(489 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical and magnetic components for tissue manipulation, with no mention of AI/ML algorithms for image analysis, decision support, or automated control. The training and testing described are for human factors and device performance, not AI/ML model validation.
No.
The device is a surgical tool designed to facilitate procedures by grasping and retracting tissue, not to provide therapy or treatment for a disease itself.
No
The device is described as a surgical system designed to grasp and retract the gallbladder during laparoscopic cholecystectomy procedures to facilitate access and visualization. Its function is to manipulate tissue during surgery, not to diagnose a condition.
No
The device description clearly outlines two physical hardware components: a Magnetic Grasper Device and an External Magnetic Controller. The summary also details bench testing, animal studies, and clinical studies involving the physical manipulation of tissue and interaction with the body, which are characteristic of a hardware medical device.
Based on the provided information, the Levita Magnetic Surgical System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Levita System Function: The Levita Magnetic Surgical System is a surgical instrument used during a laparoscopic procedure (cholecystectomy) to physically grasp and retract the gallbladder inside the patient's body. It facilitates access and visualization for the surgeon.
- Lack of Specimen Analysis: The device does not analyze any biological specimens. It is a tool for manipulating tissue during surgery.
The description clearly indicates the device's function is surgical manipulation within the body, not laboratory testing of samples.
N/A
Intended Use / Indications for Use
The Levita 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.
Product codes
PNL
Device Description
The Levita Magnetic Surgical System is composed of two hand-held instruments, the Magnetic Grasper Device and external Magnetic Controller, which are intended to facilitate tissue grasping, retraction and mobilization during laparoscopic cholecystectomy procedures.
- Magnetic Grasper Device (sterile, single use) is actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the Detachable Grasper jaws. At the distal end is the Detachable Grasper, which is attached to the Delivery/Retrieval Shaft of the full Magnetic Grasper Device. This device requires a >10mm access port to introduce the device into the abdominal cavity. The Detachable Grasper is then coupled (held in place within the abdomen) by the external Magnetic Controller. If the surgeon wishes to use a single 10-12 mm port at the umbilicus such as a Hasson port and that is the port shared by the optic, applying and adjusting the Detachable Grasper may require repetitive placement of the optic in an alternative port.
- An External Magnetic Controller (non-sterile, reusable) 3-inch diameter by 2-inch thick b(4) disk magnet. This component holds the Detachable Grasper (magnetically) and is placed on the external abdomen wall.
- Surface field strength of b(4) Gauss within an encasement with integrated handles. Static • field and does not induce current flow.
- . Mounting stem for optionally attaching it to a commercially available surgical support arm.
- Comprised of ferromagnetic material If the External Magnetic Controller is moved . within a short distance of the interior abdominal wall, it can act on the internally placed Detachable Grasper, pulling it toward the abdominal wall.
- The user varies the distance required to achieve the necessary attraction between the Detachable Grasper and Magnetic Controller during the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body and fundus of the gallbladder
Indicated Patient Age Range
18 and 60 yrs of age
Intended User / Care Setting
Surgeons / Operating Room
Description of the training set, sample size, data source, and annotation protocol
The sponsor trained the surgeons using the Instructions for Use, device labels, patient screening checklist, and a training presentation. All subjects were trained face-to-face using the training presentation and the hands-on demonstration described in the presentation. The sponsor has developed a training didactic presentation that follows the Instructions for Use to train for correct use of the system. The training presentation includes sections on safe use of the device, contraindications, warnings, precautions, potential adverse events, patient selection, instructions for use, and hands-on practice.
Description of the test set, sample size, data source, and annotation protocol
Human factors validation testing was conducted using a training didactic presentation prior to testing the participants.
Sample Size: 15 surgeons at 2 different sites.
Data Source: Simulated use environment testing.
Annotation Protocol: Not explicitly detailed as an annotation protocol, but the acceptance criteria were no critical failures (Critical Task Errors detailed in Table 8) and no more than two non-critical failures per subject (any failures with the tasks written below not indicated as critical tasks).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Animal Study:
Study Type: In Vivo Animal Study (Safety and Performance Study)
Sample Size: Two canines
Key Results:
- The Magnetic Surgical System was utilized to manipulate the gallbladder for several cycles using the Magnetic Controller, without any adverse events.
