(283 days)
No
The description focuses on a master-slave robotic system controlled by a physician, with no mention of AI/ML for image processing, navigation, or other functions. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is intended to provide "bronchoscopic visualization of patient airways." It is a diagnostic tool for visualization and does not explicitly state it provides a therapeutic function or delivers therapy. The working channel is stated for "irrigation and aspiration," which can be part of diagnostic or therapeutic procedures but does not inherently make the device therapeutic.
Yes
Explanation: The device is intended to provide "bronchoscopic visualization of patient airways." Visualization is a key component of diagnosing conditions within the bronchial tree, allowing physicians to observe abnormalities or changes that indicate disease. While it also facilitates interventional procedures by providing access, its fundamental role in offering visual information for assessment qualifies it as a diagnostic device.
No
The device description clearly outlines multiple hardware components including a Patient Side System (PSS) with robot arms, a Controller Cart, a Surgeon Console (Master Device Workstation), and a Bronchoscope with accessories. This is not a software-only device.
Based on the provided information, the Auris Robotic Endoscopy System (ARES) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "to provide bronchoscopic visualization of patient airways." This describes a procedure performed on the patient's body for direct observation, not a test performed on a sample taken from the body.
- Device Description: The description details a robotic system with a bronchoscope for navigating and visualizing the bronchial tree. This is consistent with an in-vivo (within the living body) procedure.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, tissue, etc.) outside of the body. IVD devices are specifically designed for such analysis to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies mentioned focus on functionality, durability, and in-vivo performance in an animal model, which are typical for medical devices used in procedures, not IVD devices. The standards listed are also primarily related to medical electrical equipment, biocompatibility, and sterilization, not IVD-specific standards.
- Predicate Devices: The predicate devices listed are a Video Bronchoscope System and a catheter articulation system, both of which are used for in-vivo procedures.
In summary, the ARES is a medical device used for a diagnostic procedure performed directly on the patient, not a device that analyzes samples in vitro.
N/A
Intended Use / Indications for Use
The Auris Robotic Endoscopy System (ARES) is intended to provide bronchoscopic visualization of patient airways.
Product codes
EOQ
Device Description
The Auris Robotic Endoscopy System (ARES) is intended to be used by qualified physicians to provide visualization to the Bronchial Tree during Bronchoscopic procedures. The ARES consists of four major components, (1) the Patient Side System (PSS), (2) Controller Cart, (3) Surgeon Console (also known as the Master Device Workstation) and (4) the Bronchoscope and Accessories.
The Patient Side System (PSS) includes the robot cart, two robot arms, both Endoscope and Sheath IDMs, IDS. servo drives box, Endoscope camera control box, power control box. illumination controller, and necessary cabling between the IDM/IDS and the robot cart.
The Controller Cart houses the electronic systems required to power and operate the robotic systems. The Controller Cart is broken into two smaller carts, the system controller cart, and the arm controller cart.
The Master Device Workstation is the workstation from which the surgeon drives the ARES. The console consists of a pendant that allows the surgeon to control various aspects of the system during a procedure.
The system is based on a master - slave model, where the user (i.e. physician) is controlling the robots (slaves) using a pendant (master). The flexible bronchoscope 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 four directions. The working channel of the Bronchoscope is used for irrigation and aspiration.
Each Slave includes a robotic arm with 6 degrees of freedom and an IDM (Instrument Drive Mechanism) with 4 actuated axes. The robotic arms are used to steer the Bronchoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient airways / Bronchial Tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians
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
Preclinical testing included standard bench or in vitro testing confirming functionality and durability (e.g., tensile and other durability and functional evaluation). The Porcine animal model was used to validate system performance in vivo.
Verification and validation testing was completed in compliance with the following standards:
- IEC 60601-1:2005 + CORP. 1 (2006) + CORP. 2 (2007) + AM1 (2012) or IEC 60601-. 1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
- IEC/EN 60601-1-2:2007/AC:2010, Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3). FDA recognition number: 19-2
- IEC 60601-2-18 Edition 3.0 2009-08, Medical electrical equipment Part 2-18: . Particular requirements for the basic safety and essential performance of endoscopic equipment. FDA recognition number: 9-61
- ISO 10993-1:2009(R) 2013, Biological evaluation of medical devices Part 1: . Evaluation and testing within a risk management process (Biocompatibility). FDA recognition number: 2-156
- . ISO 10993-5: 2009/(R) 2014, Biological evaluation of medical devices - part 5: tests for in vitro cytotoxicity. (Biocompatibility). FDA recognition number: 2-153
- . ISO 10993-6: 2007/(R) 2010, Biological evaluation of medical devices - part 6: tests for local effects after implantation (Biocompatibility). FDA recognition number: 2-120
- ISO 10993-10: 2010, Biological evaluation of medical devices-part 10: tests for . irritation and skin sensitization. (Biocompatibility). FDA recognition number: 2-173
- . ISO 10993-11: 2006/(R)2010, Biological evaluation of medical devices-part 11: tests for systemic toxicity. (Biocompatibility). FDA recognition number: 2-118
- ISO 14971:2012, Medical devices application of risk management to medical . devices. FDA recognition number: 5-40
- ISO 14937:2009, Sterilization of health care products General requirements for . characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices. FDA recognition number: 14-291
- . ISO 11137-2:2013, Sterilization of health care products - radiation- Part 2: Establishing the sterilization dose. FDA recognition number: 14-409
- . ANSI/AAMI ST81:2004 (R)2010, Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices. FDA recognition number: 14-295
- ANSI/AAMI ST79:2010, Comprehensive guide to steam sterilization and sterility assurance in . health care facilities. FDA recognition number: 14-439
- ISO 8600-3 First Edition 1997. Optics and Optical instruments Medical endoscopes and ● endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics [Including: Amendment 1 (2003)]. FDA recognition number: 9-84
Testing described in this 510(k) consisted of verification of all design input requirements and product specifications. All clinical input requirements were validated.
