(272 days)
Not Found
No
The summary describes a standard video duodenoscope with image processing capabilities to display images on a monitor. There is no mention of AI, ML, or any advanced image analysis or decision support features that would typically indicate the use of such technologies. The performance studies focus on device functionality, reprocessing, and safety, not on algorithmic performance.
Yes.
The device provides "therapeutic access to the Biliary Tract," allowing for medical interventions beyond just visualization.
Yes
The device is intended to "provide optical visualization of (via a video monitor)... Biliary Tract via the Upper Gastrointestinal Tract... when indications consistent with the need for the procedure are observed." This visualization is used to assess the patient's internal anatomy, which is a key characteristic of a diagnostic device.
No
The device description clearly outlines multiple hardware components including an insertion portion, control body, PVE connector, objective lens, light guide, instrument channel, cannula/forceps elevator, air/water nozzle, angulation control knob, and a CCD. The performance studies also include testing on hardware aspects like durability, chemical resistance, and optical properties of the physical device. While software is mentioned for verification and validation, it is part of a larger hardware system.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract." This describes a procedure performed in vivo (within the living body) for direct observation and intervention.
- Device Description: The description details a duodenoscope, which is an instrument inserted into the body. It describes components like an insertion portion, control body, objective lens, light guide, instrument channel, etc., all consistent with an endoscopic device used for internal examination and procedures.
- IVD Definition: An In Vitro Diagnostic (IVD) device is defined as a medical device that is used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions. These tests are performed in vitro (outside the living body).
The PENTAX Duodenoscope ED34-i10T is used to visualize and access internal anatomy directly within the patient's body, which is the opposite of an in vitro test.
N/A
Intended Use / Indications for Use
The PENTAX Duodenoscope ED34-i10T is intended to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts. These instruments are introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
Product codes
FDT
Device Description
The ED34-i10T, Video Duodenoscope is used with a compatible Video Processor.
The ED34-i10T is composed of the following main parts: an insertion portion, control body and PVE connector. The insertion portion is inserted into the body cavity of patient. The insertion includes the distal end and bending section. The objective lens, light guide, instrument channel, cannula/forceps elevator, and air/water nozzle are located on the distal end of the insertion portion. The control body is held by the user's hand. The control body includes the angulation control knob, angulation lock knob/lever, cannula/forceps elevator control lever, air/water cylinder, suction cylinder, remote button, and instrument channel inlet. The air/water feeding valve is attached to the air/water cylinder, and the suction control valve is attached to the suction cylinder. The inlet seal is attached to the instrument channel inlet. The PVE connected to the video processor via electrical contacts.
The bending section is bent by the angulation control knob to operate the endoscope angulation. The angulation lock knob/lever is used to adjust the rotation torque of the angulation control knob. The cannula/forceps elevator mechanism is used to control for position of cannula which is inserted through the Instrument Channel.
The cannula/forceps elevator control lever is used to operate the cannula/forceps elevator. The air/water feeding system is used to deliver the air and water to the objective lens from the air/water nozzle. When the hole at the top of air/water feeding valve is covered, the air is delivered. When the air/water feeding valve is pushed, the water is delivered. The suction control system is used to suction the fluid and air in body cavity from the instrument channel. When the suction control valve is pushed, the fluid and air are suctioned.
The remote button is used to operate the function of video processor and external device from the control body, as necessary.
The detachable and disposable distal cap of ED34-i10T is intended for single use, and is processed with steam sterilization prior to use. It is discarded after use.
Endoscopic devices such as biopsy forceps are inserted from the instrument channel Inlet into the body cavity through the instrument channel.
The light guide of the distal end is used to illuminate the body cavity by light which is carried through the light carrying bundle. The light carrying bundle guide plug which is connected to the light source inside the Video Processor. The CCD built into the distal end receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the body cavity is displayed on the monitor.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical visualization
Anatomical Site
Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts.
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)
Detachable Distal Cap: durability, chemical resistance, autoclave, ultrasonic wave cleaning resistance, operating environment, thermal shock, and vibration resistance. PENTAX determined that the results of all testing was within the acceptance criteria.
O-Ring Analysis: The O Ring design providing sealing of the Elevator Channel has been analyzed, and a design change created to achieve the recommended minimum compression of 10%.
Optical Testing: Optical properties including signal to noise ratio, spatial resolution (MTF), distribution, and spectral distribution were measured for the ED34-i10T in conjunction with the EPK-i5010 video processor. All results show that there are no differences between the subject device, ED34-10T, and the predicate device, ED-3490TK.
Reprocessing Validation: Simulated use testing, cleaning, high level dising (after cleaning and after HLD) validation studies of the ED34-i10T Video Duodenoscope and its detachable distal cap were conducted and confirmed the effectiveness of reprocessing procedures with FDA's 2015 Final Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling ("FDA's 2015 Reprocessing Guidance"). Acceptance criteria were established in accordance with AAMI TIR 30:2011 for amount of residual soil accumulation and extraction efficiency. Acceptance criteria were met after each phase of reprocessing. An assessment of the ability of reprocessing staff to carry out the reprocessing instructions (a human factors study for reprocessing instructions) was conducted.
