(107 days)
Not Found
No
The description focuses on the mechanical and optical function of the device (retrograde illumination and visualization) and basic image adjustments. There is no mention of automated analysis, detection, or interpretation of images using AI/ML.
No
The device is indicated for diagnostic purposes and enhances visualization during colonoscopy, which aids in detection rather than treatment of diseased tissue.
Yes.
The "Intended Use / Indications for Use" states that the device is used 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), indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- Device Function: The Third Eye System is used during a colonoscopy procedure to provide additional visualization inside the colon. It is a device that directly interacts with the patient's anatomy for diagnostic purposes through imaging, not by analyzing samples taken from the body.
- Intended Use: The intended use clearly states "to provide retrograde illumination and visualization of the colon for diagnostic purposes." This is a direct diagnostic method performed within the body.
Therefore, the Third Eye System falls under the category of a diagnostic imaging device used during an endoscopic procedure, not an In Vitro Diagnostic device.
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
FDF, FDS, KNW, KOG, ODA
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 during a colonoscopy procedure. After a colonoscope has been advanced to the cecurn, 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 Eve 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 Eve Retroscope image.
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
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)
Results from a prospective, multi-center post-market study demonstrate that retrograde viewing of the colon with the Third Eye improves the detection of polyps and adenomas compared to traditional colonoscopy alone. Results were statistically significant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K 0831.80
Image /page/0/Picture/1 description: The image shows the logo for Avantis Medical Systems. The logo consists of the word "avantis" in lowercase letters, with the words "medical systems" in smaller letters below it. Above the word "avantis" is a stylized graphic that appears to be two curved shapes with a circle in the middle.
510(k) SUMMARY
FEB 1 2 2009
Applicant Information: a)
| Date Summary Prepared | 09 February 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 |
Device Information: b)
| 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 K070330.
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.
The Third Eye is designed as an auxiliary device for use during a colonoscopy
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Image /page/1/Picture/1 description: The image shows the logo for Avantis Medical Systems. The logo features the word "avantis" in a lowercase sans-serif font, with the words "medical systems" in a smaller font below. Above the word "avantis" is a graphic of two curved shapes facing each other with a circle in the middle.
procedure. After a colonoscope has been advanced to the cecurn, 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 Eve 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 Eve 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 a) accommodate additional conventional colonoscope models and brands, b) provide product enhancements, c) improve manufacturability, and d) update software. 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.
The IFU has been updated to a) add clinical data, b) clarify procedural directions based on the clinical experiences and c) expand the indications for use based on clinical data demonstrating that the Third Eye used with a traditional colonoscope improves detection of polyps and adenomas during colonoscopy as compared to the use of a colonoscope alone.
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
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Image /page/2/Picture/0 description: The image shows the logo for Avantis Medical Systems. The logo features the word "avantis" in lowercase letters, with the words "medical systems" underneath. Above the word "avantis" is a graphic of two curved shapes that are connected by a circle in the middle.
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accessories do not raise any new or unresolved issues for safety and efficacy.
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 modifications made to the Third Eve design performs as intended.
Summary of Supporting Clinical Data i)
Results from a prospective, multi-center post-market study demonstrate that retrograde viewing of the colon with the Third Eye improves the detection of polyps and adenomas compared to traditional colonoscopy alone. Results were statistically significant.
Conclusions j)
Avantis Medical Systems, Inc. has determined, based on clinical data, that the Third Eye improves the detection of polyps and adenomas in patients for whom colonoscopies are indicated. Risks to patients in terms of adverse events are comparable to those reported in the literature for traditional screening colonoscopies. Use of the Third Eye did not increase the risks to the patients but offered a statistically significant benefit of improved detection. Results of the clinical study are included in the Instructions for Use.
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 therefore should not be construed as affecting or relating to the scope of any 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 Ct., Sunnyvale, CA 94085 TEL: (408) 733-1901, FAX: (408) 733-1847
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2009
Ms. Amrita Sethi Director of Regulatory and Quality Affairs Avantis Medical Systems, Inc. 263 Santa Ana Court SUNNYVALE CA 94085-4511.
Re: K083180
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 and ODA Dated: February 4, 2009 Received: February 5, 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, listing 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 such 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; 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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.suppot/index.html.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K083180
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 - AND/OR (Part 21 CFR 801 Subpart D) (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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Qubuthemen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.