The Medical Video Endoscope Image Processor PV210 is a video processor which is intended and designed for use during endoscopic procedures. It receives and processes image signals from digital endoscope and outputs signals to a medical monitor to display. PV210 has integrated software to control the operation of the device. PV210 is a reusable device and do not require sterilization before use, as there is no direct/in-direct patient contact material. It needs to be cleaned and disinfected before use, the cleaning and disinfection method is validated and recommend in the User Manual. The equipment is for use in a hospital or qualified medical institution. It is only to be used by skilled physicians trained in clinical endoscopic techniques and procedures.

AI/ML Overview

This document is a 510(k) summary for the Pusen™ Eview™ Medical Video Endoscope Image Processor, Model PV210. Primarily, this device processes signals from an endoscope and converts them for display on a monitor.

Here's an analysis of the provided text for acceptance criteria and study information:

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated table format. Instead, it indicates compliance with recognized safety and performance standards. The "device performance" reported is that the device "conforms to the requirements" of these standards and "met all requirements" of performance specifications.

Acceptance Criterion (Standard Compliance)	Reported Device Performance
IEC 60601-1:2012 (Electrical Safety)	Conforms to requirements
AAMI/ANSI ES60601-1:2005/(R)2012 and subsequent amendments (Electrical Safety)	Conforms to requirements
IEC 60601-2-18:2009 (Electrical Safety for Endoscopic Equipment)	Conforms to requirements
IEC 60601-1-2:2007 (Electromagnetic Compatibility - EMC)	Conforms to requirements
Software Verification and Validation	Conforms to software and system requirements
Performance Specifications (Bench Testing)	Met all requirements

Study Information:

Sample size used for the test set and the data provenance:
The document mentions "bench testing" and "software verification and validation testing," which implies that hardware and software components of the device were tested. However, it does not specify any sample sizes for these tests. Data provenance (e.g., country of origin, retrospective/prospective) is also not specified for the testing conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The testing described appears to be engineering and software validation rather than clinical performance evaluation that would typically involve expert-established ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Since the testing described is technical compliance and performance verification, adjudication methods typically associated with clinical studies (like 2+1 or 3+1 for image interpretation) are not applicable and not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
An MRMC comparative effectiveness study was not done and not mentioned. This device is an image processor, not an AI-powered diagnostic tool, and the submission primarily focuses on substantial equivalence to a predicate device based on technical specifications and safety. There is no mention of AI assistance or human reader improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes "Software verification and validation testing" and "Bench testing of performance specifications." These would be considered standalone evaluations of the device's technical functionality, but not in the context of an "algorithm only" performance for diagnostic accuracy as implied by the question. The device processes signals; it doesn't perform diagnostic algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the technical and safety testing conducted, the "ground truth" would be the requirements of the specified electrical, EMC, and software standards, and the pre-defined performance specifications. There is no mention of clinical ground truth like pathology or expert consensus.
The sample size for the training set:
This information is not applicable and not provided. The device is an image processor, not a machine learning or AI-driven system that would require a "training set."
How the ground truth for the training set was established:
This information is not applicable and not provided for the reasons stated above.

Summary

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March 29, 2019

Zhuhai Pusen Medical Technology Co., Ltd. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd. Warren, NJ 07059

Re: K190648

Trade/Device Name: Pusen™ Eview™M Medical Video Endoscope Image Processor, Model PV210 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated: March 11, 2019 Received: March 13, 2019

Dear Dave Yungvirt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Angel A. Solergarcia -S

for Benjamin R. Fisher, Ph.D.

Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190648

Device Name

Pusen™ Eview™M Medical Video Endoscope Image Processor, Model PV210

Indications for Use (Describe)

This equipment has been designed to be used to process signals from an endoscope and convert it to a signal that can be displayed on the monitor.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k)

Image /page/3/Picture/2 description: The image shows the logo for Zhuhai Pusen Medical Technology Co., Ltd. The logo consists of the word "PUSEN" in a stylized, sans-serif font, with rounded corners and a light blue color. Below the word "PUSEN" is the text "Zhuhai Pusen Medical Technology Co., Ltd." in a smaller, gray font.

