(88 days)
No
The document mentions "digital post-processing imaging enhancement technology" and "optical imaging enhancement technology" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe any training or testing of algorithms on data. The focus is on image processing techniques, which are not inherently AI/ML.
Yes.
The device is intended for "therapeutic access to" the gastrointestinal tract, indicating its use in treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "gastrointestinal endoscopic diagnosis, treatment and video observation."
No
The device description explicitly states that the system consists of a video processor, integrated light source, monitor, and ancillary equipment, which are hardware components. While it includes software for image enhancement, it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this system is used for direct visualization of the gastrointestinal tract within the patient's body. It's an endoscopic system, not a system for analyzing samples like blood, urine, or tissue outside the body.
- The purpose is direct visualization and therapeutic access. The system provides optical visualization and allows for therapeutic interventions (like taking biopsies with forceps), which are in-vivo procedures.
- The imaging enhancement is an adjunct to white light endoscopy. While there is image processing, it's applied to the live video feed from the endoscope for improved visualization during the in-vivo procedure. It's not analyzing a sample in a lab setting.
Therefore, this device falls under the category of an endoscopic system for in-vivo diagnosis and treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes.
The PENTAX Medical Video Upper GI Scope EG29-i20c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes 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 20 kg of body weight.
The PENTAX Medical Video Colonoscope EC38-120cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes 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 20 kg of body weight.
Product codes
PEA, FDS, FDF
Device Description
PENTAX Medical Video Processor EPK-i8020c
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment.
The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling.
The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is supposed to be found in the instructions for use (IFU) and/or in the commercial materials such as brochures.
PETNAX Medical Video Upper GI Scope EG29-i20c
The PENTAX Medical Video Upper GI Scope EG29-i20c is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the upper gastrointestinal tract.
PENTAX Medical Video Colonoscope EC38-i20cL
The PENTAX Medical Video Colonoscope EC38-i20cL is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the lower digestive tract. The device is equipped with stiffness setting mechanism for the insertion tube. This feature enables the physician to choose the stiffness of the insertion tube, depending on the preferred level.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical visualization
Anatomical Site
upper gastrointestinal tract (esophagus, stomach, and duodenum), lower gastrointestinal tract (Large Bowel to the cecum, terminal ileum of the small bowel)
Indicated Patient Age Range
patient populations with greater than 20 kg of body weight.
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)
- Reprocessing Validation: simulated use testing, cleaning, high level disinfecting and rinsing (after cleaning and after HLD) validation studies of the EG29-i20c and EC38-i20cL were conducted and confirmed the effectiveness of reprocessing procedures in accordance with FDA's 2015 Final Guidance. All acceptance criteria were satisfied.
- Sterilization and Shelf Life: The use of System 1E liquid chemical sterilization for the sterilization of the EG29-i20c and EC38-i20cL was validated.
- Biocompatibility: Biocompatibility of the EG29-i20c and EC38-i20cL scopes on the direct and indirect contact materials was confirmed by assessing the cytotoxicity, sensitization, and intracutaneous reactivity in accordance with ISO 10993-1: 2018. The risk levels of local toxicity were determined as "Acceptable".
- Software and Cybersecurity: Software verification and validation including cybersecurity assessments were conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidance documents.
- Electrical Safety and EMC: The acceptable level of electrical safety (ES) and electromagnetic compatibility (EMC) were confirmed by IEC 60601-1-2:2014; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; and IEC 60601-2-18:2009.
- System Performance: The system performance of the subject device demonstrated the equivalence to the predicate device.
- Mechanical Performance: The performance of stiffness setting mechanism for the PENTAX Medical Video Colonoscope EC38-i20cL was verified by comparing to the OLYMPUS EVIS EXERA III Colonovideoscope CF-HO190 (K131780).
- Optical Performance: Optical properties of imaging and illumination performances were measured. All results show that the optical characteristics of the subject device are equivalent to those of the predicate device and the reference device.
- Animal Image Capture Study: An animal image capture study was performed. The results indicate that the subject device can visualize vascularity and mucosal surface for each anatomical area as well as the predicate device and the reference device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K191282, K131902, K180292, K210177, K131855, K180285, K192245, K202365, K190805, K200090, K203166, K131780
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
July 28, 2023
PENTAX of America, Inc. William Goeller Vice President. Ouality and Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645-1782
K231249 Re:
Trade/Device Name: PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: PEA, FDS, FDF Dated: April 28, 2023 Received: May 1, 2023
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.
