(20 days)
Not Found
No
The description focuses on hardware and basic image processing adjustments (light intensity, picture settings). There is no mention of AI, ML, or any advanced image analysis beyond simple display and adjustment.
No
The device is indicated for diagnostic purposes, providing visualization of the colon, rather than treating a disease or condition.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is for "diagnostic purposes".
No
The device description explicitly states that the system consists of both disposable portions (Retroscope and Caps) and facility equipment (Video Processor and accessories), which are hardware components. While there is application software, it runs on the Video Processor hardware.
Based on the provided information, the Avantis Medical Systems, Inc. Third Eye is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide retrograde illumination and visualization of the colon for diagnostic purposes during a colonoscopy procedure. This is a direct examination of the internal anatomy of a living patient.
- Device Description: The device is described as an auxiliary device used with a colonoscope and inserted into the instrument channel. It provides a visual image of the colon.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens taken from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a person's health. The Third Eye does not process or analyze such specimens. It directly visualizes the internal anatomy.
The device is clearly an in vivo diagnostic imaging device used during a medical procedure on a living patient.
N/A
Intended Use / Indications for Use
The Third Eye Retroscope is intended for use in the instrument channel of a conventional colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.
The Avantis Medical Systems, Inc. Third Eye is indicated for use in the instrument channel of a conventional colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.
Product codes (comma separated list FDA assigned to the subject device)
FDF, FDS, KNW, KOG
Device Description
The Third Eye System consists of both disposable portions and facility equipment. The disposable portions include the Third Eye Retroscope and Caps. The facility equipment portions of the device include the Third Eye Video Processor and accessories.
The Third Eye is designed as an auxiliary device for use with a colonoscope during a colonoscopy procedure. After a colonoscope has been advanced to the cecum, the Third Eye Retroscope is inserted through the instrument channel of the colonoscope. As the Third Eye Retroscope emerges from the distal tip of the instrument channel of the colonoscope, it automatically bends 180 degrees to form a "J" shape. The Third Eye then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope.
The Third Eye Video Processor is a piece of electrical equipment that acts as an interface for the Third Eye Retroscope, the video output signals, and user input controls. The output video signals from the Video Processor are displayed on a monitor for viewing by the physician. Application software that runs on the Video Processor allows the user to adjust the light intensity and various picture settings of the Third Eye Retroscope image.
Mentions image processing
Yes
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
Physician
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 was conducted to verify that the modified device meets the design inputs and intended performance characteristics. Results demonstrate that the modified Third Eye Retroscope Auxiliary Endoscopy System performs as intended.
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.
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
K091783
py 1 of 3
JUL - 7 2009
510(k) SUMMARY
n medical systems
ਹੈ
ಗು V
Applicant Information: a)
| Date Summary Prepared | 15 June 2009 |
|---|---|
| Sponsor/Submitter | Avantis Medical Systems, Inc. |
| 263 Santa Ana Court | |
| Sunnyvale, CA 94085-4511 | |
| Correspondent Contact Information | Amrita Sethi |
| Director of Regulatory and Quality | |
| Affairs | |
| Phone: 408-733-1901 x227 | |
| Fax: 408-733-1847 | |
| E-mail: asethi@avantismedical.com |
b) Device Information:
| Device Common Name | Endoscope |
|---|---|
| Device Trade & Proprietary Name | Third Eye® Retroscope® Auxiliary |
| Endoscopy System (Third Eye) | |
| Device Classification Name | Colonoscope (per 21CFR 876.1500) |
| Device Classification Regulation | 21CFR 876.1500 |
| Device Classification | Class II (special controls) |
| Device Classification & Product Code | FDF, FDS, KNW, KOG |
Identification of Predicate Device: c)
The Avantis Third Eye is substantially equivalent in operation and fundamental scientific technology to its previous version cleared under K083180.
d) Device Description Summary:
The Third Eye System consists of both disposable portions and facility equipment. The disposable portions include the Third Eye Retroscope and Caps. The facility equipment portions of the device include the Third Eye Video Processor and accessories.
1
K 091783
pg 2 of 3
15 June 2009 Special 510(k)
The Third Eye is designed as an auxiliary device for use with a colonoscope during a colonoscopy procedure. After a colonoscope has been advanced to the cecum, the Third Eye Retroscope is inserted through the instrument channel of the colonoscope. As the Third Eye Retroscope emerges from the distal tip of the instrument channel of the colonoscope, it automatically bends 180 degrees to form a "J" shape. The Third Eye then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope.
The Third Eye Video Processor is a piece of electrical equipment that acts as an interface for the Third Eye Retroscope, the video output signals, and user input controls. The output video signals from the Video Processor are displayed on a monitor for viewing by the physician. Application software that runs on the Video Processor allows the user to adjust the light intensity and various picture settings of the Third Eye Retroscope image.
Intended Use: e)
The Third Eye Retroscope is intended for use in the instrument channel of a conventional colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.
Discussion of Substantial Equivalence to Predicate Device: f)
The Third Eye has been modified to change the hydrophilic coating on the camera polarizer from a Surmodics-manufactured hydrogel to a Hydromer-manufactured hydrogel. No changes have been made to the facility equipment portion of the Third Eye system. The modified device is substantially equivalent to the cleared predicate device in fundamental design, materials, processes, sterile barrier packaging, and sterilization. All changes have been subjected to risk analysis and have been verified to meet current design specifications.
Differences between the modified Third Eye System and the predicate device have no impact on safety and effectiveness.
Scientific Technology g)
The Third Eye® Retroscope® Auxiliary Endoscopy System includes the Retroscope, a Video Processor, Cap and accessories. Modifications made to the device and accessories did not change the fundamental scientific technology of the device. The testing described demonstrates that the differences in the device components and accessories do not raise any new or unresolved issues for safety and efficacy.
263 Santa Ana Court, Sunnyvale, CA 94085 TEL: (408) 733-1901, FAX: (408) 733-1847
2
K 091783
Pg 3 of 3
15 June 2009
Special 510(k)
Summary of Supporting Non-Clinical Performance Data h)
Bench verification testing was conducted to verify that the modified device meets the design inputs and intended performance characteristics. Results demonstrate that the modified Third Eye Retroscope Auxiliary Endoscopy System performs as intended.
Any statement regarding "substantial equivalence" made in this 510(k) submission and summary only relates to whether the product addressed in this submission may be lawfully marketed without premarket approval or reclassification, and is not intended to be interpreted as an admission or any other type of evidence in any patent proceeding, including patent infringement, litigation or proceeding before any Patent Office. The present submission and statements therein therefore should not be construed as affecting or relating to the scope of any patent or patent application, or to whether the product addressed in this submission, or its use, may be considered indistinct, from a patentability perspective, from any of the other devices referenced in this filing.
263 Santa Ana Court, Sunnyvale, CA 94085 TEL: (408) 733-1901, FAX: (408) 733-1847
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2009
Ms. Amrita Sethi Director of Regulatory Affairs and Quality Affairs Avantis Medical Systems, Inc. 263 Santa Anna Court SUNNYVALE CA 94085-4511
Re: K091783
Trade/Device Name: Third Eye® Retroscope® Auxiliary Endoscopy System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: June 15, 2009 Received: June 17, 2009
Dear Ms. Sethi:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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
4
device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/cdrh/indr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ K 09 / 7 83
Device Name: Third Eye® Retroscope® Auxiliary Endoscopy System (Third Eye)
Indications for Use: The Avantis Medical Systems, Inc. Third Eye is indicated for use in the instrument channel of a conventional colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.
Prescription Use Over-The-Counter Use X - AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hula Cluss
Page I of 1
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _