(68 days)
Not Found
No
The summary describes standard endoscopic and ultrasound imaging technology and processing. There is no mention of AI, ML, or related concepts like deep learning, algorithms for image analysis beyond basic processing, or any performance metrics typically associated with AI/ML models.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the system is intended to provide "therapeutic access" to the Upper Gastrointestinal Tract and the Pulmonary Track. The 'Device Description' also mentions that the instrument contains a "working channel through which biopsy devices, or other devices, may be introduced," further supporting its use in therapeutic procedures.
Yes
Explanation: The device provides "optical visualization of, ultrasonic visualization of" the Gastrointestinal and Pulmonary Tracts, indicating its role in gathering information for diagnosis. Furthermore, the performance studies section refers to "ultrasonic medical diagnostic and monitoring equipment," explicitly categorizing the ultrasound component as diagnostic.
No
The device description clearly details physical hardware components such as endoscopes with flexible insertion tubes, control bodies, connectors, light carrying bundles, CCDs, ultrasound transducers, and working channels. It also mentions the use of video processors and ultrasound scanners, which are described as "software-controlled devices" but are still physical hardware. The performance studies also include testing related to electrical safety and acoustic output, which are relevant to hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The PENTAX Medical EG-J10U Endoscopic Ultrasound System and the PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U are described as devices that provide optical visualization and ultrasonic visualization of internal anatomical structures (Upper GI Tract and Pulmonary Track). They also provide therapeutic access for procedures like biopsies.
- Method of Use: The devices are introduced per orally into the body.
- Lack of Specimen Analysis: The description focuses on imaging and access within the body, not on the analysis of specimens outside the body. While a working channel allows for the introduction of biopsy devices, the device itself is not performing the analysis of the collected tissue.
The device is clearly an in vivo diagnostic and therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PENTAX Medical EG-J10U Endoscopic Ultrasound System is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Product codes (comma separated list FDA assigned to the subject device)
ODG, ITX, EOQ
Device Description
PENTAX Medical EG-J10U Endoscopic Ultrasound System (Proposed)
The PENTAX Medical EG-J10U Endoscopic Ultrasound System (Proposed) includes three endoscope models EG34-J10U. EG36-J10UR, and EG38-J10UT Ultrasound Upper GI Video Scopes, and is used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. They are used with FDA cleared PENTAX Medical Video Processors (a software-controlled device) and FDA cleared Hitachi Ultrasound Scanners (a softwarecontrolled device). The endoscopes have a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE umbilical connector will be attached to the Video Processor and has connections for illumination, video signals, air, water, and suction.
The ultrasound scanner umbilical connector will be attached to the ultrasound scanner unit. A sterile, single use disposable natural rubber latex balloon is fitted over the convex array ultrasound transducer prior to the procedure. During an ultrasound endoscopy procedure, the latex balloon is inflated with water. The water that is contained within the balloon creates a water field that covers the transducer. The water field enables more effective transport of ultrasonic pulses from the ultrasound transducer to the target anatomical site and back to the ultrasound transducer.
The control body includes controls for up/ down/ left/ right angulation, air/ water delivery, and an accessory inlet port. The endoscope contains light carrying bundles to illuminate the body cavity, a charge coupled device (CCD) to collect endoscopic image data, and a linear or radial array ultrasound transducer to collect ultrasonic 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 ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received, and the signals are passed to the ultrasound scanner for processing and display. EG34-J10U, EG36-J10UR, and EG38-J10UT Ultrasound Upper GI Video Scopes are connected to the ultrasound scanner ARIETTA 70 and the ALOKA ARIETTA 850 via the scanning unit connector of the endoscope directly to the probe connector of the scanning unit. In order to connect to the Preirus scanning unit, junction box PUN-JBP1 is required to connect the scanning unit connector to the probe connector.
The instrument is immersible (with the use of supplied cleaning accessories) except for the ultrasound scanner connector (as described in the endoscope Operators Manual cleaning instructions).
PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (Proposed)
The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (Proposed) connects with a video processor and an ultrasound scanner, both of which are software-controlled devices.
The endoscope has a flexible insertion tube, a control body, PVE connector, and scanning unit connector. The PVE connector attaches to the video processor and has connections for illumination and video signals. The ultrasound umbilical connector attaches to the ultrasound scanner unit.
The control body includes remote buttons for functions assigned from the video processor. It also includes controls for up/down angulation or neutral position control, and ports for manual balloon insufflation/evacuation, and an accessory inlet.
