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.

Device Description

The Monarch™ Endoscopy Platform (Monarch Platform) is intended to be used by qualified physicians to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Monarch Platform consists of three major components, (1) Monarch™ Endoscopy Cart, (2) Monarch™ Endoscopy Tower, and (3) Monarch™ Bronchoscope System, and working channel instruments.

The Monarch Cart provides support for the effector arms. It includes two robotic arms and the electronic systems required to power and operate the robotic system.

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. In addition, the tower includes an endoscopic controller that allows the user to control the system during a procedure.

The user controls the system with an endoscopic controller which transmits user inputs through the electromechanical system to the end effectors. The Monarch Bronchoscope System comprising of a bronchoscope and sheath is attached at the end effector of a robotic arm with multiple degrees of freedom. The flexible bronchoscope has a working channel and a camera at the tip. The bronchoscope has an articulated tip that can bend in all directions. The working channel of the bronchoscope is used for irrigation, aspiration and to deliver the working channel instruments.

The single-use manually controlled working channel instruments compatible with the Monarch Platform include the Aspirating Biopsy Needle, Biopsy Forceps, and Cytology Brush. All three have the same technological characteristics as the respective predicates and reference devices, that is, they are intended to operate in the same manner for collection of tissue or cells in the patient's lungs through a flexible endoscope or other working channel.

The Aspirating Biopsy Needle is comprised of a polymeric shaft with a needle joined to the distal end. A Luer fitting at the proximal end of the shaft allows the user to provide suction to the needle via the supplied syringe. A handle mechanism interfaces with the shaft to provide extension and retraction of the needle, and an outer jacket provides protection when the needle is not in use.

The Cytology Brush is comprised of an outer sheath and an inner catheter assembly. The inner catheter assembly consists of a thumb ring at the proximal end and a shaft to connect to the distal end which terminates in a brush. When the catheter is inserted into a working channel, the distal brush would be in a retracted position inside the outer sheath. When the catheter is in position, the brush can be extended into the tissue to obtain samples by advancing the proximal thumb ring.

The Biopsy Forceps instrument is comprised of a coil pipe with a mechanical jaw assembly joined to the distal end. The jaws are opened by sliding the outer handle component distally relative to the inner, longer handle component. The jaws are closed by squeezing the two components together.

AI/ML Overview

The Monarch Endoscopy Platform (Monarch Platform) and its accessories were evaluated for safety and effectiveness through various performance tests, including biocompatibility, electrical safety, electromagnetic compatibility, software verification and validation, specific component performance testing, a navigational accuracy comparative study, animal and cadaver testing, and usability/human factors testing.

Here's a breakdown of the acceptance criteria and the studies performed, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a table format with specific quantitative targets for the Monarch Endoscopy Platform as a whole, or for each individual performance test. Instead, it states that the device "successfully tested for function, performance, and safety per FDA-recognized standards" and "complies with" or "conforms to" specific standards and design specifications. For the Navigational Accuracy Comparative Study, it mentions "substantially equivalent segmental, sub-segmental accuracy and on target accuracy, and thus equivalent Navigation Yield" compared to the predicate.

Therefore, a direct table of "acceptance criteria" and "reported performance" like for a diagnostic accuracy study is not directly extractable for every aspect. However, we can synthesize the information for the Navigational Accuracy Comparative Study:

Acceptance Criteria (Implied)	Reported Device Performance
Navigational Yield (Accuracy) substantially equivalent to predicate device (superDimension™ System)	Substantially equivalent segmental, sub-segmental accuracy and on-target accuracy to the superDimension™ System, leading to equivalent Navigational Yield.
Distance to Target accuracy substantially equivalent to predicate device (superDimension™ System)	Substantially equivalent to the superDimension™ System.

For all other performance testing categories (Biocompatibility, Electrical Safety, EMC, Software V&V, specific component testing, animal/cadaver, usability/human factors), the acceptance criterion was "compliance with recognized standards" and "meeting intended user requirements/design specifications," and the reported performance was that the device met these.

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

The document does not specify a distinct "test set" and corresponding sample sizes for most of the performance evaluations in terms of human subjects or distinct data points in a clinical context. The studies involved:

Navigational Accuracy Comparative Study: The document doesn't explicitly state the sample size (number of cases or measurements) used in this comparative study.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
Animal and Cadaver Testing: Performed to evaluate the Monarch Platform under simulated use conditions.
- Sample Size: Not specified (number of animals/cadavers).
- Data Provenance: Prospective, simulated use.
Usability/Human Factors Testing:
- Sample Size: Not specified (number of representative users).
- Data Provenance: Prospective, simulated use.
Biocompatibility, Electrical Safety, EMC, Software V&V, and individual component performance testing: These are typically bench tests or engineering evaluations, not usually associated with a "test set" sample size in the clinical data sense.

