The Monarch® Platform, Urology and its accessories are intended to access and visualize anatomical locations within the urinary tract and interior of adolescents and adults, aged 12 and up, for diagnostic and therapeutic procedures with transurethral access or transurethral access in conjunction with percutaneous access.

The Monarch® Platform, Urology, the Ureteroscope, and endourology accessories are indicated to provide endoscopic visualization and access of organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) with transurethral access or transurethral access in conjunction with 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 Monarch® Platform, Urology ("Proposed Device") is a capital equipment platform that enables electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures. The ureteroscope and suction catheter move only under continuous and direct physician control, via the Monarch Controller.

The proposed device consists of Monarch® Tower, Monarch® Cart, Monarch® Fluidics Pump, Monarch® Software, Monarch® Controller, Monarch® Ureteroscope and endourology instruments and accessories needed to perform Monarch Urology diagnostic and therapeutic procedures. The device as well as its instruments and accessories are used together during urological diaenostic and therapeutic procedures and are bundled in this 510(k) submission so they can be addressed during one review. The summary descriptions of each component are outlined below.

Monarch® Tower: The Monarch® Tower (Tower) contains the primary procedural display interface for the physician that is provided by a touchscreen monitor for physician viewing and computers running the Monarch software. The monitor has a touchscreen and allows for user input during setup and intra-operative use. The tower has integrated electromagnetic (EM) tracking and video signal processing components. In addition, the tower provides connectivity for the endoscope camera as well as the fluidics pump.

Monarch® Cart: The Monarch® Cart (Cart) contains a touchscreen, three robotic arms and electronic systems required to power and operate the robotic arms. The Cart touchscreens accepts user input and shows instructions for arm deployment and cart functions. The robotic arms possess multiple degrees of freedom. The cart transmits the physician directed movement to the Ureteroscope and other instruments during a procedure.

Monarch® Fluidics Pump: The Monarch® Fluidics Pump (Fluidics Pump) controls the irrigation and suction during a procedure. The Fluidics Pump is connected to the Monarch Tower via an umbilical cable allowing electrical and data communication. The Fluidics Pump provides the physician with the ability to control irrigation and suction levels during a procedure. The Urology Irrigation Cartridge and Suction Set are irrigation and suction tubing provided as sterile accessories to connect the Fluidics Pump to the Ureteroscope and Instruments during ureteroscopy or PCNL procedures.

Monarch® Software: The Monarch® Software provides the user with the ability to safely drive the Monarch® Ureteroscope and Monarch® Mini-PCNL suction catheter around the kidney and within the calyces of interest as well as provides optional navigation guidance to the user to insert the needle to the target during Monarch® PCNL procedure. It receives user input from the Monarch® Controller, computes the appropriate robotic motion to coordinate the movement of the robotic arms and endoscopic devices loaded onto the Cart. It provides a graphical user interface where the endoscopic camera view is shown in real time and displays important system status information.

Monarch® Controller: The Monarch® Controller) is a handheld device that serves as the user interface that allows the physician to control the system during a procedure. An Umbilical cord connects the Controller to the Tower.

Monarch® Ureteroscope: The Monarch® Ureteroscope (Ureteroscope) is comprised of an endoscope that provides vision, illumination, and a working channel to the distal tip of the device. The Ureteroscope can be navigated by the user within the bladder, urinary tract, and kidney. It contains a working channel to accommodate compatible commercially available working channel instruments. The Ureteroscope can be articulated 2-directions (along a single plane) when manually driven or can be articulated 4-directions (along two planes) when mounted to the electromechanical arms under command by the physician using the endoscopic controller. The shaft of the ureteroscope can also be rolled 155° in either direction to reorient the camera and working channel. The Ureteroscope is packaged within the Monarch® Ureteroscopy Kit. The Monarch® Ureteroscopy Kit also includes Ureteroscope Valve, Ureteroscope Driver and Laser Driver (accessories for Ureteroscopy procedure).

