(270 days)
Not Used
No
The summary describes a rigid endoscope with a traditional rod-lens system and fiber optics, similar to predicate devices. There is no mention of AI, ML, image processing, or any data-driven performance metrics that would suggest the use of such technologies.
No
The provided text states that the Canada Endoscope is used for "diagnostic and therapeutic procedures," but the device description focuses on its visualization capabilities (eyepiece, rod-lens system, light guide) for diagnostic purposes. There is no mention of the endoscope itself delivering any therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the Canada Endoscope is "used to visualize the urinary tract for diagnostic and therapeutic procedures," indicating a diagnostic function.
No
The device description explicitly details hardware components like an eyepiece, body with light guide and rod-lens system, outer and inner tubes of surgical steel, and fiber optics. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "visualize the urinary tract for diagnostic and therapeutic procedures." This describes a device used in vivo (within the living body) for direct observation and intervention.
- Device Description: The description details a rigid endoscope with lenses and fiber optics, designed for insertion into the body. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside the body to provide information about a physiological state, health, or disease. IVDs typically involve reagents, assays, or analysis of biological samples.
Therefore, the Canada Endoscope, as described, is an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Like the predicated devices, the Canada Endoscope is used to visualize the urinary tract for diagnostic and therapeutic procedures.
Product codes
FAJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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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 |
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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.
-
Biocompatibility - No issues of biocompatibility are raised with the Canada Endoscope device.
-
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)