(91 days)
Not Found
No
The summary describes a reprocessed bronchoscope and its compatibility with a robotic platform. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image analysis, navigation assistance, or other functions. The focus is on the reprocessing and functional equivalence to the predicate device.
Yes.
The "Intended Use" explicitly states that the device is for "diagnostic and therapeutic procedures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures". Visualization is a key component of diagnosis, confirming its role as a diagnostic device.
No
The device is a bronchoscope, which is a physical medical device with hardware components (scope, sheath, camera, working channel). It is used in conjunction with a platform that includes robotic arms and a display interface. The description focuses on the physical aspects and reprocessing of the bronchoscope, not solely on software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a bronchoscope used for visualization and access within the airways. It mentions a working channel for instruments like biopsy devices, but the device itself is for the procedure, not for analyzing a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The focus is on visualization and access during a procedure.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QNW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS Imager
Anatomical Site
patient airways
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician; 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Cleaning Validation: Worst case device conditioning was taken into consideration while conducting this testing. Results: Pass.
- Functional Performance and System Compatibility: Functional performance and system compatibility were performed to verify the performance of the Proposed Device was not negatively impacted by reprocessing. Worst case device conditioning was taken into consideration while conducting this testing. Results: Pass.
- Electromagnetic Compatibility and Electrical Safety: The Proposed Device has been fully evaluated for electrical safety 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 into consideration while conducting this testing. Results: 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 taken into consideration while conducting this testing. Results: Pass.
- Sterilization: Sterilization was assessed in accordance with ISO 11135: 2018. Sterilization residuals were assessed in accordance with ISO 10993-7:2008. The Proposed Device uses a validated Ethylene oxide sterilization process using a half-cycle overkill approach to achieve a minimum sterility assurance level of 10-6. Results: Pass.
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.
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
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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
1
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
2
Indications for Use
510(k) Number (if known) K203614
Device Name Monarch Bronchoscope
Indications for Use (Describe)
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.
| 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 Family
Company
150 Shoreline Drive
Redwood City, CA 94065 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Original Device
Manufacturer | Auris Health, Inc., a Johnson and Johnson Family
Company
150 Shoreline Drive
Redwood City, CA 94065 |
| Reprocessed Device
Manufacturer | Auris Health, Inc., a Johnson and Johnson Family
Company
2383 Bering Dr.
San Jose, CA 95131 |
| FDA Registration Number | 3014447948 |
| Primary Correspondent | Somi Ekwealor, MSRS, RAC
Staff Regulatory Affairs Specialist
Johnson and Johnson, Robotics & Digital Solutions |
| Contact Information | Email: sekwealo@its.jnj.com
Phone: (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 |
4
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.
Intended Use/Indications for Use
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.
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 |
5
| Key Attributes | Proposed Device (MBR-0000211-B) |
|---|---|
| Active angulation degrees up/down or | |
| 4 directions | 180/180/180/180 |
| Pixel resolution | 200 x 200 |
| Camera lens | Aluminosilicate glass |
| Light source | LED (covered in |
| cyanoacrylate adhesive) | |
| Working Channel Instruments | |
| Compatibility | Auris working channel instruments and third party |
| instruments that meet working channel length and | |
| diameter 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 into | |
| consideration while conducting this testing. | Pass | |
| Functional | ||
| Performance and | ||
| System | ||
| Compatibility | Functional performance and system compatibility were | |
| performed to verify the performance of the Proposed Device | ||
| was not negatively impacted by reprocessing. Worst case | ||
| device conditioning was taken into consideration while | ||
| conducting this testing. | Pass | |
| Electromagnetic | ||
| Compatibility and | ||
| Electrical Safety | The Proposed Device has been fully evaluated for electrical | |
| safety 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 into | ||
| consideration while conducting this testing. | 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 taken into consideration while | ||
| conducting this testing. | Pass | |
| Sterilization | Sterilization was assessed in accordance with ISO 11135: |
- Sterilization residuals were assessed in accordance
with ISO 10993-7:2008. The Proposed Device uses a
validated Ethylene oxide sterilization process using a half-
cycle overkill approach to achieve a minimum sterility
assurance level of 10-6. | Pass |
6
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.
7
The following device is included in this submission:
| Description | OEM Model Number | Reprocessed Model Number |
|---|---|---|
| Monarch Bronchoscope | MBR-000211-A | MBR-000211-B |