(319 days)
Not Found
No
The summary describes a standard video endoscope system with image processing capabilities, but there is no mention of AI, ML, or any advanced algorithms for image analysis or decision support. The performance studies focus on mechanical, optical, and material properties, not algorithmic performance.
No.
The device is designed for visualization (endoscopy) and to facilitate access for endoscopic accessories (like biopsy forceps) for surgery within the urinary tract. It does not exert a therapeutic effect itself, but rather allows for diagnostic and some therapeutic procedures to be performed via its working channel.
No
Explanation: The device is described as a surgical tool used with endoscopic accessories for endoscopy and endoscopic surgery, transmitting images to a processor. Its intended use is not for diagnostic interpretation but for visualization during interventions.
No
The device description clearly outlines hardware components including a flexible ureterorenoscope with a handle, insertion portion, CMOS sensor, LEDs, and a video cable, as well as an Endoscopic Video Image Processor. This is not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney." This describes a procedure performed within the body for visualization and intervention, not a test performed on samples taken from the body.
- Device Description: The description details a flexible endoscope with a camera, light source, and working channel for accessing and visualizing internal anatomy. This is consistent with an endoscopic device used for direct observation and manipulation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on the analysis of such samples. The focus is on providing visual information of the internal anatomy.
In summary, the device is an endoscopic system used for visualization and surgical procedures within the urinary tract, which falls under the category of a surgical or diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device has been developed to be used with endoscopic accessories such as a biopsy forceps and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.
Product codes
FGB
Device Description
The Single-Use Video Flexible Ureterorenoscope System consists of a sterile Single-Use Video Flexible Ureterorenoscope (consists of handle and insertion portion) and an Endoscopic Video Image Processor (the video system, touch PC ) with its accessories power adapter, footswitch.The Ureterorenoscope is provided sterile (sterilized by EO) and intended to be single-use.The video system is powered by the main line.
The handle includes a deflection lever, a lever lock, and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion portion contains one working channel and wiring to transmit the image signals to the Video Image Processor. The distal bending section of the insertion portion controlled by the user via the deflection lever on the handle. The distal end of the insertion portion contains a CMOS sensor for capturing image and transmitting it to the Video Image Processor, LEDs for illumination, and the distal opening of the working channel. The video cable connects the endoscope handle to the Video Image Processor, which provides power and processes video signals from the endoscope.
Flexible Ureterorenoscope has the following physical and performance characteristics:
- Flexible insertion portion
- Camera and LED light source at the distal tip
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract and interior of the ureter and kidney.
Indicated Patient Age Range
Adults
Intended User / Care Setting
Hospitals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed.
Electrical Safety and Electromagnetic Compatibility Summary: The electrical safety and EMC data included in the submission are in compliance 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; IEC 60601-2-18:2009: Part 2-18; IEC 60601-1-2:2014 and A1:2020.
Photobiological safety: The subject device was tested according to IEC 62471:2006.
Bench Testing Summary - Mechanical and Optical Performance: The subject device was designed to comply with applicable parts of ISO 8600-1:2015. Optical measurements were performed according to applicable part of ISO 8600-1:2015, ISO 12233:2017 and ISO 15739:2017 standard. Mechanical characteristics evaluated: water delivery, fatigue stress of rocker, stress of the bending part, tensile strength of the insertion portion, maximum insertion width, minimum instrument channel width deflection. Optical performance characteristics evaluated: field of view, direction of view, resolution, depth of field, distortion, SNR, illumination, dynamic range, color performance.
Biocompatibility Summary: Evaluation was conducted in accordance with the FDA Guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Tests conducted based on "Surface – Mucosal Membrane" with "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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Guangzhou Red Pine Medical Instrument Co., Ltd. % Xiangfei Li Regulatory Affairs Ezisurg Medical Co., Ltd. Rm. 103, Bldg. 2, No.1690 Cailun Rd., China (Shanghai) Pilot Free Trade Zone Shanghai, 201203 China
Re: K221158
Trade/Device Name: Single-Use Video Flexible Ureterorenoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FGB Dated: February 7, 2023 Received: February 7, 2023
Dear Xiangfei Li:
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. Although this letter refers to your product as a device, please be aware 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. You must comply with all the Act's
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bonhye Koo -S
For Mark Antonino Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221158
Device Name
Single-Use Video Flexible Ureterorenoscope System
Indications for Use (Describe)
The device has been developed to be used with endoscopic accessories such as a biopsy forceps and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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REDPINE
Traditional 510(k) Premarket Notification
Guangzhou Red Pine Medical Instrument Co., Ltd.
Single-Use Video Flexible Ureterorenoscope System
Applicant: Guangzhou Red Pine Medical Instrument Co., Ltd. Room 303, 308, No. 12, Luoxuan 3 Road, Guangzhou International Bioisland, 510200 Guangzhou City, Guangdong Province, PEOPLE'S REPUBLIC OF CHINA
Revision A-3 March 06, 2023
4
510(k) Summary
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
1. Date of Preparation: 03/06/2023
2. Sponsor Identification
Guangzhou Red Pine Medical Instrument Co., Ltd.
