(147 days)
The RedEx contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation.
The Advanced Surgical Concepts Ltd, RedEx, is a contained extraction system; proposed under classification regulation 21 CFR 876.1500, device class II and product code GCJ.
The device is provided sterile for single use.
The RedEx consists of a flexible specimen containment Baq, with an integrated Opening Ring and Bag Tether and a separate Guard component to protect the Bag and incision.
The Bag is made from polyurethane (PU) film and comes preloaded in an Introducer. There is a Plunger to deploy the Bag into the abdominal cavity. Any FDA cleared 12mm trocar may be used as an accessory for device deployment. This is a standard sized trocar for use in laparoscopic surgery. A blue arrow on the Introducer provides the user with the correct orientation for insertion of the Introducer to ensure the Bag is correctly deployed.
After the Baq is ejected from the Introducer into the abdominal cavity, the mouth of the Bag returns to its original circular shape. The nitinol wire Opening Ring facilitates placement of the specimen in the Bag. When the specimen is encapsulated and ready for removal or extracorporeal manual morcellation the Bag Tether is pulled, closing the Bag. The Bag Tether and Opening Ring exit through the 12mm trocar, indicating the Bag is fully closed. The incision is then increased to the required size, 2.5-6cm, prior to removal of the trocar is removed, and the mouth of the Bag is opened outside the abdomen. The free end of the Guard. which includes the Guard Petals and is opposite the end with the Guard Ring, is then inserted through the mouth of the Bag followed by the Anchor Ring. The Guard is actuated by flipping the Rolling Ring inward until the incision is maximized. The Guard Petals, which are made from a tough polyethylene (PE) film, overlap and conform to the incision; protecting the incision and Bag material from inadvertent scalpel strikes and from the traumatic graspers that are used to grasp and hold the tissue specimen at the incision.
The physician then performs extracorporeal manual morcellation using manual surgical instruments (e.g., a grasper and a scalpel). When the tissue specimen has been removed, the surgeon flips the Rolling Ring in the opposite direction two or three times and pulls on the Removal Ribbon to remove the Guard. The Bag is removed by grasping the Opening Ring and carefully removing the Bag from the incision.
The provided text describes the RedEx device, a contained extraction system for tissue removal during surgery, and its comparison to a predicate device to establish substantial equivalence for FDA clearance. However, it does not contain a study that establishes clear acceptance criteria or reports device performance against such criteria in the quantifiable way requested. Instead, it details various performance tests conducted to demonstrate substantial equivalence to a predicate device.
Therefore, I cannot populate the table or answer all sub-questions as requested because the specific acceptance criteria and detailed device performance outcomes are not explicitly stated in the provided text in a quantifiable manner (e.g., sensitivity, specificity, accuracy, or specific thresholds for durability, puncture resistance etc.). The document focuses on demonstrating that the RedEx device performs "as intended" and "as expected" and is "as safe and effective" as the predicate device through various testing, rather than presenting a study with pre-defined, quantifiable acceptance criteria and the RedEx's performance against them.
Here's what can be extracted and what is missing based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document in a quantifiable format. The document states that "In all instances, the RedEx functioned as intended and the results observed were as expected" for the various tests. It also mentions testing areas like "Bag material and seal strength," "Bag material puncture-resistance," "Guard puncture-resistance," "Guard coverage and security," and "Simulated use," but does not provide specific numerical acceptance criteria (e.g., minimum tensile strength, maximum puncture force, minimum coverage percentage) or the corresponding measured performance values for the RedEx device for these tests. The comparison is framed in terms of "Substantial Equivalence," implying that its performance was comparable to the predicate for these aspects.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "Side-by-side testing" and "Additional testing" but does not provide the number of units or cases used in these tests.
- Data Provenance: The document implies the tests were conducted by the manufacturer, Advanced Surgical Concepts Ltd, potentially with independent laboratory assistance for biocompatibility (Toxikon). The data is associated with the device's premarket notification (K211234). There is no mention of country of origin for data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts and qualifications: Not mentioned. The testing described is primarily bench-top and simulated use. There is no mention of human experts establishing ground truth for the performance of the device in a clinical context within this document.
4. Adjudication method for the test set:
- Adjudication method: Not mentioned. Given the nature of the bench and simulated use testing, a formal adjudication method by experts is unlikely to have been part of the evaluation for these specific performance tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC study: Not applicable/Not mentioned. The device is a contained extraction system (medical device), not an AI-based diagnostic tool for interpretation by human readers. Therefore, an MRMC study or AI-related improvement metrics are not relevant or discussed in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone algorithm performance: Not applicable/Not mentioned. This is not an AI-driven device.
7. The type of ground truth used:
- Type of ground truth: For the performance tests listed (e.g., material strength, puncture resistance, simulated use), the "ground truth" would be established by physical measurements, engineering standards, and functional assessments against design specifications or a predicate device's performance. There is no biological or diagnostic "ground truth" (like pathology or clinical outcomes) being assessed in the context of these specific performance tests described.
8. The sample size for the training set:
- Training set sample size: Not applicable/Not mentioned. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- How ground truth was established for training set: Not applicable/Not mentioned for the same reason as above.
§ 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.