(231 days)
Not Found
No
The summary mentions "digital post-processing imaging enhancement technology" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe characteristics typically associated with AI/ML algorithms (training data, test data, performance metrics like AUC, sensitivity, specificity).
Yes
The intended use explicitly states "therapeutic access to the biliary tract via the upper gastrointestinal tract" for the PENTAX Medical Video Duodenoscope ED34-i10T2s.
Yes
The "PENTAX Medical Video Processor EPK-i8020c" component explicitly states its intended use for "gastrointestinal and pulmonary endoscopic diagnosis, treatment and video observation."
No
The device description clearly outlines hardware components like the duodenoscope itself, a video processor, and a distal end cap with an elevator. While there is mention of software for imaging enhancement and cybersecurity, the core device is a physical endoscope system.
Based on the provided information, none of the listed devices are IVDs (In Vitro Diagnostics).
Here's why:
-
IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
-
Device Functions:
- PENTAX Medical Video Duodenoscope ED34-i10T2s: This is an endoscope used for direct visualization and therapeutic access within the body. It does not examine specimens in vitro.
- PENTAX Gas/Water Feeding Valve OF-B194: This is an accessory for the endoscope, facilitating the delivery of gas or water into the body. It does not examine specimens in vitro.
- PENTAX Medical Video Processor EPK-i8020c: This processes the optical visualization data from the endoscope. While it enhances images, it's processing in vivo visual information, not in vitro specimen data.
- PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63: This is an accessory for the endoscope, aiding in guiding devices within the body. It does not examine specimens in vitro.
All of these devices are used for in vivo procedures (within the living body) for visualization and therapeutic intervention. They do not perform tests on samples outside of the body to diagnose conditions.
N/A
Intended Use / Indications for Use
The PENTAX Medical Video Duodenoscope ED34-i10T2s is intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to the biliary tract via the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems of the: esophagus, stomach, duodenum, common bile duct, hepatic ducts, cystic duct, and pancreatic duct. This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
Gas/water feeding valve is attached in place of air/water feeding valve to the gastrointestinal endoscope, in order to prevent the leaking of the nonflammable gas into the room, and feed the gas or water into the gastrointestinal tract or abdominal cavity. It also prevents back flow/splashing of body fluids.
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 and pulmonary 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 and bronchoscopes.
The PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63 fully integrates a movable elevator, whose function it is to guide endoscopic devices. The OE-A63 is controlled by the PENTAX Medical Video Duodenoscopes and is necessary to meet the intended use of the duodenoscope.
Product codes (comma separated list FDA assigned to the subject device)
FDT, FET
Device Description
PENTAX Medical Video Duodenoscope ED34-i10T2s is designed to be used with a PENTAX Medical Video Processor, documentation equipment, 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 biliary tract via the upper gastrointestinal tract. The PENTAX Medical Video Duodenoscope ED34-i10T2s is compatible with the hydrogen peroxide gas plasma sterilizer STERRAD 100NX.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical visualization
Anatomical Site
esophagus, stomach, duodenum, common bile duct, hepatic ducts, cystic duct, and pancreatic duct.
Indicated Patient Age Range
adult and pediatric patient populations.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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 ED34-i10T2s 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 and 1 endo liquid chemical sterilization for the sterilization of the ED34-i10T2s, and also coordinated with Advanced Sterilization Products, Inc. to validate the use of STERRAD 100NX hydrogen peroxide gas plasma sterilization for the sterilization of the ED34-i10T2s. The device is not provided sterile, therefore, shelf-life is not applicable. The Distal End Cap with Elevator OE-A63 is provided as a single-use, sterile product. However, no testing of sterilization and shelf life require since the change has been applied to the labeling only.
- iii. Biocompatibility: Biocompatibility of the ED34-i10T2s duodenoscope 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: PENTAX Medical Video Processor (EPK-i8020c) had a software update relative to the original submission (K232860) to add compatibility with the ED34-i10T2s duodenoscope and fix bugs. Software verification and validation including cybersecurity assessments were conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidance for Industry and Staff "Content of Premarket Submissions for Device Software Functions", "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions", and "Postmarket Management of Cybersecurity in Medical Devices".
- v. Electrical Safety and EMC: EMC and Electrical safety testing were successfully conducted per the new standards IEC60601-1-2 Edition 4.0:2014-02; ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text); and IEC 60601-2-18 Edition 3.0:2009-08 and recent EMC guidance.
- vi. System Performance: The system performance of the subject device demonstrated the equivalence to the predicate device.
