(205 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device's movement as being under "continuous and direct physician control". While it uses software and robotic arms, there is no indication of autonomous learning or decision-making characteristic of AI/ML.
Yes
The device is described for use in "diagnostic and therapeutic procedures" within the urinary tract. It facilitates therapeutic procedures directly, for example, by providing access and visualization for stone removal, and controls instruments like the Mini-PCNL Suction Catheter for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic and therapeutic procedures" and "to perform various diagnostic and therapeutic procedures in the urinary tract."
No
The device description clearly outlines multiple hardware components including a tower, cart, fluidics pump, controller, ureteroscope, and various instruments and accessories, in addition to the software.
Based on the provided information, the Monarch® Platform, Urology is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is defined as a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of transfusions, organs and tissue transplants.
- Monarch® Platform Function: The Monarch® Platform, Urology is a system designed for accessing and visualizing anatomical locations within the urinary tract and performing diagnostic and therapeutic procedures using a ureteroscope and other instruments. It involves direct interaction with the patient's body (transurethral or percutaneous access) for visualization and intervention.
- No Specimen Examination: The description does not mention the examination of any specimens (like urine, tissue biopsies, etc.) in vitro (outside the body) for diagnostic purposes. While it's used for diagnostic procedures, the diagnosis is made based on the in vivo visualization and potentially the results of therapeutic interventions, not on the analysis of collected samples.
Therefore, the Monarch® Platform, Urology falls under the category of a surgical or endoscopic device used for visualization and intervention within the body, not an IVD device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FGB, LJH
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
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Endoscopic camera view.
Anatomical Site
Urinary tract (urethra, bladder, ureter, calyces and renal papillae), interior of the kidney.
Indicated Patient Age Range
Adolescents and adults, aged 12 and up.
Intended User / Care Setting
Physician user, healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
Reprocessing, Sterility and Shelf Life:
Reprocessing: The cleaning and disinfection instructions provided in labeling for non-disposable components were validated against AAMI TIR-12:2020 and AAMI TIR 30:2011. Results: Pass.
Sterility: Single-use disposable sterile (EO) devices were validated in accordance with ISO11135:2014. EO residual was evaluated per ISO10993-7:2008/And-1:2019. Results: Pass.
Shelf Life and Sterile Barrier Packaging: Evaluated per ISO 11607-1:2019, ASTM F1980 – 16, ASTM F88/F88M-15, ASTM F1886/F1886M-16, ASTM F2096 – 19. Results: Pass.
Shipping and Distribution for Single Use Device: Evaluated per ASTM D4332-14 and ASTM D4169-16. Results: Pass.
Biocompatibility:
The final finished form of the subject device was used for biocompatibility evaluation in accordance with 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'". Validated per ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-6:2016, ISO 10993-10:2010, ISO 10993-11:2017. Results: Pass.
Electrical Safety and EMC:
Fully evaluated for electrical safety and EMC compliance to ANSI AAMI ES60601-1:2005 + A2(R)2012 + A1, IEC 60601-1-2:2014, and IEC 60601-2-18 2009. Results: Pass.
Software:
Developed, tested, and verified per FDA guidance "Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Results of verification and validation testing confirm that the proposed device conforms to design specifications and meets the needs of the intended users. Results: Pass.
Verification Testing:
System Level Tests executed to verify overall functionality, workflow, latency, ureteroscope and working channel instruments driving and controls, various functional safety features, and other general functionality. Sub-system level requirements for safety and efficacy verified. Results: Pass, device conforms to design specifications, meets user needs, and satisfied all specified requirements.
Design Validation:
Conducted via live porcine model under simulated use conditions to validate user needs, safety, and effectiveness. All intended user needs evaluated met acceptance criteria. Data demonstrated that the proposed device performed in conformance with its intended use and that intended users were able to perform the procedure as intended. Results: Pass.
Human Factors and Usability:
Evaluation performed in accordance with FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices". Assessed for safety and effective use by representative users during simulated use of Monarch Ureteroscopy and Monarch mini-PCNL procedures after training. Results: Pass, device found safe for intended use by intended users in intended environment.
Acute Animal Safety:
Acute animal safety studies executed to demonstrate the capability of the proposed device to safely facilitate renal diagnostic and therapeutic procedures via transurethral access route and percutaneous access route in a live animal model with relevant anatomy. Results: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K153049, K162992, K172527, K994223, K172929
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found.
§ 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.