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

This information is not provided in the document for any of the studies described. The studies appear to be primarily engineering, non-clinical (animal/cadaver), and simulated use evaluations rather than studies requiring expert adjudication of ground truth for diagnostic accuracy in patient data.

4. Adjudication Method for the Test Set

Since the document does not describe studies involving human medical experts establishing ground truth for a diagnostic test set, there is no mention of an adjudication method (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned in the provided text. The "Navigational Accuracy Comparative Study" compares the Monarch Platform's navigation metrics to the superDimension™ System, but it's not described as an MRMC study and therefore no effect size of human readers improving with AI vs. without AI assistance is provided. The Monarch Platform is described as a robotic endoscopy system that assists physicians, but the focus of the performance data section is on the device's inherent capabilities and comparison to existing technologies, not on augmented human performance in an MRMC setting.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance testing section primarily describes standalone performance aspects of the Monarch Platform and its accessories (e.g., biocompatibility, electrical safety, software V&V, mechanical performance of instruments, navigational accuracy of the system). The navigational accuracy study comparing Monarch and superDimension™ evaluates the system's navigation performance itself. The animal, cadaver, and usability studies involve human users but evaluate the system's safety and effectiveness with human interaction, not a standalone algorithm's diagnostic performance in the absence of human input.

Therefore, while the individual component and software testing represent "standalone" evaluations of those specific parts, a standalone diagnostic algorithm performance study (without human-in-the-loop) for a clinical outcome is not explicitly detailed as described for typical AI/ML devices. The Monarch Platform is a surgical robotic system with navigation features, so its "standalone" performance relates to its ability to perform its function (e.g., navigate, manipulate instruments) rather than to interpret images or diagnose conditions like a standalone AI diagnostic software.

7. The Type of Ground Truth Used

For the specific tests mentioned:

Navigational Accuracy Comparative Study: The "ground truth" for navigation metrics (segmental, sub-segmental accuracy, on-target accuracy, distance to target) would likely be established through precise measurements against a known anatomical model or imaging data, but the document does not specify the exact method for this ground truth establishment.
Animal and Cadaver Testing: Ground truth established through observation of the system's performance and impact on the tissues/anatomy, likely assessed by skilled medical professionals involved in the study.
Usability/Human Factors Testing: Ground truth related to user needs, safety, and effectiveness is established through defined task completion rates, error rates, and user feedback against pre-defined success criteria.
Other performance tests (biocompatibility, electrical safety, etc.): Ground truth is established by adherence to recognized international standards and engineering specifications.

8. The Sample Size for the Training Set

The document does not mention a training set size. This is expected as the Monarch Platform is described as a robotic surgical system with navigation, not a machine learning or AI diagnostic device that typically requires a large training set of annotated data for model development. The software verification and validation are mentioned, but this refers to traditional software development and testing, not AI/ML model training.

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

As no training set is mentioned in the context of an AI/ML model, there is no information on how its ground truth was established.

Summary

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March 22, 2018

Auris Surgical Robotics, Inc. Joy Sacmar Vice President, RA/QA 150 Shoreline Road Redwood City, CA 94065

Re: K173760

Trade/Device Name: Monarch Endoscopy Platform (Monarch Platform) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOO Dated: February 21, 2018 Received: February 22, 2018

Dear Joy Sacmar:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K173760

Device Name

Monarch Endoscopy Platform (Monarch Platform)

Indications for Use (Describe)

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.

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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AURIS

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.

K173760 510(k) Number: _

I. SUBMITTER

Auris Surgical Robotics, Inc. 150 Shoreline Drive Redwood City, CA 94065

Contact Person:	Joy Sacmar, Vice President RA/QA
Email:	joy.sacmar@aurisrobotics.com
Phone/Fax:	(650) 781-1610
Mobile:	(408) 306-3537

Date Prepared:	December 7, 2017
Prepared By:	Elizabeth Osuna, Senior Regulatory Affairs Specialist

II. DEVICE

Trade/Device Name:	Monarch Endoscopy Platform (Monarch Platform)
Common Name:	Bronchoscope (flexible or rigid) and accessories
Classification Name:	Bronchoscope (flexible or rigid) and accessories
Product Code:	EOQ
Regulatory Class:	Class II
Regulation Number:	21 CFR 874.4680
Trade/Device Name:	Aspirating Biopsy Needle
Common Name:	Bronchoscope (flexible or rigid) and accessories
Classification Name:	Bronchoscope (flexible or rigid) and accessories
Product Code:	EOQ
Regulatory Class:	Class II
Regulation Number:	21 CFR 874.4680

