The Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System is intended for use in the instrument channel of a standard colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.
The Third Eye Retroscope Auxiliary Endoscopy System is designed as an auxiliary device for use during a colonoscopy procedure. After a colonoscope has been advanced to the cecum, the Third Eye Retroscope auxiliary Endoscopy device is inserted through the instrument channel of the colonoscope. As the auxiliary device emerges from the distal tip of the instrument channel of the colonoscope, the auxiliary device automatically bends 180 degrees to form a "J" shape. The device then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope. The Third Eye Retroscope is deployed through the instrument channel of a colonoscope in what is commonly referred to as a mother-daughter configuration. As a result, only approximately 4 cm of the distal tip of the device protrudes from the distal end of the colonoscope's instrument channel except for a few seconds during insertion and removal, when up to 9 cm of the distal tip extends beyond the end of the colonoscope. Any contact of the device with the colonic mucosa is transitory. The system consists of both disposable portions, and facility equipment. The disposable portions include the Third Eye Retroscope and Cap. The Third Eye Retroscope is an endoscope that consists of a distal section, flexible insertion tube and proximal section. The distal section houses an imaging sensor, light source and related circuitry. The flexible insertion tube consists of a standard braided catheter with electrical wires located inside the lumen. These wires carry signals from the distal region to the proximal region. The proximal section includes a torquing knob, flexible wire extension region, and electrical connector. The Third Eye Cap with polarizing filter is placed on the distal end of the colonoscope. The facility equipment portions of the device include the Third Eye Retroscope Video Processor and accessories. The video processor is a piece of electrical equipment that acts as an interface box for the Third Eve 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 various picture settings of the Third Eye Retroscope image and adjust the light intensity of the Retroscope. Additionally, the software facilitates the capture of still images, the export of these still images, and allows a user to save system settings under a profile name.
This document is a 510(k) summary for the Avantis Medical Systems, Inc. Third Eye™ Retroscope™ Auxiliary Endoscopy System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design with performance metrics typically associated with AI/ML device evaluations.
Therefore, many of the requested data points (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, and ground truth for training set) are not applicable or not provided in this type of regulatory submission. This document predates the widespread use of sophisticated AI/ML in medical devices and the associated regulatory expectations for performance studies.
However, I can extract the available information related to performance and create a table for what is provided.
Here's the breakdown of the information based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices in terms of intended use, operation, materials, and safety through in vitro bench testing.
| Feature/Parameter | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as per submission) |
|---|---|---|
| Intended Use | "Indication for use" similar to predicate devices. | "Intended for use in the instrument channel of a standard colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes." This is deemed similar to the combined intended uses of the predicate devices for colonoscopy, with the difference being a retrograde view. |
| Operation | Similar operation to predicate devices (e.g., insertion method, image generation, control via video processor). | The Retroscope is inserted into the colonoscope's instrument channel similar to biopsy forceps. It provides images of the colon similar to a colonoscope, but with a retrograde view. Controlled by the Third Eye Video Processor similar to how a colonoscope is controlled by a Video System Center. |
| Materials | Similar materials to predicate devices. | (Not explicitly detailed in this summary, but presumed to be comparable to materials used in similar endoscopes/accessories to ensure biocompatibility and function). |
| Safety | Similar safety profile to predicate devices. | The device is evaluated through in vitro bench testing to demonstrate safety. Contact with colonic mucosa is described as transitory. |
| Imaging Performance | Equivalent "Imaging Performance" to predicate colonoscopes. | Provides retrograde illumination and visualization. The software allows adjustment of picture settings and light intensity. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only mentions "in vitro bench testing" without providing details on participants or specific datasets.
- Data Provenance: Not specified. Given it's "in vitro bench testing," it likely refers to laboratory testing and not human or animal study data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts/Qualifications: Not applicable/not specified. The testing described is "in vitro bench testing," which typically does not involve expert readers establishing ground truth for diagnostic accuracy in the way AI/ML systems are evaluated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/none specified. This type of adjudication is relevant for studies involving human interpretation and ground truth establishment, which isn't described here.
