(287 days)
Choledochoscope System is intended to be used by physicians through percutaneous insertion to access, visualize, and perform procedures in the pancreaticobiliary system including the hepatic ducts and the common bile duct.
The image processor provides illumination for the choledochoscope, and is also used to receive the signal from the endoscope, convert it into an image and display it on the examination monitor.
The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
The Choledochoscope System consists of a single-use choledochoscope to provide illumination and intuitive images in endoscopic surgery of the pancreatic ductal system and serves as a guide to diagnosis and management with accessories and an image processor for clinical image processing.
The single-use choledochoscope is a sterile single-use flexible choledochoscope and has the following 4 models: CH-M50, CH-M52, CH-M40, CH-M32. The four models are the same except for the difference in the characteristics of the insertion tube, including diameter of the insertion tube, maximum insertion portion width and minimum insertion channel width.
The image processor is a reusable monitor.
The single-use choledochoscope 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 choledochoscope and outputs video signals to a display.
The provided text describes the regulatory clearance of a medical device, the "Choledochoscope System," and highlights the tests performed to demonstrate its substantial equivalence to a predicate device. However, it does not include the detailed information needed to answer many of the questions regarding acceptance criteria and the study proving the device meets those criteria, particularly for performance metrics related to AI or image analysis beyond general optical performance.
Specifically, the document states: "No clinical study is included in this submission" which is critical. This means the device's performance was primarily demonstrated through bench testing and compliance with standards, not through clinical trials or comparative effectiveness studies with human readers.
Therefore, for many of the requested points, the answer will be that the information is "Not available in the provided text" or "Not applicable as no clinical or AI-based performance study was conducted."
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document mentions several performance tests and compliance with standards, but does not provide a table with specific acceptance criteria (e.g., minimum resolution, specific SNR values) and reported performance values for each. It generally states "Comply with" or "evaluated in accordance with."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: In accordance with ISO 10993-1, ISO 10993-7, ISO 10993-10, ISO 10993-11. | Complied with listed ISO standards. No cytotoxicity, not an irritant, not a sensitizer, no acute systemic toxicity, no temperature rise. |
| Sterilization: Validation in accordance with ISO 11135:2014. | Validated in accordance with ISO 11135:2014. |
| EO/ECH Residuals: According to ISO 10993-7:2008. | 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. | Determined to be 3 years. |
| Package Validation: According to ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1886/F1886M-16, ASTM F88/F88M-15, ASTM F 1929-15. | Conducted according to listed ASTM and ISO standards. |
| Electrical Safety: Compliance with IEC 60601-1 and IEC60601-2-18. | Complied with IEC 60601-1 and IEC60601-2-18. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2. | Complied with IEC 60601-1-2. |
| Software Verification and Validation (V&V): According to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | Software V&V conducted, documentation provided, considered "moderate" level of concern. |
| Optical Performance: According to ISO 8600 series. | Performed according to ISO 8600 series. |
| Color performance, geometric distortion, optical performance (resolution, depth of field and image intensity uniformity), SNR, dynamic range, image frame frequency, system delay: Compared with the predicate device. | Testing performed; stated as comparative to predicate device, implying acceptable performance relative to it. No specific numerical results are provided. |
| Mechanical Testing: Working Channel Flow Rate, bending, Insertion Portion Leak testing. | Testing performed. No specific numerical results are provided, but implies acceptable performance. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not applicable for human-data based test sets, as "No clinical study is included in this submission." For bench tests (e.g., optical, mechanical), the sample sizes are not specified in the document.
- Data Provenance: Not applicable for clinical data. For manufacturing and testing, the company is based in Shenzhen, Guangdong, China. The testing appears to be primarily bench-top and engineering performance testing rather than human clinical data.
- Retrospective/Prospective: Not applicable, as no clinical studies were conducted using human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not applicable. No clinical expert-driven ground truth was established, as no clinical study was conducted.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. No clinical test set requiring expert adjudication was used.
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
- MRMC study: No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission."
- Effect size: Not applicable, as no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This device is an endoscope system (hardware and image processor), not an AI algorithm analyzing medical images. Its performance is related to its ability to capture and display images, not interpret them. The document refers to "Software Verification and Validation Testing" but treats the software as a "moderate" level of concern, indicating it's mainly for control and image processing, not diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: For the engineering and performance tests (optical, mechanical, electrical, biocompatibility), the "ground truth" would be established physical measurements, engineering standards, chemical analyses, and standardized test methodologies. There is no biological/clinical "ground truth" in the form of expert consensus or pathology within this submission.
