(98 days)
Unknown
The description mentions "processing" of video feed and "tracking" of instruments and boundaries, which could potentially involve AI/ML algorithms for image analysis and object tracking. However, the summary does not explicitly state the use of AI, ML, or deep learning, nor does it provide details about training or test sets, which are common indicators of AI/ML development. Without more information, it's impossible to definitively confirm or deny the presence of AI/ML.
No
LaparoGuard is a surgical aid for visualization and tracking, which enhances the safety of laparoscopic procedures by guiding instrument placement within a defined safe zone but does not directly treat or restore a bodily function.
No
The device is described as tracking surgical instruments and safe zone boundaries for real-time overlay during surgery, and providing notifications. This is an intra-operative guidance tool, not a diagnostic device which identifies or characterizes a disease or condition.
No
The device description explicitly states that LaparoGuard processes video feed from a compatible laparoscope and displays an overlay on a compatible monitor. While LaparoGuard itself might be software, its functionality is intrinsically tied to and relies on specific hardware components (laparoscope and monitor) for both input and output. The performance studies also include system integration testing using anatomical phantoms, further indicating a reliance on hardware interaction.
Based on the provided information, LaparoGuard is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- LaparoGuard operates on real-time video feed from a laparoscope during surgery. It processes this video to track instruments and a "safe zone" within the patient's body cavity.
- Its purpose is to provide visual and auditory guidance to the surgical team during the procedure, not to analyze biological specimens.
The device description and intended use clearly indicate that LaparoGuard is a surgical guidance system that works with laparoscopic equipment to enhance safety during surgery. It does not perform any diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
LaparoGuard is indicated for use with compatible laparoscopic devices. LaparoGuard can be used in general laparoscopy wherever a laparoscope is indicated for use.
Product codes
GCJ
Device Description
LaparoGuard allows surgeons to virtually annotate a safe anatomical volume ("safe zone") inside the body cavity of a patient during a laparoscopic surgery. A compatible laparoscope, such as the ConMed IM3300 (K031098), captures video feed that is processed by LaparoGuard, which tracks surgical instruments and the safe zone boundaries to display a real-time overlay on a compatible laparoscope monitor, such as the Stryker Vision Elect 21" (K081995). Surgical teams receive visual and auditory notifications throughout the procedure whenever a tracked instrument has exited the safe zone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen
Indicated Patient Age Range
Any patients undergoing laparoscopic procedures
Intended User / Care Setting
Intended Users: General surgeons, gynecologists, plastic surgeons and urologists.
Care Setting: Surgical Suite
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)
Non-Clinical testing was conducted on the LaparoGuard system including:
- Characterization of system accuracy using an accuracy measurement phantom
- Characterization of laparoscopic image fidelity
- Characterization of system display latency
- Software verification and validation for each requirement
- System integration testing using anatomical phantoms
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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December 13, 2018
Mariner Endosurgery Inc. % Joel Ironstone President Ironstone Product Development Inc. Suite 222, 276 Carlaw Ave Toronto, M4M 3L1 Canada
Re: K182434
Trade/Device Name: LaparoGuard Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: August 31, 2018 Received: September 6, 2018
Dear Joel Ironstone:
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.
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/5 description: The image shows a digital signature from Long H. Chen. The signature includes the name Long H. Chen, followed by "-S". The date of the signature is December 13, 2018, at 08:54:03, with a time zone offset of -05'00'. The signature is indicated to be "for" something, but the specific context is not provided in the image.
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182434
Device Name LaparoGuard
Indications for Use (Describe)
LaparoGuard is indicated for use with compatible laparoscopic devices. LaparoGuard can be used in general laparoscopy wherever a laparoscope is indicated for use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Mariner Endosurgery's LaparoGuard
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Mariner Endosurgery Inc. Suite 305A, 175 Longwood Road South Hamilton, ON, Canada L8P 0A1
Phone: +1 905-921-8755 Contact Person: Mitchell Wilson
Date Prepared: August 31, 2018
Name of Device
LaparoGuard
Device Classification and Product Code
Endoscope and accessories, 21 CFR 876.1500, Class II, GCJ
Predicate Devices
Stryker Endoscopy's SDC3 HD Information Management System (K121893)
Indications for Use
LaparoGuard is indicated for use with compatible laparoscopic devices. LaparoGuard can be used in general laparoscopy wherever a laparoscope is indicated for use.
