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510(k) Data Aggregation
(56 days)
The Magnetic Surgical System is indicated for use in patients within a BMI range of 20 to 60 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following:
- The body and fundus of the gallbladder in laparoscopic cholecystectomy procedures
- The liver in bariatric procedures
- The prostate and periprostatic tissue in prostatectomy procedures
- The colon, rectum, and pericolorectal tissue in colorectal procedures
The Grasper Tip 12.5 is indicated for use in patients within a BMI range of 20 to 60 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following:
- The pillar of the diaphragm and peripillar tissue in bariatric or hiatal hernia procedures
Pediatric use:
The Magnetic Surgical System is indicated for use in adolescents (12-21) within a BMI range of 20 to 34 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following:
- The body and fundus of the gallbladder in laparoscopic cholecystectomy procedures
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.
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(117 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, and the prostatic tissue in prostatectomy procedures to facilitate access and visualization of the surgical site. The 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 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.
Here's a summary of the acceptance criteria and study details for the Levita Magnetic Surgical System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Special Controls - §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. | Effectiveness: The Magnetic Surgical System (MSS) was able to adequately retract the prostate to achieve an effective exposure of target tissue. It was not necessary to replace the MSS with another instrument to retract the prostate during the procedure. Safety: No cases of severe or serious adverse events and no device-related adverse events were reported. Eleven (11) adverse events occurred, all resolved with no clinical sequelae and were categorized as not related to the subject device. Procedure Times: Mean overall procedure time was 3 hours 23 minutes. |
| (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, de-coupled, and recoupled with the external magnet over the external magnet use life. | No new testing was required. The modifications did not change magnetic field strength or coupling. Previously conducted nonclinical performance testing for the predicate device applied. |
| (3) The patient-contacting components of the device must be demonstrated to be biocompatible. | No new testing was required. The modifications did not change any aspect of the device. Previously conducted biocompatibility testing for the predicate device applied. |
| (4) Performance data must demonstrate the sterility of the device components that are patient-contacting. | No new testing was required. The modifications did not change any aspect of the device. Previously conducted sterility testing for the predicate device applied. |
| (5) Methods and instructions for reprocessing reusable components must be validated. | No new testing was required. The modifications did not change any aspect of the device. Previously conducted testing validating reprocessing methods for the predicate device applied. |
| (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. | No new testing was required. The modifications did not change any aspect of the device. Previously conducted testing validating shelf life for the predicate device applied. |
| (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. | A training program was developed, and a usability study was completed to validate it. |
| (8) Labeling must include: (a) Magnetic field safezones. (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 these special controls. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): 30 subjects
- Data Provenance:
- Country of Origin: Santiago, Chile (Fundacion Arturo Lopez Perez)
- Retrospective or Prospective: Prospective clinical study
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: 5 investigators (surgeons)
- Qualifications: The document identifies them as "surgeons" and "investigators" participating in a clinical study for prostatectomy procedures. Specific experience levels (e.g., years of experience or specialization) are not detailed in this document.
4. Adjudication Method for the Test Set:
- The document states that "Investigators reported that adequate retraction was achieved since it was not necessary to replace the MSS with another instrument to retract the prostate during the procedure." and "All eleven events resolved with no clinical sequelae and were categorized as not related to the subject device."
- This suggests that the surgeons themselves were the primary adjudicators of effectiveness and relatedness of adverse events during the procedure. There is no mention of an independent adjudication panel or a numerical adjudication rule (e.g., 2+1, 3+1). The study describes itself as a "single-arm, open label study."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done.
- This was a single-arm study evaluating the device's performance in a new indication (prostatectomy), primarily to demonstrate safety and effectiveness for that specific use extension compared to the predicate device, not to show human reader improvement with AI assistance. The device itself is a surgical instrument, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This device is a surgical instrument, not an algorithm, and thus does not have "standalone" algorithm performance in the typical sense of AI/diagnostic devices. Its performance is intrinsically linked to its use by a human surgeon.
7. Type of Ground Truth Used:
- Expert Consensus/Clinical Observation during Surgery: The "ground truth" for effectiveness was established by the clinical judgment of the participating surgeons during the procedure. Specifically, effectiveness was defined as the "ability to adequately retract the prostate to achieve an effective exposure of the target tissue," and "Adequate retraction was deemed to be achieved if it is not necessary to replace the Levita Magnetic Surgical System with another instrument to retract the prostate during the procedure." Safety was based on the absence of severe or serious adverse events reported by the investigators.
8. Sample Size for the Training Set:
- Not applicable / No specific training set mentioned. This is a medical device, not an AI model, so there isn't a "training set" in the machine learning sense. The device's design and previous versions (predicate devices) would have undergone development and testing, but a distinct "training set" for an algorithm is not relevant here.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As a surgical device and not an AI model, the concept of establishing ground truth for a training set does not apply. The development would have involved engineering, material science, and prior clinical experience with similar devices, leading to verification and validation activities. The clinical study described in the document is for validation of its performance in an extended indication, not for training an algorithm.
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(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.
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