(203 days)
Not Found
No
The document describes a standard digital endoscope and image processor. While it mentions image processing, there is no indication of AI or ML being used for analysis, interpretation, or any other function. The performance studies focus on standard optical, mechanical, and safety parameters, not AI/ML performance metrics.
No
The device is primarily used for diagnostic purposes by providing images for inspection. While it allows for the use of accessories for treatment (e.g., lithotripsy), its core stated function is imaging and inspection, rather than directly applying a therapeutic effect itself. The device is a tool that facilitates therapeutic procedures.
Yes
This device is used for "endoscopic imaging of the ureter and the renal pelvis for the purpose of diagnosis and treatment." The explicit mention of "diagnosis" indicates its diagnostic capability.
No
The device description clearly outlines a physical endoscope with a CMOS chip, working channel, and flexible insertion portion, which are hardware components. The performance studies also detail testing of mechanical characteristics, optical measurements, and electrical safety, all related to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside the body (in vitro).
- Device Function: This device is an endoscope that is inserted into the human body (in vivo) to visualize the ureter and renal pelvis. It provides images for diagnosis and treatment, but it does not perform tests on samples taken from the body.
- Intended Use: The intended use clearly states it's used to "enter human body through the urethra and provide images via video monitor, and realize endoscopy inspection or operation." This is an in-vivo procedure.
Therefore, this device falls under the category of a medical device used for imaging and intervention within the body, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
As a disposable medical device, the product is used along with the company's image processor, to enter human body through the urethra and provide images via video monitor, and realize endoscopy inspection or operation to the patient's ureter and renal pelvis.
Product codes
FGB
Device Description
The Single-Use Digital Flexible Ureteroscope (Model: PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) is an endoscope which is used with the Monitor for Single-Use Endoscopy (Model:P1-D) produced by ENDOSO LIFE TECHNOLOGY for providing endoscopic imaging of the ureter and the renal pelvis for the purpose of diagnosis and treatment. The Single-Use Digital Flexible Ureteroscope is integrated with a working channel which allowing the use of flexible endoscopic accessories (e.g. stone basket, forceps, laser fibers for lithotripsy, etc.). The insertion portion of the endoscope is flexible, and the shape changes corresponding to the shape of the cavity. Anatomical images are captured by a CMOS chip at the distal end of the endoscope and the electronic signals are transmitted to the Monitor. Then, the resulting picture images are sent to and shown on a visual display. Mechanism of action: The light emitted by the LED cold light source at the distal tip of the disposable Single-Use Digital Flexible Ureteroscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Monitor via the VI circuit. The Monitor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The Monitor also controls the brightness of the LEDs on the endoscope. Single-Use Digital Flexible Ureteroscope has the following physical and performance characteristics:
- Maneuverable tip controlled by the user
- Flexible insertion cord
- Camera and LED light source at the distal tip
- Sterilized by Ethylene Oxide
- For single use
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS image sensor (Endoscopic imaging)
Anatomical Site
ureter and renal pelvis (through the urethra)
Indicated Patient Age Range
Adults
Intended User / Care Setting
Use in a Healthcare facility/hospital environment by trained surgical physicians who are familiar with endoscopic procedures.
