(220 days)
No
The summary describes standard endoscopic devices for visualization and therapeutic access, with no mention of AI/ML capabilities, image processing beyond basic visualization, or performance metrics typically associated with AI/ML algorithms. The performance studies focus on reprocessing, sterilization, biocompatibility, software/cybersecurity (standard for medical devices), electrical safety, system performance equivalence, optical performance, and animal image capture for visualization comparison.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the devices are intended to provide "therapeutic access" to the upper and lower gastrointestinal tract.
Yes
The device provides "optical visualization" of the GI tract, allowing a physician to observe and identify abnormalities, which is a diagnostic function. While it also offers "therapeutic access," its primary role in allowing visualization for the purpose of identifying health issues aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a physical endoscope (Video Upper GI Scope and Video Colonoscope) designed to be used with a video processor, monitor, and other ancillary equipment for optical visualization and therapeutic access. It is a hardware device, not software-only.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: The descriptions clearly state that these devices are endoscopes used for optical visualization and therapeutic access within the human body (the gastrointestinal tract). They are used to directly view and interact with internal anatomy.
- No Mention of Sample Analysis: There is no mention of these devices being used to analyze samples taken from the body. Their function is to provide a visual feed and allow for the introduction of tools for procedures inside the patient.
Therefore, these PENTAX Medical Video Upper GI Scope and Colonoscope devices are considered medical devices for internal visualization and intervention, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
PENTAX Medical Video Upper GI Scope EG27-i20c:
The PENTAX Medical Video Upper GI Scope EG27-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.
PENTAX Medical Video Colonoscope EC34-i20cL:
The PENTAX Medical Video Colonoscope EC34-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.
This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 5kg of body weight.
Product codes
FDS, FDF
Device Description
PETNAX Medical Video Upper GI Scope EG27-i20c
The PENTAX Medical Video Upper GI Scope EG27-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 EC34-i20cL
The PENTAX Medical Video Colonoscope EC34-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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical visualization (via a video monitor)
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 (Upper GI Scope); patient populations with greater than 5 kg of body weight (Colonoscope).
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)
Non-Clinical Performance Data:
i. Reprocessing Validation: Simulated use testing, cleaning, high level disinfecting and rinsing (after cleaning and after HLD) validation studies of the EG27-i20c and EC34-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 EG27-i20c and EC34-i20cL.
iii. Biocompatibility: Biocompatibility of the EG27-i20c and EC34-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".
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 "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: The acceptable level of electrical safety (ES) and electromagnetic compatibility (EMC) were confirmed by the following standards: IEC 60601-1-2:2014 + A1:2020; IEC 60601-1:2005 + A1:2012 + A2:2020; IEC 60601-1-6:2010 + A1:2013 +A2:2020; and IEC 60601-2-18:2009.
vi. System Performance: The system performance of the subject device demonstrated the equivalence to the predicate/reference devices.
vii. Optical Performance: Optical properties of imaging and illumination performances were measured for the subject devices. All results show that the optical characteristics of the subject devices are equivalent to those of the predicate devices.
viii. Animal Image Capture Study: An animal image capture study was conducted as part of the optical and color performance testing. The findings demonstrate that the subject devices provide visualizations of vascularity and mucosal surfaces for each anatomical area comparable to those achieved by the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PENTAX Video Upper G.I. SCOPE EG27-i10 (K131902), PENTAX Video Colonoscope EC34-i10L (K131855)
Reference Device(s)
PENTAX Medical Video Upper GI Scope EG29-i20c (K231249), PENTAX Medical Video Colonoscope EC38-i20cL (K231249)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 6, 2024
Pentax of America, Inc Gurvinder Singh Nanda Senior Director, Regulatory and Quality 3 Paragon Dr Montvale, New Jersey 07645
Re: K241213
Trade/Device Name: PENTAX Medical Video Upper GI Scope (EG27-1200); PENTAX Medical Video Colonoscope (EC34-i20cL) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDS, FDF Dated: November 4, 2024 Received: November 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.
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"
1
(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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
PENTAX Medical Video Upper GI Scope (EG27-i20c);
PENTAX Medical Video Colonoscope (EC34-i20cL)
Indications for Use (Describe)
PENTAX Medical Video Upper GI Scope EG27-i20c:
The PENTAX Medical Video Upper GI Scope EG27-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.
PENTAX Medical Video Colonoscope EC34-i20cL:
The PENTAX Medical Video Colonoscope EC34-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.
This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 5kg of body weight.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/1 description: The image displays the logo for Pentax Medical. The word "PENTAX" is written in bold, red letters, and it is positioned above a gray line. Below the line, the word "MEDICAL" is written in gray letters.
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
- Contact: Gurvinder Singh Nanda, PhD 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: 04/30/2024
2. SUBJECT DEVICE
PENTAX Medical is seeking clearance of new products, PENTAX Medical Video Upper GI Scope EG27-i20c and PENTAX Medical Video Colonoscope EC34-i20cL.
| PENTAX Medical | PENTAX Medical | |
|---|---|---|
| Device Name | Video Upper GI Scope | Video Colonoscope |
| EG27-i20c | EC34-i20cL | |
| Common Name | Gastroscope and Accessories, Flexible/Rigid | |
| Classification Name | Endoscope and accessories | |
| Regulation No. | 876.1500 | |
| Device Class | II | |
| Product Code | FDS | FDF |
| Classification Panel | Gastroenterology / Urology |
5
Image /page/5/Picture/1 description: The image shows the logo for Pentax Medical. The word "PENTAX" is written in red, bold letters on the top line. A gray line is underneath the word "PENTAX", and the word "MEDICAL" is written in gray, bold letters on the bottom line.
