(115 days)
No
The summary describes a robot-assisted flexible endoscope with a computer-assisted controller for visualization and surgical access. It mentions video image processing for display but does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies. The focus is on mechanical control and visualization, not intelligent analysis or decision-making based on data.
No.
The device is used for visualization and surgical site access, but it does not directly treat or diagnose a disease.
No
The device is intended for robot-assisted visualization and surgical site access during surgery, not for diagnosing medical conditions. It helps surgeons see and reach the surgical area, and allows for the use of flexible instruments, but it does not provide a diagnosis.
No
The device description explicitly states it is an "operator-controlled flexible endoscope" with a "digital camera incorporated in the distal end" and "two accessory channels for use of varied flexible instruments," indicating significant hardware components beyond just software.
Based on the provided information, the Medrobotics Flex® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "robot-assisted visualization and surgical site access to the oropharynx, hypopharynx, and larynx in adults...". This describes a surgical tool used in vivo (within the body) for visualization and access during procedures.
- Device Description: The description reinforces this by calling it an "operator-controlled flexible endoscope" that provides "visualization and surgical site access".
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is a surgical system used for visualization and access during procedures performed directly on the patient.
N/A
Intended Use / Indications for Use
The Medrobotics Flex® System is a device that is intended for robot-assisted visualization and surgical site access to the oropharynx, hypopharynx, and larynx in adults (≥ 22 years of age). The Flex System also provides accessory channels for compatible flexible instruments used in surgery.
Product codes
EOB, EOX, GCI
Device Description
The Flex System is an operator-controlled flexible endoscope that provides the benefits of both a rigid endoscope and a computer assisted controller. The Flex System allows for the endoscope to be introduced via an operator-controlled user interface, providing visualization and surgical site access to structures within the oropharynx, and larynx. Like some other video endoscopes, visualization is provided by a digital camera incorporated in the distal end of the endoscope. The Flex System's endoscope also provides two accessory channels for use of varied flexible instruments.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oropharynx, hypopharynx, and larynx
Indicated Patient Age Range
adults (≥ 22 years of age)
Intended User / Care Setting
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
The subject device has been successfully tested for function and performance in bench, usability/human factors, animal, and clinical studies. In addition, the Flex System has been evaluated for electrical safety and electromagnetic compatibility, and biocompatibility and toxicity testing of the patient-contacting materials. The components of the Flex System have been tested and met acceptance criteria per FDA recognized standards for the establishment of labeled shelf life, shipping, sterilization, cleaning, and disinfection, as applicable.
Bench Testing: The following testing was performed to verify that the Flex System, as a whole, and the components met their performance specifications: Flex System Components, Mechanical Engineering Verification; Flex System Components, Mechanical Engineering Verification- Disposable Reliability; Flex System Components, Mechanical Engineering Verification- Base Reliability; Flex System Components, Mechanical Engineering Verification- Base Cleaning Survivability; Flex System Hi-Res Camera Verification; Flex Cart Verification; Flex System Electrical Design Requirements Electrical Design Verification; Flex Console Safety PCA Verification; Electrical Design Verification; Overall Flex System Functionality (Simulated Use Re-Verification); Surgical Instrument Compatibility Verification.
Transportation Testing: Testing was performed to demonstrate that all components of the Flex System could withstand anticipated shipping conditions.
Usability/Human Factors Testing: Medrobotics performed usability and human factors testing of the Flex System. Such testing was performed in accordance with FDA Draft Guidance Document "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" (June 22, 2011). In addition, Wiklund's Usability Testing of Medical Devices was used as a reference. This testing assessed the performance of the Flex System when used by representative end users (i.e., head and neck surgeons and nurses/surgical technicians) in accordance with the IFU after having been trained on how to use the system. The testing demonstrated that the Flex System design meets the intended user requirements and facilitates safe and effective user interactions with little chance of committing dangerous user errors.
Animal Testing: Medrobotics performed two animal studies to evaluate the safety of the Flex System. Both studies evaluated abrasion and blunt force trauma caused by the Flex Scope (the patient contacting portion of the Flex System) compared to intubation control. The studies were conducted in accordance with Good Laboratory Practice (GLP). Both studies concluded that the Flex Scope does not cause an increased level of abrasion and/or blunt force trauma during visualization and access of the oropharynx and hypopharynx/laryngopharynx when compared to intubation control.