Procedural specific instruments and accessories for the proposed device are outlined below, these devices are single-use devices and sterilized via EO.

Monarch® Mini-PCNL Suction Catheter: The Monarch® Mini-PCNL Suction Catheter ● (Suction Catheter) is part of the Monarch® Mini-PCNL Kit. The Suction Catheter is a flexible device that is inserted into the kidney via antegrade tract under direct visualization from the ureteroscope. It has a center lumen which allows for the suction of stone debris and can articulate in 4 directions. The suction catheter is manipulated by one robotic arm under the control of a physician who is concurrently controlling the Ureteroscope.
Dilation Set: The Dilation Set is part of the Monarch® Mini-PCNL Kit. The Dilation Set ● includes:
- 8Fr dilator
- 10Fr catheter
- Percutaneous Sheath Dilator ●
Percutaneous Sheath: The Percutaneous Sheath is part of the Monarch® Mini-PCNL Kit. The Percutaneous Sheath consists of an inner metal sheath with a threaded connection and a metal outer sheath. It is designed to establish percutaneous access and designed to allow simultaneous irrigation and suction of fluid to support removal of kidney stones. The outer sheath has a molded hub with an angled luer connection for irrigation and an insertion depth marking on the distal end.

AI/ML Overview

The provided text describes performance data but does not specify quantifiable acceptance criteria for the Monarch® Platform, Urology device. Instead, it states that the device was tested against internal design specifications and applicable performance standards to demonstrate safety and effectiveness, and that "all intended user needs evaluated met their acceptance criteria." However, what those specific quantitative acceptance criteria were for different aspects (e.g., accuracy, reliability, image quality) and the reported performance against them are not detailed in the provided document.

Therefore, the following information is based on what can be extracted or inferred from the provided sections, recognizing the absence of explicit quantitative acceptance criteria and specific performance metrics for the device itself.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned above, the document does not provide a table of explicit acceptance criteria with specific quantitative targets and corresponding reported device performance values. The general statements are that all tests "Passed" or "met acceptance criteria."

Therefore, I cannot construct the requested table with specific numerical values for acceptance criteria and reported device performance.

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

The document mentions "live porcine model" for Design Validation and "Acute Animal Safety" studies.

Sample Size for Test Set: Not explicitly stated as a numerical count for either the Design Validation or Acute Animal Safety studies. The phrasing "live porcine model" and "live animal model" are general.
Data Provenance: The studies were conducted using "live porcine model" and "live animal model," indicating animal testing (pre-clinical). The location or country of origin is not specified, but it suggests a controlled laboratory setting. The studies are prospective in nature, as they involve active testing and data collection.

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

The document mentions "intended users" and "representative users" in the context of Human Factors and Usability evaluation and Design Validation. However, it does not specify the number of experts used to establish ground truth for any test set or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth for any test set. The term "ground truth" itself is not explicitly used in the context of expert review in the provided text.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

The document does not mention or describe a Multi Reader Multi Case (MRMC) comparative effectiveness study. The Monarch® Platform is described as a capital equipment platform with electromechanical articulation and control, and software for navigation, but there is no indication of an AI component designed to assist human readers in interpretation or diagnosis, nor any study comparing human performance with and without AI assistance.

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

The document describes the Monarch® Platform as a system that requires "continuous and direct physician control" and where "Device movement is only at the command of the physician." The software provides "optional navigation guidance." This indicates that the device is designed for human-in-the-loop operation, and the description does not support the idea of a standalone (algorithm-only) performance study.

7. The Type of Ground Truth Used

Based on the descriptions:

Design Validation and Acute Animal Safety: The "ground truth" for these studies would implicitly be established through direct observation, physiological measurements, and potentially post-mortem examination in the animal models, assessing safety and functionality in a simulated use environment. This is a form of direct-measurement or observation-based ground truth specific to animal model performance.
Other tests (Reprocessing, Sterility, Biocompatibility, Electrical Safety, Software, Verification Testing, Human Factors): These rely on adherence to established standards and internal specifications, where "ground truth" is defined by the objective pass/fail criteria of technical tests rather than expert consensus on diagnostic images or pathology.

