The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.

Device Description

The Single-use Flexible Cystoscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and treatment of adult bladder.

AI/ML Overview

This document describes the validation of a Single-Use Flexible Cystoscope (K221580), comparing it to a predicate device, the Ambu Ascope 4 Cysto (K193095).

Based on the provided text, there is no detailed study described that proves the device meets specific acceptance criteria based on clinical outcomes or performance metrics suitable for a table of reported device performance. The document primarily focuses on non-clinical testing to demonstrate substantial equivalence to the predicate device.

Here's an analysis of the provided information relative to your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document lists numerous performance tests conducted. For each of these, acceptance criteria would have been established internally by the manufacturer, and the device's performance would have been compared against these. However, these specific acceptance criteria and the quantified reported device performance (e.g., 'Bending angle: device achieved X degrees vs. acceptance criteria Y degrees') are NOT provided in this FDA 510(k) summary. The document only states that "All evaluation acceptance criteria were met" for biocompatibility and that the system "complies" with electrical safety and EMC standards, and that various performance tests were "conducted."

Therefore, a table cannot be fully constructed with the information given. The types of performance tests conducted are:

Performance Characteristic	Specific Test / Measurement	Reported Device Performance (Not provided in detail)	Acceptance Criteria (Not provided in detail)
Physical Dimensions	Appearance, Working length, Work channel ID, Head OD, Outer diameter of main hose, Maximum outer diameter of the insertion part, Product weight, Cable length	Stated to meet criteria	(Internal Manufacturer Spec)
Mechanical Performance	Bending angle, Rotating sleeve	Stated to meet criteria	(Internal Manufacturer Spec)
Functional Performance	Handle-based photographing function, Image display, Waterproofness, Direction of view, Lens fogging, Suction ability, Water delivery ability, Handle-based camera button reliability test, Air tightness test	Stated to meet criteria	(Internal Manufacturer Spec)
Imaging Performance	Image quality, Field of view test, Resolution test, Observation depth of field test, Geometric distortion test, SNR test, Dynamic tolerance test, Brightness uniformity test, Color reduction test	Stated to meet criteria	(Internal Manufacturer Spec)
Illumination Performance	LED illuminance test, LED color temperature test, LED temperature test	Stated to meet criteria	(Internal Manufacturer Spec)
Biocompatibility	Cytotoxicity, Irritation, Sensitization, Pyrogenicity, Acute systemic toxicity (evaluated per ISO 10993-1:2018 for "Surface – Mucosal Membrane" with contact < 24 hours)	"All evaluation acceptance criteria were met"	Per ISO 10993-1:2018
Electrical Safety / EMC	Electrical safety per IEC 60601-1 and IEC 60601-2-18, Electromagnetic compatibility (EMC) per IEC 60601-1-2	"Complies with" standards	Per IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2

2. Sample size 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 sample sizes for the non-clinical tests in terms of the number of devices tested for each characteristic. These tests are typically performed on a representative sample of devices.
Data Provenance: The tests were conducted by the manufacturer, Hunan Vathin Medical Instrument Co., Ltd., which is based in China. The data is from non-clinical bench testing, not patient data. Therefore, it is neither retrospective nor prospective in the clinical sense.

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)

Not applicable. This document describes non-clinical performance and safety testing (e.g., measuring bending angle, image resolution, electrical safety). There is no "ground truth" derived from expert clinical assessment for this type of testing. Ground truth, in this context, would be the precisely measured physical or electrical properties per engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As this is non-clinical bench testing, there are no "readers" or adjudication methods as would be found in clinical studies involving interpretation of images or patient data by multiple experts. The tests are based on objective measurements against engineering specifications.

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 MRMC study was done. This device is a flexible cystoscope, a medical instrument, not an AI-powered diagnostic algorithm. It is a tool used by human operators. The concept of "human readers improve with AI vs without AI assistance" does not apply to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical instrument, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance and safety tests, the "ground truth" is derived from established engineering standards, test methods, and predefined measurement tolerances described in relevant international standards (e.g., ISO, IEC). For example, a "bending angle" test measures the actual mechanical bending angle of the scope, which is then compared against a specified design tolerance. It's objective measurement against a technical specification, not clinical ground truth like pathology.

8. The sample size for the training set

Not applicable. This is a hardware device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set is involved.

In summary: The provided 510(k) summary focuses on demonstrating the substantial equivalence of the Single-Use Flexible Cystoscope through comprehensive non-clinical bench testing and adherence to recognized standards for biocompatibility and electrical safety. It does not include clinical studies, expert consensus reviews, or AI performance evaluations. The specific acceptance criteria and the quantitative performance results for each non-clinical test are not detailed in this public FDA summary.

Summary

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November 17, 2022

Hunan Vathin Medical Instrument Co., Ltd. Du Jing RA Manager, RA Department 1/F, Building 12, Innovation and Entrepreneurship Service Ctr, No. 9 Chuanqi West Road Jiuhua Economic Dev. Zone Xiangtan, Hunan 411100 CHINA

Re: K221580

Trade/Device Name: Single-Use Flexible Cystoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: October 19, 2022 Received: October 19, 2022

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

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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-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 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,

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) K221580

Device Name Single-use Flexible Cystoscope

Indications for Use (Describe)

The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.

Type of Use (Select one or both, as applicable)

X 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

ll 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: +86-731-55558558
	E-mail: charlene@vathin.com

II Device

Trade Name of Device: Single-Use Flexible Cystoscope Common name: Cystoscope and Accessories, Flexible/rigid Classification: Class II, 21 CFR 876.1500 Product Code: FAJ Review Panel: Gastroenterology/Urology

III Predicate Device

Trade name:	Ambu AScope 4 Cysto
Regulation number:	21 CFR 876.1500
Regulation name:	Cystoscope and Accessories, Flexible/rigid
Regulatory class:	Class II
Product code:	FAJ
Submitter:	Ambu A/S
510(k) number:	K193095

IV Device description

The Single-use Flexible Cystoscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and treatment of adult bladder.

V Indications for use

The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.

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VI Comparison of technological characteristics with the predicate devices

The Single-Use Flexible Cystoscope is similar to 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 Cystoscope is different to the predicate device in the following areas:

The bending angle is larger than the predicate .
There are 10 specifications while predicate device has 1 specification .
Working length is 450mm while working length of predicate device is 390mm .

The differences between the Single-Use Flexible Cystoscope and predicate device do not alter suitability of the proposed device for its intended use.

VII Summary of Non-clinical tests:

Biocompatibility testing

Biocompatibility of the Single-Use Flexible Cystoscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface – Mucosal Membrane" 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.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Single-Use Flexible Cystoscope. 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 Cystoscope:

Appearance
. Working length
Work channel ID ●
Head OD .

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Outer diameter of main hose ●
. Maximum outer diameter of the insertion part
. Bending angle
Product weight .
Rotating sleeve
Handle-based photographing function ●
Cable length
. Image display
Waterproofness .
Direction of view ●
Lens fogging ●
Image quality
LED illuminance test .
LED color temperature test
Air tightness test .
Suction ability ●
Water delivery ability ●
LED temperature test ●
. Handle-based camera button reliability test
field of view test ●
resolution test ●
observation depth of field test ●
geometric distortion test
SNR test ●
dynamic tolerance test ●
brightness uniformity test .
. color reduction test

VIII Conclusion

The Single-Use Flexible Cystoscope is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is safe and effective.

Regulation Number and Section

§ 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.