(266 days)
Not Found
No
The document describes a video processor with a digital image enhancement feature (i-scan) but does not mention AI or ML in its description or intended use. The image enhancement is described as a post-processing modification of RGB components, not a learned algorithm.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices (PENTAX Medical Video Colonoscope EC34-i10cL, EC38-110cL, and Video Upper GI Scope EG29-i10c) are intended to provide "therapeutic access" to the gastrointestinal tract. Additionally, the "Device Description" of the endoscopes mentions the use of an "Instrument Channel" for inserting "Endotherapy Device such as Biopsy Forceps," which indicates therapeutic capabilities.
Yes
This device is a video processor and endoscopes explicitly stated to be "intended for endoscopic diagnosis".
No
The device description clearly outlines multiple hardware components including video processors, endoscopes with insertion portions, control bodies, and scope connectors, all of which are integral to the device's function. While there is a software component (i-scan), it is part of a larger hardware system.
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.
- Device function: The PENTAX Medical Video Colonoscope, Upper GI Scope, and Video Processor are used for direct visualization of the internal anatomy of the gastrointestinal tract. They provide images to a monitor for the physician to observe.
- Lack of sample analysis: The device does not analyze samples taken from the body. It is an imaging and therapeutic access tool used within the body.
- Intended Use: The intended use clearly states "optical visualization of (via a video monitor), and therapeutic access to, the lower/upper gastrointestinal tract." This aligns with an endoscopic device, not an IVD.
- Device Description: The description details the components and function of the endoscopes and processor, all of which are focused on capturing and displaying images of the internal anatomy.
While the device includes image processing (PENTAX i-scan), this is a post-processing enhancement of the in vivo image, not an analysis of a biological sample.
Therefore, this device falls under the category of an endoscopic device used for visualization and therapeutic procedures, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The PENTAX Medical Video Colonoscope EC34-i10cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes, but is not restricted to, the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 5kg of body weight.
The PENTAX Medical Video Colonoscope EC38-110cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes, but is not restricted to, the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight.
The PENTAX Medical Video Upper GI Scope EG29-i10c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, and duodenum.
This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight.
The PENTAX Medical Video Processor EPK-i5500c is intended to be used with the PENTAX Medical camera heads, endoscopes, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. It processes signals transmitted from a video endoscope into images that are displayed on an inspection monitor. This processor has air/water pump function.
This device includes PENTAX i-scan™, a digital, post-processing imaging enhancement technology. i-scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.
Product codes (comma separated list FDA assigned to the subject device)
PEA, FDS, FDF
Device Description
PENTAX Medical Video Processor EPK-i5500c
The PENTAX Medical Video Processor EPK-i5500c consists of a video system, monitor and ancillary equipment. This processor is intended for endoscopic diagnostic, treatment and video observation. The PENTAX Medical Video Processor EPK-i5500c contains a contrast enhancement feature: PENTAX i-scan technology. All visualization is done with the white light mode first. White light (RGB) illuminates the tissue and transfers the captured light through the Complementary MOS (CMOS) of the video scope. Note that the white light visualization mode is always used first by the physician. For i-scan image enhancement, the modification of the combination of RGB components for each pixel occurs when the i-scan function is turned on in the PENTAX Medical Video Processor EPK-i5500c. The resulting i-scan image is then displayed on the observation monitor. The EPK-i5500c is compatible with PENTAX Medical endoscopes EG29-i10c, EC34-i10cL and EC38-i10cL.
PENTAX Medical Video Upper GI Scope EG29-i10c
The PENTAX Medical Video Upper GI Scope EG29-i10c is used with PENTAX Medical Video Processor EPK-i5500c. The PENTAX Medical Video Upper GI Scope EG29-i10c is composed of the following main parts: an Insertion Portion, Control Body and Scope 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, Air/Water Nozzle, and Water Jet 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, Air/Water Cylinder, Suction Cylinder, Remote Control Button, Magnification Control Lever, 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 Scope Connector is connected to the Video Processor via an Electrical Contacts. The Bending Section is bent by the Angulation Control Knob to operate the endoscope angulation. The Angulation Lock Knob/Lever is used to adjust the rotation torque of the Angulation Control Knob. 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, 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 function of video processor and external device from the control body, as necessary. Endotherapy Device such as Biopsy Forceps is inserted from the Instrument Channel Inlet into the body cavity through the instrument channel. The Water Jet System is used to stream forward the sterile water from Water Jet Nozzle. The Light Guide of the Distal End is used to illuminate the body cavity with LEDs. The CMOS 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.
