(270 days)
Like the predicated devices, the Canada Endoscope is used to visualize the urinary tract for diagnostic and therapeutic procedures.
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.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document is a 510(k) summary for a rigid cystoscope. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than conducting extensive clinical efficacy studies with predefined acceptance criteria. Therefore, the "acceptance criteria" here are aligned with demonstrating this equivalence, and the "study" is primarily a comparison to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Implicit: Substantial Equivalence to Predicate Device K031141)
| Characteristic | Acceptance Criterion (Predicate Device K031141) | Reported Device Performance (Current Device) |
|---|---|---|
| Type | Cystoscope (Rigid) | Cystoscope (Rigid) |
| Diameter | 2.7 mm - 4.00 mm | 2.7 mm - 4.0 mm |
| Working Length | 302 mm | 302 mm |
| Direction of View | 0° - 70° | 0° - 70° |
| Field of View | 70° | 70° |
| Instrument Connector | Storz, ACMI, Wolf | Storz, ACMI, Wolf |
| Light Cable Connector | Storz, ACMI, Wolf | Storz, ACMI, Wolf |
| Material (Body) | Stainless Steel 1.4301 | Stainless Steel 1.4301 |
| Sterilization | Autoclavable (Sold non-sterile, user to sterilize) | Autoclavable (Sold non-sterile, user to sterilize) |
| Weight | 0.08 kg | 0.08 kg |
| Manufactured & Test | EN13485:2003 CE | IS013485:2003 CMDCAS |
| Intended Use | Visualize the body cavities, hollow organs and canals during diagnostic and therapeutic procedures, in conjunction with additional instruments (Specifically, visualize the urinary tract). | Visualize the body cavities, hollow organs and canals during diagnostic and therapeutic procedures, in conjunction with additional instruments (Specifically, visualize the urinary tract). |
| Safety and Effectiveness | No issues with safety or effectiveness (as legally marketed and used) | No issues with safety or effectiveness (claimed based on similarity and market use) |
| Biocompatibility | No issues raised | No issues raised (due to similar materials) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a clinical test set as described for AI/diagnostic devices. This submission relies on a comparison to a predicate device's existing characteristics and performance, not a new clinical study with a "test set" of patients.
- Data Provenance: The "data" used is the documented design specifications, materials, and intended use of both the new device and the predicate device (Asap Cystoscope, K031141).
- The predicate device is described as "presently in commercial distribution globally, including the USA."
- 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." This indicates retrospective real-world usage data from Canadian hospitals, but not as part of a controlled "test set" for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not an AI/diagnostic device that generates an output requiring expert interpretation for ground truth. The submission relies on engineering specifications and comparison to an established predicate device.
4. Adjudication Method
Not applicable. No expert adjudication process is detailed as there is no diagnostic output from the device being evaluated using a test set against ground truth.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a rigid endoscope, not an AI system. The submission focuses on demonstrating substantial equivalence in design and function to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not a standalone algorithm.
7. The Type of Ground Truth Used
Not applicable in the AI/diagnostic sense. The "ground truth" for this submission is the established performance, safety, and intended use of the predicate device, and the engineering specifications and material properties of the new device that demonstrate its equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device, not an AI model.
§ 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.