The Aer-O-Scope Colonoscope System is intended to provide 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 colonoscope is a single use disposable endoscope and cannot be reprocessed.

Device Description

The Aer-O-Scope 3 Colonoscope System is a flexible, operator-controlled, colonoscope that provides visualization and therapeutic access to the colon. It is comprised of two major components, the Video Controller and the Aer-O-Scope 3 Disposable Colonoscope. The Video Controller contains all components and subsystems required for operation and control of the Aer-O-Scope 3 Colonoscope System. The Aer-O-Scope 3 Disposable Colonoscope includes channels for irrigation, insufflation, lens wash, therapeutic access, and suction. The disposable colonoscope includes an optical imaging head with a CMOS sensor and lenses for visualization with a 200° panoramic omni field of view. All commands are controlled by the operator and regulated through the Video Controller. The Aer-O-Scope 3 Disposable Colonoscope is a single use device and cannot be reprocessed. The main material that comes in contact with the patient is polyurethane that is coated with a biocompatible hydrophilic coating. The Aer-O-Scope 3 Disposable Colonoscope is biocompatible according to the ISO 10993 harmonized and FDA consensus standard.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device (Aer-O-Scope Colonoscope System) but lacks the specific details required to fully address all aspects of your request regarding acceptance criteria and the study that proves the device meets them. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with acceptance criteria.

However, based on the available information, here's an attempt to extract and infer what's possible:

There is no explicit table of acceptance criteria and reported device performance provided in the document. The document states that "GI View Ltd. conducted packaging and shelf-life testing which met all the criteria," "Biocompatibility tests were performed and met all the required criteria," "EMC and Electrical safety were tested... and found compliant with the applicable standards," and "Bench tests to measure the safety and effectiveness of device components were performed. Bench tests to measure optical parameters and safety such as photobiological safety, resolution and geometric distortion were performed. In all instances the Aer-O-Scope 3 Colonoscope System functioned as intended and met the individual test specifications and/or FDA consensus standards." For clinical performance, it states, "The data demonstrated that the Aer-O-Scope 3 Colonoscope System (with a wider field of view (200°) compared to the predicate) successfully allows cecal intubation in the intended use population and provides therapeutic access to the lower gastrointestinal tract for screening, diagnostic and surveillance endoscopy (colonoscopy) as the predicate devices."

Given the information, a table like the one requested cannot be constructed precisely as acceptance criteria values are not explicitly stated for each performance aspect, nor are the quantitative results. The text only confirms that criteria were "met" or "functioned as intended."

Here's an attempt to answer the other questions based on the provided text:

1. A table of acceptance criteria and the reported device performance:
As mentioned above, an explicit table is not provided. The document generally states that "all criteria were met" for various tests.

Acceptance Criteria (Inferred from text)	Reported Device Performance (Summary from text)
Packaging and Shelf-life standards	Met all the criteria
Biocompatibility standards	Met all the required criteria
EMC and Electrical safety standards	Found compliant with the applicable standards
Device component safety & effectiveness	Functioned as intended; met individual test specifications
Optical parameters (photobiological safety, resolution, geometric distortion)	Functioned as intended; met individual test specifications and/or FDA consensus standards
Cecal Intubation Success Rate	Successfully allows cecal intubation
Therapeutic Access to lower GI tract	Provides therapeutic access to the lower gastrointestinal tract for screening, diagnostic, and surveillance endoscopy
Overall Safety and Efficacy (in vivo)	Demonstrated overall safety and efficacy

2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "Pre-clinical in vivo tests in swine" and a "clinical investigation" in humans.
  - For the clinical investigation, the number of human subjects is not specified.
  - For the in vivo tests, the number of swine is not specified.
- Data Provenance: The document does not explicitly state the country of origin for the clinical investigation data. Given the "Owner" (GI View Ltd.) is based in "Ramat Gan, Israel," it implies the clinical study could have been conducted in Israel or elsewhere, but this is not confirmed. The document refers to "GI View Ltd. conducted" studies.
- Retrospective or Prospective: The clinical investigation is described as being performed "to demonstrate safety and effectiveness," which strongly suggests a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The text does not elaborate on how ground truth was established for "cecal intubation" or "therapeutic access" during the clinical or pre-clinical studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not mentioned. The document focuses on the device's performance for visualization and therapeutic access, primarily in comparison to a predicate device's functionality, not on AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is an endoscope system (hardware) for visualization and access, not a standalone AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable to this device's description. The system provides visualization to a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not explicitly detailed. For the clinical investigation, "cecal intubation" success and "therapeutic access" would likely be determined by direct observation by the participating endoscopists. The document does not specify if additional ground truth like pathology reports for lesions found or long-term outcomes data were used to evaluate the device's diagnostic or therapeutic efficacy.
8. The sample size for the training set:
This device is a hardware system, not an AI model that requires a "training set" in the traditional machine learning sense. Therefore, the concept of a "training set" sample size is not applicable.
9. How the ground truth for the training set was established:
As above, this question is not applicable as the device is not an AI model with a training set.

