(168 days)
No
The summary describes a standard video colonoscope and does not mention any AI/ML capabilities, image processing beyond basic visualization, or performance studies related to algorithmic analysis of images.
Yes
The "Intended Use / Indications for Use" section explicitly states "and therapeutic access to, the lower gastrointestinal tract." The "Device Description" also mentions its use with "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." This indicates the device is used for therapeutic purposes, not just diagnostic.
Yes
The device provides optical visualization of the lower gastrointestinal tract, which is used by a physician to observe indications consistent with the need for a procedure, thereby aiding in diagnosis.
No
The device description clearly states it is a "Video Colonoscope" and is designed to be used with a "Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment". This indicates a physical hardware device with associated components, not a software-only medical device.
Based on the provided information, the PENTAX Medical Video Colonoscope EC38-i20cWL is not an IVD (In Vitro Diagnostic).
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 these samples outside of the body.
- Device Function: The description clearly states that the colonoscope is used for "optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract." This involves directly visualizing the inside of the body and potentially performing procedures within the body.
- No Sample Analysis: There is no mention of the device analyzing samples taken from the patient. Its primary function is direct visualization and access.
Therefore, the PENTAX Medical Video Colonoscope EC38-i20cWL is an endoscopic device used for in-vivo procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PENTAX Medical Video Colonoscope EC38-i20cWL 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 20kg of body weight.
Product codes
FDF
Device Description
The PENTAX Medical Video Colonoscope EC38-i20cWL 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
Anatomical Site
lower gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel.
Indicated Patient Age Range
Patient populations with greater than 20kg of body weight.
Intended User / Care Setting
as decided by the physician
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 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." All acceptance criteria were satisfied in accordance with AAMI TIR 30: 2011 for amount of residual soil accumulation and extraction efficiency.
- Sterilization and Shelf Life: Validated the use of System 1E liquid chemical sterilization. Not provided sterile, so shelf-life is not applicable.
- Biocompatibility: Confirmed by assessing cytotoxicity, sensitization, and intracutaneous reactivity in accordance with ISO 10993-1: 2018. 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: Confirmed by 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.
- System Performance: Demonstrated equivalence to predicate/reference devices.
- Optical Performance: Optical properties of imaging and illumination performances were measured. All results show that the optical characteristics are equivalent to those of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PENTAX Video Colonoscope EC38-i10L (K131855)
Reference Device(s)
PENTAX Medical Video Colonoscope EC38-i20cL (K231249)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 3, 2025
Pentax of America, Inc. Gurvinder Singh Nanda Senior Director, Regulatory and Quality 3 Paragon Dr Montvale, New Jersey 07645
Re: K242110
Trade/Device Name: PENTAX Medical Video Colonoscope (EC38-i20cWL) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDF Dated: December 5, 2024 Received: December 6, 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"
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(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).
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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
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Indications for Use
Submission Number (if known)
Device Name
PENTAX Medical Video Colonoscope (EC38-i20cWL)
Indications for Use (Describe)
The PENTAX Medical Video Colonoscope EC38-i20cWL 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 20kg of body weight.
Type of Use (Select one or both, as applicable)
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."
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PENTAX Medical Video Colonoscope EC38-i20cWL Traditional 510(k) Submission
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 21 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
Gurvinder Singh Nanda, PhD Contact: 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: 07/18/2024
2. SUBJECT DEVICE
PENTAX Medical is seeking clearance of new products, PENTAX Medical Video Colonoscope EC38-i20cWL.
| Device Name | PENTAX Medical Video Colonoscope EC38-i20cWL |
|---|---|
| Common Name | Gastroscope and Accessories, Flexible/Rigid |
| Classification Name | Endoscope and accessories |
| Regulation No. | 876.1500 |
| Device Class | II |
| Product Code | FDF |
| Classification Panel | Gastroenterology / Urology |
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3. PREDICATE DEVICE and REFERENCE DEVICE
Previously cleared PENTAX Medical Video Scopes have been chosen as predicate device and reference device:
| Subject Device | Predicate Device | Reference Device |
|---|---|---|
| PENTAX Medical Video | ||
| Colonoscope EC38-i20cWL | PENTAX Video | |
| Colonoscope EC38-i10L | ||
| (K131855) | PENTAX Medical Video | |
| Colonoscope EC38-i20cL | ||
| (K231249) |
4. DEVICE DESCRIPTION
PENTAX Medical Video Colonoscope EC38-i20cWL
The PENTAX Medical Video Colonoscope EC38-i20cWL 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 Colonoscope EC38-i20cWL
The PENTAX Medical Video Colonoscope EC38-i20cWL 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 20kg of body weight.
6. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE/REFERENCE DEVICES
The subject device is functionally equivalent to the predicate/reference devices, and the differences between the devices are minor technological changes such as the application of wide field of view for the new endoscope. There is no new technological feature in the subject device in comparison to the reference device, K231249.
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The change made to the subject device have been evaluated by successful performance testing 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 device have the same fundamental technology and principle of operation as the predicate/reference devices. Both the subject device and the predicate device are intended for illuminating and viewing the inside of the human body.
The subject device 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 ●
- Minimum instrument channel width
- Software requirements .
7. NON-CLINICAL PERFORMANCE DATA
The subject device 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.
-
- 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 EC38-i20cWL 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.
- Reprocessing Validation
-
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 EC38-i20cWL.
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The device is not provided sterile, therefore, shelf-life is not applicable.
- iii. Biocompatibility
The biocompatibility of EC38-i20cWL on the direct 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: Ouality System Considerations and Content of Premarket Submissions", and "Postmarket Management of Cybersecurity in Medical Devices".
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 + 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 device. All results show that the optical characteristics of the subject device are equivalent to those of the predicate device.
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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/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.
8. CONCLUSION
The PENTAX Medical Video Colonoscope EC38-i20cWL does not pose any unique questions regarding safety and effectiveness. It is deemed to be substantially equivalent to the identified predicates: the PENTAX Video Colonoscope EC38-i10L (K131855).