8. The sample size for the training set
- Sample size (Training Set): Not applicable. This submission is for a medical device (endoscope system), not an AI/ML model for which a training set would be described in this context. The software mentioned is for device operation and image display, not for learning from data.
9. How the ground truth for the training set was established
- Ground truth (Training Set): Not applicable, as this device does not involve a machine learning training set with biological or clinical ground truth.
In summary, the provided document focuses on demonstrating the substantial equivalence of the Choledochoscope System to a predicate device through adherence to established regulatory standards for medical device safety and performance (biocompatibility, sterilization, electrical safety, mechanical, and optical bench tests), rather than clinical efficacy or AI-driven performance.
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March 6, 2024
Shenzhen HugeMed Medical Technical Development Co., Ltd % Yang Jie Consultant Shenzhen Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue Nanshan District Shenzhen, Guangdong 518067 China
Re: K231497
Trade/Device Name: Choledochoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FBN, FET Dated: February 5, 2024 Received: February 5, 2024
Dear Yang Jie:
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/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.
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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" (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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 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).
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Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K231497
Device Name Choledochoscope System
Choledochoscope System is intended to be used by physicians through percutaneous insertion to access, visualize, and perform procedures in the pancreaticobiliary system including the hepatic ducts and the common bile duct.
The image processor provides illumination for the choledochoscope, and is also used to receive the signal from the endoscope, convert it into an image and display it on the examination monitor.
The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site
Type of Use (Select one or both, as applicable)
X 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
Prepared Date: 2023/05/05
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: Cathy Title: Regulatory engineer E-mail: cathy.shi@hugemed.cn Tel: +86-755-22275833
2. Submission correspondent
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 | Choledochoscope System |
|---|---|
| Model | single-use Choledochoscope: CH-M50, CH-M52, CH-M40, CH-M32image processor: HUV-01 |
| Common Name | Choledochoscope System |
| Regulatory Class | Class II |
| Classification | 21CFR 876.1500 / Choledochoscope AndAccessories, Flexible/Rigid / FBN, FET |
| Submission type | Traditional 510(K) |
3. Subject Device Information
Predicate Device 4.
510(k) number: K210579 Product name: WiScope® OM Endoscope System Submitter: OTU Medical Inc.
5. Device Description
The Choledochoscope System consists of a single-use choledochoscope to provide illumination and intuitive images in endoscopic surgery of the pancreatic ductal system and
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serves as a guide to diagnosis and management with accessories and an image processor for clinical image processing.
The single-use choledochoscope is a sterile single-use flexible choledochoscope and has the following 4 models:
| Models | Description of similarities and difference |
|---|---|
| CHM32 | The four models are the same except for the difference in the |
| CH-M40 | characteristics of the insertion tube, including diameter of the |
| CH-M50 | insertion tube, maximum insertion portion width and minimum |
| CH-M52 | insertion channel width. |
The image processor is a reusable monitor.
The single-use choledochoscope 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 choledochoscope and outputs video signals to a display.
6. Intended use & Indication for use
Choledochoscope System is intended to be used by physicians through percutaneous insertion to access, visualize, and perform procedures in the pancreaticobiliary system including the hepatic ducts and the common bile duct.
The image processor provides illumination for the choledochoscope, and is also used to receive the signal from the endoscope, convert it into an image and display it on the examination monitor.