Electrical Safety: The Flex System has been tested to demonstrate electrical safety and compliance with UL 60601-1 (1) Issued: 2003/04/25 Ed: 1 Rev: 2006/04/26 Medical Electrical Equipment, Part 1:General Req. for Safety; CSA C22.2#601.1 Issued: 1990/01/01 (R2005) Medical Electrical Equipment Part 1: General Requirements for Safety General Instruction No. 1: 1990, Supplement 1: 1994, Amendment 2:1998; General Instruction No. 2: 2003; ANSI/AAMI ES60601-1:2005/(R)2012 Issued: 2012/01/17 Medical electrical equipment - Part1: General requirements for basic safety and essential performance with C1:2009/(R)2012 and A2:2010/(R)2012; CAN/CSA-C22.2 No. 60601-1: 08(R2013) Issued: 2011/06/01 Medical Electrical Equipment -Part 1: General Req. for Basic Safety & Essential Perf.; Cor. 2: 2011; IEC 60601-1-6: 2010, Edition 3.0 Version: 2010/01/27 Medical electrical equipment - Part 1- 6:General requirements for basic safety and essential performance -Collateral standard: Usability; IEC 62366: 2007, Edition 1.0 Issued: 2007/10/18 Ed. 1 Medical Devices -Application Of Usability Engineering To Medical Devices; IEC 60601-1-6: 2004. First Edition Issued: 2004/06/24 Medical electrical systems – Part 1- 6:General requirements for safety - Collateral standard: Usability; IEC 60601-1-4: 2000, Edition 1.1 Issued 2000/04/01 Medical electrical systems Part 1- 4:General requirements for safety - Collateral standard: Programmable electrical medical systems.
Electromagnetic Compatibility Testing: The Flex System was tested and determined to be in compliance with EN 60601-1-2:2007/AC:2010 Electromagnetic emissions and immunity requirements for medical electrical equipment -- Group 1 Equipment, Class A for non-life supporting equipment; IEC 60601-1-2 Ed. 3.0 Electromagnetic emissions and immunity requirements for medical electrical equipment -Group 1 Equipment, Class A for non-life supporting equipment.
Biocompatibility: The Flex Scope contains the patient contacting portions of the Flex System. In accordance with ANSI/AAMI/ISO 10993-1:2009, and FDA 510(k) Memorandum - #G95-1 Table 1 Initial Evaluation Tests for Consideration, the Flex Scope is classified as "external communicating device", in contact with "tissue/bone/dentin" and "limited exposure" (≤24 hours). Biocompatibility and toxicity testing performed on the Flex System included Cytotoxicity Study, ISO Systemic Toxicity Study in Mice (two studies), ISO -Intracutaneous Study (two studies), ISO - Maximization Sensitization Study (two studies), and ISO - Oral Mucosal Irritation Test, all of which passed.
Sterilization, Packaging and Shelf Life for Single Use Flex Scope: The Flex Scope is supplied sterile and is a single use device. The EtO cycle has been validated to a sterility assurance level (SAL) of 10-6, in accordance with the following standards: ANSI/AAMI/ISO 11135-1:2007; ANSI/AAMI/ISO TIR 11135-2:2008; AAMI TIR 28:2009; ANSI/AAMI/ISO/EN 10993-7:2008. The Flex Scope sterile packaging was validated in accordance with the following standards as part of a study demonstrating that the packaging system is stable over its labeled shelf life: ISO 11607-1:2006 (R) 2010; ASTM F1886M-09; ASTM F1929-12; ASTM F88M-09; ASTM F190-07.
Cleaning and Sterilization of Reusable System Components: The Flex Instrument Support cleaning instructions were validated in accordance with the following standards: ANSI/AAMI ST79:2010; AAMI TIR12:2010; AAMI TIR30:2011. The Flex Instrument Support sterilization process was validated in accordance with the following standards: ANSI/AAMI/ISO 17665-1:2006; ANSI/AAMI ST79:2010; AAMI TIR12:2010. The cleaning instructions for the Flex Base, Flex Cart, Stand, Flex Console, and Monitor were validated in accordance with the following standards: AAMI TIR12:2010; AAMI TIR30:2011. The disinfection instructions for the Flex Base, Flex Cart, Stand and Flex Console (excluding the Monitor) were validated in accordance with the following standards: AAMI TIR12:2010; AAMI TIR30:2011.
