The LapBox Tissue Containment Removal System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.

Device Description

The LapBox Tissue Containment Removal System is a single use sterile device. It is comprised of a double wall inflatable polyurethane chamber which is mounted on an insertion shaft and is provided with two port sizes. Once the shaft is inserted to the abdominal cavity, the chamber is deployed and the organ to be morcellated is placed within the chamber. The chamber is then inflated using an external handpump and the sleeve of the chamber is exteriorized. The selected port is then placed over the sleeve in the incision site and the organ can be manually morcellated. Once morcellation is complete, the port is removed, and the chamber is deflated and removed from the patient.

AI/ML Overview

The FDA 510(k) summary for the LapBox Tissue Containment Removal System does not contain the level of detail typically found in reports of diagnostic device performance, such as sensitivity, specificity, or accuracy. This is a surgical device designed for tissue containment and removal, rather than a diagnostic AI-powered device. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.

Here's an attempt to answer the questions based on the information available in the provided text:

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

The document primarily focuses on demonstrating substantial equivalence to a predicate device through various performance tests, rather than providing specific numerical acceptance criteria and performance data for a diagnostic algorithm. The acceptance criteria described are often a "pass" or "same as predicate" for various engineering and biocompatibility tests.

Acceptance Criteria Category	Specific Test/Evaluation	Reported Device Performance (LapBox)	Comparison to Predicate (K142427)
Regulatory & Classification	Regulation Number	876.1500	Same
	Product Code	GCJ	Same
	Indications for Use	To contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation. Contraindicated for laparoscopic power morcellation during gynecologic procedures and with powered cutting devices.	Same
Biocompatibility	Cytotoxicity	Successfully passed	Same (predicate also tested)
	Sensitization	Successfully passed	Same (predicate also tested)
	Irritation	Successfully passed	Same (predicate also tested)
	Acute Systemic Toxicity	Successfully passed	Not explicitly stated for predicate in table, but overall "Same" implied for biocompatibility
	Pyrogenicity	Successfully passed	Not explicitly stated for predicate in table, but overall "Same" implied for biocompatibility
	Infrared Spectroscopy	Successfully passed	Not explicitly stated for predicate in table, but overall "Same" implied for biocompatibility
Material/Design Properties	Chamber/bag & Port/Guard Materials	TPU (Polyurethane) film, Nylon reinforced fabric and polyurethane port	Similar (Predicate: TPU and coiled HDPE port)
	Single use	Yes	Same
	Sterility	EtO	Same
	Puncture Force (chamber/Bag)	Tested against predicate, yielded superior results	Superior results for LapBox
	Puncture Force (Port/Guard)	Tested against predicate, yielded superior results	Superior results for LapBox
	Viral Penetration per ASTM F 1671	Pass	Same
Functionality (Non-Clinical Performance Testing)	Performance Characterization In-Vivo Study	Performed and successfully passed	Not explicitly in comparison table, but overall supports substantial equivalence.
	Corrosion Resistance	Performed and successfully passed	Not explicitly in comparison table, but overall supports substantial equivalence.
	Pressure Relief Valve Testing	Performed and successfully passed	Not explicitly in comparison table, but overall supports substantial equivalence.
	Burst Pressure Evaluation	Performed and successfully passed	Not explicitly in comparison table, but overall supports substantial equivalence.
	Bond Strength Test	Performed and successfully passed	Not explicitly in comparison table, but overall supports substantial equivalence.
	Dimensional Verification Test	Performed and successfully passed	Not explicitly in comparison table, but overall supports substantial equivalence.
	Closure Integrity Test: Bubble Test	Performed and successfully passed	Not explicitly in comparison table, but overall supports substantial equivalence.
	Design and Performance Validation Test	Performed and successfully passed	Not explicitly in comparison table, but overall supports substantial equivalence.
	Clinical Simulation Study	Performed and successfully passed	Not explicitly in comparison table, but overall supports substantial equivalence.
	Training Validation Study	Performed and successfully passed	Not explicitly in comparison table, but overall supports substantial equivalence.
	Maximum organ size testing	Performed and successfully passed	Not explicitly in comparison table, but overall supports substantial equivalence.