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)
The Single-Use Digital Flexible Ureteroscope was designed to comply with applicable parts of ISO 8600. Optical measurements were performed according to applicable part of ISO 8600 standard. Mechanical characteristics were tested and include leakage tightness, bending, deflection endurance, withstand of channel. Photobilogical safety of lamps test according to IEC 62471. In addition, comparative testing related to image quality parameters including Color performance (color reproduction), optical performance (resolution, depth of field and image intensity uniformity, distortion), and dynamic range test was performed for submitted Single-Use Digital Flexible Ureteroscope and the predicate device to support substantial equivalence. Biocompatibility evaluation was performed according to ISO 10993-1 and FDA Guidance, including Cytotoxicity, Sensitization, Material-mediated pyrogenicity, and Acute systemic toxicity. The sterilization method was validated to ISO 11135:2014, and EO/ECH residual test was performed according to ISO 10993-7:2008. Shelf life was determined based on stability study including accelerated aging test according to ASTM F1980-16. Package integrity testing was conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, and F88/F88M-15, ASTM F 1929-15, as well as transport and shipping testing as per ASTM D4169-16. Electrical safety and EMC data complied with ANSI/AAMI ES:60601-1:2005/A2:2010, IEC 60601-2-18:2009, and IEC 60601-1-2:2014. No clinical studies were required.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
January 22, 2025
Hunan Endoso Life Technology Co., Ltd. % Eric Zhang RA manager Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza, West Guangzhong Road 555, Jingan District Shanghai, 200000 CHINA
Re: K241956
Trade/Device Name: Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: December 23, 2024 Received: December 23, 2024
Dear Eric Zhang:
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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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
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 J. Antonino -S
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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)
Indications for Use (Describe)
As a disposable medical device, the product is used along with the company's image processor, to enter human body through the urethra and provide images via video monitor, and realize endoscopy inspection or operation to the patient's ureter and renal pelvis.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
510(k) Summary
| Date Prepared: | April 3. 18th, 2024 |
|---|---|
| Manufacturer: | Hunan Endoso Life Technology Co., Ltd. |
| 4th floor, Building 10, Innovation and | |
| Entrepreneurship Center, 31 Dongfeng Road, Heping | |
| Street, Xiangtan Economic Development | |
| District,HuNan,China 411199 | |
| Contact Person: | WangFu/RA Manager |
| Hunan Endoso Life Technology Co., Ltd. | |
| Tel: (86) 0731-52331999 | |
| Email: wangfu@endoso.com.cn | |
| Submission Correspondent: | Mr.Eric Zhang |
| Landlink Healthcare Technology (Shanghai) Co., Ltd. | |
| Email: eric.zhang@landlink-health.com | |
| Identification of the Device: | |
| Proprietary/Trade Name: | Single-Use Digital Flexible Ureteroscope |
| Model: | PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, |
| PUR12-6, PUR12-S, PUR12-S1, PUR12-S2 | |
| Common Name: | Ureteroscope and accessories, flexible/rigid |
| Regulatory Number: | 21 CFR Part 876.1500 |
| Product Code: | FGB |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
| Predicate Device: | |
| 510(k) Number : | K230200 |
| Trade name : | Single-Use Flexible Ureteroscope |
| Classification Name: | Endoscope and accessories |
| Regulatory Number: | 21 CFR Part 876.1500 |
| Product Code: | FGB |
| Device Class: | Class II |
Device Description:
The Single-Use Digital Flexible Ureteroscope (Model: PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) is an endoscope which is used with the Monitor for Single-Use Endoscopy (Model:P1-D) produced by ENDOSO LIFE TECHNOLOGY for providing endoscopic imaging of the ureter and
5
the renal pelvis for the purpose of diagnosis and treatment. The Single-Use Digital Flexible Ureteroscope is integrated with a working channel which allowing the use of flexible endoscopic accessories (e.g. stone basket, forceps, laser fibers for lithotripsy, etc.). The insertion portion of the endoscope is flexible, and the shape changes corresponding to the shape of the cavity. Anatomical images are captured by a CMOS chip at the distal end of the endoscope and the electronic signals are transmitted to the Monitor. Then, the resulting picture images are sent to and shown on a visual display. Mechanism of action:
The light emitted by the LED cold light source at the distal tip of the disposable Single-Use Digital Flexible Ureteroscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Monitor via the VI circuit. The Monitor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The Monitor also controls the brightness of the LEDs on the endoscope.
Single-Use Digital Flexible Ureteroscope has the following physical and performance characteristics:
- Maneuverable tip controlled by the user
- Flexible insertion cord
- Camera and LED light source at the distal tip
- Sterilized by Ethylene Oxide
- For single use
Indications for Use:
As a disposable medical device, the product is used along with the company's image processor, to enter human body through the urethra and provide images via video monitor, and realize endoscopy inspection or operation to the patient's ureter and renal pelvis.
Comparison with Predicate Device:
The Single-Use Digital Flexible Ureteroscope and its predicate device, Hunan Vathin Medical Instrument Co., Ltd. (K230200) have the same intended use, sterilization Methods and similar physical characteristics, optical characteristics.
