LapBox Tissue Containment Removal System

K221365 · Ark Surgical, Ltd. · GCJ · Aug 25, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K221365
• Device Name: LapBox Tissue Containment Removal System
• Applicant: Ark Surgical, Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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.

Device Story

Single-use sterile tissue containment system; double-wall inflatable polyurethane chamber mounted on insertion shaft. Used in laparoscopic surgery; physician inserts shaft into abdominal cavity; deploys chamber; places organ inside; inflates chamber via external handpump; exteriorizes sleeve; attaches port to incision site; performs manual morcellation; removes port; deflates and removes chamber. Facilitates safe tissue removal; prevents potential spread of tissue during manual morcellation.

Clinical Evidence

Bench testing only. Includes biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, infrared spectroscopy), sterilization validation (ISO 11135), shelf-life, and mechanical performance (burst pressure, puncture force, bond strength, closure integrity, viral penetration per ASTM F 1671). Clinical simulation and training validation studies performed.

Technological Characteristics

Materials: TPU (polyurethane) film, nylon-reinforced fabric, polyurethane port. Principle: Inflatable chamber with handpump. Connectivity: None. Sterilization: EtO. Single-use. Mechanical: Puncture force, burst pressure, and closure integrity testing.

Indications for Use

Indicated for containment and isolation of tissue during or prior to surgical removal and/or extracorporeal manual morcellation. Contraindicated for laparoscopic power morcellation in gynecologic procedures and use with powered cutting devices (e.g., power morcellators, electrosurgical, laser instruments).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Tissue Containment System (K142427)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 [phone] stav(@ark-surgical.com

## Contact Person:

Bosmat Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: [phone] 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

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.

## 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 Removal<br>System | Tissue Containment System<br>(K142427) | Comparison to<br>Primary<br>Predicate |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reg. Number | 876.1500 | 876.1500 | Same |
| Product Code | GCJ | GCJ | Same |
| Indication for<br>Use | The LapBox Tissue Containment Removal<br>System is indicated to contain and isolate<br>tissue during, or prior to, surgical removal<br>and/or extracorporeal manual<br>morcellation.<br>Contraindications: The LapBox Tissue<br>Containment Removal System is<br>contraindicated for laparoscopic power<br>morcellation during gynecologic<br>procedures.<br>The LapBox Tissue Containment Removal<br>System is contraindicated for use with | The Applied Medical Tissue<br>Containment System is indicated to<br>contain and isolate tissue during, or<br>prior to, surgical removal and/or<br>extracorporeal manual morcellation.<br>Contraindications: The Tissue<br>Containment System is<br>contraindicated for laparoscopic<br>power morcellation during<br>gynecologic procedures.<br>The Tissue Containment System is<br>contraindicated for use with powered | Same |
| Feature | LapBox Tissue Containment Removal<br>System | Tissue Containment System<br>(K142427) | Comparison to<br>Primary<br>Predicate |
| powered cutting devices (e.g., power<br>morcellators, electrosurgical and laser<br>instruments), and when, in the judgment<br>of the physician, use of such a device<br>would be contrary to the best interest of<br>the patient. | cutting devices (e.g., power<br>morcellators, electrosurgical and laser<br>instruments), and when, in the<br>judgment of the physician, use of such<br>a device would be contrary to the best<br>interest of the patient | | |
| Principle of<br>Operation | Inserted through umbilical incision to the<br>abdominal cavity, hand pump is connected<br>and chamber is inflated, organ placed in<br>chamber, incision size is increased and<br>chamber sleeve is exteriorized, port is<br>placed, manual morcellation is performed<br>and at completion port is removed, and<br>chamber is deflated and removed. | Folded and inserted through umbilical<br>incision to the abdominal cavity,<br>organ placed in bag, bag opening is<br>exteriorized, bag rim folded until<br>organ reaches the surface and Guard is<br>placed, manual morcellation is<br>performed and at completion Guard<br>and bag are removed. | Similar; The<br>performance of<br>the LapBox<br>System was<br>evaluated via<br>bench and<br>usability<br>testing, the<br>results of which<br>support our<br>substantial<br>equivalency<br>claim |
| Chamber/bag<br>and Port/Guard<br>Materials | TPU (Polyurethane) film, Nylon<br>reinforced fabric and polyurethane port | TPU (Polyurethane) and coiled HDPE<br>port | Similar |
| Biocompatibility | The chamber was tested for Cytotoxicity,<br>Sensitization, Irritation, Acute Systemic<br>Toxicity, Pyrogenicity and Infrared<br>Spectroscopy. All tests successfully<br>passed. | Per 510(k) summary, the device was<br>tested for Cytotoxicity, Irritation and<br>Sensitization | Same |
| Single use | Yes | Yes | Same |
| Sterility | EtO | EtO | Same |
| Mechanical Properties | | | |
| Puncture Force<br>chamber/Bag | Tested against predicate | Tested against predicate | LapBox yielded<br>superior results |
| Puncture Force<br>Port/Guard | Tested against predicate | Tested against predicate | LapBox yielded<br>superior results |
| Viral<br>Penetration per<br>ASTM 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.