The LithoVue Elite Digital Flexible Ureteroscope System is intended to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

Device Description

The LithoVue Elite System is a software-controlled digital flexible ureteroscope system that consists of the Workstation (to be marketed as StoneSmart Connect Console) and the Single-Use Digital Flexible Ureteroscope (sterile, single-use disposable).

The LithoVue Elite System is designed to allow the physician to access, visualize and perform procedures in the urinary tract, and to provide real-time intraluminal pressure monitoring in the kidney and ureter during ureteroscopy.

AI/ML Overview

The provided text is a 510(k) summary for the LithoVue Elite Digital Flexible Ureteroscope System. Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of "acceptance criteria" with quantitative targets alongside reported device performance for all aspects. Instead, it discusses performance testing and successful outcomes against design specifications. However, we can infer some criteria and reported performance from the "Comparison of Key Technological/Performance Characteristics" table and the "Performance Testing" section.

Feature/Criterion	Acceptance Metric/Target (Inferred)	Reported Device Performance
General
Reusability (Ureteroscope)	Single Use	Single Use
Reusability (Workstation)	Reusable	Reusable
Ureteroscope Type	Flexible	Flexible
Ureteroscope Provided Status	Sterile	Sterile
Sterilization Agent	Ethylene Oxide (EO)	Ethylene Oxide (EO)
Power Input (Workstation)	100-240 VAC, 50-60 Hz	100-240 VAC, 50-60 Hz
Imager Type	CMOS	CMOS
Imager Location	Distal	Distal
Illumination Source	LED	LED
Ureteroscope Mechanical Specifications
Shaft Working Length	68 cm	68 cm
Shaft OD	9.5F	9.5F
Insertion Portion Width (Distal Face)	7.7 F	7.7 F
Working Channel Size	3.6 F (1.15mm MIN ABS)	3.6 F (1.15mm MIN ABS)
Working Length	82 cm	82 cm
Deflection	Active and Passive	Active and Passive
Degree of Active Deflection	270° in both directions	270° in both directions
Optical Specifications
Field of View (in air)	120° (diagonal)	120° (diagonal)
Working Distance	2 - 50 mm	2 - 50 mm
Direction of View	0° (forward viewing)	0° (forward viewing)
Resolution	>5.04 lp/mm at 5mm distance (predicate)	>9.81 lp/mm at 5mm distance (proposed)
Video Latency	155 ms	155 ms
Pressure Measurement Capability
Gauge Pressure Accuracy in Water	Meets design specifications	Evaluated, met design specifications
Pressure Sensor Bandwidth	Meets design specifications	Evaluated, met design specifications
Pressure Measurement Durability	Meets design specifications	Evaluated, met design specifications
Pressure Measurement Zero Point Drift	Meets design specifications	Evaluated, met design specifications
Pressure Measurement Accuracy	Meets design specifications	Evaluated, met design specifications
Pressure Measurement Latency	Meets design specifications	Evaluated, met design specifications
Biocompatibility
Cytotoxicity	Biocompatible	Biocompatible
Irritation	Biocompatible	Biocompatible
Sensitization	Biocompatible	Biocompatible
Acute Systemic Toxicity	Biocompatible	Biocompatible
Pyrogen	Biocompatible	Biocompatible
EMC & Electrical Safety
Compliance with ANSI AAMI ES60601-1	Meets requirements	Demonstrates compliance
Compliance with IEC 60601-2-18	Meets requirements	Demonstrates compliance
Compliance with IEC 60601-1-2	Meets requirements	Demonstrates compliance
Software
Software Verification and Validation	Completed, meets FDA guidance	Completed
Intraluminal Pressure Monitoring Accuracy (in vivo)	Accurate	Demonstrated in GLP Animal Study

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

The document mentions "Bench testing" and a "GLP Animal Study."

Bench Testing: The sample size for bench testing is not specified. The provenance is internal to the manufacturer (Boston Scientific Corporation). Nature of the data is not applicable (bench tests, not patient data).
GLP Animal Study: The specific sample size (number of animals) for the GLP Animal Study is not provided. The provenance is internal to the manufacturer, conducted under Good Laboratory Practice (GLP) standards, which implies a controlled, prospective study.

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

Not applicable. The reported performance testing primarily involved objective measurements against design specifications and recognized standards (e.g., electrical safety, biocompatibility) and an animal study for pressure accuracy. There is no indication of human experts establishing ground truth for perception or diagnostic accuracy.

4. Adjudication method for the test set

Not applicable. The testing described does not involve expert adjudication for decision-making or image interpretation.

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. The device does not involve AI assistance for human readers; it is a diagnostic/therapeutic tool for visualization and pressure monitoring. Clinical testing was explicitly stated as not required to demonstrate substantial equivalence.

