(51 days)
Not Found
No
The description focuses on standard image processing and hardware components without mentioning AI or ML algorithms for analysis or interpretation.
Yes
The device is designed to be used with other accessories like biopsy forceps and laser fibers, which are therapeutic tools, implying the endoscope facilitates therapeutic procedures.
Yes
The device is designed to provide image solutions for endoscopy and endoscopic surgery within the urinary tract and interior of the kidney, allowing for visualization of the capillary network and mucosal morphology. This imaging capability is inherently used to aid in the diagnosis of conditions by allowing physicians to observe and assess internal body structures.
No
The device description clearly outlines hardware components such as optical fibers, LED lights, CMOS imaging sensors, cables, an insertion shaft, handpiece, sheath, and a video system (Eview) which includes a touch PC and data processing center. While there is image processing, the device is fundamentally a hardware system with integrated software for image processing and display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for visualization and surgical procedures within the urinary tract and kidney using endoscopic techniques and accessories. This is a direct medical procedure performed on the patient's body.
- Device Description: The device is a video endoscope system that captures images of the internal anatomy. It does not analyze biological samples (like blood, urine, or tissue) outside of the body to provide diagnostic information.
- Function: The device's primary function is to provide visual access and facilitate surgical interventions. While it processes image data, this processing is for displaying the internal anatomy, not for performing diagnostic tests on biological specimens.
IVD devices are specifically designed to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device operates in vivo (within the body) and is used for visualization and procedural purposes.
N/A
Intended Use / Indications for 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.
Product codes
FGB
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 cable 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, as provided sterile, contains an insertion portion, handpiece and the cable. The handpiece is made with polymer plastic, Contacted with users. The insertion portion, as the part connected with patients, includes the sheath which is braided tube made of SUS 304 stainless steel and PEBAX, the controllable portion and the distal tip. The controllable portion is made of SUS 304 stainless steel, covered with silicone rubber. The distal tip is made with ABS. There is a working channel that terminates at the distal tip, which is indirect patient-contacting component, made of Fluorinated ethylene propylene.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract and interior of the kidney
Indicated Patient Age Range
Adults
Intended User / Care Setting
The Medical Video Endoscope system is for use in a hospital or qualified medical institution. The system is only to be used by skilled physicians trained in clinical endoscopic techniques and procedures.
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
Non-Clinical Performance Data:
Electrical safety 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. All evaluation acceptance criteria were met.
Electromagnetic compatibility evaluated in accordance with IEC 60601-1-2:2007. All evaluation acceptance criteria were met.
Biocompatibility evaluation conducted in accordance with ISO 10993-1: The body contact category is "Surface – Mucosal Membrane" with a contact duration of "Limited" (
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2017
Zhuhai Pusen Medical Technology Co., Ltd. % Dave Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, NJ 07041
Re: K172098
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: August 22, 2017 Received: August 23, 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, 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.
1
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 (reporting of medical devicerelated 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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Charles Viviano -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) K172098
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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Traditional 510(k)
510(k) SUMMARY
K172098
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:
86-07566880096
86-07566880401
Contact person: B.
Ms. Wang ChangShen
Manager, Regulatory Affairs
Phone: 86-07566880865
C. Date prepared:
August 17, 2017
Name of the device: D.
Trade name: Medical Video Endoscope system Common name: Ureteroscope and Accessories, Flexible/rigid Model Number of the Handle: PU3022、PU3022A Model Number of the Video system: UTV100 21 CFR 876.1500 Endoscope and accessories. Class II Classification: Product Code: FGB
Predicate Device: E.
Trade name: Karl Storz Flexible Video-Uretero-Renoscope System
Section 5: 510(k) summary 5-1
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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, 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.
Traditional 510(k)
Common name: Ureteroscope and Accessories, Flexible/rigid
Classification: Endoscope and accessories. 21 CFR 876.1500. Class II
Premarket Notification: Storz K131369
Device description: F.
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 cable 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, as provided sterile, contains an insertion portion, handpiece and the cable. The handpiece is made with polymer plastic, Contacted with users. The insertion portion, as the part connected with patients, includes the sheath which is braided tube made of SUS 304 stainless steel and PEBAX, the controllable portion and the distal tip. The controllable portion is made of SUS 304 stainless steel, covered with silicone rubber. The distal tip is made with ABS. There is a working channel that terminates at the distal tip, which is indirect patient-contacting component, made of Fluorinated ethylene propylene.
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 رخ
This instrument has been designed to be used with endo-therapy accessories such as
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Image /page/5/Picture/1 description: The image contains 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, the company name "Zhuhai Pusen Medical Technology Co., Ltd." is written in a smaller, gray font.
a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.
The intended use of subject and predicate devices are the same. Both of the subject and predicate devices are indicated for endoscopic examination 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.
The Medical Video Endoscope system is for use in a hospital or qualified medical institution. The system is only to be used by skilled physicians trained in clinical endoscopic techniques and procedures.
H. Technological Characteristics
The technological principle for both the subject and predicate devices 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 image system.
The following basic technological elements are the same or similar for the subject and predicate devices:
| Compared items | Subject device | Predicate device |
|---|---|---|
| Same technological characteristics | ||
| Scope type | Flexible | Flexible |
| anatomical site | Urinary tract and interior of | |
| the kidney | Urinary tract and interior | |
| of the kidney | ||
| target population | Adults | Adults |
| where used (hospital, | ||
| home, ambulance, etc) | Hospitals | Hospitals |
| Digital | ||
| video | ||
| technology | CMOS | CMOS |
| Illumination source | LED | LED |
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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, with the letters in a light blue color. Below the logo is the company name, "Zhuhai Pusen Medical Technology Co., Ltd.", in a smaller, gray font.
| Traditional 510(k) | ||
|---|---|---|
| Up/down deflection (° ) | Up 270 ° | |
| Down 270 ° | Up 270 ° | |
| Down 270 ° | ||
| Direction of view | 0 ° | 0 ° |
| Similar technological characteristics | ||
| Field of view | 120 ° | 90 ° |
| Maximum insertion portion width (mm) | 3.2 | 2.9 |
| Working length(mm) | 650 | 700 |
| Minimum instrument channel width (mm) | 1.0 | 1.2 |
| Image system | UTV100 as the image system | Image 1HD system |
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. This does not create a difference in intended use.
The technological characteristics of the Medical Video Endoscope system and the predicate device are substantially equivalent.
Non-Clinical Performance Data I.
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.
Biocompatibility evaluation for the Medical Video Endoscopy system was conducted
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Image /page/7/Picture/1 description: The image features the word "PUSEN" in a stylized, sans-serif font, rendered in a light blue color. Below the wordmark, in a smaller, darker font, is the text "Zhuhai Pusen Medical Technology Co., Ltd." The text appears to be the name of a company, possibly a medical technology firm, with the wordmark serving as its logo.
Traditional 510(k)
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 Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
The body contact category is "Surface – Mucosal Membrane" with a contact duration of "Limited" (