8. The Sample Size for the Training Set

The document describes pre-market testing and validation for a medical device (Monarch® Platform, Urology). It does not mention a "training set" in the context of machine learning or AI, as the primary focus seems to be on the electromechanical system and software components rather than a learning algorithm that requires a training set.

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

As no "training set" for an AI/ML algorithm is mentioned, this question is not applicable based on the provided text.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 29, 2022

Auris Health, Inc. Angela Wong Staff Regulatory Affairs Analyst 150 Shoreline Drive Redwood City, CA 94065

Re: K213334

Trade/Device Name: Monarch® Platform, Urology Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB, LJH Dated: March 25, 2022 Received: March 29, 2022

Dear Angela Wong:

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, 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) K213334

Device Name Monarch® Platform, Urology

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

1) General Information

510(k) Submitter	Auris Health, Inc., a Johnson and Johnson FamilyCompany150 Shoreline DriveRedwood City, CA 94065
FDA Registration Number	3014447948
Primary Correspondent	Angela WongStaff Regulatory Affairs SpecialistAuris Health, Inc., a Johnson and Johnson FamilyCompany
Contact Information	Email: lwong6@its.jnj.comPhone: (408) 613-9734
Date Prepared	March 25th, 2022

2) Device Identification

The Monarch® Platform, Urology consists of Monarch® Tower, Monarch® Cart, Monarch® Fluidics Pump, Monarch® Controller, Monarch® Ureteroscope and endourology instruments and accessories needed to perform Monarch® Urology diagnostic and therapeutic procedures. The Monarch® Platform, Urology can be identified as follows:

Proprietary Name:	Monarch ® Platform, Urology
Device Classification Name:	Ureteroscope and Accessories, Flexible/Rigid
Regulation Description:	Endoscope and Accessories
Regulation Number:	876.1500
Device Class	Class II
Product Code:	FGB, LJH

Devices bundled within the Monarch® Platform, Urology and its instruments and accessories can be identified as follows:

a)	Proprietary Name:	Monarch® Fluidics Pump
	Device Classification Name:	System, Irrigation, Urological
	Regulation Description:	Urological Catheter and Accessories
	Regulation Number:	876.5130
	Device Class	Class II
	Product Code:	LJH

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b) Proprietary Name: Monarch® Mini-PCNL Suction Catheter Device Classification Name: Needle, Catheter Regulation Description: Introduction/drainage catheter and accessories Regulation Number: 878.4200 Device Class Class I Product Code: GCB

c)	Proprietary Name:	Dilation Set
	Device Classification Name:	Catheter, Nephrostomy
	Regulation Description:	None
	Regulation Number:	None
	Device Class	Unclassified
	Product Code:	LJE

d)	Proprietary Name:	Percutaneous Sheath
d)	Device Classification Name:	Kit, Nephroscope; Catheter, Nephrostomy
d)	Regulation Description:	Endoscope and Accessories; None
d)	Regulation Number:	876.1500, None
d)	Device Class	Class II, Unclassified
d)	Product Code:	FGA, LJE

3) Predicate Devices

Proprietary Name:	LithoVue System
Device Classification Name:	Ureteroscope and Accessories, Flexible/Rigid
Regulation Description:	Endoscope and Accessories
510(k) Number:	K153049
Regulation Number:	876.1500
Device Class	Class II
Product Code:	FGB

Proprietary Name:	Karl Storz Uromat E.A.S.I.
Device Classification Name:	System, Irrigation, Urological
Regulation Description:	Urological Catheter and Accessories
510(k) Number:	K162992
Regulation Number:	876.5130
Device Class:	Class II
Product Code:	LJH

