Medical Video Endoscope System

K171076 · Zhuhai Pusen Medical Technology Co., Ltd. · FGB · May 5, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K171076
• Device Name: Medical Video Endoscope System
• Applicant: Zhuhai Pusen Medical Technology Co., Ltd.
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: May 5, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.

Device Story

Medical Video Endoscope System (Uscope and Eview) provides visualization for urinary tract and kidney procedures. Uscope (single-use, sterile) features distal CMOS imaging sensor and LED light source in handle; fiber optics transmit light to site; CMOS captures reflected light, converting to electrical signals. Eview (video system/touch PC) processes signals for display of mucosal morphology and capillary networks. Used by clinicians in clinical settings; supports use of ancillary tools (biopsy forceps, laser fibers) via working channel. System powered by mains or lithium battery. Single-use design eliminates reprocessing requirements associated with reusable endoscopes, reducing cross-contamination risk.

Clinical Evidence

Bench testing only. Performance verified per IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2. Biocompatibility evaluated per ISO 10993-1. Sterilization validated per ISO 11135:2014. Functional performance verified per ISO 8600, including insertion width, channel width, field of view, direction of view, deflection, image quality, illumination, articulation, leak testing, and water flow rate.

Technological Characteristics

Digital flexible ureteroscope system. Components: Uscope (single-use, EO sterilized) and Eview (video processing unit/touch PC). CMOS imaging sensor at distal tip. LED light source integrated in handle. Fiber light guides. Connectivity: Eview processes video signals for display. Power: Mains or lithium battery. Standards: IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, ISO 10993-1, ISO 11607, ISO 11135, ISO 8600.

Indications for Use

Indicated for endoscopic examination and surgery within the urinary tract and interior of the kidney in patients requiring such 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

• Karl Storz Flexible Video-Uretero-Renoscope System (K131369)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 5, 2017

Zhuhai Pusen Medical Technology Co., Ltd. % Dave Yungvirt Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, NJ 07041

Re: K171076

> Trade/Device Name: Medical Video Endoscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: April 4, 2017 Received: April 11, 2017

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 may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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.

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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Benjamin R. Fisher -S

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)

## K171076

Device Name Medical Video Endoscope System

Indications for Use (Describe)

This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.

| 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)

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Image /page/3/Picture/1 description: The image contains the word "PUSEN" in a stylized, sans-serif font, with rounded corners and a light blue color. Below the word "PUSEN", there is the text "Zhuhai Pusen Medical Technology Co., Ltd" in a smaller, gray font. The text indicates that "PUSEN" is the name of a medical technology company based in Zhuhai.

## 510(k) SUMMARY

#### Submitter's Name, Address and Phone and Fax Number A.

Name & Address of the manufacturer: Zhuhai Pusen Medical Technology Co., Ltd.

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

Phone :

Fax:

86-07566880401

86-07566880096

#### Contact person: B.

Ms Wang ChangShen Manager, Regulatory Affairs Phone : [phone]

#### Date prepared: C.

August 19, 2016

#### Name of the device: D.

Trade name: Medical Video Endoscope system Common name: Ureteroscope and Accessories, Flexible/rigid Model Number of the Handle: UE3011 Model Number of the Video system: UTV100 Classification: 21 CFR 876.1500 Endoscope and accessories. Class II Product Code: FGB

#### Predicate Device: E.

Karl Storz Flexible Video-Uretero-Renoscope System Trade name :

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Image /page/4/Picture/1 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. The letters are in a light blue color. Below the logo is the company name, "Zhuhai Pusen Medical Technology Co., Ltd.", in a smaller, gray font.

Common name: Ureteroscope and Accessories, Flexible/rigid Endoscope and accessories. 21 CFR 876.1500. Class II Classification: Premarket Notification: Storz K131369

#### F. Device description:

The Medical Video Endoscope system is designed to provide image solution for endoscopy and endoscopic surgery, and perform procedures in the urinary tract and interior of the kidney using appropriate accessory devices (e.g. laser fibers, forceps baskets).

The optical fiber transmits the light emitting from the LED light built in the handle to the coelom. The complementary metal-oxide-semiconductor CMOS imaging sensor in the distal tip of the insertion shaft receives the reflected light from the surface of mucosa and transforms the light into electric signal. The wire transfers the electric signal to the data processing center of the Eview , where the electric signal is processed. As a result the color imaging of the capillary network and mucosal morphology is displayed on the screen of the Eview.

The Medical Video Endoscope system is a digital flexible ureteroscope system that consists of the Eview( the video system, touch PC with data processing center) and the Uscope. The Uscope is provided sterile( sterilized by EO) and intended to be single-use.

The Uscope contains an insertion portion, handpiece, cable and water tube.

The Eview, the video system contains touch PC with data processing center and provide energy to Uscope. The Eview can be powered by the main line or lithium battery.

#### Intended Use G.

This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.

# H. Technological Characteristics

Both of the subject and predicate devices are indicated for endoscopic examination

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Image /page/5/Picture/1 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 logo is the company name, "Zhuhai Pusen Medical Technology Co., Ltd.", in a smaller, gray font.

in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories to perform various diagnostic and therapeutic procedures.

It is based on the use of an LED light integrated in the handle and fiber light guides to illuminate the cavity under examination, and the CMOS imaging sensor located at the tip of the insertion portion to transfers the video signal to the system(the Video system of the subject device and the Image 1HD system of the predicate device).

The following basic technological elements are the same for the subject and predicate devices:

- a) The handle-used to illuminate the cavity under examination and provide working channel for surgery.
- b) The CMOS sensor-receives the reflected light from the surface of mucosa and transforms the light into electric signal, and transfers the electric signal to the system.
- c) The Video system(subject device) and the Image 1 HD system(predicate device)-process the image and control the image features.

The main difference between the Medical Video Endoscope system and the predicate devices is reusability. The Uscope of the subject device is single-use and provided sterile, while the predicate devices are reusable.

The technological characteristics of the Medical Video Endoscope system and the predicate device are substantially equivalent.

#### I. Non-Clinical Performance Data

The Medical Video Endoscope system has been verified for its safety and effectivity based on the following performance data.

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 And A2:2010/(R)2012 and IEC 60601-2-18:2009. Electromagnetic compatibility was evaluated in accordance with IEC 60601-1-2:2007. All evaluation acceptance criteria were met.

The biocompatibility evaluation for the Medical Video Endoscopy system was conducted in accordance with the Guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process""June 16, 2016, and International

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Traditional 510(k)

Image /page/6/Picture/1 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. The letters are a light blue color. Below the logo is the text "Zhuhai Pusen Medical Technology Co., Ltd." in a smaller, gray font.

Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Biocompatibility of the patient contacting materials were evaluated safe in accordance with ISO 10993-1:2009.

Sterile barrier systems were evaluated in accordance with ISO 11607:2006. Sterilization Process has been validated accordance with ISO 11135:2014.

Technological characteristics has been tested for its functions as intended .including verification of performance characteristics per ISO8600 (The maximum insertion portion width, The minimum instrument channel width, field of view, direction of view, deflection) and performances characteristics relevant to functions as intended (Image quality, Illumination, Articulation ,Leak, Flow rate of water).

The results of Non-Clinical Performance testing demonstrate that the Medical Video Endoscope is considered safe and effective for its intended use.

# Conclusion:

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