(115 days)
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 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.
The Medrobotics Flex System acceptance criteria and performance are as follows:
1. Table of Acceptance Criteria & Reported Device Performance:
| Acceptance Criteria (Study Type) | Target Performance | Reported Device Performance |
|---|---|---|
| Clinical Study: Five-Point Visualization & Access Procedure | ||
| Visualization Achieved - Palatine tonsil area | >90% | 100% (45/45 subjects) |
| Access Gained - Palatine tonsil area | >90% | 98% (44/45 subjects) |
| Visualization Achieved - Base of tongue area | >90% | 100% (45/45 subjects) |
| Access Gained - Base of tongue area | >90% | 98% (44/45 subjects) |
| Visualization Achieved - Epiglottis | >90% | 100% (45/45 subjects) |
| Access Gained - Epiglottis | >90% | 98% (44/45 subjects) |
| Visualization Achieved - Posterior pharyngeal wall | >90% | 100% (45/45 subjects) |
| Access Gained - Posterior pharyngeal wall | >90% | 98% (44/45 subjects) |
| Visualization Achieved - False vocal cords | >90% | 93% (42/45 subjects) |
| Access Gained - False vocal cords | >90% | 91% (41/45 subjects) |
| Clinical Study: Surgical Procedures | ||
| Surgical procedures successfully completed with surgical site access and visualization provided by Flex System | Not explicitly defined as a numerical percentage, but generally implied to be high for effectiveness. | 89% of 46 surgical procedures were successfully completed. |
| Bench Testing | Met performance specifications | Met performance specifications (Various tests listed) |
| Transportation Testing | Withstand anticipated shipping conditions | Withstood anticipated shipping conditions |
| Usability/Human Factors Testing | Meets intended user requirements and facilitates safe and effective user interactions with little chance of committing dangerous user errors | Meets intended user requirements and facilitates safe and effective user interactions with little chance of committing dangerous user errors |
| Animal Testing (Abrasion and blunt force trauma) | No increased level of abrasion and/or blunt force trauma compared to intubation control | No increased level of abrasion and/or blunt force trauma compared to intubation control |
| Electrical Safety | Compliance with UL 60601-1, CSA C22.2#601.1, ANSI/AAMI ES60601-1:2005, CAN/CSA-C22.2 No. 60601-1, IEC 60601-1-6, IEC 62366, IEC 60601-1-4 | Compliant |
| Electromagnetic Compatibility Testing | Compliance with EN 60601-1-2:2007/AC:2010, IEC 60601-1-2 Ed. 3.0 | Compliant |
| Biocompatibility (Flex Scope patient-contacting materials) | Pass Cytotoxicity, ISO Systemic Toxicity in Mice, ISO Intracutaneous Study, ISO Maximization Sensitization Study, ISO Oral Mucosal Irritation Test | Passed all studies |
| Sterilization (Flex Scope) | Sterility assurance level (SAL) of 10-6 | Validated to SAL of 10-6 |
| Packaging and Shelf Life (Flex Scope) | Packaging system stable over labeled shelf life | Validated |
| Cleaning and Sterilization of Reusable System Components (Flex Instrument Support) | Compliance with ANSI/AAMI ST79, AAMI TIR12, AAMI TIR30, ANSI/AAMI/ISO 17665-1 | Validated |
| Cleaning and Disinfection (Flex Base, Flex Cart, Stand, Flex Console, Monitor) | Compliance with AAMI TIR12, AAMI TIR30 | Validated |
| Software | Verified and Validated according to FDA guidance for "moderate level of concern" software | Verified and Validated |
2. Sample size used for the test set and the data provenance:
- Clinical Study: 45 subjects.
- Data Provenance: European post-market clinical follow-up study (prospective, originating from Europe).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the clinical study. It mentions that "investigator visualized and accessed" the anatomical locations, implying the assessment was made by the medical professionals conducting the study.
4. Adjudication method for the test set:
- The document does not specify an adjudication method like 2+1 or 3+1 for the clinical study results. The reported percentages (e.g., "45 (100%)" or "44 (98%)") suggest direct observation and recording by the study investigators.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done to compare human readers with and without AI assistance described in this document. The Flex System is a robot-assisted visualization and surgical access device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The Flex System is an "operator-controlled flexible endoscope" and "robot-assisted visualization and surgical site access" device, explicitly designed for human-in-the-loop operation. Therefore, a standalone algorithm-only performance study would not be applicable or conducted for this type of device.
7. The type of ground truth used:
- Clinical Study: The ground truth was based on direct observation and assessment by the study investigators (medical professionals) during the "Five-Point Visualization & Access Procedure" and "Surgical Procedures." This is best described as expert consensus/direct observation by medical professionals.
- Bench, Animal, Electrical Safety, EMC, Biocompatibility, Sterilization, Packaging, Cleaning, Software Testing: Ground truth established through compliance with recognized standards, specifications, and validated test methodologies.
