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510(k) Data Aggregation
(275 days)
The Levita Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures; the liver in bariatric procedures; the prostate and periprostatic tissue in prostatectomy procedures; and the colon, rectum, and pericolorectal procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients with a BMI range of 20-60-kg/m².
The Levita Magnetic Surgical System is composed of two hand-held instruments, the Magnetic Grasper and external Magnetic Controller. The Magnetic Grasper (sterile, single use), comprised of a distal detachable Grasper Tip attached to a Shaft with handle, is actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the detachable Grasper Tip jaws. Once the Magnetic Grasper is inserted through a compatible ≥ 10 mm laparoscopic port and the Grasper Tip is attached to the desired tissue, the Grasper Tip can be detached from the Shaft and controlled externally using the Magnetic Controller. Traction of the tissue is maintained through the magnetic field attraction between the Grasper Tip and the Magnetic Controller. The Magnetic Controller (non-sterile, reusable) is a single unit with handles that is held external to the body and emits a magnetic field that attracts the Grasper Tip. Once the Grasper Tip is attached to the desired tissue and detached from the Shaft, the Magnetic Controller is placed external to the body to magnetically attract the Grasper Tip to manipulate the target tissue. Adjusting the distance between the Magnetic Controller and the Grasper Tip will modulate the magnetic attraction used for tissue retraction/mobilization. If desired, the user can connect the Magnetic Controller to a commercially available surgical support arm that is compatible with its arm mount.
The Levita Magnetic Surgical System is a medical device designed to grasp and retract soft tissues and organs during surgical procedures. The device, which consists of a Magnetic Grasper and an external Magnetic Controller, received an administrative change related to its previous substantial equivalence (SE) determination from the FDA on April 15, 2020. The change was an update to its indications for use, expanding its application to colorectal procedures.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Special Control - 21 CFR 878.4815) | Reported Device Performance |
|---|---|
| (1) In vivo performance data must demonstrate that the device performs as intended under anticipated conditions of use. Testing must demonstrate the ability of the device to grasp, hold, retract, mobilize or manipulate soft tissue and organs. (Specifically, for the new indication: colorectal procedures, including grasping and retracting the colon, pericolorectal tissue and adjacent organs) | Met: An animal study in a porcine model demonstrated the safety and effectiveness of the Levita Magnetic Surgical System (MSS) in simulated colorectal procedures. The results met all predetermined acceptance criteria: - The MSS provided adequate retraction of the colon, peri-colorectal tissues, and adjacent organs to achieve effective access and visualization of the target tissue. - No device-related serious or severe adverse events were reported. - There was no post-excision or intraoperative tissue trauma. - Surgeons reported that the MSS was the same or better than conventional laparoscopic graspers for use in the subject procedures. The study concluded that the MSS is safe and effective in colorectal procedures while using one fewer access port (trocar), supporting the risk assessment that there are no new or different risks. |
| (2) Non-clinical performance data must demonstrate that the system performs as intended under anticipated conditions of use. (a) Magnetic field strength testing characterization; (b) Ability of the internal surgical instrument(s) to be coupled, de-coupled, and re-coupled. | Met (by previous submission): The modifications for the current submission did not change the magnetic field strength or the coupling mechanism. Therefore, previously conducted non-clinical performance testing, which demonstrated that the device performs as intended under anticipated conditions, was deemed applicable. |
| (3) The patient-contacting components of the device must be demonstrated to be biocompatible. | Met (by previous submission): The modifications did not change any aspect of the device relevant to biocompatibility. Therefore, previously conducted testing demonstrating biocompatibility was deemed applicable. |
| (4) Performance data must demonstrate the sterility of the device components that are patient-contacting. | Met (by previous submission): The modifications did not change any aspect of the device relevant to sterility. Therefore, previously conducted testing demonstrating sterility was deemed applicable. |
| (5) Methods and instructions for reprocessing reusable components must be validated. | Met (by previous submission): The modifications did not change any aspect of the device relevant to reprocessing. Therefore, previously conducted testing validating reprocessing methods and instructions was deemed applicable. |
| (6) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components and device functionality over the labeled shelf life. | Met (by previous submission): The modifications did not change any aspect of the device relevant to shelf life. Therefore, previously conducted testing validating shelf life was deemed applicable. |
| (7) Training must be developed and validated by human factors testing and analysis to ensure users can follow the instructions for use to allow safe use of the device. | Met (by previous submission): A usability study to validate the training program was previously conducted for the predicate device. Changes to the training program for the updated Indications for Use did not require a repeat of the previous usability study. |
| (8) Labeling must include: (a) Magnetic field safezones; (b) Instructions for proper device use; (c) Screening checklist; (d) Reprocessing instructions; (e) Shelf life; (f) Use life. | Met: The labeling complies with all the stated special controls. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document specifies an "animal study... in the porcine model." It does not explicitly state the number of animals used in the test set.
- Data Provenance: The study was an "animal study," specifically in a "porcine model." The country of origin of the data is not specified, nor is whether it was prospective or retrospective, though animal studies for device approval are typically prospective.
3. Number of Experts and Qualifications to Establish Ground Truth for the Test Set
- Number of Experts: The document states, "Surgeons reported that the MSS was the same or better than conventional laparoscopic graspers." It does not specify the exact number of surgeons (experts) involved in this assessment.
- Qualifications of Experts: The experts are referred to as "Surgeons." No further details on their specific qualifications (e.g., years of experience, subspecialty) are provided in the provided text.
4. Adjudication Method for the Test Set
- The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The assessment seems to be based on the reports of "surgeons."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study is mentioned in the provided text. The study described is an animal study evaluating the device's performance, not a comparison of human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- The Levita Magnetic Surgical System is a physical surgical instrument, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed. The performance evaluation focuses on the instrument's ability to manipulate tissue.
7. Type of Ground Truth Used
- For the in vivo performance, the ground truth was established by direct observation and assessment of the device's performance during simulated surgical procedures in live animals (porcine model). This included:
- Direct visualization of access and visualization of the target tissue.
- Monitoring for device-related serious or severe adverse events.
- Pathological assessment for post-excision or intraoperative tissue trauma.
- Subjective feedback from "Surgeons" regarding the device's effectiveness compared to conventional instruments.
8. Sample Size for the Training Set
- The supplied text does not refer to a "training set" in the context of machine learning or AI models, as the Levita Magnetic Surgical System is a physical surgical device. Therefore, this question is not applicable.
9. How Ground Truth for the Training Set Was Established
- As the device is a physical surgical system and not an AI/ML product, the concept of a "training set" and establishing ground truth for it does not apply.
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