(174 days)
This device is intended to resist the backflow of fluid around an instrument inserted through the working channel of a ureteroscope, cystoscope, or other endoscope.
The Endoscopic Cap covers female Luer locks and bulb-type endoscopic fittings. The Endoscopic Cap is constructed from silicone. The proximal end is manufactured in three ways: without a hole, with a small hole, and with a large hole. The small hole is compatible with instruments that are 0.025 - 0.038 inches in diameter. The large hole is compatible with devices that are 7.0-12.0 Fr.
The Check-Flo Adapters have a linear, cylindrical shape and attach to female Luer locks and bulb-type endoscopic fittings. The Check-Flo Adapter is constructed from four components: male Luer lock, body, valve, and cap. The distal side of the Check-Flo Adapter is an acetal male Luer lock. The body is constructed from acetal and connects all the components. The valve is a silicone disc and is seated in the cap. The cap is constructed from acetal and is located at the distal end of the Check-Flo Adapter. The Check-Flo Adapters are compatible with devices that are less than or equal to 9.0 Fr.
The Check-Flo Adapter design has two variations: a side-arm assembly and universal tubing. The side-arm assembly is a 10 cm length of vinyl tubing with a female Luer lock made from polycarbonate. The side-arm assembly comes with an additional one-way or three-way stopcock constructed from polycarbonate and polyethylene. The Check-Flo Adapter with universal tubing includes a segment of white silicone tubing. It protrudes 2.5 cm from the distal end of the male Luer lock and is 4.0 French in diameter.
The Side-Arm Adapter is shaped like the letter "y" and attaches to female Luer locks. It is constructed from four components: the body, male Luer lock, o-ring, and cap. The body is constructed from acetal. The protruding side-arm of the body has a female Luer lock. A one-way stopcock is provided and is constructed from polycarbonate and polyethylene. The male Luer lock is constructed from acetal and is located on the distal end of the body. The o-ring is seated inside the cap located on the proximal end of the body. The Side-Arm Adapter is compatible with instruments that are 3.0 - 6.0 Fr.
The Tuohy-Borst Adapter has a linear, cylindrical shape and attaches to female Luer locks. The Tuohy-Borst Adapter is constructed from four components: tightening knob, body, sealing ring, and rotator. The tightening knob is located on the proximal side of the Tuohy-Borst Adapter. The body is constructed from polycarbonate and connects all the components. The sealing ring is seated inside the rotator located on the distal end of the body. The Touhy-Borst is compatible with instruments that are 6.0 Fr and smaller.
The Tuohy-Borst has an alternate design where the body has an additional side-arm with female Luer lock. This design has the same four basic components.
This document is a 510(k) premarket notification for various endoscopic accessories. It does not contain the detailed acceptance criteria and study results typically found in a clinical study report or a more extensive engineering report.
However, based on the Performance Data section, we can infer some aspects of the acceptance criteria and the studies conducted.
