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Magnetic Surgical System

Page Type
Product Code
Definition
System 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 device is intended for prescription use only.
Physical State
The device is two different instruments, the magnetic controller which is outside of the body and is 3x2 inches, oval-shaped with handles and is a large magnet made of NdFeB, Grade N42 disk magnet. The second instrument is the detachable grasper which is magnetic and actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the detachable grasper jaws.
Technical Method
Uses a detachable grasper that can be attracted with a magnet that goes into the body to grasp and retract the gallbladder. Externally, a large magnet is kept outside of the body to hold the detachable grasper in place during surgery with its magnetic field strength.
Target Area
The magnetic controller is kept external to the body on the abdomen. The detachable grasper is used during laparoscopic cholecystectomy to grasp and retract the gallbladder inside the body.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4815
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4815 Magnetic surgical instrument system

§ 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.

[81 FR 64763, Sept. 21, 2016]

Magnetic Surgical System

Page Type
Product Code
Definition
System 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 device is intended for prescription use only.
Physical State
The device is two different instruments, the magnetic controller which is outside of the body and is 3x2 inches, oval-shaped with handles and is a large magnet made of NdFeB, Grade N42 disk magnet. The second instrument is the detachable grasper which is magnetic and actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the detachable grasper jaws.
Technical Method
Uses a detachable grasper that can be attracted with a magnet that goes into the body to grasp and retract the gallbladder. Externally, a large magnet is kept outside of the body to hold the detachable grasper in place during surgery with its magnetic field strength.
Target Area
The magnetic controller is kept external to the body on the abdomen. The detachable grasper is used during laparoscopic cholecystectomy to grasp and retract the gallbladder inside the body.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4815
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4815 Magnetic surgical instrument system

§ 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.

[81 FR 64763, Sept. 21, 2016]