The Aer-O-Scope Colonoscope System is intended to provide panoramic (3600) visualization (via a video monitor) and visual access to the adult lower gastrointestinal tract, (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy. The Aer-O-Scope Disposable Scanner (colonoscope component of the Aer-O-Scope Colonoscope System) is a single use disposable device. An Aer-O-Scope TM Scanner cannot be reprocessed.
Device Story
Aer-O-Scope Colonoscope System provides panoramic 360-degree visualization of the adult lower GI tract. System comprises a Controlling Work Station and a single-use, disposable Aer-O-Scope Scanner. Scanner utilizes a CO2-powered propulsion system with soft balloons to navigate the colon without manual pushing force; rectal balloon acts as a sealer; driving balloons facilitate movement. Operator controls tip deflection and navigation via a joystick on the workstation. CMOS camera at the tip captures video for display on a monitor. Used in clinics, ambulatory surgical centers, and hospitals by physicians. Provides visual diagnostic access; does not support endoscopic surgery. Benefits include reduced manual manipulation and enhanced visualization via panoramic view.
Clinical Evidence
Clinical study at Tel Aviv Medical Center with 56 subjects (18 training, 38 study). Primary safety endpoint: frequency/severity of adverse device effects (ADEs). Primary efficacy endpoint: cecal intubation rate. Results: 98.2% cecal intubation rate (95% CI lower bound 90.4%). No reportable adverse events or ADEs observed. Study included tandem colonoscopy (Aer-O-Scope followed by conventional colonoscopy) to monitor for mucosal damage. Bench testing confirmed biocompatibility (ISO 10993), electrical safety, and mechanical force limits.
Technological Characteristics
System includes Controlling Work Station and disposable scanner. Scanner materials: polyurethane and Pebax with hydrophilic coating. Propulsion: CO2-driven balloon system. Imaging: CMOS sensor (1.3 MP), 360° panoramic and forward-view optics. Connectivity: DVI video output. Power: 100-240V, 50/60Hz. Biocompatibility per ISO 10993. Electrical safety per applicable standards.
Indications for Use
Indicated for adult patients requiring visualization and visual diagnostic access to the lower gastrointestinal tract, including the anus, rectum, sigmoid colon, colon, cecum, and ileocecal valve, for endoscopy.
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.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2014
GI View, Ltd. % Mark Heller Partner Goodwin Proctor, LLP 901 New York Avenue, NW Washington, DC 20001
Re: K141286
> Trade/Device Name: Aer-o-scope Colonoscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF Dated: August 15, 2014 Received: August 15, 2014
Dear Mark Heller,
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 device
{1}------------------------------------------------
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 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,
# Herbert P. Lerner -S
for 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
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known) K141286
Device Name Aer-O-Scope™
#### Indications for Use (Describe)
The Aer-O-Scope Colonoscope System is intended to provide panoramic (3600) visualization (via a video monitor) and visual access to the adult lower gastrointestinal tract, (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy.
The Aer-O-Scope Disposable Scanner (colonoscope component of the Aer-O-Scope Colonoscope System) is a single use disposable device. An Aer-O-Scope TM Scanner cannot be reprocessed.
## Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
## FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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{3}------------------------------------------------
GI View Ltd. Owner: Address: 5 Shoham St. Paz Towers 52510001 Ramat Gan lsrael Contact: Sharon Goldfarb VP Regulatory and Clinical Phone: +972-3-575-3199 ext. 4154 Fax: +972-73-253-9666/7 Email: Sharon@giview.com Summary Date: March 27, 2014
Device Name, 21 CFR 807.92(a)(2)
Trade Name: Aer-O-Scope Colonoscope System
Common Name: Colonoscope
Classification Name: Endoscope and accessories, 21 CFR § 876.1500
Product Code: FDF
Predicate Device, 21 CFR 807.92(a)(3):
Trade Name: Invendo C20 Colonoscopy System
510(k) Number: K100624 and K121582
Common Name: Colonoscope
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Classification Name: Endoscope and accessories, 21CFR 876.1500
FDF Product Code:
Device Description, 21 CFR 807.92(a)(4)
The Aer-O-Scope Colonoscope System is a flexible, operator-controlled, colonoscope that utilizes a propulsion mechanism to provide visualization and visual (diagnostic) access to the colon. It is comprised of two major components, the Controlling Work Station and the Aer-O-Scope Disposable Scanner (the colonoscope component). The work station system console contains all internal components and subsystems required for operation and control of the Aer-O-Scope Colonoscope System, including a joystick component for controlling scope tip deflection. The Aer-O-Scope Disposable Scanner includes a soft narrow multilumen tube with channels for irrigation, insufflation, suction, CO2 delivery to the balloons and colon, soft balloons for the propulsion system and an optical imaging head with a CMOS chip and lenses for both forward visualization and a 360° panoramic omni view. All commands are controlled by the operator and regulated through the Controlling Work Station.
