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.

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.

AI/ML Overview

The provided document describes the clearance of two PENTAX Medical Video Scopes, the Upper GI Scope (EG27-i20c) and the Colonoscope (EC34-i20cL), and does not contain acceptance criteria for specific device performance metrics in the format of a table with reported performance. The document focuses on showing substantial equivalence to predicate devices through various non-clinical performance data categories.

Therefore, I cannot fulfill your request for "A table of acceptance criteria and the reported device performance".

However, I can extract information related to the studies conducted to support the substantial equivalence:

Non-Clinical Performance Data / Studies Conducted:

The document mentions several non-clinical performance tests but does not define specific acceptance criteria or report numerical performance results against those criteria. Instead, it generally states that "All acceptance criteria were satisfied" or that the devices demonstrated equivalence.

Here's a breakdown of the studies mentioned and related information:

Sample size used for the test set and the data provenance: Not specified for any of the tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified for any of the tests. The document does not mention the use of experts to establish ground truth for testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned. The document primarily focuses on technical and safety equivalence.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The devices are endoscopes, which are human-in-the-loop devices. The document does not describe any standalone algorithm performance testing.
The type of ground truth used: Not explicitly stated for any test. For the "Animal Image Capture Study," it compares "visualizations of vascularity and mucosal surfaces" to predicate devices, implying a qualitative assessment.
The sample size for the training set: Not applicable, as these are hardware medical devices (endoscopes) and not AI/machine learning algorithms that require training sets in the typical sense.
How the ground truth for the training set was established: Not applicable for the reasons mentioned above.

Detailed Information from the Document Regarding Studies:

Reprocessing Validation:
- Study: Simulated use testing, cleaning, high-level disinfecting, and rinsing validation studies for EG27-i20c and EC34-i20cL.
- Purpose: Confirmed effectiveness of reprocessing procedures.
- Acceptance Criteria: Established in accordance with AAMI TIR 30:2011 for amount of residual soil accumulation and extraction efficiency.
- Results: "All acceptance criteria were satisfied."
Sterilization and Shelf Life:
- Study: Validation of System 1E liquid chemical sterilization with STERIS Corporation.
- Purpose: Confirmed suitable sterilization method.
- Results: Devices are not provided sterile, shelf-life not applicable.
Biocompatibility:
- Study: Assessment of cytotoxicity, sensitization, and intracutaneous reactivity for direct and indirect contact materials.
- Standard: In accordance with ISO 10993-1:2018.
- Results: Risk levels of local toxicity determined as "Acceptable."
Software and Cybersecurity:
- Study: Software verification and validation, including cybersecurity assessments.
- Standards/Guidance: IEC 62304:2006 + A1:2015 and FDA Guidance for Industry and Staff.
Electrical Safety and EMC:
- Study: Testing to confirm acceptable levels of electrical safety (ES) and electromagnetic compatibility (EMC).
- 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.
System Performance:
- Results: "The system performance of the subject device demonstrated the equivalence to the predicate/reference devices."
Optical Performance:
- Study: Measurement of optical properties of imaging and illumination performances.
- Results: "All results show that the optical characteristics of the subject devices are equivalent to those of the predicate devices."
Animal Image Capture Study:
- Study: Used as part of optical and color performance testing.
- Purpose: To demonstrate visualization capabilities.
- Results: "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."

In summary, the document provides evidence of various non-clinical performance studies demonstrating that the new PENTAX Medical Video Scopes meet established safety and performance standards and are substantially equivalent to predicate devices. However, it does not present this information in the specific structured format requested for acceptance criteria and reported numerical performance values.

Summary

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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"

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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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241213

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.

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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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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

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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 VideoUpper GI ScopeEG27-i20c	PENTAX Video UpperG.I. SCOPE EG27-i10(K131902)	PENTAX Medical VideoUpper GI ScopeEG29-i20c (K231249)
PENTAX Medical VideoColonoscope EC34-i20cL	PENTAX VideoColonoscope EC34-i10L(K131855)	PENTAX Medical VideoColonoscope 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

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.

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Intended use and Indications for use for PENTAX Medical Video Colonoscope K241213 EC34-i20cL Page 3 of 6

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

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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

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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.

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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.

K241213

Regulation Number and Section

§ 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.