(232 days)
No
The summary describes a standard video ureteroscope and image processor without mentioning any AI/ML capabilities or related performance metrics.
Yes
Explanation: The device is used with "Endo-Therapy accessories" and for "irrigation of kidney stones and stone dust during ureteral lithotripsy," indicating a therapeutic purpose in treating a medical condition.
Yes
Explanation: The device is described as having LEDs and a CMOS imaging sensor at its distal tip and needs to be connected to an "HD Medical Video Endoscope Image Processor." It conducts optical measurements and image quality assessments, which align with diagnostic functions for visualization and assessment within the urinary tract and kidney.
No
The device description clearly indicates the device is a physical instrument (ureteroscope) with hardware components (LEDs, CMOS imaging sensor, buttons, suction access) and requires connection to a separate hardware image processor. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is an instrument used for endoscopy and endoscopic surgery within the urinary tract and kidney. It's used for visualization, accessing the area with accessories like biopsy forceps, and for irrigation and aspiration during lithotripsy.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient. Its function is entirely focused on direct visualization and manipulation within the body.
Therefore, this device falls under the category of a surgical or endoscopic instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is also used as a suction catheter that establishes a conduit used for irrigation of kidney stones and stone dust during ureteral lithotripsy.
Product codes
FGB, FED
Device Description
The Pusen Single Use Flexible Video Ureteroscope (Model: PU3033H, PU3033AH) and Pusen Single Use Suction Access Ureteroscope (Model: PU400A, PU411A) have been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is also used as a suction catheter that establishes a conduit used for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy. This product is for use in a hospital or qualified medical institution.
- Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope are provided sterile with the following model differences:
| Product name | Single Use Ureteroscope | Suction Access | Single Use Ureteroscope | Flexible Video |
|---|---|---|---|---|
| Model | PU400A | PU411A | PU3033H | PU3033AH |
| Suction access | Yes | Yes | Yes | Yes |
| Buttons | Yes | Yes | No | Yes | - . The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope have two LEDs and CMOS imaging sensor at its distal tip. The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope need to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system. The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope are powered by the HD Medical Video Endoscope Image Processor PV300.
- The HD Medical Video Endoscope Image Processor PV300 was cleared under 510(k) number K222602.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract and interior of the kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital or qualified medical institution.
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: The biocompatibility evaluation for the Pusen Single Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope 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 breached/compromised or compromised surfaces, contacting tissue for a limited duration (
§ 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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July 16, 2024
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 519000 CHINA
Re: K233778
Trade/Device Name: Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB, FED Received: June 18, 2024
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 (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.
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"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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
2
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) K233778
Device Name
Single Use Suction Access Ureteroscope (PU400A, PU411A); Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
Indications for Use (Describe)
This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is also used as a suction catheter that establishes a conduit used for irrigation of kidney stones and stone dust during ureteral lithotripsy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ✘ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
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: July 16, 2024
II. DEVICE
Name of Device: Pusen Single Use Flexible Video Ureteroscope (Model: PU3033H, PU3033AH) and Pusen Single Use Suction Access Ureteroscope (Model: PU400A, PU411A) Common Name: Ureteroscope and Accessories 510(k) number: K233778 Classification Name: Ureteroscope and Accessories, Flexible/Rigid (21 CFR 876.1500) Regulatory Class: Class II Product Code: FGB
III. PREDICATE DEVICE
Predicate device
Name of Device: Medical Video Endoscope system
510(k) number: K172098
Classification regulation: Ureteroscope and Accessories, Flexible/rigid
Product code: FGB
This predicate device has not been subject to a design-related recall.
5
Reference device
Name of Device: ClearPetra Suction-Evacuation Sheath 510(k) number: K203119 Classification regulation: Endoscope and Accessories Product code: FED, FAJ, FGA This reference device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Pusen Single Use Flexible Video Ureteroscope (Model: PU3033H, PU3033AH) and Pusen Single Use Suction Access Ureteroscope (Model: PU400A, PU411A) have been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is also used as a suction catheter that establishes a conduit used for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy. This product is for use in a hospital or qualified medical institution.
- Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope are provided sterile with the following model differences:
| Product name | Single Use
Ureteroscope | Suction Access | Single Use
Ureteroscope | Flexible Video |
|----------------|----------------------------|----------------|----------------------------|----------------|
| Model | PU400A | PU411A | PU3033H | PU3033AH |
| Suction access | Yes | Yes | Yes | Yes |
| Buttons | Yes | Yes | No | Yes |
- . The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope have two LEDs and CMOS imaging sensor at its distal tip. The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope need to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system. The Pusen Single Use Flexible Video Ureteroscope and 510(k) summary
6
Pusen Single Use Suction Access Ureteroscope are powered by the HD Medical Video Endoscope Image Processor PV300.