Device Description
LaparoGuard allows surgeons to virtually annotate a safe anatomical volume ("safe zone") inside the body cavity of a patient during a laparoscopic surgery. A compatible laparoscope, such as the ConMed IM3300 (K031098), captures video feed that is processed by LaparoGuard, which tracks surgical instruments and the safe zone boundaries to display a real-time overlay on a compatible laparoscope monitor, such as the Stryker Vision Elect 21" (K081995). Surgical teams receive visual and auditory notifications throughout the procedure whenever a tracked instrument has exited the safe zone. LaparoGuard consists of the components listed in the table below:
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| LaparoGuard Component | Part Number | Single Use / Reusable |
|---|---|---|
| Trackers | Type #1: C00261 | Single Use |
| Type #2: C00262 | Single Use | |
| Trackers | Type #3: C00263 | Single Use |
| Type #4: C00264 | Single Use | |
| Type #5: C00265 | Single Use | |
| Probe | C00234 | Single Use |
| Calibrator | C00233 | Single Use |
| NDI Camera | M00034 | Reusable |
| Controlling PC | X00021 | Reusable |
| Power Supply | X00026 | Reusable |
| Video Capture Box | X00022 | Reusable |
| DVI-D Bypass Cable | X00023 | Reusable |
| Support Cart | X00019 | Reusable |
Table 1 - LaparoGuard Components
Non-Clinical Testing
Non-Clinical testing was conducted on the LaparoGuard system including:
- . Characterization of system accuracy using an accuracy measurement phantom
- Characterization of laparoscopic image fidelity ●
- . Characterization of system display latency
- . Software verification and validation for each requirement
- . System integration testing using anatomical phantoms
Standards Compliance
LaparoGuard has been tested to be in compliance with the following FDA recognized standards:
- Electrical safety testing per IEC 60601-1:2005 (Third Edition) + C1:2006 + C2:2007 + ● A1:2012
- EMC per IEC 60601-1-2:2014 (4th Edition). .
- . Positional accuracy of computer assisted surgical systems, as per ASTM F2554-10
- Software validation per FDA's Guidance for the Content of Premarket Submission for Software Contained in Medical Devices (May 11, 2005)
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Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern, as failures or latent design flaws are unlikely to cause any injury to the patient or operator.
Substantial Equivalence
LaparoGuard is substantially equivalent to Stryker Endoscopy's SDC3 HD Information Management System. LaparoGuard has the same intended use as the predicate device. The differences in technological characteristics do not raise new questions of safety or effectiveness. LaparoGuard has been tested to FDA-recognized standards to demonstrate its safety and effectiveness. Thus, LaparoGuard is substantially equivalent to the predicate device. A summary of the substantial equivalence comparison is provided in the table below:
| CHARACTERISTIC | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE |
|---|---|---|---|
| Device Name | LaparoGuard | SDC3 HD Information | |
| Management System | Explorer Liver --- Passive | ||
| Tracking | |||
| Manufacturer | Mariner Endosurgery | Stryker Endoscopy | Pathfinder Therapeutics |
| 510(k) Number | - | K121893 | K101979 |
| Regulatory Class | Class II | Class II | Class II |
| Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 882.4560 |
| Product | |||
| Classification | GCJ | GCJ | OEW |
| Classification Name | Endoscope and | ||
| accessories | Endoscope and accessories | Stereotaxic instrument | |
| Intended Use | Adjunctive aid for the | ||
| monitoring of compatible | |||
| instruments during | |||
| laparoscopic surgery | Adjunctive aid for the monitoring | ||
| and control of compatible | |||
| instruments during endoscopic, | |||
| laparoscopic, or arthroscopic | |||
| procedures. Additionally, has | |||