Similar to the predicate device, the Aer-O-Scope Colonoscope System utilizes a propulsion system for colonic intubation and scanning. The propulsion system relies on CO2 gas and soft pliable balloons that allow the Aer-O-Scope scanner to travel through the colon without the need for pushing force. A rectal balloon that sits at the base of the rectum and acts as a sealer prevents gas from escaping via the rectum. Two other balloons at the tip of the scope act as driving balloons. The space between the rectal balloon and the driving balloons is filled with low pressured CO2 gas via the rear channel through the rectal introducer that helps move the optical imaging head forward. For retraction, the gas behind the driving balloons is vented via the two-way rear channel in the rectal introducer. The space between the cecum and the driving balloons is filled with low pressure CO2 gas via the front channel, easing the driving balloons back towards the rectum. The tip of the scope with the optical imaging head can be deflected in any direction to ensure full visualization.
The Aer-O-Scope Disposable Scanner is a single use device and cannot be reprocessed. The main materials that come in contact with the patient are polyurethane and Pebax™ that are coated with a hydrophilic coating. The Aer-O-Scope Disposable Scanner has been demonstrated to be
{5}------------------------------------------------
biocompatible according to the ISO 10993 harmonized and FDA consensus standard.
| Item | Sub System | Output |
|-----------------------|----------------------------|------------------------------------------|
| Computer | Operating System | Windows XP Professional |
| | | |
| Video System | Camera Type | CMOS (1.3 Megapixels) |
| | Screen Resolution Support | 1600*1200; 1920*1080;<br>1920*1200 |
| | Screen ratio Support | 4:3; 16:9; 16:10 |
| | Video Output Format | RGB |
| | Video Output Connector | DVI |
| | Light Intensity Adjustment | Automatic |
| | | |
| Pneumatic<br>System | Maximal Input Pressure | 4.5 Bar |
| | Maximal Output Pressure | 60 mBar |
| Power<br>Requirements | Voltage | 100-240V |
| | Frequency | 50/60Hz |
| | Fuses | 6.3A for 115VAC |
| Measurements | Work Station weight | 167kg |
| | Work Station dimensions | 1200 mm (H) * 400 mm<br>(W) * 600 mm (D) |
Aer-O-Scope Controlling Work Station Specification Chart:
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| Item | Sub-system | Output |
|----------------------------------|-----------------------------------------------|--------------------------------|
| Optical Head | Sensor | $1280 * 1024$ CMOS<br>sensor |
| | Depth of Field - OMNI | 11-50 mm |
| | Depth of Field - Front | 10-60 mm |
| | Field of View - OMNI | front tilt 30° - back tilt 40° |
| | Angular Field of View - OMNI | 360° |
| | Field of View - Front | 90° |
| | Tip Deflection - All Directions | 160° |
| | Multi-lumen Working Length | 2000 mm |
| | Multi-lumen Total Length | 2300 mm |
| Optical<br>and<br>Lumen<br>Width | Optical Imaging Head Length | 42 mm |
| | Diameter of insertion point -<br>optical head | 13 mm |
| | Multi Lumen maximal diameter | 7.5 mm |
| Pneumatic<br>System | Insufflation Air Pressure | 70 mBar |
| | Insufflation Air Flow Rate | 3 liter/min |
| | Rectal Balloon maximal<br>pressure | 60mb |
| | Main and front balloon maximal<br>pressure | 60mb |
Aer-O-Scope Disposable Scanner Specification Chart
Predicate Comparison, 21 CFR 807.92(a)(6)
The Aer-O-Scope Colonoscope System has the same intended use as the predicate Invendo C20 Colonoscopy System (K100624 and K121582) of examining the colon or rectum, see 21 CFR § 876.1500, product code FDF. While the Invendo C20 Colonoscopy System is indicated for visualization and therapeutic access, the Aer-O-Scope Colonoscope System is indicated only for visualization and visual (diagnostic) access to the colon. Both systems are indicated for adult populations who may undergo colonoscopy in physicians' clinics, ambulatory surgical centers and hospital settings. Because the Aer-O-Scope Colonoscope System provides only visual (diagnostic) access to the colon, it is not indicated for endoscopic surgery.
