(255 days)
The Avantis Medical Systems, Inc. Third Eye Panoramic Auxiliary Endoscopy System is indicated for use as an accessory to a conventional colonoscope to provide additional visualization and illumination of the colon for diagnostic purposes.
Third Eye Panoramic Auxiliary Endoscopy System consists of two main portions:
- Disposable device components packaged and supplied together as a 1. single-use sterilized unit.
- a. The Panoramic Device: (catheter with cameras and LED light sources at the distal end and connection to video processors at the proximal end)
- b. Attached Water Module to rinse the camera lenses: (catheter with water rinse sprayer distal end and connection to water source at the proximal end)
-
- Facility Equipment: The non-disposable facility equipment portions of the device include two Third Eye Video Processors and cables (No change from predicate except for a minor label change).
The Panoramic Device is designed as an accessory 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 Panoramic Device (including the Water Module) is attached to the distal end of the colonoscope with a flexible clip. The Panoramic Device 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 and the Panoramic Device are displayed simultaneously on three separate monitors, providing a panoramic image with a total angle of view of approximately 310° as shown schematically below.
Here's a breakdown of the acceptance criteria and study information for the Third Eye Panoramic Auxiliary Endoscopy System, based on the provided document:
This device is not an AI/ML device, therefore, many of the typical acceptance criteria and study components related to AI/ML devices (e.g., standalone performance, MRMC studies, training set details) are not applicable. The device is an accessory to a colonoscope that provides additional visualization.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is not an AI/ML device, the acceptance criteria are focused on the device's functional performance, safety, and its ability to provide additional visualization without obstructing the colonoscope. The document does not explicitly state quantitative acceptance criteria in a table format, but rather describes the desired performance outcomes.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance: | |
| Provide additional visualization and illumination of the colon. | The Panoramic Device provides continuous left-side and right-side views that supplement the forward view of the colonoscope. Images from both devices are displayed simultaneously, offering a panoramic image with a total angle of view of approximately 310°. The side-viewing cameras were useful for detecting lesions not found in the colonoscope’s forward view. |
| Maintain colonoscope function and not interfere with its operation. | The presence of the Third Eye Panoramic Device did not interfere with any of the functions of the colonoscope. Its external attachment allows the colonoscope channel to remain unobstructed, facilitating use during both intubation and withdrawal, and permitting biopsies or polypectomies without removal. |
| Assist in determining colonoscope deflection. | The left and right-lateral views assist the endoscopist in determining the most appropriate direction to deflect the colonoscope’s tip during intubation, potentially reducing patient discomfort and perforation risk. |
| Safety: | |
| Meet design specifications and safety requirements. | Bench verification testing demonstrated that the modified device meets design inputs and intended performance requirements. All changes from the predicate device were subjected to risk analysis and verified to meet current design specifications. |
| No new or unresolved issues for safety and efficacy. | The testing described demonstrates that the proposed Third Eye Panoramic Auxiliary Endoscopy System does not raise any new or unresolved issues for safety and efficacy. |
| Operability: | |
| Simplification of operation compared to predicate. | The Panoramic Device reduces the complexity of setup and simplifies operability compared to the Retroscope (predicate) by being externally attached to the colonoscope rather than inserted through its channel. This allows it to remain in place during various procedure phases and when instruments are used. Results from the feasibility study supported the operability of the device. |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to a clinical feasibility study for performance and operability.
- Sample Size: Initial 17 subjects.
- Data Provenance: Conducted at New York Hospital Queens Medical Center (USA). This indicates prospective data collection from a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or qualifications of "experts" used to establish ground truth in the context of lesion detection for the 17-subject feasibility study. For a device like this, the "ground truth" would implicitly be the clinical findings made by the performing endoscopist(s) during the colonoscopy procedures, potentially confirmed by pathology for detected lesions. The document only mentions that the side-viewing cameras were useful for detecting lesions that were not found in the colonoscope's forward view, implying that clinicians using the device made these observations.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method for the test set. Given this was a feasibility study for an accessory device, the assessment of usefulness and non-interference likely came from the endoscopist(s) performing the procedures, integrated into their clinical decision-making.
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, an MRMC study was not done for this device. This is not an AI/ML device; it is a mechanical and optical accessory providing additional visualization. Therefore, metrics like "human readers improve with AI vs. without AI assistance" are not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone study was not done. This device is an accessory that enhances human visualization; it does not operate as a standalone algorithm.
7. The Type of Ground Truth Used
For the clinical feasibility study, the "ground truth" for the device's performance regarding lesion detection would be the clinical findings and observations made by the endoscopist during the procedures, potentially corroborated by pathology results for any detected and biopsied lesions. The key finding mentioned, "side-viewing cameras were useful for detecting lesions that were not found in the colonoscope's forward view," suggests that the ground truth was the actual presence of lesions identified by the physician using the device.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware accessory with optical components, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable. As established, there is no training set for this type of device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2014
Avantis Medical Systems, Inc. Louis Fries Consultant, Regulatory Affairs 263 Santa Ana Court Sunnyvale, CA 97085-4511
Re: K140595
Trade/Device Name: Third Eye Panoramic Auxiliary Endoscopy System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDF, FDS Dated: October 3, 2014 Received: October 6, 2014
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,
Herbert P.
