← Product Code [FAJ](/productcode/FAJ) · K093725 # CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C (K093725) _Canada Endoscope Corporation · FAJ · Aug 30, 2010 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K093725 ## Device Facts - **Applicant:** Canada Endoscope Corporation - **Product Code:** [FAJ](/productcode/FAJ.md) - **Decision Date:** Aug 30, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use Like the predicated devices, the Canada Endoscope is used to visualize the urinary tract for diagnostic and therapeutic procedures. ## Device Story Canada Endoscope is a rigid cystoscope used for visualization of urinary tract during diagnostic and therapeutic procedures. Device consists of eyepiece, body with light guide, and rod-lens system. Body constructed of inner and outer surgical steel tubes with fiber optics located between tubes. Used in clinical settings by physicians. Device is non-sterile upon delivery and requires user-performed sterilization (autoclavable) prior to each procedure. Provides direct visualization to assist clinicians in performing urological interventions. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on design, material, and performance characteristics compared to the predicate device. ## Technological Characteristics Rigid endoscope; surgical steel (1.4301) construction; rod-lens optical system; fiber optic light transmission. Dimensions: 2.7 mm - 4.0 mm diameter, 302 mm length. Field of view: 70°. Direction of view: 0°-70°. Connectors: Storz, ACMI, Wolf. Sterilization: Autoclavable. Standards: ISO 13485:2003, EN 13485:2003. ## Regulatory 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. ## Special Controls *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. In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period. ## Predicate Devices - Asap Cystoscope ([K031141](/device/K031141.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K093725 Pages 1 of 2 ### Section 10 ## 510 (K) Executive Summary AUG 3 0 2010 #### 1. Submitter's Information Company Name: Canada Endoscope Corporation Company Address: 160 Konrad Crescent, Unit 4, Markham, Ontario L3R9T9 Trade Name: 1) Cystoscope Regulation Description: Endoscope and accessories #### 2. Predicate Device Identification 21 CFR 876.1500 Endoscope and Accessories Product Code FAJ Device Class II #### 3. Legally Marketed Equivalent Device Asap Cystoscope (K031141) #### 4. Intended Use and Device Description Like the predicate devices, the Canada Endoscope is used to visualize the body cavities, hollow organs and canals during diagnostic and therapeutic procedures, in conjunction with additional instruments. The intended use is the same as the predicate device. The Canada Endoscope is a rigid type endoscope with a compact objectives and a developed rod-lens system. The basic design of the Canada Endoscope is similar to those legally available for sale in the USA. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The fiber optics (light carrying fibers) are located between these tubes. The inner tube of the body contains the rod-lens system. #### 5. Characteristics of the Device as Compared to Predicate Device | | Characteristics | Current Device | Predicate Device (K031141) | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-------------------------------------------------|--------------------------------------------------------|--| | ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ | lype
Diameter
Working length | Cystoscope (Rigid)
2.7 mm - 4.0 mm
302 mm | Asap Cystoscope (Rigid)
2.7 mm -- 4.00 mm
302 mm | | {1}------------------------------------------------ K093725 Pages 2 of 2 Direction of View Field of View Instrument Connector Light Cable Connector Material (Body) Sterilization Weight Manufactured & Test 0°- 70° 70° Storz ACMI, Wolf, Storz, Stainless Steel 1.4301 Autoclavable 0.08 Ka IS013485:2003 CMDCAS 0° - 70° 70° Storz ACMI, Wolf, Storz, Stainless Steel 1.4301 Autoclavable 0.08 kg EN13485:2003 CE #### Conclusion - The intended use of the Canada Endoscope is the same of the predicate device. . - The predicate endoscope device is presently in commercial distribution globally . including the USA. - . The Canada Endoscope is similar in design, function, and application to the predicate device. - The Canada Endoscope like the predicate device has no issues with safety or effectiveness. - . The Canada Endoscope body is designed of the same material to ensure biocompatibility as the predicate device. It also complies with applicable ISO standards. - The device will be sold non-sterile, and to be sterile prior to each procedure by the . user. Repeatability of sterilization has been confirmed by validation protocol. 6. Biocompatibility - No issues of biocompatibility are raised with the Canada Endoscope device. 7. Performance Testing - The device is similar in design and construction, and has the same intended use and performance characteristics to the predicate device. It utilizes materials that are already in use in the predicated devices. Like the predicate devices there are no issues with safety or effectiveness with the Canada Endoscope device. The Canada Endoscope Cystoscope has been on the Canadian market since the year 2000 and is currently used at major hospitals such as Toronto General Hospital. Mount Sinai Hospital, Sunnybrook Hospital, St. Mikes Hospital, North York General Hospital, Sudbury Regional Hospital, Southlake Hospital, and Sick Kids Hospital Toronto. - 2 - {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 Canada Endoscope Corporation % Mr. Roger Leclerc Director Regulatory Affairs Medical Devices & Biosciences Int'l 1590 Oakburn Street PICKERING ON LIV 6M9 CANADA AUG 30 2010 Re: K093725 Trade/Device Name: Cystoscope Types: CE0004-C, CE0027-C, CE3004-C, CE3027-C, CE1204-C, CE1227-C, CE7004-C Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: August 19, 2010 Received: August 23, 2010 Dear Mr. Leclerc: 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 of medical device-related {3}------------------------------------------------ Page 2 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/Resourcesfor You/Industry/default.htm. Sincerely yours, Huker Lemur MD Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health. Enclosure {4}------------------------------------------------ # K093725 # Section 4 Indications for Use Statement New 510(K) Submission Indications for Use 093725 510(k) Number (if known): Device Name: - a) Cystoscope Types: CE0004-C, CE0027-C, CE3004-C,CE3027-C, CE1204-C, CE1227-C, CE7004-C Indications for Use: Prescription Use (Part 21 CFR 801 Subpart D) Like the predicated devices, the Canada Endoscope is used to visualize the urinary tract for diagnostic and therapeutic procedures. the world around 'em. But You'll see it, Baby, / You'll understand." AND/OR Concurrence of CDRH, Office of Device Evaluation (ODE) X (Division Sign-Off) Division of Reproductive, Abdominal, -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------and Radiological Devices 510(k) Number Over-The-Counter Use (21 CFR 801 Subpart C) --- **Source:** [https://fda-staging.innolitics.com/device/K093725](https://fda-staging.innolitics.com/device/K093725) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com