| operating room documentation | |||
| functionality and ability to export | |||
| recorded video/images. | Adjunctive aid for monitoring of | ||
| compatible instruments during | |||
| open liver surgical procedures, | |||
| along with image-guidance using | |||
| preoperative, patient-specific | |||
| MRI or CT medical images. | |||
| Indications for Use | |||
| Statement | LaparoGuard device is | ||
| indicated for use with | |||
| compatible laparoscopic | |||
| devices. LaparoGuard can | |||
| be used in general | |||
| laparoscopy wherever a | |||
| laparoscope is indicated for | |||
| use. | The Stryker SDC3 HD | ||
| Information Management System | |||
| (SDC3) is intended for use with | |||
| compatible endoscopic and | |||
| general surgery devices. SDC3 | |||
| can be used in general | |||
| laparoscopy, | |||
| nasopharyngoscopy, ear | |||
| endoscopy, sinuscopy, and | |||
| plastic surgery wherever a | |||
| laparoscope, endoscope, or an | |||
| arthroscope is indicated for use. | The Explorer™ Liver --- Passive | ||
| Tracking device is indicated for | |||
| open liver surgical procedures | |||
| where image-guidance may be | |||
| appropriate and where the | |||
| patient can tolerate long apneic | |||
| periods under general | |||
| anesthesia. | |||
| CHARACTERISTIC | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE |
| A few examples of the more | |||
| common endoscopic surgeries | |||
| are laparoscopic | |||
| cholecystectomy, laparoscopic | |||
| hernia repair, laparoscopic | |||
| appendectomy, laparoscopic | |||
| pelvic lymph node dissection, | |||
| laparoscopically assisted | |||
| hysterectomy, laparoscopic & | |||
| thorascopic anterior spinal | |||
| fusion, anterior cruciate ligament | |||
| reconstruction, knee arthroscopy, | |||
| shoulder arthroscopy, small joint | |||
| arthroscopy, decompression | |||
| fixation, wedge resection, lung | |||
| biopsy, pleural biopsy, dorsal | |||
| sympathectomy, pleurodesis, | |||
| internal mammary artery | |||
| dissection for coronary artery | |||
| bypass, coronary artery bypass | |||
| grafting where endoscopic | |||
| visualization is indicated and | |||
| examination of the evacuated | |||
| cardiac chamber during | |||
| performance of valve | |||
| replacement. SDC3 users are | |||
| general surgeons, gynecologists, | |||
| cardiac surgeons, thoracic | |||
| surgeons, plastic surgeons, | |||
| orthopedic surgeons, ENT | |||
| surgeons, and urologists. | |||
| Environment | Surgical Suite | Surgical Suite | Surgical Suite |
| Users | General surgeons, | ||
| gynecologists, plastic | |||
| surgeons and urologists. | General surgeons, | ||
| gynecologists, cardiac surgeons, | |||
| thoracic surgeons, plastic | |||
| surgeons, | |||
| orthopedic surgeons, ENT | |||
| surgeons and urologists. | General surgeons | ||
| Patient Population | Any patients undergoing | ||
| laparoscopic procedures | Any patients undergoing | ||
| endoscopic procedures | Patients undergoing open liver | ||
| surgical procedures where | |||
| image-guidance may be | |||
| appropriate and who can tolerate | |||
| long apneic periods under | |||
| general anesthesia | |||
| Anatomical Sites | Abdomen | Whole Body (anywhere where an | Liver |
| endoscope may be used) | |||
| CHARACTERISTIC | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE |
| Procedural | |||
| Overview | Allows the surgeon to | ||
| monitor the position of | |||
| tracked compatible | |||
| instruments relative to a | |||
| virtual three-dimensional | |||
| "safe zone" and target | |||
| location established by the | |||
| surgeon at the initiation of | |||
| the procedure, using a | |||
| tracked probe. Using a | |||
| digital representation, | |||
| tracked instruments are | |||
| displayed relative to each | |||
| other and to the safe zone. | Allows the surgeon to monitor | ||
