(189 days)
No
The summary describes a standard endoscopic ultrasound system with optical and ultrasonic imaging capabilities. There is no mention of AI, ML, or any features that would typically utilize these technologies for image analysis, diagnosis, or guidance. The software mentioned is for controlling the video processor and ultrasound scanner, not for advanced data processing.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "therapeutic access to, the Upper Gastrointestinal Tract".
Yes
The device provides "optical visualization of, ultrasonic visualization of," the Upper Gastrointestinal Tract. It collects "endoscopic image data, and a linear or radial array ultrasound transducer to collect ultrasonic image data." This visualization and image data collection are used for diagnostic purposes (identifying issues in the GI tract).
No
The device description clearly outlines physical hardware components including flexible insertion tubes, control bodies, umbilical connectors, a latex balloon, light carrying bundles, a CCD, and ultrasound transducers. While it mentions being used with software-controlled devices (Video Processors and Ultrasound Scanners), the device itself is a physical endoscope with integrated hardware for visualization and ultrasound.
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 providing optical and ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract within the body. This is an in vivo procedure, meaning it is performed on a living organism.
- Device Description: The description details an endoscope with an insertion tube, control body, and connections for video and ultrasound. It describes how the device is introduced into the body and used to collect images and potentially perform therapeutic interventions inside the patient.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices that are used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body. The testing is performed outside the body (in vitro).
This device is a medical imaging and therapeutic device used for internal examination and intervention, which falls under a different regulatory category than IVDs.
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.
Product codes (comma separated list FDA assigned to the subject device)
ODG, ITX
Device Description
The EG34-J10U, EG36-J10UR and EG38-J10UT Ultrasound Upper GI Video Scopes, are endoscopes used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. They are used with cleared Pentax Video Processors (a softwarecontrolled device) and cleared Hitachi Ultrasound Scanners (a software-controlled 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 effectively 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 couple 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 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 operator manual cleaning instructions)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical visualization, ultrasonic visualization
Anatomical Site
Upper Gastrointestinal Tract including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum and underlying areas.
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)
Non-Clinical Performance Data: The PENTAX Medical EG-J10U Endoscopic Ultrasound System has been successfully tested for its functions, performance and safety as per FDA recognized consensus standards.
Human Factors: A human factors study to assess the ability of reprocessing staff to carry out the reprocessing instructions for use (rIFU) was conducted. The device was been found to be safe and effective for the intended patients, intended users, and in their use environments.
Reprocessing Validation: Simulated use testing, soil accumulation analysis, cleaning, and high-level disinfection validation studies of the EG34-J10U, EG36-J10UR and EG38-J10UT Upper GI Video Scopes and accessories were conducted and confirmed the effectiveness of reprocessing procedures.
Sterilization and Shelf Life: PENTAX Medical coordinated with STERIS Corporation to validate the use of System 1E liquid chemical sterilization for the sterilization of the EG-J10U series Ultrasound Upper GI Video Scopes. The devices are not provided sterile. PENTAX Medical conducted Gamma Ray Sterilization for packaging and for PENTAX Medical Ultrasound Balloons made of natural rubber latex. A shelf-life of 2 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 A under the Software Safety Classification per IEC 62304:2006, Medical device software- 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.
EMC and Electrical Safety: The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX Medical Endoscopic EG-J10U Ultrasound System were confirmed by the following standards: IEC 60601-1-2:2007; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; IEC 60601-2-18:2009; and IEC 60601-2-37:2007.
Optical Testing: As a part of Design Verification and Validation, optical properties including signal to noise ratio, spatial resolution (MTF), distortion, light distribution, color (IEEE), spectral distribution and photobiological safety were measured for the EG34-J10U, EG36-J10UR and EG38-J10UT in conjunction with the EPK - i5010 and EPK-i7010 video processors. All results show that there are no differences between the subject device, and 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 Medical Endoscopic Ultrasound System (K182004)
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.
EPK-i5010 (K122470), EPK-i7010 (K150618), HI VISION Preirus (K093466), ARIETTA 70 (K134016)
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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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 23, 2020
PENTAX of America, Inc. William Goeller Vice President, Quality/Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645-1782
Re: K200090
Trade/Device 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 Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: ODG, ITX Dated: June 29, 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 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.
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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-regulatoryinformation/postmarketing-safety-reporting-combination-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,
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
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Indications for Use
510(k) Number (if known) K200090
Device 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)
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 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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Image /page/3/Picture/1 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold letters. Below the word "PENTAX" is a gray line, and below the line is the word "MEDICAL" in gray, bold letters.
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 21 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: 1/14/2020
Common Name: Endoscopic Ultrasound / Ultrasound Gastroscope Device/Trade Name: PENTAX Medical EG-J10U Endoscopic Ultrasound System-EG34-J 10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper Gl Video Scope(Radial Array Type), EG38-J10UT Ultrasound Upper Gl Video Scope (Convex Array Type)
Regulation Number: 21 CFR Part 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Codes: ODG, ITX Predicate Device: PENTAX Medical Endoscopic Ultrasound System (K182004) PENTAX Medical is seeking clearance of a new line of ultrasound upper GI video scopes EG-J10U with the Pentax Video Processors EPK-i5010 and EPK-i7010, for use with Hitachi's HI VISION Preirus and ARIETTA 70. PENTAX Video Processors EPK-i5010 (K122470) and EPK-i7010 (K150618) as well Hitachi HI VISION Preirus (K093466) and ARIETTA 70 (K134016) have been previously cleared.