- The gross pathological findings demonstrated that there was no evidence of clinically relevant trauma to the abdominal wall associated with the test articles.
- The histopathological findings demonstrated that there were no significant increases in trauma associated with the test article when compared to a 5mm trocar.
- The safety endpoint acceptance criteria for intra-procedural adverse events, gross pathology, and histopathology evaluation were met.
- In the performance evaluation, the Magnetic Surgical System was employed to complete a single-incision laparoscopic cholecystectomy. The performance endpoint acceptance criteria for the completion of a laparoscopic cholecystectomy and compatibility with equipment/instrumentation were met.
- All study objectives were successfully met.
Human Factors Study:
Study Type: Human Factors Validation Testing
Sample Size: 15 surgeons
Key Results: All 15 test subjects passed all tests without any critical or non-critical errors.
Clinical Study:
Study Type: Prospective, single arm, open label study (both feasibility and pivotal)
Sample Size:
Feasibility Study: 22 enrolled, 21 subjects underwent surgery
Pivotal Study: 50 subjects underwent surgery
Key Results:
- Safety results: No cases of device failure (device breakage or malfunction requiring additional surgical intervention). Three serious adverse events and thirty-five non-serious AEs were reported; none were found to be device-related. Twenty device-related events were noted as mild petechiae, resolved with no clinical sequelae and considered clinically insignificant.
- Performance results: In all cases, the device was able to adequately mobilize the gallbladder to achieve an effective exposure of the target tissue. An additional trocar was placed in one procedure but was not needed to mobilize the gallbladder and was placed after the Magnetic Grasper device use was complete.
- The device can be used in laparoscopic cholecystectomy procedures in subjects with varying abdominal wall thicknesses (1.8 – 4.6 cm) corresponding with a BMI range of 20.4 – 34.1 kg/m2.
- The device facilitates three-port cholecystectomy procedures, providing adequate exposure and mobilization of the target tissue.
- Average overall procedure time: 63 minutes.
- Average coupling time between Magnetic Controller and Magnetic Detachable Grasper: 34 minutes.
- All procedures completed with no conversions to an open surgical approach.
- No device malfunctions or equipment interferences were reported in a standard operating room with conventional electrosurgical equipment.
- Patient survey indicated over 90% patient satisfaction on postoperative days 7 and 30.
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not applicable for this device type.
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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DE NOVO CLASSIFICATION REQUEST FOR LEVITA MAGNETIC SURGICAL SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Magnetic Surgical Instrument System. 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.
NEW REGULATION NUMBER: 21 CFR 878.4815
CLASSIFICATION: II
PRODUCT CODE: PNL
BACKGROUND
DEVICE NAME: LEVITA MAGNETIC SURGICAL SYSTEM
SUBMISSION NUMBER: DEN150007
DATE OF DE NOVO: FEBRUARY 10, 2015
LEVITA MAGNETICS INTERNATIONAL CORP. CONTACT: 1430 S. AMPHLETT BLVD, SUITE 240 SAN MATEO, CA 94402
REQUESTER'S RECOMMENDED CLASSIFICATION: II
INDICATIONS FOR USE
The Levita 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.
LIMITATIONS
The sale, distribution, and use of the Levita Magnetic Surgical System are restricted to prescription use in accordance with 21 CFR 801.109.
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Limitations on device use are also achieved through the following statements included in the instructions for use:
Contraindications:
- Do not use on patients or near anyone with pacemakers, defibrillators, or other ● electromedical implants.
- Do not use on patients or near anyone with ferromagnetic implants. .
Warnings and Precautions:
Failure to adhere to the instructions below may result in patient or user injury and/or damage to the device.
- Do not use on patients or near anyone who does not pass the Magnetic Surgery . Screening Checklist. A screening checklist is provided by Levita Magnetics for this purpose.
- Do not use the Magnetic Controller to attempt to retrieve a lost Detachable . Grasper. Doing so could result in significant patient harm, including significant damage to tissue and/or vasculature.
