The Aer-O-Scope Colonoscope System is intended to provide panoramic (3600) visualization (via a video monitor) and diagnostic/therapeutic access to the adult lower gastrointestinal tract, (including but not limited to, the anus, rectum, sigmoid colon, transverse 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 Scanner cannot be reprocessed.

Device Description

The Aer-O-Scope 2 is a flexible, operator-controlled, colonoscope that utilizes a propulsion mechanism to provide visualization and therapeutic access to the colon. It is comprised of two major components, the Controlling Work Station and the Aer-O-Scope 2 Disposable Scanner (the colonoscope component). The work station system console contains all 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 2 Disposable Scanner includes a soft narrow multi-lumen tube with channels for irrigation, insufflation, therapeutic access and suction, CO2 delivery to the balloons and colon and the soft balloons for the propulsion system. The Disposable Scanner also includes an optical imaging head with a CMOS sensor 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.

The Aer-O-Scope 2 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 2 scanner to travel through the colon without the need for pushing force. The tip of the scope with the optical imaging head can be deflected in any direction to ensure full visualization. This propulsion system is identical to the Aer-O-Scope 1 Colonoscope System.

The Aer-O-Scope 2 Colonoscope System contains optional post processing spectral filtering capabilities that assist the physician in examining features captured in standard white light colonoscopy images.

The Aer-O-Scope 2 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 2 Disposable Scanner is biocompatible according to the ISO 10993 harmonized and FDA consensus standard.

AI/ML Overview

The provided text is related to the FDA 510(k) clearance for the Aer-O-Scope Colonoscope System and details the substantial equivalence to predicate devices, particularly focusing on mechanical and biocompatibility aspects, rather than detailed performance criteria for an AI/CADe device. Therefore, a direct answer to the request regarding acceptance criteria and study proving performance for an AI/CADe device cannot be fully formulated from the given text.

The text does not include information about:

A table of acceptance criteria and reported device performance (in terms of clinical efficacy metrics like sensitivity, specificity, PPV, NPV).
Sample size for the test set or its provenance for clinical performance evaluation.
Number and qualifications of experts for ground truth establishment.
Adjudication method for a test set.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone (algorithm only) performance.
The type of ground truth used for clinical performance.
Sample size for the training set.
How ground truth for the training set was established.

The provided document describes the Aer-O-Scope Colonoscope System and focuses on its substantial equivalence to predicate devices based on bench testing and pre-clinical in vivo tests. It explicitly states that no clinical data is needed for the determination of substantial equivalence for this device, as the propulsion system is identical to a previously cleared device. Therefore, the questions related to clinical performance metrics, ground truth, expert review, and AI assistance are not addressed by this document.

The document highlights:

Bench tests to measure forces, biocompatibility, and safety.
Ex-vivo studies to demonstrate therapeutic access.
Pre-clinical in vivo tests in swine for overall safety and efficacy.

These are general device safety and performance criteria, not specific clinical performance metrics (e.g., sensitivity/specificity for disease detection) that would be expected for an AI/CADe device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 11, 2016

GI View Ltd. % Mark Heller Partner Goodwin Procter LLP 901 New York Avenue, NW Washington, D.C. 20001

Re: K161791

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: June 30, 2016 Received: June 30, 2016

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.

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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 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) K161791

Device Name

Aer-O-Scope Colonoscope System

Indications for Use (Describe)

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 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)

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510(K) SUMMARY

Owner:	GI View Ltd.
Address:	5 Shoham St.5251001 Ramat Ganlsrael
Contact:	Sharon GoldfarbVP Regulatory and ClinicalPhone: +972-3-575-3199 ext. 4154Fax: +972-73-253-9666/7Email: Sharon@giview.com
Summary Date:	February 4, 2016

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 § 876.150
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

Classification Name: Endoscope and accessories, 21CFR 876.1500

Product Code: FDF

Predicate Device, 21 CFR 807.92(a)(3):

Trade Name: Aer-O-Scope Colonoscope System

510(k) Number: K141286

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Common Name: Colonoscope

Classification Name: Endoscope and accessories, 21CFR 876.1500

Product Code: FDF

Device Description, 21 CFR 807.92(a)(4)

The Aer-O-Scope Colonoscope System subject to the 510(k) Premarket Notification and the Aer-O-Scope predicate device share the same name and hereafter will be distinguished by referring to as Aer-O-Scope 1 (the predicate) and Aer-O-Scope 2 (the new device).