| and control the status/settings of | |||
| any compatible instrument | |||
| attached to it. | Allows the surgeon to monitor | ||
| the position of tracked | |||
| compatible instruments relative | |||
| to tumors and surrounding | |||
| anatomic structures, based on | |||
| preoperative, patient-specific | |||
| MRI or CT medical images. | |||
| Using a digital representation, | |||
| tracked instruments are | |||
| displayed relative to each other | |||
| and to the surrounding anatomy. | |||
| Electrical Safety | Compliance to IEC 60601-1 | Compliance to IEC 60601-1 | Compliance to IEC 60601-1 |
| Energy delivered or | |||
| controlled | None delivered to patient | None directly delivered to | |
| patient; however, device can | |||
| control the delivery of energy | |||
| from compatible instruments | Some laser energy delivered to | ||
| patient through the use of a | |||
| Laser Range Scanner | |||
| component | |||
| Notifications | Provide visual and auditory | ||
| notification when tracked | |||
| instruments exit the | |||
| surgeon-defined "safe | |||
| zone" | Provides visual and auditory | ||
| notification of surgeon-defined | |||
| "time outs" during which all | |||
| compatible instruments are | |||
| turned off | N/A | ||
| Display of | |||
| Monitored | |||
| Instruments | Both integrated into | ||
| laparoscopic camera video | |||
| feed output and digitally | |||
| represented on a | |||
| standalone monitor | Integrated into endoscopic | ||
| camera video feed output | Digitally represented on a | ||
| standalone monitor | |||
| Tracking | |||
| Technology | Polaris Spectra optical | ||
| position sensor | N/A | Polaris Spectra or Vicra optical | |
| position sensors | |||
| Method of Optical | |||
| Tracking | Retroreflective passively | ||
| tracked spheres (NDI | |||
| Passive Spheres - | |||
| K033621) incorporated | |||
| onto tracked adapters | N/A | Retroreflective passively tracked | |
| spheres (NDI Passive Spheres - | |||
| K033621) incorporated onto | |||
| tracked adapters | |||
| Number of Passive | |||
| Spheres per | |||
| Tracked Adapter | Four | N/A | Four |
| Compatible | |||
| Instruments | Rigid instruments only | Powered instruments | Rigid instruments only |
| Number of | |||
| Compatible | |||
| Instruments | |||
| Monitored or | |||
| Controlled at a Time | Five | Five | Five |
| Connection to | |||
| Compatible | |||
| Instruments | Passively optically tracked | ||
| adapters | Wired connection | Passively optically tracked | |
| adapters | |||
| CHARACTERISTIC | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE |
| Compatible | |||
| Instrument | |||
| Calibration | Supports calibration of an | ||
| instrument's tip position | |||
| and orientation | |||
| simultaneously | |||
| using a calibration fixture | N/A | Supports calibration of an | |
| instruments's tip position and | |||
| orientation simultaneously | |||
| using a calibration fixture | |||
| Method for User | |||
| Indication of | |||
| Targeted | |||
| Anatomical | |||
| Structures | Tracked probe | N/A | Tracked Probe |
| Patient Contacting | |||
| Components | Tracked probe | No patient contacting | |
| components | Tracked probe and tracked | ||
| abdominal reference | |||
| Biocompatibility | Biocompatible stainless | ||
| steel | N/A | Biocompatible stainless steel and | |
| other materials tested per ISO | |||
| 10993-1 | |||
| Sterility | Manufacturer-sterilized, | ||
| single use only | N/A | End-user sterilized, reusable |
Table 2 - Substantial Equivalence Comparison Table
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Conclusions
LaparoGuard has the same intended use and indications for use as its predicate device. Differences in technological characteristics do not raise new questions of safety or effectiveness. Therefore, LaparoGuard is substantially equivalent to its predicate.