3. PREDICATE DEVICE and REFERENCE DEVICE
K241213 Page 2 of 6
Previously cleared PENTAX Medical Video Scopes have been chosen as predicate devices and reference devices:
| Subject Device | Predicate Device | Reference Device |
|---|---|---|
| PENTAX Medical Video | ||
| Upper GI Scope | ||
| EG27-i20c | PENTAX Video Upper | |
| G.I. SCOPE EG27-i10 | ||
| (K131902) | PENTAX Medical Video | |
| Upper GI Scope | ||
| EG29-i20c (K231249) | ||
| PENTAX Medical Video | ||
| Colonoscope EC34-i20cL | PENTAX Video | |
| Colonoscope EC34-i10L | ||
| (K131855) | PENTAX Medical Video | |
| Colonoscope EC38-i20cL | ||
| (K231249) |
4. DEVICE DESCRIPTION
PETNAX Medical Video Upper GI Scope EG27-i20c
The PENTAX Medical Video Upper GI Scope EG27-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 EC34-i20cL
The PENTAX Medical Video Colonoscope EC34-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.
5. INTENDED USE AND INDICATIONS FOR USE
Intended use and Indications for use for PENTAX Medical Video Upper GI Scope EG27-i20c
The PENTAX Medical Video Upper GI Scope EG27-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.
6
Image /page/6/Picture/1 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold, sans-serif font. Below it is a gray line, and below that is the word "MEDICAL" in gray, bold, sans-serif font.
Intended use and Indications for use for PENTAX Medical Video Colonoscope K241213 EC34-i20cL Page 3 of 6
The PENTAX Medical Video Colonoscope EC34-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.
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 5 kg of body weight.
6. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE/REFERENCE DEVICES
The subject devices are functionally equivalent to the predicate/reference devices, and the differences between the devices are minor technological changes such as the application of CMOS image sensor for the new endoscopes. There is no new technological feature in the subject device in comparison to the reference device, K231249.
The change made to the subject devices have been evaluated by sucessful performance testing, including an animal study assessing image quality, with no safety or effectiveness concerns raised. These differences have no impact on the overall performance, functionality, or intended use of the devices.
The components of the subject devices have the same fundamental technology and principle of operation as the predicate/reference devices. Both the subject devices and the predicate devices are intended for illuminating and viewing the inside of the human body.
The subject devices are identical or enhanced to the predicate/reference devices with regards to;
- . Scope working length
- Scope field of view
- Scope depth of field
- Scope tip angulation
- Rigid distal width
- Insertion tube width
- Maximum insertion portion width
- Maximum instrument channel width
- Software requirements
7
Image /page/7/Picture/1 description: The image contains the logo for PENTAX Medical. The word "PENTAX" is in red, bold letters above a gray line. Below the line, the word "MEDICAL" is in gray, bold letters.
7. NON-CLINICAL PERFORMANCE DATA
The subject devices have 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 EG27-i20c and EC34-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 EG27-i20c and EC34-i20cL. The devices are not provided sterile, therefore, shelf-life is not applicable. -
iii. Biocompatibility
Biocompatibility of the EG27-i20c and EC34-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 "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".
K241213 Page 4 of 6
8
Image /page/8/Picture/1 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold, sans-serif letters. Below it is a gray line, and below that is the word "MEDICAL" in gray, bold, sans-serif letters. The logo is simple and modern.
-
Electrical Safety and EMC V.
K241213 The acceptable level of electrical safety (ES) and electromagnetic compatibility Page 5 of 6 (EMC) were confirmed by the following standards: IEC 60601-1-2:2014 + A1:2020; IEC 60601-1:2005 + A1:2012 + A2:2020; IEC 60601-1-6:2010 + A1:2013 +A2:2020; and IEC 60601-2-18:2009. -
vi. System Performance
The system performance of the subject device demonstrated the equivalence to the predicate/reference devices. -
vii. Optical Performance
As a part of Design Verification and Validation, optical properties of imaging and illumination performances were measured for the subject devices. All results show that the optical characteristics of the subject devices are equivalent to those of the predicate devices. -
viii. Animal Image Capture Study
An animal image capture study was conducted as part of the optical and color performance testing. The findings demonstrate that the subject devices provide visualizations of vascularity and mucosal surfaces for each anatomical area comparable to those achieved by the predicate devices.
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 devices are as safe and effective as the predicate/reference devices. There are no differences in indications for use and intended use between the subject and predicate/reference devices and are therefore, substantially equivalent. The technological differences in terms of design features, performance characteristics and constituent materials are not significant.
9
Image /page/9/Picture/1 description: The image contains the logo for Pentax Medical. The word "PENTAX" is written in large, red, bold letters. Below the word "PENTAX" is a gray line. Below the gray line, the word "MEDICAL" is written in gray, bold letters.
8. CONCLUSION
Accordingly, PENTAX Medical believes that the PENTAX Medical Video Upper GI Scope EG27-i20c and the PENTAX Medical Video Colonoscope EC34-i20cL do not pose any unique questions regarding safety and effectiveness. They are deemed substantially equivalent to the identified predicates: the PENTAX Video Upper G.I. Scope EG27-i10 (K131902) and the PENTAX Video Colonoscope EC34-i10L (K131855), respectively.