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.

AI/ML Overview

The provided text describes the LaparoGuard device and its substantial equivalence to a predicate device, focusing on non-clinical testing and software validation. However, it does not include detailed information regarding clinical study results, acceptance criteria for performance metrics (like sensitivity, specificity, accuracy), or specifics about a test set and its ground truth establishment involving experts.

Therefore, I cannot populate the table or answer questions 2-9 from the provided input, as that information is not present.

Here's what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document mentions non-clinical testing, but does not provide specific acceptance criteria or reported performance values for metrics typically found in clinical studies (e.g., accuracy, sensitivity, specificity, etc. related to its primary function of "safe zone" monitoring). It does state adherence to standards for accuracy, but not the specific thresholds or measured performance of the device against those thresholds.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document mentions "system integration testing using anatomical phantoms" but does not detail a clinical test set with human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC study or AI assistance to human readers. The device is purely a monitoring system providing visual and auditory notifications.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a "standalone" system in its monitoring function, providing alerts to the surgeon. The "system accuracy using an accuracy measurement phantom" and "system integration testing using anatomical phantoms" could be considered standalone performance tests in a controlled environment, but detailed results and specific metrics are not given.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing mentioned (accuracy measurement phantom, anatomical phantoms), the ground truth would be based on the known, precisely defined physical properties of these phantoms. No mention of expert consensus, pathology, or outcomes data is made for establishing ground truth for any performance claims.

8. The sample size for the training set

This information is not provided. The document focuses on verification and validation of the software and system, not on a machine learning model's training set.

9. How the ground truth for the training set was established

This information is not provided.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA acronym and the words "U.S. FOOD & DRUG ADMINISTRATION" are in blue.