- . The Magnetic Controller contains a strong magnet. Safe working zones have been defined for the Magnetic Controller. Adhere to the safe zones described in the following tables, and maintain a safe working distance. Failure to adhere to the safety zones may result in patient and/or user injury.
| Safe Zones for Magnetic Controller | Safe Working Distance. Do not position
closer than distance specified. |
|--------------------------------------------------------------------|---------------------------------------------------------------------------|
| Outside of Carrying Case Category | |
| Personnel/patients with cardiac pacemakers,
or medical implants | 50 cm (20 inches) |
| Equipment with cathode-ray tubes (i.e. CRT
monitors) | 50 cm (20 inches) |
| Equipment with magnetic data storage | 50 cm (20 inches) |
| Small ferromagnetic objects | 25 cm (10 inches) |
| General electrical equipment | 25 cm (10 inches) |
| Safe Zones for Magnetic Controller Inside
of Carrying Case Category | Safe Working Distance. Do not position
closer than distance specified. |
|------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Personnel/patients with cardiac pacemakers,
or medical implants | 50 cm (20 inches) |
| Equipment with cathode-ray tubes (i.e. CRT
monitors) | 50 cm (20 inches) |
| Equipment with magnetic data storage | 20 cm (8 inches) |
| Small ferromagnetic objects | 5 cm (2 inches) |
| General electrical equipment | 5 cm (2 inches) |
- Place the manufacturer-supplied safety signage on all entry doors of the operating ● room.
- The safety and effectiveness of the Magnetic Surgical System for use in patients ● with BMI 34 has not been established.
- Assess the gallbladder and do not use the Magnetic Surgical System if adhesions, ● stones, or fibrosis interfere with exposure of the critical view of safety or
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definition of the components of the hepatocystic triangle.
- . When the Detachable Grasper is detached from the gallbladder, reestablishing attachment requires a greater number of steps and may be more time consuming than with a shafted (i.e., traditional) grasper.
- Placement of an additional trocar port may be required if exposure is inadequate . and/or additional treatment is needed after complete removal of the gallbladder from the hepatic bed.
- . The Magnetic Grasper Device should be used to grasp only the fundus or the body of the gallbladder.
- The Magnetic Grasper Device is for single use only. Do not resterilize or reuse.
- . Do not use multiple Magnetic Controllers simultaneously.
- Inability to adequately grasp, retract and /or mobilize target tissue using the Magnetic Surgical System during the procedure may require the use of an additional trocar to complete the surgery.
- . Always store the Magnetic Controller in the manufacturer-supplied carrying case.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Levita Magnetic Surgical System is composed of two hand-held instruments, the Magnetic Grasper Device and external Magnetic Controller, which are intended to facilitate tissue grasping, retraction and mobilization during laparoscopic cholecystectomy procedures.
-
- Magnetic Grasper Device (sterile, single use) is actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the Detachable Grasper jaws as shown in Figure 1. At the distal end is the Detachable Grasper, which is attached to the Delivery/Retrieval Shaft of the full Magnetic Grasper Device. This device requires a >10mm access port to introduce the device into the abdominal cavity. The Detachable Grasper is then coupled (held in place within the abdomen) by the external Magnetic Controller. If the surgeon wishes to use a single 10-12 mm port at the umbilicus such as a Hasson port and that is the port shared by the optic, applying and adjusting the Detachable Grasper may require repetitive placement of the optic in an alternative port. The Detachable Grasper is shown in Figure 2.
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Image /page/3/Figure/0 description: This image shows a magnetic grasper device with labels and measurements. The device has four labeled parts: the delivery/retrieval shaft (1), the detachable grasper (2), the jaws (3), and the handle (4). The delivery/retrieval shaft is 47 cm long, the detachable grasper is 6.5 cm long, and the handle is 10 cm long.
Image /page/3/Figure/1 description: In the image, a detailed view of a surgical instrument is presented, showcasing its various components. The instrument features a "Jaw Base", a "Jaw Actuator", and a "Jaw Pin". Additionally, "Torsion Springs" are visible, contributing to the instrument's functionality.
-
- An External Magnetic Controller (non-sterile, reusable) 3-inch diameter by 2-inch thick b(4) disk magnet, shown in Figure 3. This component holds the
Detachable Grasper (magnetically) and is placed on the external abdomen wall.
- An External Magnetic Controller (non-sterile, reusable) 3-inch diameter by 2-inch thick b(4) disk magnet, shown in Figure 3. This component holds the
-
Surface field strength of b(4) Gauss within an encasement with integrated handles. Static ● field and does not induce current flow.
