Pusen Eview Medical Video Endoscope Image Processor

K190648 · Zhuhai Pusen Medical Technology Co., Ltd. · FET · Mar 29, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K190648
• Device Name: Pusen Eview Medical Video Endoscope Image Processor
• Applicant: Zhuhai Pusen Medical Technology Co., Ltd.
• Product Code: FET · Gastroenterology, Urology
• Decision Date: Mar 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended 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.

Device Story

Pusen PV210 is a reusable medical video endoscope image processor; receives image signals from digital endoscopes; processes signals for output to medical monitors. Used in hospitals/medical institutions by trained physicians. Device features front-panel buttons for system control (e.g., light source, enhancement, white balance, zoom). Does not support image/video storage. Provides visual feedback to physicians during endoscopic procedures to assist in clinical decision-making and visualization.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety (IEC 60601-1, IEC 60601-2-18), electromagnetic compatibility (IEC 60601-1-2), and software verification/validation.

Technological Characteristics

Reusable video processor; powered by main line. Connectivity: SDI, DVI-D, VGA, VIDEO outputs. Controls: front-panel buttons. Standards: IEC 60601-1:2012, AAMI/ANSI ES60601-1:2005/(R)2012, IEC 60601-2-18:2009, IEC 60601-1-2:2007. No direct patient contact materials.

Indications for Use

Indicated for use by skilled physicians trained in clinical endoscopic techniques and procedures to process signals from an endoscope for display on a medical monitor during endoscopic procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Image 1 SPIES (K131953)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo for 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

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: [phone]

Fax: [phone]

Contact Person: Ms. Wang ChangShen

Manager, Regulatory Affairs Phone: [phone]

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)

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.

#### 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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Image /page/5/Picture/1 description: The image shows the word "PUSEN" in a stylized, sans-serif font. The letters are a light blue color. Below the word "PUSEN" is the text "Zhuhai Pusen Medical Technology Co., L" in a smaller, sans-serif font. The text is also a light blue color.

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.