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

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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 InformationManagement System	Explorer Liver --- PassiveTracking
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
ProductClassification	GCJ	GCJ	OEW
Classification Name	Endoscope andaccessories	Endoscope and accessories	Stereotaxic instrument
Intended Use	Adjunctive aid for themonitoring of compatibleinstruments duringlaparoscopic surgery	Adjunctive aid for the monitoringand control of compatibleinstruments during endoscopic,laparoscopic, or arthroscopicprocedures. Additionally, hasoperating room documentationfunctionality and ability to exportrecorded video/images.	Adjunctive aid for monitoring ofcompatible instruments duringopen liver surgical procedures,along with image-guidance usingpreoperative, patient-specificMRI or CT medical images.
Indications for UseStatement	LaparoGuard device isindicated for use withcompatible laparoscopicdevices. LaparoGuard canbe used in generallaparoscopy wherever alaparoscope is indicated foruse.	The Stryker SDC3 HDInformation Management System(SDC3) is intended for use withcompatible endoscopic andgeneral surgery devices. SDC3can be used in generallaparoscopy,nasopharyngoscopy, earendoscopy, sinuscopy, andplastic surgery wherever alaparoscope, endoscope, or anarthroscope is indicated for use.	The Explorer™ Liver --- PassiveTracking device is indicated foropen liver surgical procedureswhere image-guidance may beappropriate and where thepatient can tolerate long apneicperiods under generalanesthesia.
CHARACTERISTIC	SUBJECT DEVICE	PREDICATE DEVICE	REFERENCE DEVICE
		A few examples of the morecommon endoscopic surgeriesare laparoscopiccholecystectomy, laparoscopichernia repair, laparoscopicappendectomy, laparoscopicpelvic lymph node dissection,laparoscopically assistedhysterectomy, laparoscopic &thorascopic anterior spinalfusion, anterior cruciate ligamentreconstruction, knee arthroscopy,shoulder arthroscopy, small jointarthroscopy, decompressionfixation, wedge resection, lungbiopsy, pleural biopsy, dorsalsympathectomy, pleurodesis,internal mammary arterydissection for coronary arterybypass, coronary artery bypassgrafting where endoscopicvisualization is indicated andexamination of the evacuatedcardiac chamber duringperformance of valvereplacement. SDC3 users aregeneral surgeons, gynecologists,cardiac surgeons, thoracicsurgeons, plastic surgeons,orthopedic surgeons, ENTsurgeons, and urologists.
Environment	Surgical Suite	Surgical Suite	Surgical Suite
Users	General surgeons,gynecologists, plasticsurgeons and urologists.	General surgeons,gynecologists, cardiac surgeons,thoracic surgeons, plasticsurgeons,orthopedic surgeons, ENTsurgeons and urologists.	General surgeons
Patient Population	Any patients undergoinglaparoscopic procedures	Any patients undergoingendoscopic procedures	Patients undergoing open liversurgical procedures whereimage-guidance may beappropriate and who can toleratelong apneic periods undergeneral anesthesia
Anatomical Sites	Abdomen	Whole Body (anywhere where an	Liver
		endoscope may be used)
CHARACTERISTIC	SUBJECT DEVICE	PREDICATE DEVICE	REFERENCE DEVICE
ProceduralOverview	Allows the surgeon tomonitor the position oftracked compatibleinstruments relative to avirtual three-dimensional"safe zone" and targetlocation established by thesurgeon at the initiation ofthe procedure, using atracked probe. Using adigital representation,tracked instruments aredisplayed relative to eachother and to the safe zone.	Allows the surgeon to monitorand control the status/settings ofany compatible instrumentattached to it.	Allows the surgeon to monitorthe position of trackedcompatible instruments relativeto tumors and surroundinganatomic structures, based onpreoperative, patient-specificMRI or CT medical images.Using a digital representation,tracked instruments aredisplayed relative to each otherand to the surrounding anatomy.
Electrical Safety	Compliance to IEC 60601-1	Compliance to IEC 60601-1	Compliance to IEC 60601-1
Energy delivered orcontrolled	None delivered to patient	None directly delivered topatient; however, device cancontrol the delivery of energyfrom compatible instruments	Some laser energy delivered topatient through the use of aLaser Range Scannercomponent
Notifications	Provide visual and auditorynotification when trackedinstruments exit thesurgeon-defined "safezone"	Provides visual and auditorynotification of surgeon-defined"time outs" during which allcompatible instruments areturned off	N/A
Display ofMonitoredInstruments	Both integrated intolaparoscopic camera videofeed output and digitallyrepresented on astandalone monitor	Integrated into endoscopiccamera video feed output	Digitally represented on astandalone monitor
TrackingTechnology	Polaris Spectra opticalposition sensor	N/A	Polaris Spectra or Vicra opticalposition sensors
Method of OpticalTracking	Retroreflective passivelytracked spheres (NDIPassive Spheres -K033621) incorporatedonto tracked adapters	N/A	Retroreflective passively trackedspheres (NDI Passive Spheres -K033621) incorporated ontotracked adapters
Number of PassiveSpheres perTracked Adapter	Four	N/A	Four
CompatibleInstruments	Rigid instruments only	Powered instruments	Rigid instruments only
Number ofCompatibleInstrumentsMonitored orControlled at a Time	Five	Five	Five
Connection toCompatibleInstruments	Passively optically trackedadapters	Wired connection	Passively optically trackedadapters
CHARACTERISTIC	SUBJECT DEVICE	PREDICATE DEVICE	REFERENCE DEVICE
CompatibleInstrumentCalibration	Supports calibration of aninstrument's tip positionand orientationsimultaneouslyusing a calibration fixture	N/A	Supports calibration of aninstruments's tip position andorientation simultaneouslyusing a calibration fixture
Method for UserIndication ofTargetedAnatomicalStructures	Tracked probe	N/A	Tracked Probe
Patient ContactingComponents	Tracked probe	No patient contactingcomponents	Tracked probe and trackedabdominal reference
Biocompatibility	Biocompatible stainlesssteel	N/A	Biocompatible stainless steel andother materials tested per ISO10993-1
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.

Regulation Number and Section

§ 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.