(275 days)
Not Found
No
The device description and performance studies focus on mechanical and magnetic principles for tissue manipulation, with no mention of AI or ML for image processing, decision-making, or control.
No.
A therapeutic device is one that treats or cures a disease or condition. This device is used to grasp and retract tissue during surgery to facilitate access and visualization, which is a surgical tool, not a therapeutic treatment itself.
No
The device is designed to grasp and retract tissue during surgical procedures to facilitate access and visualization, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical hardware components: two hand-held instruments (Magnetic Grasper and external Magnetic Controller) with mechanical actions and magnetic interaction for tissue manipulation. There is no mention of software being the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical system designed for grasping and retracting tissues (gallbladder, liver, prostate, colon, rectum) during laparoscopic procedures. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a magnetic surgical system with a grasper and external controller used to manipulate tissue within the body during surgery. This is consistent with a surgical tool.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the device's ability to grasp and retract tissue effectively and safely during simulated surgical procedures. This is relevant to surgical performance, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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; the liver in bariatric procedures; the prostate and periprostatic tissue in prostatectomy procedures; and the colon, rectum, and pericolorectal 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.
Product codes (comma separated list FDA assigned to the subject device)
PNL
Device Description
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 ≥ 10 mm laparoscopic port 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 (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gallbladder, liver, prostate and periprostatic tissue, colon, rectum, and pericolorectal tissue.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: In vivo animal study (porcine model)
Sample Size: Not specified
Key Results: The study demonstrated that the MSS is safe and effective in colorectal procedures while using one fewer access port (trocar), supporting the risk assessment that there are no new or different risks. The study demonstrates that the MSS performs as intended under anticipated conditions of use during colorectal procedures and that the MSS is able to grasp and retract the colon, pericolorectal tissue and adjacent organs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Levita Magnetic Surgical System, K190006
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA. On the right is the logo for the FDA U.S. Food & Drug Administration. The FDA logo has the letters FDA in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font in blue.
April 15, 2020
Levita Magnetics International Corp. % Cindy Domecus Principal, Domecus Consulting Services LLC Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010
Re: K191762
Trade/Device Name: Magnetic Surgical System Regulation Number: 21 CFR 878.4815 Regulation Name: Magnetic surgical instrument system Regulatory Class: Class II Product Code: PNL
Dear Cindy Domecus:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 1, 2020. Specifically, FDA is updating this SE Letter as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Long Chen, Ph.D., OHT4: Office of Surgical and Infection Control Devices, Assistant Director at 301-796-6389 or Long.Chen@fda.hhs.gov.
Sincerely,
Digitally signed by Long H. Chen
Long H. Chen -S -s
Date: 2020.04.15 13:23:36 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
April 1, 2020
Levita Magnetics International Corp. % Cindy Domecus Regulatory Consultant to Levita Magnetics Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010
Re: K191762
Trade/Device Name: Magnetic Surgical System Regulation Number: 21 CFR 878.4815 Regulation Name: Magnetic Surgical Instrument System Regulatory Class: Class II Product Code: PNL Dated: February 26, 2020 Received: February 28, 2020
Dear Cindy Domecus:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Long H. Chen
Long H. Chen -S-s
Date: 2020.04.01 07:33:30 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191762
Device Name Levita Magnetic Surgical System
Indications for Use (Describe)
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 prostate and periprostatic tissue in prostatectomy procedures; and the colon, rectum, and pericolorectal 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This summary is being submitted in accordance with the requirements of 21 CFR 807.92.
510(k) Owner Information:
Levita Magnetics International Corp. 1430 S. Amphlett Blvd, Suite 240 San Mateo, CA 94402 Phone: 650-241-0320 Fax: 650-241-1825
Submission Correspondent:
Cindy Domecus, R.A.C. (US & EU) Principal, Domecus Consulting Services LLC Regulatory Consultant to Levita Magnetics Email: domecusconsulting@comcast.net Phone: (650) 343-4813
Device Information:
Trade Name: Levita Magnetic Surgical System Common Name: Magnetic Surgical System 21 CFR 878.4815 Regulation: Classification Panel: General & Plastic Surgery Device Type: Magnetic Surgical Instrument System Device Class: ll Product Code: PNL
Predicate Devices:
Levita Magnetic Surgical System, K190006
Date Prepared:
April 8, 2020
Device Description:
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
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≥ 10 mm laparoscopic port 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 (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.