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Trade/Device Name:	Biopsy Forceps
Common Name:	Bronchoscope (flexible or rigid) and accessories
Classification Name:	Bronchoscope (flexible or rigid) and accessories
Product Code:	EOQ
Regulatory Class:	Class II
Regulation Number:	21 CFR 874.4680
Trade/Device Name:	Cytology Brush
Common Name:	Bronchoscope (flexible or rigid) and accessories
Classification Name:	Bronchoscope (flexible or rigid) and accessories
Product Code:	EOQ
Regulatory Class:	Class II
Regulation Number:	21 CFR 874.4680

III. PREDICATE DEVICE(S)

Trade name:	Karl Storz Bronchoscope
510(k) Number:	K071530
Classification Name:	Bronchoscope (flexible or rigid) and accessories21 CFR 874.4680
Product Code:	EOQ
Manufacturer:	Karl Storz Endoscopy-America, Inc.

Trade name:	PeriFLEX Transbronchial Aspiration Needle
510(k) Number:	K162611
Classification Name:	Bronchoscope (flexible or rigid) and accessories21 CFR 874.4680
Product Code:	EOQ
Manufacturer:	Spiration, Inc.

Trade name:	Olympus FB series biopsy forceps
510(k) Number:	K962555
Classification Name:	Bronchoscope (flexible or rigid) and accessories21 CFR 874.4680
Product Code:	EOQ
Manufacturer:	Olympus America, Inc.

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Trade name:	Wang Bronchial Needle Brush
510(k) Number:	K944650
Classification Name:	Bronchoscope (flexible or rigid) and accessories21 CFR 874.4680
Product Code:	EOQ
Manufacturer:	Mill-Rose Laboratory

In compliance with FDA Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]' we are including the following as a reference device:

Trade name:	Auris Robotic Endoscopy System (ARES)
510(k) Number:	K152319
Manufacturer:	Auris Surgical Robotics, Inc.
Trade name:	superDimensionTM Navigation System
510(k) Number:	K151376
Manufacturer:	Covidien LLC.
Trade name:	superDimensionTM, SuperTrax Transbronchial AspiratingNeedle
510(k) Number:	K860582
Manufacturer:	Covidien LLC.
Trade name:	superDimensionTM, SuperTrax Biopsy Forceps
510(k) Number:	K925392
Manufacturer:	Covidien LLC.
Trade name:	superDimensionTM Cytology Brush
510(k) Number:	K834402
Manufacturer:	Covidien LLC.

DEVICE DESCRIPTION IV.

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The Monarch Cart provides support for the effector arms. It includes two robotic arms and the electronic systems required to power and operate the robotic system.

V. INTENDED USE/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.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERSTICS WITH THE PREDICATE AND REFERENCE DEVICE

Overall, the Monarch Platform, Karl Storz Bronchoscope and ARES are based on the following similar basic technological elements:

Device contains a flexible bronchoscope to visualize and gain access to the A tracheobronchial tree.
A Device is intended for procedures performed by physician users via access through the bronchoscope working channel.
A Device requires continuous direct control by physician user to move the bronchoscope.
A Device moves the distal tip by pulling wires.
A Device enables use of working channel instruments to perform diagnostic and therapeutic procedures via working channel.
A Monarch Bronchoscope System is sterile.

The Karl Storz bronchoscope lacks the electro-mechanical control mechanism and navigation included with the Monarch Platform. For this reason, we are using the cleared ARES and SuperDimension Navigation System as reference devices. The cleared reference devices have been selected to address issues of safety and effectiveness for the differing technologies.

The Aspirating Biopsy Needle and the PeriFLEX Transbronchial Aspiration Needle have similar technological characteristics. Both devices operate in the same manner to obtain a tissue biopsy using a bronchoscope. The primary difference between the subject and predicate devices is the handle design. Other differences between the subject and predicate include the working outer diameter, needle protrusion length, needle tip material, needle gauge, and the working length. There are no differences that raise different questions of safety and effectiveness relative to the predicate.

The Biopsy Forceps and the Olympus FB series biopsy forceps have the same intended use with minor technological differences, namely the jaw diameter and the working length; and do not raise new or different questions of safety and effectiveness relative to the predicate.

