning accessories) as described in the endoscope reprocessing instructions.
Intended Use /Indications for Use (EB11-J10)
The PENTAX Medical Video Bronchoscope EB11-J10 has 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), EB11-J10 is compatible with a new processor EPK-3000 that has been previously cleared to be used with PENTAX Medical Video Bronchoscopes EB-
5
PENTAX Medical Video Bronchoscope EB11-J10 Traditional 510(k) Submission
J10 series (K200678). EPK-3000 labeling has been revised to reflect compatibility of the processor with the EB11-J10.
Summary of Technology Characteristics:
The subject device is functionally equivalent to the predicate device, the PENTAX Medical Video Bronchoscope EB-1170K (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 do not raise different 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.
Non-Clinical Performance Data
The subject device 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.
Reprocessing Validation
Simulated use testing, soil accumulation analysis, cleaning, high-level disinfection, and rinsing validation studies of the subject device 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 subject device and accessories. The subject device is not provided sterile.
Biocompatibility
Biocompatibility of the EB11-J10 scope on direct and indirect contact materials was confirmed by assessing the cytotoxicity, sensitization, and intracutaneous reactivity. The risk levels of local toxicity were determined as "Acceptable" as a result of applying the risk level of local toxicity to the risk evaluation criteria.
Software
Software verification and validation including cybersecurity assessments were conducted according to IEC 62304: 2006 and FDA Guidances for Industory 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."
EMC and Electrical Safety
The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX Medical Video Bronchoscope EB11-J10 was 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, and IEC 60601-1-2:2014.
6
Optical Testing
As a part of Design Verification and Validation, optical properties of imaging and illumination performances were measured for subject device in conjunction with the EPK-3000, EPK-i7010, and EPK-i5010 Video Processors. All results show that the optical characteristics of the subject device is equivalent to those of the predicate device.
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 each anatomical area as well or better than the predicate device.
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, PENTAX Medical concludes that the subject device PENTAX Medical Video Bronchoscopes EB11-J10 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 devices 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 EB11-110 is substantially equivalent to the identified the predicate device, the PENTAX Video Bronchoscope EB-1170K, cleared by FDA in 2014 (K131028).