Proprietary Name:	LithAssist Suction Control for Laser Lithotripsy
Device Classification Name:	NA
Regulation Description:	NA
510(k) Number:	510(k) Exempt

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Regulation Number:	NA
Device Class	NA
Product Code:	NA

Proprietary Name:	Amplatz, Renal Dilator Kit
Device Classification Name:	Catheter, Nephrostomy
Regulation Description:	Unclassified
510(k) Number:	K172527
Regulation Number:	None
Device Class	Class II
Product Code:	LJE

Proprietary Name:	Richard Wolf Nephroscope Set
Device Classification Name:	Kit, Nephroscope
Regulation Description:	Endoscope and accessories
510(k) Number:	K994223
Regulation Number:	876.1500
Device Class	Class II
Product Code:	FGA

Proprietary Name:	Amplatz Type Renal Sheaths
Device Classification Name:	Catheter, Nephrostomy
Regulation Description:	None
510(k) Number:	K172929
Regulation Number:	None
Device Class	Unclassified
Product Code:	LJE

In compliance with Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] we are including the following as reference devices:

Proprietary Name:	Monarch Platform
Device Classification Name:	Bronchoscope (Flexible or Rigid)
Regulation Description:	Bronchoscope (Flexible or Rigid) And Accessories
510(k) Number:	K193534
Regulation Number:	21 CFR 874.4680
Device Class	II
Product Code:	EOQ

Proprietary Name:	FluidSmart
Device Classification Name:	Insufflator, Hysteroscopic
Regulation Description:	Hysteroscopic Insufflator
510(k) Number:	K172048

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Regulation Number:	21 CFR 884.1700
Device Class	II
Product Code:	HIG, LGZ, HRX

Proprietary Name:	Karl Storz Flexible Video-Uretero-Renoscope System
Device Classification Name:	Ureteroscope and Accessories, Flexible/Rigid
Regulation Description:	Endoscope and accessories
510(k) Number:	K141250
Regulation Number:	21 CFR 876.1500
Device Class	II
Product Code:	FGB

4) Device Description

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provides the physician with the ability to control irrigation and suction levels during a procedure. The Urology Irrigation Cartridge and Suction Set are irrigation and suction tubing provided as sterile accessories to connect the Fluidics Pump to the Ureteroscope and Instruments during ureteroscopy or PCNL procedures.

Procedural specific instruments and accessories for the proposed device are outlined below, these devices are single-use devices and sterilized via EO.

Monarch® Mini-PCNL Suction Catheter: The Monarch® Mini-PCNL Suction Catheter ● (Suction Catheter) is part of the Monarch® Mini-PCNL Kit. The Suction Catheter is a flexible device that is inserted into the kidney via antegrade tract under direct visualization from the ureteroscope. It has a center lumen which allows for the suction of stone debris and can articulate in 4 directions. The suction catheter is manipulated by one robotic arm under the control of a physician who is concurrently controlling the Ureteroscope.
Dilation Set: The Dilation Set is part of the Monarch® Mini-PCNL Kit. The Dilation Set ● includes:
- 8Fr dilator
- 10Fr catheter
- Percutaneous Sheath Dilator ●

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The 8Fr dilator and 10 Fr catheter are constructed of PTFE. The Percutaneous Sheath Dilator is 21Fr and has a lumen sized to fit over the 8Fr dilator. The Percutaneous Sheath Dilator is used to dilate the percutaneous tract to 18 Fr to accommodate the Percutaneous Sheath.

Percutaneous Sheath: The Percutaneous Sheath is part of the Monarch® Mini-PCNL Kit. The Percutaneous Sheath consists of an inner metal sheath with a threaded connection and a metal outer sheath. It is designed to establish percutaneous access and designed to allow simultaneous irrigation and suction of fluid to support removal of kidney stones. The outer sheath has a molded hub with an angled luer connection for irrigation and an insertion depth marking on the distal end.

