(28 days)
No
The summary describes a standard video duodenoscope and its components, focusing on optical visualization and therapeutic access. There is no mention of AI, ML, image processing beyond basic visualization, or any data processing that would suggest the use of such technologies.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is intended to provide "therapeutic access" to the Biliary Tract. The "Device Description" also mentions a "working channel through which biopsy devices or other devices may be introduced," further supporting its therapeutic capability.
Yes
The device is described as providing "optical visualization" of various anatomical structures to assist in procedures, which implies it is used to diagnose or assist in the diagnosis of conditions by allowing visual inspection.
No
The device description clearly outlines physical components like a flexible insertion tube, control body, umbilicus, light carrying bundles, a CCD, and a working channel, indicating it is a hardware device. While it mentions being used with a "software controlled device" (the video processor), the device itself is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that this device is a Video Duodenoscope used for optical visualization and therapeutic access within the body (specifically the Biliary Tract via the Upper GI Tract). It is introduced via the mouth.
- No Sample Analysis: There is no mention of the device collecting or analyzing samples from the body. Its primary function is to provide a visual image and a channel for introducing other instruments for therapeutic purposes.
Therefore, the device operates in vivo (within the living body) rather than in vitro (outside the living body), which is the defining characteristic of 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.
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
These Video Duodenoscopes must be used with a PENTAX compatible Video Processor (software controlled device). The endoscopes have 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 devices contain light carrying bundles to illuminate the body cavity and a charge couple device (CCD) to collect image data. The instruments contain a working channel through which biopsy devices or other devices may be introduced.
Mentions image processing
Not Found
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 / 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)
No performance standards or special controls applicable to these devices have been adopted under Section 513 or 514 of the Federal Food, Drug, and Cosmetic Act.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 9, 2018
PENTAX of America, Inc. William Goeller Vice President, Quality and Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645-1782
Re: K181522
Trade/Device Name: PENTAX Medical ED3490TK Video Duodenoscope PENTAX Medical ED34-i10T Video Duodenoscope Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDT Dated: June 6, 2018 Received: June 11, 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 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.
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); 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.
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/6 description: The image shows the FDA logo. The logo is in white and consists of the letters "FDA" in a stylized font. The letters are connected and have a three-dimensional appearance. The logo is simple and recognizable.
Jeffrey W. Cooper -S 2018.07.09 11:30:02 -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
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Indications for Use
510(k) Number (if known) K181522
Device Name PENTAX Medical ED3490TK 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.
| Рассии в полнания с семой се седания в пристем в полника на присание на пристементации и полнения примента по седения при при подательные примента по седения по седения по се
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 1 2000 Class Class Card Canadian Collection Controller - Statis Home - Statis Home - Statistics of California, Collection |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K181522
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) | ||
|---|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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 of Quality / Regulatory Affairs
PENTAX of America, Inc.
3 Paragon Drive
Montvale, New Jersey 07645-1782
Phone: 800-431-5880 x 2318, 201-251-2300 x2318
Cell: 848-482-0481
Fax: 201-799-4117
Email: william.goeller@pentaxmedical.com |
| Date Prepared: | June 18, 2018 |
| Trade/Device Names: | PENTAX Medical ED3490TK Video Duodenoscope
PENTAX Medical ED34-i10T Video Duodenoscope |
| 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 (K161222, clearance received on
February 7, 2018) |
Device Description:
These Video Duodenoscopes must be used with a PENTAX compatible Video Processor (software controlled device). The endoscopes have 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 devices contain light carrying bundles to illuminate the body cavity and a charge couple device (CCD) to collect image data. The instruments contain a working channel through which biopsy devices or other devices may be introduced.
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.
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.
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Image /page/5/Picture/1 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold, sans-serif letters. Below the word "PENTAX" is a gray line. Below the gray line, the word "MEDICAL" is in gray, bold, sans-serif letters.
Comparison of Technological Characteristics
The difference between the subject devices and the predicate devices are as follows:
- O-ring Thickness
- Elevator Link Concentricity
The proposed design change requirement for the ED3490TK was to demonstrate a minimum of 10% Compression Ratio for the O-rings used to seal the elevator channel. Through analysis, the modification has demonstrated a Compression Ratio that met the pre-determined acceptance criterion. This change applies to both the ED3490TK and the ED34-i10T.
Summary of Technology Characteristics:
The technological characteristics of the modified ED-3490TK and ED34-i10T are functionally equivalent to the predicate device, the ED-3490TK.
There are no changes to materials, design, or manufacture of the modified PENTAX Medical ED3490TK and ED34i10T Video Duodenoscope devices, and only two mechanical dimensional changes to the O-rings, which also do not change in material composition or manufacturing process. These modifications do not impact the intended use, safety and/or effectiveness of the two devices.
The sealed elevator mechanism of the ED34-10T can be accessed after removal of the single use, detachable and disposable distal cap compared with the permanently fixed cap of ED-3490TK. The detachable and disposable distal cap of ED34-i10T allows the user to access the back side of the elevator for reprocessing.
Performance Data:
No performance standards or special controls applicable to these devices have been adopted under Section 513 or 514 of the Federal Food, Drug, and Cosmetic Act.
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 devices the ED3490TK and ED34-i10T Video Duodenoscope are substantially equivalent to the predicate ED-3490TK Video Duodenoscope. The ED3490TK and the ED-34i10T are as safe and effective as the predicate device and neither of the differences raise new questions of safety or effectiveness.