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

K190805 · Pentax of America, Inc. · PEA · Dec 20, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K190805
• 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
• Applicant: Pentax of America, Inc.
• Product Code: PEA · Gastroenterology, Urology
• Decision Date: Dec 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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-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. 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.

Device Story

System comprises video processor EPK-i5500c and compatible endoscopes (EG29-i10c, EC34-i10cL, EC38-i10cL). Endoscopes feature distal CMOS sensors capturing reflected light from body cavities illuminated by LEDs. Processor converts raw image data into video signals for display on external monitors. Includes i-scan digital post-processing for image enhancement, used as an optional adjunct to white light endoscopy. Physician operates endoscope via control body (angulation knobs, suction/irrigation valves) and inserts into GI tract. Processor provides air/water pump functions. Output assists physicians in endoscopic diagnosis and therapeutic procedures. Benefits include improved visualization of GI anatomy and potential for enhanced tissue observation via i-scan. Not intended to replace histopathological sampling.

Clinical Evidence

Bench testing only. Performance validated through optical characterization, backflow prevention, compatibility, and product life testing.

Technological Characteristics

System includes video processor and flexible endoscopes. Features CMOS imaging sensors, LED illumination, and air/water/suction channels. Connectivity via electrical contacts to processor. i-scan technology performs digital post-processing of RGB pixel components. Class II device.

Indications for Use

Indicated for optical visualization and therapeutic access to the upper GI tract (esophagus, stomach, duodenum) in patients >20kg, and the lower GI tract (large bowel to cecum, terminal ileum) in patients >5kg (EC34-i10cL) or >20kg (EC38-i10cL).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• PENTAX EPK-i5010 VIDEO PROCESSOR (K122470)
• PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) (K131902)
• PENTAX VIDEO COLONOSCOPES (EC FAMILY) (K131855)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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## 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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## 510(k) Summary