Software: Medrobotics followed the FDA guidance document, "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices May 11, 2005." to classify the Flex System software as a "moderate level of concern." The software was verified and validated, and the software verification and validation documents were prepared and presented in accordance with FDA's guidance document.
Clinical Study: A European post-market clinical follow up study with 45 subjects was performed using the Flex System. The study protocol required that clinical study subjects undergo two separate procedures. The first was a five-point visualization and access procedure, in which the investigator visualized and accessed (1) the palatine tonsil area; (2) the base of tongue area; (3) the epiglottis; (4) the posterior pharyngeal wall; and (5) the false vocal cords. The second was a surgical procedure to treat the patient's previously diagnosed condition with surgical site access and visualization being provided by the Flex System. Forty five (45) subjects were treated in a total of 46 surgical procedures.
Five-Point Visualization & Access Procedure:
- Palatine tonsil area: Visualization Achieved (N=45) = 45 (100%), Access Gained (N=45) = 44 (98%)
- Base of tongue area: Visualization Achieved (N=45) = 45 (100%), Access Gained (N=45) = 44 (98%)
- Epiglottis: Visualization Achieved (N=45) = 45 (100%), Access Gained (N=45) = 44 (98%)
- Posterior pharyngeal wall: Visualization Achieved (N=45) = 45 (100%), Access Gained (N=45) = 44 (98%)
- False vocal cords: Visualization Achieved (N=45) = 42 (93%), Access Gained (N=45) = 41 (91%)
The study investigators reported total inability to visualize and access the false vocal cords in 3 and 4 out of 45 subjects, respectively. The study investigators reported difficulty in visualization and/or access in 7 out of 42 visualization-achieved/41 access-gained patients.
Surgical Procedures: A variety of surgical procedures were successfully completed (89%) in the oropharynx, hypopharynx and larynx with surgical site access and visualization provided by the Flex System. A wide variety of anatomical locations in the oropharynx, hypopharynx and larynx were visualized and accessed during the surgical procedures. The safety and effectiveness of the Flex System for providing visualization and access to the true vocal cords was not assessed in the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072073, K102733, K052930, K070622
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or fabric.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 16, 2015
Medrobotics Corporation Mr. John D. Bonasera Director of Regulatory Affairs 475 Paramount Drive Raynham, MA 02767
Re: K150776
Trade/Device Name: Medrobotics Flex System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB, EOX, GCI Dated: June 16, 2015 Received: June 18, 2015
Dear Mr. Bonasera:
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.
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
Eric A. Mann -S
Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150776
Device Name Medrobotics Flex® System
Indications for Use (Describe)
The Medrobotics Flex® System is a device that is intended for robot-assisted visualization and surgical site access to the oropharynx, hypopharynx, and larynx in adults (≥ 22 years of age). The Flex System also provides accessory channels for compatible flexible instruments used in surgery.
| 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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510(k) Summary Medrobotics Flex System (K150776)
| Date prepared: | July 16, 2015 |
|---|---|
| ---------------- | --------------- |
Applicant's Name and Address
| Applicant | Medrobotics Corporation | |
|---|---|---|
| Address | 475 Paramount Drive | |
| Raynham, MA 02767 | ||
| Telephone Number | 508-692-6460 x 254 | |
| Fax Number | 508-832-1703 | |
| Contact Person: | John D. Bonasera | |
| Title | Director of Regulatory Affairs |
Name of the Device
| Trade Name: | Flex® System |
|---|---|
| Common Name: | Nasopharyngoscope (flexible or rigid) |
| Classification Name | Nasopharyngoscope (flexible or rigid) and accessories |
| Device Classification: | II |
| Primary Product Code: | EOB |
| Subsequent Product Codes: | EOX and GCI |
| FDA Regulation | 21 C.F.R. § 874.4760 |
Predicate Device
The legally marketed predicate device to which substantial equivalence is claimed:
- The Vision-Sciences Flexible Endoscope with digital video processor and 1. Disposable EndoSheath® System, K072073, K102733 ("Vision-Sciences System"), and
Reference Device
The Flex System was also compared to the Hansen Medical Vascular Catheter Control System, K111004, because both devices employ a physician controller located at the physician console/workstation to drive and articulate the scope/catheter.
