(649 days)
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 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.
This document is a 510(k) premarket notification for the PENTAX Medical ED-3490TK, Video Duodenoscope. The document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI or diagnostic performance claim.
Therefore, many of the requested sections regarding AI/algorithm performance studies, such as specific acceptance criteria for diagnostic metrics, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable to this submission. This is a medical device clearance for an endoscope, not an AI-powered diagnostic tool.
The document highlights changes to the device (distal end design, reprocessing procedures) and discusses non-clinical tests conducted to support safety and effectiveness.
Here's a breakdown based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant for an AI-driven diagnostic device. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and showing that design changes do not raise new questions of safety or effectiveness.
- Reported Device Performance:
- Safety and Performance Data (Non-clinical tests): "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."
- 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)."
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable for diagnostic performance. The document mentions "performance testing and design analysis" for mechanical and reprocessing aspects, but does not specify sample sizes in the context of a "test set" for a diagnostic algorithm because one is not being evaluated.
- The studies conducted are internal engineering and validation tests, not clinical studies with patient data for diagnostic evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This information is relevant for AI/diagnostic performance studies where ground truth is established by medical experts for image interpretation. This document pertains to an endoscope's mechanical and sterilization properties.
4. Adjudication Method for the Test Set:
- Not applicable. This applies to clinical diagnostic studies, not device engineering or reprocessing validation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
- No, an MRMC study was NOT done. This device is an endoscope, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, a standalone algorithm performance study was NOT done. This device is an endoscope, not an AI algorithm.
7. The Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" would be established through engineering specifications, direct measurements, and established industry standards (e.g., ISO 10993-1 for biocompatibility, AAMI TIRs for reprocessing). It's not clinical "ground truth" like pathology or outcomes data.
8. The Sample Size for the Training Set:
- Not applicable. There is no AI algorithm being trained for this device notification.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no AI algorithm being trained for this device notification.
In summary, this 510(k) submission for the PENTAX Medical ED-3490TK Video Duodenoscope focuses on non-clinical testing (biocompatibility, reprocessing, mechanical integrity, software validation for functionality, EMC/electrical safety) to demonstrate substantial equivalence to a predicate device. It does not involve AI or diagnostic performance studies, and therefore, most of the requested fields regarding acceptance criteria and studies for AI performance are not relevant to this document.
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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
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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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510(k) Summary
| Submitter: | PENTAX of America, Inc.,HOYA CorporationPENTAX Division3 Paragon DriveMontvale, New Jersey 07645-1782 |
|---|---|
| Contact: | James W. MonroeDirector, Regulatory AffairsPENTAX of America, Inc.3 Paragon DriveMontvale, New Jersey 07645-1782Phone: 800-431-5880 x 2129, 201-251 3300 x2129Fax: 201-799-4117Email: 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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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).
§ 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.