The Single-use Video Ureterorenoscope (SVU-220US) is intended to be used with the HUGER'S Medical Video Processor (cleared in K230475). The Single-use Video Ureterorenoscope is a single use device. The Single-use Video Ureterorenoscope is consist of distal end, bending section, insertion portion, operational portion and connection portion. The Single-use Video Ureterorenoscope is a single-channel endoscope. Only one instrument channel is in the distal end of the endoscope.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Single-use Video Ureterorenoscope, model SVU-220US), seeking clearance from the FDA. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (Single-use Video Ureterorenoscope, model SVU-220).

This document does not describe the specific acceptance criteria for an AI/CADe device, nor does it detail a study proving such a device meets those criteria. The information provided is for a ureteroscope, which is an optical instrument, not an AI or computer-aided detection/diagnosis (CADe) device.

Therefore, many of the requested details about acceptance criteria, AI performance metrics, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies are not applicable to the information contained in this 510(k) summary.

However, I can extract information related to the device's performance testing and the comparison made for demonstrating substantial equivalence.

Here's a breakdown of the relevant information from the document, acknowledging the limitations regarding AI/CADe systems:

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

The document does not explicitly present "acceptance criteria" in the format of a table with specific thresholds for image quality or clinical performance that would be typical for an AI/CADe device. Instead, it states that the subject device (SVU-220US) and its predicate (SVU-220) comply with various standards to demonstrate performance and safety. The equivalence is primarily based on the devices being "exactly the same" in fundamental technology, optical and physical characteristics, structure, sterilization methods, and components, with one minor difference in deflection marking.

Implicit "Performance" aspects (compared to predicate or standards):

Parameter	Acceptance/Compliance Criterion (Implicit)	Reported Device Performance (Subject Device SVU-220US)
Product Code	FGB (matches predicate)	FGB
Regulation No.	876.1500 (matches predicate)	876.1500
Class	II (matches predicate)	II
Structure & Components	Same as Predicate Device Ureterorenoscope	Same as Predicate Device Ureterorenoscope
Indications for Use	Identical to the Single-use Video Ureterorenoscope component of the predicate device's Indications for Use.	"Single-use Video Ureterorenoscope is intended to connect with Medical Video Processor to provide video imaging." (Identical to predicate's SVU component use)
Single use/Reuse	Single use (matches predicate)	Single use
Sterile	Yes (matches predicate)	Yes
Anatomical Site	Urinary tract and interior of the kidney (matches predicate)	Urinary tract and interior of the kidney
Where used	Hospital (matches predicate)	Hospital
Label/Labeling	Conform with 21CFR Part 801 (matches predicate)	Conform with 21CFR Part 801
Scope type	Flexible (matches predicate)	Flexible
Field of view	120° (matches predicate)	120°
Direction of view	0° (matches predicate)	0°
Depth of field	2-100mm (matches predicate)	2-100mm
Sensor type	CMOS (matches predicate)	CMOS
Max. outer diameter of insertion section	2.9mm (matches predicate)	2.9mm
Up/down deflection	Up: 270°, Down: 270° (matches predicate, though the labeling of up/down for clockwise/counter-clockwise rotation differs)	Up: 270°, Down: 270°
Work length	700mm (matches predicate)	700mm
Minimum instrument channel width	1.2mm (matches predicate)	1.2mm
Product Performance	Comply with ISO 8600-1, ISO 8600-3, ISO 8600-4, ISO 8600-7 (matches predicate)	Comply with ISO 8600-1, ISO 8600-3, ISO 8600-4, ISO 8600-7
Biocompatibility	Meet ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-10 (Irritation) - applied from predicate.	Results of predicate device testing confirm no negative impacts for Cytotoxicity, Sensitization, Intracutaneous. (Subject device shares same raw materials and contact level/duration)
Sterilization Method	EO sterilization, SAL 10^-6 (matches predicate)	EO sterilization, SAL 10^-6
Optical Performance	Passed photobiological safety test (IEC 62471:2006) on predicate; aged and unaged optical performance similar.	"Photobiological safety test was performed according to IEC 62471: 2006 on predicate device;" "The test results demonstrate that the optical performance of the aged endoscope is similar as those of the unaged endoscope."
Physical/Functional	Passed irrigation valve leakage test (on predicate).	"Irrigation valve leakage test was performed on the predicate device."

