The device has been developed to be used with endoscopic accessories such as a biopsy forceps and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.

Device Description

The Single-Use Video Flexible Ureterorenoscope System consists of a sterile Single-Use Video Flexible Ureterorenoscope (consists of handle and insertion portion) and an Endoscopic Video Image Processor (the video system, touch PC ) with its accessories power adapter, footswitch.The Ureterorenoscope is provided sterile (sterilized by EO) and intended to be single-use.The video system is powered by the main line.

The handle includes a deflection lever, a lever lock, and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion portion contains one working channel and wiring to transmit the image signals to the Video Image Processor. The distal bending section of the insertion portion controlled by the user via the deflection lever on the handle. The distal end of the insertion portion contains a CMOS sensor for capturing image and transmitting it to the Video Image Processor, LEDs for illumination, and the distal opening of the working channel. The video cable connects the endoscope handle to the Video Image Processor, which provides power and processes video signals from the endoscope.

Flexible Ureterorenoscope has the following physical and performance characteristics:

Flexible insertion portion
Camera and LED light source at the distal tip

AI/ML Overview

The provided text describes a submission for a Single-Use Video Flexible Ureterorenoscope System seeking 510(k) clearance.

However, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does NOT present acceptance criteria or a study proving the device meets specific performance criteria through a clinical or performance study in the way typically seen for AI/ML devices or novel diagnostic tools.

Instead, the submission details a comparison of the subject device's technological characteristics to a legally marketed predicate device and summarizes various engineering and bench tests, along with biocompatibility and sterilization validations, to show that the new device performs similarly and is safe and effective for its intended use.

Therefore, many of the requested sections regarding acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and MRMC studies are not applicable to the information provided in the given text.

Based on the provided text, here is what can be inferred:

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

The document does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) with numerical targets. Instead, it indicates that the device's characteristics and performance were evaluated against established specifications and recognized standards, and compared to a predicate device.

Category	Acceptance Criteria (Implied)	Reported Device Performance
Predicate Comparison	Be similar to or better than the predicate device in technological characteristics (indications for use, anatomical site, target population, environment, flexible scope, CMOS imager, LED light source, deflection (at least 270°), 0° direction of view, 120° field of view, 3-50mm depth of field, system composition, patient-contacting materials, single-use, EO sterilized) to not raise new questions of safety and effectiveness.	Matches or is similar to the predicate device in all listed characteristics. Differences in deflection, insertion width, working length, and channel width are noted as either better or not raising new safety/effectiveness questions, confirmed by performance testing. For example, deflection is 275° (better), working length 670mm (longer).
Electrical Safety	Compliance with IEC 60601-1:2012, AAMI/ANSI ES60601-1:2005/(R)2012, IEC 60601-2-18:2009, and IEC 60601-1-2:2014 and A1:2020.	In compliance with the listed FDA recognized standards.
Photobiological Safety	Compliance with IEC 62471:2006.	Tested according to IEC 62471:2006.
Mechanical & Optical Performance	Compliance with ISO 8600-1:2015 (applicable parts), ISO 12233:2017, ISO 15739:2017, and internal specifications for water delivery, fatigue, stress of bending, tensile strength, insertion width, channel width, deflection, field of view, direction of view, resolution, depth of field, distortion, SNR, illumination, dynamic range, color performance.	The device was designed to comply, and performance measurements were performed according to, the listed standards. Bench test results claim "same or similar image quality, optical performance and mechanical performance" compared to the predicate. Specific numerical performance values are not provided.
Biocompatibility	Compliance with ISO 10993-1, -5, -10, -11 for "Surface – Mucosal Membrane" with "Limited (< 24 hours)" contact.	Evaluation conducted according to FDA guidance and specific ISO 10993 parts. Tests for Cytotoxicity, Sensitization, Intracutaneous reactivity/irritation, Material-mediated pyrogenicity, and Acute systemic toxicity were performed. (Results not detailed, but implied compliance).
Sterilization & Shelf Life	Compliance with ISO 11607:2006, ISO 11135:2014, ISO 10993-7:2008, ASTM F1980-16, ASTM F 1980 07. Maintain sterility and functionality after aging.	Sterile barrier systems evaluated per ISO 11607. Sterilization validated per ISO 11135. EO/ECH residual test per ISO 10993-7. Shelf life determined by stability studies including accelerated aging (ASTM F1980).
Package Validation	Compliance with ISO 11607-1:2019, ISO 11607-2:2019, F88/F88M-15, ASTM F 1929-15, and ISTA 2A:2011.	Conducted according to the listed standards for package validation and transport/shipping testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. The document discusses non-clinical bench testing, not a clinical "test set" in the context of patient data for a diagnostic algorithm. The tests involve physical samples of the device and its components.
Data Provenance: Not applicable, as it concerns non-clinical tests.

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. There is no mention of "ground truth" established by human experts for a data set, as this is a device clearance based on engineering and performance characteristics, not a diagnostic AI/ML algorithm.

