(117 days)
Not Found
No
The summary describes a robotic bronchoscopy platform with electromagnetic navigation, but there is no mention of AI or ML being used for image processing, navigation, or any other function. The navigation relies on integrating a pre-operative CT scan with intra-operative EM tracking.
Yes.
The device's intended use includes providing access for "therapeutic procedures," indicating its involvement in treatments to alleviate or cure medical conditions.
Yes
The intended use description explicitly states that the device is for "diagnostic and therapeutic procedures," and it facilitates visualization and access to airways, which are crucial for diagnostic processes. The text also mentions the use of biopsy instruments (Aspirating Biopsy Needle, Biopsy Forceps, Cytology Brush) that are typically used to collect samples for diagnostic analysis.
No
The device description explicitly details multiple hardware components: Monarch Cart (robotic arms, electronic systems), Monarch Tower (monitor, computers, connectivity), and Monarch Bronchoscope (flexible bronchoscope, camera, working channel). It also mentions working channel instruments and accessories. This is not a software-only device.
Based on the provided information, the Monarch Platform is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures." This describes a device used within the body for direct observation and intervention, not a device used to examine samples outside the body.
- Device Description: The description details a robotic system with a bronchoscope, camera, and instruments for accessing and visualizing the airways. This is consistent with an in-vivo procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) outside the body, which is the defining characteristic of an IVD. The instruments mentioned (biopsy needle, forceps, brush) are used to obtain samples, but the device itself is not performing the diagnostic analysis of those samples.
- Performance Studies: The performance studies focus on the device's functionality, safety, usability, and ability to access and visualize the airways, not on the accuracy of analyzing biological samples.
In summary, the Monarch Platform is a medical device used for performing procedures within the patient's body, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The Monarch Platform 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 three major components, (1) Monarch Cart, (2) Monarch Tower, and (3) Monarch Bronchoscope, and working channel instruments and accessories. The Monarch Cart provides support for the effector arms. It includes 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 tip. The working channel of the Bronchoscope is used for irrigation, aspiration and to deliver the working channel instruments. The single-use manually controlled Auris instruments compatible with the Monarch Platform include the Aspirating Biopsy Needle, Biopsy Forceps, and Cytology Brush.
Additionally, the Monarch Platform includes electromagnetic (EM) navigation that 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (CT) scan
Anatomical Site
patient airways / lung anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician operator / Not Found
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
Auris performed animal and cadaver testing to evaluate the Monarch Platform under simulated use conditions to validate the user needs, including the safety and effectiveness of the system as per its intended clinical use.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility: The Monarch Platform patient contacting materials were evaluated for biocompatibility. The results demonstrate that the Monarch Platform is biocompatible for its intended use.
Electrical Safety and Electromagnetic Compatibility: The Monarch Platform has been fully evaluated and tested for EMC compliance and electrical safety to the following standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-18.
Verification Testing: System Level Tests were executed to verify the overall functionality of the Monarch Platform to operate as specified by the design input requirements including pre-operative planning, workflow, latency, various functional safety features, irrigation/aspiration, 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 Monarch Platform 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.
Validation Testing: Auris performed animal and cadaver testing to evaluate the Monarch Platform under simulated use conditions to validate the user needs, including the safety and effectiveness of the system as per its intended clinical use. These studies demonstrated that the Monarch Platform design meets the intended user requirements and facilitates safe and effective use.
Human Factors and Usability Testing: Auris performed human factors and usability testing for the Monarch Platform. Simulated use testing was performed in accordance with finalized guidance: "Applying Human Factors and Usability Engineering to Medical Devices" issued February 3, 2016. This testing assessed the Monarch Platform for safety and effective use by representative users during a simulated use bronchoscopy procedure after training on using the Monarch Platform.
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.
Not Found
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
April 15, 2020
Auris Health, Inc. Anna Libman Director Regulatory Affairs 150 Shoreline Drive Redwood City, California 94065
Re: K193534
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: March 13, 2020 Received: March 16, 2020
Dear Anna Libman:
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. 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
1
devices or postmarketing safety reporting (21 CFR 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 (OS) 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 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,
for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Monarch Platform
Indications for Use (Describe)
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)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
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
I. SUBMITTER
Address:
Auris Health, Inc. 150 Shoreline Drive, Redwood City, CA 94065
Contact Person:
Anna Libman Director, Regulatory Affairs anna.libman@aurishealth.com 408-204-3370
Date Prepared: December 18, 2019
II. DEVICE
| Manufacturer: | Auris Health., Inc. |
|---|---|
| Trade/Proprietary Name: | Monarch Platform |
| Common Name: | Bronchoscope (flexible or rigid) and accessories |
| Product Code: | EOQ |
| Regulatory Class: | Class II |
| Classification: | 21 CFR§874.4680 Bronchoscope (flexible or rigid) and accessories |
| Product Codes: | EOQ, JAK |
III. PREDICATE DEVICE(S)
| Manufacturer: | Auris Health., Inc. (Formerly Auris Surgical Robotic, Inc.) |
|---|---|
| Trade name: | Monarch Endoscopy Platform (Monarch Platform) |
| 510(k) Number: | K173760 |
| Classification Name: | 21 CFR§874.4680 Bronchoscope (flexible or rigid) and accessories |
| Product Codes: | EOQ, JAK |
IV. 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
4
Platform allows for precise access of the lung anatomy and continuous visualization using the bronchoscope distal tip camera.
