The reprocessed Monarch Bronchoscope, used in conjunction with the Monarch Platform, is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Device Description

The reprocessed Monarch Bronchoscope, MBR-000211-B, (hereafter referred to as "Proposed Device") is identical to the Original Monarch Bronchoscope, MBR-000211-A, (hereafter referred to as "Predicate Device"), which is a component of, and must be used with, the Monarch Platform, cleared under K193534. The Monarch Bronchoscope is connected to the robotic arms of the Monarch Platform to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Proposed Device is a reprocessed single-use device that can be reprocessed up to one (1) time.

The Monarch Bronchoscope, consisting of the Inner Scope ("scope") and the Outer Sheath ("sheath"), has 4-way articulation controlled by continuous, direct, visual control of the physician using the Monarch Platform. The Proposed Device contains a working channel through which biopsy devices, or other working channel instruments, may be introduced. The distal tip of the Proposed Device has a camera control unit (CCU) that collects live images that are then transmitted to the physician's display interface of the Monarch Platform. The camera transmits vision data to the Monarch Tower through the camera cable. The single-use, manually controlled, working channel instruments compatible with the Proposed Device are identical to the working channel instruments compatible with the predicate Monarch Platform bronchoscope.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Test Name	Description	Acceptance Criteria (Implied)	Reported Device Performance
Cleaning Validation	Worst-case device conditioning was considered.	Device is adequately cleaned	Pass
Functional Performance and System Compatibility	Performance of the Proposed Device was verified to not be negatively impacted by reprocessing. Worst-case device conditioning was considered.	No negative impact from reprocessing	Pass
Electromagnetic Compatibility and Electrical Safety	Evaluated for electrical safety and EMC compliance to AAMI/ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-2-18. Worst-case device conditioning was considered.	Compliance with standards	Pass
Biocompatibility	Evaluates the end-of-life biocompatibility of the limited-contact device in accordance with ISO 10993-1:2018. Worst-case device conditioning was considered.	Compliance with ISO 10993-1	Pass
Sterilization	Assessed in accordance with ISO 11135:2018. Sterilization residuals assessed in accordance with ISO 10993-7:2008. Uses a validated Ethylene oxide sterilization process with a half-cycle overkill approach to achieve a minimum sterility assurance level of 10-6.	Sterility Assurance Level of 10-6 and compliance with standards	Pass

Note: The document implies the acceptance criteria through the description of the tests and the "Pass" results. Specific numerical or qualitative thresholds for "Pass" are not detailed in the provided text.

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

The document does not explicitly state the numerical sample size used for the test set for each performance test. It mentions "worst case device conditioning" for several tests, implying that specific devices were subjected to these conditions.

Regarding data provenance:

Country of Origin: Not specified in the provided text.
Retrospective or Prospective: Not explicitly stated. Given the nature of performance testing for reprocessing validation, it would typically involve prospective testing of reprocessed devices.

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

This information is not provided in the given text. The tests described are primarily engineering and safety validation tests (cleaning, functional, electrical, biocompatibility, sterilization) rather than clinical studies requiring expert interpretation of results to establish ground truth in a diagnostic context.

4. Adjudication Method for the Test Set:

This information is not provided in the given text. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) where disagreement needs resolution. The described tests are objective performance tests which would not typically involve such adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in the provided document. The submission focuses on demonstrating the safety and effectiveness of a reprocessed bronchoscope compared to its original form, primarily through laboratory and performance testing, not direct comparative clinical effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable to the device described. The Monarch Bronchoscope is a physical medical device, specifically a reprocessed bronchoscope, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The performance tests described (cleaning, functional, electrical, biocompatibility, sterilization) are evaluations of the hardware itself.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests is established by:

Engineering Specifications/Design Requirements: Functional and system compatibility tests verify performance against the original design.
International Standards: Compliance with standards like AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-18 for electrical safety and EMC, ISO 10993-1:2018 for biocompatibility, and ISO 11135:2018 for sterilization.
Validated Processes: For cleaning and sterilization, the ground truth is established by the successful validation of the reprocessing protocol itself, ensuring devices meet specified cleanliness and sterility levels (e.g., SAL of 10-6).

8. The Sample Size for the Training Set:

This information is not applicable as the device is a reprocessed physical instrument, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as the device is a reprocessed physical instrument, not an AI/ML algorithm.

Summary

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March 11, 2021

Auris Health Inc., a Johnson and Johnson Family Company Somi Ekwealor Staff Regulatory Affairs Analyst 150 Shoreline Drive Redwood City, California 94065

Re: K203614

Trade/Device Name: Monarch Bronchoscope Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: QNW Dated: December 8, 2020 Received: December 14, 2020

Dear Somi Ekwealor:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shu-Chen Peng, Ph.D. Assistant 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203614

Device Name Monarch Bronchoscope

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Remediation Use (Part 31, GER 321, Corrective Action)☐ On-site Corrective Use (31, GER 321, Corrective Action)	☑ Remediation Use (Part 31, GER 321, Corrective Action)	☐ On-site Corrective Use (31, GER 321, Corrective Action)
☑ Remediation Use (Part 31, GER 321, Corrective Action)	☐ On-site Corrective Use (31, GER 321, Corrective Action)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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K203614 510(k) Summary

