THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM

K070330 · Avantis Medical Systems, Inc. · FDF · Apr 24, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070330
• Device Name: THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
• Applicant: Avantis Medical Systems, Inc.
• Product Code: FDF · Gastroenterology, Urology
• Decision Date: Apr 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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.

Device Story

Auxiliary endoscopy system designed for use with standard colonoscopes; provides retrograde (backward-looking) visualization of colonic mucosa. Device consists of disposable Retroscope and Cap, and reusable Video Processor. Retroscope inserted through colonoscope instrument channel; upon emergence, distal tip automatically bends 180 degrees into 'J' shape. Imaging sensor and light source at distal tip capture retrograde images during colonoscope withdrawal. Video Processor acts as interface, processing signals for display on monitor; allows physician to adjust picture settings, light intensity, capture still images, and save user profiles. Used in clinical settings by physicians; provides supplemental view to standard forward-viewing colonoscope, potentially improving diagnostic visualization of colonic areas hidden from forward-facing optics.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System includes disposable Retroscope (distal imaging sensor, light source, flexible braided catheter) and Cap with polarizing filter. Reusable Video Processor provides interface, signal processing, and user controls. Connectivity via electrical connector to processor; output to external monitor. Sterilization method not specified (disposable components).

Indications for Use

Indicated for use in the instrument channel of a standard colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes in patients undergoing colonoscopy.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Olympus Evis CF-140L/I/S Colonovideoscope (K032177)
• Olympus Evis Video System Center CV-100 (K853585)
• US Endoscopy, Disposable Biopsy Forceps, Colonoscope, and fenestrated Oval cup with Spike and Sheath (K924106)
• Olympus Distal Attachment (K984358)

Submission Summary (Full Text)

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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 eagle with three stripes extending from its body, representing health, human services, and well-being. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone], FAX: [phone]

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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 Court<br>Sunnyvale, 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, and<br>fenestrated Oval cup with Spike and Sheath, part number<br>00711205 |
| 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: [phone], FAX: [phone]

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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: [phone], FAX: [phone]

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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: [phone], FAX: [phone]

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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

| Avantis<br>Product | Parameter | Predicate Devices | | | |
|---------------------------------|--------------------------------|--------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------|
| | | Olympus Evis<br>CF-140L<br>Colono-<br>videoscope | Olympus Evis<br>Video System<br>Center<br>CV-100 | US Endoscopy,<br>Disposable Biopsy<br>Forceps<br>00711205 | Olympus Distal<br>Attachment |
| | 510K Number | K032177 | K853585 | K924106 | K984358 |
| Third Eye<br>Retroscope | Similarities: | Indication for<br>Use,<br>Imaging<br>Performance | | Delivery method<br>into colon,<br>Sterility,<br>Single Patient Use<br>Size & shape | |
| | Differences from<br>predicate: | Not steerable,<br>Less complex,<br>Auxiliary<br>device | | Not surgical<br>Includes electronics | |
| Third Eye Cap | Similarities: | | | | Attachment to<br>colonoscope,<br>Single Use,<br>Size & Shape |
| | Differences from<br>predicate: | | | | Not Surgical |
| Third Eye<br>Video<br>Processor | Similarities: | | Indication for<br>Use,<br>Size & Shape,<br>performance | | |
| | Differences from<br>predicate: | | No Light<br>Source,<br>Less Complex,<br>Split Screen<br>capability | | |

#### 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: [phone], FAX: [phone]