(44 days)
Applied Medical's Inzii Ripstop Redeployable Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgical procedures.
The Inzii Ripstop Redeployable Retrieval System is a single-use device designed for the containment and extraction of multiple tissue specimens. The device consists of a flexible specimen bag and an introducer tube which can be redeployed for multiple uses within a single procedure. The product will be available in two models, a 10 mm model with a 265 ml specimen bag and a 15 mm model with a 1600 ml specimen bag size. The device is provided sterile and is constructed of a Ripstop nylon specimen bag, various polymers and stainless steel. The major differences between the predicate and the subject device include the subject device featuring a stronger Ripstop nylon specimen bag and the ability to be redeployed multiple times within a single surgical procedure.
The Inzii Ripstop Redeployable Retrieval System is a single-use device designed for the containment and extraction of multiple tissue specimens. The study aims to demonstrate substantial equivalence to its predicate device, the Inzii Tissue Retrieval System (K060051), by performing non-clinical bench tests and simulated use tests.
Acceptance Criteria and Reported Device Performance:
| Performance Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Specimen Retrieval System Functionality testing | The device must demonstrate proper deployment, retraction (for redeployment), and cinching mechanisms. It must effectively contain and allow for the extraction of specimens. | The subject device demonstrated proper deployment, the ability to be retracted for redeployment multiple times within a single surgical procedure, and effective cinching for final retrieval. It successfully contained and allowed for extraction of specimens, meeting the functional requirements. |
| Specimen Retrieval System Leak testing | The specimen bag must be liquid-tight and prevent leakage of contents during simulated use and retrieval, ensuring no spillage of bodily fluids or extracted materials. | The specimen bags of the Inzii Ripstop Redeployable Retrieval System demonstrated liquid-tight integrity. No leakage was observed during simulated use or retrieval, confirming its ability to prevent spillage as required. |
| Specimen Bag Closure testing | The bag closure mechanism (cord loop) must reliably and securely close the bag, preventing accidental opening or spillage of contents during retrieval. | The cord loop closure mechanism was found to be reliable and secure, effectively closing the bag and preventing accidental opening or spillage of contents during simulated retrieval procedures. |
| Specimen Bag Tear Resistance Test | The Ripstop nylon specimen bag must exhibit superior tear resistance compared to the predicate device's polyurethane bag, ensuring the integrity of the bag during specimen collection and retrieval. | The Ripstop nylon specimen bag of the subject device demonstrated significantly higher tear resistance compared to the predicate device, as confirmed by additional testing referenced from K100959. This ensures enhanced integrity and durability during use. |
| Specimen Bag Strength testing | The bag must withstand forces encountered during specimen retrieval, ensuring it does not rupture under typical surgical loads. | The specimen bag demonstrated adequate strength, withstanding the forces typically encountered during specimen retrieval without any rupture or compromise to its integrity. |
| Specimen Bag Pressure testing | The specimen bag must endure internal pressure from contained specimens without bursting or leaking. | The specimen bag successfully endured internal pressure from contained specimens without bursting, leaking, or showing signs of structural failure. |
| Specimen Bag Puncture testing | The specimen bag must resist accidental punctures from instruments or sharp edges of extracted specimens, maintaining its barrier function. | The specimen bag exhibited resistance to accidental punctures from surgical instruments and sharp edges of extracted specimens, effectively maintaining its barrier function and preventing compromise of the contained material. |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity) | The device must pass all biological endpoints as per EN ISO 10993-1; 2020 for an externally communicating device with limited contact duration (up to 24 hours), contacting tissue/bone/dentin. | The device successfully passed all required biological endpoints: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity (AST), and Material Mediated Pyrogenicity (MMP), confirming its biocompatibility for the intended use and contact duration. |
Study Information:
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Sample sizes used for the test set and data provenance:
- The document does not explicitly state the exact sample sizes for each specific performance test (e.g., number of devices tested for leak, strength, etc.). It refers to "sample size" generally in the context of the performance data summary.
- The data provenance is from non-clinical bench tests and simulated use tests conducted by Applied Medical Resources Corporation. There is no indication of country of origin for data or whether it's retrospective or prospective, as these are bench tests.
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Number of experts used to establish the ground truth for the test set and qualifications:
- This information is not applicable as the document describes performance testing of a physical medical device (specimen retrieval system), not an AI/software device that requires expert-established ground truth. The 'ground truth' here is the objective outcome of the physical/mechanical and biological tests.
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Adjudication method for the test set:
- This is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving reader interpretations, not for bench testing of physical device performance.
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Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic/interpretive devices where human readers' performance is augmented by AI. The Inzii Ripstop Redeployable Retrieval System is a physical surgical tool.
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Standalone (algorithm only without human-in-the-loop performance) study:
- No, a standalone study was not done. This concept is specific to AI algorithms. The device described functions with human interaction during surgery.
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Type of ground truth used:
- For the performance testing, the "ground truth" used was based on objective measurements and observations from the non-clinical bench tests and simulated use tests. This includes parameters like liquid tightness, resistance to tearing/puncture, and mechanical functionality, as well as established ISO standards for biocompatibility.
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Sample size for the training set:
- This information is not applicable as the document describes performance testing of a physical medical device, not an AI/machine learning model that requires a training set.
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How the ground truth for the training set was established:
- This information is not applicable as there is no training set for a physical medical device.
§ 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.