5) Intended Use/Indications for Use

Intended Use:

Indications for Use:

ComparisonCriteria	Proposed DeviceMonarch® Platform, Urology	Predicate DeviceLithoVue System(K153049)	Comparison Assessment
Indicationsfor Use	The Monarch® Platform, Urology, theUreteroscope, and endourology accessoriesare indicated to provide endoscopicvisualization and access of organs, cavitiesand canals in the urinary tract (urethra,bladder, ureter, calyces and renal papillae)with transurethral access or transurethralaccess in conjunction with percutaneousaccess routes. It can also be used inconjunction with endoscopic accessories toperform various diagnostic and therapeuticprocedures in the urinary tract.	The LithoVue System is intended to beused to visualize organs, cavities andcanals in the urinary tract (urethra,bladder, ureter, calyces and renalpapillae) via transurethral orpercutaneous access routes. It can alsobe used in conjunction with endoscopicaccessories to perform variousdiagnostic and therapeutic proceduresin the urinary tract.	Similar to PredicateNote: Both devices provide access tourinary tract and interior of the kidneythrough transurethral and percutaneousroutes to perform various diagnostic andtherapeutic procedures in the urinary tract.In addition, the Monarch® Platform,Urology includes a percutaneous accessroute that uses Monarch instruments andaccessories to facilitate PCNL procedure.These instruments fall within the indicationfor use of accessing the kidney throughpercutaneous access routes when used inconjunction with endoscopic accessories as

6) Comparison of Indication for Use Statement

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ComparisonCriteria	Proposed DeviceMonarch® Platform, Urology	Predicate DeviceLithoVue System(K153049)	Comparison Assessment
			cleared in the predicate's indication for usestatement.

7) Comparison of Technological Characteristics with the Predicate and Reference Device

Overall, the proposed device, predicate and reference devices are based on the following similar basic technological elements:

. Device provides real-time images to the physicians to facilitate diagnostic and therapeutic procedures in the urinary tract and interior of the kidney.
Device provides access to urinary tract and interior of the kidney through transurethral and percutaneous routes.
Device contains a flexible ureteroscope to visualize and gain access to the urinary tract and interior of the kidney.
Device requires continuous direct control by physician user to move the ureteroscope. ●
Device movement is only at the command of the physician. ●
Device moves the distal tip by pulling wires.
Device (ureteroscope) contains a working channel to allow delivery of the lithotrite and stone retrieval basket.
. Ureteroscope working channel size is identical to the predicate to allow the use of commercially available lithotrites.
. Ureteroscope dimensions and image specifications are comparable between the subject and predicate ureteroscopes.

The main difference between the proposed device and the primary predicate. LithoVue Systems (K153049), is that the LithoVue Systems lacks the electromechanical control mechanism. For this reason, the following reference devices are being added for their similarities in technological characteristics as compared to the proposed device.

Reference Device	Name and 510(k) Number	Technological Characteristics Comparison
Reference Device 1	Monarch Platform(Bronchoscopy Indication)(K193534)	Identical electromechanical controlmechanism and optional electromagneticnavigation technological characteristics.
Reference Device 2	Karl Storz Flexible Video-Uretero-Renoscope System(K141250)	Similar in performance specification ascompared to Monarch Ureteroscope.

The LithoVue Systems also lacks the suction and irrigation functionality included within the proposed device provided via the Monarch® Fluidics Pump. For this reason, the following predicate and reference devices are being added for their similarities in technological characteristics as compared to the Monarch® Fluidics Pump.

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Predicate/Reference Device	Name and 510(k) Number	Technological Characteristics Comparison
Predicate Device	Karl Storz Uromat E.A.S.I(K162992)	Identical suction and irrigation functionalityas compared to the Monarch® FluidicsPump.
Reference Device	FluidSmart(K172048)	Similar in control mechanism, performancespecification and fluid warming capabilitiesas compared to the Monarch® FluidicsPump.