{7}------------------------------------------------
Indications for Use Comparison:
| Aer-O-Scope Colonoscope System<br>Indications for Use Statement | Invendo C20 Colonoscopy System<br>Indications for Use Statement |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The Aer-O-Scope Colonoscope System<br>is intended to provide panoramic (360°)<br>visualization (via a video monitor) and<br>visual access to the adult lower<br>gastrointestinal tract, (including but not<br>limited to, the anus, rectum, sigmoid<br>colon, colon, cecum and ileocecal valve)<br>for endoscopy.<br>The Aer-O-Scope Disposable Scanner<br>(colonoscope component of the Aer-O-<br>Scope Colonoscope System) is a single<br>use disposable device. An Aer-O-Scope<br>Scanner cannot be reprocessed. | The Invendo C20 Colonoscopy System is<br>intended to provide visualization and<br>diagnostic/therapeutic access to the adult<br>lower gastrointestinal tract (including but<br>not limited to, the anus, rectum, sigmoid<br>colon, colon, cecum and ileocecal valve)<br>for endoscopy and endoscopic surgery.<br>The colonoscope component of the<br>Invendo C20 Colonoscopy System, the<br>SC20 colonoscope, is a single use<br>disposable device. The SC20<br>colonoscope cannot be reprocessed. |
The Aer-O-Scope's indications are a subset of the predicate device's indications, and the results of bench, pre-clinical and clinical testing demonstrate that the minor technical differences between the Aer-O-Scope and its predicate raise the same types of safety and effectiveness questions, and do not adversely affect the Aer-O-Scope's safety and effectiveness profile compared to the predicate.
The Aer-O-Scope Colonoscope System has many features in common with the currently marketed Invendo C20 Colonoscopy System and with other currently marketed conventional colonoscopes.
Like the predicate device, the Aer-O-Scope Disposable Scanner (the colonoscope component) is a long flexible endoscope with optics at the deflectable tip of the device and openings for irrigation, insufflation and suction. The Aer-O-Scope Disposable Scanner uses an overtube mechanism to facilitate easier insertion into the recto-sigmoidal junction. The Invendo C20 Colonoscope also uses an overtube mechanism.
The Aer-O-Scope Colonoscope System, like the Invendo C20 Colonoscopy, consists of two components, the Controlling Work Station and a disposable colonoscope component (the Aer-O-Scope Disposable Scanner). The Aer-O-Scope Controlling Work Station supplies and controls the Aer-O-Scope Disposable Scanner according to user commands via a keyboard or buttons on the steering joystick. The distal tip of the Aer-O-Scope Disposable Scanner is deflectable (controlled by the mechanical joystick on the controlling work station) and equipped with a CMOS camera and LEDs for Illumination. Like the predicate, the Aer-O-Scope Colonoscope System is
{8}------------------------------------------------
equipped with insufflation, irrigation and suction functions. Deflection, rinsing, insufflation and suction are activated and controlled by the Controlling Work Station, in accordance with operator commands.
Like the Invendo C20 Colonoscopy System, the Aer-O-Scope Disposable Scanner is not pushed or otherwise directly manually manipulated by the operator. The Aer-O-Scope Disposable Scanner moves through the colon with the aid of a propulsion system and under the direction and control of the operator using a joystick. The propulsion system relies on the use of balloons, an ultra-flexible multi-luminal cable and low, controlled pressures of CO2 gas to move the optical imaging head at the tip of the Aer-O-Scope Disposable Scanner inward towards the cecum and then outwards for scanning the colon. While the exact propulsion mechanism is different from that of the Invendo C20 Colonoscopy System, it is similar in that it removes the necessity for manual manipulations and use of pushing force by the operator. In addition, the results of bench, pre-clinical and clinical testing show that the differences in the propulsion systems raises the same types of safety and effectiveness questions as compared to the Invendo C20 Colonoscopy System and that the Aer-O-Scope Colonoscope System is as safe and effective as its cleared predicate device.
Both the Invendo C20 Colonoscope component and the Aer-O-Scope Colonoscope component are disposable. The Aer-O-Scope Joystick is connected to the Controlling Workstation as is the hand held control of the Invendo C20 colonoscope to the base unit. Both the Invendo C20 base unit and the Aer-O-Scope Controlling Work Station contain an articulated arm with the hand held controller at the end allowing for optimal accessibility (positioning) to the patient.
The tip of the Aer-O-Scope Disposable Scanner can be deflected using the mechanical joystick. The mechanism used for deflection is different than that of the Invendo C20 Colonoscopy System; however, the results of bench, preclinical and clinical testing demonstrate that the differences raise the same types of safety and effectiveness questions as compared to the cleared predicate device.
