Third Eye Panoramic Auxiliary Endoscopy System - Resposable
K160356 · Avantis Medical Systems, Inc. · FDF · May 17, 2016 · Gastroenterology, Urology
Device Facts
Record ID
K160356
Device Name
Third Eye Panoramic Auxiliary Endoscopy System - Resposable
Applicant
Avantis Medical Systems, Inc.
Product Code
FDF · Gastroenterology, Urology
Decision Date
May 17, 2016
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
The Avantis Medical Systems, Inc. Third Eye Panoramic Auxiliary Endoscopy System - Resposable is indicated for use as an accessory to a conventional colonoscope to provide additional visualization and illumination of the colon for diagnostic purposes.
Device Story
The Third Eye Panoramic Auxiliary Endoscopy System - Resposable (TEPR) is an accessory device for standard colonoscopes; it attaches to the distal end of a colonoscope via a flexible clip. The device features two lateral-facing cameras and LED light sources; it provides continuous left-side and right-side views of the colon. These lateral views supplement the forward-facing view of the colonoscope. Images from the colonoscope and the TEPR are displayed simultaneously on three separate monitors, creating a panoramic view of approximately 310°. The system is used by endoscopists during colonoscopy procedures. The device remains in place during biopsies or polypectomies. By providing lateral and partial retrograde visualization, the device assists the endoscopist in navigating the colon, potentially reducing patient discomfort and the risk of perforation by allowing better tip deflection decisions.
Clinical Evidence
No clinical data or animal testing was performed. Bench verification testing was conducted to confirm the modified device meets design inputs and performance requirements. Cleaning and disinfection procedures were validated to demonstrate effectiveness.
Technological Characteristics
The device consists of a catheter with two cameras and two LED light sources, plus video processors. The catheter shaft is constructed of MT3000 heat-shrunk onto Pellethane (or PTFE). The system provides a 310° total angle of view. It is designed for high-level disinfection and reuse. Connectivity is via cables to existing video processors.
Indications for Use
Indicated for use as an accessory to a conventional colonoscope to provide additional visualization and illumination of the colon for diagnostic purposes in patients undergoing colonoscopy.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
Third Eye Panoramic Auxiliary Endoscopy System (K140595)
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus with three intertwined snakes and three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2016
Avantis Medical Systems, Inc. Louis Fries Consultant, Regulatory Affairs and Quality Assurance 2367 Bering Drive San Jose, CA 95131
Re: K160356
Trade/Device Name: Third Eye Panoramic Auxiliary Endoscopy System - Resposable Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Codes: FDF, FDS Dated: March 29, 2016 Received: April 4, 2016
Dear Louis Fries,
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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,
# Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K160356
### Device Name
Third Eye® Panoramic™ Auxiliary Endoscopy System - Resposable
Indications for Use (Describe)
The Avantis Medical Systems, Inc. Third Eye Panoramic Auxiliary Endoscopy System - Resposable is indicated for use as an accessory to a conventional colonoscope to provide additional visualization and illumination of the colon for diagnostic purposes.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
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# 510(k) SUMMARY
#### a) Applicant Information:
| Date Summary Prepared | 08 February 2016 |
|--------------------------------------|-------------------------------------------------------------------|
| Sponsor/Submitter | Avantis Medical Systems, Inc. |
| | 2367 Bering Drive |
| | San Jose, CA 95131 |
| Correspondent<br>Contact Information | Louis Fries<br>Consultant, Regulatory Affairs & Quality Assurance |
| | Phone: 510-862-2034 |
| | Fax: 408-733-1847 |
| | E-mail: lfries@avantismedical.com |
#### b) Device Information:
| Device Common Name | Endoscope |
|--------------------------------------|------------------------------------------------------------------|
| Device Trade & Proprietary Name | Third Eye® Panoramic™ Auxiliary<br>Endoscopy System - Resposable |
| Device Classification Name | Endoscope & Accessories (per 21<br>CFR 876.1500) |
| Device Classification Regulation | 21 CFR 876.1500 |
| Device Classification | Class II |
| Device Classification & Product Code | FDF, FDS |
#### ldentification of Predicate Device: C)
The Avantis Third Eye Panoramic Device - Resposable (TEPR) is substantially equivalent in operation and fundamental scientific technology to its previous version, the single-use Panoramic Device, cleared under K140595.
