(108 days)
The MONARCHTM Bronchoscope and the MONARCHTM Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
The MONARCH Platform is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The MONARCH Platform enables robotic electro-mechanical articulation and precise control of a flexible bronchoscope under continuous and direct control by a physician operator.
The MONARCH Platform allows for precise access of the lung anatomy and continuous visualization using the bronchoscope distal tip camera. The MONARCH Platform consists of four major components, (1) MONARCHTM Cart, (2) MONARCHTM Tower, (3) MONARCHTM Bronchoscope, (4) MONARCHTM Controller and working channel instruments and accessories. The MONARCH Cart provides support for the effector arms. It includes up to three robotic arms and the electronic systems required to power and operate the robotic system. The robotic arms possess multiple degrees of freedom. The MONARCH Tower is the primary user (i.e. physician) procedural display interface. It contains a monitor for user viewing and computers running the system software. The tower provides connectivity for the bronchoscope camera and lighting, as well as the fluidics system. The user controls the system with an endoscopic controller which transmits user inputs through the electromechanical system to the bronchoscope. The flexible MONARCH Bronchoscope has a working channel and a camera at the distal end. The working channel of the Bronchoscope is used for irrigation, aspiration and to deliver the working channel instruments.
Additionally, the Monarch Platform includes electromagnetic (EM) navigation and integrates a pre-operative computed tomography (CT) scan into an intra-operative interface, displaying the modeled bronchoscope tip location relative to the pre-operative scan anatomy.
The MONARCH Platform is being updated to receive 3D imaging data via an ethernet connection directly from a Cone Beam CT (CBCT) System with 3D imaging technology. This will enable real time navigation updates during a procedure with the device. This integration feature is optional for the user, but if selected, use of the MONARCHTM Window Field Generator is required.
The modified device includes software updates for navigation and presentation of the anatomy for display and planning purposes, firmware updates for a revised controller, and hardware and software revisions for the purposes of cybersecurity.
The document provided does not contain a table of acceptance criteria and reported device performance. It outlines various non-clinical performance tests conducted to verify the modified MONARCH™ Platform's safety and effectiveness.
Here's the information that could be extracted from the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table with acceptance criteria and corresponding reported device performance values. However, it lists several non-clinical tests performed and states that the device "passed all tests in accordance with appropriate test criteria and standards."
Non-Clinical Performance Tests Performed:
- Proof of Design electrical tests: Verified all hardware modules perform within specifications.
- Location accuracy tests: For navigation purposes.
- Software functional tests: Covered complete system functionality, including error handling, usability, time, and ability to receive, process, and display imaging data from cone beam CT Systems.
- Safety, EMC, and mechanical tests: Performed by an independent nationally recognized testing laboratory to verify compliance with safety and EMC standards for medical devices to address hardware changes.
- Simulated use accuracy test: A complete CT image registration and instrument navigation workflow was performed to verify the overall accuracy of the system.
- Usability (Human Factors) Pre-clinical (cadaver) tests: Designed to mimic surgical procedures using the MONARCH™ Platform in a simulated clinical environment to assess the execution of a complete robotically assisted bronchoscopy procedure workflow and to qualitatively estimate the system clinical accuracy.
Reported Performance (General Statement):
"The proposed MONARCH Platform passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Simulated use accuracy test" and "Usability (Human Factors) Pre-clinical (cadaver) tests."
- For the simulated use accuracy test, no specific sample size (number of cases or measurements) is provided.
- For the usability (human factors) pre-clinical tests, it states "cadaver tests," indicating ex-vivo human anatomical models were used.
