(108 days)
No
The summary describes a robotic bronchoscopy platform with navigation capabilities based on pre-operative and intra-operative imaging, but it does not mention the use of AI or ML for image analysis, navigation, or control.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic and therapeutic procedures," and the device description reiterates this.
Yes
The intended use of the MONARCH Platform explicitly includes "diagnostic procedures" as it provides "bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures."
No
The device description explicitly details multiple hardware components including a cart, tower, bronchoscope, and controller, and mentions hardware revisions and testing.
Based on the provided information, the MONARCH Platform is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures." This describes a device used in vivo (within the living body) for direct observation and intervention, not for testing samples in vitro (outside the living body).
- Device Description: The description details a robotic system with a bronchoscope, camera, and working channel for accessing and visualizing the airways. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing. The focus is on direct visualization and access.
While the device uses imaging data (CT and CBCT) and software for navigation and planning, this is for guiding the in vivo procedure, not for performing in vitro diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The MONARCHTM Bronchoscope and the Monarch PlatformTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
EOQ, JAK
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), Cone Beam Computed Tomography (CBCT)
Anatomical Site
patient airways for diagnostic and therapeutic procedures. (Specifically lung anatomy for precise access)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician operator / Clinical environment (simulated)
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)
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.
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.
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
§ 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.
0
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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).
1
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.
2
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
3
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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4
510(k) Summary MONARCH™ Platform
| [807.92(a)(1)] Submitter Information | ||
|---|---|---|
| Applicant: | Johnson & Johnson MedTech | |
| Auris Health, Inc. | ||
| 5490 Great America Parkway | ||
| Santa Clara, CA 95054 | ||
| USA | ||
| Telephone: +650.264.6000 | ||
| Contact Person: | James Patrick Garvey II | |
| Director, Regulatory Affairs | ||
| Johnson & Johnson MedTech | ||
| Auris Health, Inc. | ||
| 5490 Great America Parkway | ||
| Santa Clara, CA, 95054 | ||
| USA | ||
| Telephone: 650-590-6907 | ||
| pgarvey@its.jnj.com | Amy Clendening-Wheeler | |
| Sr. 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 Platform | |
| 510(k) #: K211493 | ||
| [807.92(a)(4)] Device Description | ||
| Device Description: | 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. | |
| [807.92(a)(5)] Intended Use | | |
| Indications for Use: | 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. | |
| Difference in Indications
from Predicate Device: | The Indications for Use have been updated from the predicate K211493,
however they have not materially changed. The Indications for Use
statement cleared in K211493 are "The Monarch Platform and its
accessories are intended to provide bronchoscopic visualization of and
access to patient airways for diagnostic and therapeutic procedures." | |
| | The Indications for Use in this submission have been updated to reflect
the essential role of the bronchoscope and now reads: | |
| | "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." | |
| [807.92(a)(6)] Technical Characteristics | | |
| Technological
Characteristics: | The substantial equivalence of the MONARCH Platform to the
predicates is shown by similarity in intended use, indications for use,
and performance. | |
| | The subject device and the predicate device have similar technological
characteristics with respect to principles of operation, system design,
and performance. The subject and predicate device achieve the same
outcomes; however, the main design difference of the subject device is
the ability to directly connect to Cone Beam Computed Tomography | |
5
510(k) Summary MONARCH™ Platform
6
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.