510(k) SUMMARY

1. Submitter's Name, Address and Phone and Fax Number

Zhuhai Pusen Medical Technology Co., Ltd.

5/F, Building 1, No 33, Keji San Road, High-tech Zone, Tangjiawan Town, 519085 Zhuhai, Guangdong, PRC.

Phone: 86-07566880096

Fax: 86-07566880401

Contact Person: Ms. Wang ChangShen

Manager, Regulatory Affairs Phone: 86-07566880865

Date prepared: February 22, 2019

Device: 2.

Pusen ™ Eview™ Medical Video Endoscope Image Processor Trade name:

Model Number: PV210

Common name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology

21 CFR 876.1500 Endoscope and accessories. Class II Classification:

Product Code: FET

Predicate Device: 3.

Trade name: Image 1 SPIES

Premarket Notification: K131953

4. Device description:

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Image /page/4/Picture/1 description: The image shows the logo for PUSEN, a medical technology company based in Zhuhai. The logo is in a sans-serif font and is a light blue color. Below the logo is the text "Zhuhai Pusen Medical Technology Co., Ltd."

Traditional 510(k)

PV210 has integrated software to control the operation of the device.

PV210 is a reusable device and do not require sterilization before use, as there is no direct/in-direct patient contact material. It needs to be cleaned and disinfected before use, the cleaning and disinfection method is validated and recommend in the User Manual.

The equipment is for use in a hospital or qualified medical institution. It is only to be used by skilled physicians trained in clinical endoscopic techniques and procedures.

5. Indications for Use

This equipment has been designed to be used to process signals from an endoscope and convert it to a signal that can be displayed on the monitor.

Comparison of Technological Characteristics 6.

The predicate and subject devices are both video processors that can be used for the visualization of endoscopic procedures, while the predicate device can work with camera head, therefore it can also be used for microscopic procedures. There are similarities and differences in the technological characteristics.

These similarities are:

Have the same intended use in endoscopic procedures. .
. Have similar functions such as: light source control, enhancement control, white balance, zoom and HD video output.
. Are used in conjunction with digital endoscope and medical monitor.
Reusable
. Powered by main line

These differences are:

. the predicate supports both camera head and digital endoscope while the subject only supports digital endoscope
. the predicate supports image and video storage while the subject is not capable of storage
. the predicate supports display brightness control while the subject only supports

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predetermined display brightness setting which cannot be adjusted

. The predicate supports 3G-SDI and DVI-D video output formats while the subject supports SDI, DVI-D, VGA and VIDEO output formats.
. The predicate incorporates an external keyboard to control the system operation while the subject does not have an external keyboard, it is equipped with buttons on front panel to control the system operation.

The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness. Bench testing as identified below was conducted to verify and validate that the product performs as intended.

Non-Clinical Performance Data 7.

The following bench testing conducted for the subject device PV210 demonstrates substantial equivalence in safety:

Electrical safety

Electrical safety of the system was evaluated in accordance with IEC 60601-1:2012, and AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 C1:2009/(R)2012 C1:2009/(R)2012 and A2:2010/(R)2012 and IEC 60601-2-18:2009.

According to the test result, the subject device conforms to the requirements of the above standards.

Electromagnetic compatibility (EMC)

Electromagnetic compatibility was evaluated in accordance with IEC 60601-1-2:2007. According to the test result, the subject device conforms to the requirements of the above standard.

Software Verification and Validation testing

Software verification and validation testing were conducted.

According to the test result, the subject device conforms to software and system requirements.

Bench testing of performance specifications were completed and demonstrate that the device met all requirements.

8. Conclusion:

The subject device is substantially equivalent to the predicate device and does not raise any questions of safety and effectiveness.

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.