Key Metrics
Not Found
Predicate Device(s)
Karl Storz Video Bronchoscope System - K071530
Reference Device(s)
Olympus Bronchoscope K121959, Hansen Medical catheter articulation system - K052480
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2016
Auris Surgical Robotics, Inc. % Mr. Michael Daniel President, Daniel & Daniel Consulting, Llc Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, Nevada 89460
Re: K152319
Trade/Device Name: Auris Robotic Endoscopy System (ARES) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOQ Dated: April 28, 2016 Received: April 29, 2016
Dear Mr. Daniel:
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
6. Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(K) Number (if known)
Device Name
Auris Robotic Endoscopy System (ARES)
· Indications for Use (Describe)
The Auris Robotic Endoscopy System (ARES) is intended to provide bronchoscopic visualization of patient airways.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 El
3
7. Premarket Notification 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.
510(k) Number: K152319
Applicant Information:
Date Prepared: May 26, 2016
| Name: | Auris Surgical Robotics |
|---|---|
| Address: | 125 Shoreway Road, Suite D |
| San Carlos, CA 94070 | |
| Contact Person: | Michael A Daniel, Consultant |
| madaniel@clinregconsult.com | |
| Mobile Number: | (415) 407-0223 |
| Office Number: | (775) 392-2970 |
| Facsimile Number: | (610) 545-0799 |
| Company Contact: | Joy Sacmar, VP RA/QA, Auris Surgical Robotics |
| joy.sacmar@aurisrobotics.com |
Device Information:
| Device Trade Name: | Auris Robotic Endoscopy System (ARES) |
|---|---|
| Common Name: | Bronchoscope (Flexible) and Accessories |
| Classification Name(s): | Bronchoscope (Flexible) and Accessories |
| Product Code/ Regulation: | EOQ 21 CFR 874.4680 |
| Classification: | Class II |
Predicate Device:
- Karl Storz Video Bronchoscope System - K071530
In compliance with FDA Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" we are including the following as reference devices:
Reference Devices:
Device Description:
The Auris Robotic Endoscopy System (ARES) is intended to be used by qualified physicians to provide visualization to the Bronchial Tree during Bronchoscopic procedures. The ARES consists of four major components, (1) the Patient Side System (PSS), (2) Controller Cart, (3)
4
K152319-S002 - Auris Response to FDA RFAI and Q-Sub 160066 May 26, 2016
Surgeon Console (also known as the Master Device Workstation) and (4) the Bronchoscope and Accessories.
The Patient Side System (PSS) includes the robot cart, two robot arms, both Endoscope and Sheath IDMs, IDS. servo drives box, Endoscope camera control box, power control box. illumination controller, and necessary cabling between the IDM/IDS and the robot cart.
The Controller Cart houses the electronic systems required to power and operate the robotic systems. The Controller Cart is broken into two smaller carts, the system controller cart, and the arm controller cart.
The Master Device Workstation is the workstation from which the surgeon drives the ARES. The console consists of a pendant that allows the surgeon to control various aspects of the system during a procedure.
The system is based on a master - slave model, where the user (i.e. physician) is controlling the robots (slaves) using a pendant (master). The flexible bronchoscope 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 four directions. The working channel of the Bronchoscope is used for irrigation and aspiration.
Each Slave includes a robotic arm with 6 degrees of freedom and an IDM (Instrument Drive Mechanism) with 4 actuated axes. The robotic arms are used to steer the Bronchoscope.
Indications for Use:
The Auris Robotic Endoscopy System (ARES) is intended to provide bronchoscopic visualization of patient airways.
Comparison to Predicate and Reference Devices
The tables on the following pages provide a summary of substantial equivalence between the subject device and the cited predicate as well as the similarity between the subject device and the chosen reference device. The subject device has the same intended use and substantially equivalent technological characteristics that do not raise different questions of safety or effectiveness.
