(54 days)
The ClearPetra Suction-Evacuation Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during endoscopic procedures.
The ClearPetra Suction-Evacuation Sheath consists of a straight distal tube and a proximal bifurcated tube. The distal straight tube of the ureteral access sheath is reinforced with metal wires for torque resistance. One segment of the proximal bifurcated tube is straight and is contiguous with the distal tube. The other is constructed in an oblique angle with a longitudinal pressure control vent. An obturator is included for the insertion of the sheath. The obturator can be locked to the proximal end of the straight tube using a luer lock mechanism. A rubber cap with central aperture is included as an accessory. It is to be placed at the proximal end of the straight tube after the removal of the obturator. The oblique tube is to be connected directly to a negative pressure aspirator with a clear tube or alternatively, connected to a specimen collector (packed separately) then onto a negative pressure aspirator.
The provided document is a 510(k) Summary for a medical device called the "ClearPetra Suction-Evacuation Sheath." It primarily focuses on demonstrating substantial equivalence to a predicate device (K161110 - ClearPetra Suction-Evacuation Sheath) rather than presenting a performance study against specific acceptance criteria for a new AI/software device.
Therefore, many of the requested sections about acceptance criteria, study details, expert involvement, and ground truth are not applicable in this context, as this submission is for a modified hardware device, not an AI software.
Here's an analysis based on the information provided in the document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, etc.) for a diagnostic or AI device. Instead, it relies on comparison to a predicate device and bench testing to demonstrate that the modifications do not negatively impact safety and effectiveness.
The "acceptance criteria" can be inferred from the "Verdict" column in the comparison table and the subsequent non-clinical testing. These broadly aim to demonstrate that the modified device performs as well as or similarly to the predicate device, or within acceptable safety parameters for the new specifications.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Material: Same as predicate device (PE, PA) | Same |
| Sterilization Method: Same as predicate device (EO sterilized) | Same |
| Size: New product specifications (24Fr, 26Fr) for Nephrostomy Sheath are safe and effective. | Different. "Since the new product specification is not far outside cleared product specification, the change could not significantly affect the device's safety or effectiveness. The new product specifications were tested as per Product Specification." |
| Length: Modified dimension (15cm added to Nephrostomy Sheath) is safe and effective. | Similar. "Although a modified dimension is within a range of dimensions previously cleared for the original device, the change could not significantly affect the device's safety or effectiveness. The new product specifications were tested as per Product Specification." (Note: The table also lists 13cm to 55cm for both, implying the range is similar, but new specific lengths were added.) |
| Component: Similar to predicate (Sheath, Obturator, Connector, Rubber Cap) | Similar |
| Biocompatibility: Meet ISO 10993-1 standards (Cytotoxicity, Irritation, Sensitization, Acute System Toxicity, Material mediated pyrogenicity) | Similar. Subject device tested for Material mediated pyrogenicity (in addition to the others already covered by the predicate), fulfilling the ISO 10993-1 standard. |
| Overall Performance (Bench Testing): Verify performance is substantially equivalent to predicate and performs as intended. | "A Performance Bench testing has been conducted to verify that the performance of the proposed ClearPetra Suction-Evacuation Sheath is substantially equivalent to the predicate device, and that the ClearPetra Suction-Evacuation Sheath will perform as intended." |
| Sterilization Efficacy: Ethylene oxide sterilization process is validated. | "A Sterilization by ethylene oxide has been validated for ClearPetra Nephrostomy Sheath." |
| Safety and Effectiveness: Modifications do not raise new issues of safety and effectiveness. | "No new issues of safety and effectiveness were identified during this process [Risk Analysis]." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The studies mentioned are primarily "Non-Clinical Testing" and "Bench Testing" rather than clinical studies with human participants. Therefore, concepts like "test set," "data provenance," and "retrospective/prospective" as they relate to clinical data are not applicable here. The testing would have likely involved physical samples of the device components.
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 information is not applicable as the document describes a hardware device modification and bench testing, not a study requiring expert-established ground truth for diagnostic accuracy (e.g., for an AI system evaluating medical images).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as above. No clinical expert adjudication is mentioned or implied for the non-clinical testing performed.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and was not performed. This type of study is relevant for AI-powered diagnostic aids, not for the modification of a physical medical device like a suction-evacuation sheath.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm is not applicable as this submission is for a physical medical device, not an algorithm or AI software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" (in the context of expert consensus, pathology, or outcomes data) is not applicable here. The ground for determination of "acceptance" or "substantial equivalence" relies on:
- Physical/material specifications comparison.
- Biocompatibility testing against ISO standards.
- Performance bench testing results demonstrating functional equivalence and intended performance.
- Sterilization validation.
8. The sample size for the training set
This information is not applicable as there is no AI algorithm or software being trained.
9. How the ground truth for the training set was established
This information is not applicable as there is no AI algorithm or software being trained.
§ 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.