(30 days)
Not Found
No
The document describes a standard video duodenoscope and its components. There is no mention of AI, ML, or any advanced image processing beyond converting image data for display. The software changes mentioned are minor and related to manufacturing timing, not AI/ML functionality.
Yes
The device is described as providing "therapeutic access" and allowing for the insertion of "endoscopic devices such as biopsy forceps," indicating its use in performing therapeutic procedures.
No
The device is intended for optical visualization and therapeutic access, allowing doctors to see and work inside the body, but it does not diagnose conditions itself.
No
The device is a physical endoscope with various hardware components (insertion portion, control body, connector, lenses, channels, etc.) and is used for optical visualization and therapeutic access. While it includes software, it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The PENTAX Medical Video Duodenoscope ED34-110T2 is an endoscope used for direct visualization of internal anatomy (Biliary Tract via the Upper Gastrointestinal Tract) and for providing therapeutic access for procedures. It operates by inserting a device into the body to capture images and allow for the introduction of other instruments.
- Lack of Specimen Analysis: The device does not analyze specimens (like blood, urine, tissue samples) outside the body. It provides real-time visual information and a pathway for therapeutic interventions.
The device is a medical device used for in vivo (within the body) procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The PENTAX Medical Video Duodenoscope ED34-110T2 is intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Billary 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.
This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
Product codes (comma separated list FDA assigned to the subject device)
FDT
Device Description
The PENTAX Medical Video Duodenoscope ED34-i10T2 is intended to be used with a PENTAX Video Processor, documentation equipment, video monitor, endoscopic device ancillary equipment for optical visualization (via a video monitor) of, and/or 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.
The ED34-i10T2 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 portion includes the distal end and bending section. The objective lens, light guide, instrument channel, elevator link, 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 connector is connected to the video processor via electrical contacts.
The bending section is bent by the angulation control knob to operate the endoscope 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 the position of the cannula which is inserted through the Instrument Channel.
The cannula/forceps elevator control lever is used to operate the cannula/forceps elevator of the Distal End Cap with Elevator (OE-A63). 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 functions of the video processor and any external device from the control body, as necessary.
The single use, Distal End Cap with elevator (OE-A63) is provided as a sterile product. OE-A63 is attached to the elevator link of the distal end of ED34-i10T2. 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 image inside the body cavity is displayed on the monitor.
The PENTAX Medical Video Processors EPK-i5010 and EPK-i7010 are compatible with PENTAX Medical Video Duodenoscope ED34-i10T2.
The primary components of the system include the following:
The PENTAX Medical ED34-i10T2 Video Imaging System is provided with the following accessories:
- Keyboard input device for the video processor. .
- . White Balance Adjuster – controls the white balance feature.
- . Condenser Earth Cable - used to reduce high-frequency noise generated during high-frequency electro cautery device use with Pentax endoscopes.
- . Inlet Seal - prevents suctioned fluid from coming out of the instrument Channel Inlet during the use of suction function. During reprocessing, it seals the instrument Channel Inlet in order to fill the chemical solution inside the channel.
- Bite Block - prevents patients from biting the endoscope insertion tube during an endoscopic examination.
- Suction Control Valve - intended to control suction.
- . Air/Water Valve - intended to control air and waterfeeding.
- Distal End Cap with Elevator intended to guide the endoscopicdevice. ●
Additional accessories for reprocessing are provided with the device. These include a Cleaning Adapter, Soaking Cap, Ventilation Cap, Endoscope Cleaning Brush Kits, and replacement O- Rings.
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)
Software verification and validation including cybersecurity assessments were conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidances for Industry and Staff "Guidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices.", "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" and "Postmarket Management of Cybersecurity in Medical Devices."
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.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services USA logo, which features a stylized caduceus. To the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name in blue text.
April 9, 2021
PENTAX of America, Inc. William Goeller VP Quality Assurance and Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645-1782
Re: K210710
Trade/Device Name: PENTAX Medical Video Duodenoscope ED34-i10T2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDT Dated: March 7, 2021 Received: March 10, 2021
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);
1
labeling (21 CFR Part 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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. 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
Indications for Use
510(k) Number (if known) K210710
Device Name
PENTAX Medical Video Duodenoscope ED34-i10T2
Indications for Use (Describe)
The PENTAX Medical Video Duodenoscope ED34-110T2 is intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Billary 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.