- The HD Medical Video Endoscope Image Processor PV300 was cleared under 510(k) number K222602.
V. INDICATIONS FOR USE
This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is also used as a suction catheter that establishes a conduit used for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy.
VI. COMPARISON WITH THE PREDICATE DEVICE
a. INDICATIONS FOR USE
| Item | Subject device | Predicate device | Reference device |
|---|---|---|---|
| Trade name | Single Use Flexible Video | ||
| Ureteroscope | |||
| Single Use Suction Access | |||
| Ureteroscope | Medical Video Endoscope | ||
| System | ClearPetra Suction- | ||
| Evacuation Sheath | |||
| 510(K) number | K233778 | K172098 | K203119 |
| Indications for | |||
| use | This instrument has been | ||
| designed to be used with | |||
| Endo-Therapy accessories | |||
| such as a biopsy forceps | |||
| and | |||
| other | |||
| ancillary | |||
| equipment for endoscopy | |||
| and | |||
| endoscopic surgery | |||
| within urinary tract and | |||
| interior of the kidney. This | |||
| instrument is also used as a | |||
| suction | |||
| catheter | |||
| that | |||
| establishes a conduit used | This instrument has been | ||
| designed to be used with | |||
| endo-therapy accessories | |||
| such as a biopsy forceps | |||
| and | |||
| other | |||
| ancillary | |||
| equipment for endoscopy | |||
| and | |||
| endoscopic surgery | |||
| within urinary tract and | |||
| interior of the kidney. | The ClearPetra Suction- | ||
| Evacuation Sheath is | |||
| used to establish a | |||
| conduit | |||
| during | |||
| endoscopic | |||
| urological | |||
| procedures facilitating | |||
| the | |||
| passage | |||
| of | |||
| endoscopes and other | |||
| instruments into the | |||
| urinary tract. It is | |||
| designed to establish a | |||
| conduit for the treatment |
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Image /page/7/Picture/1 description: The image displays the logo for Zhuhai Pusen Medical Technology Co., Ltd. The logo features the company name in a clean, sans-serif font. The word "PUSEN" is prominently displayed in a light blue color, while the rest of the company name is in a smaller, gray font.
| for irrigation and aspiration
of kidney stones and stone
dust during ureteral
lithotripsy | of urinary stones or other
urinary diseases during
endoscopic procedures. |
| ---------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
|---|
The subject device's indications for use is similar to that of the predicate device, the difference is only supplementary descriptions to the suction access functionality which aligns with that of the reference device, and this difference does not change the intended use of the subject device.
TECHNOLOGICAL CHARACTERISTICS b.
| Item | Subject device | Predicate device |
|---|---|---|
| Trade name | Single Use Flexible Video Ureteroscope | |
| Single Use Suction Access Ureteroscope | Medical Video Endoscope System | |
| 510(K) number | K233778 | K172098 |
| Scope type | Flexible | Flexible |
| Scope reusability | Single-use | Single-use |
| Energy used | Powered by chargeable battery or line | |
| power. | Powered by chargeable battery or line | |
| power. | ||
| Digital | ||
| video | ||
| technology | CMOS | CMOS |
| Illumination | ||
| source | LED | Fiber |
| Field of view | 120 ° | 120 ° |
| Direction of view | 0° | 0° |
| Depth of field | 3~50 mm | 3~50 mm |
| Maximum | ||
| insertion portion | ||
| width | PU3033AH, PU3033H: 2.7 mm | |
| PU400A, PU411A: 3.2 | 3.2 mm | |
| Working length | PU3033AH, PU3033H: 650 mm | 650 mm |
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Image /page/8/Picture/1 description: The image contains 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 full company name, "Zhuhai Pusen Medical Technology Co., Ltd.," is written in a smaller, gray font.
| | PU400A: 650 mm
PU411A: 680 mm | |
|-------------------------|-----------------------------------------------------------------|----------------------------------|
| Working channel
size | PU3033AH, PU3033H: $\ge$ 1.2 mm
PU400A, PU411A: $\ge$ 5.1 Fr | 1.0 mm |
| Up/down
deflection | Up: 270°
Down: 270° | Up: 270°
Down: 270° |
| Irrigation | Provided | Provided |
| Suction | Provided | Not Provided |
| Sterility | Ethylene Oxide (EO)
SAL: 10-6 | Ethylene Oxide (EO)
SAL: 10-6 |
The subject and the predicate device have different dimensions (e.g., working length, channel size) and illumination source. However, these differences do not raise different questions of safety and effectiveness.
9
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 Ureteroscope and Pusen Single Use Suction Access Ureteroscope 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 breached/compromised or compromised surfaces, contacting tissue for a limited duration (