-
. Mounting stem for optionally attaching it to a commercially available surgical support arm.
-
Comprised of ferromagnetic material If the External Magnetic Controller is moved . within a short distance of the interior abdominal wall, it can act on the internally placed Detachable Grasper, pulling it toward the abdominal wall.
-
The user varies the distance required to achieve the necessary attraction between the Detachable Grasper and Magnetic Controller during the procedure.
Image /page/3/Picture/9 description: The image shows a gray object with two handles and an arm mount. The handles are located on either side of the object, and the arm mount is located on the top. The object appears to be made of plastic. The handles are curved and the arm mount is cylindrical.
Figure 3 – External Magnetic Controller
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SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
Biocompatibility testing was not conducted on the Magnetic Controller because it is not patient-contacting. It is a noncritical reusable device because it is placed in a sterile bag or covered with a drape during use and does not have direct contact with the patient's skin.
Biocompatibility testing was conducted on the Magnetic Grasper Device in accordance with the FDA's modified matrix Blue Book Memorandum #G95-1, entitled Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices, Part 1 Evaluation and Testing within a risk management process. The tests were performed on the patient-contacting materials identified in Table 1 below. As seen in Table 2, the tests performed included cytotoxicity, sensitization, and irritation.
Table 1: Patient Contacting Materials
| Components | Materials | |
|---|---|---|
| Torsion Springs | b(4) | Stainless Steel |
| Top Jaw | b(4) | Stainless Steel |
| Jaw Actuator, Jaw Pin, Shaft, Distal Taper, | ||
| Actuation Rod, Magnet Puller | b(4) | Stainless Steel |
| Jaw Base | b(4) | Stainless Steel |
| Cup Tip, Magnet Stop | b(4) | Stainless Steel |
Table 2: Biocompatability Tests
| Biocompatibility Test | Standard | Acceptance Criteria | Results |
|---|---|---|---|
| Cytotoxicity (MEM | |||
| Elution) | ISO 10993-5 | Test Sample Reactivity $\leq$ 2 | PASS |
| Sensitization (0.9% NaCl, | |||
| sesame oil) | ISO 10993-10 | Test samples $Device Failure defined as device breakage or other | |
| malfunction requiring additional surgical intervention including reoperation | |||
| and/or device removal. |
- There is no Serious Adverse Event probably or definitely related to the
grasping and tissue manipulation procedure or to the device resulting in: (a)
revision/removal of device; and/or (b) permanent damage to the organ (i.e.
perforation of the gallbladder or surrounding organs), (c) death of the study
subject.
Overall morbidity rate defined as occurrence of any complications directly or
indirectly related to the investigational device assessed intra-operatively, post-
operatively and at 30 day follow-up occurring within 30 days of surgery. |
| Primary Feasibility
Endpoint: | Ability to adequately mobilize the gallbladder to achieve an effective exposure of the
target tissue.
*Feasibility will be considered a "failure" if during the procedure, it becomes necessary
to use another trocar to insert another instrument to mobilize the gallbladder. |
| Other Outcome
Assessments: | Operative time (time from the first incision to the last suture's placement) Device use time (time of coupling between the internal grasper and the
external magnetic controller) Time spent in Post-anesthesia care unit (PACU) Length of stay (LOS) (time from post-anesthesia care unit until discharge) Perioperative pain as measured on a Numeric Rating Scale (NRS) at pre-op
(baseline), 3 and 6 hours post-op and discharge (24 hour post-op assessment
will be done if patient is not discharged) and at 7 and 30 day follow-up Pain medication usage while in PACU and until hospital discharge Conversion rate (reduced port to 4-port) Blood loss Umbilical incisional length Access site herniation Patient satisfaction with the overall procedure based on patient survey at 30
day follow-up Ease of use based on surgeon assessment post-operatively Cosmesis or scarring (patient and surgeon assessed satisfaction survey) at 7
and 30 day follow-up Final post-operative diagnosis |
| Inclusion Criteria: | Patient between 18 and 60 years of age Undergoing elective cholecystectomy due to: Cholelithiasis (Gallbladder stones 7mm in size as determined by ultrasound Has a gallbladder wall thickness that is > 5mm Diabetic Blood coagulation issues Has signs of hepatic endocrinology (i.e: cirrhosis, liver failure, increase in liver enzymes, etc.) History of endoscopic papillotomy (i.e: Preoperative indication of endoscopic retrograde cholangiopancreatography (ERCP) Patient is pregnant or wishes to become pregnant during the length of study participation or lactation Patient is not likely to comply with the follow-up evaluation schedule Patient is participating in a clinical trial of another investigational drug or device |