PENTAX Medical Video Colonoscopes EC34-i10cL and EC38-i10cL
The PENTAX Medical Video Colonoscopes EC34-i10cL and EC38-i10cL are used with PENTAX Medical Video Processor EPK-i5500c. The endoscopes are composed of the following main parts: an Insertion Portion, Control Body and Scope 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, Air/Water Nozzle, and Water Jet 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, Air/Water Cylinder, Suction Cylinder, Remote Button, Suction Selector Cylinder, 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 Suction Channel Selector is attached to the Suction Selector Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet. The Scope Connector is connected to the Video Processor via an Electrical Contacts. The Bending Section is bent by the Angulation Control Knob to operate the endoscope angulation. The Angulation Lock Knob/Lever is used to adjust the rotation torque of the Angulation Control Knob. 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 endoscopes have two channels; the primary channel and secondary one. Suction Channel Selector is used to switch between the primary and secondary channels as necessary. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary. Endotherapy Device such as Biopsy Forceps is inserted from the Instrument Channel Inlet into the body cavity through the instrument channel. The Water Jet System is used to stream forward the sterile water from Water Jet Nozzle. The Light Guide of the Distal End is used to illuminate the body cavity with LEDs. The CMOS 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical visualization (video endoscopy), White light endoscopy
Anatomical Site
Lower gastrointestinal tract (Large Bowel to the cecum, terminal ileum of the small bowel), Upper gastrointestinal tract (esophagus, stomach, and duodenum)
Indicated Patient Age Range
Patient populations with greater than 5kg of body weight (EC34-i10cL)
Patient populations with greater than 20kg of body weight (EC38-i10cL, EG29-i10c)
Intended User / Care Setting
Physician / Not explicitly stated, but implies a clinical setting.
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)
Optical Characterization
Backflow Prevention
Compatibility
Product Life
Bench testing demonstrate there are no additional risks.
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 the logo of the U.S. Food and Drug Administration (FDA). On the left 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.
December 20, 2019
PENTAX of America, Inc. % Beryl Jeanne Regulatory Specialist NAMSA Inc. 400 Highway 169. Suite 500 Minneapolis, MN 55426
Re: K190805
Trade/Device Name: PENTAX Medical Video Processor EPK-i5500c PENTAX Medical Video Upper GI Scope EG29-i10c PENTAX Medical Video Colonoscope EC34-i10cL PENTAX Medical Video Colonoscope EC38-i10cL Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: PEA, FDS, FDF Dated: November 20, 2019 Received: November 21, 2019
Dear Beryl Jeanne:
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.
1
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 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 medical devices and radiation-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, 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
Indications for Use
510(k) Number (if known) K190805
Device Name
PENTAX Medical Video Colonoscope EC34-i10cL; PENTAX Medical Video Colonoscope EC38-i10cL; PENTAX Medical Video Upper GI Scope EG29-i10c; PENTAX Medical Video Processor EPK-i5500c
Indications for Use (Describe)
The PENTAX Medical Video Colonoscope EC34-i10cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes, but is not restricted to, the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for
the procedure are observed in patient populations with greater than 5kg of body weight.
The PENTAX Medical Video Colonoscope EC38-110cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes, but is not restricted to, the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight.
The PENTAX Medical Video Upper GI Scope EG29-i10c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, and duodenum.
This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight.
The PENTAX Medical Video Processor EPK-i5500c is intended to be used with the PENTAX Medical camera heads, endoscopes, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. It processes signals transmitted from a video endoscope into images that are displayed on an inspection monitor. This processor has air/water pump function.
This device includes PENTAX i-scan™, a digital, post-processing imaging enhancement technology. i-scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.
