(105 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a tissue containment system, with no mention of AI or ML technologies.
No.
The device's intended use is to contain and isolate tissue during or prior to surgical removal and/or extracorporeal manual morcellation, which is a supportive function during a surgical procedure, not a direct therapeutic intervention.
No
The device is described as a "Tissue Containment Removal System" for isolating and containing tissue during surgical removal or manual morcellation. Its primary function is to physically contain and remove tissue, not to diagnose a condition or disease.
No
The device description clearly outlines physical components like an inflatable polyurethane chamber, insertion shaft, ports, and an external handpump, indicating it is a hardware device.
Based on the provided information, the LapBox Tissue Containment Removal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- LapBox Function: The LapBox is a surgical device used during a surgical procedure to contain and isolate tissue within the body for removal or manual morcellation. It does not analyze or test the tissue itself to provide diagnostic information.
The description clearly outlines a physical device used for containment and removal of tissue during surgery, which falls under the category of surgical instruments or accessories, not IVDs.
N/A
Intended Use / 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 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.
Product codes
GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key results: The LapBox yielded superior results in Puncture Force chamber/Bag and Puncture Force Port/Guard compared to the predicate device. Viral Penetration per ASTM F 1671 passed for both the subject and predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
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
1
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
2
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (6/20)
Page 1 of 1
3
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.
4
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
System | Tissue Containment System
(K142427) | Comparison to
Primary
Predicate |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reg. Number | 876.1500 | 876.1500 | Same |
| Product Code | GCJ | GCJ | Same |
| Indication 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 | The Applied Medical Tissue
Containment System is indicated to
contain and isolate tissue during, or
prior to, surgical removal and/or
extracorporeal manual morcellation.
Contraindications: The Tissue
Containment System is
contraindicated for laparoscopic
power morcellation during
gynecologic procedures.
The Tissue Containment System is
contraindicated for use with powered | Same |
| Feature | LapBox Tissue Containment Removal
System | Tissue Containment System
(K142427) | Comparison to
Primary
Predicate |
| 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. | 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 | | |
| Principle of
Operation | Inserted through umbilical incision to the
abdominal cavity, hand pump is connected
and chamber is inflated, organ placed in
chamber, incision size is increased and
chamber sleeve is exteriorized, port is
placed, manual morcellation is performed
and at completion port is removed, and
chamber is deflated and removed. | Folded and inserted through umbilical
incision to the abdominal cavity,
organ placed in bag, bag opening is
exteriorized, bag rim folded until
organ reaches the surface and Guard is
placed, manual morcellation is
performed and at completion Guard
and bag are removed. | Similar; The
performance of
the LapBox
System was
evaluated via
bench and
usability
testing, the
results of which
support our
substantial
equivalency
claim |
| Chamber/bag
and Port/Guard
Materials | TPU (Polyurethane) film, Nylon
reinforced fabric and polyurethane port | TPU (Polyurethane) and coiled HDPE
port | Similar |
| Biocompatibility | The chamber was tested for Cytotoxicity,
Sensitization, Irritation, Acute Systemic
Toxicity, Pyrogenicity and Infrared
Spectroscopy. All tests successfully
passed. | Per 510(k) summary, the device was
tested for Cytotoxicity, Irritation and
Sensitization | Same |
| Single use | Yes | Yes | Same |
| Sterility | EtO | EtO | Same |
| Mechanical Properties | | | |
| Puncture Force
chamber/Bag | Tested against predicate | Tested against predicate | LapBox yielded
superior results |
| Puncture Force
Port/Guard | Tested against predicate | Tested against predicate | LapBox yielded
superior results |
| Viral
Penetration per
ASTM F 1671 | Pass | Pass | Same |
The following table provides a comparison with the predicate:
5
LapBox System - Section 5: 510(k) Summary
Any differences in technological characteristics do not raise different questions of safety or effectiveness.
6
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
7
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.