| 510(k) Number | K190805 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preparation Date: | November 20, 2019 |
| Submitter: | PENTAX of America, Inc. |
| Contact Person: | US Agent:<br>William Goeller<br>Vice President, Quality Assurance and Regulatory Affairs<br>PENTAX of America, Inc.<br>3 Paragon Drive<br>Montvale, New Jersey 07645-1782<br><br>Official Correspondent:<br>Beryl St. Jeanne<br>Regulatory Consultant<br>NAMSA<br>400 Highway 169 South, Suite 500<br>Minneapolis, MN 55426 |
| Device Name: | PENTAX Medical Video Processor EPK-i5500c<br>PENTAX Medical Video Upper GI Scope EG29-i10c<br>PENTAX Medical Video Colonoscope EC34-i10cL<br>PENTAX Medical Video Colonoscope EC38-i10cL |
| Device Classification: | Regulation: 21 CFR 876.1500<br>Regulation Description: Endoscope and accessories<br>Regulatory Class: Class II<br>Product Code: PEA, FDS, FDF<br>Classification Panel: Gastroenterology/Urology<br>Devices: Endoscope, Accessories, Image Post-<br>Processing For Color Enhancement; Gastroscopic and Accessories,<br>Flexible/Rigid; Colonoscope and<br>Accessories, Flexible/Rigid |
| | PENTAX Medical Video Processor EPK-i5500c<br>This device is intended to be used with the PENTAX Medical camera<br>heads, endoscopes, monitors, and other ancillary equipment for<br>endoscopic diagnosis, treatment, and video observation.<br>It processes signals transmitted from a video endoscope into images<br>that are displayed on an inspection monitor. This processor has<br>air/water pump function.<br>This device includes PENTAX i-scan™, a digital, post-processing<br>imaging enhancement technology. i-scan is intended to be used as an<br>optional adjunct following traditional white light endoscopy and is not<br>intended to replace histopathological sampling. |
| Indications for Use | PENTAX Medical Video Upper GI Scope EG29-i10c<br>The PENTAX Medical Video Upper GI Scope EG29-i10c is intended<br>to provide optical visualization of (via a video monitor), and<br>therapeutic access to, the upper gastrointestinal tract. This anatomy<br>includes, but is not restricted to, the organs; tissues; and subsystems:<br>esophagus, stomach, and duodenum.<br>This endoscope is introduced via the mouth when indications<br>consistent with the need for the procedure are observed in patient<br>populations with greater than 20kg of body weight. |
| | PENTAX Medical Video Colonoscope EC34-i10cL<br>The PENTAX Medical Video Colonoscope EC34-i10cL is intended<br>to provide optical visualization of (via a video monitor), and<br>therapeutic access to, the lower gastrointestinal tract. This anatomy<br>includes, but is not restricted to, the organs, tissues, and subsystems:<br>Large Bowel to the cecum, terminal ileum of the small bowel.<br>This endoscope is introduced via the rectum, as decided by the<br>physician, when indications consistent with the need for the procedure<br>are observed in patient populations with greater than 5kg of body<br>weight. |
| | PENTAX Medical Video Colonoscope EC38-i10cL<br>The PENTAX Medical Video Colonoscope EC38-i10cL is intended<br>to provide optical visualization of (via a video monitor), and<br>therapeutic access to, the lower gastrointestinal tract. This anatomy<br>includes, but is not restricted to, the organs, tissues, and subsystems:<br>Large Bowel to the cecum, terminal ileum of the small bowel.<br>This endoscope is introduced via the rectum, as decided by the<br>physician, when indications consistent with the need for the procedure<br>are observed in patient populations with greater than 20kg of body<br>weight. |
| Device Description | PENTAX Medical Video Processor EPK-i5500c<br>The PENTAX Medical Video Processor EPK-i5500c consists of a<br>video system, monitor and ancillary equipment. This processor is<br>intended for endoscopic diagnostic, treatment and video observation.<br>The PENTAX Medical Video Processor EPK-i5500c contains a<br>contrast enhancement feature: PENTAX i-scan technology.<br>All visualization is done with the white light mode first. White light<br>(RGB) illuminates the tissue and transfers the captured light through<br>the Complementary MOS (CMOS) of the video scope. Note that the<br>white light visualization mode is always used first by the physician.<br>For i-scan image enhancement, the modification of the combination of<br>RGB components for each pixel occurs when the i-scan function is<br>turned on in the PENTAX Medical Video Processor EPK-i5500c. The<br>resulting i-scan image is then displayed on the observation monitor.<br>The EPK-i5500c is compatible with PENTAX Medical endoscopes<br>EG29-i10c, EC34-i10cL and EC38-i10cL.<br>PENTAX Medical Video Upper GI Scope EG29-i10c |
