The LithoVue 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.

Device Description

The LithoVue™ System is a software-controlled digital flexible ureteroscope system that consists of the LithoVue System Workstation (Touch PC with installed Interface Box and Cart) and the Litho Vue Single-Use Digital Flexible Ureteroscope (sterile, single-use disposable).

The LithoVue System is designed to allow physicians to access, visualize, and perform procedures in the urinary tract, using appropriate accessory devices (e.g., baskets, laser fibers, forceps).

AI/ML Overview

This FDA 510(k) summary describes the Boston Scientific LithoVue System, a digital flexible ureteroscope for visualizing and performing procedures in the urinary tract. The document primarily focuses on demonstrating substantial equivalence to predicate devices through performance testing.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance testing conducted but does not explicitly provide a table of acceptance criteria alongside the reported device performance. It only states that "All evaluation acceptance criteria were met" for various tests.

However, based on the types of tests performed, we can infer some general acceptance criteria categories and the claimed performance:

Acceptance Criteria Category	Reported Device Performance
Optical Performance	All acceptance criteria met for:
- Working Distance Resolution in Air (Near, Typical, Far)	- Good image resolution at various distances
- Field of View in Air	- Appropriate field of view
- Direction of View	- Correct viewing direction
- Image Orientation	- Correct image orientation
- Contrast Sensitivity	- Sufficient contrast for visualization
- Image Signal to Noise	- Clear images with low noise
- Uniformity of Image Brightness	- Even illumination
- Total Flux Available at Tip	- Adequate illumination at the tip
- Automatic Light Control (ALC)	- Effective automatic brightness adjustment
- ALC Response Time	- Fast response to light changes
Mechanical Performance	All acceptance criteria met for:
- Width of Insertion Portion Distal Tip	- Appropriate tip size
- Maximum Width of Insertion Portion (Overall Shaft Diameter and Size Designation)	- Appropriate shaft diameter
- Working Length (Shaft Length)	- Correct working length
- Minimum Instrument Channel Width	- Sufficient channel width for accessories
- Tortuous Path Ability	- Ability to navigate curved paths
- Surface and Edges	- Smooth surfaces and edges
- SUD Working Channel Freedom from Leakage	- Channel integrity
- SUD Shaft Leakage	- Shaft integrity
- Torsional Resistance of Tip	- Good tip stability
- Tip Column Strength	- Strong tip
- Shaft Flexural Resistance	- Resistant to bending
- Maximum Angle of Deflection	- Sufficient deflection range
- Bend Radius	- Appropriate bend radius
- Secondary Deflection	- Good secondary deflection capability
- Deflection Life Cycling	- Durable deflection mechanism
- Shaft to Handle Tensile Strength	- Strong connection
- Tip to Shaft Tensile Strength	- Strong connection
- Handle to Active Deflection Torque Angle at Break	- Durable handle connection
- Umbilicus to Handle Tensile Strength	- Strong connection
- Umbilicus to Connector Tensile Strength	- Strong connection
- Critical Shaft Bend Radius	- Resistant to critical bends
- Shaft Bend Fatigue	- Durable under bending stress
- SUD Durability (Procedure Duration)	- Durable for intended procedure duration
- SUD Mechanical Durability	- Good overall mechanical durability
- Neutral Position Marking	- Clear marking
- Deflection Direction Marking	- Clear marking
- Lever Force	- Appropriate force for operation
- Connector Retention Strength	- Secure connection
Compatibility & Safety	All acceptance criteria met for:
- Laser Aiming Beam Compatibility	- Compatible with laser aiming beams
- Laser Lithotripsy Compatibility	- Compatible with laser lithotripsy
- Radiopacity	- Visible under X-ray
- Working Channel Connection Compatibility	- Compatible with accessories
- Maximum Endotherapy Tool Blind Insertion Distance	- Safe insertion distance
- Working Channel Length	- Correct channel length
- Monitor and Switcher Compatibility	- Compatible with external displays
- SUD Packaging Integrity	- Intact packaging
- SUD Package Seal Strength	- Secure seal
- Photobiologic Safety per IEC 62471	- No photobiologic hazards
- Software verification and validation	- Software functions as intended
- Biocompatibility (ISO 10993-1)	- Demonstrates biocompatibility
- Electrical Safety (IEC 60601-1, -1-2, -1-4, -2-18)	- Meets electrical safety standards

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document mentions "LithoVue Flexscope samples aged at T=0 and T=3 months accelerated aged" for performance testing. It does not provide specific numerical sample sizes for each test.
Data Provenance: The testing was conducted by Boston Scientific Corporation. This implies the data is internal (manufacturer-generated) and likely prospective, specifically designed to demonstrate device performance for regulatory submission. There is no mention of country of origin for the data or whether it was retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of experts being used to establish ground truth for the performance testing described. The tests are bench evaluations (e.g., measuring resolution, strength, dimensions) and safety standards (biocompatibility, electrical safety), which are typically assessed against predefined engineering specifications and international standards, not expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. As noted in point 3, the described tests are bench and safety evaluations against specifications, not clinical assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in this 510(k) summary. The document focuses on demonstrating substantial equivalence through bench testing to predicate devices, not on comparing reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The LithoVue System is a physical medical device (a ureteroscope), not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable in this context. The device itself performs visual acquisition, and its performance characteristics (optical, mechanical, safety) are what were evaluated. The "software verification and validation" mentioned refers to the functionality of the device's control software, not an AI for diagnosis or interpretation.

