(649 days)
Not Found
No
The summary describes a standard video duodenoscope and video processor. While it mentions image data collection and display, there is no mention of AI, ML, or any advanced image processing beyond formatting for display. The description focuses on the hardware components and basic functionality.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "therapeutic access to the Biliary Tract," and the "Device Description" mentions a "working channel through which biopsy devices or other devices may be introduced," indicating its capability for therapeutic interventions.
Yes
The device is intended to provide optical visualization of tissues and organs via a video monitor, which is a method used for diagnostic purposes. Its use is also predicated on "indications consistent with the need for procedure," implying an assessment of conditions.
No
The device description clearly outlines hardware components such as a flexible insertion tube, control body, umbilicus, light-carrying bundles, CCD, working channel, and requires a separate video processor with a Xenon lamp. While software is mentioned as controlling the video processor, the core device is a physical endoscope.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the ED-3490TK is to provide optical visualization directly of the Biliary Tract via the Upper GI Tract. It is introduced into the body, not used to analyze samples taken from the body.
- The device description focuses on direct visualization and therapeutic access. It describes light delivery, image collection via a CCD, and a working channel for instruments, all of which are characteristic of an endoscope used for in-vivo procedures.
- There is no mention of analyzing biological samples. The device processes image data from within the body, not from a specimen.
Therefore, the ED-3490TK Video Duodenoscope is a medical device used for direct visualization and intervention within the body, not an IVD.
N/A
Intended Use / Indications for Use
The ED-3490TK, Video Duodenoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to the Biliary Tract via the Upper GI Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic, and Cystic Ducts. This instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric populations.
Product codes (comma separated list FDA assigned to the subject device)
FDT
Device Description
The ED-3490TK Video Duodenoscope must be used with a PENTAX compatible Video Processor (software controlled device). The endoscope has a flexible insertion tube, a control body and umbilicus. The umbilicus provides connection to the video processor. The control body includes controls for up/down/left/right angulation, air/water delivery, suction and an accessory inlet port. The device contains lightcarrying bundles to illuminate the body cavity and a charge couple device (CCD) to collectimage data. The instrumentcontains a working channel through which biopsy devices or other devices may be introduced. The Video Processor contains a 300 watt short Arc Xenon lamp which provides white light that is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical visualization
Anatomical Site
Biliary Tract via the Upper GI 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 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)
PENTAX Medical has conducted performance testing and design analysis to demonstrate the safety and effectiveness of the elevator wire channel seal, as well as the distal end cap seal strength and integrity. No animal or clinical performance testing has been completed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 7, 2018
Pentax Medical William Goeller Vice President, Quality Assurance and Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645
Re: K161222
Trade/Device Name: PENTAX MEDICAL ED-3490TK, Video Duodenoscope Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDT Dated: October 6, 2017 Received: December 21, 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
1
medical device-related 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
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
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Indications for Use
510(k) Number (if known) K161222
Device Name PENTAX Medical ED-3490TK, Video Duodenoscope
Indications for Use (Describe)
The ED-3490TK, Video Duodenoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to the Biliary Tract via the Upper GI Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic, and Cystic Ducts. This instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric 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, and the word "MEDICAL" is in gray. Below the logo is the text "K161222 Page 1 of 3".
510(k) Summary
| Submitter: | PENTAX of America, Inc.,
HOYA Corporation
PENTAX Division
3 Paragon Drive
Montvale, New Jersey 07645-1782 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | James W. Monroe
Director, Regulatory Affairs
PENTAX of America, Inc.
3 Paragon Drive
Montvale, New Jersey 07645-1782
Phone: 800-431-5880 x 2129, 201-251 3300 x2129
Fax: 201-799-4117
Email: James.Monroe@pentaxmedical.com |
| Date Prepared: | January 19, 2018 |
| Trade/Device Name: | PENTAX Medical ED-3490TK |
| 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: | The PENTAX ED-3490TK, Video Duodenoscope (K092710, clearance received on December 2, 2009) |
Device Description:
The ED-3490TK Video Duodenoscope must be used with a PENTAX compatible Video Processor (software controlled device). The endoscope has a flexible insertion tube, a control body and umbilicus. The umbilicus provides connection to the video processor. The control body includes controls for up/down/left/right angulation, air/water delivery, suction and an accessory inlet port. The device contains lightcarrying bundles to illuminate the body cavity and a charge couple device (CCD) to collectimage data. The instrumentcontains a working channel through which biopsy devices or other devices may be introduced. The Video Processor contains a 300 watt short Arc Xenon lamp which provides white light that is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
Intended Use/Indications for Use:
The ED-3490TK, Video Duodenoscope, is intended to provide optical visualization (via a video monitor) of, and therapeuticaccess to the Biliary Tract via the Upper Gl Tract. This anatomy includes, but is not
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Image /page/4/Picture/1 description: The image shows the Pentax Medical logo, with the word "PENTAX" in red and "MEDICAL" in gray underneath. Below the logo, the text "K161222 Page 2 of 3" is displayed, indicating a document identifier and page number.
restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile Hepatic, and Cystic Ducts. This instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric populations.
Summary of Technology Characteristics:
The optical properties and imaging characteristics remain unchanged since the prior submission. The differences between the subject and predicate devices are as follows:
- Distal end design differences (changes in materials and dimensions)
- Modifications to the device's reprocessing procedure and recommendation for annual maintenance.
Safety and Performance Data (Non-clinical tests):
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.
PENTAX Medical has conducted performance testing and design analysis to demonstrate the safety and effectiveness of the elevator wire channel seal, as well as the distal end cap seal strength and integrity. No animal or clinical performance testing has been completed.
Biocompatibility:
Biocompatibility of the ED-3490TK was evaluated in accordance with ISO 10993-1.
Software:
Software changes were made to enhance functionality and do not raise new or different questions of safety and effectiveness. Changes were validated in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Reprocessing Validation:
Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". The following Technical Information Reports (TIRs) were referenced: AAMI TIR 12:2010, AAMI TIR30:2011.
EMC and Electrical Safety:
No changes have been made to the EMC or electrical safety as compared to prior submission (K092710).
Substantial Equivalence Discussion:
Based on an analysis of the intendeduse, 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 ED-3490TK Video Duodenoscope is substantially equivalent to
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the predicate ED-3490TK Video Duodenoscope (K092710). Labeling and design changes were made to the ED-3490TK that were identified in the bench testing. They have the identical intended use and indications for use. Performance testing and design analysis demonstrate that the ED-3490TK is substantially equivalent to the predicate and the differences raise no new issues of safety or effectiveness
Accordingly, PENTAXMedical believes the ED-3490TK Video Duodenoscope is substantially equivalent to the identified ED-3490TK predicate (K092710).