(207 days)
Not Found
No
The summary describes standard image processing and visualization capabilities without mentioning any AI or ML algorithms for analysis, interpretation, or decision support.
No
The device is described as an examination and visualization tool, used for diagnosis, rather than treatment.
Yes
The "Intended Use" states it is "intended to be used for endoscopic access to and examination of the lower urinary tract." The "Device Description" further clarifies it "serves as a guide to diagnosis and management." These phrases indicate its role in identifying medical conditions.
No
The device description clearly outlines hardware components including a single-use cystoscope with an on-tip camera module and LED lighting source, and a reusable image processor/monitor. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "endoscopic access to and examination of the lower urinary tract" and to "provide visualization via image processor". This describes a device used for direct visualization and physical examination within the body, not for testing samples taken from the body.
- Device Description: The description details a flexible cystoscope with an on-tip camera and LED lighting source, used in conjunction with an image processor. This aligns with the function of an endoscope for internal examination.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. IVDs are designed to perform tests on these types of samples to diagnose conditions.
In summary, this device is a medical device used for direct visualization and examination of the lower urinary tract, which falls under the category of an endoscope, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The single-use cystoscope is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The single-use is intended to provide visualization via image processor and can be used with endoscopic accessories. The cystoscope system is intended for use in a hospital environment or medical office environment. The cystoscope system is designed for use for adult patients requiring cystoscopy.
Product codes (comma separated list FDA assigned to the subject device)
FAJ
Device Description
The Cystoscope System consists of a single-use Cystoscope to provide illumination and intuitive images in endoscopic surgery of the lower urinary tract and serves as a guide to diagnosis and management with accessories and an image processor for clinical image processing.
The single-use Cystoscope is a sterile single-use flexible Cystoscope. The image processor is a reusable monitor.
The single-use Cystoscope 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 Cystoscope 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
lower urinary tract
Indicated Patient Age Range
adult patients
Intended User / Care Setting
hospital environment or medical office environment.
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: 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 Cystoscope 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): 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: 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 the following:
- Force/bending/tensile stress testing of the insertion portion
- Force testing of the electrical cable to determine resistance to disconnection from the cystoscope handle and image system
- Irrigation flow testing through the working channel
- Functionality of Type T valve, including sealing
- Functionality of the suction joint
- Functionality of the image capture and video recording functions
- Compatibility with endoscopic accessories without damage to the cystoscope
Clinical study: No clinical study is included in this submission.
Key results: Performance testing and compliance with voluntary standards demonstrate that the proposed Cystoscope system is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 13, 2023
Shenzhen HugeMed Medical Technical Development Co., Ltd. % Yang Jie Consultant Shenzhen Chonconn Medical Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China
Re: K231118
Trade/Device Name: Cystoscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ Dated: October 13, 2023 Received: October 13, 2023
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.
1
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.
2
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,
Mark R. Kreitz -S
for 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
3
Indications for Use
510(k) Number (if known)
Device Name
Cystoscope System
Indications for Use (Describe)
The single-use cystoscope is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The single-use is intended to provide visualization via image processor and can be used with endoscopic accessories. The cystoscope system is intended for use in a hospital environment or medical office environment. The cystoscope system is designed for use for adult patients requiring cystoscopy.
| 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ 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: 2023/10/13
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
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 | Cystoscope System |
|---|---|
| Model | single-use Cystoscope: CY-M52, CY-M50, CY-M40, CY-M32 |
| image processor: HUV-01 | |
| Common Name | Cystoscope System |
| Regulatory Class | Class II |
| Classification | 21CFR 876.1500 / Endoscope and Accessories / FAJ |
| Submission type | Traditional 510(K) |
3. Subject Device Information
4. Predicate Device
510(k) number: K193095 Product name: Ambu aScope 4 Cysto Submitter: Ambu Inc.
5. Device Description
The Cystoscope System consists of a single-use Cystoscope to provide illumination and intuitive images in endoscopic surgery of the lower urinary tract and serves as a guide to diagnosis and management with accessories and an image processor for clinical image
5
processing.
The single-use Cystoscope is a sterile single-use flexible Cystoscope. The image processor is a reusable monitor.
The single-use Cystoscope 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 Cystoscope and outputs video signals to a display.
6. Intended use & Indication for use
The single-use cystoscope is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The single-use cystoscope is intended to provide visualization via image processor and can be used with endoscopic accessories. The cystoscope system is intended for use in a hospital environment or medical office environment. The cystoscope system is designed for use for adult patients requiring cystoscopy.
| Features | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Trade name | Cystoscope System | Ambu® aScopeTM 4 | |
| Cysto | / | ||
| 510(K) Submitter | Shenzhen HugeMed | ||
| Medical Technical | |||
| Development Co., Ltd. | Ambu Inc. | / | |
| K number | - | K193095 | / |
| Classification | |||
| Regulation | 21CRF 876.1500 | 21CRF 876.1500 | Same |
| Classification | |||
| and Code | Class II, | ||
| FAJ | Class II, | ||
| FAJ | Same | ||
| Common name | Cystoscope and | ||
| Accessories,, | |||
| Flexible/rigid | Cystoscope and | ||
| Accessories,, | |||
| Flexible/rigid | Same | ||
| Cystoscope | Single-Use | Single-Use | Same |
| Indication for use | The single-use | ||
| cystoscope is a sterile, | |||
| single-use, flexible | |||
| cystoscope intended to be | |||
| used for endoscopic | |||
| access to and | |||
| examination of the lower | Ambu® aScopeTM 4 | ||
| Cysto is a sterile, | |||
| single-use, flexible | |||
| cystoscope intended to | |||
| be used for endoscopic | |||
| access to and | |||
| examination of the | Same | ||
| Features | Subject Device | Predicate Device | Comparison |
| urinary tract. The single- | |||
| use cystoscope is | |||
| intended to provide | |||
| visualization via image | |||
| processor and can be | |||
| used with endoscopic | |||
| accessories. The | |||
| cystoscope system is | |||
| intended for use in a | |||
| hospital environment or | |||
| medical office | |||
| environment. The | |||
| cystoscope system is | |||
| designed for use for adult | |||
| patients requiring | |||
| cystoscopy. | lower urinary tract. The | ||
| Ambu® aScope™ 4 | |||
| Cysto is intended to | |||
| provide visualization | |||
| via Ambu® displaying | |||
| unit and can be used | |||
| with endoscopic | |||
| accessories. | |||
| Ambu® aScope™ 4 | |||
| Cysto is intended for | |||
| use in a hospital | |||
| environment or medical | |||
| office environment. | |||
| Ambu® aScope™ 4 | |||
| Cysto is designed for | |||
| use in adults. | |||
| Digital video | |||
| technology | CMOS | CMOS | Same |
| Illumination | LED | LED | Same |
| Field of view | |||
| (degree) | 120° | 120° | Same |
| Working length | |||
| (mm) | 350 mm±10% | 390mm | Different |
| Outer Shaft | |||
| Diameter | CY-M52: $Φ$ 5.0 | ||
| CY-M50: $Φ$ 5.0 | |||
| CY-M40: $Φ$ 4.2 | |||
| CY-M32: $Φ$ 3.1 | 16.2Fr(5.4mm) | Different | |
| Working Channel | |||
| Diameter | CY-M52: $Φ$ ≥2.10 mm | ||
| CY-M50: $Φ$ 2.8±10%mm | |||
| CY-M40: $Φ$ ≥1.1 mm | |||
| CY-M32: $Φ$ 1.2±10%mm | 6.6Fr(2.2mm) | Different | |
| Up/Down | |||
| Deflection | 210° upward and 210° | ||
| downward | UP: 210° | ||
| DOWN: 120° | Different | ||
| Sterilization | EO | ||
| SAL: 10-6 | EO | ||
| SAL: 10-6 | Same | ||
| Packaging | Cystoscope is packaged | ||
| in a tray which is sealed | |||
| by sterile barrier. | Cystoscope is packaged | ||
| by paper-plastic bag. | Same | ||
| Label and | |||
| Labeling | Meet FDA's | ||
| Requirements | Meet FDA's | ||
| Requirements | Same | ||
| Features | Subject Device | Predicate Device | Comparison |
| 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 |
Comparison to the Predicate Device 7.
6
7
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the single-use Cystoscope 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 Cystoscope 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 Bronchoscope 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."
8
The software for this device was considered as a "moderate" level of concern.
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 the following:
- · Force/bending/tensile stress testing of the insertion portion
- · Force testing of the electrical cable to determine resistance to disconnection from the cystoscope handle and image system
- · Irrigation flow testing through the working channel
- · Functionality of Type T valve, including sealing
- · Functionality of the suction joint
- · Functionality of the image capture and video recording functions
- · Compatibility with endoscopic accessories without damage to the cystoscope
Clinical study 9.
No clinical study is included in this submission
10. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed Cystoscope system is substantially equivalent to the predicate device.