8. The sample size for the training set:
- The document does not provide details about a "training set" in the context of machine learning, as the device primarily involves robotic assistance and control rather than a learning algorithm. The software was verified and validated, but no specific training set size is mentioned.
9. How the ground truth for the training set was established:
- This question is not applicable as there is no mention or indication of a machine learning "training set" or corresponding ground truth establishment process for the Flex System in the provided text. The software validation refers to standard engineering verification and validation processes against requirements and specifications.
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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.
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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
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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
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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
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- 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
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- 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
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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
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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
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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 accessand visualization ofpatient anatomy througha natural orifice. | For endoscopic access and visualization of patientanatomy through a natural orifice. | For endoscopic accessand visualization ofpatient anatomy througha natural orifice. | For endoscopic accessand visualization ofpatient anatomy througha natural orifice. |
| Indications for Use | The Medrobotics Flex®System is a device that isintended for robot-assisted visualization andsurgical site access to theoropharynx,hypopharynx, and larynxin adults (≥ 22 years ofage). The Flex Systemalso provides accessorychannels for compatibleflexible instruments usedin surgery. | The flexible ENTvideoscope with theEndoSheath System isintended for use inflexible endoscopicexamination of theupper airway, vocalcords, and/or nasalpassages.The digital videoprocessor is intended foruse with the VSI flexiblevideo scope. | The flexible ENT-500Video ENT Scope withEndoSheath Technologyis intended for use inflexible endoscopicexamination of theupper airway, vocalcords and/or nasalpassages; and for use indiagnostic arthroscopicand endoscopicprocedures to provideillumination andvisualization of theinterior cavity of thebody through either anatural or surgicalopening. | The NeoGuide NavigatorEndoscopy System isintended to providevisualization anddiagnostic/therapeuticaccess to the adult lowergastrointestinal tract(including, but notlimited to, the anus,rectum, sigmoid colon,colon, cecum, andileocecal valve) forendoscopy andendoscopic surgery. |
| Flex System[K150776] | Vision-Sciences System[K072073] | Vision-Sciences System[K102733] | NeoGuide System[K052930, K070622] | |
| OperationalPrinciples | Cable-steered CMOS-based video endoscopeusing electromechanicalcontrols driven from aconsole-based, computer-controlled physicianhandle. | A cable-steered flexible video laryngoscope withCCD-based imaging allowing for high resolutionpicture quality. | A cable-steered flexible video laryngoscope withCCD-based imaging allowing for high resolutionpicture quality. | Cable-steered endoscopeusing electromechanicalcontrols on the handledistal tip CCD cameraand tool channels forinstrument-basedtherapeutic procedures,valves for air insufflation,water irrigation, andsuction. |
| Rigidity | Flexible/semi-rigidendoscope. | Continuously flexible endoscope. | Continuously flexible endoscope. | Flexible/semi-rigidendoscope. |
| Advance/Retract | Electromechanicallyaided with physiciancontroller on console. | Manual. | Manual. | Manual. |
| Steering | Electromechanicaljoystick controls (thePhysician Controller) ona console aid steering. | Manual control. | Manual control. | Electromechanicaljoystick controls on thehandle of the scope aidsteering. |
| Direct Visualization | Yes, during the entireprocedure. | Yes, during the entire procedure. | Yes, during the entire procedure. | Yes, during the entireprocedure. |
| Flex System[K150776] | Vision-Sciences System[K072073] | Vision-Sciences System[K102733] | NeoGuide System[K052930, K070622] | |
| Multi-SegmentedEndoscopeStructure | Yes. | One continuously extruded flexible structure. | Yes. | |
| Semi-Rigid Followthe Leader/GuidingFunction | Yes. | No, manual. | Yes. | |
| ElectromechanicallyCable-Driven/ControlledSegments | Yes. | No, manual. | Yes. | |
| 3D FlexibleMovements and TipOrientation | Yes. | Yes. | Yes. | |
| Haptic Feedback toUser | Yes. | No. | No. | |
| Fluid Lumen | Yes. | Yes. | Yes. | |
| WorkingChannel(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/OpticalSensor | Lens/solid state camera(CMOS). | Lens/solid state camera(CCD). | Lens/solid state camera(CCD). | |
| Light Source | LED. | LED. | LED. | |
| Video ImageProcessing | Video data display, | Video data display, | Video data display, | |
| Biocompatibility | Patient contactingmaterials have beenshown to bebiocompatible aftertesting to ISO 10993. | Patient contacting materials have been shown to bebiocompatible after testing to ISO 10993. | Patient contactingmaterials have beenshown to bebiocompatible aftertesting to ISO 10993. | |
| Sterilization | The Flex Scope isprovided sterile. Thereusable components ofthe Flex System areprovided clean/non-sterile. | Sheath for scope provided sterile. | Provided clean/non-sterile. | |
| Electrical Safetyand EMC | Passed the applicableelectrical safetyrequirements of IEC60601-1-2 and IEC60601-1. | Passed. | Passed. |
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§ 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.