The endoscope contains light carrying bundles to illuminate the body cavity, a charge coupled device (CCD) to collect endoscopic image data, and a convex array ultrasound transducer to collect ultrasonic 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 focused at the endoscope 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 ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and the signals are passed to the ultrasound scanner for processing and display. The instrument is immersible (with the use of supplied cleaning accessories). EB19-J10U is connected to the ultrasound scanners ARIETTA 70, ALOKA ARIETTA 850, and Noblus via the scanning unit connector of the endoscope directly to the probe connector of the scanning unit. In order to connect to the Preirus scanning unit, junction box PUN-JBP1 is required to connect the scanning unit connector to the probe connector.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, Optical
Anatomical Site
Upper Gastrointestinal Tract (Esophagus, Stomach, Duodenum), Pulmonary Track (Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree)
Indicated Patient Age Range
adult and pediatric patient populations.
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)
Performance testing was conducted to support the proposed modifications of the subject devices, and it was determined that the proposed modifications do not raise issues regarding safety and effectiveness, or significantly change the performance, function, or general intended use of the devices.
Performance testing was performed to support the modifications of the proposed devices.
Risks and Verification/Validation activities:
-
Thermal injury(ies) to a patient, caused by the high temperature at the distal end of ultrasound scope, due to the excessive ultrasonic energy.
- Verification / Validation Methods: Measure distal end temperature
- Results: Testing according to IEC 60601-2-37: 2007 +A1: 2015 of Electrical safety standard (Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment) was conducted and it was confirmed that the ultrasound output power is properly adjusted and that the temperature at the distal end does not reach a point which would create thermal injuries.
-
Electrical shock(s) to a patient, caused by the increased leak current from ultrasound scope, due to the excessive ultrasound energy.
- Verification / Validation Methods: Measure leak current
- Results: Testing according to IEC 60601-2-37: 2007 of Electrical safety standard (Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment) was conducted, and it was confirmed that the ultrasound output power is properly adjusted and that the leakage current satisfies the standard.
-
Incorrect performance(s) of endoscopic system, caused by electromagnetic irradiation from a connection part of the ultrasound scanning unit.
- Verification / Validation Methods: Measure electromagnetic irradiation
- Results: Testing according to IEC 60601-1-2: 2014 of EMD standard (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests) was conducted and it was confirmed that electromagnetic irradiation from the connection part satisfied the standard.
-
Ultrasonic performance of the new combinations is insufficient
- Verification / Validation Methods: Measure acoustic output of new combinations, Measure doppler sensitivity of new combinations
- Results: Verification test to measure acoustic output of the new combinations was performed in accordance with FDA guidance, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound systems and Transducers" and doppler sensitivity of the new combinations by methods used to evaluate the ARIETTA 70 combinations in K200090 and K183516. The test results passed criteria and confirmed that the new combinations are acceptable.
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.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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December 30, 2020
PENTAX of America, Inc. % Fumiaki Kanai President & CEO MIC International 4-1-17 Hongo Bunkyo-ku, Tokyo 113-0033 JAPAN
Re: K203166
Trade/Device Name: PENTAX Medical Ultrasound Upper GI Video Scope EG34-110U PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODG, ITX, EOQ Dated: December 1, 2020 Received: December 4, 2020
Dear Fumiaki Kanai:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 medical devices and radiation-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
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203166
Device Name
PENTAX Medical EG-110U Endoscopic Ultrasound System - EG34-110U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GL Video Scope (Convex Array Type), and PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
Indications for Use (Describe)
The PENTAX Medical EG-J10U Endoscopic Ultrasound System is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediations.
The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
| 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) |
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510(k) Summary
a. Owner/Company name, address
PENTAX of America, Inc.
3 Paragon Drive Montvale. New Jersey 07645-1782
William Goeller Vice President, Quality Assurance and Regulatory Affairs
Phone: 800-431-5880 Ext 2318 201-571-2318 Ext 2318 Fax: 201-571-2340
b. Contact/Application Correspondent
Fumiaki Kanai President & CEO, MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan
Email: kanaif@mici.co.jp Phone: +81-3-3818-8577 Fax: +81-3-3818-8573
c. Date prepared
October 19, 2020
d. Name of device
This submission includes the following two devices in accordance with FDA guidance entitled "Bundling Multiple Devices or Multiple Indications in a Single Submission."
Device 1
Trade Name: PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)
Regulation Name: Endoscope and accessories Regulation Number: 21 CFR Part 876.1500 Regulation Class: II
4
Product Code: ODG Subsequent Product Code: ITX Classification Panel: Gastroenterology/Urology
Hereinafter, the Proposed Device is called as "PENTAX Medical EG-J10U Endoscopic Ultrasound System (Proposed)" in this submission.