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-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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) K231249
Device Name
PENTAX Medical EPK-i8020c Video Imaging System
Indications for Use (Describe)
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes.
The PENTAX Medical Video Upper Gl Scope EG29-i20c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes 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 20 kg of body weight.
The PENTAX Medical Video Colonoscope EC38-120cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes 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 20 kg of body weight.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 221 CFR 807.92. All data included in this document is accurate and complete to the best of PENTAX Medical's knowledge.
1. SUBMITTER
Applicant: PENTAX Medical HOYA Corporation PENTAX Division 3 Paragon Drive Montvale. New Jersey 07645-1782
William Goeller Contact: Vice President, Quality and Regulatory Affairs PENTAX Medical 3 Paragon Drive Montvale, New Jersey 07645-1782 Telephone: (201)571-2300 ext. 2318 FAX: (201)391-4189 Email: william.goeller@pentaxmedical.com
Date Prepared: 7/7/2023
2. SUBJECT DEVICE
The PENTAX Medical EPK-i8020c Video Imaging System comprises of three devices: (1) the PENTAX Medical Video Processor EPK-i8020c, (2) the PENTAX Medical Video Upper GI Scope EG29-i20c, and (3) the PENTAX Medical Video Colonoscope EC38i20cL.
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| PENTAX Medical EPK-i8020c Video Imaging System | |||
|---|---|---|---|
| Device | |||
| Name | PENTAX Medical | ||
| Video Processor | |||
| EPK-i8020c | PENTAX Medical | ||
| Video Upper GI Scope | |||
| EG29-i20c | PENTAX Medical | ||
| Video Colonoscope | |||
| EC38-i20cL | |||
| Common | |||
| Name | Gastroscope and Accessories, Flexible/Rigid | ||
| Classification | |||
| Name | Endoscope and accessories | ||
| Regulation No. | 876.1500 | ||
| Device Class | II | ||
| Product Code | PEA | FDS | FDF |
| Classification | |||
| Panel | Gastroenterology / Urology |
The PENTAX Medical Video Processor EPK-i8020c is compatible also with the following endoscopes that have been cleared in the past Premarket Notifications:
| Device Name | Model name |
|---|---|
| PENTAX / PENTAX Medical | |
| Video Upper GI Scope | EG34-i10, EG29-i10, EG27-i10, |
| EG17-J10, EG-3890TK, EG-2490K, | |
| EG29-i10c | |
| PENTAX / PENTAX Medical | |
| Video Colonoscope | EC38-i10L, EC34-i10L, EC34-i10TL, |
| EC-2990Li, EC-3890TLK, | |
| EC38-i10cL, EC34-i10cL | |
| PENTAX Medical | |
| Video Duodenoscope | ED34-i10T2, ED32-i10 |
| PENTAX Medical | |
| Ultrasound Upper GI Video Scope | EG38-J10UT, EG36-J10UR, EG34-J10U |
3. PREDICATE DEVICE
A previously cleared PENTAX Medical Video Processor and Video Scopes have been chosen as a predicate device:
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| Subject Device | Predicate Device |
|---|---|
| PENTAX Medical Video Processor | |
| EPK-i8020c | PENTAX Medical Video Processor |
| EPK-i7010 (K150618) | |
| PENTAX Medical Video Upper GI Scope | |
| EG29-i20c | PENTAX Video Upper G.I. Scope |
| EG29-i10 (K131902) | |
| PENTAX Medical Video Colonoscope | |
| EC38-i20cL | PENTAX Video Colonoscope |
| EC38-i10L (K131855) |
4. REFERENCE DEVICE
A previously cleared PENTAX Medical Video Scopes have been chosen as a reference device:
| Model Name | Model Number | Compatible
Video processor | 510(k) Clearance
Number |
|----------------------------------------|-------------------------------------------|-------------------------------|----------------------------|
| PENTAX Medical
Video Processor | EPK-i7010
(With water bottle assembly) | | K191282 |
| | EG-3890TK | | |
| PENTAX
Video Upper G.I. Scope | EG27-i10
EG-2490K | | K131902 |
| PENTAX Medical
Video Upper GI Scope | EG34-i10
EG17-J10 | | K180292
K210177 |
| PENTAX
Video Colonoscope | EC-3890TLK
EC34-i10L
EC-2990Li | EPK-i7010 | K131855 |
| PENTAX Medical
Video Colonoscope | EC34-i10TL | | K180285 |
| PENTAX Medical
Video Duodenoscope | ED34-i10T2
ED32-i10 | | K192245
K202365 |
| PENTAX Medical
Video Upper GI Scope | EG29-i10c | EPK-i5500c | K190805 |
| PENTAX Medical
Video Colonoscope | EC38-i10cL
EC34-i10cL | | |
Reference device for video scopes
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| Model Name | Model
Number | Compatible
Video
processor | Ultrasound
Scanner | 510(k)
Clearance
Number |