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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)
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.
| 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 Family
Company
150 Shoreline Drive
Redwood City, CA 94065 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------|
| FDA Registration Number | 3014447948 |
| Primary Correspondent | Angela Wong
Staff Regulatory Affairs Specialist
Auris Health, Inc., a Johnson and Johnson Family
Company |
| Contact Information | Email: lwong6@its.jnj.com
Phone: (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 |
4
- 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
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
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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.
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 ●
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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:
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.
Indications for Use:
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.
| Comparison
Criteria | Proposed Device
Monarch® Platform, Urology | Predicate Device
LithoVue System
(K153049) | Comparison Assessment |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | 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. | 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. | Similar to Predicate
Note: Both devices provide access to
urinary tract and interior of the kidney
through transurethral and percutaneous
routes to perform various diagnostic and
therapeutic procedures in the urinary tract.
In addition, the Monarch® Platform,
Urology includes a percutaneous access
route that uses Monarch instruments and
accessories to facilitate PCNL procedure.
These instruments fall within the indication
for use of accessing the kidney through
percutaneous access routes when used in
conjunction with endoscopic accessories as |
6) Comparison of Indication for Use Statement
9
| Comparison
Criteria | Proposed Device
Monarch® Platform, Urology | Predicate Device
LithoVue System
(K153049) | Comparison Assessment |
|------------------------|-----------------------------------------------|--------------------------------------------------|-------------------------------------------------------------|
| | | | cleared in the predicate's indication for use
statement. |
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 control | |
| mechanism and optional electromagnetic | ||
| navigation technological characteristics. | ||
| Reference Device 2 | Karl Storz Flexible Video- | |
| Uretero-Renoscope System | ||
| (K141250) | Similar in performance specification as | |
| compared 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.
10
| 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 functionality | |
| as compared to the Monarch® Fluidics | ||
| Pump. | ||
| Reference Device | FluidSmart | |
| (K172048) | Similar in control mechanism, performance | |
| specification and fluid warming capabilities | ||
| as compared to the Monarch® Fluidics | ||
| Pump. |
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:
| Proposed
Device | Predicate/
Reference
Device | Name and 510(k)
Number | Technological Characteristics as
Comparison |
|----------------------------------------------|-----------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| Monarch®
Mini-PCNL
Suction
Catheter | Predicate | LithAssist Suction
Control for Laser
Lithotripsy
(510(k) Exempt) | Identical Characteristics:
Functionality: To provide suction during
lithotripsy.
Differences:
Different size for improved suction of
stone fragments.Electromechanical control of the catheter
after manual insertion. |
| Dilation Set | Predicate | Amplatz Renal Dilator
Kit (K172527) | Identical Characteristics:
Functionality: To establish dilation of the
percutaneous tract to allow for placement
of a sheath.
Differences:
Minor dimensional differences in working
length and dilator outer diameter.Minor differences in material |
| *Percutaneous
Sheath | Primary
Predicate | Richard Wolf
Nephroscope Set
(K994223) | Identical Characteristics:
*Functionality: To provide
irrigation/aspiration to support removal of
kidney stone.
Differences:
Minor dimensional differences in working
length and sheath diameter.Minor differences in material |
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| Proposed
Device | Predicate/
Reference
Device | Name and 510(k)
Number | Technological Characteristics as
Comparison |
|--------------------|-----------------------------------|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Secondary
Predicate | Amplatz Type Renal
Shealths
(K172929) | Identical Characteristics:
*Functionality: To establishing percutaneous
access
Differences:
• Minor dimensional differences in working
length 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 Shelf | ||
| Life | Reprocessing: | |
| The cleaning and disinfection instructions provided in | ||
| labeling for non-disposable components were validated | ||
| against the following standards: | ||
| • AAMI TIR-12:2020 - Designing, Testing, And Labeling | ||
| Medical Devices Intended for Processing by Health | ||
| Care Facilities: A Guide For Device Manufacturers | ||
| • AAMI TIR 30:2011 - A compendium of processes, | ||
| materials, test methods, and acceptance criteria for | ||
| cleaning reusable medical devices |
Sterility:
Single-use disposable sterile (EO) devices were validated in
accordance with the following standard:
• ISO11135:2014 - Sterilization of health care products -
Ethylene Oxide - Requirements for the development,
validation and routine control of a sterilization process
for medical devices. | Pass |
| Test Name | Description | Results |
| | EO residual has been evaluated per:
• ISO10993-7:2008/And-1:2019 - Biological Evaluation
of medical devices - Part 7: Ethylene Oxide Sterilization
Residuals | |
| | Shelf Life and Sterile Barrier Packaging:
The shelf life and sterile barrier packaging of the single-use
disposable devices were evaluated per the following
Standards:
• ISO 11607-1:2019 - Packaging for terminally sterilized
medical devices – Part 1: Requirements for materials,
sterile barrier systems and packaging systems
• ASTM F1980 – 16 - Standard Guide for Accelerated
Aging of Sterile Barrier Systems for Medical Devices
• ASTM F88/F88M-15 - Standard Test Method for Seal
Strength of Flexible Barrier Materials
• ASTM F1886/F1886M-16 - Standard Test Method for
Determining Integrity of Seals for Flexible Packaging
by Visual Inspection
• ASTM F2096 – 19 - Standard Test Method for
Detecting Gross Leaks in Packaging by Internal
Pressurization (Bubble Test) | |
| | Shipping and Distribution for Single Use Device:
• ASTM D4332-14 - Standard Practice for Conditioning
Containers, Packages, or Packaging Components for
Testing.