Summary

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August 17, 2023

GI View Ltd. % Kristin Davenport Partner Covington & Burling LLP One City Center, 850 Tenth St, NW Washington, DC, District of Columbia 20001-4956

Re: K230588

Trade/Device Name: Aer-O-Scope Colonoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDF Dated: July 17, 2023 Received: July 18, 2023

Dear Kristin Davenport:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230588

Device Name Aer-O-Scope Colonoscope System

Indications for Use (Describe)

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 GanIsrael
Contact:	Sharon GoldfarbVP Regulatory and ClinicalPhone: +972-54-6454034Fax: +972-3-761-7974Email: Sharon@giview.com
Summary Date:	March 1, 2023
Device Name, 21 CFR 807.92(a)(2)
Trade Name:	Aer-O-Scope Colonoscope System¹
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:	Evis Exera II 180 System
510(k) Number:	K100584
Common Name:	Endoscopic Video Imaging System
Classification Name:	Endoscope and accessories, 21 CFR 876.1500.

Product Code: NWB, FDF, FDS

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

1 The Aer-O-Scope Colonoscope System subject to the 510(k) Premarket Notification and the Aer-O-Scope Reference device share the same name and hereafter will be distinguished by referring to as Aer-O-Scope 2 (the Reference K161791) and Aer-O-Scope 3 (the device subject to this 510(k) submission).

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Trade Name: Aer-O-Scope Colonoscope System (2)

510(k) Number: K161791

Common Name: Colonoscope

Classification Name: Endoscope and accessories, 21 CFR 876.1500

Product Code: FDF

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

The Aer-O-Scope 3 Disposable Colonoscope is a single use device and cannot be reprocessed. The main material that comes in contact with the patient is polyurethane that is coated with a biocompatible hydrophilic coating. The Aer-O-Scope 3 Disposable Colonoscope is biocompatible according to the ISO 10993 harmonized and FDA consensus standard.

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

The main technological and operational features of the Aer-O-Scope 3 (other than the visualization system) are the same as those of the Evis Exera II 180 System (Evis Exera II Video System Center Olympus CV-180 ("CV-180") & Evis Exera II Colonovideoscope Olympus CF type H180AL ("CF H180AL")). The only differences between the Aer-O-Scope 3 and the predicate relate to visualization (including a CMOS chip and LED lighting) and disposability and the hydrophilic coating, features that are also present in the Aer-O-Scope Colonoscope System 2 (reference device). GI View submitted data from the Aer-O-Scope 2 Colonoscope System for the visualization, hydrophilic coating & disposability features, as well as performance testing to show that the technological differences between the Aer-O-Scope 3 and the predicate do not affect the substantial equivalence determination.

The Aer-O-Scope 3 Colonoscope System has a subset of the indicated uses and associated technological and operational characteristics of the predicate Olympus Evis Exera II 180 System (the indication for the Olympus device also includes surgery). Both devices are indicated for adult populations who may undergo colonoscopy in physicians' clinics, ambulatory surqical centers, and hospital settings.

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While operationally the same as the Olympus predicate device, the technology differs in that the Aer-O-Scope 3 uses a CMOS chip and LED lighting and the Olympus predicate uses a CCD chip and fiber optic lighting.