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)
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3
510(k) Summary
| 510(k) Number | K190805 |
|---|---|
| Preparation Date: | November 20, 2019 |
| Submitter: | PENTAX of America, Inc. |
| Contact Person: | US Agent: |
| William Goeller | |
| Vice President, Quality Assurance and Regulatory Affairs | |
| PENTAX of America, Inc. | |
| 3 Paragon Drive | |
| Montvale, New Jersey 07645-1782 |
Official Correspondent:
Beryl St. Jeanne
Regulatory Consultant
NAMSA
400 Highway 169 South, Suite 500
Minneapolis, MN 55426 |
| Device Name: | PENTAX Medical Video Processor EPK-i5500c
PENTAX Medical Video Upper GI Scope EG29-i10c
PENTAX Medical Video Colonoscope EC34-i10cL
PENTAX Medical Video Colonoscope EC38-i10cL |
| Device Classification: | Regulation: 21 CFR 876.1500
Regulation Description: Endoscope and accessories
Regulatory Class: Class II
Product Code: PEA, FDS, FDF
Classification Panel: Gastroenterology/Urology
Devices: Endoscope, Accessories, Image Post-
Processing For Color Enhancement; Gastroscopic and Accessories,
Flexible/Rigid; Colonoscope and
Accessories, Flexible/Rigid |
| | PENTAX Medical Video Processor EPK-i5500c
This device is intended to be used with the PENTAX Medical camera
heads, endoscopes, monitors, and other ancillary equipment for
endoscopic diagnosis, treatment, and video observation.
It processes signals transmitted from a video endoscope into images
that are displayed on an inspection monitor. This processor has
air/water pump function.
This device includes PENTAX i-scan™, a digital, post-processing
imaging enhancement technology. i-scan is intended to be used as an
optional adjunct following traditional white light endoscopy and is not
intended to replace histopathological sampling. |
| Indications for Use | PENTAX Medical Video Upper GI Scope EG29-i10c
The PENTAX Medical Video Upper GI Scope EG29-i10c is intended
to provide optical visualization of (via a video monitor), and
therapeutic access to, the upper gastrointestinal tract. This anatomy
includes, but is not restricted to, the organs; tissues; and subsystems:
esophagus, stomach, and duodenum.
This endoscope is introduced via the mouth when indications
consistent with the need for the procedure are observed in patient
populations with greater than 20kg of body weight. |
| | PENTAX Medical Video Colonoscope EC34-i10cL
The PENTAX Medical Video Colonoscope EC34-i10cL is intended
to provide optical visualization of (via a video monitor), and
therapeutic access to, the lower gastrointestinal tract. This anatomy
includes, but is not restricted to, the organs, tissues, and subsystems:
Large Bowel to the cecum, terminal ileum of the small bowel.
This endoscope is introduced via the rectum, as decided by the
physician, when indications consistent with the need for the procedure
are observed in patient populations with greater than 5kg of body
weight. |
| | PENTAX Medical Video Colonoscope EC38-i10cL
The PENTAX Medical Video Colonoscope EC38-i10cL is intended
to provide optical visualization of (via a video monitor), and
therapeutic access to, the lower gastrointestinal tract. This anatomy
includes, but is not restricted to, the organs, tissues, and subsystems:
Large Bowel to the cecum, terminal ileum of the small bowel.
This endoscope is introduced via the rectum, as decided by the
physician, when indications consistent with the need for the procedure
are observed in patient populations with greater than 20kg of body
weight. |
| Device Description | PENTAX Medical Video Processor EPK-i5500c
The PENTAX Medical Video Processor EPK-i5500c consists of a
video system, monitor and ancillary equipment. This processor is
intended for endoscopic diagnostic, treatment and video observation.
The PENTAX Medical Video Processor EPK-i5500c contains a
contrast enhancement feature: PENTAX i-scan technology.
All visualization is done with the white light mode first. White light
(RGB) illuminates the tissue and transfers the captured light through
the Complementary MOS (CMOS) of the video scope. Note that the
white light visualization mode is always used first by the physician.
For i-scan image enhancement, the modification of the combination of
RGB components for each pixel occurs when the i-scan function is
turned on in the PENTAX Medical Video Processor EPK-i5500c. The
resulting i-scan image is then displayed on the observation monitor.
The EPK-i5500c is compatible with PENTAX Medical endoscopes
EG29-i10c, EC34-i10cL and EC38-i10cL.
