(81 days)
Not Found
No
The summary describes a mechanical containment system for laparoscopic procedures and bench/animal testing focused on physical properties and integrity. There is no mention of AI or ML.
No.
The ContainOR is described as a bag containment system for tissue extraction and/or power morcellation during laparoscopic procedures, providing a contained space for the safe morcellation of tissue. It is an accessory to a surgical procedure, designed to contain tissue, rather than directly treat a disease or medical condition.
No
The ContainOR is described as a bag containment system for tissue extraction and/or power morcellation during laparoscopic procedures. Its function is to provide a contained space for tissue handling, not to diagnose medical conditions or provide information for diagnosis.
No
The device description clearly states it consists of physical components: a laparoscopic multi-instrument port and a tissue pouch (bag). The performance studies also focus on the physical properties and functionality of these hardware components.
Based on the provided information, the ContainOR device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "tissue extraction and/or power morcellation during general laparoscopic procedures." This is a surgical procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The device consists of a port and a tissue pouch. These are surgical tools for containing tissue during a procedure.
- Performance Studies: The performance studies focus on the physical integrity, barrier properties, and functionality of the device during simulated surgical use. They evaluate things like leak resistance, material strength, and compatibility with other surgical instruments. There are no studies related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue samples for diagnostic purposes), detecting analytes, or providing diagnostic results.
In summary, the ContainOR is a surgical containment system, not a device used for diagnosing diseases or conditions based on in vitro analysis of biological samples.
N/A
Intended Use / Indications for Use
The ContainOR is a bag containment system intended for use by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures. The ContainOR is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15mm and 18mm in shaft outer diameter and 135mm and 180mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.
Product codes (comma separated list FDA assigned to the subject device)
PZQ
Device Description
The ContainOR device consists of two main components:
- A laparoscopic multi-instrument port.
- Tissue pouch (Bag) intended to provide a contained space in the abdomen for the safe morcellation of tissue.
The laparoscopic multi-instrument port consists of the Retractor, Retractor Introducer, and the Valve Assembly. The Retractor Introducer is placed through the abdominal incision to deliver the distal ring on the Retractor. The Retractor retracts the incision to allow passage of laparoscopic instruments and provides an anchor for the Valve Assembly. The Valve Assembly consists of two insufflation ports and two instrument ports. The insufflation ports are used to maintain pneumoperitoneum and to vent smoke during the course of the procedure. The instrument ports consist of the large instrument valve port which allows the introduction for the Bag and Morcellator and a 5mm valve port that can accommodate a 5mm instrument such as a laparoscope or grasper. The large instrument valve includes a reducer than can reduce the valve opening to 5mm for smaller instruments. The Bag is preloaded into the Bag Introducer, which is inserted through the Large Instrument Valve in the Valve Assembly. The Bag Introducer Plunger is depressed into the shaft, ejecting the Bag into the abdominal cavity. An opening ring on the neck of the Bag ensures the bag remains open. Once the specimen is placed in the bag, a tether closes the Bag and exteriorizes the collar section. The Valve Assembly can then be reattached inside the exteriorized Bag enabling inflation of the bag and re-establishing pneumoperitoneum. The multi-instrument port may now be used for power morcellation under direct visualization. After morcellation is complete, the Bag is deflated and the Valve Assembly is removed. The Bag is removed followed by the Retractor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified surgeons. The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109.
Description of the training set, sample size, data source, and annotation protocol
A training program for the ContainOR system was validated using a porcine model. Thirty-four participants with a range of experience in laparoscopy (21 experienced, 13 inexperienced) were recruited. Each participant used at least 3 ContainOR systems during training. Four different morcellators were used (2 bipolar and 2 electromechanical). The training validation consisted of:
- A study coordinator showing and describing use of the ContainOR system while the participant reads the Instructions for Use (IFU).
- Assisted device set up and use where the coordinator assists the participant in set up and use of the ContainOR system in the training rig.
