(99 days)
The Avantis Medical Systems, Inc. Third Eye Panoramic Auxiliary Endoscopy System - Resposable is indicated for use as an accessory to a conventional colonoscope to provide additional visualization and illumination of the colon for diagnostic purposes.
The Third Eye Panoramic Auxiliary Endoscopy System - Resposable consists of two main portions:
- Resposable Panoramic Device (catheter with cameras and LED light sources at the distal end and connections to video processors at the proximal end) packaged and supplied as a non-sterile unit.
- Facility Equipment: The non-disposable facility equipment portions of the device includes Third Eye Video Processors and cables (No change from predicate).
The TEPR is designed as an adjunct 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 TEPR is attached to the distal end of the colonoscope with a flexible clip. The TEPR 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 (forward) and the Panoramic Device (left and right lateral) 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 TEPR utilizes the same video processors as used in the predicate.
The provided text describes a medical device, the Third Eye Panoramic Auxiliary Endoscopy System - Resposable (TEPR), which is an accessory to a colonoscope for diagnostic purposes. The document is a 510(k) summary, indicating a submission to the FDA for market clearance based on substantial equivalence to a predicate device.
However, the document does not contain specific acceptance criteria, quantitative performance metrics, or detailed study results that would allow for the direct completion of the requested table and detailed study description. The summary states that "Bench verification testing was conducted to verify that the modified device meets the design inputs and intended performance requirements. Results demonstrate that the TEPR performs as intended. The cleaning and disinfection procedures were validated to demonstrate effectiveness." This is a general statement and lacks the specific data points requested.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's an attempt to answer the questions based only on the provided text, with explicit notation where information is missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance (Quantitative/Qualitative) |
|---|---|
| Meets design inputs and intended performance requirements | "Results demonstrate that the TEPR performs as intended." |
| Effective cleaning and disinfection procedures | "The cleaning and disinfection procedures were validated to demonstrate effectiveness." |
| Provides additional visualization and illumination of the colon for diagnostic purposes | "Provides continuous left-side and right-side views of the colon that supplement the forward view of the colonoscope, providing a panoramic image with a total angle of view of approximately 310°." |
| No new or unresolved issues for safety and efficacy | "The testing described demonstrates that the proposed TEPR does not raise any new or unresolved issues for safety and efficacy." |
| Compatibility with standard colonoscope | "Designed as an adjunct device for use with a standard colonoscope." |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified in the provided text.
- Data provenance: Not explicitly stated, but the submission is for FDA clearance in the USA. The testing mentioned is "Bench verification testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text. The document refers to "Bench verification testing" rather than human-reader studies requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no expert-adjudicated test set is described.
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 MRMC comparative effectiveness study is mentioned. The device is an "Auxiliary Endoscopy System," and the document focuses on its technical performance and safety, not on AI assistance or human reader improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device itself is an auxiliary visualization system, not an algorithm. Therefore, "standalone (algorithm only)" is not directly applicable. The device's performance is inherently tied to its use by a human endoscopist. The document mentions "Bench verification testing" for the device's technical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "Bench verification testing," the ground truth likely refers to engineering specifications and performance standards rather than clinical "ground truth" like pathology. The document does not specify the exact nature of this "ground truth." For the cleaning and disinfection validation, the ground truth would be microbiological standards.
