(255 days)
No
The description focuses on providing additional visualization through multiple cameras and displaying the images simultaneously. There is no mention of any processing or analysis of these images using AI or ML techniques.
No
The device is described as an accessory to a colonoscope for diagnostic purposes, providing additional visualization and illumination for detecting lesions. It is not indicated for treating any condition or disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as an accessory to a conventional colonoscope to provide additional visualization and illumination of the colon for diagnostic purposes." This directly indicates its role in diagnosis.
No
The device description explicitly details disposable hardware components (catheter with cameras and LED lights, water module) and non-disposable facility equipment (video processors and cables), indicating it is not a software-only device.
Based on the provided information, the Avantis Medical Systems, Inc. Third Eye Panoramic Auxiliary Endoscopy System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to analyze these samples outside of the body.
- Device Function: The Third Eye Panoramic Auxiliary Endoscopy System is a device used inside the body during a colonoscopy procedure. It provides additional visualization and illumination of the colon.
- Intended Use: The intended use is for "diagnostic purposes" but this refers to the visual diagnosis made by the endoscopist based on the images provided by the device, not an analysis of a biological sample.
- Device Description: The description clearly outlines a system with cameras, light sources, and a water module that is attached to a colonoscope and used within the colon.
Therefore, the device is an in vivo diagnostic or imaging device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FDF, FDS
Device Description
Third Eye Panoramic Auxiliary Endoscopy System consists of two main portions:
- Disposable device components packaged and supplied together as a single-use sterilized unit.
- The Panoramic Device: (catheter with cameras and LED light sources at the distal end and connection to video processors at the proximal end)
- 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.
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
colon
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench verification testing: 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.
Clinical Feasibility Study: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K070330, K083180, K091783, K093187
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping heads suggesting community and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
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
1
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
2
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)
Page __ of ___________________________________________________________________________________________________________________________________________________________________
Page 3-1
3
510(k) SUMMARY
a) Applicant Information:
| Date Summary Prepared | 17 November 2014 |
|---|---|
| Sponsor/Submitter | Avantis Medical Systems, Inc. |
| 263 Santa Ana Court | |
| Sunnyvale, CA 94085-4511 | |
| Correspondent Contact Information | Louis Fries |
| Consultant Regulatory Affairs | |
| Phone: 510-862-2034 | |
| Fax: 408-733-1847 | |
| E-mail: lfries@avantismedical.com |
Salmaan Hameed
Vice President Research and
Development
Phone: 408-826-9740
Fax: 408-733-1847
E-mail: shameed@avantismedical.com |
b) Device Information:
| Device Common Name | Endoscope |
|---|---|
| Device Trade & Proprietary Name | Third Eye® Panoramic™ Auxiliary |
| Endoscopy System (Third Eye) | |
| Device Classification Name | Endoscope & Accessories (per |
| 21CFR 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.
4
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.
Page 4-3
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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.