(28 days)
The Pusen Single Use Flexible Video Cystem is intended to be used for endoscopic access to and examination of the lower urinary tract. The Pusen Single Video Cystoscope is intended to provide visualization via video processor and can be used with endoscopic accessories. This system is intended for use in a hospital environment or medical office environment.
The Pusen Single Use Flexible Video Cystoscope System includes a Single Use Flexible Video Cystoscope and an HD Medical Video Endoscope Image Processor. The Pusen Single Use Flexible Video Cystoscope is provided sterile and has the following 4 models: PC200-AS, PC200-AR, PC200-S and PC200-R. The Pusen Single Use Flexible Video Cystoscope has two LEDs and CMOS imaging sensor at its distal tip. The Pusen Single Use Flexible Video Cystoscope needs to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system. The Pusen Single Use Flexible Video Cystoscope is powered by the HD Medical Video Endoscope Image Processor PV300. The HD Medical Video Endoscope Image Processor PV300 is a reusable device, used to process the image signal from the Pusen Single Use Flexible Video Cystoscope and display the real-time video on its LCD screen, which enables visual examination of the lower urinary tract (the urethra and the bladder).
The provided FDA 510(k) summary for the Pusen Single Use Flexible Video Cystoscope System does not describe specific acceptance criteria in quantitative terms nor does it detail a study that proves the device meets such criteria in the format requested. The document outlines general categories of performance data that were used to demonstrate substantial equivalence to a predicate device.
Here's an attempt to extract and present the information based on the provided text, acknowledging where specific details are missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for the performance tests, nor does it provide specific numerical results for the device performance beyond stating that tests were "passed" or "complies with." The table below summarizes the listed performance tests and the general outcome.
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Passed |
| Intracutaneous Irritation | Passed |
| Sensitization | Passed |
| Overall compliance with ISO 10993-1 | Complies |
| Electrical Safety & EMC: | |
| Compliance with IEC 60601-1 | Complies |
| Compliance with IEC 60601-2-18 | Complies |
| Compliance with IEC 60601-1-2 (EMC) | Complies |
| Software Verification & Validation: | |
| Compliance with FDA Guidance | Relevant documentation provided |
| Bench Performance Testing: | |
| Mechanical & Optical Performance (ISO 8600) | Complies |
| Image Quality: | |
| Color Performance Testing | Performed (for substantial equivalence) |
| Optical Performance Testing | Performed (for substantial equivalence) |
| Photobiological Safety: | |
| Compliance with IEC 62471:2006 | Tested (implies compliance) |
| Luer Taper: | |
| Compliance with ISO 80369-7:2021 | Tested (implies compliance) |
| Sterilization & Shelf Life: | |
| Shelf Life (3 years) validation | Supported |
| EO sterilization validation to ISO 11135:2014 | Validated |
| Reprocessing validation (HD Medical Video Endoscope Image Processor) | Validated |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the described performance tests (e.g., how many cystoscopes were tested for mechanical performance, how many individuals for biocompatibility, etc.). It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, though the nature of these tests (bench, lab-based) inherently implies prospective testing within a controlled environment.
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)
The document does not mention the involvement of experts for establishing ground truth, as the performance data is primarily technical and bench-test based (e.g., biocompatibility passes, electrical safety compliance). No clinical studies or expert consensus for interpretation were conducted as part of this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The reported data relates to bench testing, not clinical interpretation that would require an adjudication method.
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
No such study was conducted or reported. The device is a "Single Use Flexible Video Cystoscope System," not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the device is a medical instrument (cystoscope system), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests described would be derived from:
- Compliance with international standards: For biocompatibility, electrical safety, EMC, photobiological safety, Luer taper, and sterilization validation (e.g., ISO 10993-1, IEC 60601 series, IEC 62471, ISO 80369-7, ISO 11135).
- Engineering specifications/measurements: For mechanical and optical performance (e.g., working length, channel diameter, angle of deflection, field of view, depth of field, flow rates, tensile strength, resolution, color reproduction, distortion).
- Accelerated aging and package integrity testing: For shelf life validation.
8. The sample size for the training set
Not applicable, as this is a medical device approval, not an AI/machine learning algorithm submission that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no "training set."