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

Not applicable, as no human adjudication of a clinical test set is 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

Not applicable. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study was performed or reported.

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

Not applicable. This is a medical device (ureterorenoscope), not an AI algorithm.

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

Not applicable. The concept of "ground truth" as it applies to clinical diagnostics or AI/ML performance evaluation is not relevant to this submission. The "ground truth" for the device's performance is compliance with international standards and direct measurement of physical and optical properties during bench testing.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. This is a medical device, not an AI/ML algorithm requiring a training set and ground truth establishment.

Summary

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Guangzhou Red Pine Medical Instrument Co., Ltd. % Xiangfei Li Regulatory Affairs Ezisurg Medical Co., Ltd. Rm. 103, Bldg. 2, No.1690 Cailun Rd., China (Shanghai) Pilot Free Trade Zone Shanghai, 201203 China

Re: K221158

Trade/Device Name: Single-Use Video Flexible Ureterorenoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FGB Dated: February 7, 2023 Received: February 7, 2023

Dear Xiangfei Li:

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. You must comply with all the Act's

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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 (OS) 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,

Bonhye Koo -S

For Mark Antonino 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) K221158

Device Name

Single-Use Video Flexible Ureterorenoscope System

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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REDPINE

Traditional 510(k) Premarket Notification

Guangzhou Red Pine Medical Instrument Co., Ltd.

Single-Use Video Flexible Ureterorenoscope System

Applicant: Guangzhou Red Pine Medical Instrument Co., Ltd. Room 303, 308, No. 12, Luoxuan 3 Road, Guangzhou International Bioisland, 510200 Guangzhou City, Guangdong Province, PEOPLE'S REPUBLIC OF CHINA

Revision A-3 March 06, 2023

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510(k) Summary

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:

1. Date of Preparation: 03/06/2023

2. Sponsor Identification

Guangzhou Red Pine Medical Instrument Co., Ltd.

Room 303, 308, No. 12, Luoxuan 3 Road, Guangzhou International Bioisland, 510200 Guangzhou City, Guangdong Province, PEOPLE'S REPUBLIC OF CHINA

Establishment Registration Number: 3021246306

Contact Person: Xiangfei Li Position: Regulatory Affairs Specialist Manager Tel: +86-20-8092-7258 Fax: +86-20-3831-5611 Email: lixiangfei@gzredpine.com

3. Designated Submission Correspondent

Mr. Xiangfei Li (Primary Contact Person)(Primary Contact Person) Mr. Weihua Yang (Alternative Contact Person)(Alternative Contact Person)

Guangzhou Red Pine Medical Instrument Co., Ltd.

Room 303, 308, No. 12, Luoxuan 3 Road, Guangzhou International Bioisland, 510200 Guangzhou City, Guangdong Province, PEOPLE'S REPUBLIC OF CHINA

Tel: +86-20-8092-7258 Fax: +86-20-3831-5611 Email: lixiangfei@gzredpine.com

4. Identification of Subject device

Trade Name: Single-Use Video Flexible Ureterorenoscope System Common Name: Ureteroscope and Accessories, Flexible/rigid Model: RP-U-C12, RP-U-C0304, RP-U-C0305 Classification Name: Endoscope and accessories Classification: II Product Code: FGB Regulation Number: 21 CFR 876.1500 Review Panel: Gastroenterology/Urology

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Indication for Use Statement:

Device Description:

Flexible Ureterorenoscope has the following physical and performance characteristics:

Flexible insertion portion
Camera and LED light source at the distal tip

5. Identification of Predicate Devices

Trade/Device Name: Medical Video Endoscope System Regulation Number: 21 CFR 876.1500 Regulatory Class: Class II Product Code: FGB 510(k) Number: K172098

6. Summary of Technological Characteristics and Comparison

The principles of operation of the subject device is similar to that of the predicate device. The following basic technological elements are the same or similar for the subject and predicate devices:

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Compared	Subject device	Predicate Device	Comparison
items	Single-Use Video FlexibleUreterorenoscope System	Medical Video Endoscopesystem(K172098)
Classification
Product Code	FGB	FGB	Same
RegulationNumber	21 CFR 876.1500	21 CFR 876.1500	Same
Classification	Class II	Class II	Same
Indications For Use
Indications forUse	The device has beendeveloped to be used withendoscopic accessories suchas a biopsy forceps andEndoscopic Video ImageProcessor for endoscopy andendoscopic surgery withinurinary tract and interior ofthe ureter and kidney.	This instrument has beendesigned to be used withendo-therapy accessories suchas a biopsy forceps and otherancillary equipment forendoscopy and endoscopicsurgery within urinary tractand interior of the kidney.	SimilarSee Note1.
anatomical site	Urinary tract and interior ofthe kidney	Urinary tract and interior ofthe kidney	Same
targetpopulation	Adults	Adults	Same
Environmentof use	Hospitals	Hospitals	Same
Physical Characteristics
Type of Scope	Flexible	Flexible	Same
Type of Imager	CMOS	CMOS	Same
Light source	LED	LED	Same
Up/downdeflection(°)	Up 275 °Down 275 °	Up 270 °Down 270 °	SimilarSee Note2.
Direction ofview	0 °	0 °	Same
Field of view	120 °	120 °	Same
Maximuminsertionportion width(mm)	RP-U-C12: 3.2RP-U-C0304: 3.15RP-U-C0305: 3.18	3.2	SimilarSee Note2.
Workinglength(mm)	670	650	SimilarSee Note2.
Minimuminstrumentchannel width(mm)	1.2	1.0	SimilarSee Note2.
Depth of field	3mm-50mm	3mm-50mm	Same
Systemcomposition	- Endoscopic Video ImageProcessor- Single-use video flexibleureterorenoscope and	- Eview (the video system,touch PC with data processingcenter)- Uscope	Same
Patient Contacting Materials
Generalmaterial typeof mainpatient-contactpart	Compliance withISO10993-1	Compliance withISO10993-1	SimilarSee Note2.
Duration andtype ofcontact	"Surface –MucosalMembrane" with a contactduration of "Limited (< 24hours)"	"Surface –MucosalMembrane" with a contactduration of "Limited (< 24hours)"	Same
Sterilization Methods
Number ofUsers	Single-Use	Single-Use	Same
Sterilization	EO Sterilized,SAL 10-6	EO Sterilized,SAL 10-6	Same

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Note.

The indications for use statement for the subject device is similar to that of the predicate device. The differences do not alter the intended use of the device nor do they raise different questions of safety and effectiveness of the device relative to the predicate.
The subject and predicate device have similar principles of operation, type of scope, type of imager, light source, sterilization method, number of users and environment. The subject device differs from the predicate in deflection, maximum insertion portion width, working length, minimum instrument channel width, and patient-contacting materials, most of them are better than the predicate device in clinic use. These differences do not raise different questions of safety and effectiveness as compared to the predicate, and can be evaluated through performance testing.

7. Non clinical testing summary

Electrical Safety and Electromagnetic Compatibility Summary

The electrical safety and EMC data included in the submission are in compliance with the following FDA recognized standards:

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•IEC 60601-1:2012, and AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 •IEC 60601-2-18:2009: Part 2-18

•IEC 60601-1-2:2014 and A1:2020

Photobiological safety

The subject device were tested according to the following FDA recognized standards:

• IEC 62471:2006 Medical electrical equipment, Photobiological safety of lamps and lamp systems

Bench Testing Summary

Mechanical and Optical Performance

The subject device was designed to comply with applicable parts of ISO 8600-1:2015. Optical measurements were performed according to applicable part of ISO 8600-1:2015, ISO 12233:2017 and ISO 15739:2017 standard.

The following mechanical characteristics were evaluated: water delivery, fatigue stress of rocker, stress of the bending part, tensile strength of the insertion portion, maximum insertion width, minimum instrument channel width deflection.

Optical performance characteristics relevant to functions as intended were tested include field of view, direction of view, resolution, depth of field, distortion, SNR, illumination, dynamic range,color performance.

Biocompatibility Summary

Biocompatibility evaluation for the Flexible Ureterorenoscope was conducted in accordance with the FDA Guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

The following tests were conducted based contact category of "Surface - Mucosal Membrane" with a contact duration of "Limited (< 24 hours):

Cytotoxicity: ISO 10993-5:2009/(R) 2014
Sensitization, Intracutaneous reactivity/irritation: ISO 10993-10:2010
· Material-mediated pyrogenicity: ISO 10993-11:2017
· Acute systemic toxicity: ISO 10993-11:2017

Sterilization and shelf life testing

Sterile barrier systems were evaluated in accordance with ISO 11607:2006. Sterilization Process has been validated accordance with ISO 11135:2014. EO/ECH residual test was performed according to ISO 10993-7:2008. The shelf life of the Flexible Ureterorenoscope is determined based on stability study which includes ageing test according to ASTM F1980-16 and ASTM F 1980

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07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Package Validation

Package validation was conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, and F88/F88M-15, ASTM F 1929-15 Transport and shipping testing as per ISTA 2A :2011.

The collective results of Non-clinical testing demonstrate that the materials chosen, the manufacturing processes and design of Ureterorenoscope System meet the established specifications necessary for consistent performance during its intended use. In addition, the Bench Test results demonstrate that compared with the predicate , Ureterorenoscope System has the same or similar image quality, optical performance and mechanical performance.

8. Clinical Test Conclusion

No clinical study is included in this submission.

9. Conclusion

Non clinical tests demonstrated that the Single-Use Video Flexible Ureterorenoscope System is as safe and effective as the predicate. Therefore, the Single-Use Video Flexible Ureterorenoscope System 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.