- Participant setting up and using the ContainOR system without assistance in the training rig.
- Participant setting up and using the ContainOR system in a porcine model (beef tongue in various sizes used for morcellation specimen).
Description of the test set, sample size, data source, and annotation protocol
For the Design Validation for ContainOR System, participants used one ContainOR system in a porcine model with beef tongue for the morcellation specimen. Specimen sizes tested ranged from approximately (b) (4) with three samples (b) (4) range. 31 participants (21 experienced, 10 inexperienced) performed set up and use of the morcellator. Following removal, the test coordinator performed a leak test on the ContainOR pouch. The ContainOR pouch was filled with water (b) (4) and observed for leaks.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility/Materials:
- Study Type: Biocompatibility evaluation
- Sample Size: Not specified, but the complete device in its final finished form was evaluated.
- Key Results: The ContainOR system is an externally communicating device, contacting tissue/bone/dentin for limited duration
§ 878.4825 General laparoscopic power morcellation containment system.
(a)
Identification. A general 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 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) Performance testing must demonstrate the sterility of patient-contacting components of the device.
(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life.
(4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. 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/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 compatible laparoscopic instruments and morcellators do not compromise the integrity of the containment system; and
(v) Demonstration that 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.
(6) Labeling must include:
(i) A contraindication for use in gynecological procedures;
(ii) A contraindication against use of tissue that is known or suspected to contain malignancy;
(iii) The following boxed warning: “Warning: Information regarding the potential risks of a procedure with this device should be shared with patients. The use of laparoscopic power morcellators 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) A shelf life.
0
DE NOVO CLASSIFICATION REQUEST FOR CONTAINOR
REGULATORY INFORMATION
FDA identifies this generic type of device as:
General laparoscopic power morcellation containment system: A general 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 tissue that is not suspected to contain malignancy.
NEW REGULATION NUMBER: 21 CFR 878.4825
CLASSIFICATION: II
PRODUCT CODE: PZQ
BACKGROUND
DEVICE NAME: ContainOR
SUBMISSION NUMBER: DEN170075
DATE OF DE NOVO: September 29, 2017
- CONTACT: Advanced Surgical Concepts Unit 4 Sunnybank Centre Upper Dargle Road Bray, County Wicklow Ireland
INDICATIONS FOR USE
The ContainOR is a bag containment system intended for use by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures. The ContainOR is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15mm and 18mm in shaft outer diameter and 135mm and 180mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.
LIMITATIONS
The sale, distribution, and use of the device are restricted to prescription use in
1
accordance with 21 CFR 801.109.
Contraindications
- o Do not use for gynecological procedures.
- Do not use on tissue that is known or suspected to contain malignancy. O
- Do not use this device on patients with known or suspected allergies to O polyurethane.
- Do not use where the abdominal wall thickness is larger than 10 cm. O
Boxed Warning
o Information regarding the potential risks of a procedure with this device should be shared with patients. The use of laparoscopic power morcellators may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk.
Warnings
- o Do not cut, puncture or scrape the Bag with the morcellator tip, tenaculum/grasper or any sharp instrument.
- o Do not use if package or printed information is damaged. The device is supplied sterile; inspect the package to ensure it is intact.
- o This device is single-use only. Do not re-sterilize or reuse any portion of this device.
- o Re-use or re-sterilization may create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
- o Check for and remove adhesions that may inhibit proper placement of the device.
- o The Bag must be fully inflated (12 15 mmHg) to minimize the risk of damage to the bag and adjacent organs during morcellation.
- o At all times prior to morcellating, make sure the tenaculum/grasper is within view when grasping tissue, to prevent it contacting the Bag.
- o The tip of the morcellator must be brought into view, prior to and during each activation to provide confirmation of the position of the morcellator tip and its proximity to the Bag.
- 0 With the tip of the morcellator in view, prior to activating the morcellator, confirm that the tissue specimen is centered within the Bag.