2. Sample sizes used for the test set and the data provenance

Sample Size: Not explicitly stated in terms of a "test set" for performance evaluation in a quantitative manner as would be done for an AI/CADe. The information provided heavily relies on direct comparison to the predicate device and compliance with general standards. For biocompatibility and optical/physical testing, it states tests were performed on the "predicate device" or "aged/unaged Single-use Video Ureterorenoscope (SVU-220)", implying a sample was used but the size (N) is not given.
Data Provenance: Not specified. The manufacturer is based in Shanghai, China. The document does not indicate if the performance testing data was gathered retrospectively or prospectively, or the country of origin of the physical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the device is a direct imaging instrument, not an AI/CADe system requiring expert ground truth for classification or detection tasks. The "ground truth" for its performance is assessed through engineering and biocompatibility testing against defined industry standards.

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

This is not applicable for the type of device and performance testing described.

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, as this is not an AI-assisted device.

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

Not applicable; this is an instrument, not an algorithm.

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

The "ground truth" for this device revolves around its physical characteristics, material composition, optical performance, and biocompatibility conforming to established international standards (e.g., ISO, ASTM, IEC). There is no "patient outcome" or "pathology" ground truth discussed in the context of validating the device's core functionality as an endoscope. Its function is to provide video imaging to a physician, who then uses clinical judgment.

8. The sample size for the training set

Not applicable; this device does not involve a "training set" as it is not an AI/machine learning product.

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

Not applicable for the same reason as above.

Summary

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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.

July 1, 2024

HUGER Medical Instrument Co., Ltd. Shen Junjie RA Specialist Building 26A, No. 3825, Xinzhuan Highway, Dongjing Town, Songjiang District Shanghai. 201619 CHINA

Re: K241639

Trade/Device Name: Single-use Video Ureterorenoscope (SVU-220US) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Received: June 7, 2024

Dear Shen Junjie:

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.

The FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is

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consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.

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.

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

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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

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Indications for Use

510(k) Number (if known) K241639

Device Name

Single-use Video Ureterorenoscope (SVU-220US)

Indications for Use (Describe)

Single-use Video Ureterorenoscope is intended to connect with Medical Video Processor to provide video imaging.

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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Image /page/4/Picture/0 description: The image shows the logo for Huger Endoscopy System. The word "HUGER" is in large, red, bold letters. Below the word is a thin red line, and below that is the phrase "ENDOSCOPY SYSTEM" in smaller, black letters.

Page 1 of 7 HUGER Medical Premarket Notification Special 510(k) Single-use Video Ureterorenoscope Section 2 510(k) Summary

K241639

Section 2: 510 (k) Summary

SVU-220US Single-use Video Ureterorenoscope

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Image /page/5/Picture/0 description: The image contains the logo for "HUGER ENDOSCOPY SYSTEM". The word "HUGER" is in large, bold, red letters. Underneath "HUGER" is a red line. Below the red line, the words "ENDOSCOPY SYSTEM" are written in a smaller, black font.

510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number:

1. Date of Preparation: 02/16/2023
1. Submitter Identification

HUGER Medical Instrument Co., Ltd.

Building 26A, No. 3825, Xinzhuan Highway, Dongjing Town, Songjiang District, 201619, Shanghai, China.

Establishment Registration Number: Not yet registered.

Contact Person: Shen Junjie Position: RA Specialist Tel: +86-021-67626235 Fax: +86-021-67691721 Email: junjie.shen(@huger.cn

3. Identification of Proposed Device

Trade Name/ Common Name: Single-use Video Ureterorenoscope

Classification Name: Ureteroscope and Accessories, Flexible/rigid Classification: II Product Code: FGB Regulation Number: 21CFR 876.1500 Review Panel: Gastroenterology/Urology

Intended use/ Indications for Use:

Single-use Video Ureterorenoscope is intended to connect with Medical Video Processor to provide video imaging.

Device Description:

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Image /page/6/Picture/0 description: The image shows the logo for Huger Endoscopy System. The word "HUGER" is in large, red, bold letters. Underneath the word "HUGER" is a thin red line. Below the red line, the words "ENDOSCOPY SYSTEM" are written in smaller, black letters.

of the endoscope.

