(60 days)
Not Found
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 for analysis, or any performance metrics typically associated with AI/ML algorithms. The performance study mentioned is human factors testing, not related to algorithmic performance.
Yes.
The device provides "therapeutic access to the Biliary Tract via the Upper GI Tract" and has a working channel for the introduction of biopsy or other devices, indicating its use in therapeutic procedures beyond just visualization.
Yes
The "Intended Use / Indications for Use" states that the device is intended to "provide optical visualization... of, and therapeutic access to the Biliary Tract via the Upper GI Tract." Visualization of internal anatomy is a key aspect of diagnosis.
No
The device description clearly outlines physical components like a flexible insertion tube, control body, umbilicus, light carrying bundles, CCD, and a working channel, indicating it is a hardware device with software control.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The PENTAX Medical ED-3490TK Video Duodenoscope is used for direct visualization of internal anatomy and for providing therapeutic access to the Biliary Tract. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states "to provide optical visualization (via a video monitor) of, and therapeutic access to the Biliary Tract via the Upper GI Tract." This is an in-vivo procedure, not an in-vitro diagnostic test.
The device is an endoscope used for internal examination and intervention, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The PENTAX Medical 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, 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
FDT
Device Description
The PENTAX Medical ED-3490TK Video Duodenoscope is used with a PENTAX compatible Video Processor (software controlled device). The duodenoscope 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 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, 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)
The purpose of this 510(k) Premarket Notification is to obtain clearance of revised reprocessing instructions for use (RIFU) for the PENTAX Medical ED-3490TK Video Duodenoscope. The RIFU has been modified from the previously cleared version to more readily support user comprehension of and adherence to the reprocessing instructions. The revision to the RIFU was based upon human factors testing conducted by PENTAX Medical.
The revision to the RIFU does not affect the biocompatibility, electrical safety, electromagnetic compatibility, software verification and validation, or performance testing for the scope. No additional performance testing has been performed and no performance standards or special controls applicable to this device have been adopted under Section 513or 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.
0
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October 21, 2019
Pentax Medical William Goeller Vice President, Ouality Assurance and Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645
Re: K192280
Trade/Device Name: PENTAX Medical ED-3490TK Video Duodenoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FDT Dated: August 21, 2019 Received: August 22, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Martha Betz, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name PENTAX Medical ED-3490TK Video Duodenoscope
Indications for Use (Describe)
The PENTAX Medical 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, 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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Confidential
3
PENTAX Medical ED-3490TK Video Duodenoscope Traditional 510(k) Premarket Notification
510(k) SUMMARY
PENTAX Medical ED-3490TK Video Duodenoscope
1. Submitter
PENTAX Medical 3 Paragon Drive Montvale, NJ 07645
Phone: 201-571-2318 Facsimile: 201-571-2340 Contact Person: William Goeller Date Prepared: October 16, 2019
2. Device
| Name of Device: | PENTAX Medical ED-3490TK Video Duodenoscope |
|---|---|
| Common or Usual Name: | Duodenoscope And Accessories, Flexible/Rigid |
| Classification Name: | Endoscope and accessories |
| Classification Number: | 21 C.F.R. § 876.1500 |
| Regulatory Class: | II |
| Product Code: | FDT |
3. Predicate Device
PENTAX Medical ED-3490TK Video Duodenoscope (K181522)
4. Device Description
The PENTAX Medical ED-3490TK Video Duodenoscope is used with a PENTAX compatible Video Processor (software controlled device). The duodenoscope 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 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.
Confidential
4
PENTAX Medical ED-3490TK Video Duodenoscope Traditional 510(k) Premarket Notification
The subject device is identical to the predicate device. There are no changes to the design, specifications, or technological characteristics of the PENTAX Medical ED-3490TK Video Duodenoscope as described in the predicate device 510(k) Premarket Notification, K181522.
5. Indications for Use
The PENTAX Medical 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 indications for use of the subject and predicate devices are identical. There have been no changes to the indications for use for the PENTAX Medical ED-3490TK Video Duodenoscope as described in the predicate device 510(k) Premarket Notification, K181522.
6. Comparison of Technological Characteristics with the Predicate Device
The technological characteristics of the subject and predicate device are identical with the exception of improvements to the RIFU resulting from completion of a Human Factors study. The reprocessing manual was revised to promote user adherence and comprehension of the reprocessing instructions. The subject device has the same fundamental technology and operating principles of the predicate device. There are no differences in specifications, design, materials, or manufacture.
7. Performance Data
The purpose of this 510(k) Premarket Notification is to obtain clearance of revised reprocessing instructions for use (RIFU) for the PENTAX Medical ED-3490TK Video Duodenoscope. The RIFU has been modified from the previously cleared version to more readily support user comprehension of and adherence to the reprocessing instructions. The revision to the RIFU was based upon human factors testing conducted by PENTAX Medical.
The revision to the RIFU does not affect the biocompatibility, electrical safety, electromagnetic compatibility, software verification and validation, or performance testing for the scope. No additional performance testing has been performed and no performance standards or special controls applicable to this device have been adopted under Section 513or 514 of the Federal Food, Drug, and Cosmetic Act.
5
PENTAX Medical ED-3490TK Video Duodenoscope Traditional 510(k) Premarket Notification
8. Conclusions
The subject PENTAX Medical ED-3490TK Video Duodenoscope is identical to the predicate PENTAX Medical ED-3490TK Video Duodenoscope. The intended use and indications for use, technological characteristics, and principles of operation are the same for both devices. The sole difference between the subject and predicate device is that the RIFU has been revised to more readily support user comprehension of and adherence to the reprocessing instructions. This has been supported by Human Factors testing which demonstrates that the revision to the RIFU does not raise new issues of safety or effectiveness and thus, the data provided in this 510(k) Premarket Notification support the equivalence of the subject and predicate devices.