Both the Aer-O-Scope Colonoscope System and the predicate device use a CMOS camera at the tip of the scope and LEDs for illumination. The Aer-O-Scope™ Colonoscope System provides a higher sensor resolution than the predicate device. The Aer-O-Scope Colonoscope System video output shows both a forward view, similar to the Invendo C20 colonoscope. The Invendo C20 colonoscope's video output has a front view of the colonic mucosa. The
{9}------------------------------------------------
Aer-O-Scope Colonoscope System shows both a front view and a 360° panoramic view of a cross section of the colonic mucosa, both slightly ahead and to the area behind the optical imaging head. While the Aer-O-Scope video output is different in terms of the views that are provided, the results of the bench, pre-clinical and clinical testing demonstrate that these differences raise the same types of safety and effectiveness questions as compared to the cleared predicate device. In essence, the Aero-Scope provides the same view as the Invendo C20 colonoscope, and provides an additional panoramic view.
The materials used in the Aer-O-Scope Colonoscope System are different from those of the predicate device; however, complete biocompatibility data demonstrate that the new device is at least as safe and effective as the predicate.
Clinical data confirm that the Aer-O-Scope Colonoscope System can navigate the colon and visualize abnormalities.
The Aer-O-Scope™ Colonoscope System raises the same types of safety and effectiveness questions as the predicate device. Additionally performance data demonstrate that the Aer-O-Scope Colonoscope System is at least as safe and effective as the predicate device; therefore, the Aer-O-Scope Colonoscope System is substantially equivalent to the Invendo C20 Colonoscopy System.
Performance Data - Bench, 21 CFR 807.92(b)(1):
GI View Ltd. conducted bench tests to measure forces during device use, biocompatibility of device components and safety. In all instances the Aer-O-Scope Colonoscope System functioned as intended and met the individual test specifications.
Forces measured were less than the force needed to cause a perforation as determined by the professional literature.
Biocompatibility tests were performed and met all of the required criteria.
EMC and Electrical safety were tested and found compliant with the applicable standards.
{10}------------------------------------------------
Animal studies were performed to show safety. In addition a visualization study was performed comparing the Aer-O-Scope Colonoscope System to a conventional colonoscope.
Performance Data - Clinical, 21 CFR 807.92(b)(2);
A clinical study was carried out in the Tel Aviv Medical Center. 56 patients (18 training cohort and 38 study cohort) underwent Aer-O-Scope colonoscopy followed by conventional colonoscopy. The primary safety endpoint was frequency and severity of adverse device effects (ADEs) using the Aer-O-Scope for all subjects (training and study).
The primary efficacy objective was cecal intubation in 90% of all study cases. The secondary endpoints asked operators to evaluate the ease of use and visualization using the Aer-O-Scope based on their experience with conventional colonoscopes.
Two tertiary objectives were set forth in the clinical investigational plan. The first objective was to observe the number of Aer-O-Scope Colonoscopies needed to acquire proficiency in device operation, and was intended to aid the sponsor in developing a training program. The second objective was to document the number of pathologies visualized during procedures. This tertiary objective was intended as an observational endpoint.
This study called for tandem colonoscopy using the Aer-O-Scope Colonoscope for the first procedure and a conventional colonoscope for the second procedure to monitor for any mucosal damage during treatment with the experimental device. During the course of this investigation, there were no reportable adverse events or adverse device effects during the course of this study.
In the pooled sample size of 56 subjects, the success rate was 98.2% for cecal intubation and the lower boundary of the 95% confidence interval was 90.4%. One Aer-O-Scope procedure in the training cohort did not reach the cecum. This was attributed to insufficient colonic preparation which led the physician to wrongly conclude that he reached the cecum. While this was not a comparative study it should be noted that the cecal intubation rate for the conventional colonoscope in the pooled sample size of 56 subjects was also 98.2%. One patient in the study cohort was not intubated to the cecum with the conventional colonoscope due to poor colonic prep but was intubated to the cecum with the Aer-O-Scope Colonoscope.
{11}------------------------------------------------
Summary, 21 CFR 807.92(b)(3);
The bench tests included studies related to forces, biocompatibility, constructive and electrical safety and demonstrated that the Aer-O-Scope Colonoscope System performed as well as the predicate device. The clinical data also demonstrated that the Aer-O-Scope Colonoscope System can successfully provide a simple visualization tool for the adult lower gastrointestinal tract for screening endoscopy (colonoscopy).
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Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
