(24 days)
The Guardenia 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, Guardenia, 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.
Guardenia consists of a flexible specimen containment/extraction Bag, with an integrated Opening Ring and Bag Tether with a separate Guard component to protect the Bag and incision during morcellation with a scalpel.
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 standard sized 12mm trocar cleared to market by the FDA may be used as an accessory for device deployment. A blue arrow on the Introducer provides the user with an indicator of the correct orientation during deployment in the abdominal cavity to ensure the Bag is correctly deployed.
After the Bag is ejected from the Introducer into the abdominal cavity, the nitinol wire Opening Ring recovers its shape, opening the mouth of the Bag. This facilitates the encapsulation of the specimen. When the specimen is encapsulated, the Bag Tether, which extends externally through the trocar after deployment, is pulled, pulling the Opening Ring out through the trocar. This action also closes the mouth of the Bag inside the abdomen.
The incision is then increased to the required size (2.5-6 cm) prior to removal of the trocar is removed, the mouth of the Bag is exteriorized, and then opened outside the abdomen. If the specimen is small enough, the Bag and specimen can be removed at this stage without the need for morcellation or the use of the Guard.
If the specimen requires reduction, the Guard must be deployed first.
To deploy the Guard, the free end of the end opposite to the blue Guard Ring) is inserted through the mouth of the Bag. The yellow Anchor Ring is then inserted through the center of 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 & Bag from damage due to inadvertent scalpel strikes or the traumatic graspers that are used to grasp and hold the tissue specimen at the incision.
The physician then performs extracorporeal manual morcellation using a grasper and a scalpel. When the tissue specimen has been removed or sufficiently reduced, the surgeon flips 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.
This document is a 510(k) premarket notification from the FDA, specifically concerning a labeling change for the "Guardenia (GAR-1)" contained extraction system. The content explicitly states that the submission is for a label change only and that no non-clinical tests were required to support the change. This means there is no study described within this document that proves the device meets acceptance criteria through performance evaluation.
Therefore, I cannot provide the requested information regarding acceptance criteria and device performance based on the provided text. The document does not describe any specific testing, acceptance criteria, sample sizes, expert involvement, or ground truth establishment relevant to device performance outside of the label change.
However, I can extract the relevant information regarding the nature of this submission:
- Device Name: Guardenia (GAR-1)
- Device Type: Contained extraction system (Tissue Bag)
- Regulation Number: 21 CFR 876.1500 (Endoscope And Accessories)
- Regulatory Class: Class II
- Product Code: GCJ
- Indications for Use: To contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.
- Contraindications:
- Contraindicated for use with laparoscopic power morcellators.
- Contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.
- Nature of Submission: Special 510(k) for a label change only.
- Specific Label Change: Removal of the contraindication "Do not use on tissue that is known or suspected to contain malignancy" and addition of a precaution: "Use caution when using the Guardenia contained extraction system for removal/manual morcellation of uterine tissue may contain unsuspected cancer."
Conclusion:
The provided text does not contain any information about performance studies, acceptance criteria, or data proving the device meets performance criteria, as it is a submission solely for a labeling change. The document explicitly states: "This Special 510(k) is for a label change only. There is no non-clinical tests required to support the change."
§ 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.