The Single-use Urology Videoscope is sterilized by Ethylene Oxide Gas to achieve a SAL of 10t6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

4. Identification of Predicate Device

510(k) Number: K230475

Product Name: Medical Video Endoscope system

Information on Legally Marketed Predicate Device:

Predicate#	Predicate Trade Name	Product Code
K230475	Single-use Video Ureterorenoscope(model: SVU-220)	FGB

Differences between the subject device and predicate device

The subject and predicate devices have the same fundamental technology, optical and physical characteristics, materials, structure, sterilization methods and components. The only difference is the deflection at the distal end. A comparison between the proposed device and predicate devices is included in the table below:

ITEM	Subject DeviceSingle-use VideoUreterorenoscope (model:SVU-220US)	Predicate DeviceSingle-use VideoUreterorenoscope (model:SVU-220)	Remark
Product Code	FGB	FGB	Same
Regulation No.	876.1500	876.1500	Same
Class	II	II	Same
Structure andcomponents	Image: Subject Device Ureterorenoscope	Image: Predicate Device Ureterorenoscope	Same
Indications for Use	Single-use VideoUreterorenoscope is intended toconnect with Medical Video	Medical Video EndoscopeSystem has been designed to beused with endo-therapy	Similar, referto differenceanalysis ①

	Processor to provide videoimaging	accessories such as abiopsy forceps and otherancillary equipment forendoscopy and endoscopicsurgery within urinary tractand interior of the kidney.Medical Video Processor isintended to be used inconjunction with the endoscopesto enhance and display theimage of the field of view of theendoscope on the monitor, andalso provides functional supplyfor the endoscope.Single-use VideoUreterorenoscope is intended toconnect with Medical VideoProcessor to provide videoimaging.	below
Single use/ Reuse	Single use	Single use	Same
Sterile	Yes	Yes	Same
Anatomical Site	Urinary tract and interior of thekidney	Urinary tract and interior of thekidney	Same
Where used	Hospital	Hospital	Same
Label/Labeling	Conform with 21CFR Part 801	Conform with 21CFR Part 801	Same
	Performance of Single-use Video Ureterorenoscope
Scope type	Flexible	Flexible	Same
Field of view	120°	120°	Same
Direction of view	0°	0°	Same
Depth of field	2-100mm	2-100mm	Same
Sensor type	CMOS	CMOS	Same
Max. outerdiameter ofinsertion section	2.9mm	2.9mm	Same
Up/down deflection	Up:270° Down: 270°	Up:270° Down: 270°	Same
Work length	700mm	700mm	Same
Minimuminstrument channelwidth	1.2mm	1.2mm	Same
ProductPerformance	Comply with ISO 8600-1, ISO8600-3, ISO 8600-4 and ISO8600-7	Comply with ISO 8600-1, ISO8600-3, ISO 8600-4 and ISO8600-7	Same
Deflection	Refer to figure 1 below	Refer to figure 2 below	Different
			refer todifferenceanalysis ②below
Patient-contact component and material
Bending section	Thermoplastic Polyurethane(TPU)	Thermoplastic Polyurethane(TPU)	Same
Insertion section	Thermoplastic Polyurethane(TPU)	Thermoplastic Polyurethane(TPU)
Distal End Section	Polycarbonate (PC)	Polycarbonate (PC)
CMOS Front End	Glass	Glass
Instrument channel	Pebax and Barium sulfate	Pebax and Barium sulfate
Tuohy Borst ValveAssembly	Polycarbonate (PC) andPolyethylene copolymer	Polycarbonate (PC) andPolyethylene copolymer
UV Glue	Epoxy resin	Epoxy resin
Biocompatibility	Cytotoxicity: ISO 10993-5	Cytotoxicity: ISO 10993-5	Same
	Sensitization: ISO 10993-10	Sensitization: ISO 10993-10
	Irritation: ISO 10993-10	Irritation: ISO 10993-10
Sterilization method
Method	EO sterilization	EO sterilization	Same
SAL	10-6	10-6	Same

Comparison Table: Subiect vs. Predicate Device (SVU-220US vs. SVU-220)

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Image /page/7/Picture/0 description: The image shows the logo for Huger Endoscopy System. The word "HUGER" is in large, red, bold letters. Below the word "HUGER" is a thin red line, and below that is the text "ENDOSCOPY SYSTEM" in smaller, black letters.

