(267 days)
The Peel-Away Introducer is intended to be used to establish a conduit during endoscopic urological procedures (e.g. nephrostomy, cystoscopy, ureteroscopy, etc.) facilitating the passage of endoscopes and other instruments into the urinary tract.
The subject device, Peel-Away Introducer, consists of an inner dilator and outer peel-away sheath. The outer sheath fits over the inner dilator and has dual knobs allowing the sheath, manufactured from radiopaque polytetrafluoroethylene (PTFE), to be peeled back and removed. The sheath is manufactured with a length of 32 centimeters. The dilator has an outside diameter of 9, 10, or 12 French, and has a length of 37 centimeters. The 10 French dilator is manufactured from radiopaque polyethylene, while the 9 and 12 French dilators are manufactured from ethylene-vinyl acetate (EVA). The dilator is also tapered 1.2 to 1.5 centimeters from the distal end, depending on its outer diameter, and has a proximal hub composed of polyethylene. The Peel-Away Introducer is supplied sterile and intended for one-time use.
The provided document is a 510(k) Summary for the Cook Incorporated Peel-Away® Introducer. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain specific acceptance criteria or detailed results of a study that proves the device meets those criteria, as typically found in comprehensive study reports for AI/software devices.
Instead, it lists the types of performance tests conducted and provides a general statement of compliance. This device is a physical medical instrument (introducer sheath), not an AI/software device, so the requested information about AI model performance metrics, sample sizes for test and training sets, expert adjudication, or MRMC studies is not applicable to this document.
Therefore, I cannot provide the requested information in the format specified for an AI device.
Here's what can be extracted from the document, tailored for a physical device, but acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (General Goal) | Reported Device Performance |
|---|---|
| Reliable design and performance under testing parameters | "The subject device Peel-Away Introducer was subjected to applicable testing to assure reliable design and performance under the testing parameters." |
| Tensile Strength (Dilator Shaft) | "Performance: Tensile (Time-Zero and Aged) - Dilator Shaft" (implies testing performed and met criteria, but no specific values provided) |
| Tensile Strength (Dilator Shaft-to-Hub) | "Performance: Tensile (Time-Zero and Aged) - Dilator Shaft-to-Hub" (implies testing performed and met criteria, but no specific values provided) |
| Tensile Strength (Peel-Away Sheath) | "Performance: Tensile (Time-Zero and Aged) - Peel-Away Sheath" (implies testing performed and met criteria, but no specific values provided) |
| Peel Force (Peel-Away Sheath) | "Performance: Peel Force (Time-Zero and Aged) - Peel-Away Sheath" (implies testing performed and met criteria, but no specific values provided) |
| Rollback | "Performance: Rollback (Time-Zero and Aged)" (implies testing performed and met criteria, but no specific values provided) |
| Compatibility | "Performance: Compatibility (Time-Zero and Aged)" (implies testing performed and met criteria, but no specific values provided) |
| Radiopacity | "Performance: Radiopacity" (implies testing performed and met criteria, but no specific values provided) |
| Packaging Integrity | "Performance: Packaging" (implies testing performed and met criteria, but no specific values provided) |
| Sterility | "Performance: Sterility" (implies testing performed and met criteria, but no specific values provided) |
| Biocompatibility (Cytotoxicity) | "Biocompatibility Testing: ...testing for cytotoxicity... were performed to ensure the biocompatibility of the subject device set." (implies testing performed and met criteria) |
| Biocompatibility (Sensitization) | "Biocompatibility Testing: ...testing for ...sensitization... were performed to ensure the biocompatibility of the subject device set." (implies testing performed and met criteria) |
| Biocompatibility (Intracutaneous Irritation) | "Biocompatibility Testing: ...testing for ...intracutaneous irritation... were performed to ensure the biocompatibility of the subject device set." (implies testing performed and met criteria) |
| Biocompatibility (Acute Systemic Toxicity) | "Biocompatibility Testing: ...testing for ...acute systemic toxicity... were performed to ensure the biocompatibility of the subject device set." (implies testing performed and met criteria) |
| Biocompatibility (Hemocompatibility) | "Biocompatibility Testing: ...testing for ...hemocompatibility were performed to ensure the biocompatibility of the subject device set." (implies testing performed and met criteria) |
| Overall Design Input Requirements Met | "The results of these tests confirm that the Peel-Away Introducer meets the design input requirements based on the intended use..." |
Information Not Available in the Document (and why):
- Sample size used for the test set and the data provenance: Not applicable. For physical devices, typically a certain number of units are manufactured and subjected to physical and chemical testing. The document does not specify the number of units tested or their manufacturing origin beyond being a product of Cook Incorporated.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. Ground truth for physical device performance typically relies on engineering specifications, material science standards, and established testing methodologies, not expert consensus in the diagnostic sense.
- Adjudication method for the test set: Not applicable. Physical device testing doesn't typically involve adjudication.
- 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 is a physical introducer, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical introducer, not an AI algorithm.
- The type of ground truth used: For physical performance tests, the "ground truth" is typically defined by industry standards (e.g., ISO, ASTM, internal engineering specifications) and established by objective measurements and analyses of the device's physical properties and behavior under various conditions. For biocompatibility, it's defined by standards like ISO 10993-1.
- The sample size for the training set: Not applicable. There is no AI training set for this physical device.
- How the ground truth for the training set was established: Not applicable.
§ 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.