Device 2
Trade Name: PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulation Number: 21 CFR Part 874.4680, Regulation Class: II Product Code: EOQ, ITX Classification Panel: Ear Nose & Throat
Hereinafter, the Proposed Device is called as "PENTAX Medical Ultrasound Video Bronchoscope (Proposed)" in this submission because the predicate device has the same trade name.
e. Predicate device
Predicate device for PENTAX Medical EG-J10U Endoscopic Ultrasound System (Proposed) is as follows.
Trade Name: PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-110U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)
510(k) Number: K200090 Regulation Name: Endoscope and accessories Regulation Number: 21 CFR Part 876.1500 Regulation Class: II Product Code: ODG Subsequent Product Code: ITX Classification Panel: Gastroenterology/Urology
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Predicate device for PENTAX Medical Ultrasound Video Bronchoscope (Proposed) is as follows.
Trade Name: PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
510(k) Number: K183516 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulation Number: 21 CFR Part 874.4680 Regulation Class: II Product Code: EOQ, ITX Classification Panel: Ear Nose & Throat
f. Description of the device
PENTAX Medical EG-J10U Endoscopic Ultrasound System (Proposed)
The PENTAX Medical EG-J10U Endoscopic Ultrasound System (Proposed) includes three endoscope models EG34-J10U. EG36-J10UR, and EG38-J10UT Ultrasound Upper GI Video Scopes, and is used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. They are used with FDA cleared PENTAX Medical Video Processors (a software-controlled device) and FDA cleared Hitachi Ultrasound Scanners (a softwarecontrolled device). The endoscopes have a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE umbilical connector will be attached to the Video Processor and has connections for illumination, video signals, air, water, and suction.
The ultrasound scanner umbilical connector will be attached to the ultrasound scanner unit. A sterile, single use disposable natural rubber latex balloon is fitted over the convex array ultrasound transducer prior to the procedure. During an ultrasound endoscopy procedure, the latex balloon is inflated with water. The water that is contained within the balloon creates a water field that covers the transducer. The water field enables more effective transport of ultrasonic pulses from the ultrasound transducer to the target anatomical site and back to the ultrasound transducer.
The control body includes controls for up/ down/ left/ right angulation, air/ water delivery, and an accessory inlet port. The endoscope contains light carrying bundles to illuminate the body cavity, a charge coupled device (CCD) to collect endoscopic image data, and a linear or radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working
6
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 ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received, and the signals are passed to the ultrasound scanner for processing and display. EG34-J10U, EG36-J10UR, and EG38-J10UT Ultrasound Upper GI Video Scopes are connected to the ultrasound scanner ARIETTA 70 and the ALOKA ARIETTA 850 via the scanning unit connector of the endoscope directly to the probe connector of the scanning unit. In order to connect to the Preirus scanning unit, junction box PUN-JBP1 is required to connect the scanning unit connector to the probe connector.
The instrument is immersible (with the use of supplied cleaning accessories) except for the ultrasound scanner connector (as described in the endoscope Operators Manual cleaning instructions).
PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (Proposed)
The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (Proposed) connects with a video processor and an ultrasound scanner, both of which are software-controlled devices.
The endoscope has a flexible insertion tube, a control body, PVE connector, and scanning unit connector. The PVE connector attaches to the video processor and has connections for illumination and video signals. The ultrasound umbilical connector attaches to the ultrasound scanner unit.
The control body includes remote buttons for functions assigned from the video processor. It also includes controls for up/down angulation or neutral position control, and ports for manual balloon insufflation/evacuation, and an accessory inlet.
The endoscope contains light carrying bundles to illuminate the body cavity, a charge coupled device (CCD) to collect endoscopic image data, and a convex array ultrasound transducer to collect ultrasonic 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 focused at the endoscope PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image
7
data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and the signals are passed to the ultrasound scanner for processing and display. The instrument is immersible (with the use of supplied cleaning accessories). EB19-J10U is connected to the ultrasound scanners ARIETTA 70, ALOKA ARIETTA 850, and Noblus via the scanning unit connector of the endoscope directly to the probe connector of the scanning unit. In order to connect to the Preirus scanning unit, junction box PUN-JBP1 is required to connect the scanning unit connector to the probe connector.
g. Indications for Use Statement
The PENTAX Medical EG-J10U Endoscopic Ultrasound System is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
h. Comparative Information
Regarding the design, the only difference between the PENTAX Medical EG-J10U Endoscopic Ultrasound System (Proposed) and the predicate (K200090) is the addition of compatibility with the diagnostic ultrasound system ALOKA ARIETTA 850 (K183456) to the predicate device (K200090).