- vii. Optical Performance: No testing of optical characteristics was performed for the ED34-i10T2s since the subject device has the same optical designs as the predicate device. Details are described in the "Performance Testing" section.
- viii. Human Factors Testing: The Human Factors study results of the predicate K192245 were leveraged and additional supplemental usability testing was successfully conducted to support human factors validation of the ED34-i10T2s. Details are described in the "Performance Testing" section.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 1, 2024
Pentax of America, Inc. Gurvinder Singh Nanda Senior Director, Regulatory and Quality 3 Paragon Drive Montvale, New Jersey 07645
Re: K233942
Trade/Device Name: PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDT, FET Dated: July 5, 2024 Received: July 5, 2024
Dear Gurvinder Singh Nanda:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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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
3
Indications for Use
Submission Number (if known)
Device Name
PENTAX Medical Video Duodenoscope (ED34-i10T2s);
PENTAX Medical Video Processor (EPK-i8020c);
PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63);
Gas/Water Feeding Valves (OF-B194 )
Indications for Use (Describe)
PENTAX Medical Video Duodenoscope ED34-i10T2s
The PENTAX Medical Video Duodenoscope ED34-i10T2s is intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to the biliary tract via the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems of the: esophagus, stomach, duodenum, common bile duct, hepatic ducts, cystic duct, and pancreatic duct.
This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
PENTAX Gas/Water Feeding Valve OF-B194
Gas/water feeding valve is attached in place of air/water feeding valve to the gastrointestinal endoscope. in order to prevent the leaking of the nonflammable gas into the room, and feed the gas or water into the gastrointestinal tract or abdominal cavity. It also prevents back flow/splashing of body fluids.
PENTAX Medical Video Processor EPK-i8020c
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 and pulmonary 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 and bronchoscopes.
PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63 The PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63 fully integrates a movable elevator, whose function it is to guide endoscopic devices. The OE-A63 is controlled by the PENTAX Medical Video Duodenoscopes and is necessary to meet the intended use of the
duodenoscope.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/1 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, with horizontal lines running through each letter. Below the word "PENTAX" is a gray line, and below that is the word "MEDICAL" in gray.
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 of America, Inc. HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782
Contact: Gurvinder Singh Nanda Sr. Director, Regulatory and Quality PENTAX of America, INC. 3 Paragon Drive Montvale, New Jersey 07645-1782 Telephone: 650-722-4189 Email: gurvinder.nanda@pentaxmedical.com
Date Prepared: 12-13-2023
2. SUBJECT DEVICE
PENTAX Medical is seeking clearance of a new product of PENTAX Medical Video Duodenoscope ED34-i10T2s with the compatible PENTAX Medical Video Processors EPK-i8020c, and PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63.
| Device Name | PENTAX Medical Video Duodenoscope ED34-i10T2s,
PENTAX Medical Video Processor (EPK-i8020c);
PENTAX Medical Single Use, Sterile Distal End Cap with
Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Video Duodenoscope |
| Classification Name | Endoscope and accessories |
| Regulation No. | 876.1500 |
| Device Class | II |
| Product Code | FDT, FET |
| Classification Panel | Gastroenterology/ Urology |
K233942 Page 1 of 6
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3. PREDICATE DEVICE
A previously cleared PENTAX Medical Video Duodenoscope ED34-i10T2 (K192245) has been chosen as a predicate device and a recently cleared version of the EPK-i8020c as the secondary predicate device (K232860)
Page 2 of 6
4. DEVICE DESCRIPTION
PENTAX Medical Video Duodenoscope ED34-i10T2s is designed to be used with a PENTAX Medical Video Processor, documentation equipment, 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 biliary tract via the upper gastrointestinal tract. The PENTAX Medical Video Duodenoscope ED34-i10T2s is compatible with the hydrogen peroxide gas plasma sterilizer STERRAD 100NX.
5. INTENDED USE AND INDICATIONS FOR USE
PENTAX Medical Video Duodenoscope ED34-i10T2s
The PENTAX Medical Video Duodenoscope ED34-i10T2s is intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to the biliary tract via the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems of the: esophagus, stomach, duodenum, common bile duct, hepatic ducts, cystic duct, and pancreatic duct. This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
Indications for Use for the PENTAX Gas/Water Feeding Valve OF-B194
Gas/water feeding valve is attached in place of air/water feeding valve to the gastrointestinal endoscope, in order to prevent the leaking of the nonflammable gas into the room, and feed the gas or water into the gastrointestinal tract or abdominal cavity. It also prevents back flow/splashing of body fluids.
Indications for Use for the PENTAX Medical Video Processor EPK-i8020c
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 and pulmonary 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
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histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes and bronchoscopes.