The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
| Features | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Trade name | CholedochoscopeSystem | WiScope®OM EndoscopeSystem | / |
| 510(K) Submitter | ShenzhenHugeMedMedicalTechnicalDevelopment Co.,Ltd. | OTU Medical Inc. | / |
| K number | K231497 | K210579 | / |
| ClassificationRegulation | 21CRF 876.1500 | 21CRF 876.1500 | Same |
| Features | Subject Device | Predicate Device | Comparison |
| Classificationand Code | Class II,FBN, FET | Class II,FGB, FBN | Different |
| Common name | Choledochoscopeand Accessories,Flexible/rigid | Choledochoscope andAccessories, Flexible/rigid | Same |
| Indication for use | CholedochoscopeSystem isintended to beused byphysiciansthroughpercutaneousinsertion toaccess, visualize,and performprocedures in thepancreaticobiliarysystem includingthe hepatic ductsand the commonbile duct.The imageprocessorprovidesillumination forthecholedochoscope,and is also used toreceive the signalfrom theendoscope,convert it into animage and displayit on theexaminationmonitor.The instrumentenables deliveryand use of | WiScope® OM EndoscopeSystem is intended to beused by physicians to access,visualize, and performprocedures in the urinarytract and the kidney.WiScope® OM EndoscopeSystem is also intended to beused by physicians throughpercutaneous insertion toaccess, visualize, andperform procedures in thepancreaticobiliary systemincluding the hepatic ductsand the common bile duct.The instrument enablesdelivery and use ofaccessories such as biopsyforceps, laser fibers, graspersand retrieval baskets at asurgical site. | Different |
| Features | Subject Device | Predicate Device | Comparison |
| accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site. | |||
| Item | Choledochoscope System- single-useCholedochoscope: CH-M50, CH-M52, CH-M40, CH-M32 | WiScope OM Endoscope System- WiScope Single-UseDigital FlexibleUreteroscope.Choledochoscope | |
| Choledochoscope | Single-Use | Single-Use | Same |
| Digital videotechnology | CMOS | CMOS | Same |
| Illumination | LED | LED | Same |
| Field of view(degree) | 120°±15% | 100° | Different |
| Working length(mm) | 605 | 670 | Different |
| Outer ShaftDiameter | CH-M52:$Φ$ 5.2±10%mmCH-M50:$Φ$ 5.0±10%mmCH-M40:$Φ$ 4.4±10%mmCH-M32:$Φ$ 3.2±10% mm | 2.8mm | Different |
| Working ChannelDiameter | CH-M52: $Φ$ ≥2.10 mmCH-M50:$Φ$ 2.8±10%mmCH-M40: $Φ$ ≥1.1 mmCH-M32:$Φ$ 1.2±10%mm | 1.2mm | Different |
| Up/Down | 210° upward and | UP: 275° | Different |
| Features | Subject Device | Predicate Device | Comparison |
| Deflection | 210° downward | DOWN: 275° | Same |
| Direction ofview (degree) | 0°±10° | 0° | Same |
| Camera HeadConfigurable | No | Yes | Different |
| Sterilization | EOSAL: 10-6 | EOSAL: 10-6 | Same |
| Packaging | Choledochoscopeis packaged in atray which issealed by sterilebarrier. | Ureteroscope/Choledochoscopeis packaged in a traywhich is sealed by sterilebarrier. | Same |
| Label andLabeling | Meet FDA'sRequirements | Meet FDA's Requirements | Same |
| Cytotoxicity | Comply with ISO10993-5,No cytotoxicity effect | Comply with ISO 10993-5,No cytotoxicity effect | Same |
| Irritation | Comply with ISO10993-10,not an irritant | Comply with ISO 10993-10,not an irritant | Same |
| Sensitization | Comply with ISO10993-10,not a sensitizer. | Comply with ISO 10993-10,not a sensitizer. | Same |
| Acute systemictoxicity &Material-MediatedPyrogenicity | Comply with ISO10993-11,no acute systemictoxicity, notemperature rise | Comply with ISO 10993-11,no acute systemic toxicity,no temperature rise | Same |
| Item | CholedochoscopeSystem -ImageProcessor HUV-01 | WiScope OM Endoscope System-WiScope Image System | |
| Output Formats | USB/DVI/S-Video/CVBS | USB/AV/HDMI | Different |
| BrightnessControl | Yes | Yes | Same |
| White Balance | Yes | Yes | Same |
| Image/VideoCapture | Yes | No | Different |
| Features | Subject Device | Predicate Device | Comparison |
| Separate monitor | Yes | Yes | Same |
| Reusability | Reusable | Reusable | Same |
| Electrical | Comply with | Comply with | Same |
| Performance | Comply withANSI AAMIES60601-1IEC60601-1-2IEC 60601-2-18 | Comply withANSI AAMI ES60601-1IEC60601-1-2IEC 60601-2-18 | Same |
Comparison to the Predicate Device 7.
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Performance Data 8.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the single-use choledochoscope 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: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Sterilization and shelf life testing
The Single-use choledochoscope 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 after 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 Choledochoscope 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, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
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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 Working Channel Flow Rate, bending and Insertion Portion Leak testing.
9. Clinical study
No clinical study is included in this submission
10. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.
§ 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.