7. The Type of Ground Truth Used

The ground truth for the reported tests primarily consists of:

Engineering Specifications: For mechanical and optical properties (e.g., width, length, resolution, field of view).
International Standards: For biocompatibility (ISO 10993-1) and electrical safety (IEC 60601 series).
Functional Requirements: For aspects like ALC response, tortuous path ability, and compatibility.

There is no mention of pathology, outcomes data, or expert consensus in a clinical sense as ground truth for these engineering and safety evaluations.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a "training set" in the machine learning sense. The "samples" referred to in the document are physical units of the device used for engineering and safety testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no AI training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 13, 2015

Boston Scientific Corporation % Dave Yungvirt CEO Third Party Review Group, LLC 45 Rockefeller Plaza, Suite 2000 New York, NY 10111

Re: K153049

Trade/Device Name: LithoVue System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: November 5, 2015 Received: November 9, 2015

Dear Dave Yungvirt,

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153049

Device Name LithoVue System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subnart D)	Over-The-Counter Use (21 C.FR 801 Subnart C

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SECTION 6 510K SUMMARY

510(k) Summary for LithoVue™ System

A. Date Prepared

August 12, 2015

B. Sponsor

Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01756

C. Contact

Jeanne O'Toole Senior Specialist, Regulatory Affairs 508-683-4271 jeanne.otoole@bsci.com or Nichole Riek

Manager, Regulatory Affairs 508-683-4175 nichole.riek@bsci.com

D. Device Name

Trade name:	LithoVue System
Common usual/name:	Digital Flexible Ureteroscope
Classification:	FGB – Ureteroscope and accessories, flexible/rigid
	21 CFR 876.1500, Class II

E. Predicate Device(s)

Trade name:	DUR-Digital Ureteroscope and Choledochoscope(DUR-D)
Common usual/name:	Ureteroscope and Accessories, Flexible/Rigid
Classification:	FGB – Endoscope, associated accessories21 CFR 876.1500, Class II
Premarket Notification:	ACMI, K060269

and

Trade name:	Olympus URF-V (cleared as the Video UreteroscopeNTSC)
Common usual/name:	Ureteroscope and Accessories, Flexible/Rigid
Classification:	FGB – Endoscope, associated accessories21 CFR 876.1500. Class II

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Premarket Notification: Olympus, K033651

F. Device Description

The LithoVue System is designed to allow physicians to access, visualize, and perform procedures in the urinary tract, using appropriate accessory devices (e.g., baskets, laser fibers, forceps).

G. Intended Use

This Intended Use is equivalent to that for the predicates, which are also used to perform various diagnostic and therapeutic procedures in the urinary tract using additional accessories.

H. Technological Characteristics

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

The main difference between the LithoVue System and the predicate devices is reusability. The LithoVue Single-Use Digital Flexible Ureteroscope is single-use, while the predicate devices are reusable.

I. Substantial Equivalence

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

J. Performance Testing (Bench Evaluation)

Boston Scientific has conducted performance testing with LithoVue Flexscope samples aged at T=0 and T=3 months accelerated aged.

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The following testing was completed to demonstrate the LithoVue System functions as intended:

· Working Distance Resolution in Air -Near, Typical and Far
Field of View in Air
· Direction of View
· Image Orientation
· Contrast Sensitivity
· Image Signal to Noise
· Uniformity of Image Brightness
Total Flux Available at Tip
· Image Latency
Automatic Light Control (ALC)
· ALC Response Time
Width of Insertion Portion Distal Tip
Maximum Width of Insertion Portion (Overall Shaft Diameter and Size Designation)
Working Length (Shaft Length)
Minimum Instrument Channel Width
Tortuous Path Ability
· Surface and Edges
· SUD Working Channel Freedom from Leakage
· SUD Shaft Leakage
· Torsional Resistance of Tip
· Tip Column Strength
Shaft Flexural Resistance
· Maximum Angle of Deflection
Bend Radius
· Secondary Deflection
· Deflection Life Cycling
· Shaft to Handle Tensile Strength
Tip to Shaft Tensile Strength
· Handle to Active Deflection Torque Angle at Break
Umbilicus to Handle Tensile Strength
Umbilicus to Connector Tensile Strength
Critical Shaft Bend Radius
· Shaft Bend Fatigue
· SUD Durability (Procedure Duration)
SUD Mechanical Durability
· Neutral Position Marking
· Deflection Direction Marking
· Lever Force
· Connector Retention Strength
· Laser Aiming Beam Compatibility
· Laser Lithotripsy Compatibility
· Radiopacity
· Working Channel Connection Compatibility
Maximum Endotherapy Tool Blind Insertion Distance
· Working Channel Length
· Monitor and Switcher Compatibility
SUD Packaging Integrity
SUD Package Seal Strength
· Photobiologic Safety per IEC 62471
Software verification and validation

Biocompatibility of the LithoVue Single-Use Digital Flexible Ureteroscope was evaluated in accordance with ISO 10993-1:2009 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, USP Physiochemical <661>, and Latex. All evaluation acceptance criteria were met.

Electrical safety testing of the System was evaluated in accordance with IEC 60601-1 (2005) Edition 3, IEC 60601-1-2 (2007) Edition 3, IEC 60601-1-4 (2000), Edition 1.1 Consolidated Edition, and IEC 60601-2-18 (2009), Edition 3. All evaluation acceptance criteria were met.

The results of the performance testing demonstrate that the LithoVue System is considered safe and effective for its intended use.

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.