Like the predicate, the Aer-O-Scope 3 Disposable Colonoscope 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 3's Video Controller supplies and controls the Aer-O-Scope Disposable Colonoscope according to user command inputs via a touchpad (on the Video Controller) or buttons on the colonoscope handle, similar to the Olympus predicate. The distal tip deflection of both the device subject to this Premarket Notification and the predicate are controlled by angulation knobs on the scope handles. The Aer-O-Scope 3 utilizes a CMOS image sensor and LEDs incorporated directly into the distal tip of the Aer-O-Scope Disposable Colonoscope; whereas the CCD image sensor and Xenon light source of the Olympus predicate are external, and signals are carried over fiber optics. Like the predicate, the Aer-O-Scope 3 Colonoscope System is equipped with insufflation, iens wash and suction.

Hydrophilic coating and predefined variable stiffness along the insertion tube are incorporated into the Aer-O-Scope 3 to facilitate colonic intubation. The Olympus CF H180AL Colonoscope has an operator controlled variable stiffness mechanism to facilitate colonic intubation. While the mechanisms for colonic intubation facilitation are different, both methods have shown to be successful for streamlining colonic intubation. These differences do not affect the safety and effectiveness of the Aer-O-Scope 3 compared to the predicate.

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Indications for Use Comparison:

Aer-O-Scope 3Colonoscope System	Evis Exera II 180System(K100584)	(Reference) Aer-O-Scope 2 ColonoscopeSystem
Indications for UseStatement	Indications for UseStatement	(K161791)Indications for UseStatement
The Aer-O-Scope (3)Colonoscope System isintended to providevisualization (via avideo monitor) &diagnostic / therapeuticaccess to the adultlower gastrointestinaltract, (including but notlimited to, the anus,rectum, sigmoid colon,transverse colon,cecum and ileocecalvalve) for endoscopy.The Aer-O-ScopeDisposablecolonoscope is a singleuse disposableendoscope and cannotbe reprocessed.	EVIS EXERA IICOLONOVIDEOSCOPEOLYMPUS CF TYPEH180AL,These instruments havebeen designed to beused with an Olympusvideo systemcenter, light source,documentationequipment, monitor,Endotherapy accessories(such as a biopsyforceps), and otherancillary equipment forendoscopy andendoscopicsurgery within thelower digestive tract(including the anus,rectum, sigmoid colon,colon,and ileocecal valve).	The Aer-O-Scope (2)Colonoscope System isintended to providepanoramic (360°)visualization (via avideomonitor) & diagnostic /therapeutic access tothe adult lowergastrointestinal tract,(Including but notlimited to, the anus,rectum, sigmoid colon,transverse colon,cecum and ileocecalvalve) for endoscopy.The Aer-O-ScopeDisposable Scanner(Colonoscopecomponent of the Aer-O-ScopeColonoscope System) isa single use disposabledevice. An Aer-O-ScopeScanner cannot bereprocessed.

Performance Data - Bench, 21 CFR 807.92(b)(1):

GI View Ltd. conducted packaging and shelf-life testing which met all the criteria.

Biocompatibility tests were performed and met all the required criteria.

EMC and Electrical safety were tested (voluntary ASCA Pilot) and found compliant with the applicable standards.

Bench tests to measure the safety and effectiveness of device components were performed.

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Bench tests to measure optical parameters and safety such as photobiological safety, resolution and geometric distortion were performed.

In all instances the Aer-O-Scope 3 Colonoscope System functioned as intended and met the individual test specifications and/or FDA consensus standards.

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

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

Clinical data support the determination of substantial equivalence. A clinical investigation was performed to demonstrate safety and effectiveness of cecal intubation and the performance of the Aer-O-Scope Colonoscope System 3. The data demonstrated that the Aer-O-Scope 3 Colonoscope System (with a wider field of view (200°) compared to the predicate) successfully allows cecal intubation in the intended use population and provides therapeutic access to the lower gastrointestinal tract for screening, diagnostic and surveillance endoscopy (colonoscopy) as the predicate devices.

Summary, 21 CFR 807.92(b)(3):

The bench tests included studies related to forces, biocompatibility, optical performance and constructive and electrical safety. The tests demonstrated that the Aer-O-Scope 3 Colonoscope System performed as expected and met the specifications/FDA consensus standards requirements. As such, the bench tests demonstrated the Aer-O-Scope 3 performed as well as the predicate devices. The data also demonstrated that the Aer-O-Scope 3 Colonoscope System successfully provided a wider field of view (200°) as well as therapeutic access to the lower gastrointestinal tract for screening, diagnostic and surveillance endoscopy as other colonoscopes.

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.