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Predicate Comparison, 21 CFR 807.92(a)(6)

The Aer-O-Scope 1 Colonoscope System was deemed substantially equivalent to the predicate Invendo C20 Colonoscopy System in the 510(k) clearance letter for the Premarket Notification 510(k) number K141286.

The substantial equivalence determination applies to the Aer-O-Scope 2 insofar as its technological features are the same as those of the Aer-O-Scope 1. In terms of those technological characteristics that differ between the Aer-O-Scope 1 and the Aer-O-Scope 2, GI View submitted bench testing to show that these differences in technological characteristics do not affect the substantial equivalence determination, i.e., the Aer-O-Scope 2 is also substantially equivalent to the Invendo C20 Colonoscopy System.

The focus of this Premarket Notification 510(k) is the Aer-O-Scope 2's indication that, like the Invendo C20 Colonoscopy System indication, includes diagnostic/therapeutic access.

The Invendo C20 Colonoscopy System and the Aer-O-Scope 2 Colonoscope System have the same indications for use for visualization and diagnostic/therapeutic access. The Aer-O-Scope 1's indications are a subset of the Aer-O-Scope 2's indications in that Aer-O-Scope 1 is indicated for visual but not diagnostic/therapeutic access.

The Aer-O-Scope 1, Aer-O-Scope 2 and the Invendo C20 all have the same intended use, i.e., providing access, illumination, and allowing observation or manipulation of body cavities, hollow organs, and canals, see 21 CFR § 876.1500. All three systems are indicated for adult populations who may undergo colonoscopy in physicians' clinics, ambulatory surgical centers and hospital settings.

Indications for Use Comparison:

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Aer-O-Scope 2	Invendo C20	Aer-O-Scope 1
Colonoscope System	Colonoscopy System	Colonoscope System
	(K100624 & K121582)	(K141286)
Indications for Use	Indications for Use	Indications for Use
Statement	Statement	Statement
The Aer-O-Scope	The Invendo C20	The Aer-O-Scope
Colonoscope System is	Colonoscopy System is	Colonoscope System is
intended to provide	intended to provide	intended to provide
panoramic (360°)	visualization and	panoramic (360°)
visualization (via a video	diagnostic/therapeutic	visualization (via a video
monitor) and	access to the adult lower	monitor) and visual access
diagnostic/therapeutic	gastrointestinal tract	to the adult lower
access to the adult lower	(including but not limited to,	gastrointestinal tract,
gastrointestinal tract,	the anus, rectum, sigmoid	(including but not limited to,
(including but not limited to,	colon, transverse colon,	the anus, rectum, sigmoid
the anus, rectum, sigmoid	cecum and ileocecal valve)	colon, transverse colon,
colon, transverse colon,	for endoscopy and	cecum and ileocecal valve)
cecum and ileocecal valve)	endoscopic surgery.	for endoscopy.
for endoscopy.		The Aer-O-Scope
The Aer-O-Scope	The colonoscope	Disposable Scanner
Disposable Scanner	component of the Invendo	(colonoscope component of
(colonoscope component of	C20 Colonoscopy System,	the Aer-O-Scope
the Aer-O-Scope	the SC20 colonoscope, is a	Colonoscope System) is a
Colonoscope System) is a	single use disposable	single use disposable
single use disposable	device. The SC20	device. An Aer-O-Scope
device. An Aer-O-Scope	colonoscope cannot be	Scanner cannot be
Scanner cannot be	reprocessed.	reprocessed.
reprocessed.

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 2 Colonoscope System functioned as intended and met the individual test specifications.

Biocompatibility tests were performed and met all of the required criteria.

EMC and Electrical safety were tested and found compliant with the applicable standards.

Ex-vivo studies were performed to demonstrate the ability to provide therapeutic access to the lower bowel.

Pre-clinical in vivo tests in swine were performed to demonstrate overall safety and efficacy.

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Performance Data - Clinical, 21 CFR 807.92(b)(2);

No clinical data is needed for the determination of substantial equivalence. The predicate Aer-O-Scope 1 Colonoscope System Premarket Notification (K141286) included a clinical section demonstrating the performance of the system as related to cecal intubation. The Aer-O-Scope 2 device utilizes the identical propulsion system for colonic intubation; therefore there was no need for further clinical performance data for the determination of substantial equivalence.

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 2 Colonoscope System performed as well as the predicate devices. The data also demonstrated that the Aer-O-Scope 2 Colonoscope System can successfully provide a simple visualization tool and therapeutic access to the lower gastrointestinal tract for screening endoscopy (colonoscopy).

Regulation Number and Section

§ 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.