Comparison of technological characteristics with the Predicate Device for devices bundled within the instruments and accessories kit of the Monarch® Platform, Urology are described below:

ProposedDevice	Predicate/ReferenceDevice	Name and 510(k)Number	Technological Characteristics asComparison

Monarch®Mini-PCNLSuctionCatheter	Predicate	LithAssist SuctionControl for LaserLithotripsy(510(k) Exempt)	Identical Characteristics:Functionality: To provide suction duringlithotripsy.Differences:Different size for improved suction ofstone fragments.Electromechanical control of the catheterafter manual insertion.
Dilation Set	Predicate	Amplatz Renal DilatorKit (K172527)	Identical Characteristics:Functionality: To establish dilation of thepercutaneous tract to allow for placementof a sheath.Differences:Minor dimensional differences in workinglength and dilator outer diameter.Minor differences in material
*PercutaneousSheath	PrimaryPredicate	Richard WolfNephroscope Set(K994223)	Identical Characteristics:*Functionality: To provideirrigation/aspiration to support removal ofkidney stone.Differences:Minor dimensional differences in workinglength and sheath diameter.Minor differences in material

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ProposedDevice	Predicate/ReferenceDevice	Name and 510(k)Number	Technological Characteristics asComparison
	SecondaryPredicate	Amplatz Type RenalShealths(K172929)	Identical Characteristics:*Functionality: To establishing percutaneousaccessDifferences:• Minor dimensional differences in workinglength and sheath diameter.• Minor differences in material

*The Percutaneous Sheath has two functionalities: 1) To provide irrigation/aspiration to support removal of kidney stones and 2) To establish percutaneous access.

8) Performance Data

The Monarch® Platform, Urology was tested for performance in accordance with internal design specification with the applicable performance standards to demonstrate safety and effectiveness. The testing identified no new issues of safety or effectiveness. The testing performed are summarized below:

