PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
K210485 · Pentax of America, Inc. · FDS · May 13, 2021 · Gastroenterology, Urology
Device Facts
Record ID
K210485
Device Name
PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
Applicant
Pentax of America, Inc.
Product Code
FDS · Gastroenterology, Urology
Decision Date
May 13, 2021
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
EG Family: This instrument is intended to be used with a PENTAX video processor (including light source), documentation equipment, monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach, and duodenum. EC Family: This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
Device Story
PENTAX Medical Video Upper GI Scopes (EG Family) and Colonoscopes (EC Family) are flexible endoscopes used for visualization and endoscopic surgery. The device consists of an insertion portion (with distal end, objective lens, light guide, instrument channel, and air/water nozzles), a control body (with angulation levers, suction controls, and instrument channel inlet), and a PVE connector. The device connects to a PENTAX video processor and light source. Light is transmitted to the distal end to illuminate the body cavity; a CCD sensor captures reflected light, converting it into image data for display on a monitor. The clinician operates the scope manually to navigate the GI tract and perform procedures. This submission specifically addresses the reorganization of reprocessing instructions into five separate manuals to improve usability for reprocessing personnel. The device is used in clinical settings by trained medical professionals.
Clinical Evidence
No clinical data. A summative human factors study was conducted to validate the effectiveness of the updated reprocessing instructions for the EG29-i10 and EC-3890TLK models. Results indicated that identified use errors and risks can be mitigated through further refinement of the instructions and training materials.
Technological Characteristics
Reusable semi-critical endoscopes. Components: insertion portion, control body, PVE connector. Illumination: fiberoptic light guide. Imaging: distal CCD sensor. Connectivity: electrical contacts to video processor. Reprocessing: high-level disinfection or sterilization required. No changes to materials or specifications (depth of field, distal end width, etc.) from predicates.
Indications for Use
Indicated for endoscopic examination and surgery in the upper digestive tract (esophagus, stomach, duodenum) for the EG family, and the lower digestive tract (anus, rectum, sigmoid colon, colon, ileocecal valve) for the EC family. Used by clinicians in a medical setting.
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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
PENTAX Medical Video Upper G.I. scopes (EG Family) (K131902)
PENTAX Medical Video Colonoscopes (EC Family) (K131855)
Submission Summary (Full Text)
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May 13, 2021
PENTAX of America, Inc. William Goeller VP Quality Assurance and Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645-1782
Re: K210485
Trade/Device Name: PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDS, FDF Dated: February 17, 2021 Received: February 19, 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
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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. 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) K210485
#### Device Name
PENTAX Medical Video Upper GI Scopes (EG Family) PENTAX Medical Video Colonoscopes (EC Family)
## Indications for Use (Describe)
EG Family:
This instrument is intended to be used with a PENTAX video processor (including light source), documentation equipment, monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach, and duodenum.
#### EC Family:
This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
| 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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## PENTAX Medical Video Upper G.I. scopes (EG Family) and Colonoscopes (EC Family)- 5 rIFUs Traditional 510(k) Submission
## 510(k) Summary
#### SUBMITTER l.
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: February 17, 2021
## II. DEVICE
The purpose of this 510(k) is to obtain clearance for the simplified reprocessing instructions which are separated into (5) rIFU's to eliminate the need for reprocessing personnel to identify what configuration endoscope they are working with.
There are no other changes to the reprocessing instructions for use, nor are there any changes to the design, intended use, or indications for use of the EG Family and EC Family of endoscopes.
| Table 5.1: Regulatory Classification of PENTAX Medical Video Upper GI Scopes. | |
|-------------------------------------------------------------------------------|--|
|-------------------------------------------------------------------------------|--|
| Device Name | PENTAX Video Upper GI Scopes (EG Family) |
|----------------------|---------------------------------------------|
| 510(k) Number | K131902 |
| Common Name | Gastroscope And Accessories, Flexible/Rigid |
| Classification Name | Endoscope and accessories |
| Regulation No. | 876.1500 |
| Device Class | 2 |
| Product Code | FDS |
| Classification Panel | Gastroenterology/ Urology |
### Table 5.2: Regulatory Classification of PENTAX Medical Video Colonoscopes
| Device Name | PENTAX Video Colonoscopes (EC Family) |
|---------------------|---------------------------------------|
| 510(k) Number | K131855 |
| Common Name | Colonoscopes And Accessories |
| Classification Name | Endoscope and accessories |
| Regulation No. | 876.1500 |
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## PENTAX Medical Video Upper G.I. scopes (EG Family) and Colonoscopes (EC Family)- 5 rIFUs Traditional 510(k) Submission
| Device Class | 2 |
|----------------------|---------------------------|
| Product Code | FDF |
| Classification Panel | Gastroenterology/ Urology |
## III. PREDICATE DEVICES
The predicate devices for this submission are also the subject of this submission, the PENTAX Medical Video Upper G.I. scopes (EG Family) (K131902) and PENTAX Medical Video Colonoscopes (EC Family) (K131855). The predicate devices are identical to the devices subject to this 510(k); the only change relates to the reprocessing instructions that are now broken down into 5 separate manuals for each endoscope type.