- The document does not specify the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide information on the number or qualifications of experts used to establish ground truth for any of the tests. For the human factors/cadaver testing, it states the tests were "designed to mimic surgical procedures...to qualitatively estimate the system clinical accuracy," implying expert involvement, but no details are given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method used for either the test set (if referring to the simulated or cadaver testing) or for establishing ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not describe an MRMC comparative effectiveness study or any study evaluating the improvement of human readers with vs. without AI assistance. The focus of this submission is on updates to the MONARCH™ Platform for direct Cone Beam CT integration and cybersecurity, rather than a new AI-driven diagnostic or assistive feature assessed with human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document specifically describes the MONARCH™ Platform as enabling "robotic electro-mechanical articulation and precise control of a flexible bronchoscope under continuous and direct control by a physician operator." The tests performed are in the context of this human-in-the-loop operation, for example, "Simulated use accuracy test, in which a complete CT image registration and instrument navigation workflow was performed." Therefore, a standalone algorithm-only performance study without human-in-the-loop was not performed or described as relevant to this device update. The closest to an 'algorithm only' test would be software functional tests and location accuracy tests, but these are components of the overall human-controlled system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document refers to "location accuracy tests," and "simulated use accuracy test" which implies a quantitative ground truth for positional accuracy. For the "Usability (Human Factors) Pre-clinical (cadaver) tests," the goal was to "qualitatively estimate the system clinical accuracy," suggesting subjective expert assessment in a simulated environment, without specifying a formal ground truth like pathology or outcomes data.
8. The sample size for the training set
The document does not mention a training set or its sample size. This submission focuses on modifications to an existing device (software updates for navigation and display, firmware for a revised controller, and cybersecurity revisions) and integrates new input from CBCT, rather than describing a new AI model that would typically require a training set.
9. How the ground truth for the training set was established
As no training set is mentioned, information on how its ground truth was established is not provided.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 23, 2025
Auris Health, Inc. Amy Clendening-Wheeler Sr Regulatory Affairs Specialist 5490 Great America Parkway Santa Clara, California 94054
Re: K243219
Trade/Device Name: MONARCH™ Platform Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: December 26, 2024 Received: December 26, 2024
Dear Amy Clendening-Wheeler:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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For comprehensive regulatory information about medical devices and radiation-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,
Shuchen Peng -S
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
MONARCH™ Platform
Indications for Use (Describe)
The MONARCH™ Bronchoscope and the Monarch Platform™ and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary MONARCH™ Platform
| [807.92(a)(1)] Submitter Information | ||
|---|---|---|
| Applicant: | Johnson & Johnson MedTechAuris Health, Inc.5490 Great America ParkwaySanta Clara, CA 95054USATelephone: +650.264.6000 | |
| Contact Person: | James Patrick Garvey IIDirector, Regulatory AffairsJohnson & Johnson MedTechAuris Health, Inc.5490 Great America ParkwaySanta Clara, CA, 95054USATelephone: 650-590-6907pgarvey@its.jnj.com | Amy Clendening-WheelerSr. RA Specialist |
| Date Summary Prepared: | January 23, 2025 | |
| [807.92(a)(2)] Name of Device | ||
| Device Trade Name: | MONARCHTM Platform | |
| Device Common Name: | Bronchoscope (Flexible or Rigid) | |
| Device Classification: | Class II, 21 CFR 874.4680 | |
| Product Code | EOQ | |
| Subsequent Product Code | JAK | |
| [807.92(a)(3)] Legally Marketed Devices | ||
| Predicate Device: | MONARCH Platform510(k) #: K211493 | |
| [807.92(a)(4)] Device Description | ||