PENTAX Medical Video Upper GI Scope EG29-i10c |
| The PENTAX Medical Video Upper GI Scope EG29-i10c is used
with PENTAX Medical Video Processor EPK-i5500c.The PENTAX
Medical Video Upper GI Scope EG29-i10c is composed of the
following main parts: an Insertion Portion, Control Body and Scope
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,
Air/Water Nozzle, and Water Jet 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, Air/Water Cylinder, Suction Cylinder, Remote
Control Button, Magnification Control Lever, 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 Scope Connector is connected to the Video Processor via an
Electrical Contacts. The Bending Section is bent by the Angulation
Control Knob to operate the endoscope angulation. The Angulation
Lock Knob/Lever is used to adjust the rotation torque of the
Angulation Control Knob.
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, 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 function of video processor and external device from
the control body, as necessary. | |
| Endotherapy Device such as Biopsy Forceps is inserted from the
Instrument Channel Inlet into the body cavity through the instrument
channel. The Water Jet System is used to stream forward the sterile
water from Water Jet Nozzle. | |
| The Light Guide of the Distal End is used to illuminate the body
cavity with LEDs. The CMOS 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. | |
| PENTAX Medical Video Colonoscopes EC34-i10cL and EC38-
i10cL | |
| The PENTAX Medical Video Colonoscopes EC34-i10cL and EC38-
i10cL are used with PENTAX Medical Video Processor EPK-i5500c. | |
| The endoscopes are composed of the following main parts: an
Insertion Portion, Control Body and Scope 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, Air/Water Nozzle,
and Water Jet 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, Air/Water Cylinder, Suction Cylinder, Remote Button,
Suction Selector Cylinder, 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
Suction Channel Selector is attached to the Suction Selector Cylinder.
The Inlet Seal is attached to the Instrument Channel Inlet. The Scope
Connector is connected to the Video Processor via an Electrical
Contacts. | |
| The Bending Section is bent by the Angulation Control Knob to
operate the endoscope angulation. The Angulation Lock Knob/Lever | |
| | is used to adjust the rotation torque of the Angulation Control Knob.
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 endoscopes have two
channels; the primary channel and secondary one. Suction Channel
Selector is used to switch between the primary and secondary
channels as necessary. The Remote Button is used to operate the
function of video processor and external device from the control body,
as necessary. |
| | Endotherapy Device such as Biopsy Forceps is inserted from the
Instrument Channel Inlet into the body cavity through the instrument
channel. The Water Jet System is used to stream forward the sterile
water from Water Jet Nozzle. |
| | The Light Guide of the Distal End is used to illuminate the body
cavity with LEDs. The CMOS 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. |
| | K122470
PENTAX EPK-i5010 VIDEO PROCESSOR
PENTAX Medical Company |
| Predicate Devices: | K131902
PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
PENTAX Medical Company |
| | K131855
PENTAX VIDEO COLONOSCOPES (EC FAMILY)
PENTAX Medical Company |
| Performance Testing: | Optical Characterization
Backflow Prevention
Compatibility
Product Life |
| Substantial Equivalence: | The PENTAX Medical system, which includes subject devices
PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical
Video Upper GI Scope EG29-i10c, PENTAX Medical Video
Colonoscope EC34-i10cL, and PENTAX Medical Video Colonoscope
EC38-i10cL, is substantially equivalent to predicate devices K122470
PENTAX EPK-i5010 VIDEO PROCESSOR, K131902 PENTAX
VIDEO UPPER G.I. SCOPES (EG FAMILY), and K131855
PENTAX VIDEO COLONOSCOPES (EC FAMILY) when
evaluating intended use and technological characteristics.
• The system's subject devices have similar indications/intended uses
as the predicate devices. There are minor differences between the
subject devices and predicate devices with respect to
indications/intended use.
• The system's subject devices designs and the predicate devices
designs are substantially equivalent with only minor differences
relating to the light source and mode through which image is
captured. Reprocessing, biocompatibility, software, EMC and
electrical safety, and bench testing demonstrate there are no additional
risks.
• The system's subject devices do not raise new questions of safety or
effectiveness. |
| Conclusion: | The system's subject devices have similar indications/intended uses
and substantially equivalent technological characteristics as the
predicate devices. The differences do not raise new issues of safety or
effectiveness. Reprocessing, biocompatibility, software, EMC and
electrical safety, and bench testing are provided in support of this
submission. |
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