General Information

510(k) Submitter	Auris Health, Inc., a Johnson and Johnson FamilyCompany150 Shoreline DriveRedwood City, CA 94065
Original DeviceManufacturer	Auris Health, Inc., a Johnson and Johnson FamilyCompany150 Shoreline DriveRedwood City, CA 94065
Reprocessed DeviceManufacturer	Auris Health, Inc., a Johnson and Johnson FamilyCompany2383 Bering Dr.San Jose, CA 95131
FDA Registration Number	3014447948
Primary Correspondent	Somi Ekwealor, MSRS, RACStaff Regulatory Affairs SpecialistJohnson and Johnson, Robotics & Digital Solutions
Contact Information	Email: sekwealo@its.jnj.comPhone: (408) 320-5385
Date Prepared	08 December 2020

Device Identification

Proposed Reprocessed Device:

Proprietary Name	Monarch Bronchoscope
Common Name	Reprocessed Bronchoscope (Flexible Or Rigid)
Classification Name	Bronchoscope (flexible or rigid) and accessories
Regulation Number	21 CFR 874.4680
Product Code	QNW
Regulatory Class	II
Model Number	MBR-000211-B

Predicate OEM Device:

Proprietary Name	Monarch Platform
Common Name	Bronchoscope (Flexible Or Rigid)
Premarket Notification	K193534
Classification Name	Bronchoscope (flexible or rigid) and accessories
Regulation Number	21 CFR 874.4680
Product Code	EOQ
Regulatory Class	II
Model Number	MBR-000211-A

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Device Description

Intended Use/Indications for Use

Summary of Technological Characteristics

The Proposed Device (MBR-000211-B) is a single-use device identical to the Predicate Device (MBR-000211-A) in design, patient-contacting materials, clinical applications, patient population, performance specifications, and principles of operation. All technological characteristics including articulation, vision, and compatibility with working channel instruments are identical. Key technological characteristics are listed in the table below.

Key Attributes	Proposed Device (MBR-0000211-B)
Product Code	QNW
Regulation Number	21 CFR 874.4680
Classification	II
Intended for Single Use	Yes
Field of View (FOV) in air	90 degrees
Direction of view	0 degrees
FOV depth	3-30mm
Imaging type	CMOS Imager
Illumination type	LED

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Key Attributes	Proposed Device (MBR-0000211-B)
Active angulation degrees up/down or4 directions	180/180/180/180
Pixel resolution	200 x 200
Camera lens	Aluminosilicate glass
Light source	LED (covered incyanoacrylate adhesive)
Working Channel InstrumentsCompatibility	Auris working channel instruments and third partyinstruments that meet working channel length anddiameter requirements (e.g., REBUS probe)

This premarket notification is submitted to demonstrate the ability to reprocess the Monarch Bronchoscope one (1) time without impacting safety or effectiveness. Auris Health's reprocessing of the device includes removal of adherent soil and decontamination. Each individual device is tested for appropriate function of its components prior to packaging, labeling, and sterilization operations.

Performance Testing

The Reprocessed Monarch Bronchoscope was tested for performance in accordance with internal design specification and with the applicable performance standards to demonstrate safety and effectiveness. This includes the following tests:

Test Name	Description	Results
Cleaning Validation	Worst case device conditioning was taken intoconsideration while conducting this testing.	Pass
FunctionalPerformance andSystemCompatibility	Functional performance and system compatibility wereperformed to verify the performance of the Proposed Devicewas not negatively impacted by reprocessing. Worst casedevice conditioning was taken into consideration whileconducting this testing.	Pass
ElectromagneticCompatibility andElectrical Safety	The Proposed Device has been fully evaluated for electricalsafety and EMC compliance to the following standards:AAMI/ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-2-18. Worst case device conditioning was taken intoconsideration while conducting this testing.	Pass
Biocompatibility	Evaluates the end of life biocompatibility of the limitedcontact device in accordance with ISO 10993-1:2018. Worstcase device conditioning was taken into consideration whileconducting this testing.	Pass
Sterilization	Sterilization was assessed in accordance with ISO 11135:2018. Sterilization residuals were assessed in accordancewith ISO 10993-7:2008. The Proposed Device uses avalidated Ethylene oxide sterilization process using a half-cycle overkill approach to achieve a minimum sterilityassurance level of 10-6.	Pass

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The performance testing demonstrates that the reprocessed Monarch Bronchoscope is as safe and effective as the legally marketed Original Monarch Bronchoscope and operates as originally intended.

Conclusion

The indications for use/intended use, patient-contacting materials, clinical applications, patient population, performance specifications, technological characteristics, and principles of operation of the Proposed Device are identical to the Predicate Device.

Performance testing and process validation results demonstrated substantial equivalence of the Proposed Device (reprocessed Monarch Bronchoscope, MBR-000211-B) to the Predicate Device (Original Monarch Bronchoscope, MBR-000211-A) with respect to safety and and effectiveness. therefore conclude that the reprocessed Monarch We Bronchoscope is as safe, effective, and substantially equivalent to the Predicate Device, Monarch Bronchoscope.

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The following device is included in this submission:

Description	OEM Model Number	Reprocessed Model Number
Monarch Bronchoscope	MBR-000211-A	MBR-000211-B

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.