- o Do not bring the morcellator tip into contact with the Bag.
- o Any abdominal incision introduces a risk of abdominal hernia.
Precautions
- o Please read all instructions prior to use.
- o Device should only be used with 5mm laparoscopes with ≥30° lens angle or deflectable tip.
- O Only use an atraumatic grasper to manipulate the Bag.
- o Appropriate pre-operative diagnostic testing should be completed prior to using this device.
- o For procedures that contain stones, remove with an atraumatic grasper through the
2
large valve or incision. For large stones, 4-5 cm, an increase in incision size may be required. Use a surgical retractor to protect the bag if lengthening the incision.
- o This device should only be used by surgeons with advanced training in laparoscopic techniques.
- o This device should only be used by surgeons who have successfully completed the validated training program.
- 0 Regarding the grasper/tenaculum used, teeth which are curved proximally to shield their sharp tips may help reduce the risk of damage to the bag from the grasper/tenaculum. However, a lower risk grasper does not alter the risk of damage to the bag from the morcellator tip. Careful adherence to the training provided and the Instruction for Use regarding placement and visualization of the tip remains critical.
- o After use, the device is a potential biohazard. Handle and dispose of as required by hospital policy and applicable laws.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS AND PRECAUTIONS.
DEVICE DESCRIPTION
The ContainOR device consists of two main components:
- A laparoscopic multi-instrument port .
- Tissue pouch (Bag) intended to provide a contained space in the abdomen for the safe morcellation of tissue.
Image /page/2/Figure/10 description: The image shows a medical device with labeled components. The components are labeled as follows: 1. Retractor Introducer, 2. Retractor, 3. Valve Assembly, 4. Bag Introducer Shaft and Plunger, and 5. Bag. The image provides a clear view of the device and its individual parts.
Figure 1: ContainOR Device with labeled components
3
Figure 1 describes the sub-components of the device. The laparoscopic multi-instrument port consists of the Retractor, Retractor Introducer, and the Valve Assembly.
The Retractor Introducer is placed through the abdominal incision to deliver the distal ring on the Retractor. The Retractor retracts the incision to allow passage of laparoscopic instruments and provides an anchor for the Valve Assembly. The Valve Assembly consists of two insufflation ports and two instrument ports. The insufflation ports are used to maintain pneumoperitoneum and to vent smoke during the course of the procedure. The instrument ports consist of the large instrument valve port which allows the introduction for the Bag and Morcellator and a 5mm valve port that can accommodate a 5mm instrument such as a laparoscope or grasper. The large instrument valve includes a reducer than can reduce the valve opening to 5mm for smaller instruments.
The Bag is preloaded into the Bag Introducer, which is inserted through the Large Instrument Valve in the Valve Assembly. The Bag Introducer Plunger is depressed into the shaft, ejecting the Bag into the abdominal cavity.
Image /page/3/Picture/3 description: The image shows a diagram of a piece of equipment. The equipment has a circular base with a tube extending from the bottom. There is a support structure that extends upwards from the base, with a circular pad attached to the top of the support structure.
Figure 2. Tissue specimen being placed in Bag
In Figure 2, an opening ring on the neck of the Bag ensures the bag remains open. Once the specimen is placed in the bag, a tether closes the Bag and exteriorizes the collar section. The Valve Assembly can then be reattached inside the exteriorized Bag enabling inflation of the bag and re-establishing pneumoperitoneum. The multi-instrument port may now be used for power morcellation under direct visualization.
After morcellation is complete, the Bag is deflated and the Valve Assembly is removed. The Bag is removed followed by the Retractor.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The ContainOR system includes materials and colorants that have direct and indirect patient contact for duration of up to 6 hours. The complete device in its final, finished form was subject to an evaluation of biocompatibility in accordance with ISO 10993-1: Biological evaluation of medical devices, Part 1: Evaluation and Testing. The
4
ContainOR system is an externally communicating device, contacting tissue/bone/dentin for limited duration