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

The document lists "Performance Characterization In-Vivo Study" and "Clinical Simulation Study" as non-clinical performance testing, but does not specify the sample size, type of data (e.g., animal, cadaveric, human), or provenance for these studies. These are likely bench or animal studies rather than human clinical trials based on the context of a 510(k) for this type of device.

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 in the document. Given the nature of the device (surgical tissue containment), "ground truth" in the diagnostic sense is not directly applicable. For performance testing, experts might have been involved in assessing the functionality or usability, but details are absent.

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

This information is not provided and is generally not applicable to the type of device and testing described in this 510(k) summary. Adjudication methods are typically relevant for human clinical reads in diagnostic studies.

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

No MRMC study was conducted or is applicable as this is not an AI-powered diagnostic device designed to assist human readers.

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

Not applicable, as this is a physical surgical device, not an algorithm.

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

For a surgical device, ground truth usually relates to the successful and safe performance of its intended function. The document mentions an "In-Vivo Study" and "Clinical Simulation Study," which would generate data on performance. However, the specific type of "ground truth" or endpoints (e.g., successful tissue containment, absence of leakage, ease of use) and how it was established are not detailed for these studies. For biocompatibility, the ground truth is typically laboratory assay results.

8. The sample size for the training set

Not applicable, as this is a physical surgical device, not an AI model requiring a training set.

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

Not applicable, as this is a physical surgical device, not an AI model.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 25, 2022

ARK Surgical, Ltd. % Bosmat Friedman Regulatory Consultant ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, North Carolina 28269

Re: K221365

Trade/Device Name: LapBox Tissue Containment Removal System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: July 29, 2022 Received: July 29, 2022

Dear Bosmat Friedman:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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,

for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

Device Name

LapBox Tissue Containment Removal System

Indications for Use (Describe)

The LapBox Tissue Containment Removal System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.

Contraindications: The LapBox Tissue Containment Removal System is contraindicated for laparoscopic power morcellation during gynecologic procedures.

The LapBox Containment Removal System is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (6/20)

Page 1 of 1

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K221365

510(K) SUMMARY [as required by section 807.92(c)] LapBox Tissue Containment Removal System 510(k) Number K221365

5.1 SUBMITTER

Applicant's Name:

ARK Surgical, Ltd. Stav Tori, CEO 13 Wadi El Hadj Nazareth, Israel +972-4-6098600 stav(@ark-surgical.com

Contact Person:

Bosmat Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: 980-308-1636 bosmat.f(@promedoss.com

Date Prepared:

July 29, 2022

5.2 DEVICE

Trade Name: LapBox Tissue Containment Removal System

Classification Code:	Device:	Laparoscope, General & Plastic Surgery
	Product Code:	GCJ
	Regulation No:	876.1500
	Class:	2
	Medical Specialty:	Gastroenterology/Urology
	Review Panel:	General & Plastic Surgery

5.3 PREDICATE DEVICE

Primary predicate device:

Tissue Containment System; 10, 14, 17, 25, manufactured by Applied Medical ● Resources, cleared under K142427; Product Code: GCJ.

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5.4 DEVICE DESCRIPTION

5.5 INDICATIONS FOR USE

The LapBox Tissue Containment Removal System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.

Contraindications: The LapBox Tissue Containment Removal System is contraindicated for laparoscopic power morcellation during gynecologic procedures. The LapBox Tissue Containment Removal System is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.

5.6 SUBSTANTIAL EQUIVALENCE

The subject and predicate devices are both single use tissue bags intended to retrieve and contain specimen during extracorporeal manual morcellation.