Substantial Equivalence:
The Single-Use Digital Flexible Ureteroscope employs the same fundamental scientific technology as its predicate devices, as below table:
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| Subject Device | Predicate Device K230200 | Comparison | |
|---|---|---|---|
| Trade Name | Single-Use Digital | ||
| Flexible Ureteroscope | Single-Use Flexible | ||
| Ureteroscope | / | ||
| Classification | |||
| Name | Endoscope and | ||
| accessories | Endoscope and accessories | / | |
| Product | |||
| Code | FGB | FGB | / |
| Regulation | |||
| Number | 21 CFR 876.1500 | 21 CFR 876.1500 | / |
| Indications | |||
| for | |||
| use | As a disposable | ||
| medical device, the | |||
| product is used along | |||
| with the company's | |||
| image processor, to | |||
| enter human body | |||
| through the urethra | |||
| and provide images | |||
| via video monitor, and | |||
| realize endoscopy | |||
| inspection or | |||
| operation to the | |||
| patient's ureter and | |||
| renal pelvis. | The Single-use Flexible | ||
| Ureteroscope is | |||
| designed for use with | |||
| Vathin Display | |||
| Units, endotherapy | |||
| accessories and other | |||
| ancillary devices for the | |||
| endoscopy and | |||
| endoscopic surgery within | |||
| urinary tract | |||
| and kidney in adults. | Same | ||
| Application | |||
| field | The device is for use | ||
| in a hospital or | |||
| qualified medical | |||
| institution. | The device is for use in a | ||
| hospital or | |||
| qualified medical | |||
| institution. | Same | ||
| Intended | |||
| user | Use in a Healthcare | ||
| facility/hospital | |||
| environment by | |||
| trained surgical | |||
| physicians who are | |||
| familiar with | |||
| endoscopic | |||
| procedures. | The device is only to be | ||
| used by skilled | |||
| medical staff trained in | |||
| clinical endoscopic | |||
| techniques and procedures. | Same | ||
| Patient | |||
| population | Adults | Adults | Same |
| Subject Device | Predicate Device K230200 | Comparison | |
| Field of | |||
| view | |||
| (degree) | $120°±10%$ | $110°$ | Similar 1 |
| Direction of | |||
| view | |||
| (degree) | $0°$ | $0°$ | Same |
| Bending | |||
| angle | |||
| (degree) | $260°~300°$ | Up: $285°$ | |
| Down: $285°$ | Similar 2 | ||
| Maximum | |||
| insertion | |||
| portion | |||
| width(mm) | $≤2.6mm$ (7.7Fr) | 3.15 | Similar 3 |
| Minimum | |||
| insertion | |||
| channel | |||
| width(mm) | 1.2 | 1.2 | Same |
| Working | |||
| length | |||
| (mm) | $670±3%$ | 700 | Similar 4 |
| Working | |||
| length | |||
| (mm) | CMOS | CMOS | Same |
| Illumination | |||
| source | LED | LED | Same |
| Single-use | Yes | Yes | Same |
| Sterilization | EO | EO | Same |
7
Analysis of similar1:
The Field of View of the subject device is similar as the predicate device.The optical performance of the subject device was tested and the results met the ISO 8600 series, this difference will not raise any issues in safety and effectiveness.
Analysis of similar 2:
The Bending angle (degree) of the subject device is similar as the predicate device.All the performance was tested and the results met the standard requirements, this difference will not raise any issues in safety and effectiveness.
Analysis of similar 3:
8
The Maximum insertion width(mm of the subject device is thinner than the predicate device. All the performance was tested and the results met the standard requirements, this difference will not raise any issues in safety and effectiveness.
Analysis of similar 4:
The Working length (mm) of the subject device is similar as the predicate device.All the performance was tested and the results met the standard requirements, this difference will not raise any issues in safety and effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions
The Single-Use Digital Flexible Ureteroscope was designed to comply with applicable parts of ISO 8600. Optical measurements were performed according to applicable part of ISO 8600 standard.
Mechanical characteristics were tested and include leakage tightness, bending, deflection endurance, withstand of channel. Photobilogical safety of lamps test according to IEC 62471.
In addition, comparative testing related to image quality parameters including Color performance (color reproduction), optical performance (resolution, depth of field and image intensity uniformity, distortion), and dynamic range test was performed for submitted Single-Use Digital Flexible Ureteroscope and the predicate device to support substantial equivalence.
In addition to above, subject device has also performed following non-clinical performances testing:
Biocompatibility
The biocompatibility evaluation for the patient contacting components of the Single-Use Digital Flexible Ureteroscope was performed according to ISO 10993-1 and FDA Guidance. The following tests were conducted based contact category of "Surface-Breached or compromised surface" with a contact duration of "Limited (