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 Description

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 biocompatible according to the ISO 10993 harmonized and FDA consensus standard.

AI/ML Overview

The provided document describes the Aer-O-Scope Colonoscope System and a clinical study conducted to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Primary Efficacy Endpoint)	Reported Device Performance (Clinical Study)
Cecal intubation in 90% of all study cases.	98.2% (Lower boundary of 95% confidence interval: 90.4%) in the pooled sample size of 56 subjects.
Primary Safety Endpoint: Frequency and severity of adverse device effects (ADEs).	No reportable adverse events or adverse device effects during the study.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: A total of 56 patients. This was further divided into an 18-patient training cohort and a 38-patient study cohort.
Data Provenance: Prospective. The clinical study was carried out in the Tel Aviv Medical Center.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used to establish the ground truth or their qualifications. The "ground truth" for assessing cecal intubation and pathologies was likely determined by the performing physicians themselves during the procedures (both Aer-O-Scope and conventional colonoscopy) and potentially confirmed by subsequent conventional colonoscopy for mucosal damage.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set. The study involved a "tandem colonoscopy" setup where an Aer-O-Scope colonoscopy was followed by a conventional colonoscopy. This design inherently provides a comparison, where the conventional colonoscopy can serve as a reference or confirmation for findings, including mucosal damage. However, a formal adjudication panel or process is not mentioned for conflicting findings or interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study compared the Aer-O-Scope to conventional colonoscopy by performing both procedures on the same patients, but it focused on device performance (intubation rates, safety, visualization) rather than comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The Aer-O-Scope Colonoscope System is a medical device that provides visualization for human operators. It is not an AI algorithm performing diagnostic tasks independently. Therefore, a standalone (algorithm-only) performance study is not applicable and was not performed. The device's performance is intrinsically linked to its use by a human operator.

7. The Type of Ground Truth Used

The ground truth for the clinical study appears to be a combination of:

Clinical Observation/Physician Assessment: Cecal intubation success was determined by the performing physician.
Tandem Colonoscopy: The conventional colonoscopy performed immediately after the Aer-O-Scope procedure served as a robust comparison to monitor for any mucosal damage caused by the Aer-O-Scope and potentially confirm pathologies or visualization quality.
Pathology: The "tertiary objective was to document the number of pathologies visualized during procedures." While this was an observational endpoint, the confirmation of these pathologies would typically involve histopathological examination of biopsies, implicitly.

8. The Sample Size for the Training Set

The document mentions an "18 training cohort" within the total of 56 patients. This refers to a group of patients used for initial training with the device during the clinical study, not a distinct dataset for training an artificial intelligence algorithm. The device itself (the Aer-O-Scope) does not appear to involve AI or machine learning algorithms that require a separate training dataset in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

The "training cohort" refers to a group of patients where operators gained proficiency with the device. The ground truth for this cohort would be established in the same manner as the study cohort: through real-time physician assessment during the procedure and comparison with subsequent conventional colonoscopy. There isn't an AI-specific training set ground truth to establish here.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K141286

Device Name Aer-O-Scope™

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 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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)

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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	16001200; 19201080;1920*1200
	Screen ratio Support	4:3; 16:9; 16:10
	Video Output Format	RGB
	Video Output Connector	DVI
	Light Intensity Adjustment	Automatic

PneumaticSystem	Maximal Input Pressure	4.5 Bar
	Maximal Output Pressure	60 mBar
PowerRequirements	Voltage	100-240V
	Frequency	50/60Hz
	Fuses	6.3A for 115VAC
Measurements	Work Station weight	167kg
	Work Station dimensions	1200 mm (H) * 400 mm(W) * 600 mm (D)

Aer-O-Scope Controlling Work Station Specification Chart:

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Item	Sub-system	Output
Optical Head	Sensor	$1280 * 1024$ CMOSsensor
	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
OpticalandLumenWidth	Optical Imaging Head Length	42 mm
	Diameter of insertion point -optical head	13 mm
	Multi Lumen maximal diameter	7.5 mm
PneumaticSystem	Insufflation Air Pressure	70 mBar
	Insufflation Air Flow Rate	3 liter/min
	Rectal Balloon maximalpressure	60mb
	Main and front balloon maximalpressure	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.

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Indications for Use Comparison:

Aer-O-Scope Colonoscope SystemIndications for Use Statement	Invendo C20 Colonoscopy SystemIndications for Use Statement
The Aer-O-Scope Colonoscope Systemis intended to provide panoramic (360°)visualization (via a video monitor) andvisual access to the adult lowergastrointestinal tract, (including but notlimited to, the anus, rectum, sigmoidcolon, colon, cecum and ileocecal valve)for endoscopy.The Aer-O-Scope Disposable Scanner(colonoscope component of the Aer-O-Scope Colonoscope System) is a singleuse disposable device. An Aer-O-ScopeScanner cannot be reprocessed.	The Invendo C20 Colonoscopy System isintended to provide visualization anddiagnostic/therapeutic access to the adultlower gastrointestinal tract (including butnot limited to, the anus, rectum, sigmoidcolon, colon, cecum and ileocecal valve)for endoscopy and endoscopic surgery.The colonoscope component of theInvendo C20 Colonoscopy System, theSC20 colonoscope, is a single usedisposable device. The SC20colonoscope cannot be reprocessed.

Aer-O-Scope Colonoscope SystemIndications for Use Statement

Invendo C20 Colonoscopy SystemIndications for Use Statement

The Aer-O-Scope Colonoscope Systemis intended to provide panoramic (360°)visualization (via a video monitor) andvisual access to the adult lowergastrointestinal tract, (including but notlimited to, the anus, rectum, sigmoidcolon, colon, cecum and ileocecal valve)for endoscopy.The Aer-O-Scope Disposable Scanner(colonoscope component of the Aer-O-Scope Colonoscope System) is a singleuse disposable device. An Aer-O-ScopeScanner cannot be reprocessed.

The Invendo C20 Colonoscopy System isintended to provide visualization anddiagnostic/therapeutic access to the adultlower gastrointestinal tract (including butnot limited to, the anus, rectum, sigmoidcolon, colon, cecum and ileocecal valve)for endoscopy and endoscopic surgery.The colonoscope component of theInvendo C20 Colonoscopy System, theSC20 colonoscope, is a single usedisposable device. The SC20colonoscope 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

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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

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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.

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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.

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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).

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.