(87 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 pillar of the diaphragm and peripillar tissue in bariatric or hiatal hernia procedures; the prostate and periprostatic tissue in prostatectomy procedures; and the colon, rectum, and pericolorectal tissue in colorectal 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 Grasper Tip, 12.5 is designed to grasp and retract the pillar of the diaphragm and peripillar tissue in bariatric or hiatal hernia 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 Magnetic Surgical System comprises two hand-held instruments, the Magnetic Grasper and the external Magnetic Controller. The Magnetic Grasper, disposable and provided sterile for single use, comprises two main components: a detachable Grasper Tip (6.5cm overall length) and a Shaft with Handle. An optional 12.5cm length Grasper Tip (also single use, disposable, and provided sterile) may be used as a replacement for the 6.5cm Grasper Tip and can be used interchangeably with the Shaft.
The Magnetic Grasper is actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the Grasper Tip jaws. Once the Magnetic Grasper is inserted through a compatible ≥ 10 mm laparoscopic port to the surgical site 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 is a non-sterile, reusable unit with handles that is held external to the body and emits a magnetic field that attracts the detachable 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 provided text describes the 510(k) clearance for the Levita Magnetic Surgical System. Here's a breakdown of the requested information.
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions acceptance criteria were met across various tests, but it does not specify the numerical criteria or detailed performance metrics for each. It generally states that the device "passed all tests and met all acceptance criteria."
| Test Category | Acceptance Criteria (Not explicitly stated numerically, but implied as "met") | Reported Device Performance |
|---|---|---|
| Non-Clinical Mechanical Performance | All design requirements and performance specifications met for the modified Magnetic Grasper and Grasper Tip, 12.5 line extension for 12 months. | The device "passed all tests and met all acceptance criteria." These results "demonstrate that for the entirety of the labeled shelf-life of 12 months, all design requirements and performance specifications have been met and the design conforms to user needs and meets the intended use." |
| Human Factors Assessment (IEC 62366-1) | No additional human factors validation testing required for the changes. | Concluded "no additional human factors validation testing is required for the changes." |
| Biocompatibility (ISO 10993-1) | Compliance with standard. | Biocompatibility testing of the Grasper Tip, 12.5 line extension passed. |
| Sterilization Adoption (AAMI TIR35, ISO 11137-1, ISO 11137-2) | Compliance with standards. | Sterilization adoption testing for the line extension passed. |
| Real-time Shelf-life Testing | 12-month shelf life maintained. | Real-time shelf-life testing of the modified Magnetic Grasper passed, demonstrating a 12-month shelf life. |
| Packaging Testing (ASTM F2096, ASTM F88) | Compliance with standards. | Packaging testing for the line extension passed. |
| Risk Assessment (ISO 14971: 2019) | No new or different risks identified. | "No new or different risks were identified." |
| Clinical Study - Primary Safety Endpoint | No severe or serious adverse events related to the device. | "The safety results met the criteria outlined for the primary safety endpoint for this study; there were no severe or serious adverse events related to the device." |
| Clinical Study - Performance Endpoints | MSS able to grasp the pillar of the diaphragm or peripillar tissue to adequately mobilize the liver, achieving effective exposure of the target tissue. No need for another liver retractor. No conversions to open surgery due to device malfunction. No reported device malfunctions leading to conversions or use of another retractor. No unanticipated adverse events related to the device. | "In all 30 cases, the MSS was able to grasp the pillar of the diaphragm or peripillar tissue to adequately mobilize the liver, achieving an effective exposure of the target tissue." "It was not necessary to use another liver retractor during any procedures." "No procedures required conversion to an open surgical approach." "There were no reported device malfunctions that led to conversions to open surgery or use of another liver retractor." "There were no unanticipated adverse events related to the device." |
2. Sample Size Used for the Test Set and Data Provenance
For the clinical study:
- Sample Size: Thirty (30) subjects.
- Data Provenance: Prospective, single-arm, open-label clinical study conducted at three (3) sites in Santiago, Chile.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the clinical study. It mentions that "five (5) surgeons" performed the surgeries and evaluated the device's performance, implying their clinical judgment served as the ground truth. However, their specific qualifications (e.g., years of experience, specialization) are not detailed beyond being "surgeons."
4. Adjudication Method for the Test Set
The document does not specify an adjudication method like 2+1 or 3+1. Given it was a single-arm, open-label study where surgeons performed the procedures and evaluated outcomes, the assessment of safety and performance endpoints likely relied on the treating physicians' observations and reporting, aligned with the study protocol. There is no mention of an independent adjudication committee for specific endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this submission. The clinical study was a single-arm study evaluating the device's performance directly, not comparing human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a physical surgical system (magnetic grasper and controller), not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The device's performance inherently involves human surgeons operating it.
7. The Type of Ground Truth Used
For the clinical study, the ground truth was established by clinical observation and assessment by the operating surgeons based on predefined safety and performance endpoints. This can be categorized as expert consensus/clinical judgment from the treating surgeons. The document states:
- "The study results met all predefined safety and performance endpoints."
- "The MSS was able to grasp the pillar of the diaphragm or peripillar tissue to adequately mobilize the liver, achieving an effective exposure of the target tissue."
8. The Sample Size for the Training Set
The document describes a physical medical device and primarily focuses on its hardware components and clinical performance. There is no mention of a "training set" in the context of an algorithm or AI model development. Therefore, this information is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" for an algorithm, this question is not applicable.
§ 878.4815 Magnetic surgical instrument system.
(a)
Identification. A magnetic surgical instrument system is a prescription device used in laparoscopic surgical procedures consisting of several components, such as surgical instruments, and a magnetic controller. The magnetic controller is provided separately from the surgical instrument and is used outside the patient. The external magnetic controller is magnetically coupled with the internal surgical instrument(s) at the surgical site to grasp, hold, retract, mobilize, or manipulate soft tissue and organs.(b)
Classification. Class II (special controls). The special controls for this device are:(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.
(2) Non-clinical performance data must demonstrate that the system performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Magnetic field strength testing characterization to identify the distances from the magnet that are safe for patients and users with ferromagnetic implants, devices, or objects.
(ii) Ability of the internal surgical instrument(s) to be coupled, de-coupled, and re-coupled with the external magnet over the external magnet use life.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device components that are patient-contacting.
(5) Methods and instructions for reprocessing reusable components must be validated.
(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.
(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.
(8) Labeling must include:
(i) Magnetic field safe zones.
(ii) Instructions for proper device use.
(iii) A screening checklist to ensure that all patients and operating staff are screened from bringing ferromagnetic implants, devices, or objects near the external magnet.
(iv) Reprocessing instructions for any reusable components.
(v) Shelf life.
(vi) Use life.