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

A standalone performance evaluation was conducted for the device's components and overall system. This includes bench testing for mechanical, optical, and pressure sensor characteristics, as well as an animal study for in-vivo pressure monitoring accuracy. The device itself (image capture and pressure sensing) operates in a standalone manner, providing data to the human user.

7. The type of ground truth used

Bench Testing: Engineering specifications, physical measurements, and compliance with industry standards (e.g., for resolution, field of view, electrical safety).
Biocompatibility: Results of standardized chemical and biological tests defined in ISO 10993-1.
GLP Animal Study: Direct physiological measurements of intraluminal pressure in an animal model were used as ground truth for the device's pressure monitoring accuracy. The report of this study was included in the submission.

8. The sample size for the training set

Not applicable. This device is a hardware system for visualization and pressure monitoring, not a machine learning or AI-driven diagnostic device that requires a training set in the conventional sense.

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

Not applicable, as there is no training set for an AI model.

Summary

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February 2, 2023

Boston Scientific Corporation Tanmay Shukla Prin. Regulatory Affairs Specialist 100 Boston Scientific Wav Marlborough, MA 01752

Re: K221515

Trade/Device Name: LithoVue Elite Digital Flexible Ureteroscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: January 27, 2023 Received: January 31, 2023

Dear Tanmay Shukla:

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K221515

Device Name

LithoVue Elite Digital Flexible Ureteroscope System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Summary for LithoVue Elite System

Date Prepared: May 24, 2022

A. Submitter

Boston Scientific Corporation Urology and Pelvic Health Division 100 Boston Scientific Way Marlborough, MA 01752

B. Contacts

Tanmay Shukla Prin. Regulatory Affairs Specialist 508-683-6522 Tanmay.Shukla@bsci.com

C. Device Names

Trade Name:	LithoVue Elite Digital Flexible Ureteroscope System
Common/Usual Name:	Ureteroscope And Accessories, Flexible/Rigid
Regulation Number:	21 CFR §876.1500
Regulation Name:	Endoscope and accessories
Classification:	Class II
Product Code:	FGB

D. Predicate Devices

For purposes of establishing 'substantial equivalence', the LithoVue Elite System's design and technological characteristics were compared to the following 510(k)-cleared device.

	Predicate
Device Trade Name:	LithoVue System
Regulation Name:	Endoscope and accessories
Regulation Number:	21 CFR §876.1500
Classification:	Class II
Product Code:	FGB
510(k) Submitter/Holder:	Boston Scientific Corporation, Marlborough, MA
510(k) #/	K153049
Clearance Date	November 13, 2015

Predicate Device for Establishing 'Substantial Equivalence'

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E. Device Description

F. Intended Use/Indications for Use

The LithoVue Elite Digital Flexible Ureteroscope System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

G. Operating Principle

Illumination is generated by an LED located in the single-use digital ureteroscope handle and transmitted to the distal tip lens via a fiber-optic illumination fiber. A digital CMOS imager located in the distal tip of the ureteroscope provides the raw image data from the surgical field. The raw image data is transferred from the CMOS imager through the ureteroscope handle, via the umbilicus, to the workstation for processing and output to an external display.

The LithoVue Elite System supports intraluminal pressure monitoring through a piezoresistive Micro-Electro-Mechanical Systems (MEMS) pressure sensor located at the distal tip of the ureteroscope. The pressure signals from the ureteroscope are transmitted to the workstation for real-time display of the pressure value on an external display.

H. Comparison of Key Technological/Performance Characteristics

The LithoVue Elite System has the same technological characteristics and fundamental design as the predicate device. The LithoVue Elite System and the predicate device are each designed to provide real-time images to the physician in order to facilitate diagnostic and therapeutic procedures in the urinary tract.