This endoscope is 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) |
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
PENTAX Medical Video Duodenoscope ED34-i10T2 Special 510(k) Submission
510(k) Summary
1. Submitter:
PENTAX of America, Inc., HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782 Phone: 201-571-2318 Ext 2318 Fax: 201-571-2340 Contact: William Goeller Date Prepared: March 31, 2021
II. DEVICE
The purpose of this special 510(k) is to get clearance to the updated instructions that enhance awareness of Distal End Cap attachment process.
| Table 5.1: Regulatory Classification of PENTAX Medical Video Duodenoscope ED34-i10T2 | |||||
|---|---|---|---|---|---|
| -------------------------------------------------------------------------------------- | -- | -- | -- | -- | -- |
| Device Name | PENTAX Medical Video Duodenoscope ED34-i10T2 |
|---|---|
| Common Name | Video Duodenoscope |
| Classification Name | Endoscope and accessories |
| Regulation No. | 876.1500 |
| Device Class | 2 |
| Product Code | FDT |
| Classification Panel | Gastroenterology/ Urology |
III. PREDICATE DEVICES
The predicate device for this submission, PENTAX Medical ED34-i10T2 Video Duodenoscope (K192245), is materially, optically, structurally, mechanically identical to the subject device.
Device Description:
The PENTAX Medical Video Duodenoscope ED34-i10T2 is intended to be used with a PENTAX Video Processor, documentation equipment, video monitor, endoscopic device ancillary equipment for optical visualization (via a video monitor) of, and/or 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.
The ED34-i10T2 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 portion includes the distal end and bending section. The objective lens, light guide, instrument channel, elevator link, 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
4
PENTAX Medical Video Duodenoscope ED34-i10T2 Special 510(k) Submission
seal is attached to the instrument channel inlet. The PVE connector is connected to the video processor via electrical contacts.
The bending section is bent by the angulation control knob to operate the endoscope 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 the position of the cannula which is inserted through the Instrument Channel.
The cannula/forceps elevator control lever is used to operate the cannula/forceps elevator of the Distal End Cap with Elevator (OE-A63). 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 functions of the video processor and any external device from the control body, as necessary.
The single use, Distal End Cap with elevator (OE-A63) is provided as a sterile product. OE-A63 is attached to the elevator link of the distal end of ED34-i10T2. 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 image inside the body cavity is displayed on the monitor.
The PENTAX Medical Video Processors EPK-i5010 and EPK-i7010 are compatible with PENTAX Medical Video Duodenoscope ED34-i10T2.
The primary components of the system include the following:
The PENTAX Medical ED34-i10T2 Video Imaging System is provided with the following accessories:
- Keyboard input device for the video processor. .
- . White Balance Adjuster – controls the white balance feature.
- . Condenser Earth Cable - used to reduce high-frequency noise generated during high-frequency electro cautery device use with Pentax endoscopes.
- . Inlet Seal - prevents suctioned fluid from coming out of the instrument Channel Inlet during the use of suction function. During reprocessing, it seals the instrument Channel Inlet in order to fill the chemical solution inside the channel.
- Bite Block - prevents patients from biting the endoscope insertion tube during an endoscopic examination.
- Suction Control Valve - intended to control suction.
- . Air/Water Valve - intended to control air and waterfeeding.
- Distal End Cap with Elevator intended to guide the endoscopicdevice. ●
Additional accessories for reprocessing are provided with the device. These include a Cleaning Adapter, Soaking
5
PENTAX Medical Video Duodenoscope ED34-i10T2 Special 510(k) Submission
Cap, Ventilation Cap, Endoscope Cleaning Brush Kits, and replacement O- Rings.
IV. INDICATIONS FOR USE
The PENTAX Medical Video Duodenoscope ED34-i10T2 is intended to be used with endoscopic devices and other ancillary equipment 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.
This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
V. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE
PENTAX Medical ED34-i10T2 Video Duodenoscope has the same Intended use, fundamental technology, operating principles, components and materials as the predicate device.
The only differences between the subject and predicate devices include:
- The updated instructions that enhance awareness of Distal End Cap attachment process.
- . The following minor change has been applied to the subject software: Two different software versions are installed in PENTAX Medical Video Duodenoscope ED34-i10T2, dependent on the manufacturing timing. These two software versions are released due to the obsolescence of electronic components used for the endoscope. Functions realized by these two software are identical, and the difference of the software versions does not affect safety or effectiveness for the device, or any hardware performance such as CPU processing speed.
VI. PERFORMANCE DATA
The following performance data are provided to support the subject and predicate devices.
a. Software and Cybersecurity
A minor change was applied to ED34-i10T2 software. Two different software versions are installed in PENTAX Medical Video Duodenoscope ED34-i10T2, dependent on the manufacturing timing. Functions realized by these two software are identical, and the difference of the software versions does not affect safety or effectiveness for the device, or any hardware performance such as CPU processing speed.
Software verification and validation including cybersecurity assessments were conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidances for Industry and Staff "Guidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices.", "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" and "Postmarket Management of Cybersecurity in Medical Devices."
VII. CONCLUSION
PENTAX Medical concluded that the PENTAX Medical ED34-i10T2 is substantially equivalent to the predicate device ED34-i10T2 cleared in K192245.