(24 days)
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.
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.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
The document (a 510(k) summary) describes a "Medical Video Endoscope System" and its performance testing. However, it does not provide a detailed table of acceptance criteria with specific numerical targets and reported performance values. Instead, it generally states that evaluation acceptance criteria were met. It also does not describe a study focused on proving that humans improve with AI assistance. The device appears to be a standalone system that performs image acquisition and display for endoscopic procedures with a single-use ureteroscope.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not include a specific table with numerical acceptance criteria and corresponding reported performance. It mentions several standards and states that "All evaluation acceptance criteria were met" for specific tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Evaluated in accordance with IEC 60601-1:2012, 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 (EMC) | Evaluated in accordance with IEC 60601-1-2:2007. All evaluation acceptance criteria were met. |
| Biocompatibility | Evaluated in accordance with ISO 10993-1:2009 and the FDA Guidance document "Use of International Standard ISO 10993-1..." June 16, 2016. Biocompatibility of the patient contacting materials were evaluated safe. |
| Sterile Barrier Systems | Evaluated in accordance with ISO 11607:2006. |
| Sterilization Process | Validated in accordance with ISO 11135:2014. |
| Technological Characteristics (Functionality) | Tested for functions as intended, including verification of performance characteristics per ISO8600 (Maximum insertion portion width, 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... demonstrate that the Medical Video Endoscope is considered safe and effective for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for any of the performance tests. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The tests appear to be laboratory/bench testing of the device itself rather than clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The performance tests described (electrical safety, EMC, biocompatibility, sterilization, and basic functional characteristics) do not typically involve human experts establishing a "ground truth" in the way a diagnostic algorithm might. These tests rely on established engineering and biological standards.
4. Adjudication Method for the Test Set
Not applicable. The tests described are primarily objective engineering and biological evaluations, not human-interpreted diagnostic assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done according to this document. The device is a "Medical Video Endoscope System," which is a viewing and surgical tool, not an AI diagnostic aid designed to improve human reader performance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
Yes, in a sense. The described "Non-Clinical Performance Data" are for the device's standalone operation and functionality (e.g., image quality, illumination, safety standards). There is no mention of an algorithm or AI component in the traditional sense; the "processing center" mentioned handles the video signal. The tests verify the device's ability to perform its core function: acquiring and displaying video from an endoscope.
7. Type of Ground Truth Used
The "ground truth" for the tests described is based on:
- Compliance with recognized international standards (IEC 60601 series, ISO 10993, ISO 11607, ISO 11135, ISO 8600).
- Functional specifications of the device (e.g., image quality, illumination, articulation, leak, flow rate).
This is not "expert consensus," "pathology," or "outcomes data" in the context of diagnostic performance studies. It's engineering and safety compliance.
8. Sample Size for the Training Set
Not applicable. This device is an endoscope system, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no AI training set for this device.
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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
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 (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 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.
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 : 86-07566880865
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.
§ 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.