(224 days)
No
The summary describes standard endoscopic and ultrasound imaging and processing, with no mention of AI or ML algorithms for image analysis, diagnosis, or other functions.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "therapeutic access to the Upper Gastrointestinal Track".
Yes
The device provides "optical visualization of, ultrasonic visualization of," and is used to observe "indications consistent with the requirement for procedure," which are all functions of a diagnostic device.
No
The device description clearly outlines hardware components such as a flexible insertion tube, control body, umbilical connectors, light carrying bundles, a CCD, and an ultrasound transducer. While it interacts with software-controlled devices (video processor and ultrasound scanner), 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 system is for optical and ultrasonic visualization and therapeutic access to the upper gastrointestinal tract. This is a diagnostic and therapeutic procedure performed directly on the patient's body.
- Device Description: The description details an endoscope with optical and ultrasound capabilities, used for direct visualization and intervention within the body. It involves imaging the internal anatomy.
- Lack of In Vitro Activity: An IVD device is designed to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health. This device does not perform any analysis on such specimens.
The device is a medical device used for in vivo (within the living body) diagnostic and therapeutic procedures.
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.
Product codes (comma separated list FDA assigned to the subject device)
ODG, ITX
Device Description
The EG-3270UK, Ultrasound Upper GI Video Scope, is an endoscope used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. It is used with cleared Pentax Video processors (a software controlled device) and cleared Hitachi Ultrasound Scanner (a software controlled device)
The endoscope has 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 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. The instrument is immersable (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
pediatric patient populations. (Initial indication says pediatric, later description says adult and pediatric)
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)
Biocompatibility Testing of direct and indirect contact materials for Cytotoxicity, Sensitization and Intracutaneous Reactivity. Reprocessing Validation: Simulated use testing, soil accumulation analysis, cleaning, and high level disinfection validation studies. Sterilization validation using Ethylene Oxide Gas. Electrical safety and electromagnetic compatibility (ES & EMC) confirmed by testing in accordance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-18. Software Verification and Validation Testing: Documentation provided as recommended by FDA guidance; software classified as CLASS B per IEC 62304:2006, level of concern "Moderate". Acoustic output measurement performed in accordance with FDA guidance.
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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of three human profiles facing to the right, with a flowing ribbon-like element below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2017
Pentax of America, Inc. Krishna Govindarajan Senior Manager, Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645-1782
K162447 Re:
Trade/Device Name: PENTAX Medical Endoscopic Ultrasound System - EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Codes: ODG, ITX Dated: February 28, 2017 Received: March 1, 2017
Dear Krishna Govindarajan:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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
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Indications for Use
510(k) Number (if known) K162447
Device Name
PENTAX Medical Endoscopic Ultrasound System – EG-3270UK Upper G.1. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner
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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Image /page/3/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold, sans-serif letters. Below the word "PENTAX" is a gray line. Below the gray line is the word "MEDICAL" in gray, bold, sans-serif letters.
510(k) Summary
The following summary is provided in accordance with 21 CFR 807.92:
SUBMITTER .
PENTAX of America, Inc., HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782
Phone: 201-251-2300 x 2125 Fax: 201-799-4117
Contact Person: Krishna Govindarajan Date Prepared: August 31, 2016
II. DEVICE/SYSTEM
Name of System: PENTAX Medical Endoscopic Ultrasound System
EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor (K122470) and HI VISION Preirus Ultrasound Scanner (K093466)
| Common/Usual Name: | Endoscopic Ultrasound / Ultrasound Gastroscope |
|---|---|
| Regulation Number: | 21 CFR Part 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Diagnostic Ultrasound Transducer | |
| Regulatory Class: | Class II |
| Product Code: | ODG and ITX |
III. PREDICATE DEVICE
Predicate Device: PENTAX EG-3870UTK Ultrasound Video Gastroscope + HI VISION Preirus (K130247; dated March 20, 2013)
| Regulation Number: | 21 CFR Part 876.1500 |
|---|---|
| Regulation Name: | Endoscope and accessories |
| Diagnostic Ultrasound Transducer | |
| Regulatory Class: | Class II |
| Product Code: | ODG and ITX |
This reference device has not been subject to a design-related recall.