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
- MRMC Study: No. This document is for a traditional medical device (an auxiliary endoscope system), not an AI/ML diagnostic system. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The Third Eye Retroscope is an auxiliary endoscopy system used by a physician (human-in-the-loop). It's a visual aid, not an autonomous diagnostic algorithm. While it has "application software that runs on the video processor," this software adjusts picture settings and light intensity, and facilitates image capture, rather than providing autonomous diagnostic interpretations. The document refers to "in vitro bench testing" for performance evaluation, which is likely about image quality, functional integrity, and safety attributes of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated or required for this type of 510(k) submission which relies on substantial equivalence based on physical and functional characteristics of the device tested via "in vitro bench testing." For imaging performance, the "ground truth" would likely be objective measurements of image resolution, clarity, field of view, illumination, and mechanical reliability, compared against expected performance or established standards.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is not an AI/ML product developed using training datasets in the conventional sense. Its "application software" serves control and display functions, not machine learning.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable for the reasons mentioned above.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Avantis Medical System, Inc. Mr. Scott Rutherford Director of Regulatory and Quality Affairs 263 Santa Ana Ct. Sunnyvale, CA 94085
JUL 27 2015
Re. K070330
Trade/Device Name: Avantis Medical Systems, Inc. Third Eye™ Retroscope™ Auxiliary Endoscopy System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF, FDF, FCQ and KNW Dated (Date on orig SE ltr): April 5, 2007 Received (Date on orig SE ltr): April 6, 2007
Dear Mr. Rutherford,
This letter corrects our substantially equivalent letter of April 24, 2007.
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
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Page 2 -
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 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 contact 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/ResourcesforYou/Industry/default.htm. 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/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 STATEMENT
510(k) Number (if known): _K070330
Device Name: Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System
Indications for Use:
The Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System is intended for use in the instrument channel of a standard colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Szymanski
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K070336
I vantis Medical Systems 263 Santa Ana Ct., Sunnyvale, CA. 94085 Tel: (408) 733-1901, FAX: (408) 733-1847
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Колоззе
Section 1
APR 2 4 2007
Section 1: 510(k) Summary
This section is prepared in accordance with the requirements of 21 CFR 807.92.
Applicant Information:
| Summary Date: | February 2nd, 2007 |
|---|---|
| Owners Name: | Avantis Medical Systems, Inc |
| Address: | 263 Santa Ana CourtSunnyvale, CA 94085 |
| Phone: | 408-733-1901 |
| Fax: | 408-733-1784 |
| Contact Person: | Scott Rutherford |
| Phone: | 408-733-1901 x227 |
Device Information:
| Classification: | Class II |
|---|---|
| Classification Name: | Colonoscope, FDF / 21 CFR 876.1500 |
| Trade Name: | Third Eye™ Retroscope™ System |
| Common Name: | Endoscope |
Identification of Predicate Devices:
The Avantis Third Eye Retroscope is substantially equivalent in intended use and operation to a combination of predicate devices:
| K032177 | Olympus Evis CF-140L/I/S Colonovideoscope (see note 1) |
|---|---|
| K853585 | Olympus Evis Video System Center CV-100 (see note 2) |
| K924106 | US Endoscopy, Disposable Biopsy Forceps, Colonoscope, andfenestrated Oval cup with Spike and Sheath, part number00711205 |
| K984358 | Olympus Distal Attachment |
Note 1 - No direct 510K was found for the CF-140L/V/S under FDF classification code. This product is currently available in the resale market. K032177 lists Olympus Colonoscope XCF-Q140ML/I in intended use which relates to the predicate CF-140L/S.
Note 2 - No direct 510 was found for the Evis Video Center CV-100. This product is currently available in the resale market under Olympus CV-100 Evis Video System Center. K853585 describes a full video system center for multiple modalities. The Third Eye Retroscope Video Processor indications are applicable to the colonoscopy section of the predicate video system center.
Avantis Medical Systems 263 Santa Ana Ct., Sunnyvale, CA 94085 Tel: (408) 733-1901, FAX: (408) 733-1847
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Device Description Summary:
The Third Eye Retroscope Auxiliary Endoscopy System is designed as an auxiliary device for use during a colonoscopy procedure.