8. The sample size for the training set:
- Not applicable. This device is a hardware endoscopy accessory, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is a hardware endoscopy accessory, not an AI algorithm that requires a training set.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus with three intertwined snakes and three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2016
Avantis Medical Systems, Inc. Louis Fries Consultant, Regulatory Affairs and Quality Assurance 2367 Bering Drive San Jose, CA 95131
Re: K160356
Trade/Device Name: Third Eye Panoramic Auxiliary Endoscopy System - Resposable Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Codes: FDF, FDS Dated: March 29, 2016 Received: April 4, 2016
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,
Benjamin R. Fisher -S
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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Indications for Use
510(k) Number (if known) K160356
Device Name
Third Eye® Panoramic™ Auxiliary Endoscopy System - Resposable
Indications for Use (Describe)
The Avantis Medical Systems, Inc. Third Eye Panoramic Auxiliary Endoscopy System - Resposable is indicated for use as an accessory to a conventional colonoscope to provide additional visualization and illumination of the colon for diagnostic purposes.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
a) Applicant Information:
| Date Summary Prepared | 08 February 2016 |
|---|---|
| Sponsor/Submitter | Avantis Medical Systems, Inc. |
| 2367 Bering Drive | |
| San Jose, CA 95131 | |
| CorrespondentContact Information | Louis FriesConsultant, Regulatory Affairs & Quality Assurance |
| Phone: 510-862-2034 | |
| Fax: 408-733-1847 | |
| E-mail: lfries@avantismedical.com |
b) Device Information:
| Device Common Name | Endoscope |
|---|---|
| Device Trade & Proprietary Name | Third Eye® Panoramic™ AuxiliaryEndoscopy System - Resposable |
| Device Classification Name | Endoscope & Accessories (per 21CFR 876.1500) |
| Device Classification Regulation | 21 CFR 876.1500 |
| Device Classification | Class II |
| Device Classification & Product Code | FDF, FDS |
ldentification of Predicate Device: C)
The Avantis Third Eye Panoramic Device - Resposable (TEPR) is substantially equivalent in operation and fundamental scientific technology to its previous version, the single-use Panoramic Device, cleared under K140595.
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d) Device Description Summary:
The Third Eye Panoramic Auxiliary Endoscopy System - Resposable (consists of two main portions:
- Resposable Panoramic Device (catheter with cameras and LED light 1. sources at the distal end and connections to video processors at the proximal end) packaged and supplied as a non-sterile unit.
-
- Facility Equipment: The non-disposable facility equipment portions of the device includes Third Eye Video Processors and cables (No change from predicate).
Description
The TEPR is designed as an adjunct 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 TEPR is attached to the distal end of the colonoscope with a flexible clip. The TEPR 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 (forward) and the Panoramic Device (left and right lateral) 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/8 description: This image shows a diagram of a colonoscope with a panoramic device. The colonoscope is a long, thin tube that is inserted into the colon to view the lining. The panoramic device is attached to the end of the colonoscope and has two panoramic cameras that provide a wide-angle view of the colon. There is also a colonoscope camera at the end of the device.
The TEPR utilizes the same video processors as used in the predicate.
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e) Intended Use:
The Avantis Medical Systems, Inc. Third Eye Panoramic Auxiliary Endoscopy System - Resposable 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 TEPR (the subject of this 510(k)) and the predicate single-use Third Eye Panoramic Auxiliary Endoscopy System (TEP) are both indicated for use with a colonoscope to provide visualization and illumination of the colon for diagnostic purposes using video camera(s).
The TEPR is indicated for the same use as the predicate device. Both utilize 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.
Both the TEPR and predicate single-use TEP are inserted into the colon for viewing visualization and illumination and remain in place when the endoscopist is performing biopsies or polypectomies.
The TEPR contains the same cameras, and LED light sources as the predicate single-use TEP. It is constructed of the same materials as the predicate single-use TEP with the exception of the catheter shaft. The shaft of the TEPR is made of MT3000 heat-shrunk onto Pellethane (or Polytetrafluoroethylene (PTFE) as an equivalent alternate material) instead of Pebax used in the predicate device. The change was made to accommodate high-level disinfection.
The TEPR'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 TEPR is substantially equivalent to the cleared predicate (single-use TEP) in fundamental design, materials of construction, manufacturing processes, and packaging.
The primary differences between the subject TEPR and the predicate single-use TEP are that the resposable TEPR is provided non-sterile, its shaft is made of MT3000 (or PTFE) instead of Pebax, and that it requires the user to perform a cleaning and disinfection procedure prior to first use and after each subsequent use.
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All changes from the predicate device have been subjected to risk analysis and have been verified to meet current design specifications.
Scientific Technology g)
The TEPR includes the Panoramic Device containing two cameras and two LED light sources, and two Video Processors. Modifications made to the device, change of shaft material from Pebax to MT3000 (or PTFE), 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 TEPR does not raise any new or unresolved issues for safety and efficacy.
Summary of Supporting Non-Clinical Performance Data h)
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 TEPR performs as intended. The cleaning and disinfection procedures were validated to demonstrate effectiveness.
§ 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.