| | Known or suspected drug or alcohol abuse Patient has systemic infection or evidence of any surgical site infection (superficial or organ space) Patient has compromised immune system or autoimmune disease (WBC 20,000), including prior or pending treatment for HIV or Hep. C Patient intra-operatively needs an additional surgery while undergoing elective cholecystectomy |
| Study Duration / Follow-up Period | Patients were followed for a maximum of 30 days post-procedure, with follow-up visits at hospital discharge and at 7 and 30 days post-procedure. |
Table 12: Clinical Study Data
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Results:
The safety results met the criteria outlined for the primary safety endpoint for this study, because there were no cases of a device failure. Device failure is defined as device breakage or other malfunction requiring additional surgical intervention including reoperation and/or device removal. Three (3) serious adverse events and thirty-five (35) non serious AEs were reported throughout the course of the study. No severe or serious adverse events were found to be devicerelated. Twenty (20) device-related events were noted. The device-related events were categorized as mild petechiae that were observed during the index procedure. The observed petechiae were mild and were not considered clinically significant by the study investigators, as all events resolved with no clinical sequelae. The mild petechiae reported represent much less trauma to the tissue than would be the case with a trocar insertion. This is a single arm study and patient survey indicated that over 90% of the patients were satisfied on postoperative day 7 and 30.
The device performance results met the criteria outlined for the primary performance endpoint for this study, because in all cases the device was able to adequately mobilize the gallbladder to achieve an effective exposure of the target tissue. While an additional trocar was placed in one procedure, this additional trocar was not needed to mobilize the gallbladder and this trocar was placed after the Magnetic Grasper device use was complete and removed from the abdomen. As a result, no additional trocars were placed to insert another instrument to mobilize the gallbladder.
The results show that the Magnetic Surgical System can be used in laparoscopic cholecystectomy procedures in subjects with varying abdominal wall thicknesses (1.8 – 4.6 cm) that correspond with a range of BMIs (20.4 – 34.1 kg/m2). Additionally, the device can be used to facilitate three-port cholecystectomy procedures in a manner that provides adequate exposure and mobilization of the target tissue. The average overall procedure time was 63 minutes and the amount of coupling time between the Magnetic Controller and the Magnetic Detachable Grasper was 34 minutes. All procedures were completed with no conversions to an open surgical approach required. Importantly, the Magnetic Surgical System was used in a standard operating room with conventional electrosurgical equipment and no device malfunctions or equipment interferences were reported.
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LABELING
Labeling has been provided, which includes the instructions for use and an appropriate prescription statement as required by 21 CFR 801.109.
The sponsor has provided the magnetic field strength testing results, including tables detailing the magnetic safe zones, in the User Manual and on the external magnetic controller carrying case. In addition, the sponsor has included a Screening Checklist to ensure that all patients and Operating Staff are screened from bringing ferromagnetic implants, devices or objects near the external magnet. These magnetic safe zones tables and the Screening Checklist mitigate the risk of electromagnetic field incompatibility or interference.
The sponsor has provided detailed instructions for proper device use, which mitigate the risks of tissue damage, need for extended or additional surgery, abdominal wall injury, and electromagnetic field incompatibility or interference.
The sponsor has included sterilization, cleaning and disinfection instructions, along with determined shelf life, which mitigate the risk of infection.
RISKS TO HEALTH
Table 13 identifies the risks to health that may be associated with use of the Magnetic Surgical Instrument System and the measures necessary to mitigate these risks.
