(93 days)
No
The summary describes standard image processing and hardware components without mentioning AI/ML algorithms or capabilities.
Yes
The device is designed to be used with "endo-therapy accessories" for "endoscopic surgery," indicating a therapeutic rather than just a diagnostic role.
Yes
The device description states that the Ureterorenoscope System "serves as a guide to diagnosis and management." The combination of providing intuitive images, processing clinical images, and guiding diagnosis indicates a diagnostic function, even if used for surgical purposes.
No
The device description clearly outlines hardware components including a single-use Ureterorenoscope with a camera module and LED lighting source, and an image processor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for endoscopic surgery within the urinary tract and interior of the kidney, using accessories for diagnosis and management. This involves direct visualization and intervention within the body.
- Device Description: The device is a Ureterorenoscope system that provides illumination and images for endoscopy and endoscopic surgery. It's a tool used in vivo (within the living body).
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not analyze specimens outside the body.
The device is clearly designed for direct visualization and intervention within the patient's body, which falls under the category of an endoscopic surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Ureterorenoscope System has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopic surgery within urinary tract and interior of the kidney.
Product codes
FGB
Device Description
The Ureterorenoscope System consists of a single-use Ureterorenoscope(HU30S) to provide illumination and intuitive images in endoscopy and endoscopic surgery within urinary tract and interior of the kidney and serves as a guide to diagnosis and management with accessories and an image processor, previous clearly by K231118, for clinical image processing.
The single-use Ureterorenoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image processor processes the images from the Ureterorenoscope and outputs video signals to a display.
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
Not Found
Intended User / Care Setting
Not Found
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
Biocompatibility testing: evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" 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.
Sterilization and shelf life testing: validated accordance with ISO 11135:2014. EO/ECH residual test was performed according to ISO 10993 - 7:2008. Shelf life determined based on optical testing and product performance testing after accelerated aging test according to ASTM F1980 - 16. Package validation conducted according to ISO 11607 - 1:2019 and ISO 11607 -2:2019, and ASTM F1886/F1886M-16, ASTM F88/F88M - 15, ASTM F 1929 - 15.
Electrical safety and electromagnetic compatibility (EMC): complies with IEC 60601-1 and IEC60601-2-18 for safety and IEC 60601-1-2 for EMC.
Software Verification and Validation Testing: conducted, and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".
Bench performance testing:
- Optical performance testing according to ISO 8600 series.
- Color performance (color reproduction), geometric distortion, optical performance (resolution, depth of field and image intensity uniformity). SNR and dynamic range, image frame frequency and system delay test compared with the predicate device.
- Mechanical testing including water resistance, deflection, leakage and flow rate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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May 10, 2024
Shenzhen HugeMed Medical Technical Development Co., Ltd. % Jie Yang Consultant Shenzhen Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong CHINA
Re: K240374
Trade/Device Name: Ureterorenoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Received: April 19, 2024
Dear Jie Yang:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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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,
Mark J. Antonino -S
Mark J. Antonino, M.S. 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
Submission Number (if known)
Device Name
Ureterorenoscope System
Indications for Use (Describe)
The Ureterorenoscope System has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for 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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510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
The assigned 510(k) number: K240374
Prepared Date: 2024/04/19
1. Submission sponsor
Name: Shenzhen HugeMed Medical Technical Development Co., Ltd.
Address: 415,416-1,516-1, Building 2, No. 1, Mawu Road, Baoan Community, Yuanshan Street, Longgang District, Shenzhen, Guangdong, 518115, China Contact person: Jiang Yuanning Title: Regulatory engineer E-mail: jiangyuanning(@hugemed.net Tel: +86-755-22275833
Submission correspondent 2.
Name: Shenzhen Chonconn Medical Device Consulting Co., Ltd. Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China Contact person: Yang Jie E-mail: yangjie@chonconn.com Tel: +86-755 33941160
| Trade/Device Name | Ureterorenoscope System |
|---|---|
| Model | single-use Ureterorenoscope: HU30S |
| image processor: HUV-01 | |
| Common Name | Endoscope and accessories |
| Regulatory Class | Class II |
| Classification | 21CFR 876.1500 / Ureteroscope And Accessories, |
| Flexible/Rigid / FGB | |
| Submission type | Traditional 510(K) |
3. Subject Device Information
Predicate Device 4.
510(k) number: K230475 Product name: Medical Video Endoscope System Product code: FGB
5. Device Description
The Ureterorenoscope System consists of a single-use Ureterorenoscope(HU30S) to provide illumination and intuitive images in endoscopy and endoscopic surgery within urinary tract and interior of the kidney and serves as a guide to diagnosis and management
5
with accessories and an image processor, previous clearly by K231118, for clinical image processing.
The single-use Ureterorenoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image processor processes the images from the Ureterorenoscope and outputs video signals to a display.
Intended use & Indication for use 6.
The Ureterorenoscope System 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.
7. Comparison to the Predicate Device
The device has the same sterilization method, energy source, principle of operation and similar design with same parameters such as FOV, DOV, deflection angle etc. They have similar technological characteristics as below. These differences will not raise new question on safety and effectiveness of the proposed device.
- Depth of view of the proposed Ureterorenoscope is within the range of the predicate device.
2.The Max. outer diameter of insertion of the proposed Ureterorenoscope is slight thinner than the predicate device.
3.The proposed Ureterorenoscope evaluated the biocompatibility based on more strict risk classification with two more testing including Acute Systemic Toxicity and Materialmediated Pyrogens.
4.The proposed image processor has slightly different dimensions and weight compared with the predicate device due to different outlook design.
5.The proposed image processor has more types of signal output than the predicate device to give physicians more usage options.
Performance Data 8.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the single-use Ureterorenoscope was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1:
6
Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Sterilization and shelf life testing
The Single-use Ureterorenoscope is provided sterile and its shelf-life is 3 years. Sterilization Process has been validated accordance with ISO 11135:2014. EO/ECH residual test was performed according to ISO 10993 - 7:2008. The shelf life is determined based on optical testing and product performance testing affer accelerated aging test according to ASTM F1980 - 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Package validation was conducted according to ISO 11607 - 1:2019 and ISO 11607 -2:2019, and ASTM F1886/F1886M-16, ASTM F88/F88M - 15, ASTM F 1929 - 15.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Ureterorenoscope System. The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".
Bench performance testing
The following bench tests were performed:
-
Optical performance testing according to ISO 8600 series.
-
Color performance (color reproduction), geometric distortion, optical performance (resolution, depth of field and image intensity uniformity). SNR and dynamic range, image frame frequency and system delay test compared with the predicate device.
-
Mechanical testing including water resistance, deflection, leakage and flow rate.
9. Clinical study
Not applicable.
10. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed Ureterorenoscope system is substantially equivalent to the predicate device.