(27 days)
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.
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 Eve 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 Eve 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 Eve 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 Eye Retroscope image.
The provided document is a 510(k) summary for the Avantis Medical Systems, Inc. Third Eye® Retroscope® Auxiliary Endoscopy System. This submission is a "Special 510(k)" indicating modifications to a previously cleared device (K091783).
Therefore, the primary focus of this document is to demonstrate that the modifications made to the device do not raise new issues of safety or effectiveness and that the modified device remains substantially equivalent to its predicate. The study described is bench verification testing rather than a clinical study assessing diagnostic performance against a ground truth.
Because this is a Special 510(k) for modifications to an existing device, a full clinical study with specific acceptance criteria related to diagnostic performance (like sensitivity, specificity, accuracy) using a human-in-the-loop or standalone algorithm performance on a clinical test set is not typically required or presented in such a submission. The focus is on demonstrating that the changes do not negatively impact safety or effectiveness.
Based on the provided information, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from 510(k) Summary) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Modified device meets design inputs and intended performance characteristics. | "Results demonstrate that the modified Third Eye Retroscope Auxiliary Endoscopy System performs as intended." |
| Modifications do not change the fundamental scientific technology of the device. | "Modifications made to the device and accessories did not change the fundamental scientific technology of the device." |
| Modifications do not raise any new or unresolved issues for safety and efficacy. | "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." |
| Support both standard and High Definition (HD) colonoscopes. | The modified Video Processor (VP) expands function to support both standard and HD colonoscopes. |
| Display standard and HD colonoscope images on a HD monitor. | The modified VP displays standard and HD colonoscope images on a HD monitor. |
| Smaller chassis to decrease footprint and improve aesthetics. | The VP was upgraded with a smaller chassis. |
| No changes in the function or capability of the VP result from chassis changes. | "No changes in the function or capability of the VP result from these changes." |
| No changes to disposable portions. | "No changes have been made to the disposable portions of the Third Eye system." |
| Substantially equivalent to the cleared predicate device in fundamental design, materials, processes, sterile barrier packaging, and sterilization. | "The modified device is substantially equivalent to the cleared predicate device in fundamental design, materials, processes, sterile barrier packaging, and sterilization." |
| All changes subjected to risk analysis and verified to meet current design specifications. | "All changes have been subjected to risk analysis and have been verified to meet current design specifications." |
| Minor changes to IFU as a result of VP modifications. | "Minor changes have been made to the IFU as a result of the modifications to the Video Processor." |
| Differences between modified and predicate have no impact on safety and effectiveness. | "Differences between the modified Third Eye System and the predicate device have no impact on safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "Bench verification testing." This typically involves laboratory-based tests of the device's hardware and software specifications, rather than clinical data from human subjects. Therefore, there is no human "test set" in the traditional sense of clinical data reported in this document. The testing is of the device's components and system functionality. If any data was used, it would likely be synthetic or internal test data generated to assess performance against engineering specifications. Data provenance is not applicable as this is not a study using retrospective or prospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the testing described is bench verification testing against engineering specifications, not a clinical study requiring expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
This is not applicable as there is no clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The document focuses on demonstrating substantial equivalence of the modified device through bench testing, not on assessing the improvement of human readers with AI assistance. The device itself is an auxiliary endoscopy system providing visualization, not an AI-assisted diagnostic tool in the typical sense of interpreting images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an auxiliary endoscopy system, not an AI algorithm performing standalone interpretation. Therefore, a standalone algorithm performance study was not done or reported. The device provides images to a physician, who then performs the interpretation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
As this was bench verification testing, the "ground truth" would be the design specifications and engineering requirements for the device's performance (e.g., video quality, illumination, mechanical movement, electrical functionality).
8. The Sample Size for the Training Set
This is not applicable as the device is not an AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is not an AI algorithm that requires a training set with established ground truth.
In summary: The provided 510(k) summary for the Third Eye® Retroscope® Auxiliary Endoscopy System describes modifications to a previously cleared device. The "study" mentioned is bench verification testing aimed at confirming that the modified device still meets its design specifications and intended performance, and that the changes do not introduce new safety or efficacy concerns, thus maintaining substantial equivalence to its predicate. It is not a clinical study involving human subjects or AI algorithm performance assessment.
{0}------------------------------------------------
d > medical systems
NOV - 5 2009
510(k) SUMMARY
Applicant Information: a)
| Date Summary Prepared | 08 October 2009 |
|---|---|
| Sponsor/Submitter | Avantis Medical Systems, Inc.263 Santa Ana CourtSunnyvale, CA 94085-4511 |
| Correspondent Contact Information | Amrita Sethi |
| Director of Regulatory and QualityAffairs | |
| 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® AuxiliaryEndoscopy 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 |
c) Identification of Predicate Device:
The Avantis Third Eye is substantially equivalent in operation and fundamental scientific technology to its previous version cleared under K091783.
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}------------------------------------------------
Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System
Ko93187
Pg 2 of 3
08 October 2009 Special 510(k)
The Third Eve 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 Eve 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 Eve 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 Eye Retroscope image.
-
Intended Use: e)
The Third Eve 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 Eve has been modified to
- a) Expand the function and capabilities of the Video Processor (VP) to support both standard and High Definition (HD) colonoscopes. The modified VP displays standard and HD colonoscope images on a HD monitor.
- b) Upgrade the VP with a smaller chassis to decrease the footprint and improve aesthetics. No changes in the function or capability of the VP result from these changes.
No changes have been made to the disposable portions 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.
Minor changes have been made to the IFU as a result of the modifications to the Video Processor.
Differences between the modified Third Eye System and the predicate device have no impact on safety and effectiveness.
263 Santa Ana Court, Sunnyvale, CA 94085 TEL: (408) 733-1901, FAX: (408) 733-1847
{2}------------------------------------------------
Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System
08 October 2009 Special 510(k)
Scientific Technology a)
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.
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 The present submission and statements therein therefore should not be construed as Patent Office. 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 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 the department's name arranged in a circular fashion around a stylized symbol. The symbol is composed of three abstract shapes that resemble a person embracing another person.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Amrita Sethi Director of Regulatory and Quality Affairs Avantis Medical Systems 263 Santa Ana Court SUNNYVALE CA 94085-4511
NOV - 5 2009
Re: K093187
Trade/Device Name: Third Eye® Retroscope® Auxiliary Endoscopy System (Third Eye) Regulation Number: 21 CFR 876.1500 . . .
Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: October 8, 2009 Received: October 9, 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 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}------------------------------------------------
Page 2 -
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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
[signature]
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): 40093187
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 X 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)
Page _ of
Hémm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
§ 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.