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September 26, 2022
Zhuhai Pusen Medical Technology Co., Ltd. Changshen Wang Regulatory Affairs Director 5/F, Building 1, No 33, Ke Ji San Road High-tech Zone, Tangjiawan Town Zhuhai, Guangdong 519085 China
Re: K22602
Trade/Device Name: Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300) Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ Dated: August 25, 2022 Received: August 29, 2022
Dear Changshen Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
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
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Indications for Use
510(k) Number (if known) K222602
Device Name
Pusen Single Use Flexible Video Cystem (Single Use Flexible Video Cystoscope: PC200-AR, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)
Indications for Use (Describe)
The Pusen Single Use Flexible Video Cystem is intended to be used for endoscopic access to and examination of the lower urinary tract. The Pusen Single Video Cystoscope is intended to provide visualization via video processor and can be used with endoscopic accessories. This system is intended for use in a hospital environment or medical office environment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 201. Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/2 description: The image shows the logo for Zhuhai Pusen Medical Technology Co., Ltd. The logo consists of the word "PUSEN" in a stylized, sans-serif font, with each letter rendered in a light blue color. Below the logo, the company name "Zhuhai Pusen Medical Technology Co., Ltd." is written in a smaller, gray font.
510(k) Summary
I. SUBMITTER
Submitter's name: Zhuhai Pusen Medical Technology Co, Ltd. Submitter's address: 5/F, Building 1, No 33, Keji San Road, High-tech Zone, Tangjiawan Town, 519085 Zhuhai, Guangdong, People's Republic of China.
Phone: +86 756 688 0865
Contact Person: Ellen Wang Date Prepared: September 22, 2022
II. DEVICE
Name of Device: Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300) Common Name: Cystoscope and accessories 510(k) number: K222602 Classification Name: Endoscope and Accessories (21 CFR 876.1500) Regulatory Class: Class II Product Code: FAJ
III. PREDICATE DEVICE
Predicate device
Name of Device: Ambu aScope 4 Cysto 510(k) number: K193095 Classification regulation: Cystoscope and Accessories, Flexible/Rigid Product code: FAJ This predicate device has not been subject to a design-related recall.
Reference device
Name of Device: EVIS EXERA II 180 SYSTEM 510(k) number: K133538 Classification regulation: Endoscope and Accessories Product code: NWB; FAJ This reference device has not been subject to a design-related recall.
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Image /page/4/Picture/2 description: The image shows the logo for Zhuhai Pusen Medical Technology Co., Ltd. The logo consists of the word "PUSEN" in a stylized, sans-serif font, with rounded corners and a light blue color. Below the logo is the company name, "Zhuhai Pusen Medical Technology Co., Ltd.," in a smaller, gray font.
IV. DEVICE DESCRIPTION
The Pusen Single Use Flexible Video Cystoscope System includes a Single Use Flexible Video Cystoscope and an HD Medical Video Endoscope Image Processor.
The system is intended to be used by physicians for endoscopic access to and examination of the lower urinary tract in adults. This system is intended to provide visualization and can be used with endoscopic accessories. This system is intended for use in a hospital environment or medical office environment.
- The Pusen Single Use Flexible Video Cystoscope is provided sterile and has the following 4 models:
| Model | Description of difference |
|---|---|
| PC200-AS | 'A' means this model has function buttons; 'S' means standard deflection. |
| PC200-AR | 'A' means this model has function buttons; 'R' means reverse deflection. |
| PC200-S | 'S' means standard deflection. |
| PC200-R | 'R' means reverse deflection. |
- The Pusen Single Use Flexible Video Cystoscope has two LEDs and CMOS imaging sensor at its distal tip. The Pusen Single Use Flexible Video Cystoscope needs to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system. The Pusen Single Use Flexible Video Cystoscope is powered by the HD Medical Video Endoscope Image Processor PV300.
- The HD Medical Video Endoscope Image Processor PV300 is a reusable device, used to process the image signal from the Pusen Single Use Flexible Video Cystoscope and display the real-time video on its LCD screen, which enables visual examination of the lower urinary tract (the urethra and the bladder).
V. INDICATIONS FOR USE
The subject device: The Pusen Single Use Flexible Video Cystoscope System is intended to be used for endoscopic access to and examination of the lower urinary tract. The Pusen Single Use Flexible Video Cystoscope is intended to provide visualization via video processor and can be used with endoscopic accessories. This system is intended for use in a hospital environment or medical office environment.
The predicate device: Ambu® aScope™ 4 Cysto is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the 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.
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Image /page/5/Picture/1 description: The image shows the logo for Zhuhai Pusen Medical Technology Co., Ltd. The logo consists of the word "PUSEN" in a stylized, sans-serif font, with each letter rendered in a light blue color. Below the logo, the company name "Zhuhai Pusen Medical Technology Co., Ltd." is written in a smaller, gray font.
