(168 days)
No
The summary describes a standard colonoscope system with optical imaging and operator control. There is no mention of AI, ML, image processing for analysis, or any data related to training or testing AI/ML models.
Yes
The 'Intended Use / Indications for Use' section states that the device is intended to provide "diagnostic/therapeutic access" and the 'Device Description' mentions "therapeutic access to the colon" and "channels for ... therapeutic access".
No
Explanation: The device is used for visualization, diagnostic/therapeutic access, and therapeutic procedures, but it does not perform diagnostic functions itself. It provides the means for a healthcare professional to diagnose.
No
The device description clearly states it is comprised of two major hardware components: the Video Controller and the Aer-O-Scope 3 Disposable Colonoscope, which includes physical channels, an optical imaging head with a CMOS sensor, and lenses.
Based on the provided information, the Aer-O-Scope Colonoscope System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Aer-O-Scope Function: The Aer-O-Scope Colonoscope System is used to visualize the lower gastrointestinal tract in vivo (inside the body) and provide therapeutic access. It does not analyze specimens outside the body.
The device is an endoscope used for direct visualization and intervention within the patient's body, which falls under the category of medical devices, but not specifically IVD devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FDF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical imaging
Anatomical Site
lower gastrointestinal tract, (including but not limited to, the anus, rectum, sigmoid colon, transverse colon, cecum and ileocecal valve)
Indicated Patient Age Range
adult
Intended User / Care Setting
physicians' clinics, ambulatory surqical centers, and hospital settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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
2
Indications for Use
510(k) Number (if known) K230588
Device Name Aer-O-Scope Colonoscope System
Indications for Use (Describe)
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.
| 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 Gan | |
| Israel | |
| Contact: | Sharon Goldfarb |
| VP Regulatory and Clinical | |
| Phone: +972-54-6454034 | |
| Fax: +972-3-761-7974 | |
| Email: 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).
4
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 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.
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.
5
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 3
Colonoscope System | Evis Exera II 180
System
(K100584) | (Reference) Aer-O-
Scope 2 Colonoscope
System |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use
Statement | Indications for Use
Statement | (K161791)
Indications for Use
Statement |
| The Aer-O-Scope (3)
Colonoscope System is
intended to provide
visualization (via a
video monitor) &
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. | EVIS EXERA II
COLONOVIDEOSCOPE
OLYMPUS CF TYPE
H180AL,
These instruments have
been designed to be
used with an Olympus
video system
center, light source,
documentation
equipment, monitor,
Endotherapy accessories
(such as a biopsy
forceps), and other
ancillary equipment for
endoscopy and
endoscopic
surgery within the
lower digestive tract
(including the anus,
rectum, sigmoid colon,
colon,
and ileocecal valve). | The Aer-O-Scope (2)
Colonoscope System is
intended to provide
panoramic (360°)
visualization (via a
video
monitor) & 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. |
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.
7
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.