The Monarch Platform consists of three major components, (1) Monarch Cart, (2) Monarch Tower, and (3) Monarch Bronchoscope, and working channel instruments and accessories. The Monarch Cart provides support for the effector arms. It includes 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 tip. The working channel of the Bronchoscope is used for irrigation, aspiration and to deliver the working channel instruments. The singleuse manually controlled Auris instruments compatible with the Monarch Platform include the Aspirating Biopsy Needle, Biopsy Forceps, and Cytology Brush.
Additionally, the Monarch Platform includes electromagnetic (EM) navigation that 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.
INDICATIONS FOR USE V.
The Monarch Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
Overall, the subject, predicate and reference devices are based on the following similar basic technological elements:
| Key Attributes | Predicate Device
Monarch Endoscopy Platform
K173760 | Subject Device
Monarch Platform |
|-------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|
| Regulation Number | 21 CFR §874.4680, Bronchoscope
(flexible or rigid) and accessories | 21 CFR §874.4680, Bronchoscope
(flexible or rigid) and accessories |
| Class | II | II |
| Product Code | EOQ, Bronchoscope (Flexible Or
Rigid) | EOQ, Bronchoscope (Flexible Or
Rigid) |
5
| | JAK, System, X-Ray, Tomography,
Computed | JAK, System, X-Ray, Tomography,
Computed |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Monarch Endoscopy Platform
(Monarch Platform) and its
accessories are intended to provide
bronchoscopic visualization of and
access to patient airways for
diagnostic and therapeutic
procedures. | The Monarch Platform and its
accessories are intended to provide
bronchoscopic visualization of and
access to patient airways for
diagnostic and therapeutic
procedures. |
| Major
components | • Auris Cart
• Auris Tower
• Bronchoscope (Scope and Sheath)
• Accessories (working channel
instruments, patient introducer
adaptor, fluidics tubing,
navigation field generator, field
generator mount, USB stick,
patient sensors, patient patches,
etc.) | • Auris Cart
• Auris Tower
• Bronchoscope (Scope and Sheath)
• Accessories (working channel
instruments, patient introducer
adaptor, fluidics tubing, navigation
field generator, field generator
mount, USB stick, patient sensors,
patient patches, etc.) |
| Robotic arms | • Two identical arms (2)
• Built-in instrument device
manipulator (IDM)
• Arm weight: 26 lbs. | • Three identical arms (3)
• Built-in instrument device
manipulator (IDM)
• Arm weight: 26 lbs. |
| Bronchoscope
use | • Single-use, sterile | • Single-use, sterile |
| Working
channel
instruments | • Auris Aspirating biopsy needle,
Biopsy Forceps, Cytology Brush
• Third party compatible (meet
working channel length and
diameter requirements)
instruments and tools (e.g., RBUS
probe) | • Auris Aspirating biopsy needle,
Biopsy Forceps, Cytology Brush
(cleared in K173760)
• Third party compatible (meet
working channel length and
diameter requirements) instruments
and tools (e.g., RBUS probe) |
VII. PERFORMANCE DATA
Verification and validation testing were conducted for the Monarch Platform to ensure that the system performs as intended to meet its intended use and to ensure that differences in technological characteristics between the Monarch Platform and the predicate do not raise different questions of safety or effectiveness.
Biocompatibility
The Monarch Platform patient contacting materials were evaluated for biocompatibility in accordance with the provisions of the guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff issued
6
on: June 16, 2016. The results demonstrate that the Monarch Platform is biocompatible for its intended use.
Electrical Safety and Electromagnetic Compatibility
The Monarch Platform has been fully evaluated and tested for EMC compliance and electrical safety to the following standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-18.
Verification Testing
System Level Tests were executed to verify the overall functionality of the Monarch Platform to operate as specified by the design input requirements including pre-operative planning, workflow, latency, various functional safety features, irrigation/aspiration, 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 Monarch Platform 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.
Validation Testing
Auris performed animal and cadaver testing to evaluate the Monarch Platform under simulated use conditions to validate the user needs, including the safety and effectiveness of the system as per its intended clinical use. These studies demonstrated that the Monarch Platform design meets the intended user requirements and facilitates safe and effective use.
Human Factors and Usability Testing
Auris performed human factors and usability testing for the Monarch Platform. Simulated use testing was performed in accordance with finalized guidance: "Applying Human Factors and Usability Engineering to Medical Devices" issued February 3, 2016. This testing assessed the Monarch Platform for safety and effective use by representative users during a simulated use bronchoscopy procedure after training on using the Monarch Platform.
VIII. CONCLUSION
The Monarch Platform and the predicate device have the same intended use, same indications for use, and highly similar technological characteristics. The testing verified and validated through performance testing that the device performs as intended to its specifications and meets its intended use. Any differences between the subject and predicate device have been evaluated and found to not raise different questions of safety or effectiveness. As such, the subject device is substantially equivalent to the predicate device and the minor differences in technological characteristics between the two devices do not raise different questions of safety or effectiveness.