## IV. DEVICE DESCRIPTION
The subject devices are identical to the predicate devices. There are no changes to the design, specifications, or technological characteristics of the PENTAX Medical Video Upper GI Scopes and PENTAX Medical Video Colonoscopes as described in K131902 and K131855 respectively. The associated model numbers for the PENTAX Medical Video Upper GI Scopes are provided in Table 5.2.
| PENTAX Video Upper G.I. scopes (EG Family) | | | | | |
|--------------------------------------------|----------|----------|-----------|----------|--|
| EG-2990i | EG-1690K | EG-2790K | EG-3490K | EG27-i10 | |
| EG-2790i | EG-2490K | EG-2990K | EG-3890TK | EG29-i10 | |
Table 5.2: Model Numbers Associated with the PENTAX Medical Video Upper GJ Scopes
The associated model numbers for the PENTAX Medical Video Colonoscopes are provided in Table 5.3.
| | | | Table 5.3: Model Numbers Associated with the PENTAX Medical Video Colonoscopes |
|--|--|--|--------------------------------------------------------------------------------|
| | | | |
| PENTAX Video Colonoscopes (EC Family) | | | | |
|---------------------------------------|-----------|------------|------------|-----------|
| EC-3890TLK | EC-3490Li | EC-3490TLi | EC-3890LK | EC34-i10L |
| EC-2990Li | EC-3890Li | EC-3490LK | EC-3890LZi | EC38-i10L |
The PENTAX Medical Video Upper G.I. scopes (EG Family) and Colonoscopes (EC Family) are used with Video Processors. They are composed of three main components: 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, and Instrument Channel are located on the Distal End of the Insertion. The Distal End also contains an Air/Water
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## PENTAX Medical Video Upper G.I. scopes (EG Family) and Colonoscopes (EC Family)- 5 rlFUs Traditional 510(k) Submission
Nozzle and Water Jet Nozzle. This Air/Water Feeding System is used to deliver the air and water to the Objective Lens.
The Control Body is held by the user's hand. The Control Body includes the Angulation Control lever used to operate the endoscope angulation; Suction Cylinder and Suction Nipple for suctioning fluid and air in the body cavity; Remote Button used to operate the function of video processor; and Instrument Channel Inlet used to insert endotherapy devices, such as biopsy forceps, into the body cavity.
The Magnification Control Lever is used to magnify the image on the video monitor, as necessary. As this magnification function is performed electrically, focus and depth of field are not changed.
The PVE Connector is connected to the Video Processor via an Electrical Contacts. The PVE Connector includes the Electrical Contacts and Light Guide Plug. The Light Guide Plug is connected to the Light Source inside the Video Processor. The Light Guide of the Distal End is used to illuminate the body cavity by light that is carried through the Light Carrying Bundle. The Light Carrying Bundle guides the light from Light Guide Plug that is connected to the Light Source. 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 Upper G.I. scopes and Colonoscopes are reusable semi-critical devices. Since they are packaged non-sterile, they must be high-level disinfected or sterilized before initial use. Prior to each subsequent procedure, they must be subjected to an appropriate cleaning and either high-level disinfection or sterilization processes.
## V. INDICATIONS FOR USE
There are no changes to the Indications for Use for the subject devices. The sole purpose of this 510(k) is to simplify the reprocessing instructions by breaking two rIFU's into (5) to eliminate the need for reprocessing personnel to identify what configuration endoscope they are working with.
The PENTAX Medical Video Upper Gl Scopes (EG Family) are intended to be used with a PENTAX video processor (including light source), documentation equipment, monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach, and duodenum.
The PENTAX Medical Video Colonoscopes (EC Family) are intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
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## VI. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE
The subject devices are identical to the predicate devices. The subject devices have the same fundamental technology and operating principles of the predicate devices, including the same intended use and design technological characteristics, such as Insertion Portion, Control Body and fiberoptic illumination. There are no differences in specifications, including, but not limited to, the depth of field, distal end width, insertion tube width, instrument channel width, and total length. The sole difference between the subject and predicate device is that the reprocessing instructions have been simplified by breaking down rIFUs into (5) separate groups. This modification does not impact the intended use and does not raise different questions of safety and effectiveness.
### VII. PERFORMANCE DATA
The optimization of the reprocessing instructions for the PENTAX Medical Video Upper GI scopes and Colonoscopes do not affect the biocompatibility, electrical safety, electromagnetic compatibility, software verification and validation, or performance testing for the scopes.
#### VIII. HUMAN FACTORS
PENTAX Medical conducted a Summative Human Factors Study to validate the effectiveness and the risk management measures that are in place for the reprocessing of the EG29-i10 Video Gastroscope with a water jet channel. An ancillary study of the EC-3890TLK limited to its second therapeutic channel was carried out with the same group of stakeholders.
The combination of these 2 scopes provides adequate Human Factors evaluation of all design features of EG/EC families related to reprocessing.
As a result of testing, use errors, close calls and difficulties were observed to have occurred in some critical tasks. However, it is estimated that the risks identified, and the root causes assigned to those risks can be reduced and/or mitigated via additional modifications of the rIFU design and the further refinement of the training materials.
### VIII. CONCLUSION
The subject devices are identical to the predicate devices. The subject devices have the same intended use and technological characteristics as the predicate devices. There are no changes to the design of the subject devices.
The data submitted support the separation of reprocessing instructions into 5 groups for the PENTAX Medical Video Upper G.I. scopes and Colonoscopes demonstrate that the scopes can be reprocessed in a safe and effective manner.
The data provided in this 510(k) Premarket Notification support the equivalence of the subject and predicate devices.
