(287 days)
Not Found
No
The summary describes standard image processing for visualization and does not mention any AI/ML capabilities for analysis, diagnosis, or other functions.
No
The device is primarily for visualization and access, allowing physicians to perform procedures using other accessories. It does not provide a therapeutic effect on its own.
Yes
The device is described as "a guide to diagnosis and management" and its primary function involves visualizing anatomical structures and converting the signal into an image, which implies a role in identifying conditions or pathologies.
No
The device description clearly outlines hardware components including a single-use choledochoscope (with camera module and LED lighting) and a reusable image processor (monitor). The software is part of a larger system that includes physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The Choledochoscope System is used inside the body to visualize and perform procedures within the pancreaticobiliary system. It is an endoscopic system for direct visualization and intervention, not for analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's for "access, visualize, and perform procedures in the pancreaticobiliary system," which is an in-vivo (within the living organism) application.
- Device Description: The description details a flexible endoscope with a camera and lighting, and an image processor to display the internal images. This aligns with an endoscopic system, not an IVD.
Therefore, the Choledochoscope System is a medical device, but it falls under the category of an endoscopic system for in-vivo procedures, not an In Vitro Diagnostic.
N/A
Intended Use / Indications 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.
Product codes
FBN, FET
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic vision (optical)
Anatomical Site
pancreaticobiliary system including the hepatic ducts and the common bile duct.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 in 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.
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 Working Channel Flow Rate, bending and Insertion Portion Leak testing.
Clinical study:
- No clinical study is included in this submission
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.
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-M32 |
| image processor: HUV-01 | |
| Common Name | Choledochoscope System |
| Regulatory Class | Class II |
| Classification | 21CFR 876.1500 / Choledochoscope And |
| Accessories, 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
5
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 | Choledochoscope | ||
| System | WiScope®OM Endoscope | ||
| System | / | ||
| 510(K) Submitter | Shenzhen | ||
| HugeMed | |||
| Medical | |||
| Technical | |||
| Development Co., | |||
| Ltd. | OTU Medical Inc. | / | |
| K number | K231497 | K210579 | / |
| Classification | |||
| Regulation | 21CRF 876.1500 | 21CRF 876.1500 | Same |
| Features | Subject Device | Predicate Device | Comparison |
| Classification | |||
| and Code | Class II, | ||
| FBN, FET | Class II, | ||
| FGB, FBN | Different | ||
| Common name | Choledochoscope | ||
| and Accessories, | |||
| Flexible/rigid | Choledochoscope and | ||
| Accessories, Flexible/rigid | Same | ||
| 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 | WiScope® OM Endoscope | ||
| System is intended to be | |||
| used by physicians to access, | |||
| visualize, and perform | |||
| procedures in the urinary | |||
| tract and the kidney. | |||
| WiScope® OM Endoscope | |||
| System is also 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 instrument enables | |||
| delivery and use of | |||
| accessories such as biopsy | |||
| forceps, laser fibers, graspers | |||
| and retrieval baskets at a | |||
| surgical 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-use
Choledochoscope
: CH-M50, CH-M52, CH-M40, CH-M32 | WiScope OM Endoscope System - WiScope Single-Use
Digital Flexible
Ureteroscope.
Choledochoscope | |
| Choledochoscope | Single-Use | Single-Use | Same |
| Digital video
technology | CMOS | CMOS | Same |
| Illumination | LED | LED | Same |
| Field of view
(degree) | 120°±15% | 100° | Different |
| Working length
(mm) | 605 | 670 | Different |
| Outer Shaft
Diameter | CH-M52:
$Φ$ 5.2±10%mm
CH-M50:
$Φ$ 5.0±10%mm
CH-M40:
$Φ$ 4.4±10%mm
CH-M32:
$Φ$ 3.2±10% mm | 2.8mm | Different |
| Working Channel
Diameter | CH-M52: $Φ$ ≥2.10 mm
CH-M50:
$Φ$ 2.8±10%mm
CH-M40: $Φ$ ≥1.1 mm
CH-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 of
view (degree) | 0°±10° | 0° | Same |
| Camera Head
Configurable | No | Yes | Different |
| Sterilization | EO
SAL: 10-6 | EO
SAL: 10-6 | Same |
| Packaging | Choledochoscope
is packaged in a
tray which is
sealed by sterile
barrier. | Ureteroscope/Choledochoscope
is packaged in a tray
which is sealed by sterile
barrier. | Same |
| Label and
Labeling | Meet FDA's
Requirements | Meet FDA's Requirements | Same |
| Cytotoxicity | Comply with ISO
10993-5,
No cytotoxicity effect | Comply with ISO 10993-5,
No cytotoxicity effect | Same |
| Irritation | Comply with ISO
10993-10,
not an irritant | Comply with ISO 10993-10,
not an irritant | Same |
| Sensitization | Comply with ISO
10993-10,
not a sensitizer. | Comply with ISO 10993-10,
not a sensitizer. | Same |
| Acute systemic
toxicity &
Material-
Mediated
Pyrogenicity | Comply with ISO
10993-11,
no acute systemic
toxicity, no
temperature rise | Comply with ISO 10993-11,
no acute systemic toxicity,
no temperature rise | Same |
| Item | Choledochoscope
System -Image
Processor HUV-
01 | WiScope OM Endoscope System
-WiScope Image System | |
| Output Formats | USB/DVI/S-
Video/CVBS | USB/AV/HDMI | Different |
| Brightness
Control | Yes | Yes | Same |
| White Balance | Yes | Yes | Same |
| Image/Video
Capture | 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 with
ANSI AAMI
ES60601-1
IEC60601-1-2
IEC 60601-2-18 | Comply with
ANSI AAMI ES60601-1
IEC60601-1-2
IEC 60601-2-18 | Same |
Comparison to the Predicate Device 7.
6
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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.