Similarly, the only difference between the PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (Proposed) and the predicate (K183516) is the addition of compatibility with the diagnostic ultrasound system ALOKA ARIETTA 850 (K183456) to the predicate device (K183516).
As there is commonality in the devices, proposed design changes, and method of evaluation;
8
changes to the K200090 and K183516 have been bundled in this submission according to the FDA guidance, "Bundling Multiple Devices or Multiple Indications in a Single Submission."
Performance testing was conducted to support the proposed modifications of the subject devices, and it was determined that the proposed modifications do not raise issues regarding safety and effectiveness, or significantly change the performance, function, or general intended use of the devices.
Performance testing was performed to support the modifications of the proposed devices.
Minor revisions were made to the labeling, which included the addition of the ALOKA ARIETTA 850 (K183456) as a compatible scanner, and conformance to IEC 60601-1-2:2014.
i. Performance data
Our risk analysis identified the following risks and verification/validation activities for mitigation of risks regarding the addition of the ALOKA ARIETTA 850 (K183456) as a compatible scanner.
| Risks | Verification / Validation Methods | |
|---|---|---|
| I | Thermal injury(ies) to a patient, caused by the high | |
| temperature at the distal end of ultrasound scope, due | ||
| to the excessive ultrasonic energy. | Measure distal end temperature | |
| 2 | Electrical shock(s) to a patient, caused by the | |
| increased leak current from ultrasound scope, due to | ||
| the excessive ultrasound energy. | Measure leak current | |
| 3 | Incorrect performance(s) of endoscopic system, | |
| caused by electromagnetic irradiation from a | ||
| connection part of the ultrasound scanning unit. | Measure electromagnetic irradiation | |
| 4 | Ultrasonic performance of the new | |
| combinations is insufficient | Measure acoustic output of new | |
| combinations | ||
| 5 | Measure doppler sensitivity of new | |
| combinations |
Table 6.1 Risks and Verification/Validation activities
9
-
- Thermal injury(ies) to a patient, caused by the high temperature at the distal end of ultrasound scope, due to excessive ultrasonic energy.
Testing according to IEC 60601-2-37: 2007 +A 1 : 2015 of Electrical safety standard (Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential pelformance of ultrasonic medical diagnostic and monitoring equipment) was conducted and it was confirmed that the ultrasound output power is properly adjusted and that the temperature at the distal end does not reach a point which would create thermal injuries.
- Thermal injury(ies) to a patient, caused by the high temperature at the distal end of ultrasound scope, due to excessive ultrasonic energy.
-
- Electrical shock(s) to a patient, caused by the increased leakage current from ultrasound scope, due to excessive ultrasound energy.
Testing according to IEC 60601-2-37: 2007 of Electrical safety standard (Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment) was conducted, and it was confirmed that the ultrasound output power is properly adjusted and that the leakage current satisfies the standard.
- Electrical shock(s) to a patient, caused by the increased leakage current from ultrasound scope, due to excessive ultrasound energy.
IEC 60601-2-37:2007 has been superseded with IEC 60601-2-37: 2007+A1: 2015, which is currently recognized by the FDA as a consensus standard. However, there is no difference in Clause 201.8, "Protection Against Electrical Hazards from ME Equipment" between the 2007 and the 2015 editions of the IEC standard.
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- Incorrect performance(s) of the endoscopic system, caused by electromagnetic irradiation from a connection part of the ultrasound scanning unit.
Testing according to IEC 60601-1-2: 2014 of EMD standard (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests) was conducted and it was confirmed that electromagnetic irradiation from the connection part satisfied the standard.
- Incorrect performance(s) of the endoscopic system, caused by electromagnetic irradiation from a connection part of the ultrasound scanning unit.
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- Ultrasonic performance of the new combinations is insufficient.
Verification test to measure acoustic output of the new combinations was performed in accordance with FDA guidance, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound systems and Transducers" and doppler sensitivity of the new combinations by methods used to evaluate the ARIETTA 70 combinations in K200090 and K183516. The test results passed criteria and confirmed that the new combinations are acceptable.
- Ultrasonic performance of the new combinations is insufficient.
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The results of the above testing did not raise any new questions or concerns regarding safety and effectiveness.
j. Conclusion
PENTAX Medical concludes that the PENTAX Medical EG-J10U Endoscopic Ultrasound System (Proposed) and the PENTAX Medical Ultrasound Video Bronchoscope (Proposed) are substantially equivalent to the predicates (K200090) and (K183516), respectively.