| Device Description: | The MONARCH Platform is intended to provide bronchoscopicvisualization of and access to patient airways for diagnostic andtherapeutic procedures. The MONARCH Platform enables roboticelectro-mechanical articulation and precise control of a flexiblebronchoscope under continuous and direct control by a physicianoperator.The MONARCH Platform allows for precise access of the lunganatomy and continuous visualization using the bronchoscope distal tipcamera. The MONARCH Platform consists of four major components,(1) MONARCHTM Cart, (2) MONARCHTM Tower, (3) MONARCHTMBronchoscope, (4) MONARCHTM Controller and working channelinstruments and accessories. The MONARCH Cart provides support forthe effector arms. It includes up to three robotic arms and the electronicsystems required to power and operate the robotic system. The roboticarms possess multiple degrees of freedom. The MONARCH Tower isthe primary user (i.e. physician) procedural display interface. It containsa monitor for user viewing and computers running the system software.The tower provides connectivity for the bronchoscope camera andlighting, as well as the fluidics system. The user controls the system | |
| with an endoscopic controller which transmits user inputs through theelectromechanical system to the bronchoscope. The flexibleMONARCH Bronchoscope has a working channel and a camera at thedistal end. The working channel of the Bronchoscope is used forirrigation, aspiration and to deliver the working channel instruments. | ||
| Additionally, the Monarch Platform includes electromagnetic (EM)navigation and integrates a pre-operative computed tomography (CT)scan into an intra-operative interface, displaying the modeledbronchoscope tip location relative to the pre-operative scan anatomy. | ||
| The MONARCH Platform is being updated to receive 3D imaging datavia an ethernet connection directly from a Cone Beam CT (CBCT)System with 3D imaging technology. This will enable real timenavigation updates during a procedure with the device. This integrationfeature is optional for the user, but if selected, use of the MONARCHTMWindow Field Generator is required. | ||
| The modified device includes software updates for navigation andpresentation of the anatomy for display and planning purposes, firmwareupdates for a revised controller, and hardware and software revisions forthe purposes of cybersecurity. | ||
| [807.92(a)(5)] Intended Use | ||
| Indications for Use: | The MONARCHTM Bronchoscope and the MONARCHTM Platformand its accessories are intended to provide bronchoscopicvisualization of and access to patient airways for diagnostic andtherapeutic procedures. | |
| Difference in Indicationsfrom Predicate Device: | The Indications for Use have been updated from the predicate K211493,however they have not materially changed. The Indications for Usestatement cleared in K211493 are "The Monarch Platform and itsaccessories are intended to provide bronchoscopic visualization of andaccess to patient airways for diagnostic and therapeutic procedures." | |
| The Indications for Use in this submission have been updated to reflectthe essential role of the bronchoscope and now reads: | ||
| "The MONARCHTM Bronchoscope and the MONARCHTM Platform andits accessories are intended to provide bronchoscopic visualization ofand access to patient airways for diagnostic and therapeutic procedures." | ||
| [807.92(a)(6)] Technical Characteristics | ||
| TechnologicalCharacteristics: | The substantial equivalence of the MONARCH Platform to thepredicates is shown by similarity in intended use, indications for use,and performance. | |
| The subject device and the predicate device have similar technologicalcharacteristics with respect to principles of operation, system design,and performance. The subject and predicate device achieve the sameoutcomes; however, the main design difference of the subject device isthe ability to directly connect to Cone Beam Computed Tomography |
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510(k) Summary MONARCH™ Platform
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510(k) Summary MONARCH™ Platform K243219
systems for the purpose of receiving imaging data during a procedure. Performance testing on the subject device and comparison to the reference device support that there are no new questions of safety or effectiveness.
Like the predicate MONARCH Platform, the modified MONARCH Platform is an electromagnetic and image-guided navigation system intended for use during robotically assisted bronchoscopy procedures. Physicians can track and display the real-time location of the bronchoscope relative to pre-acquired CT images, while simultaneously receiving a live and continuous video image from the bronchoscope, and navigational displays on the device monitor. The modified MONARCH Platform may be optionally interfaced to Cone Beam Computed Tomography (CBCT) systems to receive near-realtime imaging updates during a procedure.
The subject device of this submission has the same technological characteristics as the predicate except for updated software and new hardware to facilitate communications with a Cone Beam Computed Tomography system. Like the predicate, the MONARCH Platform utilizes electromagnetic tracking technology for navigation, uses anatomical reference points on the patient's anatomy for intraoperative registration to the image-based model of the anatomy, and uses CT image sets as reference images for the image-based model. The instructions for use and product labels have been updated to reflect the revised device. Refer to Table 1 on the following pages for a Comparison of Technological Characteristics with the Predicate device.
