(175 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 the endoscopic procedures.
The ClearPetra Suction-Evacuation Sheath is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. The intended use is for the passage of endoscopes and other urological devices for the purpose of performing diagnostic and surgical procedures such as, nephroscopy, ureteroscopy, or cystoscopy. It is used for the treatment of stones and for the removal of foreign bodies in the urinary tract.
The ClearPetra Suction-Evacuation Sheath comes in three models: ClearPetra Ureteral Access Sheath, ClearPetra Cystoscope Sheath and ClearPetra Nephrostomy Sheath. The Ureteral Access Sheath includes two versions: Access Sheath for the Semi-rigid Ureteroscope and Access Sheath for the Flexible Ureteroscope.
The ClearPetra Suction-Evacuation Sheath is comprised of the following components:
- Sheath
- Obturator
- Luer Connector
- Y Connector
- Rubber Cap
The sheath is fitted with a Y connector on the proximal end. The Y connector is bifurcated: straight tube and oblique tube, The distal straight tube of the ureteral access sheath is reinforced with metal wires for torque resistance.
one seqment of the Y connector is straight and is contiguous with the sheath: The other is constructed in an oblique angle with a longitudinal pressure control vent. The oblique tube is to be connected to a negative pressure aspirator with clear tube or alternatively, connected to a specimen collector then onto a negative pressure aspirator, then to collect stones or foreign bodies during the endoscopic procedure.
An obturator is included for the insertion of the sheath. The obturator is radiopaque and is fitted with a luer connector on the proximal end. 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 device is offered in French size ranging from 10Fr to 22Fr and length 13cm to 55cm. The device is composed of biologically safe materials. It is supplied sterile and intended for single use only.
The provided text is a 510(k) Summary for the ClearPetra Suction-Evacuation Sheath. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with human readers or AI.
Therefore, many of the requested elements for describing an AI/CADe device's acceptance criteria and study are not applicable to this document. The document describes a traditional medical device and its non-clinical performance testing.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| General Performance: | |
| Connection Strength | Meets all pre-determined testing and acceptance criteria. |
| Bending Resistance | Meets all pre-determined testing and acceptance criteria. |
| Coefficients of Friction | Meets all pre-determined testing and acceptance criteria. |
| Determining the Dimensions | Meets all pre-determined testing and acceptance criteria. |
| Biocompatibility (as per ISO 10993-1): | |
| Cytotoxicity (ISO 10993-5) | Device components in contact with the patient are biocompatible. |
| Irritation (ISO 10993-10) | Device components in contact with the patient are biocompatible. |
| Sensitization (ISO 10993-10) | Device components in contact with the patient are biocompatible. |
| Acute Systemic Toxicity (ISO 10993-11) | Device components in contact with the patient are biocompatible. |
| Sterilization Assurance: | The method of sterilization difference provides equivalent sterility assurance. |
Study Details (Based on the provided document)
Since this is a 510(k) for a physical medical device and not an AI/CADe system, much of the requested information regarding AI/CADe studies is not present.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable for a clinical study of an AI/CADe device. The document refers to "testing datas and results" for general performance and "Biocompatibility testing reports" for biocompatibility. The specific sample sizes for these non-clinical tests are not detailed in this summary. Data provenance for such engineering and biocompatibility tests typically refers to the testing lab and materials, not patient data.
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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):
- Not applicable. This document describes non-clinical performance testing (e.g., connection strength, bending resistance, biocompatibility), not a study requiring expert-established ground truth on patient data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This pertains to clinical studies often involving discrepancy resolution among human readers, which is not described here.
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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 not an AI/CADe device, and no MRMC study is mentioned.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of expert-derived ground truth for patient data. For the non-clinical performance tests, the "ground truth" or acceptance criteria would be defined by engineering specifications, regulatory standards (like ISO 10993 for biocompatibility), and internal product design requirements.
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The sample size for the training set:
- Not applicable. This is not an AI/CADe device that undergoes machine learning training.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/CADe device that undergoes machine learning training.
§ 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.