The Cytology Brush and Wang Bronchial Needle Brush have the same intended use and minor technological characteristic differences, namely brush length, brush diameter and working length; and do not raise new or different questions of safety and effectiveness relative to the predicate.

VII. PERFORMANCE DATA

The Monarch Platform has been subjected to and successfully tested for function, performance, and safety per FDA-recognized standards. In addition, the Monarch Platform has been evaluated for electrical safety and electromagnetic compatibility, biocompatibility and toxicity testing of patient-contacting materials. The following performance data was provided in support of the substantial equivalence determination.

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Biocompatibility testing

The biocompatibility evaluation for the direct and indirect body contacting components of the Monarch Platform - specifically the Monarch Bronchoscope System , working channel instruments, and accessories - was conducted in accordance with the FDA Blue Book Memorandum #95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

The Ethylene Oxide sterilized devices were validated as biocompatible with the appropriate selection of tests indicated for Externally Communicating Devices, in contact with Tissue/Bone/Dentin, with limited contact duration (less than 24 hours). Tests included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity and Material-Mediated Pyrogenicity.

The non-sterilized devices have been validated as biocompatible with the appropriate suite of biocompatibility tests indicated for Surface Devices, in contact with the Skin, with limited contact duration (less than 24 hours). Tests included Cytotoxicity, Sensitization, and Irritation.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Monarch Platform, consisting of the Monarch Tower, Monarch Cart, and Monarch Bronchoscope System. The system complies with the IEC 60601-1, and IEC 60601-2-18 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005. Results of verification and validation testing confirm that the Monarch Platform conforms to design specifications and meets the needs of the intended users.

Monarch Platform Performance Testing

Monarch Cart
Monarch Tower
Robotic Arms and Instrument Device Manipulators ●
Endoscopic Controller
Vision
Navigation
Fluidics
System Algorithms
Bronchoscope and Sheath ●
Working Channel Instruments and Accessories
Simulated Use Testing ●

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Aspirating Biopsy Needle Performance Testing

Puncture Force
Insertabilty into Bronchoscope Working Channel Bronchoscope Deflection ●
Positive/Negative Pressure and Leak Test ●
Inadvertent Needle Deployment
Minimum Needle Deployment
Handle Assembly Strength and Durability
Handle Actuation Torque and Force
Nitinol Needle Buckling and Shear
Catheter to Handle Joint Strength
Nitinol Needle to Catheter Joint Strength
Device Radiopacity ●
Device Durability
Gold Marker Adhesion
Needle Targeting Accuracy
Dimensional Testing ●
Simulated Use
Sterilization Validation ●
Packaging and Shelf Life .

Cytology Brush Performance Testing

Insertabilty into Bronchoscope Working Channel ●
Bronchoscope Deflection ●
Inadvertent Brush Deployment
Minimum Brush Deployment
Ability to Cut with Scissors
Atraumatic Ball Retention Strength
Handle Assembly Strength and Durability
Catheter to Handle Joint Strength
Brush Head to Catheter Joint Strength
Device Radiopacity
Device Durability ●
Dimensional Testing
Simulated Use
Sterilization Validation ●
Packaging and Shelf Life

Biopsy Forceps Performance Testing

Insertabilty into Bronchoscope Working Channel ●
Bronchoscope Deflection
Handle Assembly Strength and Durability
Catheter to Handle Joint Strength
Distal Assembly Strength ●
Jaw Opening Angle

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Device Radiopacity ●
Device Durability ●
Dimensional Testing ●
. Simulated Use
Sterilization Validation .
Packaging and Shelf Life .

Navigational Accuracy Comparative Study

A comparative study of the 'Navigation Yield' and 'Distance to Target' metrics of the Medtronic/Covidien superDimension™ System (superDimension™) against the Monarch Platform was completed. The Monarch Platform Navigation System and superDimension™ System have substantially equivalent segmental, sub-segmental accuracy and on target accuracy, and thus equivalent Navigation Yield.

Animal and Cadaver 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.

Usability/Human Factors Testing

Auris performed usability and human factors testing of the Monarch Platform. Simulated 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. The testing demonstrated that Monarch Platform design meets the intended user requirements and facilitates safe and effective user interactions with little chance of committing dangerous user errors.

VIII. CONCLUSION

Based on the indications for use, technological characteristics, and performance testing, Auris has demonstrated that the Monarch Platform and Auris working channel instruments are as safe and effective as the predicate and reference devices for the stated intended use to collect tissue samples, and that the Monarch Platform and Auris' working channel instruments are, as a result, substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.