(113 days)
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.
The Single-use Flexible ureteroscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and endoscopic surgery within urinary tract and kidney in adults. The Single-use Flexible ureteroscope is provided sterile (sterilized by EO) and intended to be single-use. The compatible Digital Video Monitor: Model: DVM-A1. The Single-use Flexible ureteroscope and Display Unit make up the video ureteroscope system. During diagnosis and treatment with the video ureteroscope system, the Single-use Flexible ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the image sensor (CMOS) at the end of the Single-use Flexible ureteroscope converts the received mucosal reflected light signals into electrical signals, transmitted to the Display Unit through the cable, the Display Unit receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display. There are 4 models of Single-Use Flexible Ureteroscope, the difference between US-S170 and US-E170,US-S180 and US-E180 lies in the US-SXXX series with self-lock and suction function, US-EXXX series does not come with self-lock and suction functions, the rest is exactly the same. The difference between the 2 models of US-EXXX series lies in work channel ID, head OD and outer diameter of main hose OD, while the rest are exactly the same. The difference between the 2 models of US-SXXX series also lies in work channel ID, head OD and outer diameter of main hose OD, and the rest are the same. The Single-use Flexible Ureteroscope includes insertion part, control part, connection part. The control part is made with ABS, contacted with users. The insertion part, as the part connected with patients, includes the sheath which is braided tube made with PEBAX tube, the bending section and the distal end. The bending section is made of snake bone, covered with snake bend eraser. The distal end is made of sensor and LED.
The provided text describes the regulatory filing for a medical device (Single-use Flexible Ureteroscope) and details the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria related to its performance in a clinical setting or its impact on human readers, especially regarding AI assistance. The document focuses on physical, optical, electrical and biocompatibility performance.
Therefore, I cannot provide the requested information about acceptance criteria for clinical performance or studies involving human readers/AI assistance based on the text.
However, I can extract information regarding the non-clinical performance acceptance criteria and proof as described in the document.
Here's an interpretation based on the provided text, focusing on the available non-clinical performance and acceptance testing:
Device: Single-use Flexible Ureteroscope
Study Type: Non-clinical Performance Testing and Biocompatibility Testing (for 510(k) Substantial Equivalence)
1. Table of Acceptance Criteria (Non-Clinical) and Reported Device Performance:
The document mentions that "All evaluation acceptance criteria were met" for biocompatibility and that the device "complies with" relevant electrical safety and EMC standards. For functional, mechanical, and optical performance, it lists the tests performed, implying that the device passed these tests to demonstrate equivalence. Specific quantitative acceptance values are not explicitly stated for all tests, but compliance with standards and successful completion of tests serve as the "proof."
| Category | Test Performed | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | No Cytotoxicity (as per ISO 10993-1:2018) | Met acceptance criteria |
| Irritation | No Irritation to Skin (as per ISO 10993-1:2018) | Met acceptance criteria | |
| Sensitization | No significant evidence of sensitization (as per ISO 10993-1:2018) | Met acceptance criteria | |
| Pyrogenicity | (Not explicitly stated for acceptance, but implied by ISO) | Met acceptance criteria | |
| Acute Systemic Toxicity | (Not explicitly stated for acceptance, but implied by ISO) | Met acceptance criteria | |
| Sterility | Sterile barrier systems evaluation | Compliance with ISO 11607 | Complies |
| Sterilization process validation | Compliance with ISO 11135 | Validated | |
| Electrical Safety | Electrical safety testing | Compliance with IEC 60601-1 and IEC 60601-2-18 | Complies |
| Electromagnetic | EMC testing | Compliance with IEC 60601-1-2 | Complies |
| Functional Performance | Appearance, Working length, Work channel ID, Head OD, Outer diameter of main hose, Max outer diameter of insertion part, Bending angle, Product weight, Rotating sleeve, Handle-based photographing function, Self-locking function, Wire length, Image display, Waterproofness, Lens fogging, Image quality, LED illuminance test, LED color temperature test, Air tightness test, Suction ability, Water delivery ability, LED temperature test | Met design specifications and intended performance | Passed/Met (Implied by conclusion of substantial equivalence) |
| Mechanical Performance | Handle-based camera button reliability, Passively bent part reliability, Self-locking component reliability, Insertion end tension, Pull out tension of plug end | Met design specifications and intended performance | Passed/Met (Implied by conclusion of substantial equivalence) |
| Optical Performance | Direction of view, Field of view, Observation depth of field, Geometric distortion, SNR, Dynamic tolerance, Brightness uniformity | Met design specifications and intended performance | Passed/Met (Implied by conclusion of substantial equivalence) |
| Color Performance | Color restoration test | Met design specifications and intended performance | Passed/Met (Implied by conclusion of substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for each test. These are non-clinical (bench) tests, so the "sample size" would refer to the number of device units tested. This might range from a few units to a statistically significant number depending on the specific test and standard, but the document does not specify.