Device Description
The Flex System is an operator-controlled flexible endoscope that provides the benefits of both a rigid endoscope and a computer assisted controller. The Flex System allows for the
4
endoscope to be introduced via an operator-controlled user interface, providing visualization and surgical site access to structures within the oropharynx, and larynx. Like some other video endoscopes, visualization is provided by a digital camera incorporated in the distal end of the endoscope. The Flex System's endoscope also provides two accessory channels for use of varied flexible instruments.
Intended Use
The Medrobotics Flex® System is a device that is intended for robot-assisted visualization and surgical site access to the oropharynx, hypopharynx, and larynx in adults (≥ 22 years of age). The Flex System also provides accessory channels for compatible flexible instruments used in surgery.
Substantial Equivalence
Medrobotics believes that the subject device is substantially equivalent to the Vision Sciences System and the NeoGuide System. As shown in the comparison table (Table 3) at the end of this section, the Flex System has very similar functionality and the same intended use as the predicate devices.
Summary of Performance Testing
The subject device has been successfully tested for function and performance in bench, usability/human factors, animal, and clinical studies. In addition, the Flex System has been evaluated for electrical safety and electromagnetic compatibility, and biocompatibility and toxicity testing of the patient-contacting materials. The components of the Flex System have been tested and met acceptance criteria per FDA recognized standards for the establishment of labeled shelf life, shipping, sterilization, cleaning, and disinfection, as applicable.
Bench Testing
The following testing was performed to verify that the Flex System, as a whole, and the components met their performance specifications:
- Flex System Components, Mechanical Engineering Verification ●
- Flex System Components, Mechanical Engineering Verification- Disposable Reliability
- Flex System Components, Mechanical Engineering Verification- Base Reliability
- Flex System Components, Mechanical Engineering Verification- Base Cleaning Survivability
- Flex System Hi-Res Camera Verification
- Flex Cart Verification
- Flex System Electrical Design Requirements Electrical Design Verification
- Flex Console Safety PCA Verification
5
- Electrical Design Verification
- Overall Flex System Functionality (Simulated Use Re-Verification)
- Surgical Instrument Compatibility Verification
Transportation Testing
Testing was performed to demonstrate that all components of the Flex System could withstand anticipated shipping conditions.
Usability/Human Factors Testing
Medrobotics performed usability and human factors testing of the Flex System. Such testing was performed in accordance with FDA Draft Guidance Document "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" (June 22, 2011). In addition, Wiklund's Usability Testing of Medical Devices was used as a reference.
This testing assessed the performance of the Flex System when used by representative end users (i.e., head and neck surgeons and nurses/surgical technicians) in accordance with the IFU after having been trained on how to use the system. The testing demonstrated that the Flex System design meets the intended user requirements and facilitates safe and effective user interactions with little chance of committing dangerous user errors.
Animal Testing
Medrobotics performed two animal studies to evaluate the safety of the Flex System. Both studies evaluated abrasion and blunt force trauma caused by the Flex Scope (the patient contacting portion of the Flex System) compared to intubation control. The studies were conducted in accordance with Good Laboratory Practice (GLP). Both studies concluded that the Flex Scope does not cause an increased level of abrasion and/or blunt force trauma during visualization and access of the oropharynx and hypopharynx/laryngopharynx when compared to intubation control.