|-------------------------------------------------------|-----------------|----------------------------------|-----------------------|-------------------------------|
| PENTAX Medical
Ultrasound Upper GI
Video Scopes | EG38-J10UT | EPK-i7010 | ARIETTA 70 | K200090 |
| | EG36-J10UR | | | |
| | EG34-J10U | | ARIETTA 850 | K203166 |
Reference device for ultrasound video scopes
Reference device for stiffness setting mechanism (EC38-i20cL)
| Model Name | Manufacturer | 510(k) Clearance Number |
|---|---|---|
| EVIS EXERA III | ||
| COLONOVIDEOSCOPE | ||
| CF-HQ190L | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K131780 |
5. DEVICE DESCRIPTION
PENTAX Medical Video Processor EPK-i8020c
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment.
The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling.
The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is supposed to be found in the instructions for use (IFU) and/or in the commercial materials such as brochures.
PETNAX Medical Video Upper GI Scope EG29-i20c
The PENTAX Medical Video Upper GI Scope EG29-i20c is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the upper gastrointestinal tract.
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Image /page/7/Picture/2 description: The image shows the Pentax Medical logo. The word "PENTAX" is in large, bold, red letters. Below "PENTAX" is a gray line. Below the line, the word "MEDICAL" is in gray letters. At the top of the image, the text "Page 5 of 9" is visible.
PENTAX Medical Video Colonoscope EC38-i20cL
The PENTAX Medical Video Colonoscope EC38-i20cL is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the lower digestive tract. The device is equipped with stiffness setting mechanism for the insertion tube. This feature enables the physician to choose the stiffness of the insertion tube, depending on the preferred level.
6. INTENDED USE AND INDICATIONS FOR USE
Intended use and Indications for use for PENTAX Medical Video Processor EPKi8020c
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-Scan [14), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes.
Intended use and Indications for use for PENTAX Medical Video Upper GI Scope EG29-i20c
The PENTAX Medical Video Upper GI Scope EG29-i20c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes 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 20 kg of body weight.
Intended use and Indications for use for PENTAX Medical Video Colonoscope EC38-i20cL
The PENTAX Medical Video Colonoscope EC38-i20cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel.
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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.
7. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE
The subject device is functionally equivalent to the predicate device, and the difference between the two devices are minor technological changes such as the application of CMOS image sensor for the new endoscopes and of LED light source for the new video processor.
The changes in the subject device have been evaluated through performance testing including image quality animal study and raised no issue of safety and effectiveness of the device as these differences have no effect on the performance, function, or general intended use of the device.
The components of the subject device have the same fundamental technology and principle of operation as the predicate device. Both the subject device and the predicate device are intended for illuminating and viewing the inside of the human body. The components of the subject device consist of the same components as the predicate device, including:
- . A video processor
- . Video Upper GI Scope and Video Colonoscope to provide optical visualization of (via a video monitor), and therapeutic access to the Upper and Lower Gastrointestinal Tract.
- . Accessories, including but not limited to a keyboard, foot switch, White Balance Adjuster, and Condenser Earth Cable
The subject device is identical or enhanced to the predicate device with regards to;
- . Scope working length
- Scope field of view
- Scope depth of field ●
- Scope tip angulation
- Software requirements
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Image /page/9/Picture/2 description: The image shows the Pentax Medical logo. The word "PENTAX" is in large, bold, red letters. Below "PENTAX" is a gray line, and below the line is the word "MEDICAL" in gray letters. At the top left of the image is the text "Page 7 of 9".