Here's an attempt to structure the information based on your request, highlighting what is implicitly stated or can be inferred, and explicitly noting what is not provided in this regulatory letter and 510(k) summary:
1. A table of acceptance criteria and the reported device performance
| Test Category | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | The device materials must be biocompatible according to established standards (e.g., ISO 10993 series), demonstrating no unacceptable biological response (e.g., cytotoxicity, irritation, sensitization). | "[Testing was performed in order to demonstrate that the proposed devices] met applicable design and performance requirements." (Implies compliance with biocompatibility standards.) |
| Sterilization | The device must be able to be effectively sterilized by a validated method (e.g., EtO, moist heat, radiation) to achieve a specified sterility assurance level (SAL), typically 10⁻⁶, and maintain material integrity post-sterilization. | "[Testing was performed in order to demonstrate that the proposed devices] met applicable design and performance requirements." (Implies successful sterilization validation and maintenance of properties.) |
| Leakage | The device must effectively "resist the backflow of fluid" around an instrument. Acceptance criteria would likely define a maximum allowable leakage rate or pressure withstand capacity for various instrument sizes and fluid pressures, to ensure clinical efficacy and prevent fluid egress during endoscopic procedures. | "[Testing was performed in order to demonstrate that the proposed devices] met applicable design and performance requirements." (Implies devices meet a predefined leakage resistance threshold, consistent with preventing backflow as per the Indications for Use.) The "Conclusion" states: "The results of these tests support a conclusion that the... Adapter... will perform as intended." |
| Device Compatibility and Integrity | The devices must be mechanically compatible with specified endoscopes (ureteroscope, cystoscope, other endoscope) and instruments of defined diameters (e.g., 0.025-0.038 inches, 7.0-12.0 Fr for Endoscopic Cap; ≤ 9.0 Fr for Check-Flo Adapters; 3.0-6.0 Fr for Side-Arm Adapter; ≤ 6.0 Fr for Tuohy-Borst Adapter) without damage or compromising function during use. Acceptance criteria would likely include proper fit, ease of insertion/removal, and structural integrity under normal forces. | "The small hole is compatible with instruments that are 0.025 - 0.038 inches in diameter. The large hole is compatible with devices that are 7.0-12.0 Fr." (Endoscopic Cap) "The Check-Flo Adapters are compatible with devices that are less than or equal to 9.0 Fr." "The Side-Arm Adapter is compatible with instruments that are 3.0 - 6.0 Fr." "The Touhy-Borst is compatible with instruments that are 6.0 Fr and smaller." "[Testing was performed in order to demonstrate that the proposed devices] met applicable design and performance requirements." (Implies successful testing for physical compatibility and structural integrity.) |
| Flow Rate | Not explicitly stated what "flow rate" refers to. It could be related to fluid ingress/egress through the side ports (e.g., for irrigation) or maintaining sufficient working channel flow. Acceptance criteria would define minimum/maximum flow rates. | "[Testing was performed in order to demonstrate that the proposed devices] met applicable design and performance requirements." (Implies the devices meet predefined flow rate specifications.) |
| Accelerated Age | The device must maintain its functional and structural integrity (including leakage resistance, compatibility, and material properties) after accelerated aging test, simulating its intended shelf life, without degradation that compromises its safety or effectiveness. | "[Testing was performed in order to demonstrate that the proposed devices] met applicable design and performance requirements." (Implies successful accelerated aging demonstrating shelf-life stability.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The number of units tested for each performance criterion (Biocompatibility, Sterilization, Leakage, Device Compatibility and Integrity, Flow Rate, Accelerated Age) is not mentioned.
- Data Provenance: Not specified. This document is a regulatory submission, and the tests would typically be performed by the manufacturer (Cook Incorporated) in a controlled laboratory setting. Whether it's entirely in-house or outsourced to specific labs is not detailed. The data is prospective, in the sense that the tests were specifically conducted to demonstrate the device's performance for this submission. There is no indication of clinical data or patient data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the document describes in-vitro performance testing of physical medical devices, not an AI/software device that requires human expert annotation for ground truth. The "ground truth" for these tests is established by objective engineering measurements and adherence to established standards (e.g., leakage measurement, material properties testing).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, this document describes objective performance testing of physical devices, not an AI/software device requiring human adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document describes a traditional medical device (accessories for endoscopes), not an AI-assisted device. Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is hardware; it does not involve an algorithm. The "standalone" performance testing refers to the various engineering tests (leakage, flow rate, etc.) performed on the device models themselves without human clinical intervention beyond operating the test equipment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests described (Biocompatibility, Sterilization, Leakage, Device Compatibility and Integrity, Flow Rate, Accelerated Age) is established through:
- Objective Engineering Measurements: For tests like leakage and flow rate, the "ground truth" is the measured physical property of the device compared against a pre-defined performance specification.
- Adherence to Standards: For biocompatibility and sterilization, the "ground truth" is compliance with recognized international standards (e.g., ISO for biocompatibility) that define acceptable levels of biological response or sterility assurance.
- Material and Design Specifications: For device compatibility and integrity, the "ground truth" is the device meeting its specified dimensions, material properties, and functionality under test conditions.
8. The sample size for the training set
Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/machine learning device, there is no "training set" and thus no ground truth to establish for it.
§ 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.