- Data Provenance: The tests were conducted internally by the manufacturer (Hunan Vathin Medical Instrument Co., Ltd.) or by accredited labs on their behalf, likely in China given the company's location. This is inherently retrospective data gathered for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This section typically applies to studies where human interpretation of medical images or clinical data is involved. Since this document describes non-clinical, bench testing, no human experts were used to establish a "ground truth" in the clinical sense. The "ground truth" for these tests are the objective measurements against engineering specifications and international standards.
4. Adjudication Method for the Test Set:
- Not Applicable. As no human interpretation and subsequent need for consensus are involved in these non-clinical tests, no adjudication method was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not describe any MRMC study. There is no mention of human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-loop) Performance:
- No. This device is an endoscope, not an AI algorithm. Therefore, "standalone" AI performance is not applicable. The performance described is the inherent performance of the optical, mechanical, and electrical components of the device itself.
7. Type of Ground Truth Used:
- For Biocompatibility, Electrical Safety, EMC, and Sterility: Adherence to International Standards (e.g., ISO 10993, ISO 11607, ISO 11135, IEC 60601 series) and Regulatory Requirements.
- For Functional, Mechanical, and Optical Performance: Engineering Specifications and Design Requirements agreed upon during device development.
8. Sample Size for the Training Set:
- Not Applicable. This device is a physical instrument, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As above, no training set is involved.
In summary, the provided FDA clearence letter and supporting summary pertains to the substantial equivalence of a physical medical device (endoscope) based on its non-clinical performance and safety characteristics, not on the performance of a diagnostic AI algorithm or its impact on human readers.
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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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
May 18, 2023
Hunan Vathin Medical Instrument Co., Ltd. Du Jing RA Manager 1/F, Building 12, Innovation Entrepreneurship Service Center No.9 Chuangi West Road, Jiuhua Economic Development Zone Xiangtan, Hunan 411100 China
Re: K230200
Trade/Device Name: Single-use Flexible Ureteroscope Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: April 18, 2023 Received: April 19, 2023
Dear Du Jing:
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.
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.
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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 (QS) 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 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 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
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Indications for Use
510(k) Number (if known) K230200
Device Name Single-use Flexible Ureteroscope
Indications for Use (Describe)
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.
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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Section 5 510(k) summary
Submitter
| Device submitter: | Hunan Vathin Medical Instrument Co., Ltd. | |
|---|---|---|
| Address: | 1/F, Building 12, Innovation and Entrepreneurship Service Center, | |
| No 9 Chuanqi west road, Jiuhua Economic Development Zone, | ||
| 411100 Xiangtan, Hunan, China | ||
| Contact person: | Du Jing | |
| Title: RA Manager | ||
| Phone: +86-18915069265 | ||
| E-mail: charlene@vathin.com |
Device
Trade Name of Device: Single-use Flexible Ureteroscope Common name: Ureteroscope and Accessories, Flexible/rigid Classification name: Endoscope and accessories Classification: Class II, 21 CFR 876.1500 Product Code: FGB Review Panel: Gastroenterology/Urology Date prepared: January 18, 2023
Predicate Device
| Trade name: | Medical Video Endoscope system. |
|---|---|
| Regulation number: | 21 CFR 876.1500 |
| Regulation name: | Ureteroscope and Accessories, Flexible/rigid |
| Regulatory class: | Class II |
| Product code: | FGB |
| Submitter: | Zhuhai Pusen Medical Technology Co., Ltd. |
| 510(k) number: | K172098 |
Device description
The Single-use Flexible ureteroscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and endoscopic surgery within urinary tract and kidney in adults. The Single-use Flexible ureteroscope is provided sterile (sterilized by EO) and intended to be singleuse.
The compatible Digital Video Monitor: Model: DVM-A1
The Single-use Flexible ureteroscope and Display Unit make up the video ureteroscope system. During diagnosis and treatment with the video ureteroscope system, the Single-use Flexible ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the
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image sensor (CMOS) at the end of the Single-use Flexible ureteroscope converts the received mucosal reflected light signals into electrical signals , transmitted to the Display Unit through the cable, the Display Unit receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display.
There are 4 models of Single-Use Flexible Ureteroscope, the difference between US-S170 and US-E170,US-S180 and US-E180 lies in the US-SXXX series with self-lock and suction function, US-EXXX series does not come with self-lock and suction functions, the rest is exactly the same. The difference between the 2 models of US-EXXX series lies in work channel ID, head OD and outer diameter of main hose OD, while the rest are exactly the same. The difference between the 2 models of US-SXXX series also lies in work channel ID, head OD and outer diameter of main hose OD, and the rest are the same.
The Single-use Flexible Ureteroscope includes insertion part, control part, connection part. The control part is made with ABS, contacted with users. The insertion part, as the part connected with patients, includes the sheath which is braided tube made with PEBAX tube, the bending section and the distal end. The bending section is made of snake bone, covered with snake bend eraser. The distal end is made of sensor and LED.