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 ED34-i10T.
Biocompatibility: Biocompatibility of direct and indirect contact materials was confirmed by assessing the cytotoxicity, sensitization, and intracutaneous reactivity of the surface device with limited (less than 24 hours) contact with mucosal membrane in accordance with ISO 10993-1, 5, and 10: Biological Evaluation of Medical Devices. A biocompatibility assessment of the amount of carbon black and titanium oxide contained in the patient contact parts of the device as well as the tolerable exposure (TE) value was conducted. The risk level determined as "Very Low" based on the low concern for toxicity of colorant. The risk level of local toxicity was determined as "Acceptable" as a result of applying the risk level of local toxicity to the risk evaluation criteria.
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 B under the Software Safety Classification per IEC 62304:2006, Medical device 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."
EMC and Electrical Safety: The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX ED34-iT10 Video Duodenoscope were confirmed by the following standards: IEC 60601-1-2:2001, A1:2004; IEC 60601 1:2005+CORR 1:2006+CORR 2:2007+AM 1:2012; and IEC 60601-2-18:2009.
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 ED-3490TK Video Duodenoscope (K092710, clearance received on December 2, 2009)
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
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 20, 2017
PENTAX Medical William Goeller Vice President, Quality Assurance and Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645
Re: K163614 Trade/Device Name: PENTAX Medical ED34-i10T, Video Duodenoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDT Dated: August 9, 2017 Received: August 11, 2017
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. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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
1
the quality systems (OS) 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 -S
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) K163614
Device Name
PENTAX Medical ED34-i10T Video Duodenoscope
Indications for Use (Describe)
The PENTAX Duodenoscope ED34-i10T is intended to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts. These instruments are introduced via the mouth when indications consistent with the need for the 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/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, and below that is the word "MEDICAL" in gray, bold letters.
ED34-i10T Traditional 510(k) Submission
510(k) Summary
| Submitter: | PENTAX of America, Inc.,
HOYA Corporation PENTAX Division
3 Paragon Drive
Montvale, New Jersey 07645-1782 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | William Goeller
Vice President, QA/RA
PENTAX of America, Inc.
3 Paragon Drive
Montvale, New Jersey 07645-1782
Phone: 800-431-5880 x 5170, 201-251-2300 x5170
Fax: 201-799-4117
Email: William.Goeller@pentaxmedical.com |
| Date Prepared: | September 18, 2017 |
| Trade/Device Name: | PENTAX Medical ED34-i10T |
| Common/Usual Name: | Video Duodenoscope |
| Regulation Number: | 21 CFR Part 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Regulatory Class: | Class II |
| Product Code: | FDT |
| Predicate Device: | PENTAX ED-3490TK Video Duodenoscope (K092710, clearance received on
December 2, 2009) |
Device Description:
The ED34-i10T, Video Duodenoscope is used with a compatible Video Processor.
The ED34-i10T is composed of the following main parts: an insertion portion, control body and PVE connector. The insertion portion is inserted into the body cavity of patient. The insertion includes the distal end and bending section. The objective lens, light guide, instrument channel, cannula/forceps elevator, and air/water nozzle are located on the distal end of the insertion portion. The control body is held by the user's hand. The control body includes the angulation control knob, angulation lock knob/lever, cannula/forceps elevator control lever, air/water cylinder, suction cylinder, remote button, and instrument channel inlet. The air/water feeding valve is attached to the air/water cylinder, and the suction control valve is attached to the suction cylinder. The inlet seal is attached to the instrument channel inlet. The PVE connected to the video processor via electrical contacts.
The bending section is bent by the angulation control knob to operate the endoscope angulation. The angulation lock knob/lever is used to adjust the rotation torque of the angulation control knob. The cannula/forceps elevator mechanism is used to control for position of cannula which is inserted through the Instrument Channel.
The cannula/forceps elevator control lever is used to operate the cannula/forceps elevator. The air/water feeding system is used to deliver the air and water to the objective lens from the air/water nozzle. When the hole at the top of air/water feeding valve is covered, the air is delivered. When the air/water feeding valve is pushed, the water is delivered. The suction control system is used to suction the fluid and air in body cavity from the instrument channel. When the suction control valve is pushed, the fluid and air are suctioned.
The remote button is used to operate the function of video processor and external device from the control body,
4
ED34-i10T Traditional 510(k) Submission
Image /page/4/Picture/1 description: The image contains the logo for Pentax Medical. The word "PENTAX" is written in red, bold letters on the top line. Below it is a gray line, and below that is the word "MEDICAL" in gray, bold letters.
as necessary.
The detachable and disposable distal cap of ED34-i10T is intended for single use, and is processed with steam sterilization prior to use. It is discarded after use.