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Image /page/4/Picture/1 description: The image contains the logo for PENTAX Medical. The word "PENTAX" is in red, bold letters, and it is positioned above a gray line. Below the line, the word "MEDICAL" is written in gray, bold letters. The logo is simple and professional.
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 Ultrasound Upper Gl Video Scopes
The subject devices have virtually the same indications for use, viewing directions, and image size as the predicates. The subject devices use the same processors and peripherals as the predicate device.
The main differences between the subject devices and predicate devices are as follows:
- . Introduction of a new line of ultrasound upper GI video scopes EG-J10U, which includes EG34-J10U, EG36-J10UR and EG38-J10UT as compatible Ultrasound Upper GI Video Scopes.
- . A Reprocessing Instructions for Use (rIFU) that demonstrates a streamlined, easy-to-follow format that is the output of Human Factors Testing.
Device Description:
The EG34-J10U, EG36-J10UR and EG38-J10UT Ultrasound Upper GI Video Scopes, are endoscopes used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. They are used with cleared Pentax Video Processors (a softwarecontrolled device) and cleared Hitachi Ultrasound Scanners (a software-controlled 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 effectively 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 couple 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.
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Image /page/5/Picture/1 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold, sans-serif letters. Below "PENTAX" is the word "MEDICAL" in gray, bold, sans-serif letters. There is a gray line separating the two words.
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 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 operator manual cleaning instructions)
Intended Use
The PENTAX Medical Ultrasound Upper Gl Video Scopes (EG34-J10U, EG36-J10UR, and EG38-J10UT) are intended to provide optical and ultrasound visualization of (via a video monitor), and therapeutic access to the upper gastrointestinal tract including the organs; tissues; and subsystems: esophagus, stomach and duodenum.
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.
Summary of Technology Characteristics:
The PENTAX Medical EG-J10U Endoscopic Ultrasound System is functionally equivalent to its predicate device, the PENTAX Medical Endoscopic Ultrasound System cleared by FDA in 2018. The only difference between the two devices is that the predicate is used with the Legacy Ultrasound Video Gastroscopes, and the subject is used with the additional EG-J10U series of Ultrasound GI Video Scopes that includes EG34-J10U, EG36-J10UR and EG38-J10UT
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Image /page/6/Picture/1 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold, sans-serif font. Below "PENTAX" is a horizontal line, and below that is the word "MEDICAL" in gray, bold, sans-serif font.
The additional devices 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 EG-J10U Endoscopic Ultrasound System has been successfully tested for its functions, performance and safety as per FDA recognized consensus standards. The following performance data are provided in support of the substantial equivalence determination.
Operational and Reprocessing Instructions for Use are provided for the scopes.
Human Factors
A human factors study to assess the ability of reprocessing staff to carry out the reprocessing instructions for use (rIFU) was conducted. The device was been found to be safe and effective for the intended patients, intended users, and in their use environments.
Reprocessing Validation
Simulated use testing, soil accumulation analysis, cleaning, and high-level disinfection validation studies of the EG34-J10U, EG36-J10UR and EG38-J10UT Upper GI Video Scopes and accessories were conducted and confirmed the effectiveness of reprocessing procedures.
Sterilization and Shelf Life
PENTAX Medical coordinated with STERIS Corporation to validate the use of System 1E liquid chemical sterilization for the sterilization of the EG-J10U series Ultrasound Upper GI Video Scopes. The devices are not provided sterile.
PENTAX Medical conducted Gamma Ray Sterilization for packaging and for PENTAX Medical Ultrasound Balloons made of natural rubber latex. A shelf-life of 2 years after sterilization was verified.
The labeling for the PENTAX Medical Ultrasound Balloons and their packaging prominently bears the 21 CFR 801.437 warning in bold: Caution: This product contains natural rubber latex which may cause allergic reactions. Also, the Operating Instructions for Use of the EG-J10U series of Ultrasound Upper Gl Video Scopes prominently bears the warning in bold: Caution: The balloon contains natural rubber latex which may cause allergic reactions.
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Image /page/7/Picture/1 description: The image contains the logo for Pentax Medical. The word "PENTAX" is in red, bold letters on the top line. Below that, there is a gray line, and then the word "MEDICAL" is in gray, bold letters. The logo is simple and clean, with a focus on the company name.
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 A under the Software Safety Classification per IEC 62304:2006, Medical device software- 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 Endoscopic EG-J10U Ultrasound System were confirmed by the following standards:
IEC 60601-1-2:2007; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; IEC 60601-2-18:2009; and IEC 60601-2-37:2007.
Optical Testing
As a part of Design Verification and Validation, optical properties including signal to noise ratio, spatial resolution (MTF), distortion, light distribution, color (IEEE), spectral distribution and photobiological safety were measured for the EG34-J10U, EG36-J10UR and EG38-J10UT in conjunction with the EPK - i5010 and EPK-i7010 video processors. All results show that there are no differences between the subject device, and 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, we conclude that the subject device PENTAX Medical EG-J10U Endoscopic Ultrasound System 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.
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Image /page/8/Picture/1 description: The image contains the logo for Pentax Medical. The word "PENTAX" is in red, bold letters on the top line. Below that, there is a gray line, and then the word "MEDICAL" is in gray, bold letters on the bottom line.
Conclusion:
Accordingly, PENTAX Medical believes the PENTAX Medical EG-J10U Endoscopic Ultrasound System is substantially equivalent to the identified predicate, the PENTAX Medical Endoscopic Ultrasound System, cleared by FDA in 2018.