Indications for use
The indications for use of subject and predicate device are the same. Both of the subject and predicate device are indicated for endoscopy and endoscopic surgery within urinary tract and kidney. The indications for use of subject device: 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. The indications for use of predicate device: 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.
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Comparison of technological characteristics with the predicate devices
The Single-Use Flexible Ureteroscope is like the predicate device in the following areas:
- Intended use (including application field, intended user and patient population) .
- . Principal operation
- Design and performance specifications .
- Digital video technology and illumination source .
- It allows for irrigation .
- It is single-use and delivered sterile .
The Single-Use Flexible Ureteroscope is different to the predicate device in the following areas:
- The bending angle is larger than the predicate .
- There are 4 specifications while predicate device has 2 specifications .
- Working length is 700mm while working length of predicate device is 650mm .
The differences between the Single-Use Flexible Ureteroscope and predicate device do not alter suitability of the proposed device for its intended use.
| Device feature | Proposed Device | Predicate Device |
|---|---|---|
| Trade Name | Single-Use Flexible Ureteroscope | Medical Video Endoscopesystem(K172098) |
| ClassificationName | Endoscope and accessories | Endoscope and accessories |
| Product Code | FGB | FGB |
| RegulationNumber | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Indications for use | The Single-use Flexible Ureteroscope isdesigned for use with Vathin DisplayUnits, endotherapy accessories and otherancillary devices for the endoscopy andendoscopic surgery within urinary tractand kidney in adults. | This instrument has been designed to beused with endo-therapy accessories suchas a biopsy forceps and other ancillaryequipment for endoscopy and endoscopicsurgery within urinary tract and interior ofthe kidney. |
| Applicationfield | The device is for use in a hospital orqualified medical institution. | The Medical Video Endoscope system isfor use in a hospital or qualified medicalinstitution. |
| Intended user | The device is only to be used by skilledmedical staff trained in clinical endoscopictechniques and procedures. | The system is only to be used by skilledphysicians trained in clinical endoscopictechniques and procedures. |
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| Device feature | Proposed Device | Predicate Device |
|---|---|---|
| Trade Name | Single-Use Flexible Ureteroscope | Medical Video Endoscopesystem(K172098) |
| Patientpopulation | Adults | Adults |
| Scope type | Flexible | Flexible |
| Field of view(degree) | 110° | 120° |
| Directionofview (degree) | 0° | 0° |
| Bending angle(degree) | Up: 285°Down: 285° | Up: 270°Down: 270° |
| Maximuminsertionportionwidth(mm) | US-S170、US-E170: 3.15US-S180、US-E180: 3.25 | 3.2 |
| Minimuminsertionchannelwidth(mm) | US-S170、US-E170: 1.2US-S180、US-E180: 1.4 | 1.0 |
| Working length(mm) | 700 | 650 |
| Digitalvideotechnology | CMOS | CMOS |
| Illuminationsource | LED | LED |
| Single-use | Yes | Yes |
| Biocompatibility | No CytotoxicityNo Irritation to SkinNo significant evidence of sensitization | No CytotoxicityNo Irritation to SkinNo significant evidence of sensitization |
| Sterilization | EO | EO |
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Summary of Non-clinical tests:
Biocompatibility testing
Biocompatibility of the Single-Use Flexible Ureteroscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "breached or compromised surface" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation, Sensitization, Pyrogenicity and Acute systemic toxicity. All evaluation acceptance criteria were met.
Sterility testing
Sterile barrier systems were evaluated in accordance with ISO 11607. Sterilization Process has been validated accordance with ISO 11135.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Single-Use Flexible Ureteroscope. The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC.
Performance testing
The following performance testing was conducted on the Single-Use Flexible Ureteroscope.
Functional performance
- Appearance ●
- . Working length
- Work channel ID ●
- Head OD .
- Outer diameter of main hose .
- . Maximum outer diameter of the insertion part
- Bending angle
- Product weight ●
- . Rotating sleeve
- Handle-based photographing function
- Self-locking function
- . Wire length
- Image display
- . Waterproofness
- . Lens fogging
- Image quality
- LED illuminance test ●
- LED color temperature test ●
- . Air tightness test
- Suction ability .
- Water delivery ability .
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- . LED temperature test
Mechanical performance
- Handle-based camera button reliability test .
- Passively bent part reliability test
- . Self-locking component reliability test
- Insertion end tension
- . Pull out tension of plug end
Optical performance
- . Direction of view
- field of view test
- observation depth of field test
- geometric distortion test .
- . SNR test
- . dynamic tolerance test
- . brightness uniformity test
Color performance
- . color restoration test
Conclusion
The Single-Use Flexible Ureteroscope is substantially equivalent to predicate device.
The non-clinical testing demonstrates that the device is as effective and performs as well as the legally marketed device.
§ 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.