The Novadag Disposable Rigid Scope Introducer is intended to facilitate passage of a laparoscope through the anus allowing visual examination of the rectum and distal portions of the colon.

Device Description

The single-use Disposable Rigid Scope Introducer is used in conjunction with a laparoscope to allow visual examination of the rectum and distal portions of the colon. When used with the laparoscope, the Disposable Rigid Scope Introducer and laparoscope are advanced into the rectum under visual guidance to a maximum insertion length of 25cm. An insufflation port is provided as part of the Endoscopic Introducer to allow insufflation of the rectum and lower colon.

AI/ML Overview

The provided document does not contain information about specific acceptance criteria, a study proving device meeting acceptance criteria, or performance metrics. It is a 510(k) summary for a medical device (Disposable Rigid Scope Introducer) seeking substantial equivalence to predicate devices. The document outlines:

Device Description: The Novadaq Disposable Rigid Scope Introducer is a single-use device used with a laparoscope for visual examination of the rectum and distal colon, featuring an insufflation port.
Indications for Use: To facilitate the passage of a laparoscope through the anus for visual examination of the rectum and distal portions of the colon.
Predicate Devices: K092221 Colonic Splinting Overtube (US Endoscopy), K033954 Shape Locking Endoscopic Overtube (USGI Medical Inc.), K770291 Disposable Rigid Sigmoidoscope (Welch Allyn).
Technological Comparison: The device is considered similar to predicates in shape, materials, and effect on the patient. Differences include length (shorter than predicates) and the provision of an insufflation channel, similar to one predicate.
Nonclinical Tests: Safety and performance were verified by tests conducted by Novadaq Technologies and accredited third-party laboratories, adhering to ISO 10993-1:2009, ISO 8600-1 Second Ed., and ISO 8600-4 First Ed.
Clinical Performance Data: An "exhaustive literature search" was conducted via a written protocol, and the clinical evaluation report is based on clinical data from this literature review and an adverse events database. It states that this data "provide evidence that supports the safety and performance claims."
Safety & Effectiveness Conclusion: The submission claims that differences do not raise safety/effectiveness questions and the device is substantially equivalent to the referenced predicate devices.

Based on the provided text, I cannot complete the requested tables and information as the document does not include quantitative acceptance criteria, detailed study designs, sample sizes for test/training sets, expert qualifications, or ground truth establishment methods in the way a performance study report would.

The document states that "Data presented in the clinical evaluation report provide evidence that supports the safety and performance claims made for the Endoscopic Introducer," but it does not present that data or the methodology of the studies.

This is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed clinical study report with specific performance metrics and acceptance criteria for a novel algorithm or diagnostic device. For the types of information you're asking for (e.g., AUC, sensitivity, specificity, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance), a different type of document, such as a clinical study report or a more detailed section of the 510(k) itself (which is often proprietary and not included in the summary), would be necessary.

Summary

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Summary Date:

R123013
pg. 1 of 2

Endoscopic Introducer

MAR 2 2 2013

510(k) Summary For the Novadag Disposable Riqid Scope Introducer

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

Applicant: Novadaq Technologies Inc. 13155 Delf Place, Unit 250 Richmond, British Columbia Canada V6V 2A2 Tel: (604) 232 9861

Contact Name: Tim Verspagen Sr. Manager, Requlatory Compliance Tel: (604) 232-9861 Ext. 240 Fax: (604) 232-9641
March 14, 2013
Trade Name: Disposable Rigid Scope Introducer
Classification Name: Endoscopic Access Overtube
Classification: 21 CFR § 876.1500
Product Code: 78 (FED)
Classification: Class II
Predicate Devices: K092221 Colonic Splinting Overtube (US Endoscopy)

K033954 Shape Locking Endoscopic Overtube (USGI Medical Inc.)

K770291 Disposable Rigid Sigmoidoscope (Welch Allyn)

Device Description:

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K123013
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Indications for Use:

The Novadag Disposable Rigid Scope Introducer is intended to facilitate passage of a laparoscope through the anus allowing visual examination of the rectum and distal portions of the colon.

Predicate Device Technological Comparison Summary:

Considered in combination, the predicate devices are used to provide an introduction pathway to enable visual examination of the rectum and distal colon by also providing a channel for insufflation.

The predicate devices and the Disposable Rigid Scope Introducer are similar in shape and materials. The effect of use of the Disposable Rigid Scope Introducer and the predicate devices on the patient is the same. With respect to mechanical dimensions, the diameters of the devices are similar, while the length of the Disposable Rigid Scope Introducer is less than the predicate device as it is intended to be inserted a shorter distance.

Similar to one of the predicate devices, the Disposable Rigid Scope Introducer provides a channel to insufflate the rectum and distal colon which enables the visual examination.

Any additional indications for use claimed by the predicate device do not affect the safe and effective use of the Disposable Rigid Scope Introducer when used according to its instructions for use.

Nonclinical Tests:

The device safety and performance were verified by tests conducted by Novadaq Technologies and accredited third party laboratories. Standards used / relied upon for testing are:

ISO 10993-1:2009 .
ISO 8600-1 Second Ed. .
. ISO 8600-4 First Ed.

Clinical Performance Data:

For clinical evaluation, an exhausive literature search was conducted according to written protocol. The clinical evaluation report is based on clinical data obtained from review of clinical literature and clinical experience from adverse events database.

Data presented in the clinical evaluation report provide evidence that supports the safety and performance claims made for the Endoscopic Introducer.

Safety & Effectiveness:

It has been shown in this 510(k) submission that any differences in intended use or technological characteristics between the Disposable Rigid Scope Introducer and the referenced predicate device do not raise any questions regarding its safety and effectiveness. The Endoscopic Introducer, as designed, manufactured and used according to its labeled intended use is determined to be substantially equivalent to the referenced predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

March 22, 2013

Novadaq Technologies, Inc. % Mr. Tim Verspagen Sr. Manager Regulatory Compliance 13155 Delf Place, Unit 250 RICHMOND BRITISH COLUMBIA CANADA V6V 2A2

Re: K123013

Trade/Device Name: Disposable Rigid Scope Introducer Regulation Number: 21 CFR8 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: February 19, 2013 Received: February 20, 2013

Dear Mr. Verspagen:

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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. Verner -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): -K123013

Device Name: Disposable Rigid Scope Introducer

Indications for Use:

The Novadaq Disposable Rigid Scope Introducer is intended to facilitate passage of a laparoscope through the anus allowing visual examination of the rectum and distal portions of the colon.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

HerbertLerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123013 510(k) Number _

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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.