5
| Key Attributes | Subject Device | Predicate Device | Reference
Device 1 | Reference
Device 2 |
|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ARES System
(electromechanical
control system plus
integrated
Bronchoscope) | Karl Storz
Bronchoscope | Olympus
Bronchoscope | Hansen Medical
Catheter and Control
System | |
| K Number | K152319 | K071530 | K121959 | K052480 |
| Indication for Use | The Auris Robotic
Endoscopy System
(ARES) is intended
to provide
bronchoscopic
visualization of
patient airways. | The Karl Storz Video
Bronchoscope
System is intended
for use by physicians
for diagnostic and
therapeutic
procedures in nasal,
sinus and
nasopharyngeal
endoscopy,
bronchoscopy,
tracheoscopy and
esophagoscopy and
laryngoscopy. The
Karl Storz; Video
Bronchoscope is
intended to provide
visualization via a
video monitor. | These instruments
have been designed
to be used with an
Olympus video
system center, light
source,
documentation
equipment, video
monitor, endo-
therapy accessories
(such as biopsy
forceps) and other
ancillary equipment
for endoscopy and
endoscopic surgery
within the airways
and tracheobronchial
tree. | The Hansen Medical
Catheter Control
System, Steerable
Guide Catheter,
Sheath, and
accessories are
intended to facilitate
manipulation,
positioning and
control, for collecting
electrophysiological
data within the heart
atria with electro-
anatomic mapping
and recording
systems, using the
following
percutaneous
mapping catheters... |
| Method of Distal tip
movement | Pull Wires | Pull Wires | Pull Wires | Pull Wires |
| Method of pulling
pull wires | Electromechanical
(servo/stepper motors
- software) | Mechanical linkage
to handle (no
electromechanics) | Mechanical linkage
to handle (no
electromechanics) | Electromechanical
(servo/stepper motors - software) |
| Control / Physician
interface | Joysticks and buttons
on pendant controller | Thumb and finger
wheels on handle | Thumb and finger
wheels on handle | Joysticks and buttons
on pendant
controller? |
| Bronchoscope
Dimensions and
optical attributes | Reference Bronchoscope Comparison Chart below | | | N/A |
| Scope | Channel I.D. | Scope O.D. | Working Length | |
| Olympus BF-Q190 | 2.0 mm | 4.8 mm | 60 cm | |
| Olympus EVIS Exera (BF-3C160) | 1.2 mm | 3.8 mm | 60 cm | |
| Olympus Exera (BF-MP160F) | 2.0 mm | 4.0 mm | 600 mm | |
| Olympus Diagnostic (BF-XP190) | 1.2 mm | 3.1 mm | 600 mm | |
| Storz Broncho-fiberscope (11003) | 1.2 mm | 2.8 mm | N.S. | |
Comparison to Predicate and Reference Devices:
6
K152319-S002 - Auris Response to FDA RFAI and Q-Sub 160066 May 26, 2016
Testing Completed:
Preclinical testing included standard bench or in vitro testing confirming functionality and durability (e.g., tensile and other durability and functional evaluation). The Porcine animal model was used to validate system performance in vivo.
Verification and validation testing was completed in compliance with the following standards:
- IEC 60601-1:2005 + CORP. 1 (2006) + CORP. 2 (2007) + AM1 (2012) or IEC 60601-. 1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
- IEC/EN 60601-1-2:2007/AC:2010, Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3). FDA recognition number: 19-2
- IEC 60601-2-18 Edition 3.0 2009-08, Medical electrical equipment Part 2-18: . Particular requirements for the basic safety and essential performance of endoscopic equipment. FDA recognition number: 9-61
- ISO 10993-1:2009(R) 2013, Biological evaluation of medical devices Part 1: . Evaluation and testing within a risk management process (Biocompatibility). FDA recognition number: 2-156
- . ISO 10993-5: 2009/(R) 2014, Biological evaluation of medical devices - part 5: tests for in vitro cytotoxicity. (Biocompatibility). FDA recognition number: 2-153
- . ISO 10993-6: 2007/(R) 2010, Biological evaluation of medical devices - part 6: tests for local effects after implantation (Biocompatibility). FDA recognition number: 2-120
- ISO 10993-10: 2010, Biological evaluation of medical devices-part 10: tests for . irritation and skin sensitization. (Biocompatibility). FDA recognition number: 2-173
- . ISO 10993-11: 2006/(R)2010, Biological evaluation of medical devices-part 11: tests for systemic toxicity. (Biocompatibility). FDA recognition number: 2-118
7
- ISO 14971:2012, Medical devices application of risk management to medical . devices. FDA recognition number: 5-40
- ISO 14937:2009, Sterilization of health care products General requirements for . characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices. FDA recognition number: 14-291
- . ISO 11137-2:2013, Sterilization of health care products - radiation- Part 2: Establishing the sterilization dose. FDA recognition number: 14-409
- . ANSI/AAMI ST81:2004 (R)2010, Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices. FDA recognition number: 14-295
- ANSI/AAMI ST79:2010, Comprehensive guide to steam sterilization and sterility assurance in . health care facilities. FDA recognition number: 14-439
- ISO 8600-3 First Edition 1997. Optics and Optical instruments Medical endoscopes and ● endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics [Including: Amendment 1 (2003)]. FDA recognition number: 9-84
Testing described in this 510(k) consisted of verification of all design input requirements and product specifications. All clinical input requirements were validated.
Summary:
Based upon the Intended Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the Auris Robotic Endoscopy System (ARES), has been shown to be substantially equivalent to the cited predicates and very similar to the cited reference device.