| Identified Risk | Mitigation Measures |
|---|---|
| Tissue Damage | In vivo Performance Testing Human Factors Testing and Analysis Training Labeling |
| Need for Extended or Additional Surgery: | |
| Inability to couple the external magnet with the internal surgical instrument Inability to retrieve or maneuver device Inability to visualize critical anatomical structures | In vivo Performance Testing Non-clinical Performance Testing Human Factors Testing and Analysis Training Labeling |
| Abdominal Wall Injury | In vivo Performance Testing Human Factors Testing and Analysis Labeling |
| Electromagnetic Field Incompatibility or Interference (including ferromagnetic implants in users and patients, electrosurgical devices, etc.) | Non-clinical Performance Testing Human Factors Testing and Analysis Training Labeling |
| Adverse Tissue Reaction | Biocompatibility Evaluation |
Table 13: Identified Risks to Health and Mitigation Measures
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| Identified Risk | Mitigation Measures |
|---|---|
| Infection | • Sterilization Validation |
| • Reprocessing Validation | |
| • Shelf Life Validation | |
| • Labeling |
SPECIAL CONTROLS:
In combination with the general controls of the FD&C Act, the Magnetic Surgical Instrument System is subject to the following special controls:
- (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:
- (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.
- (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 patientcontacting.
- (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:
- (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.
BENEFIT/RISK DETERMINATION
The risks of the Levita Magnetic Surgical System are based on nonclinical laboratory and animal studies as well as data collected in the clinical studies described above. One such risk could be diminished haptic feedback, which can result in applying to much force on the gallbladder wall resulting in tearing of the wall with bile and stone spillage. In the animal and clinical study, based on user feedback, there was some haptic feedback in dragging the external magnetic controller which also moves the internal detachable grasper when coupled.
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One minor risk is the abdominal wall injury, such as petechiae. Twenty (20) device-related events were noted in the clinical study. The device-related events were categorized as mild petechiae that were observed during the index procedure. The observed petechiae were mild and were not considered clinically significant by the study investigators, as all events resolved with no clinical sequelae. In addition, the mild petechiae reported represent much less trauma to the tissue than would be the case with a trocar insertion.
Another probable risk includes device usage in a contracted inflamed gallbladder may not provide ideal anatomic exposure and may require additional training to mitigate anatomic and pathologic variations in the gallbladder when using this device. Traditional laparoscopic graspers frequently require additional force and torque to achieve adequate exposure. The manipulation of this grasper in removing the gallbladder from the liver bed requires surgeon action and fundus response. However, this issue has been mitigated within the labeling by preventing the use of this device in difficult situations, such as "if adhesions, stones, or fibrosis interfere with exposure of the critical view of safety or definition of the components of the hepatocystic triangle". In addition, acute decoupling of the controller magnet and the grasper at critical points in surgery can be difficult to re-establish and the loss of exposure can result in injury. This is mitigated in the labeling by including language that explains that steps to re-establish coupling between the detachable grasper and the magnetic controller. Also, another risk involves injury resulting from recovery of loss of the detachable grasper in the abdominal cavity. However, this has been mitigated in the labeling by providing a safe and tested method of retrieving a lost detachable grasper and cautioning against doing it improperly.
The probable benefits of the device are also based on nonclinical laboratory and animal studies as well as data collected in the clinical studies as described above. The device allows for one less 5 mm port in the performance of laparoscopic cholecystectomy. This should result in several probable benefits. Since the studies presented were single armed, comparisons could not be made due to lack of a traditional laparoscopic cholecystectomy control. However, the subject device presents a novel method of providing surgical retraction that may provide a stepping stone to future minimally invasive surgical procedures. Such probable benefits include fewer episodes of inadvertent trocar injuries of intra-abdominal organs and structures within the abdominal wall (nerves and blood vessels), fewer episodes of instrument crowding, and one less abdominal wall scar resulting in better cosmesis.
The Levita Magnetic Surgical System, while providing tangible benefits, may be difficult to use by a surgeon who has not been familiarized with it prior to using it for the first time. A robust training program should overcome any learning curve that may exist.
Patient Perspectives
Although not a primary outcome of the clinical study conducted, a patient survey was completed as an additional assessment. The survey indicated that over 90% of the patients were satisfied on postoperative days 7 and 30.
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Benefit/Risk Conclusion
Given the information submitted in the de novo request, the data support that for the indication of "grasping and retracting the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site", the probable benefits outweigh the probable risks for the Levita Magnetic Surgical System. The device provides benefits and the risks can be mitigated by the use of general controls and the identified special controls.
CONCLUSION
The de novo request for the Levita Magnetic Surgical System is granted and the device is classified under the following:
Product Code: PNL Device Type: Magnetic Surgical Instrument System Class: II Regulation: 21 CFR 878.4815