Endoscopic devices such as biopsy forceps are inserted from the instrument channel Inlet into the body cavity through the instrument channel.
The light guide of the distal end is used to illuminate the body cavity by light which is carried through the light carrying bundle. The light carrying bundle guide plug which is connected to the light source inside the Video Processor. The CCD built into the distal end receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the body cavity is displayed on the monitor.
Intended Use/Indications for Use:
"The PENTAX Duodenoscope ED34-i10T is intended to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Common Bile, Hepatic and Cystic Ducts.
This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations."
Summary of Technology Characteristics:
The technological characteristics of the ED34-i10T are functionally equivalent to the ED-3490TK.
While there are some differences in the materials that comprise the distal cap, the air/water channel system, and the control body of the ED-34i10T, those materials that are direct contact with the human body were assessed for biocompatibility in accordance with ISO 10993-1, 5, and 10: Biological Evaluation of Medical Devices.
The sealed elevator mechanism can be accessed after removal of the single and disposable distal cap compared with the permanently fixed cap of ED-3490TK. The detachable and disposable distal cap of ED34i10T allows the user to access the back side of the elevator for reprocessing.
The ED34-i10T has smaller distance between the control buttons, the shape of the RL knob is changed to from five spokes to six spokes, and the elevator knob surface is wider.
The ED34-i10T has more pixels for optical visualization.
The total overall length of ED34-i10T is slightly shorter than the length of ED-3490TK. As a result of the length reduction, the dimensions of the suction, air and water channels were changed accordingly.
PENTAX has submitted performance testing for the above referenced design differences with this 510(k) that demonstrate that the ED34-i10T is as safe and effective as the predicate device.
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Performance Data:
No performance standards or special controls applicable to this device have been adopted under Section 513 or 514 of the Federal Food, Drug, and Cosmetic Act. The following performance data are provided in support of the substantial equivalence determination.
Detachable Distal Cap
The following performance testing was done for the detachable distal cap: durability, chemical resistance, autoclave, ultrasonic wave cleaning resistance, operating environment, thermal shock, and vibration resistance. PENTAX determined that the results of all testing was within the acceptance criteria.
O-Ring Analysis
The O Ring design providing sealing of the Elevator Channel has been analyzed, and a design change created to achieve the recommended minimum compression of 10%.
Optical Testing
Optical properties including signal to noise ratio, spatial resolution (MTF), distribution, and spectral distribution were measured for the ED34-i10T in conjunction with the EPK-i5010 video processor. All results show that there are no differences between the subject device, ED34-10T, and the predicate device, ED-3490TK.
Reprocessing Validation
Simulated use testing, cleaning, high level dising (after cleaning and after HLD) validation studies of the ED34-i10T Video Duodenoscope and its detachable distal cap were conducted and confirmed the effectiveness of reprocessing procedures with FDA's 2015 Final Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling ("FDA's 2015 Reprocessing Guidance"). Acceptance criteria were established in accordance with AAMI TIR 30:2011 for amount of residual soil accumulation and extraction efficiency. Acceptance criteria were met after each phase of reprocessing.
Reprocessing and Processing Instructions for Use are provided for the scope and for the singleuse detachable distal cap, respectively.
An assessment of the ability of reprocessing staff to carry out the reprocessing instructions (a human factors study for reprocessing instructions) was conducted.
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 ED34-i10T. The device is not provided sterile, therefore, shelf-life is not applicable.
Maintenance
Annual maintenance of the duodenoscope is recommended. This allows PENTAX to inspect the forceps elevator mechanism for wear and required maintenance.
Biocompatibility
Biocompatibility of direct and indirect contact materials was confirmed by assessing the cytotoxicity, sensitization, and intracutaneous reactivity of the surface device with limited (less than 24 hours) contact with mucosal membrane in accordance with ISO 10993-1, 5, and 10: Biological Evaluation of Medical Devices.
A biocompatibility assessment of the amount of carbon black and titanium oxide contained in the patient contact
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parts of the device as well as the tolerable exposure (TE) value was conducted. The risk lev determined as "Very Low" based on the low concern for toxicity of colorant. The risk level of local toxicity was determined as "Acceptable" as a result of applying the risk level of local toxicity to the risk evaluation criteria.
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 B under the Software Safety Classification per IEC 62304:2006, Medical device 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."
EMC and Electrical Safety
The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX ED34-iT10 Video Duodenoscope were confirmed by the following standards: IEC 60601-1-2:2001, A1:2004; IEC 60601 1:2005+CORR 1:2006+CORR 2:2007+AM 1:2012; and IEC 60601-2-18:2009.
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 ED34-i10T Video Duodenoscope is substantially equivalent to the predicate ED-3490TK Video Duodenoscope. While there are some differences in technological characteristics, the ED-34i10T is as safe and effective as the predicate device and none of the differences raise new questions of safety or effectiveness.