• ASTM D4169-16 - Standard Practice for Performance
Testing of Shipping Containers and Systems | |
| Biocompatibility | The final finished form of the subject device has been used
for the biocompatibility evaluation.
Biocompatibility for direct and indirect body contacting
component has been evaluated in accordance with the
provision of the following FDA Guidance document:
• Guidance for Industry and Food and Drug
Administration 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 risk
management process | |
| | Biocompatibility has been validated per the following
standards:
ISO 10993-1:2018 - Biological evaluation of medical
devices - Part 1: Evaluation and testing within a risk
management process ISO 10993-5:2009 - Biological evaluation of medical
devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-6:2016 - Biological evaluation of medical
devices -- Part 6: Tests for local effects after
implantation ISO 10993-10:2010 - Biological evaluation of medical
devices - Part 10: Tests for irritation and skin
sensitization ISO 10993-11:2017 - Biological evaluation of medical
devices - Part 11: Tests for systemic toxicity | |
| Electrical Safety and
EMC | The proposed device has been fully evaluated for electrical
safety and EMC compliance to the following standards:
ANSI AAMI ES60601-1:2005 + A2(R)2012 + A1 -
Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
(IEC 60601-1:2005, MOD) IEC 60601-1-2:2014 - General requirements for basic
safety and essential performance – Collateral
Standard: Electromagnetic disturbances – Requirements
and tests IEC 60601-2-18 2009 - Medical electrical equipment -
Part 2-18: Particular requirements for the basic safety
and essential performance of endoscopic equipment | Pass |
| Software | Software was developed, tested, and verified per the
following FDA guidance document:
Guidance for Industry and FDA Staff - Guidance for the
Content of Premarket Submissions for Software
Contained in Medical Devices | Pass |
| Test Name | Description | Results |
| | Results of verification and validation testing confirm that
the proposed device conforms to design specifications and
meets the needs of the intended users. | |
| Verification Testing | System Level Tests were executed to verify the overall
functionality of the proposed device to operate as specified
by the design input requirements including workflow,
latency, ureteroscope and working channel instruments
driving and controls, various functional safety features, and
other general functionality. Sub-system level requirements
for safety and efficacy of the system, including but not
limited to the adherence to regulatory standards were
verified. Results of verification testing confirm that the
proposed device conforms to design specifications and
meets the needs of the intended users. The device met all
applicable design input requirements, satisfied all sub-
system specifications, and exhibit the electrical, mechanical
and functional integrity necessary. | Pass |
| Design Validation | Design Validations were conducted via live porcine model
to evaluate the proposed device under simulated use
conditions to validate the user needs, including the safety
and effectiveness of the system as per its intended clinical
use. All intended user needs evaluated met their acceptance
criteria. Data collected demonstrated that the proposed
device performed in conformance with its intended use and
that the intended users were able to perform the procedure
as intended. | Pass |
| Human Factors and
Usability | Human factors and usability evaluation was performed in
accordance with FDA guidance:
Guidance for Industry and Food and Drug
Administration Staff - Applying Human Factors and
Usability Engineering to Medical Devices
This evaluation assessed the proposed device for safety and
effective use by representative users during a simulated use
of Monarch Ureteroscopy and Monarch mini-PCNL
procedures after training on using the proposed device in | Pass |
| Test Name | Description | Results |
| | the intended environment. Based on the results of the
Human Factors and Usability Test, the proposed device has
been found to be safe for the intended use by the intended
users in the intended environment. | |
| Acute Animal Safety | Acute animal safety studies were executed to demonstrate
the capability of the proposed device to safely facilitate
renal diagnostic and therapeutic procedures via the
transurethral access route and percutaneous access route in a
live 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.