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Image /page/8/Picture/0 description: The image contains the word "HUGER" in large, bold, red letters. Below the word "HUGER" is a thin red line. Underneath the red line, the words "ENDOSCOPY SYSTEM" are written in a smaller, thinner font, also in red. The text appears to be a logo or brand name.

Difference analysis:

(1) For the difference on Indications of use, since the predicate device includes indications of use of medical video endoscope System, medical video processor and Single-use Video Ureterorenoscope, only the indications of use of single-use Video Ureterorenoscope of the predicate device has been adopted for the subject device SVU-220US. In conclusion, the indications of use of subject device is identical with that of single-use video Ureterorenoscope SVU-220 of predicate device.
(2) The only difference between the subject device and predicate device is deflection at the distal end. For SVU-220US, the direction of the clockwise rotation is marked "up", and that of the counterclockwise rotation is marked as "down". For SVU-220, the direction of the clockwise rotation is marked "down", and that of the counterclockwise rotation is marked as "up".

Figure 1. Deflection of subject device (SVU- Figure 2. Deflection of predicate device 220US) (SVU-220)

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Image /page/9/Picture/0 description: The image shows the logo for Huger Endoscopy System. The word "HUGER" is in large, red, bold letters. Underneath the word "HUGER" is a thin red line, and underneath the line is the phrase "ENDOSCOPY SYSTEM" in smaller, black letters.

Image /page/9/Figure/2 description: The image shows a diagram of a hand holding a medical instrument. The diagram shows the instrument being moved up and down. The words "Up" and "Down" are written above the instrument to indicate the direction of movement. There are two sets of diagrams, one on the left and one on the right, showing the same movement.

ડ. Non-Clinical Test Conclusion

Since the subject device is exactly the same as the predicate device in terms of fundamental technology, optical and physical characteristics, structure, sterilization methods and components, the only difference between these models is deflection at their distal end, and through a risk analysis was completed to identify the risks associated with assembly process in production, but not in product design. HUGER Medical believed that the verification testing of Predicate device (SVU-220) can be fully covered with subject device (SVU-220US).

Therefore, the subject device also complies with the following standards:

ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials
A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ISO 8600-1:2015 Endoscopes-Medical endoscopes and endotherapy devices - Part 1: General requirements
ISO 8600-3:1997/Amd1:2003 Optics and optical instruments -Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics
A ISO 8600-4:2014 Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
A ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
A ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
60601-1-2005+CORR.1:2006+CORR.2:2007+AM1:2012, IEC Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance, including the US National Differences
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic disturbances -

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Image /page/10/Picture/0 description: The image shows the logo for Huger Endoscopy System. The word "HUGER" is in large, red, bold letters. Below the word "HUGER" is a thin red line. Below the red line, the words "ENDOSCOPY SYSTEM" are in smaller, black letters.

Requirements and tests

IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and > Systems
A ISO 14971:2019 Medical Devices - Application of risk management to medical devices
IEC 62471:2006 Photobiological safety of lamps and lamp systems

Biocompatibility testing

Since the raw materials of the subject device is exactly the same as that of predicate device The contact level of the subject device is mucosal membrane, and the contact duration is limited contact (<24 hours). Therefore, the biocompatibility testing results of the predicate device apply to the subject device. The results of the biocompatibility testing as following showed that there are no negative impacts from the materials that are used in the predicate device.

A Cytotoxicity,
A Sensitization,
Intracutaneous,

Bench performance testing

Optical performance testing

A Photobiological safety test was performed according to IEC 62471: 2006 on predicate device;

Physical/functional performance testing

A Irrigation valve leakage test was performed on the predicate device.

Endoscope and video processor use-life testing

The optical performance comparison test was conducted on the un-aged Single-use Video Ureterorenoscope (SVU-220) and aged Single-use Video Ureterorenoscope (SVU-220). The test results demonstrate that the optical performance of the aged endoscope is similar as those of the unaged endoscope.

6. Clinical Test Conclusion

No Clinical study is included in this submission

7. Substantially Equivalent (SE) Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, the Singleuse Video Ureterorenoscope (Model: SVU-220US) is substantially equivalent to the predicate devices.

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.