Electrical Safety
The Flex System has been tested to demonstrate electrical safety and compliance with:
- UL 60601-1 (1) Issued: 2003/04/25 Ed: 1 Rev: 2006/04/26 Medical Electrical Equipment, Part 1:General Req. for Safety
- CSA C22.2#601.1 Issued: 1990/01/01 (R2005) Medical Electrical Equipment Part ● 1: General Requirements for Safety General Instruction No. 1: 1990, Supplement 1: 1994, Amendment 2:1998; General Instruction No. 2: 2003
- ANSVAAMI ES60601-1:2005/(R)2012 Issued: 2012/01/17 Medical electrical ● equipment - Part1: General requirements for basic safety and essential performance with C1:2009/(R)2012 and A2:2010/(R)2012
6
- CAN/CSA-C22.2 No. 60601-1: 08(R2013) Issued: 2011/06/01 Medical Electrical Equipment -Part 1: General Req. for Basic Safety & Essential Perf.; Cor. 2: 2011
- IEC 60601-1-6: 2010, Edition 3.0 Version: 2010/01/27 Medical electrical equipment - Part 1- 6:General requirements for basic safety and essential performance -Collateral standard: Usability
- IEC 62366: 2007, Edition 1.0 Issued: 2007/10/18 Ed. 1 Medical Devices -● Application Of Usability Engineering To Medical Devices
- . IEC 60601-1-6: 2004. First Edition Issued: 2004/06/24 Medical electrical systems – Part 1- 6:General requirements for safety - Collateral standard: Usability
- IEC 60601-1-4: 2000, Edition 1.1 Issued 2000/04/01 Medical electrical systems ● Part 1- 4:General requirements for safety - Collateral standard: Programmable electrical medical systems
Electromagnetic Compatibility Testing
The Flex System was tested and determined to be in compliance with:
- EN 60601-1-2:2007/AC:2010 Electromagnetic emissions and immunity requirements for medical electrical equipment -- Group 1 Equipment, Class A for non-life supporting equipment.
- IEC 60601-1-2 Ed. 3.0 Electromagnetic emissions and immunity requirements for ● medical electrical equipment -Group 1 Equipment, Class A for non-life supporting equipment.
Biocompatibility
The Flex Scope contains the patient contacting portions of the Flex System. In accordance with ANSI/AAMI/ISO 10993-1:2009, and FDA 510(k) Memorandum - #G95-1 Table 1 Initial Evaluation Tests for Consideration, the Flex Scope is classified as "external communicating device", in contact with "tissue/bone/dentin" and "limited exposure" (≤24 hours). Table 1, below, provides a summary of the biocompatibility and toxicity testing performed on the Flex System.
| Test | Outcome of Evaluation |
|---|---|
| Cytotoxicity Study | Pass |
| ISO Systemic Toxicity Study in Mice | Pass |
| ISO Systemic Toxicity Study in Mice | Pass |
| ISO -Intracutaneous Study | Pass |
| ISO -Intracutaneous Study | Pass |
| ISO - Maximization Sensitization Study | Pass |
| ISO - Maximization Sensitization Study | Pass |
| ISO - Oral Mucosal Irritation Test | Pass |
Table 1. Summary of Biocompatibility and Toxicity Testing
Sterilization, Packaging and Shelf Life for Single Use Flex Scope
7
The Flex Scope is supplied sterile and is a single use device. The Flex Scope is sterilized via ethylene oxide (EtO). The EtO cycle has been validated to a sterility assurance level (SAL) of 10-6, in accordance with the following standards:
- ANSI/AAMI/ISO 11135-1:2007. Sterilization of health care products Ethylene ● Oxide - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
- ANSI/AAMI/ISO TIR 11135-2:2008, Sterilization of health care products Ethylene ● Oxide - Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1
- AAMI TIR 28:2009, Product adoption and process equivalence for ethylene oxide ● sterilization
- ANSI/AAMI/ISO/EN 10993-7:2008, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
The Flex Scope sterile packaging was validated in accordance with the following standards as part of a study demonstrating that the packaging system is stable over its labeled shelf life:
- ISO 11607-1:2006 (R) 2010, Packaging for terminally sterilized medical devices -● Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ASTM F1886M-09, Standard Test Method for Determining Integrity of Seals for ● Flexible Packaging by Visual Inspection
- ASTM F1929-12, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F190-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for ● Medical Devices
Cleaning and Sterilization of Reusable System Components
The Flex System consists of reusable capital equipment supplied non-sterile, with the exception of the Flex Scope, as discussed above.