K233942 Page 3 of 6
PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63
The PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63 fully integrates a movable elevator, whose function it is to guide endoscopic devices. The OE-A63 is controlled by the PENTAX Medical Video Duodenoscopes and is necessary to meet the intended use of the duodenoscope.
6. 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 compatibility with the Hydrogen peroxide gas plasma sterilizer STERRAD 100NX.
The changes in the subject device have been evaluated through performance testing and raised no issues of safety and effectiveness of the device. 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 Duodenoscope to provide optical visualization of (via a video monitor), and therapeutic access to Biliary Tract via the Upper Gastrointestinal Tract.
- Accessories, including but not limited to a keyboard, foot switch, White Balance Adjuster, and Condenser Earth Cable (with EPK-i7010 and EPK-i5010 only)
The subject device is identical or enhanced to the predicate device with regards to;
- . Working length
- Field of view
- . Depth of field
- . Tip angulation
- Rigid distal width ●
- Insertion tube width
- Maximum insertion portion width
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Image /page/7/Picture/1 description: The image contains the logo for Pentax Medical. The word "PENTAX" is in red, block letters, with horizontal lines running through each letter. Below that, there is a gray line, and below that, the word "MEDICAL" is in gray, block letters.
- Maximum instrument channel width
- Software requirements
Following changes have also been implemented to the existing PENTAX Medical accessories:
- . The Instructions for Use for PENTAX Gas/Water Feeding Valve OF-B194 has been updated to provide users with detailed reprocessing procedures.
- The Intended Use/Indications for Use of PENTAX Medical Single-use, Sterile Distal End Cap with Elevator OE-A63 has been modified so that the accessory is compatible with the subject device (ED34-i10T2s) as well as the predicate device (ED34-i10T2).
7. NON-CLINICAL PERFORMANCE DATA
PENTAX Medical Video Duodenoscope ED34-i10T2s 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 ED34-i10T2s 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 and 1 endo liquid chemical sterilization for the sterilization of the ED34- i10T2s, and also coordinated with Advanced Sterilization Products, Inc. to validate the use of STERRAD 100NX hydrogen peroxide gas plasma sterilization for the sterilization of the ED34-i10T2s. The device is not provided sterile, therefore, shelf- life is not applicable.
The Distal End Cap with Elevator OE-A63 is provided as a single-use, sterile product. However, no testing of sterilization and shelf life require since the change has been applied to the labeling only.
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- iii. Biocompatibility
Biocompatibility of the ED34-i10T2s duodenoscope 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.
K233942 Page 5 of 6
-
iv. Software and Cybersecurity
PENTAX Medical Video Processor (EPK-i8020c) had a software update relative to the original submission (K232860) to add compatibility with the ED34-i10T2s duodenoscope and fix bugs. Software verification and validation including cybersecurity assessments were conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidance for Industry and Staff "Content of Premarket Submissions for Device Software Functions", "Cybersecurity in Medical Devices: Oualitv System Considerations and Content of Premarket Submissions", and "Postmarket Management of Cybersecurity in Medical Devices". -
v. Electrical Safety and EMC
EMC and Electrical safety testing were successfully conducted per the new standards IEC60601-1-2 Edition 4.0:2014-02; ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text); and IEC 60601-2-18 Edition 3.0:2009-08 and recent EMC guidance. -
vi. System Performance
The system performance of the subject device demonstrated the equivalence to the predicate device. -
vii. Optical Performance
No testing of optical characteristics was performed for the ED34-i10T2s since the subject device has the same optical designs as the predicate device. Details are described in the "Performance Testing" section. -
viii. Human Factors Testing
The Human Factors study results of the predicate K192245 were leveraged and additional supplemental usability testing was successfully conducted to support human factors validation of the ED34-i10T2s. Details are described in the "Performance Testing" section.
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Image /page/9/Picture/1 description: The image contains the logo for Pentax Medical. The word "PENTAX" is in red, block letters, with horizontal lines running through each letter. Below that, there is a gray line, and below that, the word "MEDICAL" is in gray, block letters. The logo is simple and modern.
K233942 Page 6 of 6
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 devices. 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.
8. CONCLUSION
PENTAX Medical Video Duodenoscope ED34-i10T2s does not raise any different questions of safety and effectiveness. The subject device PENTAX Medical Video Duodenoscope ED34-i10T2s with the compatible PENTAX Medical Video Processors EPK-i8020c, and PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63 is substantially equivalent to the identified predicates, the PENTAX Medical Video Duodenoscope ED34-i10T2 cleared by FDA in K192245 and as the secondary predicate device (K232860).