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#### d) Device Description Summary:
The Third Eye Panoramic Auxiliary Endoscopy System - Resposable (consists of two main portions:
- Resposable Panoramic Device (catheter with cameras and LED light 1. sources at the distal end and connections to video processors at the proximal end) packaged and supplied as a non-sterile unit.
- 2. Facility Equipment: The non-disposable facility equipment portions of the device includes Third Eye Video Processors and cables (No change from predicate).
# Description
The TEPR is designed as an adjunct device for use with a standard colonoscope to provide lateral and partial retrograde visualization and illumination of the colon during a colonoscopy procedure. Prior to insertion of a standard colonoscope, the TEPR is attached to the distal end of the colonoscope with a flexible clip. The TEPR travels with the colonoscope and provides continuous left-side and right-side views of the colon that supplement the forward view of the colonoscope. The images from the colonoscope (forward) and the Panoramic Device (left and right lateral) are displayed simultaneously on three separate monitors, providing a panoramic image with a total angle of view of approximately 310° as shown schematically below.
Image /page/4/Figure/8 description: This image shows a diagram of a colonoscope with a panoramic device. The colonoscope is a long, thin tube that is inserted into the colon to view the lining. The panoramic device is attached to the end of the colonoscope and has two panoramic cameras that provide a wide-angle view of the colon. There is also a colonoscope camera at the end of the device.
The TEPR utilizes the same video processors as used in the predicate.
## Page 4-2
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#### e) Intended Use:
The Avantis Medical Systems, Inc. Third Eye Panoramic Auxiliary Endoscopy System - Resposable is indicated for use as an accessory to a conventional colonoscope to provide additional visualization and illumination of the colon for diagnostic purposes.
#### f) Substantial Equivalence:
The TEPR (the subject of this 510(k)) and the predicate single-use Third Eye Panoramic Auxiliary Endoscopy System (TEP) are both indicated for use with a colonoscope to provide visualization and illumination of the colon for diagnostic purposes using video camera(s).
The TEPR is indicated for the same use as the predicate device. Both utilize two cameras oriented laterally on the left and right sides of the device with angles of view that are sufficient to allow examination of the colonic mucosa in the lateral and backward directions.
Both the TEPR and predicate single-use TEP are inserted into the colon for viewing visualization and illumination and remain in place when the endoscopist is performing biopsies or polypectomies.
The TEPR contains the same cameras, and LED light sources as the predicate single-use TEP. It is constructed of the same materials as the predicate single-use TEP with the exception of the catheter shaft. The shaft of the TEPR is made of MT3000 heat-shrunk onto Pellethane (or Polytetrafluoroethylene (PTFE) as an equivalent alternate material) instead of Pebax used in the predicate device. The change was made to accommodate high-level disinfection.
The TEPR's left and right-lateral views, complementing the forward view of the colonoscope, may assist the endoscopist in determining the most appropriate direction to deflect the colonoscope's tip during intubation without excessive pressure against the wall of the colon, which may reduce patient discomfort and lower the risk of perforation of the colon.
The TEPR is substantially equivalent to the cleared predicate (single-use TEP) in fundamental design, materials of construction, manufacturing processes, and packaging.
The primary differences between the subject TEPR and the predicate single-use TEP are that the resposable TEPR is provided non-sterile, its shaft is made of MT3000 (or PTFE) instead of Pebax, and that it requires the user to perform a cleaning and disinfection procedure prior to first use and after each subsequent use.
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All changes from the predicate device have been subjected to risk analysis and have been verified to meet current design specifications.
#### Scientific Technology g)
The TEPR includes the Panoramic Device containing two cameras and two LED light sources, and two Video Processors. Modifications made to the device, change of shaft material from Pebax to MT3000 (or PTFE), did not change the fundamental scientific technology of the device which is to provide additional visualization and illumination of the colon during colonoscopy. The testing described demonstrates that the proposed TEPR does not raise any new or unresolved issues for safety and efficacy.
#### Summary of Supporting Non-Clinical Performance Data h)
No animal testing was performed. Bench verification testing was conducted to verify that the modified device meets the design inputs and intended performance requirements. Results demonstrate that the TEPR performs as intended. The cleaning and disinfection procedures were validated to demonstrate effectiveness.
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