The Flex Instrument Support is provided non-sterile. The Flex Instrument Support is intended to be cleaned and sterilized before each use. The Flex Instrument Support cleaning instructions were validated in accordance with the following standards:
- ANSI/AAMI ST79:2010, Comprehensive guide to steam sterilization and sterility ● assurance in health care facilities
- AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for ● reprocessing in health care facilities: A guide for medical device manufacturers
- AAMI TIR30:2011, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
8
The Flex Instrument Support sterilization process was validated in accordance with the following standards:
- ANSI/AAMI/ISO 17665-1:2006, Sterilization of health care products - Moist heat -Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
- ANSI/AAMI ST79:2010, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
The Flex Base, Flex Cart, Stand and Flex Console, with the exception of the monitor, are intended to be cleaned and disinfected before each use. None of these components have direct patient contact during a surgical procedure. The Monitor is intended to be cleaned before each use. These pieces of equipment are intended to be covered prior to each use with sterile drapes.
The cleaning instructions for the Flex Base, Flex Cart, Stand, Flex Console, and Monitor were validated in accordance with the following standards:
- AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
- AAMI TIR30:2011, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
The disinfection instructions for the Flex Base, Flex Cart, Stand and Flex Console (excluding the Monitor) were validated in accordance with the following standards:
- AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
- AAMI TIR30:2011, A compendium of processes, materials, test methods, and ● acceptance criteria for cleaning reusable medical devices
Software
Medrobotics followed the FDA guidance document, "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices May 11, 2005." to classify the Flex System software as a "moderate level of concern." The software was verified and validated, and the software verification and validation documents were prepared and presented in accordance with FDA's guidance document.
Clinical Study
A European post-market clinical follow up study with 45 subjects was performed using the Flex System. The study protocol required that clinical study subjects undergo two separate procedures. The first was a five-point visualization and access procedure, in which the
9
investigator visualized and accessed (1) the palatine tonsil area; (2) the base of tongue area; (3) the epiglottis; (4) the posterior pharyngeal wall; and (5) the false vocal cords. The second was a surgical procedure to treat the patient's previously diagnosed condition with surgical site access and visualization being provided by the Flex System. Forty five (45) subjects were treated in a total of 46 surgical procedures.
Five-Point Visualization & Access Procedure
As shown in Table 2, below, the Flex System was effective (>90%) in providing visualization and access in the oropharynx, hypopharynx and larynx during the Five-Point Visualization & Access Procedure.
| Anatomical Location | Visualization Achieved
(N=45) | Access Gained
(N=45) |
|---------------------------|----------------------------------|-------------------------|
| Palatine tonsil area | 45 (100%) | 44 (98%) |
| Base of tongue area | 45 (100%) | 44 (98%) |
| Epiglottis | 45 (100%) | 44 (98%) |
| Posterior pharyngeal wall | 45 (100%) | 44 (98%) |
| False vocal cords1, 2 | 42 (93%) | 41 (91%) |
Table 2. Five Points Visualization and Access
1 The study investigators reported total inability to visualize and access the false vocal cords in 3 and 4 out of 45 subjects, respectively.
- 2 The study investigators reported difficulty in visualization and/or access in 7 out of 42 visualization-achieved/41 access-gained patients.
Surgical Procedures
A variety of surgical procedures were successfully completed (89%) in the oropharynx, hypopharynx and larynx with surgical site access and visualization provided by the Flex System. A wide variety of anatomical locations in the oropharynx, hypopharynx and larynx were visualized and accessed during the surgical procedures. The safety and effectiveness of the Flex System for providing visualization and access to the true vocal cords was not assessed in the study.
Conclusion
Based on the indications for use, technological characteristics, and performance testing, Medrobotics has demonstrated that the Flex System is as safe and effective as the predicate
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devices for the stated intended use, and the Flex System is, as a result, substantially equivalent to the predicate devices.
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Table 3. Proposed and Predicate Device Comparison
| | Flex System
[K150776] | Vision-Sciences System
[K072073] | Vision-Sciences System
[K102733] | NeoGuide System
[K052930, K070622] |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For endoscopic access
and visualization of
patient anatomy through
a natural orifice. | For endoscopic access and visualization of patient
anatomy through a natural orifice. | For endoscopic access
and visualization of
patient anatomy through
a natural orifice. | For endoscopic access
and visualization of
patient anatomy through
a natural orifice. |
| Indications for Use | The Medrobotics Flex®
System is a device that is
intended for robot-
assisted visualization and
surgical site access to the
oropharynx,
hypopharynx, and larynx
in adults (≥ 22 years of
age). The Flex System
also provides accessory
channels for compatible
flexible instruments used
in surgery. | The flexible ENT
videoscope with the
EndoSheath System is
intended for use in
flexible endoscopic
examination of the
upper airway, vocal
cords, and/or nasal
passages.