Test Name	Description	Results
Reprocessing,Sterility and ShelfLife	Reprocessing:The cleaning and disinfection instructions provided inlabeling for non-disposable components were validatedagainst the following standards:• AAMI TIR-12:2020 - Designing, Testing, And LabelingMedical Devices Intended for Processing by HealthCare Facilities: A Guide For Device Manufacturers• AAMI TIR 30:2011 - A compendium of processes,materials, test methods, and acceptance criteria forcleaning reusable medical devicesSterility:Single-use disposable sterile (EO) devices were validated inaccordance with the following standard:• ISO11135:2014 - Sterilization of health care products -Ethylene Oxide - Requirements for the development,validation and routine control of a sterilization processfor medical devices.	Pass
Test Name	Description	Results
	EO residual has been evaluated per:• ISO10993-7:2008/And-1:2019 - Biological Evaluationof medical devices - Part 7: Ethylene Oxide SterilizationResiduals
	Shelf Life and Sterile Barrier Packaging:The shelf life and sterile barrier packaging of the single-usedisposable devices were evaluated per the followingStandards:• ISO 11607-1:2019 - Packaging for terminally sterilizedmedical devices – Part 1: Requirements for materials,sterile barrier systems and packaging systems• ASTM F1980 – 16 - Standard Guide for AcceleratedAging of Sterile Barrier Systems for Medical Devices• ASTM F88/F88M-15 - Standard Test Method for SealStrength of Flexible Barrier Materials• ASTM F1886/F1886M-16 - Standard Test Method forDetermining Integrity of Seals for Flexible Packagingby Visual Inspection• ASTM F2096 – 19 - Standard Test Method forDetecting Gross Leaks in Packaging by InternalPressurization (Bubble Test)
	Shipping and Distribution for Single Use Device:• ASTM D4332-14 - Standard Practice for ConditioningContainers, Packages, or Packaging Components forTesting.• ASTM D4169-16 - Standard Practice for PerformanceTesting of Shipping Containers and Systems
Biocompatibility	The final finished form of the subject device has been usedfor the biocompatibility evaluation.Biocompatibility for direct and indirect body contactingcomponent has been evaluated in accordance with theprovision of the following FDA Guidance document:• Guidance for Industry and Food and DrugAdministration Staff - Use of International Standard	Pass
Test Name	Description	Results
	ISO 10993-1, "Biological evaluation of medical devices- Part 1: Evaluation and testing within a riskmanagement process
	Biocompatibility has been validated per the followingstandards:ISO 10993-1:2018 - Biological evaluation of medicaldevices - Part 1: Evaluation and testing within a riskmanagement process ISO 10993-5:2009 - Biological evaluation of medicaldevices - Part 5: Tests for in vitro cytotoxicity ISO 10993-6:2016 - Biological evaluation of medicaldevices -- Part 6: Tests for local effects afterimplantation ISO 10993-10:2010 - Biological evaluation of medicaldevices - Part 10: Tests for irritation and skinsensitization ISO 10993-11:2017 - Biological evaluation of medicaldevices - Part 11: Tests for systemic toxicity
Electrical Safety andEMC	The proposed device has been fully evaluated for electricalsafety and EMC compliance to the following standards:ANSI AAMI ES60601-1:2005 + A2(R)2012 + A1 -Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance(IEC 60601-1:2005, MOD) IEC 60601-1-2:2014 - General requirements for basicsafety and essential performance – CollateralStandard: Electromagnetic disturbances – Requirementsand tests IEC 60601-2-18 2009 - Medical electrical equipment -Part 2-18: Particular requirements for the basic safetyand essential performance of endoscopic equipment	Pass
Software	Software was developed, tested, and verified per thefollowing FDA guidance document:Guidance for Industry and FDA Staff - Guidance for theContent of Premarket Submissions for SoftwareContained in Medical Devices	Pass
Test Name	Description	Results
	Results of verification and validation testing confirm thatthe proposed device conforms to design specifications andmeets the needs of the intended users.
Verification Testing	System Level Tests were executed to verify the overallfunctionality of the proposed device to operate as specifiedby the design input requirements including workflow,latency, ureteroscope and working channel instrumentsdriving and controls, various functional safety features, andother general functionality. Sub-system level requirementsfor safety and efficacy of the system, including but notlimited to the adherence to regulatory standards wereverified. Results of verification testing confirm that theproposed device conforms to design specifications andmeets the needs of the intended users. The device met allapplicable design input requirements, satisfied all sub-system specifications, and exhibit the electrical, mechanicaland functional integrity necessary.	Pass
Design Validation	Design Validations were conducted via live porcine modelto evaluate the proposed device under simulated useconditions to validate the user needs, including the safetyand effectiveness of the system as per its intended clinicaluse. All intended user needs evaluated met their acceptancecriteria. Data collected demonstrated that the proposeddevice performed in conformance with its intended use andthat the intended users were able to perform the procedureas intended.	Pass
Human Factors andUsability	Human factors and usability evaluation was performed inaccordance with FDA guidance:Guidance for Industry and Food and DrugAdministration Staff - Applying Human Factors andUsability Engineering to Medical DevicesThis evaluation assessed the proposed device for safety andeffective use by representative users during a simulated useof Monarch Ureteroscopy and Monarch mini-PCNLprocedures after training on using the proposed device in	Pass
Test Name	Description	Results
	the intended environment. Based on the results of theHuman Factors and Usability Test, the proposed device hasbeen found to be safe for the intended use by the intendedusers in the intended environment.
Acute Animal Safety	Acute animal safety studies were executed to demonstratethe capability of the proposed device to safely facilitaterenal diagnostic and therapeutic procedures via thetransurethral access route and percutaneous access route in alive animal model with relevant anatomy.	Pass

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9) Conclusion

Based on the indication for use, technological characteristic, performance testing and comparison to the predicate and reference devices, the Monarch® Platform, Urology raises no new questions of safety and effectiveness as compared to the predicate devices and is substantially equivalent to the predicate devices in terms of safety, efficacy, and performance.

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.