After a colonoscope has been advanced to the cecum, the Third Eye Retroscope auxiliary Endoscopy device is inserted through the instrument channel of the colonoscope. As the auxiliary device emerges from the distal tip of the instrument channel of the colonoscope, the auxiliary device automatically bends 180 degrees to form a "J" shape. The device then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope
The Third Eye Retroscope is deployed through the instrument channel of a colonoscope in what is commonly referred to as a mother-daughter configuration. As a result, only approximately 4 cm of the distal tip of the device protrudes from the distal end of the colonoscope's instrument channel except for a few seconds during insertion and removal, when up to 9 cm of the distal tip extends beyond the end of the colonoscope. Any contact of the device with the colonic mucosa is transitory.
The system consists of both disposable portions, and facility equipment.
The disposable portions include the Third Eye Retroscope and Cap. The Third Eye Retroscope is an endoscope that consists of a distal section, flexible insertion tube and proximal section. The distal section houses an imaging sensor, light source and related circuitry. The flexible insertion tube consists of a standard braided catheter with electrical wires located inside the lumen. These wires carry signals from the distal region to the proximal region. The proximal section includes a torquing knob, flexible wire extension region, and electrical connector. The Third Eye Cap with polarizing filter is placed on the distal end of the colonoscope.
The facility equipment portions of the device include the Third Eye Retroscope Video Processor and accessories. The video processor is a piece of electrical equipment that acts as an interface box for the Third Eve 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 various picture settings of the Third Eye Retroscope image and adjust the light intensity of the Retroscope. Additionally, the software facilitates the capture of still images, the export of these still images, and allows a user to save system settings under a profile name.
Intended Use:
រដ្ឋ
The Third Eye Retroscope Auxiliary Endoscopy System is intended for use in the instrument channel of a standard colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.
vantis Medical Systems 263 Santa Ana Ct., Sunnyvale, CA 94085 Tel: (408) 733-1901, FAX: (408) 733-1847
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Comparison to Predicate Device
The Third Eye Retroscope Auxiliary Endoscopy System is intended to be used as an auxiliary imaging system for colonoscopes. The Third Eye Retroscope Auxiliary Endoscopy System is similar to the combination of listed predicate devices in indication for use, sterilization method, physician operation, materials, and safety.
The Third Eye Retroscope is inserted into the instrument channel of a colonoscope in a similar manner to the predicate biopsy forceps. Once in place, the Third Eye Retroscope is designed to provide images of the colon in a similar manner as the predicate colonoscope. However, the Third Eye Retroscope image provides a retrograde view of the colon whereas the colonoscone provides a forward view. The Third Eye Retroscope is controlled by the Third Eye Video Processor in a similar manner as a colonoscope is controlled by the predicate Video System Center.
Based on the intended use, descriptive information, and performance evaluation provide in this premarket notification, including in vitro bench testing, the Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System has been shown to be substantially equivalent to the currently marketed predicate devices.
vantis Medical Systems 263 Santa Ana Ct., Sunnyvale, CA 94085 Tel: (408) 733-1901, FAX: (408) 733-1847
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The table below lists a summary of the predicate devices, and key similarities and differences:
Table 1-1 -- Comparison of Third Eye Retroscope Auxiliary Endoscopy System and Predicate Devices
| AvantisProduct | Parameter | Predicate Devices | |||
|---|---|---|---|---|---|
| Olympus EvisCF-140LColono-videoscope | Olympus EvisVideo SystemCenterCV-100 | US Endoscopy,Disposable BiopsyForceps00711205 | Olympus DistalAttachment | ||
| 510K Number | K032177 | K853585 | K924106 | K984358 | |
| Third EyeRetroscope | Similarities: | Indication forUse,ImagingPerformance | Delivery methodinto colon,Sterility,Single Patient UseSize & shape | ||
| Differences frompredicate: | Not steerable,Less complex,Auxiliarydevice | Not surgicalIncludes electronics | |||
| Third Eye Cap | Similarities: | Attachment tocolonoscope,Single Use,Size & Shape | |||
| Differences frompredicate: | Not Surgical | ||||
| Third EyeVideoProcessor | Similarities: | Indication forUse,Size & Shape,performance | |||
| Differences frompredicate: | No LightSource,Less Complex,Split Screencapability |
Summary
Based on the intended use, descriptive information, and performance evaluation provided in this premarket notification, including in vitro bench testing, the Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System has been shown to be substantially equivalent to the currently marketed predicate devices.
Avantis Medical Systems
263 Santa Ana Ct., Sunnyvale, CA 94085
Tel: (408) 733-1901, FAX: (408) 733-1847
§ 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.