Feature	LapBox Tissue Containment RemovalSystem	Tissue Containment System(K142427)	Comparison toPrimaryPredicate
Reg. Number	876.1500	876.1500	Same
Product Code	GCJ	GCJ	Same
Indication forUse	The LapBox Tissue Containment RemovalSystem is indicated to contain and isolatetissue during, or prior to, surgical removaland/or extracorporeal manualmorcellation.Contraindications: The LapBox TissueContainment Removal System iscontraindicated for laparoscopic powermorcellation during gynecologicprocedures.The LapBox Tissue Containment RemovalSystem is contraindicated for use with	The Applied Medical TissueContainment System is indicated tocontain and isolate tissue during, orprior to, surgical removal and/orextracorporeal manual morcellation.Contraindications: The TissueContainment System iscontraindicated for laparoscopicpower morcellation duringgynecologic procedures.The Tissue Containment System iscontraindicated for use with powered	Same
Feature	LapBox Tissue Containment RemovalSystem	Tissue Containment System(K142427)	Comparison toPrimaryPredicate
powered cutting devices (e.g., powermorcellators, electrosurgical and laserinstruments), and when, in the judgmentof the physician, use of such a devicewould be contrary to the best interest ofthe patient.	cutting devices (e.g., powermorcellators, electrosurgical and laserinstruments), and when, in thejudgment of the physician, use of sucha device would be contrary to the bestinterest of the patient
Principle ofOperation	Inserted through umbilical incision to theabdominal cavity, hand pump is connectedand chamber is inflated, organ placed inchamber, incision size is increased andchamber sleeve is exteriorized, port isplaced, manual morcellation is performedand at completion port is removed, andchamber is deflated and removed.	Folded and inserted through umbilicalincision to the abdominal cavity,organ placed in bag, bag opening isexteriorized, bag rim folded untilorgan reaches the surface and Guard isplaced, manual morcellation isperformed and at completion Guardand bag are removed.	Similar; Theperformance ofthe LapBoxSystem wasevaluated viabench andusabilitytesting, theresults of whichsupport oursubstantialequivalencyclaim
Chamber/bagand Port/GuardMaterials	TPU (Polyurethane) film, Nylonreinforced fabric and polyurethane port	TPU (Polyurethane) and coiled HDPEport	Similar
Biocompatibility	The chamber was tested for Cytotoxicity,Sensitization, Irritation, Acute SystemicToxicity, Pyrogenicity and InfraredSpectroscopy. All tests successfullypassed.	Per 510(k) summary, the device wastested for Cytotoxicity, Irritation andSensitization	Same
Single use	Yes	Yes	Same
Sterility	EtO	EtO	Same
Mechanical Properties
Puncture Forcechamber/Bag	Tested against predicate	Tested against predicate	LapBox yieldedsuperior results
Puncture ForcePort/Guard	Tested against predicate	Tested against predicate	LapBox yieldedsuperior results
ViralPenetration perASTM F 1671	Pass	Pass	Same

The following table provides a comparison with the predicate:

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LapBox System - Section 5: 510(k) Summary

Any differences in technological characteristics do not raise different questions of safety or effectiveness.

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5.7 PERFORMANCE DATA

The following performance data is provided in support of the substantial equivalence determination.

Sterilization and Shelf-Life:

Sterilization validation was performed in accordance with ISO 11135, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. Shelf-life testing was performed to evaluate package integrity and device functionality following artificial aging and simulated transit conditioning.

Biocompatibility:

The following biocompatibility tests were performed on the LapBox Tissue Containment Removal System:

Cytotoxicity -
Sensitization -
-Irritation
-Acute Systemic Toxicity
-Pyrogenicity
-Infrared Spectroscopy

Non-Clinical Performance Testing:

The LapBox Tissue Containment Removal System has undergone and successfully passed the following tests:

Performance Characterization In-Vivo Study -
-Corrosion Resistance
-Pressure Relief Valve Testing
Burst Pressure Evaluation -
-Puncturing Force Comparative Test
Bond Strength Test -
-Dimensional Verification Test
Closure Integrity Test: Bubble Test -
Viral Penetration ASTM Method F 1671 -
-Design and Performance Validation Test
Clinical Simulation Study -
Training Validation Study -
-Maximum organ size testing

5.8 CONCLUSION

The LapBox Tissue Containment Removal System has the same indications for use as its predicate, the Tissue Containment System. The main technological difference between the LapBox Tissue Containment Removal System and the predicate have been evaluated through extensive bench testing coupled with usability testing. The company has provided sufficient comparative testing between the LapBox Tissue

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Containment Removal System and the predicate, Manual Morcellation Containment as well as additional pre-clinical bench and usability data to demonstrate our substantial equivalency claim. Consequently, it is clear that the LapBox Tissue Containment Removal System is as safe and effective as its primary predicate without raising any new safety and/or effectiveness concerns.

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.