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Image /page/4/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is written in large, red, bold letters. Below the word "PENTAX" is a gray line, and below that is the word "MEDICAL" in gray, bold letters.
IV. DEVICE DESCRIPTION
The EG-3270UK, Ultrasound Upper GI Video Scope, is an endoscope used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. It is used with cleared Pentax Video processors (a software controlled device) and cleared Hitachi Ultrasound Scanner (a software controlled device)
The endoscope has 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 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. The instrument is immersable (with the use of supplied cleaning accessories) except for the ultrasound scanner connector (as described in the endoscope operator manual cleaning instructions)
V. 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 observed in adult and pediatric patient populations.
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Image /page/5/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is written in large, red, bold letters. Below "PENTAX" is a gray line. Below the gray line, the word "MEDICAL" is written in gray, bold letters.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The PENTAX Medical Endoscopic Ultrasound System - EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner has the same fundamental technology and operating principles in comparison to those of the predicate device, including same intended use, design technological characteristics, such as Insertion Portion, Control Body and fiber-optics illumination. The minor differences in the Depth of Field, Distal end width, Insertion Tube width, instrument channel width, and Total Length between two devices do not impact the intended use, and do not raise different questions of safety and effectiveness and that the device is as safe and effective as a legally marketed device.
VII. PERFORMANCE DATA
The following performance data are provided in support of the substantial equivalence determination.
Biocompatibility Testing
Biocompatibility of direct and indirect contact materials were confirmed by testing the Cytotoxicity, Sensitization and Intracutaneous Reactivity of the materials of the EG-3270UK Upper G.I. Video Scope with limited (less than 24 hours) contact with mucosal membrane in accordance with the ISO 10993-1, 5, and 10 Biological Evaluation of Medical Devices.
Reprocessing Validation, Sterilization and Shelf Life
Reprocessing Validation
Simulated use testing, soil accumulation analysis, cleaning, and high level disinfection validation studies of the EG-3270UK Upper G.I. Video Scope and its accessories were conducted and confirmed the effectiveness of reprocessing procedures.
Sterilization and Shelf Life
PENTAX Medical validated the EG-3270UK Upper G.I. Video Scope with Ethylene Oxide Gas Sterilization method and confirmed the effectiveness of sterilization method. The device is not provided sterile, therefore, shelf-life is not applicable.
Electrical safety and electromagnetic compatibility (ES & EMC)
The acceptable level of Electromagnetic Compatibility (EMC) and Electrical Safety (ES) for the PENTAX Medical Endoscopic Ultrasound System has been confirmed by testing the EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner in accordance with the following standards:
-
- IEC 60601-1:1988+A1:1991+A2:1995 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
- IEC 60601-1-1:2000 requirements for safety- Collateral standard: Safety requirements for medical electrical systems
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Image /page/6/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold letters on the top line. Below that is a gray line, and below that is the word "MEDICAL" in gray, bold letters.
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- IEC 60601-1-2:2001+A1:2004 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
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- IEC 60601-1-4:2000 Ed. 1.1 Medical electrical equipment- Part 1-4: General requirements for safety- Collateral Standard: Programmable electrical medical systems
-
- IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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- IEC 60601-2-18:1996+A1:2000 Medical electrical equipment- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
Software Verification and Validation Testing
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 B 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."
Acoustic output measurement
Acoustic output data of the PENTAX Medical Endoscopic Ultrasound System (EG-3270UK Upper G.I. Video Scope (Transducer) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner) were measured in accordance with the FDA's Guidance for Industry and FDA Staff, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers".
VIII. CONCLUSIONS
After analyzing the intended use, indications for use, technological characteristics (including fundamental operating principle, energy source, scientific technology, functional characteristics, design features, and performance characteristics), labeling, and sterilization method, we conclude that the subject device, the PENTAX Medical Endoscopic Ultrasound System (EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner), is substantially equivalent to the predicate, PENTAX EG-3870UTK Ultrasound Video Gastroscope + HI VISION Preirus (K130247; dated March 20, 2013). The minor differences in the Depth of Field, Distal end width. Insertion Tube width, instrument channel width, and Total Length between the two devices does not change the intended use, and/or raise different questions of safety and effectiveness.