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510(k) Summary
MONARCH™ Platform
K243219 K243219
Table 1: Comparison of Predicate & Subject Device of this Submission
| Key Attributes | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| RegulatoryClassificationInformation | Auris Health, Inc.MONARCH Platform K211493Regulation Number: 21 CFR 874.4680Regulation Name: Bronchoscope (Flexible orRigid) And AccessoriesRegulatory Class: Class IIProduct Code: EOQ | Auris Health, Inc.MONARCH PlatformRegulation Number: 21 CFR 874.4680Regulation Name: Bronchoscope (Flexible orRigid) And AccessoriesRegulatory Class: Class IIProduct Code: EOQ | Same. The Predicate Device and Subject Devicehave the same regulatory classificationinformation. |
| Device Description | The MONARCH Platform is intended to providebronchoscopic visualization of and access topatient airways for diagnostic and therapeuticprocedures. The MONARCH™ Platform enablesrobotic electro-mechanical articulation and precisecontrol of a flexible bronchoscope undercontinuous and direct control by a physician andallows for precise access of the lung anatomy andcontinuous visualization using the bronchoscopedistal tip camera, under the control of a physicianoperator. | The MONARCH Platform is intended to providebronchoscopic visualization of and access topatient airways for diagnostic and therapeuticprocedures. The MONARCH Platform enablesrobotic electro-mechanical articulation and precisecontrol of a flexible bronchoscope undercontinuous and direct control by a physician andallows for precise access of the lung anatomy andcontinuous visualization using the bronchoscopedistal tip camera, under the control of a physicianoperator.Additionally, the MONARCH Platform canintegrate imaging data directly from a Cone BeamComputed Tomography system to update the scopeand target position to overcome any changes inanatomy not reflected in the pre-op CT scan. | Different. Compared to the Predicate Device, theSubject Device has been equipped with additionalhardware and software to optionally enable receiptof imaging data directly from a Cone BeamComputed Tomography System, to update thescope and target position to overcome changes inanatomy not reflected in the pre-op CT scan.¹Additional changes were made to update certainhardware, and to implement Cybersecuritycountermeasures. |
| Intended use /Indications for use | The MONARCH Platform is intended to providebronchoscopic visualization of and access topatient airways for diagnostic and therapeuticprocedures. | The MONARCH Bronchoscope and theMONARCH Platform and its accessories areintended to provide bronchoscopic visualization ofand access to patient airways for diagnostic andtherapeutic procedures. | Equivalent. The verbiage of the Intended Use /Indications for Use has been updated to reflect thecontribution of the previously cleared MONARCHBronchoscope in the MONARCH Platformmeeting its Intended Use and Indications for Use. |
| Fundamentalscientific technology | Electromechanical system using direct (cameraand light source) supplemented by indirect(electromagnetic navigation) visualization of theflexible bronchoscope position by the physicianoperator. Steering, as well as insertion andwithdrawal is under continuous and direct control | Electromechanical system using direct (camera andlight source) supplemented by indirect(electromagnetic navigation) visualization of theflexible bronchoscope position by the physicianoperator. Steering, as well as insertion andwithdrawal is under continuous and direct control | Same. The fundamental scientific technology,consisting of an electromechanical system usingdirect (camera and light source) inputssupplemented by indirect (electromagneticnavigation) visualization of the flexiblebronchoscope position by the physician operator is |
| Key Attributes | Predicate DeviceAuris Health, Inc.MONARCH Platform K211493by the physician operator. | Subject DeviceAuris Health, Inc.MONARCH Platformby the physician operator. | Comparison |
| Primary mode ofaction | Physician input (movement of endoscopiccontroller) to move the endoscope. | Physician input (movement of endoscopiccontroller) to move the endoscope. | unchanged. Like the predicate, steering, includinginsertion and withdrawal, remains undercontinuous and direct control by the physicianoperator. |
| Method of distal tipmovement | Pull wires | Pull wires | Additionally, the Subject device can integrateimaging data directly from a Cone BeamComputed Tomography system during a procedureto update the scope and target position toovercome changes in anatomy not reflected in thepre-op CT scan. |
| Major components | Auris CartAuris TowerBronchoscope and SheathAccessories (working channel instruments, patientintroducer adaptor, fluidics tubing, navigation fieldgenerators, field generator mount, USB stick,patient sensors, patient patches, etc.) | Auris CartAuris TowerBronchoscope (Inner Scope and Outer Sheath)Accessories (working channel instruments, patientintroducer adaptor, fluidics tubing, navigation fieldgenerator, field generator mount, USB stick,patient sensors, patient patches, etc.) | Same. The Predicate and Subject devices have thesame primary modes of action.Same. The Predicate and Subject devices have thesame mechanism of distal tip movement.Same. The Predicate and Subject devices arecomprised as the same major components. |