The digital video
processor is intended for
use with the VSI flexible
video scope. | The flexible ENT-500
Video ENT Scope with
EndoSheath Technology
is intended for use in
flexible endoscopic
examination of the
upper airway, vocal
cords and/or nasal
passages; and for use in
diagnostic arthroscopic
and endoscopic
procedures to provide
illumination and
visualization of the
interior cavity of the
body through either a
natural or surgical
opening. | The NeoGuide Navigator
Endoscopy System is
intended to provide
visualization and
diagnostic/therapeutic
access to the adult lower
gastrointestinal tract
(including, but not
limited to, the anus,
rectum, sigmoid colon,
colon, cecum, and
ileocecal valve) for
endoscopy and
endoscopic surgery. |
| | Flex System
[K150776] | Vision-Sciences System
[K072073] | Vision-Sciences System
[K102733] | NeoGuide System
[K052930, K070622] |
| Operational
Principles | Cable-steered CMOS-
based video endoscope
using electromechanical
controls driven from a
console-based, computer-
controlled physician
handle. | A cable-steered flexible video laryngoscope with
CCD-based imaging allowing for high resolution
picture quality. | A cable-steered flexible video laryngoscope with
CCD-based imaging allowing for high resolution
picture quality. | Cable-steered endoscope
using electromechanical
controls on the handle
distal tip CCD camera
and tool channels for
instrument-based
therapeutic procedures,
valves for air insufflation,
water irrigation, and
suction. |
| Rigidity | Flexible/semi-rigid
endoscope. | Continuously flexible endoscope. | Continuously flexible endoscope. | Flexible/semi-rigid
endoscope. |
| Advance/Retract | Electromechanically
aided with physician
controller on console. | Manual. | Manual. | Manual. |
| Steering | Electromechanical
joystick controls (the
Physician Controller) on
a console aid steering. | Manual control. | Manual control. | Electromechanical
joystick controls on the
handle of the scope aid
steering. |
| Direct Visualization | Yes, during the entire
procedure. | Yes, during the entire procedure. | Yes, during the entire procedure. | Yes, during the entire
procedure. |
| | Flex System
[K150776] | Vision-Sciences System
[K072073] | Vision-Sciences System
[K102733] | NeoGuide System
[K052930, K070622] |
| Multi-Segmented
Endoscope
Structure | Yes. | One continuously extruded flexible structure. | | Yes. |
| Semi-Rigid Follow
the Leader/Guiding
Function | Yes. | No, manual. | | Yes. |
| Electromechanically
Cable-
Driven/Controlled
Segments | Yes. | No, manual. | | Yes. |
| 3D Flexible
Movements and Tip
Orientation | Yes. | Yes. | | Yes. |
| Haptic Feedback to
User | Yes. | No. | | No. |
| Fluid Lumen | Yes. | Yes. | | Yes. |
| Working
Channel(s) | Yes, 4.7 mm in diameter. | Yes. | | Yes, 3.2 mm in diameter. |
| | Flex System
[K150776] | Vision-Sciences System
[K072073] | | NeoGuide System
[K052930, K070622] |
| View Optics/Optical
Sensor | Lens/solid state camera
(CMOS). | Lens/solid state camera
(CCD). | | Lens/solid state camera
(CCD). |
| Light Source | LED. | LED. | | LED. |
| Video Image
Processing | Video data display, | Video data display, | | Video data display, |
| Biocompatibility | Patient contacting
materials have been
shown to be
biocompatible after
testing to ISO 10993. | Patient contacting materials have been shown to be
biocompatible after testing to ISO 10993. | | Patient contacting
materials have been
shown to be
biocompatible after
testing to ISO 10993. |
| Sterilization | The Flex Scope is
provided sterile. The
reusable components of
the Flex System are
provided clean/non-
sterile. | Sheath for scope provided sterile. | | Provided clean/non-
sterile. |
| Electrical Safety
and EMC | Passed the applicable
electrical safety
requirements of IEC
60601-1-2 and IEC
60601-1. | Passed. | | Passed. |
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