	Proposed LithoVue EliteSystem	Predicate LithoVueSystem (K153049)	Substantial EquivalenceDiscussion
Reusability	Ureteroscope: Single UseWorkstation: Reusable	Ureteroscope: Single UseWorkstation: Reusable	Identical
UreteroscopeType	Flexible	Flexible	Identical
Ureteroscopeis Provided	Sterile	Sterile	Identical
	Proposed LithoVue EliteSystem	Predicate LithoVueSystem (K153049)	Substantial EquivalenceDiscussion
SterilizationAgent	Ethylene Oxide (EO)	Ethylene Oxide (EO)	Identical
Power Input(Workstation)	100-240 VAC, 50-60 Hz	100-240 VAC, 50-60 Hz	Identical
Imager Type	CMOS	CMOS	Identical
ImagerLocation	Distal	Distal	Identical
IlluminationSource	LED	LED	Identical
	Ureteroscope Mechanical Specifications
Shaft WorkingLength	68 cm	68 cm	Identical
Shaft OD	9.5F	9.5F	Identical
InsertionPortion Width(Distal Face)	7.7 F	7.7 F	Identical
WorkingChannel Size	3.6 F (1.15mm MIN ABS)	3.6 F (1.15mm MIN ABS)	Identical
WorkingLength	82 cm	82 cm	Identical
Deflection	Active and Passive	Active and Passive	Identical
Degree ofActiveDeflection	270° in both directions	270° in both directions	Identical
Optical Specifications
Field of View(in air)	120° (diagonal)	85° (horizontal)	Identical. The predicatedevice listed the field ofview as 85°, as measured inthe horizontal direction of asquare image. This equatesto 120°, as measured in thediagonal direction for theproposed device.
WorkingDistance	2 - 50 mm	2 - 50 mm	Identical
Direction ofView	0° (forward viewing)	0° (forward viewing)	Identical
Resolution	Typical (5mm Distance):>9.81 lp/mm	Typical (5mm Distance):>5.04 lp/mm	Substantially equivalent.The proposed device hashigher resolution comparedto the predicate device.
Video Latency	155 ms	155 ms	Identical

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The main difference between the LithoVue Elite System and the predicate (LithoVue System) is the LithoVue Elite System's intraluminal pressure monitoring capability in the kidney and ureter. Currently, an irrigation bag with a pressure cuff or an automated pressurized irrigation system is used with the predicate LithoVue System to estimate the pressure in the anatomy during flexible ureteroscopy (fURS) procedures. The LithoVue Elite System uses a piezoresistive MEMS absolute pressure sensor, located at the distal tip of the single-use, digital flexible ureteroscope, to measure the intraluminal pressure in the anatomy during ureteroscopy. The pressure sensor is incorporated within the distal tip without increasing the overall width of the insertion of the ureteroscope. Additionally, the fundamental technology for measuring of intraluminal pressure is the use of solid-state sensors in a bridge circuit, similar to that used for many years in various other medical devices.

I. Substantial Equivalence

A direct comparison of key characteristics demonstrates that the Litho Vue Elite System is substantially equivalent to the predicate LithoVue System in terms of its intended use, technological characteristics, and performance characteristics. The differences between the LithoVue Elite System and the predicate device do not alter suitability of the proposed device for its intended use.

J. Performance Testing

There are no performance standards or special controls developed under Section 514 of the FD&C Act for endoscopes. Bench testing was performed to demonstrate that the device performs as intended under anticipated conditions of use, and that it meets its design specifications. In addition to the performance testing typically associated with ureteroscopes (including, but not limited to. Working Distance Resolution in Air, Field of View in Air, Direction of View, Image Signal-to-Noise Ratio, Total Flux Available at Tip, Uniformity of Image Brightness, Image Latency, and Photobiological Safety), the following performance characteristics for the pressure measurement capability were evaluated during bench testing:

Gauge Pressure Accuracy in Water
Pressure Sensor Bandwidth
. Pressure Measurement Durability
. Pressure Measurement Zero Point Drift
. Pressure Measurement Accuracy
. Pressure Measurement Latency

Biocompatibility of the LithoVue Elite Single-Use Digital Flexible Ureteroscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Externally Communicating - Tissue/Bone/Dentin" with a contact duration of "Limited (≤24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, and Pyrogen. The results concluded that the ureteroscope is biocompatible.

EMC & Electrical Safety testing were conducted in accordance with the following FDArecognized standards, and the results of the testing demonstrate that the device has met the applicable requirements:

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and a. A2:2010/(R)2012 (Consolidated Text), Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) (FR Recognition No. 19-4)

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IEC 60601-2-18: Edition 3.0. 2009-08. Medical electrical equipment Part 2-18: b. Particular requirements for the basic safety and essential performance of endoscopic equipment
(FR Recognition No. 9-114)
IEC 60601-1-2: Edition 4.0, 2014-02, Medical electrical equipment Part 1-2: General C. requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (FR Recognition No. 19-8)
Software verification and validation was completed. The software documentation stipulated in FDA guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 2005), was included in this premarket submission.

A GLP Animal Study was conducted to demonstrate intraluminal pressure monitoring accuracy in vivo. GLP animal study report was included in this premarket submission.

Clinical testing was not required to demonstrate substantial equivalence to the predicate device. Non-clinical testing was sufficient to establish substantial equivalence.

K. Conclusion

Based on the intended use/indications for use, comparison of key technological characteristics, and performance testing presented in this premarket submission, it is concluded that the LithoVue Elite System is substantially equivalent to the predicate device.

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.