(51 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 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 tip 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.
The provided text describes a 510(k) premarket notification for a "Medical Video Endoscope System," which is a device for endoscopy and endoscopic surgery within the urinary tract and interior of the kidney. The document discusses device characteristics, intended use, and non-clinical performance data to establish substantial equivalence to a predicate device.
However, the document does not contain specific acceptance criteria for a study showing device performance in the context of an AI/ML algorithm or a human-in-the-loop scenario. The performance data presented is related to safety, electrical safety, EMC, biocompatibility, sterilization, and general functional characteristics of the endoscope itself, rather than performance in terms of diagnostic accuracy or treatment efficacy compared to a predefined benchmark.
Therefore, many of the requested information points, particularly those related to AI/ML specific studies, human reader performance, expert consensus, and ground truth establishment for diagnostic performance, are not available in the provided text.
Here's a summary of what can be extracted from the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various tests performed and states that "All evaluation acceptance criteria were met." However, it does not provide the specific quantitative acceptance criteria or detailed results for device performance in a diagnostic or clinical efficacy context. The tests reported are primarily related to safety and functional specifications.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety (IEC 60601-1:2012, AAMI/ANSI ES60601-1:2005, IEC 60601-2-18:2009) | All evaluation acceptance criteria were met. |
| Electromagnetic Compatibility (IEC 60601-1-2:2007) | All evaluation acceptance criteria were met. |
| Biocompatibility (ISO 10993-1, Cytotoxicity, Irritation, Sensitization) | All evaluation acceptance criteria were met. |
| Sterile Barrier Systems (ISO 11607:2006) | Evaluated in accordance with the standard. |
| Sterilization Process (ISO 11135:2014) | Validated in accordance with the standard. |
| Technological Characteristics (ISO 8600-1:2015 - insertion width, channel width, field of view, direction of view, deflection; Image quality, Illumination, Articulation, Leak, Flow rate of water) | Tested for functions as intended; results demonstrate the device is safe and effective for its intended use. |
2. Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical performance data (electrical, EMC, biocompatibility, sterilization, and functional testing), not a diagnostic or clinical study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not established as this is not a diagnostic performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. 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: Not applicable. This document does not describe a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an endoscope system, not an AI algorithm.
7. The type of ground truth used: For the non-clinical performance evaluations, the "ground truth" or reference was against established engineering standards (e.g., IEC, ISO) and regulatory guidance for safety and performance.
8. The sample size for the training set: Not applicable, as this is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.
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.
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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 (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 ofthe kidney | Urinary tract and interiorof the kidney |
| target population | Adults | Adults |
| where used (hospital,home, ambulance, etc) | Hospitals | Hospitals |
| Digitalvideotechnology | 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" (<24 hours). The Following tests were performed as recommended: Cytotoxicity, Irritation and Sensitization. All evaluation acceptance criteria were met.
Sterile barrier systems were evaluated in accordance with ISO 11607:2006. Sterilization Process has been validated accordance with ISO 11135:2014.
Technological characteristics have been tested for its functions as intended, including verification of performance characteristics per ISO 8600-1:2015(Fourth Edition) (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.