| Control/physicianinterfaces | Controller with joystick and buttons | Controller with joystick and buttons | Same. The Predicate and Subject devices feature thesame Control/physician interfaces. |
| Cart base elements | Touch screen monitor and embedded PC. | Touch screen monitor and embedded PC. | Equivalent. The Predicate and Subject devices havethe same cart base elements, however the modifieddevice includes an additional Ethernet connectionfor the interface Cone Beam ComputedTomography System data. |
| Robotic arms | Two identical arms (2) | Two identical arms (2) | Same. The Predicate and Subject device have thesame number of arms. |
| Tower keycharacteristics | Touch screen monitor, on-board computers,fluidics pump, power supply. | Touch screen monitor, on-board computers,fluidics pump, power supply, door lock. | Equivalent. The Tower in Predicate and Subjectdevices have largely the same key characteristics,however the Subject device has been equipped witha door lock for cybersecurity purposes |
| Key Attributes | Predicate DeviceAuris Health, Inc.MONARCH Platform K211493 | Subject DeviceAuris Health, Inc.MONARCH Platform | Comparison |
| ElectromagneticNavigation | Yes | Yes | Same. The Predicate and Subject Devices bothinclude Electromagnetic Navigation. |
| Working channelinstruments | Auris Aspirating biopsy needle, Biopsy Forceps,Cytology Brush | Auris Aspirating biopsy needle, Biopsy Forceps,Cytology Brush (cleared in K211493) | Same. The Predicate and Subject Devices are bothcompatible with the same working channelaccessories. |
| Third party compatible (meet working channellength and diameter requirements) instruments andtools (e.g., RBUS probe) | Third party compatible (meet working channellength and diameter requirements) instruments andtools (e.g., RBUS probe) | ||
| Direct Interface withCBCT system toreduce potentialbody divergence. | Not available | Implemented - subject of this submission. | Different. Compared to the predicate, the subjectdevice can integrate imaging data directly from aCone Beam Computed Tomography system duringa procedure to update the scope and target positionto overcome changes in anatomy not reflected inthe pre-op CT scan. 1 |
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| Reference Device | The Galaxy System, K223144 may be considered a reference device, as K223144 was cleared with a description including "full procedure navigation that integrates a pre-operative computed tomography scan to display scope tip location relative to the pre-operative scan anatomy. |
|---|---|
| Noah Medical Galaxy System™ | Additionally, Galaxy integrates a tomosynthesis spin to update the scope and target position to overcome any changes in anatomy not reflected in the pre-op CT scan." Note: the reference to K223144 is included for informational purposes only, and is not intended to serve as a decision point for determination of Substantial Equivalence. |
| K223144 |
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510(k) Summary MONARCH™ Platform
| Non-clinical Performance Data: | The MONARCH Platform was tested to ensure that it functions in accordance with the system design specifications related to substantial equivalence in terms of device safety and effectiveness. The following nonclinical tests were performed to verify the modified device continued to meet performance specifications: Proof of Design electrical tests, to verify all hardware modules perform within specifications.Location accuracy tests for navigation purposes.Software functional tests, covering the complete system functionality, and including error handling, usability, time and the ability to receive, process, and display imaging data from cone beam CT Systems.Safety, EMC, and mechanical tests were performed by an independent nationally recognized testing laboratory to verify compliance with safety and EMC standards for medical devices to address hardware changes.Simulated use accuracy test, in which a complete CT image registration and instrument navigation workflow was performed, to verify the overall accuracy of the system.Usability (Human Factors) Pre-clinical (cadaver) tests were designed to mimic surgical procedures using the MONARCH Platform in a simulated clinical environment, to assess the execution of a complete robotically assisted bronchoscopy procedure workflow and to qualitatively estimate the system clinical accuracy.The proposed MONARCH Platform passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness. |
|---|---|
| Clinical Performance Data: | Clinical data was not necessary to determine that the modified MONARCH Platform was substantially equivalent to the predicate device. The performance data demonstrated that the device performs as intended. |
| Conclusion: | The modified MONARCH Platform is substantially equivalent to the currently cleared MONARCH Platform based on the completion of non-clinical bench testing as well as similar principles of design, operation and indications for use. |
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.