8. NON-CLINICAL PERFORMANCE DATA
The PENTAX Medical EPK-i8020c Video Imaging System has been successfully tested for their functions, performance, and safety as per FDA recognized consensus standards. The following performance data are provided in support of the substantial equivalence determination.
-
i. Reprocessing Validation
As result of the assessment, simulated use testing, cleaning, high level disinfecting and rinsing (after cleaning and after HLD) validation studies of the EG29-i20c and EC38-i20cL were conducted and confirmed the effectiveness of reprocessing procedures in accordance with FDA's 2015 Final Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." Acceptance criteria were established in accordance with AAMI TIR 30: 2011 for amount of residual soil accumulation and extraction efficiency. All acceptance criteria were satisfied. -
ii. Sterilization and Shelf Life
PENTAX Medical coordinated with STERIS Corporation to validate the use of System 1E liquid chemical sterilization for the sterilization of the EG29-i20c and EC38-i20cL. The device is not provided sterile; therefore, shelf-life is not applicable. -
iii. Biocompatibility
Biocompatibility of the EG29-i20c and EC38-i20cL scopes on the direct and indirect contact materials was confirmed by assessing the cytotoxicity, sensitization, and intracutaneous reactivity in accordance with ISO 10993-1: 2018 "Biological evaluation of medical devices". The risk levels of local toxicity were determined as "Acceptable" as a result of applying the risk level of local toxicity to the risk evaluation criteria. -
iv. Software and Cybersecurity
Software verification and validation including cybersecurity assessments were conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidance for Industry and Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", and "Postmarket Management of Cybersecurity in Medical Devices".
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Image /page/10/Picture/1 description: The image shows the text "Page 8 of 9" in the upper left corner. Below this text is the word "PENTAX" in large, red, bold letters. Underneath "PENTAX" is a gray line, and below that is the word "MEDICAL" in gray, bold letters.
- Electrical Safety and EMC v.
The acceptable level of electrical safety (ES) and electromagnetic compatibility (EMC) were confirmed by the following standards:
IEC 60601-1-2:2014; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; and IEC 60601-2-18:2009.
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vi. System Performance
The system performance of the subject device demonstrated the equivalence to the predicate device. -
vii. Mechanical Performance
The performance of stiffness setting mechanism for the PENTAX Medical Video Colonoscope EC38-i20cL was verified by comparing to the OLYMPUS EVIS EXERA III Colonovideoscope CF-HO190 (K131780) that is equipped with the variable stiffness feature. -
viii. Optical Performance
As a part of Design Verification and Validation, optical properties of imaging and illumination performances were measured for the PENTAX Medical EPK-i8020c Video Imaging System. All results show that the optical characteristics of the subject device are equivalent to those of the predicate device and the reference device. -
ix. Animal Image Capture Study
An animal image capture study was performed as a part of optical and color performance testing. The results indicate that the subject device can visualize vascularity and mucosal surface for each anatomical area as well as the predicate device and the reference device.
Substantial Equivalence Discussion:
After analyzing the intended use, indications for use, technological characteristics (including fundamental operating principle, energy source, scientific technology, functional characteristics, design features, performance characteristics, and constituent materials), labeling, and sterilization method, PENTAX Medical concludes that the subject device is as safe and effective as the predicate device. There are no differences in indications for use and intended use between the subject and predicate device and are therefore, substantially equivalent. The technological differences in terms of design features, performance characteristics and constituent materials are not substantive.
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9. CONCLUSION
Accordingly, PENTAX Medical believes the PENTAX Medical EPK-i8020c Video Imaging System does not raise any different questions of safety and effectiveness, and that the subject device of the PENTAX Medical Video Processor EPK-i8020c, the PENTAX Medical Video Upper GI Scope EG29-i20c, and the PENTAX Medical Video Colonoscope EC38-i20cL is substantially equivalent to the identified predicate, the PENTAX Medical Video Processor EPK-i7010, cleared by FDA in K150618, the PENTAX Video Upper G.I. Scope EG29-i10 (K131902), and the PENTAX Video Colonoscope EC38-i10L (K131855), respectively.