Lerner -S
for 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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SECTION 3
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K140595
Device Name: Third Eye® Panoramic™ Auxiliary Endoscopy System
Indications for Use: The Avantis Medical Systems, Inc. Third Eye Panoramic Auxiliary Endoscopy System is indicated for use as an accessory to a conventional colonoscope to provide additional visualization and illumination of the colon for diagnostic purposes.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) SUMMARY
a) Applicant Information:
| Date Summary Prepared | 17 November 2014 |
|---|---|
| Sponsor/Submitter | Avantis Medical Systems, Inc.263 Santa Ana CourtSunnyvale, CA 94085-4511 |
| Correspondent Contact Information | Louis FriesConsultant Regulatory AffairsPhone: 510-862-2034Fax: 408-733-1847E-mail: lfries@avantismedical.comSalmaan HameedVice President Research andDevelopmentPhone: 408-826-9740Fax: 408-733-1847E-mail: shameed@avantismedical.com |
b) Device Information:
| Device Common Name | Endoscope |
|---|---|
| Device Trade & Proprietary Name | Third Eye® Panoramic™ AuxiliaryEndoscopy System (Third Eye) |
| Device Classification Name | Endoscope & Accessories (per21CFR 876.1500) |
| Device Classification Regulation | 21CFR 876.1500 |
| Device Classification | Class II (special controls) |
| Device Classification & Product Code | FDF, FDS |
ldentification of Predicate Device: C)
The Avantis Third Eye Panoramic Device (Panoramic Device) is substantially equivalent in operation and fundamental scientific technology to its previous version, the Retroscope, cleared under K070330, K083180, K091783 and K093187.
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Device Description Summary: d)
Third Eye Panoramic Auxiliary Endoscopy System consists of two main portions:
- Disposable device components packaged and supplied together as a 1. single-use sterilized unit.
- a. The Panoramic Device: (catheter with cameras and LED light sources at the distal end and connection to video processors at the proximal end)
- b. Attached Water Module to rinse the camera lenses: (catheter with water rinse sprayer distal end and connection to water source at the proximal end)
-
- Facility Equipment: The non-disposable facility equipment portions of the device include two Third Eye Video Processors and cables (No change from predicate except for a minor label change).
Description
The Panoramic Device is designed as an accessory 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 Panoramic Device (including the Water Module) is attached to the distal end of the colonoscope with a flexible clip. The Panoramic Device 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 and the Panoramic Device 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/10 description: This image shows a diagram of a colonoscope with a colonoscope camera, panoramic cameras, and a panoramic device. The colonoscope camera is located at the top of the device, and the panoramic cameras are located on either side of the device. The panoramic device is located below the panoramic cameras. The colonoscope is located at the bottom of the device.
Image /page/4/Figure/11 description: The image shows the text "Page 4-2" in a simple, sans-serif font. The text is black against a white background. The words are arranged horizontally, with "Page" on the left, followed by the number "4-2".
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The Third Eye Video Processor was previously cleared under 510(k) K070330, K083180, K091783, and K093187 is unchanged for the purposes of this submission except for a minor labeling change (removal of the word "Retroscope" to allow for use with both the Retroscope and the Panoramic devices).
e) Intended Use:
The Avantis Medical Systems, Inc. Third Eye Panoramic Auxiliary Endoscopy System 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 Panoramic Device (the subject of this 510(k)) and the predicate Retroscope are both indicated for use with a colonoscope to provide visualization and illumination of the colon for diagnostic purposes using video camera(s).
The Panoramic Device is indicated for the same use as the predicate device except it utilizes 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.
The predicate Retroscope is inserted through the channel of the colonoscope after the colonoscope has been advanced to the cecum. The Retroscope cannot be used during the intubation phase and must be removed from the colonoscope channel every time a snare or forceps is inserted through the channel to perform a polypectomy or biopsy.
Like the Retroscope, the Panoramic Device is inserted into the colon for viewing visualization and illumination. However, the Panoramic Device is attached externally to the distal end of the colonoscope rather than passing through the colonoscope's instrument channel like the Retroscope.
The Panoramic Device reduces the complexity of the set up and simplifies operability compared to the Retroscope.
Since the colonoscope channel remains unobstructed, this configuration allows the Panoramic Device to be used during both the intubation and withdrawal phases of the colonoscopy procedure and it can remain in place even when the endoscopist is performing biopsies or polypectomies.
The Panoramic Device is constructed of the same materials as the predicate Retroscope with the addition of a new medical grade epoxy adhesive. The Panoramic Device utilizes the same camera, LED light source, and Video Processor as the Retroscope. Because the Panoramic Device utilizes two cameras, a second, identical video processor is required.
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The Panoramic Device'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 Panoramic Device is substantially equivalent to the cleared predicate (Retroscope) in fundamental design, materials of construction, manufacturing processes, packaging (including sterile barrier packaging) and sterilization. All changes have been subjected to risk analysis and have been verified to meet current design specifications.
Scientific Technology g)
The Third Eye Panoramic Auxiliary Endoscopy System includes the Panoramic Device containing two cameras and two LED light sources, an attached Water Module, and two Video Processors. Modifications made to the device and accessories 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 Third Eye Panoramic Auxiliary Endoscopy System does not raise any new or unresolved issues for safety and efficacy.
h) Summary of Supporting Non-Clinical Performance Data
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 modified Third Eye Panoramic Auxiliary Endoscopy System performs as intended.
i) Summary of Supporting Clinical Feasibility Data
Results from a feasibility study conducted at New York Hospital Queens Medical Center support performance and operability of the device. Results for the initial 17 subjects indicate that presence of the Third Eye Panoramic Device did not interfere with any of the functions of the colonoscope and that the side-viewing cameras were useful for detecting lesions that were not found in the colonoscope's forward view. See Section 7.
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.