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; the liver in bariatric 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.
Comparison of Intended Use, Indications for Use and Technological Characteristics with the Predicate Device:
The subject and the predicate devices are identical in technological characteristics. The subject device differs from the predicate device by only a modifications for Use and the associated changes to the labeling. Results of animal testing demonstrated that the differences in the indications for use do not raise different questions of safety and effectiveness, and, therefore, the subject device has the same intended use as the predicate device.
| Subject Device | Predicate Device | |
|---|---|---|
| Intended Use | To grasp, hold, retract, or manipulate soft tissue and organs. | Same |
| Indications for use | The 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 prostate and periprostatic tissue in prostatectomy procedures; and the colon, pericolorectal tissue and adjacent organs in colorectal procedures to facilitate access and visualization of the | The 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 prostate and periprostatic tissue in prostatectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients with a |
Comparison of Intended Use and Indications for Use
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| Subject Device | Predicate Device |
|---|---|
| surgical site. The device is indicated for | |
| use in patients with a BMI range of 20- | |
| 60 kg/m². | BMI range of 20-60 kg/m². |
The subject and predicate device share identical technological characteristics:
- . Both devices are composed of two hand-held instruments: a Magnetic Grasper comprised of a detachable Grasper Tip and a Shaft, and an external Magnetic Controller.
- . The principles of operation remain unchanged. For both devices, the Magnetic Grasper is actuated manually using the handle of the Shaft to grasp and release tissue; and the Grasper Tip is controlled manually by the handle or the external Magnetic Controller to retract tissue.
- The design, features and materials remain unchanged.
As such, the design, materials and function of the subject Levita Magnetic Surgical System are substantially equivalent to the predicate Levita Magnetic Surgical System.
Performance Data:
There were no technological changes to the subject device, thus no bench, electromagnetic compatibility testing, sterilization testing or biocompatibility testing was required.
Animal performance data demonstrated the subject device is safe and effective in grasping and retracting the colon, pericolorectal tissue and adjacent organs in colorectal procedures.
Special Controls:
The Levita Magnetic Surgical System is subject to the special controls described in §21 CFR 878.4815. These special controls are stated below. Compliance with these requirements has been met as noted in the italicized text below each requirement.
- (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.
This special control is addressed by in vivo performance data from an animal study conducted to evaluate the safety and effectiveness of the Levita Magnetic Surgical System (MSS) in simulated colorectal procedures in the porcine model.
The results met all predetermined acceptance criteria. The MSS provided adequate retraction of the colon, peri-colorectal tissues, and adjacent organs to achieve effective access and visualization of the target tissue. No device-related serious or severe adverse events were reported. There was no post-excision or intraoperative tissue trauma. Surgeons reported that the MSS was the same or better than conventional laparoscopic graspers for use in the subject
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procedures. The study demonstrated that the MSS is safe and effective in colorectal procedures while using one fewer access port (trocar), supporting the risk assessment that there are no new or different risks. The study demonstrates that the MSS performs as intended under anticipated conditions of use during colorectal procedures and that the MSS is able to grasp and retract the colon, pericolorectal tissue and adjacent 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.
The modifications that are the subject of this submission do not change the magnetic field strength or coupling of the internal surgical instrument with the external magnet. 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 patientcontacting.
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.
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A usability study to validate the training program was previously conducted and submitted in support of clearance of the predicate device. None of the changes made to the training program to reflect the change in the subject Indications for Use require a repeat of the previous usability study.
- (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 the special controls stated above.
Conclusion:
The Levita Magnetic Surgical System has the same intended use and technological characteristics as the predicate device. Therefore, the Levita Magnetic Surgical System is substantially equivalent to the cleared predicate device.