Room 303, 308, No. 12, Luoxuan 3 Road, Guangzhou International Bioisland, 510200 Guangzhou City, Guangdong Province, PEOPLE'S REPUBLIC OF CHINA
Establishment Registration Number: 3021246306
Contact Person: Xiangfei Li Position: Regulatory Affairs Specialist Manager Tel: +86-20-8092-7258 Fax: +86-20-3831-5611 Email: lixiangfei@gzredpine.com
3. Designated Submission Correspondent
Mr. Xiangfei Li (Primary Contact Person)(Primary Contact Person) Mr. Weihua Yang (Alternative Contact Person)(Alternative Contact Person)
Guangzhou Red Pine Medical Instrument Co., Ltd.
Room 303, 308, No. 12, Luoxuan 3 Road, Guangzhou International Bioisland, 510200 Guangzhou City, Guangdong Province, PEOPLE'S REPUBLIC OF CHINA
Tel: +86-20-8092-7258 Fax: +86-20-3831-5611 Email: lixiangfei@gzredpine.com
4. Identification of Subject device
Trade Name: Single-Use Video Flexible Ureterorenoscope System Common Name: Ureteroscope and Accessories, Flexible/rigid Model: RP-U-C12, RP-U-C0304, RP-U-C0305 Classification Name: Endoscope and accessories Classification: II Product Code: FGB Regulation Number: 21 CFR 876.1500 Review Panel: Gastroenterology/Urology
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Indication for Use Statement:
The device has been developed to be used with endoscopic accessories such as a biopsy forceps and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.
Device Description:
The Single-Use Video Flexible Ureterorenoscope System consists of a sterile Single-Use Video Flexible Ureterorenoscope (consists of handle and insertion portion) and an Endoscopic Video Image Processor (the video system, touch PC ) with its accessories power adapter, footswitch.The Ureterorenoscope is provided sterile (sterilized by EO) and intended to be single-use.The video system is powered by the main line.
The handle includes a deflection lever, a lever lock, and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion portion contains one working channel and wiring to transmit the image signals to the Video Image Processor. The distal bending section of the insertion portion controlled by the user via the deflection lever on the handle. The distal end of the insertion portion contains a CMOS sensor for capturing image and transmitting it to the Video Image Processor, LEDs for illumination, and the distal opening of the working channel. The video cable connects the endoscope handle to the Video Image Processor, which provides power and processes video signals from the endoscope.
Flexible Ureterorenoscope has the following physical and performance characteristics:
- Flexible insertion portion
- Camera and LED light source at the distal tip
5. Identification of Predicate Devices
Trade/Device Name: Medical Video Endoscope System Regulation Number: 21 CFR 876.1500 Regulatory Class: Class II Product Code: FGB 510(k) Number: K172098
6. Summary of Technological Characteristics and Comparison
The principles of operation of the subject device is similar to that of the predicate device. The following basic technological elements are the same or similar for the subject and predicate devices:
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| Compared | Subject device | Predicate Device | Comparison |
|---|---|---|---|
| items | Single-Use Video Flexible | ||
| Ureterorenoscope System | Medical Video Endoscope | ||
| system(K172098) | |||
| Classification | |||
| Product Code | FGB | FGB | Same |
| Regulation | |||
| Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Classification | Class II | Class II | Same |
| Indications For Use | |||
| Indications for | |||
| Use | The device has been | ||
| developed to be used with | |||
| endoscopic accessories such | |||
| as a biopsy forceps and | |||
| Endoscopic Video Image | |||
| Processor for endoscopy and | |||
| endoscopic surgery within | |||
| urinary tract and interior of | |||
| the ureter and kidney. | 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. | Similar | ||
| See Note1. | |||
| anatomical site | Urinary tract and interior of | ||
| the kidney | Urinary tract and interior of | ||
| the kidney | Same | ||
| target | |||
| population | Adults | Adults | Same |
| Environment | |||
| of use | Hospitals | Hospitals | Same |
| Physical Characteristics | |||
| Type of Scope | Flexible | Flexible | Same |
| Type of Imager | CMOS | CMOS | Same |
| Light source | LED | LED | Same |
| Up/down | |||
| deflection(°) | Up 275 ° | ||
| Down 275 ° | Up 270 ° | ||
| Down 270 ° | Similar | ||
| See Note2. | |||
| Direction of | |||
| view | 0 ° | 0 ° | Same |
| Field of view | 120 ° | 120 ° | Same |
| Maximum | |||
| insertion | |||
| portion width | |||
| (mm) | RP-U-C12: 3.2 | ||
| RP-U-C0304: 3.15 | |||
| RP-U-C0305: 3.18 | 3.2 | Similar | |
| See Note2. | |||
| Working | |||
| length(mm) | 670 | 650 | Similar |
| See Note2. | |||
| Minimum | |||
| instrument | |||
| channel width | |||
| (mm) | 1.2 | 1.0 | Similar |
| See Note2. | |||
| Depth of field | 3mm-50mm | 3mm-50mm | Same |
| System | |||
| composition | - Endoscopic Video Image | ||
| Processor |
- Single-use video flexible
ureterorenoscope and | - Eview (the video system,
touch PC with data processing
center) - Uscope | Same |
| Patient Contacting Materials | | | |
| General
material type
of main
patient-contact
part | Compliance with
ISO10993-1 | Compliance with
ISO10993-1 | Similar
See Note2. |
| Duration and
type of
contact | "Surface –Mucosal
Membrane" with a contact
duration of "Limited (