| The PENTAX Medical Video Upper GI Scope EG29-i10c is used<br>with PENTAX Medical Video Processor EPK-i5500c.The PENTAX<br>Medical Video Upper GI Scope EG29-i10c is composed of the<br>following main parts: an Insertion Portion, Control Body and Scope<br>Connector. The Insertion Portion is inserted into the body cavity of<br>patient. The Insertion Portion includes the Distal End and Bending<br>Section. The Objective Lens, Light Guide, Instrument Channel,<br>Air/Water Nozzle, and Water Jet Nozzle are located on the Distal End<br>of the Insertion Portion. The Control Body is held by the user's hand.<br>The Control Body includes the Angulation Control Knob, Angulation<br>Lock Knob/Lever, Air/Water Cylinder, Suction Cylinder, Remote<br>Control Button, Magnification Control Lever, and Instrument Channel<br>Inlet. The Air/Water Feeding Valve is attached to the Air/Water<br>Cylinder, and the Suction Control Valve is attached to the Suction<br>Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet.<br>The Scope Connector is connected to the Video Processor via an<br>Electrical Contacts. The Bending Section is bent by the Angulation<br>Control Knob to operate the endoscope angulation. The Angulation<br>Lock Knob/Lever is used to adjust the rotation torque of the<br>Angulation Control Knob.<br>The Air/Water Feeding System is used to deliver the air and water to<br>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<br>Air/Water Feeding Valve is pushed, the water is delivered. The<br>Suction Control System is used to suction the fluid and air in body<br>cavity from the Instrument Channel. When the Suction Control Valve<br>is pushed, the fluid and air are suctioned. The Remote Button is used<br>to operate the function of video processor and external device from<br>the control body, as necessary. | |
| Endotherapy Device such as Biopsy Forceps is inserted from the<br>Instrument Channel Inlet into the body cavity through the instrument<br>channel. The Water Jet System is used to stream forward the sterile<br>water from Water Jet Nozzle. | |
| The Light Guide of the Distal End is used to illuminate the body<br>cavity with LEDs. The CMOS built into the Distal End receives<br>reflected light (image data) from the body cavity, and sends the image<br>data to the Video Processor through the video cable. The image data<br>are converted into the image signal by the Video Processor, and the<br>image inside the body cavity is displayed on the Monitor. | |
| <b>PENTAX Medical Video Colonoscopes EC34-i10cL and EC38-<br/>i10cL</b> | |
| The PENTAX Medical Video Colonoscopes EC34-i10cL and EC38-<br>i10cL are used with PENTAX Medical Video Processor EPK-i5500c. | |
| The endoscopes are composed of the following main parts: an<br>Insertion Portion, Control Body and Scope Connector. | |
| The Insertion Portion is inserted into the body cavity of patient. The<br>Insertion Portion includes the Distal End and Bending Section. The<br>Objective Lens, Light Guide, Instrument Channel, Air/Water Nozzle,<br>and Water Jet Nozzle are located on the Distal End of the Insertion<br>Portion. The Control Body is held by the user's hand. The Control<br>Body includes the Angulation Control Knob, Angulation Lock<br>Knob/Lever, Air/Water Cylinder, Suction Cylinder, Remote Button,<br>Suction Selector Cylinder, and Instrument Channel Inlet. The<br>Air/Water Feeding Valve is attached to the Air/Water Cylinder, and<br>the Suction Control Valve is attached to the Suction Cylinder. The<br>Suction Channel Selector is attached to the Suction Selector Cylinder.<br>The Inlet Seal is attached to the Instrument Channel Inlet. The Scope<br>Connector is connected to the Video Processor via an Electrical<br>Contacts. | |
| The Bending Section is bent by the Angulation Control Knob to<br>operate the endoscope angulation. The Angulation Lock Knob/Lever | |
| | is used to adjust the rotation torque of the Angulation Control Knob.<br>The Air/Water Feeding System is used to deliver the air and water to<br>the Objective Lens from the Air/Water Nozzle. When the hole at the<br>top of Air/Water Feeding Valve is covered, the air is delivered. When<br>the Air/Water Feeding Valve is pushed, the water is delivered. The<br>Suction Control System is used to suction the fluid and air in body<br>cavity from the Instrument Channel. When the Suction Control Valve<br>is pushed, the fluid and air are suctioned. The endoscopes have two<br>channels; the primary channel and secondary one. Suction Channel<br>Selector is used to switch between the primary and secondary<br>channels as necessary. The Remote Button is used to operate the<br>function of video processor and external device from the control body,<br>as necessary. |
| | Endotherapy Device such as Biopsy Forceps is inserted from the<br>Instrument Channel Inlet into the body cavity through the instrument<br>channel. The Water Jet System is used to stream forward the sterile<br>water from Water Jet Nozzle. |
| | The Light Guide of the Distal End is used to illuminate the body<br>cavity with LEDs. The CMOS built into the Distal End receives<br>reflected light (image data) from the body cavity, and sends the image<br>data to the Video Processor through the video cable. The image data<br>are converted into the image signal by the Video Processor, and the<br>image inside the body cavity is, displayed on the Monitor. |
| | K122470<br>PENTAX EPK-i5010 VIDEO PROCESSOR<br>PENTAX Medical Company |
| Predicate Devices: | K131902<br>PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)<br>PENTAX Medical Company |
| | K131855<br>PENTAX VIDEO COLONOSCOPES (EC FAMILY)<br>PENTAX Medical Company…