(25 days)
Not Found
No
The summary describes a standard endoscopic ultrasound system with optical and ultrasonic imaging capabilities. It mentions software-controlled devices (video processor and ultrasound scanner) and image processing, but there is no mention of AI, ML, deep learning, or any related terms or concepts that would indicate the use of such technologies for image analysis, diagnosis, or other functions. The performance studies are described as testing functions, performance, and safety according to consensus standards, not evaluating AI/ML model performance.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to provide "therapeutic access" to the Upper Gastrointestinal Tract.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended to provide "optical visualization of, [and] ultrasonic visualization of" the Upper Gastrointestinal Track, which are diagnostic activities.
No
The device description clearly details physical hardware components such as endoscopes with flexible insertion tubes, control bodies, umbilical connectors, light carrying bundles, CCDs, ultrasound transducers, and working channels. While it mentions software-controlled components (Video processors and Ultrasound Scanner), the core device is a physical system for visualization and therapeutic access.
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 for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic purposes.
- Device Function: The PENTAX Medical Endoscopic Ultrasound System is used for direct visualization (optical and ultrasonic) and therapeutic access to the upper gastrointestinal tract within the body. It does not analyze specimens outside the body.
- Intended Use: The intended use clearly states visualization and therapeutic access to anatomical sites within the patient.
- Device Description: The description details an endoscope with imaging capabilities and a working channel for therapeutic devices, all used internally.
Therefore, the device's function and intended use fall under the category of an in vivo diagnostic and therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PENTAX Medical Endoscopic Ultrasound System is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are pediatric patient populations.
The PENTAX Medical 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, Small Bowel, 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
ODG, ITX
Device Description
The PENTAX Medical Ultrasound Video Gastroscopes used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. These endoscopes are used with cleared Pentax Video processors (a software-controlled device) and cleared Hitachi Ultrasound Scanner (a software-controlled device) to comprise the PENTAX Medical Endoscopic Ultrasound System. 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 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 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 uitrasound scanner for processing and display. 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 Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, 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)
The PENTAX Medical Endoscopic Ultrasound System has been successfully tested for its functions, performance and safety as per FDA recognized consensus standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PENTAX Medical Endoscopic Ultrasound System (K162447)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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August 21, 2018
PENTAX of America, Inc. William Goeller Vice President, Quality and Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645-1782
Re: K182004
Trade/Device Name: PENTAX Medical Endoscopic Ultrasound System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: ODG, ITX Dated: July 26, 2018 Received: July 27, 2018
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 mav, 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 avare 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.
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/7 description: The image shows the FDA logo. The logo is in a light gray color. The letters FDA are large and bold.
Jeffrey W. Cooper -2 2018.08.21 13:35:18 -04'00
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182004
Device Name
PENTAX Medical Endoscopic Ultrasound System
Indications for Use (Describe)
The PENTAX Medical Endoscopic Ultrasound System is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are 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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3
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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.
K182004 Page 1 of 3
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: July 25, 2018
Common Name: Endoscopic Ultrasound / Ultrasound Gastroscope Name of the System: PENTAX Medical Endoscopic Ultrasound System
EG-3270UK Upper G.I. Video Scope (Convex Array Type, K162447), EG-3670URK Video Gastroscope (Radial Array Type, K130206) and EG-3870UTK (Convex Array Type, K130247) with EPK-i5010 Video Processor (K122470), EPK-i7010 Video Processor (K150618) plus Hitachi HI VISION Preirus Ultrasound Scanner (K093466) and Hitachi ARIETTA 70 Ultrasound Scanner (K134016) Regulation Number:
21 CFR Part 876.1500
Regulation Names:
Endoscope and accessories Diagnostic Ultrasound Transducer Regulatory Class: Class II Product Code: ODG, ITX Predicate Device: PENTAX Medical Endoscopic Ultrasound System (K162447)
The proposed PENTAX modification is to bundle the PENTAX Medical legacy Ultrasound Video Gastroscopes EG3270UK, EG3670URK, and EG3870UTK, and Pentax Video Processors EPK-i5010 and EPK-i7010, for use with Hitachi's HI VISION Preirus and ARIETTA 70. All the devices have been previously cleared.
This 510(k) captures some minor design changes that have occurred during the evolution of the product line that includes these three legacy ultrasound video gastroscopes. 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 video gastroscopes.
The subject device has the same indications for use, composition of patient contact materials, viewing direction, image size, and reprocessing/sterilization method as the predicate. The subject device uses the same processors and peripherals as the predicate device with three additions.
PENTAX Medical Confidential
4
PENTAX Medical Endoscopic Ultrasound System
510(k) Summary
Image /page/4/Picture/2 description: The image shows the logo for Pentax Medical. The logo has the word "PENTAX" in red, with the word "MEDICAL" in gray underneath. The text "K182004 Page 2 of 3" is located in the bottom right corner of the image.
The main differences between the subject devices and predicate devices are as follows:
- Bundling of EG-3670URK and EG3870UTK Ultrasound Video Gastroscopes with EG3270UK
- Addition of the EPK-i7010 as a compatible Video Processor
- . Addition of the Hitachi ARIETTA 70 as a compatible Ultrasound Scanner
Device Description:
The PENTAX Medical Ultrasound Video Gastroscopes used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. These endoscopes are used with cleared Pentax Video processors (a software-controlled device) and cleared Hitachi Ultrasound Scanner (a software-controlled device) to comprise the PENTAX Medical Endoscopic Ultrasound System. 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 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 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 uitrasound scanner for processing and display. 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 / Indications for use
The PENTAX Medical 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, Small Bowel, 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 Technological Characteristics:
The PENTAX Medical Endoscopic Ultrasound System is functionally equivalent to its predicate device, the PENTAX Medical Endoscopic Ultrasound System cleared by FDA in 2016. The only difference between the two devices is that the predicate can be used with the EPK-i5010 video processor and HI VISION Preirus Ultrasound scanner, whereas the subject device now additionally bundles the EG-3670URK and
PENTAX Medical Confidential
5
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Page 3 of 3
510(k) Summary
EG-3870UTK Ultrasound Video Gastroscopes as a family of endoscopes and the subject device is now additionally compatabile with the EPK-i7010 video processor and Hitache ARIETTA 70 Ultrasound scanner.
The additional devices have been evaluated through performance testing and raise 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 Endoscopic Ultrasound System has been successfully tested for its functions, performance and safety as per FDA recognized consensus standards. The following performance data are summarized in support of the substantial equivalence determination.
Software
Software verification and validation testing 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) and the software level of concern is "Moderate" based on the 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 Ultrasound System were confirmed by the following standards: IEC 60601-1-2:2007; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+AM 1:2012; and IEC 60601-2-37:2007.
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 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.
Conclusion:
Accordingly, PENTAX Medical believes the PENTAX Medical Endoscopic Ultrasound System is substantially equivalent to the identified predicate, the PENTAX Medical Endoscopic Ultrasound System, cleared by FDA in 2016.
PENTAX Medical Confidential