7
510(k) Summary
MONARCH™ Platform
K243219 K243219
Table 1: Comparison of Predicate & Subject Device of this Submission
| Key Attributes | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Regulatory | |||
| Classification | |||
| Information | Auris Health, Inc. | ||
| MONARCH Platform K211493 | |||
| Regulation Number: 21 CFR 874.4680 | |||
| Regulation Name: Bronchoscope (Flexible or | |||
| Rigid) And Accessories | |||
| Regulatory Class: Class II | |||
| Product Code: EOQ | Auris Health, Inc. | ||
| MONARCH Platform | |||
| Regulation Number: 21 CFR 874.4680 | |||
| Regulation Name: Bronchoscope (Flexible or | |||
| Rigid) And Accessories | |||
| Regulatory Class: Class II | |||
| Product Code: EOQ | Same. The Predicate Device and Subject Device | ||
| have the same regulatory classification | |||
| information. | |||
| Device Description | 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 and | |||
| allows for precise access of the lung anatomy and | |||
| continuous visualization using the bronchoscope | |||
| distal tip camera, under the control of a physician | |||
| operator. | 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 and | |||
| allows for precise access of the lung anatomy and | |||
| continuous visualization using the bronchoscope | |||
| distal tip camera, under the control of a physician | |||
| operator. |
Additionally, the MONARCH Platform can
integrate imaging data directly from a Cone Beam
Computed Tomography system to update the scope
and target position to overcome any changes in
anatomy not reflected in the pre-op CT scan. | Different. Compared to the Predicate Device, the
Subject Device has been equipped with additional
hardware and software to optionally enable receipt
of imaging data directly from a Cone Beam
Computed Tomography System, to update the
scope and target position to overcome changes in
anatomy not reflected in the pre-op CT scan.¹
Additional changes were made to update certain
hardware, and to implement Cybersecurity
countermeasures. |
| Intended use /
Indications for use | The MONARCH Platform is intended to provide
bronchoscopic visualization of and access to
patient airways for diagnostic and therapeutic
procedures. | 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. | Equivalent. The verbiage of the Intended Use /
Indications for Use has been updated to reflect the
contribution of the previously cleared MONARCH
Bronchoscope in the MONARCH Platform
meeting its Intended Use and Indications for Use. |
| Fundamental
scientific technology | Electromechanical system using direct (camera
and light source) supplemented by indirect
(electromagnetic navigation) visualization of the
flexible bronchoscope position by the physician
operator. Steering, as well as insertion and
withdrawal is under continuous and direct control | Electromechanical system using direct (camera and
light source) supplemented by indirect
(electromagnetic navigation) visualization of the
flexible bronchoscope position by the physician
operator. Steering, as well as insertion and
withdrawal is under continuous and direct control | Same. The fundamental scientific technology,
consisting of an electromechanical system using
direct (camera and light source) inputs
supplemented by indirect (electromagnetic
navigation) visualization of the flexible
bronchoscope position by the physician operator is |
| Key Attributes | Predicate Device
Auris Health, Inc.
MONARCH Platform K211493
by the physician operator. | Subject Device
Auris Health, Inc.
MONARCH Platform
by the physician operator. | Comparison |
| Primary mode of
action | Physician input (movement of endoscopic
controller) to move the endoscope. | Physician input (movement of endoscopic
controller) to move the endoscope. | unchanged. Like the predicate, steering, including
insertion and withdrawal, remains under
continuous and direct control by the physician
operator. |
| Method of distal tip
movement | Pull wires | Pull wires | Additionally, the Subject device can integrate
imaging data directly from a Cone Beam
Computed Tomography system during a procedure
to update the scope and target position to
overcome changes in anatomy not reflected in the
pre-op CT scan. |
| Major components | Auris Cart
Auris Tower
Bronchoscope and Sheath
Accessories (working channel instruments, patient
introducer adaptor, fluidics tubing, navigation field
generators, field generator mount, USB stick,
patient sensors, patient patches, etc.) | Auris Cart
Auris Tower
Bronchoscope (Inner Scope and Outer Sheath)
Accessories (working channel instruments, patient
introducer adaptor, fluidics tubing, navigation field
generator, field generator mount, USB stick,
patient sensors, patient patches, etc.) | Same. The Predicate and Subject devices have the
same primary modes of action.
Same. The Predicate and Subject devices have the
same mechanism of distal tip movement.
Same. The Predicate and Subject devices are
comprised as the same major components. |
| Control/physician
interfaces | Controller with joystick and buttons | Controller with joystick and buttons | Same. The Predicate and Subject devices feature the
same Control/physician interfaces. |
| Cart base elements | Touch screen monitor and embedded PC. | Touch screen monitor and embedded PC. | Equivalent. The Predicate and Subject devices have
the same cart base elements, however the modified
device includes an additional Ethernet connection
for the interface Cone Beam Computed
Tomography System data. |
| Robotic arms | Two identical arms (2) | Two identical arms (2) | Same. The Predicate and Subject device have the
same number of arms. |
| Tower key
characteristics | 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 Subject
devices have largely the same key characteristics,
however the Subject device has been equipped with
a door lock for cybersecurity purposes |
| Key Attributes | Predicate Device
Auris Health, Inc.
MONARCH Platform K211493 | Subject Device
Auris Health, Inc.
MONARCH Platform | Comparison |
| Electromagnetic
Navigation | Yes | Yes | Same. The Predicate and Subject Devices both
include Electromagnetic Navigation. |
| Working channel
instruments | 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 both
compatible with the same working channel
accessories. |
| | Third party compatible (meet working channel
length and diameter requirements) instruments and
tools (e.g., RBUS probe) | Third party compatible (meet working channel
length and diameter requirements) instruments and
tools (e.g., RBUS probe) | |
| Direct Interface with
CBCT system to
reduce potential
body divergence. | Not available | Implemented - subject of this submission. | Different. Compared to the predicate, the subject
device can integrate imaging data directly from a
Cone Beam Computed Tomography system during
a procedure to update the scope and target position
to overcome changes in anatomy not reflected in
the pre-op CT scan. 1 |
8
9
| 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 |
10
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. |