(22 days)
The Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m².
The Magnetic Surgical System is composed of two hand-held instruments: a Magnetic Grasper Device and an external Magnetic Controller. The Magnetic Grasper Device is comprised of two main components: a Detachable Grasper and a Delivery/Retrieval Shaft. Once the Magnetic Grasper Device is inserted and the Grasper is attached to the desired tissue, the Detachable Grasper can be detached from the Delivery/Retrieval Shaft and controlled externally using the Magnetic Controller. Traction of the tissue is maintained through the magnetic field attraction between the Grasper and the Magnetic Controller. The Magnetic Grasper Device is compatible with a ≥ 10 mm laparoscopic port. The Magnetic Controller is a single unit with handles that is held external to the body and emits a magnetic field that attracts the Detachable Grasper. Once the Detachable Grasper is attached to the desired tissue and detached from the Delivery/Retrieval Shaft, the Magnetic Controller is placed external to the body to magnetically attract the Grasper to manipulate the target tissue. Adjusting the distance between the Magnetic Controller and the Detachable Grasper will modulate the magnetic attraction used for tissue retraction/manipulation.
The provided document is a 510(k) premarket notification for the Levita Magnetics International Corp. Magnetic Surgical System (K171429). This submission is a Special 510(k), meaning it addresses a modification to an already cleared device (predicate device DEN150007). In this specific case, the modification is a labeling change to the Instructions for Use regarding the use life statement.
Therefore, the document explicitly states that no new performance testing was conducted for this submission, as the modification does not change the performance characteristics of the device. The substantial equivalence is based on the previously conducted testing for the predicate device.
Given this, I cannot provide information on the acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance for this specific 510(k) submission, as no such new studies were part of this filing. The document refers to prior testing for the original clearance of the predicate device.
However, the document lists the Special Controls that were applicable to the original device and implicitly served as general acceptance criteria for its performance. These controls and the claim that the device meets them (based on prior testing) are outlined below.
Acceptance Criteria for the Magnetic Surgical System (Based on Special Controls for the original device DEN150007 and claimed continued compliance for K171429)
Since this 510(k) is for a labeling change and no new performance testing was conducted, there are no new acceptance criteria or reported performance unique to this submission. The Special Controls described in 21 CFR §878.4815 for the Magnetic Surgical System serve as the foundational acceptance criteria that the device (including its substantial equivalent K171429) must meet. The submission claims that previous testing (for DEN150007) demonstrated compliance with these controls.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from 21 CFR §878.4815 Special Controls) | Reported Device Performance (as stated in K171429, referring to prior testing for predicate DEN150007) |
|---|---|
| (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. | "The modifications that are the subject of this submission do not change the performance characteristics of the device. Therefore, previously conducted in vivo performance testing that demonstrated that the device performs as intended under the anticipated conditions of use applies here." |
| (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: (a) 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. (b) Ability of the internal surgical instrument(s) to be coupled, and recoupled with the external magnet over the external magnet use life. | "The modifications that are the subject of this submission do not change the performance characteristics of the device. Therefore, previously conducted nonclinical performance testing that demonstrated that the device performs as intended under the anticipated conditions of use applies here." |
| (3) The patient-contacting components of the device must be demonstrated to be biocompatible. | "The modifications that are the subject of this submission do not change any aspect of the device. Therefore, previously conducted testing that demonstrated that the device is biocompatible applies here." |
| (4) Performance data must demonstrate the sterility of the device components that are patient contacting. | "The modifications that are the subject of this submission do not change any aspect of the device. Therefore, previously conducted testing that demonstrated the sterility of the device applies here." |
| (5) Methods and instructions for reprocessing reusable components must be validated. | "The modifications that are the subject of this submission do not change any aspect of the device. Therefore, previously conducted testing that validated the methods and instructions for reprocessing reusable components applies here." |
| (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. | "The modifications that are the subject of this submission do not change any aspect of the device. Therefore, previously conducted testing that validated the shelf life of the device applies here." |
| (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. | "The modifications that are the subject of this submission do not change any aspect of the device. Therefore, previously conducted human factors testing which validated that users can follow the instructions to allow safe use of the device applies here." |
| (8) Labeling must include: (a) Magnetic field safe zones. (b) Instructions for proper device use. (c) A screening checklist to ensure that all patients and operating staff are screened from bringing ferromagnetic implants, devices or objects near the external magnet. (d) Reprocessing instructions for any reusable components. (e) Shelf life. (f) Use life. | "The labeling complies with the special controls stated above." (Note: This specific 510(k) is about a labeling change related to use life, affirming compliance with this aspect.) |
For the following points, as this 510(k) exclusively concerns a labeling change and refers to prior testing, the specific details are not available in this document. The information below reflects that no new studies were conducted for K171429.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable to this 510(k) submission, as no new test set was used. The submission relies on prior testing for the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable to this 510(k) submission, as no new test set requiring expert ground truth was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable to this 510(k) submission, as no new test set requiring adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable; this device is a magnetic surgical system, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable; this device is a physical surgical system, not an algorithm. Its performance is inherent to its mechanical and magnetic properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the original predicate device's in vivo testing, presumed ground truth would likely have been direct surgical observation and potentially histological assessment of tissue integrity or adverse events. For non-clinical tests, ground truth would be established by physical measurements and engineering standards. However, these details are not provided in this document.
8. The sample size for the training set
Not applicable; this physical device does not utilize a training set in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable; this physical device does not utilize a training set.
§ 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.