(79 days)
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.
When used in women with fibroids, the More-Cell System is for women who are pre-menopausal and under age 50. More-Cell-System is compatible with electromechanical laparoscopic power morcellators that are between 12 mm and 20 mm in shaft outer diameter and between 95 mm and 170 mm in shaft working length.
The More-Cell-System device is used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures (e.g., hysterectomy and myomectomy). The key components of the device include the following:
-
A. More-Cell Bag: A single use, insufflatable, transparent, EO sterilized bag made of 50 µm thick polyurethane film that is biocompatible and cell-tight. The bag includes printed lines to aid in visualization during surgery. There are two openings to the bag: one opening that is 16 cm in diameter where a morcellator can be inserted (and where tissue can be removed), and a second opening that is 16 mm in diameter x 190 mm in length where a laparoscope can be inserted to visualize the surgical procedure. The bag capacity is 2.5 L (340 x 250 mm).
-
B. Visi-Shield: A metal sleeve with a polycarbonate window for lens protection (comes in 0° or 30° angle) that is cell-tight to protect the laparoscopic camera during a surgical procedure. Using the Visi-Shield the surgical procedure can be visualized without compromising the integrity of the bag, laparoscopic view, or safety of the laparoscopic camera.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization | Sterility assurance level of 10^-6 | Validated per ANSI/AAMI/ISO 11135 and ISO 10993-7. |
| Shelf Life | Continued sterility, package integrity, and device functionality over intended shelf life (2 years) | Package integrity (visual inspection, dye penetration, peel strength, microbiological stability) and device functionality maintained after 2 years accelerated aging, shipping, and handling (per ASTM F1980 and ISO 11607). |
| Biocompatibility | Device not cytotoxic, sensitizing, irritating, or acutely toxic | All tests (Cytotoxicity, Sensitization, Intracutaneous irritation, Acute systemic toxicity) demonstrated the device was not cytotoxic, sensitizing, irritating, or acutely toxic. |
| Impermeability (Tissue/Cells/Fluids) | No evidence of permeability to E. coli under worst-case clinical pressures. | No evidence of permeability in 36 More-Cell bags after 2-years aging and simulated use conditions; positive and negative controls performed as intended. Met acceptance criteria for |
§ 884.4050 Gynecologic laparoscopic power morcellation containment system.
(a)
Identification. A gynecologic laparoscopic power morcellation containment system is a prescription device consisting of an instrument port and tissue containment method that creates a working space allowing for direct visualization during a power morcellation procedure following a laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible;
(2) Device components that are labeled sterile must be validated to a sterility assurance level of 10
−6 ;(3) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the intended shelf life;
(4) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested:
(i) Demonstration of the device impermeability to tissue, cells, and fluids;
(ii) Demonstration that the device allows for the insertion and withdrawal of laparoscopic instruments while maintaining pneumoperitoneum;
(iii) Demonstration that the containment system provides adequate space to perform morcellation and adequate visualization of the laparoscopic instruments and tissue specimen relative to the external viscera;
(iv) Demonstration that intended laparoscopic instruments and morcellators do not compromise the integrity of the containment system; and
(v) Demonstration that intended users can adequately deploy the device, morcellate a specimen without compromising the integrity of the device, and remove the device without spillage of contents;
(5) Training must be developed and validated to ensure users can follow the instructions for use; and
(6) Labeling must include the following:
(i) A contraindication for use in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy;
(ii) Unless clinical performance data demonstrates that it can be removed or modified, a contraindication for removal of uterine tissue containing suspected fibroids in patients who are: Peri- or postmenopausal, or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision;
(iii) The following boxed warning: “Warning: Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk.”
(iv) A statement limiting use of device to physicians who have completed the training program; and
(v) An expiration date or shelf life.