Traditional 510(k)
The indications for use are the same for the subject device and the predicate device. The subject and predicate device have the same intended use – to provide visualization in the lower urinary tract.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Item | Subject device | Predicate device |
|---|---|---|
| Trade name | Pusen Single Use Flexible VideoCystoscope System | Ambu aScope 4 Cysto |
| 510(K) number | K222602 | K193095 |
| Scope type | Flexible | Flexible |
| Scopereusability | Single-use | Single-use |
| Energy used | Powered by chargeable battery orline power. | Powered by chargeablebattery or line power. |
| Digitalvideotechnology | CMOS | CMOS |
| Illuminationsource | LED | LED |
| Field of view | 90 ° | 120 ° |
| Directionofview | 30° | 0° |
| Depth of field | 3~80 mm | 5~50mm |
| Maximuminsertionportion width | 18 Fr | 18 Fr |
| Working length | 380 mm | 390 mm |
| Workingchannel size | 2.3 mm | 2.2 mm |
| Up/downdeflection | Up: 210°Down: 210° | Up: 210°Down: 120° |
| Suction | Provided | Not Provided |
| Sterility | Ethylene Oxide (EO)SAI : 10⁻⁶ | EOSAI : 10⁻⁶ |
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Image /page/6/Picture/1 description: The image contains the logo for Zhuhai Pusen Medical Technology Co., Ltd. The logo is in blue and features the word "PUSEN" in a stylized font. The text "Zhuhai Pusen Medical Technology Co., L" is located below the logo.
Traditional 510(k)
The subject and the predicate device have different dimensions (e.g., working length, channel size) and optical specifications (e.g., depth of field of view, direction of view). However, these differences do not raise different questions of safety and effectiveness.
VII. PERFORMANCE DATA
The subject device has been verified for the safety and effectiveness based on the following performance data.
Biocompatibility testing
The biocompatibility evaluation for the Pusen Single Video Cystoscope was conducted in accordance with the FDA final guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" (issued on September 4, 2020) and international standard ISO 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. To support the contact classification as a surface device contacting mucosal membrane for a limited duration, the following endpoints were evaluated:
- Cytotoxicity
- Intracutaneous Irritation
- Sensitization
The subject device passed the relevant tests and complies with ISO 10993-1.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject device system, and the system complies with the IEC 60601-1 and IEC 60601-2-18 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and relevant software documentations were 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".
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Bench Performance Testing
Mechanical and Optical Performance
The subject device was designed to comply with applicable parts of ISO 8600. Optical measurements and physical performances tests were performed according to applicable part of ISO 8600 standard, include appearance, working length, working channel diameter, maximum insertion width, angle of deflection, field of view and direction of view.
Mechanical characteristics were tested and include flow rate of water, suction rate and tensile strength testing.
Image quality
Comparative testing related to image quality performances including color performance (color reproduction and color contrast enhancement), optical performance (resolution, depth of field, image intensity uniformity and distortion) tests were performed for the subject device and the predicate device to support substantial equivalence.
Photobiological safety
The LEDs in the subject device were tested according to the following FDA recognized standards:
· IEC 62471:2006 Medical electrical equipment, Photobiological safety of lamps and lamp systems.
Luer taper
Luer taper in the subject device was tested according to ISO 80369-7: 2021, Smallbore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications.
Sterilization and shelf life
- A shelf life of 3 years for the Pusen Single Use Flexible Video Cystoscope was supported with accelerated aging of final finished devices, followed by simulated shipping distribution, package integrity testing, and product performance testing.
● The EO sterilization method has been validated to ISO 11135:2014. (only applicable to the Pusen Single Use Flexible Video Cystoscope)
● Reprocessing method was validated in accordance with the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". (only applicable to the HD Medical Video Endoscope Image Processor)
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Image /page/8/Picture/1 description: The image displays the logo for Zhuhai Pusen Medical Technology Co., Ltd. The logo features the word "PUSEN" in a stylized, sans-serif font, with each letter rendered in a light blue color. Below the logo, the company's full name, "Zhuhai Pusen Medical Technology Co., Ltd," is written in a smaller, gray font.
Traditional 510(k)
Animal Study and Clinical study
No animal study or clinical study is included in this submission.
Summary of performance data
All tests were passed and all evaluation acceptance criteria were met.
VIII. CONCLUSIONS
The performance data described above demonstrate that the Pusen Single Use Flexible Video Cystoscope System is as safe and effective as the predicate device and supports a substantial equivalence determination.
§ 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.